chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: kidney pain; This is a spontaneous report from a contactable consumer (patient). The 44-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 16:30 (Batch/Lot number was not reported) as SINGLE DOSE and dose 2 via an unspecified route of administration on an unknown date as Single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included calcium carbonate (CALCIUM AL); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); melatonin; ascorbic acid, biotin, calcium pantothenate, cellulose microcrystalline, copper sulfate, folic acid, magnesium stearate, nicotinamide, pyridoxine hydrochloride, riboflavin, silicon dioxide, thiamine disulfide, vitamin b12 nos, vitamin e nos, zinc oxide (CENTRUM B). 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. The patient experienced kidney pain on 01Apr2021 05:00. Reported as: Seems to be kidney pain. I never had any kidney problems. The pain started on the second day and continued for 5 days.The same happened after the second dose. I never looked for a doctor, but took pain medicine and got better on day 6 after the medicine,The same is happening after the second dose. The event was reported as serious with seriousness criteria Congenital anomaly. Since the vaccination, the patient has not been tested for COVID-19. No treatment received (pending clarification). The outcome of the event was recovered.  Follow-ups are needed. Information about Lot/Batch number is requested.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Fatigue, Headache, Malaise
Clinical narrative: Not feeling well; I have a very low grade 99 temp; Aching in my back and chest area; Aching in my back and chest area; Full headache and just dont feel good; I was exhausted; Arm became increasingly sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2, dose 2 via an unspecified route of administration on 20Apr2021 09:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported.  The patient previously took the first dose of BNT162B2 on unknown date for Covid-19 immunization and also took Flu vaccine. The patient received 2nd dose vaccine about 9:15 am CST on 20Apr2021. Arm became increasingly sore (Much more noticeable than 1st shot by about 7pm. The patient did take ibuprofen and utilized the arm to keep it from getting as sore). By 7:30Pm the patient  was exhausted and just not feeling well and went to bed. Today (21Apr2021) 24 hours post shot the patient  has a very low grade 99 temp (the patient usually run 97.5). There was kind of aching in ther patient's back and chest area with a full headache and just didn't feel good. If this goes longer than 48 hours post injection the patient will report again but was advised some of this does happen. It makes the patient feel confident the body will be ready to ward off Covid if exposed in the future. The patient considered some symptoms a plus. However the patient was resting and not working today (21Apr2021) listening to the body. When receiving flu vaccines the only time the patient got a sore arm was  when its put in the nondominant arm. The patient chose the dominant arm for Covid and this was a pronounced arm soreness more severe than with flu shot (And much more sore than 1st injection along with these symptoms previously discussed).The outcome of events was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Not feeling well; I have a very low grade 99 temp; Aching in my back and chest area; Aching in my back and chest area; Full headache and just dont feel good; I was exhausted; Arm became increasingly sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2, dose 2 via an unspecified route of administration on 20Apr2021 09:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported.  The patient previously took the first dose of BNT162B2 on unknown date for Covid-19 immunization and also took Flu vaccine. The patient received 2nd dose vaccine about 9:15 am CST on 20Apr2021. Arm became increasingly sore (Much more noticeable than 1st shot by about 7pm. The patient did take ibuprofen and utilized the arm to keep it from getting as sore). By 7:30Pm the patient  was exhausted and just not feeling well and went to bed. Today (21Apr2021) 24 hours post shot the patient  has a very low grade 99 temp (the patient usually run 97.5). There was kind of aching in ther patient's back and chest area with a full headache and just didn't feel good. If this goes longer than 48 hours post injection the patient will report again but was advised some of this does happen. It makes the patient feel confident the body will be ready to ward off Covid if exposed in the future. The patient considered some symptoms a plus. However the patient was resting and not working today (21Apr2021) listening to the body. When receiving flu vaccines the only time the patient got a sore arm was  when its put in the nondominant arm. The patient chose the dominant arm for Covid and this was a pronounced arm soreness more severe than with flu shot (And much more sore than 1st injection along with these symptoms previously discussed).The outcome of events was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pyrexia
