chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Venous thrombosis
Clinical narrative: Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf pain 2 daysafter that. Was diagnosed with DVT via Doppler ultrasound on Monday, March 8, 2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anorectal discomfort, Proctalgia
Clinical narrative: Pressure in rectal area which escalated to pain; Pressure in rectal area which escalated to pain; This is a spontaneous report from a contactable consumer (the patient). A 65-year-old male patient received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 18Feb2021 13:00 (at the age of 65-year-old) as single dose for COVID-19 immunization. The patient did not have any medical history, any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 17:30, the patient experienced pressure in rectal area which escalated to pain. No treatment was received for the adverse events. The clinical outcome of the pressure in rectal area which escalated to pain was resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: Patient received Covid Vaccine (Moderna)  at  at 13:44. At 14:00, patient states "I'm having trouble swallowing." Dr  assessed the patient, orders given to call EMS. EMS called at 1400. Patient is spanish-speaking, and Dr. speaking spanish, no interpreter needed. Patient is AxO3, able to speak in full sentences, ambulatory, and able to take sips of water and swallow own secretions. Vitals taken, BP 145/97, HR 99, SpO2 100%, RR 20.  and  EMS arrived at 1405 . Patient's husband called from parking lot to patient's side, and informed of plan of care. Endorsed care to  EMS by Dr. . Patient sent to emergency department via ambulance at 14:15.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever,  chills,  body aches, headache
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Muscle tightness, Pain
Clinical narrative: Jaw tightness, chills, achiness, lymphatic pain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity, Peripheral swelling, Pruritus, Swelling
Clinical narrative: Large swollen circle on arm showing up 12 days post first dose. Soreness, itching, swelling. Also shortness of breath.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: About 2 hours after the injection, my right ear started ringing loudly.  At 5:00 it's abating somewhat.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient arrived at the clinic for their second dose. They received an initial dose of Pfizer on 2/26/2021. The received a second dose of Moderna 3/19/2021. Per CDC guidance, In exceptional situations in which the vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. This patient received the 2nd dose at 21 days. Patient was reached at 5:07pm. She denied any adverse affects and agreed to seek medical attention if she experienced an shortness of brealth, fast heart beat, full body rash, or dizziness.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain
Clinical narrative: Patient called Thursday around 2 pm and asked if it was normal to hurt all over.  I told her muscle pain could be an adverse effect.  The patient then said she felt that her blood pressure was up and felt as though a mack truck was on her chest.  I instructed her to go to the ER.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: SWOLLEN GLAND UNDER THE ARM PIT ON THE RIGHT SIDE A LOT, AND LESSER AMOUNT IN THE LEFT SIDE
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Nausea, Pyrexia
Clinical narrative: Brain Fog; Chills; Fever; Nausea; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 18Feb2021 15:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ivermectin (SOOLANTRA) and minocycline, both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 on 28Jan2021 (at the age of 31-years-old) in the right arm at 15:30 for COVID-19 immunisation. On 19Feb2021 at 03:00, after the second vaccination, the patient experienced brain fog, chills, fever, nausea, and headache. The patient did not receive any treatment for the events. The clinical outcomes of the brain fog, chills, fever, nausea, and headache were recovering.    No follow up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Skin warm
Clinical narrative: 9 days post initial injection a bulls-eye, hot, non-pruritic rash appeared. The rash coalesced and became slightly itchy and remained warm for several days. Nothing was done to abate symptoms.  Photo was sent to healthcare provider.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: large left supraclavicular lymphadenopathy
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable other health care professional (patient). A 71-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9262), via an unspecified route of administration on 30Jan2021; 9.30, on right arm, at single dose for covid-19 immunisation. The patient's medical history included ME (myalgic encephalomyelitis) and CFS (Chronic fatigue syndrome). Concomitant medication included Levoxyl and Restasis. On 15Feb2021; 20.00, patient experienced on day 16 after the first dose developed what patient thought were hives. Today, after patient second dose, it was diagnosed on telehealth as shingles. The outcome of the event was recovering.