Clinical narrative: I have body aches and chills; now my "back is killing me"; fever; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself. A female patient unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, expiry date: Unknown), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received her first dose of the Pfizer COVID 19 vaccine (Saturday) and had body aches and chills. She started with fever and chills and now back was killing her. The Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: she currently has sinus infections and is taking antibiotic; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration number was 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. She was scheduled to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Apr2021 (Thursday). The patient currently had a sinus infection on an unspecified date and was taking antibiotics. The patient would like to know if she could receive the vaccine while taking antibiotics and also wanted to know if there were any trials in people taking antibiotics for the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The patient was referred to her health care professional (HCP). The outcome of the event was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Oropharyngeal pain
Clinical narrative: Sore throat and a cough over the weekend; Sore throat and a cough over the weekend; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (Solution for injection), dose 1 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. It was reported that the patient was scheduled to receive her second dose of the Covid19 vaccine, tomorrow 27Apr2021. The patient developed a sore throat and a cough over the weekend and wanted to know if she could keep her appointment, tomorrow. The patient did not have a fever, reporting her temperature 26Jan2021 (reported as today) was 97-degree Fahrenheit when it was usually 97.6-degree F. She did not believe these symptoms were due to the first dose of vaccine. It was reported "contraindications and precaution of fever in CONS-who should not get the vaccine and used 'VR-Consumer Inquiry Management (Off-Label or No Info) as there was no mention of cough or sore throat. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Epistaxis
Clinical narrative: had the worst nose bleed she ever had; had the worst nose bleed she ever had/gets nose bleeds but usually lasts for 5-10 minutes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 24Apr2021 13:15 (Batch/Lot Number: EW0176) 2nd dose single for covid-19 immunisation. The patient medical history includes nose bleeds (patient states she is susceptible to nose bleeds). There were no concomitant medications. The patient previously received first dose of BNT162B2 for Covid-19 immunization on unspecified date and Shingles shot for immunization on unspecified date. The patient experienced had the worst nose bleed she ever had on 24Apr2021 22:30. It lasted until a little after 03:00 AM on the 25Apr2021, noting it took five hours to stop. The patient reported that she gets nose bleeds but usually lasts for 5-10 minutes. The patient added she was going to go to the ER if it had not stopped. The patient also reported that she gets nose bleeds but they usually stop in ten minutes. Patient was not sure if this was a side effect or a coincidence. The patient was not sure that this has anything to do with the COVID shot. The outcome of the events recovered on 25Apr2021.
Sex: M
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: "a ball on my shoulder, it's hard and it moves"; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,) for COIVD-19 immunisation. On an unknown date, the patient experienced a ball on his shoulder, it was hard and it moves. The reporter stated that the ball appeared after his second vaccine dose and asks if this was normal or something that had been experienced by others. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Lymphadenopathy, Oropharyngeal pain, Pharyngeal swelling, Swelling face
Clinical narrative: one of them is swollen lymph nodes; swelling of face and throat (severe allergic reactions).; swelling of face and throat (severe allergic reactions).; sore throat; bump in her throat; This is a spontaneous report from a contactable consumer. This 73-year-old Female patient received first dose of bnt162b2 (Pfizer- Biontech COVID-19 Vaccine; Solution for injection; Lot Number and Expiration date was not reported) on an unspecified route of administration and location on 05Apr2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced on an unspecified date she got there a list of side-effects, one of them is swollen lymph nodes, and in another list is swelling of face and throat (severe allergic reactions) and the patient stated when she received the shot everything was fine, she went home and a couple hours later she started feeling a sore throat, she also felt like a bump in her throat it did not affect anything (eating, drinking or breathing) but she could feel it. The next morning, she got up and this sensation was almost gone, in the afternoon it had disappeared completely. The patient would like to know if there are lymph nodes in her throat and would like to know if that this has happened to other people. The patient having lymph nodes in the neck area. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine three weeks ago (05APR2021), she is scheduled to receive the second dose today. Patient would like to know if this happens again after the second dose of the vaccine what would they do or what would be the antidote. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little tired; This is a spontaneous report from the Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age started to receive first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, formulation: solution for injection) via an unspecified route of administration on 19Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Apr2021, the patient had her first shot on Monday with her husband (withheld), and now they experienced an adverse reaction. She got a little tired and her husband is having fever, sore and achy muscles. Asking if that is a normal side effect. The outcome of the event a little tired was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; sore and achy muscles; This is a spontaneous report received from consumer (patient wife) via a Pfizer Sponsored Program COVAX US Support.  This is one of two reports. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber was not reported) via an unspecified route of administration on 19Apr021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced fever, sore and achy muscles. Outcome for the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Loss of consciousness