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: shingles; This is a spontaneous report from a contactable other health care professional (patient). A 71-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9262), via an unspecified route of administration on 30Jan2021; 9.30, on right arm, at single dose for covid-19 immunisation. The patient's medical history included ME (myalgic encephalomyelitis) and CFS (Chronic fatigue syndrome). Concomitant medication included Levoxyl and Restasis. On 15Feb2021; 20.00, patient experienced on day 16 after the first dose developed what patient thought were hives. Today, after patient second dose, it was diagnosed on telehealth as shingles. The outcome of the event was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swollen upper lip; This is a spontaneous report from a contactable consumer (patient). This 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered in right arm as a single dose on 29Jan2021 02:00 PM (lot number: EL3247; age at vaccination 58 years old) and then the second dose administered in right arm as a single dose on 19Feb2021 12.00 PM (lot number: EL3247; age at vaccination 58 years old) for COVID-19 immunization. The most recent COVID-19 vaccine was administered at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 before vaccination and not tested for it since.Patient received initial dose on 29Jan2021 02:00 PM. He reported a swollen upper lip four days after the initial dose. Patient received second dose on 19Feb2021 at 12:00 PM. Patient stated "tonight" he got a swollen upper lip about 30 hours after the vaccine. Start date was provided as 20Feb2021 at 07:00 PM. No treatment was given. The patient assessed the event as not serious and there was no hospitalization. The clinical outcome of swollen upper lip was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of multiple left supraclavicular lymph nodes for 46 days; This is a spontaneous report from a contactable other hcp reporting for herself.     A 35-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Dec2020 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation  .  Medical history included gastrooesophageal reflux disease . Concomitant medication included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced swelling of multiple left supraclavicular lymph nodes for 46 days  on 30Dec2020 with outcome of not recovered.  Follow up information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a non-contactable consumer (patient) via a sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient wanted to know if the second dose of Covid vaccine can be received dose if she had a UTI and take Macrobid that developed after first dose on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Feels 20 years younger. She can stay on her treadmill longer; This is a spontaneous report from a non-contactable consumer (patient) via a sponsored program. A 72-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient wanted to compliment the COVID-19 vaccine and stated, "Got second shot. Feels good. Feels 20 years younger. She can stay on her treadmill longer. It is a relief to see family again." The outcome of the event was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Retching
Clinical narrative: chills; fever; dry heaves; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Jan2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient experienced chills, fever, and dry heaves. It was also reported that the next dose was 19Feb2021, 7 days past the recommended 21. The patient wanted to know if she will have the same reaction with the second dose and wondering if she can take Tylenol before the dose. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer via the sponsored program. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On 13Feb2021, the patient experienced shingles with outcome of unknown.    Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: 24 hours after, started getting tingling in left jaw, left side of neck, left shoulder and left arm; It has been mild but it has been continual; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 09Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose last Tuesday, 09Feb2021, in a local hospital where he lives. It was reported that after the first shot, he had no side effects. On the second shot, he was told possibly, he might have side effects, maybe like a mild flu or aching at the injection site. He did not have that, but about 24 hours after the shot and to the next week, up until the day of the report, he started getting tingling in the left jaw, left side of the neck, left shoulder and left arm - it has been mild but continual. The shot was in the left arm and 24 hours after, he started getting tingling in his left jaw, the left side of his neck, his left shoulder and his left arm. He kept getting that tingling feeling. He went on every website he could find, looking for what side effects were and nowhere that he sees anybody saying anything about the tingling on the left side of the face, jaw, neck, shoulder and arm, the side where he got the injection. He did about 3 days ago, he was turning on the news and caught just the last few seconds of a report, he thinks was talking about this. All he heard was something about tingling in the face means that the vaccine is working and then they went on to something else. I did not get the whole story and again nowhere has there been any report of this as a side effect. The patient had a light tingling, but it has been continual up until the day of the report, and that day, it is just about fading away and that day is day 8 and it started 24 hours after he got the shot. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Insomnia
Clinical narrative: Could not sleep good; difficulty in breathing; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Last night, 16Feb2021, the patient could not sleep good because of difficulty in breathing and having a fast heartbeat. The patient mentioned having had the COVID-19 vaccine and does not know if these were side effects but, he/she could not sleep last night. The patient wanted to know what he/she could do. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Breaking out with a rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 23Jan2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she took the Pfizer vaccination. She took that last Friday and all of the sudden she noticed that she was breaking out with a rash (2021). She asked if it was possibly being from that. She asked a question, she received her first Pfizer vaccine on 23Jan2021, they said to come back on 13th, she could not make that appointment on 13th (further clarification was unknown, hence split was not made), she asked how can she get her second. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: His arm was puffy and swollen; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got a shot (vaccine) on 16Feb2021 in the morning. He woke up on morning of 17Feb2021 and his arm was puffy and swollen. The reporter wanted to know if this is one of the side effects as she did not see that on the sheet. The outcome of the event was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Painful Headache; Arm where I received the vaccine is still sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (COVID-19 Vaccine, lot number: EL9264), via an unspecified route of administration, administered in upper left arm on 09Feb2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. Medical history was none. Concomitant medication included vitamins (unspecified). The patient called to report that with the second shot, she experienced painful headache for 6 day no its more than 6 days and everyday she woke up with a horrible headache and this never happened before so she was assuming its because of that shot. She still has it and have been up already for four hours and already took two Tylenol (treatment). Also, her arm where she received the vaccine was still sore. The events occured on 09Feb2021. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Eye colour change, Rash
Clinical narrative: I had a heavy rash above my cheeks; My eyes turned black and blue; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient's eyes turned black and blue and patient had a heavy rash above the cheeks after vaccination on an unspecified date.The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: has not had the cycle/started to spot a little bit; This is a spontaneous report from a contactable consumer (patient's husband).   A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter stated his wife (patient) got the COVID-19 vaccine, has not had her period and they started getting little worried if she should go to the doctor. She never had this problem before. They were just wondering is this common with the side effects or anything like that. When paraphrased the concern, reporter stated, the patient  has not had the cycle in mid. She has started to spot a little bit, that is it. So they have been worried. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; I woke up dizzy this morning; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9810), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness which patient never really had before.Patient wants to know if it can affect  4 days later. Patient woke up dizzy this morning and that's it. The shot had an effect four days later. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right upper arm on an unspecified date (batch/lot number: EN6201) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included omeprazole (PRILOSEC, 20 mg capsule) taken for an unspecified indication, start and stop date were not reported. The patient stated, "I got the Pfizer shot and I got the hives from it on 12Feb2021 and they just told me to call you and tell you and report it." The patient stated it's the first dose Pfizer BioNTech it's all the patient knows. The patient was still having the hives, it was still persisting, the patient got some medicine to take it away. Therapeutic measures were taken as a result of hives which included prednisone, 50 mg. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Therapeutic response unexpected, Weight
Clinical narrative: drowsiness; reduction in the chronic mucus phlegm in his air passageways; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 15Feb2021 as a single dose for COVID-19 immunization. Relevant medical history included chronic congestion, which he had for many years; hard of hearing; and he was about 10 pounds overweight (he had weight of 219; further reported that he was good, but during this COVID stuff, all he did was to eat the whole day), from an unknown date and unknown if ongoing. Concomitant medications included fluticasone propionate (FLONASE, the cortisone nasal inhaler) and formoterol fumarate, mometasone furoate (DULERA, a Merck product); both taken for his mucus and congestion, start and stop date were not reported. The reporter got some good news about the Pfizer COVID-19 vaccine shot and it was very positive. The patient received the shot actually about 49 hours prior reporting (on 15Feb2021) and within that 30 plus hours, he noticed a reduction in the chronic mucus phlegm in his air passageways. The patient had chronic congestion for many years and this was a congestion, for which he was on his other regimen, Flonase and Dulera. The patient wanted to report that this was a very positive thing as it really helped reduce his mucus in conjunction with ingesting of the other 2 drugs (Flonase and Dulera) that he was taking. The patient had no adverse side effects other than drowsiness from taking the shot on an unspecified date. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Migraine, Nausea
Clinical narrative: Migraine; Nausea; joint pain/specifically in a joint that had a previous injury (not all joints).; This is a spontaneous report from a contactable consumer, the patient A 29-years-old non-pregnant female patient  received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 16Feb2021 at 13:15 (at the age of 29-years-old) as a single dose, for COVID-19 immunisation.  Medical history included Osteoarthritis of the knee due to an injury,  Known allergies to cats.   No  concomitant medications.  Historical Vaccination includes BNT162B2 Dose 1,  lot number=EL3247, administration date=26Jan2021 at 13:15  in the left arm for COVID 19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 03:00, The patient experienced Migraine, nausea, and joint pain specifically in a joint that had a previous injury (not all joints). No treatment was given for the events. The clinical outcome of the events migraine, nausea and  joint pain was recovering. :
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: extremely tired; chills; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9262) via an unspecified route of administration, administered on the right arm on 08Feb2021 12:00 at a single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient was vaccinated at 12 noon and felt fine thru Tues. On 10Feb2021 1:00 PM , the patient felt extremely tired and had the chills. Lasted thru the night and on Thurs. am all gone. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovered on 11Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash under both breasts; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine), via an unspecified route of administration on 13Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. This patient got the shot of Pfizer COVID-19 vaccine last Saturday, 13Feb2021. Last night, 17Feb2021, she noticed she had a rash under both breasts. She asked for recommendations on treating the rash, like if she should get something like Benzidine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Abdominal pain; diarrhoea; This is a spontaneous report from a non-contactable other health care professional. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 and dose 2; via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Abdominal pain and diarrhoea one day after receiving vaccine. This happened after each dose. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This is a spontaneous report from a contactable consumer (patient's niece). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 29Jan2021, at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's niece stated that the patient got the first Covid vaccine on 29Jan2021 and the patient was having fever and headache today, 18Feb2021. The niece wanted to know if the patient was having a reaction or if it could be Covid. The outcome of the events was unknown.  Information about the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive after the first dose; tested positive after the first dose; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose on 25Jan2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Caller was calling for her parents who tested positive after the first dose. Their first dose was last 25Jan. Caller was asking if they could take the second dose after they tested positive or they had to wait for a certain time before getting the second dose. COVID-19 test was positive on an unspecified date. The outcome of events was unknown.  The information about lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021209407 the same reporter, product and adverse events in different patients
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided.  After 1st dose had tested positive for covid. Outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he is currently COVID-19 positive after completing our vaccination series; he is currently COVID-19 positive after completing our vaccination series; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Not reported, Expiration date: Not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he is currently covid-19 positive after completing vaccination series on an unspecified date. The patient underwent COVID-19 (Nasal Swab) test on an unknown date which was positive. The outcome of event was unknown.  Information about Lot/Batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia
Clinical narrative: Insomnia; Chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. This 77-year-old male reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En5318) via an unspecified route of administration in the left arm on 05Feb2021 at 02:30 (as reported) (at the age of 77-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were not specified. The patient experienced insomnia onset at day 8 then thru day 14 and chills day 10. The patient was not treated for insomnia and chills. The clinical outcome of insomnia and chills was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: low grade fever; fatigue; headache; This is a spontaneous report from a contactable other healthcare professional. A patient with unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 20Feb2021, the patient experienced low grade fever, fatigue, and headache with the second dose of the vaccine. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: nausea; severe vertigo; This is a spontaneous report from a contactable consumer, the patient via a Pfizer sales representative. A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date 11 days post vaccination first dose, the patient experienced severe vertigo for 3 days with nausea. The outcome of events, severe vertigo and nausea was unknown.   The lot number for vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021211715 second dose
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: gout flare; This is a spontaneous report from a sponsored program. A contactable male consumer of unspecified age, the patient, reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Nine days after the first dose, the patient experienced gout flare. The outcome of gout flare was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: back spasms; This is a spontaneous report from a sponsored program a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced back spasms. The clinical outcome of the back spasms was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Vertigo
Clinical narrative: complete loss of hearing in left ear; vertigo; This is a spontaneous report from a contactable consumer (the patient).  A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 10Feb2021 (at the age of 72 years) (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation.  The patient previously took the first dose of bnt162b2, Lot number=EN3249, on 20Jan2021 at 13:00 (at the age of 72 years), in left arm for covid-19 immunisation. Vaccination was administered at Doctor's office. Medical history included high cholesterol, blood pressure increased, hypothyroidism, allergy to egg, spices, and ace inhibitors, all from an unknown date and unknown if ongoing. The patient received unspecified other medications administered in two weeks. No other vaccine administered in four weeks. No covid prior vaccination. Covid was not tested post vaccination. On 15Feb2021 at 14:30 the patient experienced complete loss of hearing in left ear and vertigo. The events required emergency room visit. Therapeutic measures taken as a result of the events included anti-nausea medications and medication for dizziness. The outcome of the events was not recovered.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre; This spontaneous case was received on 03-Mar-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-00884) with additional information (being processed together) received on the same day, and concerned a female patient od unspecified age.  The patient's medical history and concomitant medications were not reported.   On 25-Oct-2016, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number reported was 169305, expiration date: 03-Jun-2017.  On the same day, after receiving influenza virus vaccine polyvalent, the patient got Guillain-Barre.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The event of 'Guillain-Barre syndrome' was considered to be medically significant by a Physician.  Company comment: A female patient od unspecified age was vaccinated with influenza virus vaccine polyvalent. On the same day, after receiving influenza virus vaccine polyvalent, the patient got Guillain-Barre. Causal role of the suspect vaccine is assessed as not related, due to implausible chronology.; Sender's Comments: A female patient od unspecified age was vaccinated with influenza virus vaccine polyvalent. On the same day, after receiving influenza virus vaccine polyvalent, the patient got Guillain-Barre. Causal role of the suspect vaccine is assessed as not related, due to implausible chronology.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea
Clinical narrative: chills and shortness of breath
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No known reaction at this time.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: I have muscle pain on my left side, especially my leg. Frequent chills, and a headache on the left side
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Recently hospitalized for leg fracture.  Current hospital policy is to administer Janssen COVID vaccine at time of discharge to those giving consent.  Report received from interested party that individual had received and completed the Moderna COVID vaccine series an indeterminate time earlier.  No record of adverse event noted, though communication with interested family member is still pending.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Myalgia, Pain
Clinical narrative: about 15 hours post-shot, felt achey.  For the next 8 hours I had muscle and joint aches. I felt relief when I slept, therefore I was in bed all day resting. My head was a bit foggy, I couldn?t do too much. I took an advil in the afternoon, and I was fine by the evening.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: My arm was red, itchy and swollen to the size of a golf ball for a few days. Then the swelling went down to the size of a grape, and now since 3/15/21 it's swollen and itchy again, but with light redness.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Paraesthesia
Clinical narrative: Mild adverse effects.   Still experiencing.  Low grade fever (102.4), headache, weakness, aching/tingling joints, lightheadedness, very sleepy
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Mild adverse effects.   Still experiencing.  Low grade fever (102.4), headache, weakness, aching/tingling joints, lightheadedness, very sleepy
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram abnormal, Fatigue
Clinical narrative: Patient developed chest pain, shortness of breath, and fatigue approximately 10 days after receiving 2nd dose of Moderna vaccine. Patient describes symptom onset as acute, and came to hospital 2 days after chest pain developed, as it became more unbearable. Described chest pain as worse with leaning forward.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis, Troponin increased, Ventricular hypokinesia
Clinical narrative: Patient developed chest pain, shortness of breath, and fatigue approximately 10 days after receiving 2nd dose of Moderna vaccine. Patient describes symptom onset as acute, and came to hospital 2 days after chest pain developed, as it became more unbearable. Described chest pain as worse with leaning forward.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Cough, Electrocardiogram, Erythema
Clinical narrative: Severe pain/ pressure in temples,eyes,back of the head. Blood pressure spike,red on chest, heaviness in chest and bile in throat, coughing, shallow breathing. Pain in temples tarted 5min after shot chest issues 25 mins later. Paramedics, ekg, iv, shot to bring down pressure, Benadryl in iv. Hospital 60mg of Prednisone and 20 mg Benadryl and kept me for observation.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Hypopnoea
Clinical narrative: Severe pain/ pressure in temples,eyes,back of the head. Blood pressure spike,red on chest, heaviness in chest and bile in throat, coughing, shallow breathing. Pain in temples tarted 5min after shot chest issues 25 mins later. Paramedics, ekg, iv, shot to bring down pressure, Benadryl in iv. Hospital 60mg of Prednisone and 20 mg Benadryl and kept me for observation.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Tachycardia, Tremor
Clinical narrative: Tachycardia (124), lightheaded, tremulous, dysphagia. Premedicated with Allegra 180mg  PO(9.45am). Pepcid 20mg  PO(1.30pm)., Tylenol 1g  PO (1.56pm). Observation for 1hr,  HR reduced to 92. Able to drink and swallow meds.  HA & lightheadedness resolved and mild dysphagia, HR 82 at 3.13pm.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient c/o "numbness et tingling" to lower extremeties. States she does not feel SOB at this time, states she has own EPI pen but has not given herself a dose. Nurse evaluated said person, noting HR is tachy, lungs clear et person states "I can breathe" Person then states, "My lips feel a little numb." Person asked for a bottle of water. Nurse asked the person is she felt she needed Benadryl or possibly an ambulance. Person  stated, "If you tell me how to get to the ER, I will go there and get checked out." Nurse led person to ER where she states she no longer needed nurse's services.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Moderna COVID?19 Vaccine EUA: Hives on both arms, hips and legs 1 week after 1st dosage
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu-like full-body muscle aches, headaches, fatigue, chilling
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache, fever, achy, nauseous
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriosclerosis, Death
Clinical narrative: Patient died approx. 5 hours after shot was administered. Cause of death reported is Atherosclerotic Cardiovascular Disease. The death certificate was signed by the county coroner without autopsy, based on the report by the onsite deputy coroner. No doctors or hospitals were involved. This report is FYI only; there has been no direct connection made between my mother's death and the  vaccine other than one followed shorty after the other.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Oral discomfort, Paraesthesia oral, Pruritus, Rash macular
Clinical narrative: 1st day of symptoms.  Hands started itching.  Felt like I had placed my hands in scalding hot water.  Slightly red blotchy look to palms of hands.  2nd day I have additional Symptoms, I woke up with strange feeling in my mouth.  Feels like i drank scolding hot drink.  Mouth is also Tingly feeling,   I am definitely having some kind of allergic reaction i-week after the Covid vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Moderna COVID-19 Vaccine EUA
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hyperhidrosis
Clinical narrative: chills and sweats, tightness of breath for two days
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Caesarean section, Exposure during pregnancy, Foetal biophysical profile score abnormal, Premature delivery, Ultrasound antenatal screen
Clinical narrative: Pregnancy with EDC of 5/7/2021.  On 3/17/2021 infant was not moving as expected, went to hospital and emergency c-section performed due to failure of BPP score.  Score was 2.  Infant delivered @ 32 week.  Wt. was 4#4 oz.  Infant had blood in urine.  After numerous studies my baby was found to have thrombosis in the intrahepatic IVC.  Treatment has started.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling hot, Gait inability, Nervousness
Clinical narrative: Within 5 minutes I became very light headed and weak.  Also very hot and shaky. They had to put me into another room that was much cooler and put me into a recliner with feet up, ice behind my neck and on my forehead. I was pushing water so it was not dehydration, and I had eaten my normal healty breakfast also so not low blood sugar. This was my second shot and I had the same reaction with the first shot. It took about an hour before I could stand and walk again, but was still a bit shaky and faintly light headed for about another hour.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Within 5 minutes I became very light headed and weak.  Also very hot and shaky. They had to put me into another room that was much cooler and put me into a recliner with feet up, ice behind my neck and on my forehead. I was pushing water so it was not dehydration, and I had eaten my normal healty breakfast also so not low blood sugar. This was my second shot and I had the same reaction with the first shot. It took about an hour before I could stand and walk again, but was still a bit shaky and faintly light headed for about another hour.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Seven (7) days after receipt of first vaccination shot, the site of injection became itchy and there appeared a raised knot approximately the size of a baseball. The raised knot was tender to touch. I visited the clinic to alert the nurse of my reaction. I was told to take benadryl. I took one benadryl  per day on both Tuesday, March 16 - Wednesday, March 17.  By Thursday, March 18, 2021, I did not experience anymore itching and the raised knot was no longer present. I am no longer taking benadryl.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Flushing
Clinical narrative: Pt reported mild sob, lightheadedness, flushed, elevated BP
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pain, Swelling
Clinical narrative: Swelling and soreness  8 days after injection.  Lasted 24 hours. Redness and slight itch at site starting day 10. Lasted 24 hours.