Clinical narrative: passed out; felt dizzy; Felt fatigue; headache which lasted about 10 hours; This is a spontaneous report from a contactable consumer report for self. A 48-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 23Apr2021 08:30 as single dose for covid-19 immunisation. None Medical history reported. No covid prior vaccination. No other vaccine in four weeks, no Other medications in two weeks. Patient received first dose of bnt162b2 (Lot number=ER8733) on 26Mar2021 03:30 PM in left arm. About 20 hours (on 24Apr2021 04:00 AM) after injection felt dizzy, passed out. Felt fatigue and headache which lasted about 10 hours. No treatment received, Patient recovered from the events. Patient has not been tested for COVID-19 Since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: dull pain from the elbow to the shoulder; This is a spontaneous report from a contactable consumer female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 09Apr2021 as single dose in arm left for COVID-19 immunization. Medical history reported was history of breast cancer and having the lymph nodes in her right arm removed 4 years ago. The patient experienced a sensation like a dull pain from the elbow up to the shoulder after the injection. The sensation felt like a dull pain only happened sporadically and did not last long before it went away completely. The consumer mentioned she does take a drug to suppress estrogen as treatment for her breast cancer. She reported she had cancer and the lymph nodes was removed in her right arm 4 years ago and do not want to take any chances. Outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Illness
Clinical narrative: He had an allergic reaction to the first dose of Pfizer's COVID vaccine; He has been sick for 3 months; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had a historical vaccine of Flu vaccine for immunisation and a allergic reaction. The patient reported he had an allergic reaction to the first dose of Pfizer COVID vaccine. The reporter had assumed it may have been due to the PEG/polysorbate 80 allergic reaction, which is why he has been sick for 3 months. The allergist offered to give the second dose of the vaccine in small doses. Medical history included allergic reaction to the flu vaccine. The Patient was advised to speak to his HCP with regard to test for allergic reaction to Polyethylene glycol. Relayed PMI number but advised no listing of where to get tested, Medical Information can only answer medical questions. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: severe pain in her back and legs; severe pain in her back and legs; This is a spontaneous report received from a contactable consumer (patient) via a medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient had experienced severe pain in her back and legs caused by her vertebrae and will be receiving a shot on her spine on 28Apr2021. She asked if it will be okay for her to receive the 2nd dose as scheduled. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient, self-reported). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after her first dose of the vaccine, she had arm soreness, tired, chills, fever, body aches and pain for 2-3 days and then went away. The patient also received the second dose of vaccine on Friday morning and at evening she reported that she had a sore arm, nausea and feeling tired. On Saturday and Sunday, she reported that she was feeling tired and dizzy. Today, she was no longer tired but still had dizziness. There was no information about blood pressure changes as a side effect. Outcome of the events was recovered on an unknown date.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the second dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration in the Right Arm on Apr2021, as a single dose for COVID-19 immunisation. Medical history included non-hodgkin's lymphoma three times, stem cell transplant from an unknown date and cancer for 20 plus years. The patient's concomitant medications were not reported. The patient was transferred from another department to find out more information regarding his side effects that he is experiencing after the second dose of the Pfizer COVID-19 vaccine. He received his second dose of the Pfizer COVID-19 vaccine almost 3 weeks ago. He states that this Wednesday, 28Apr2021 it will be 3 weeks since his second dose. Two weeks after his second dose he started to develop swollen lymph nodes on his right collar bone and up the right side of his neck. He received his second dose injection "high up on my right arm." He states that the development of the swollen lymph nodes was kind of slow and not all of the sudden but it scared it him because this is the same sign of Non-Hodgkin's Lymphoma except it's a suddenly enlarged lymph node that seems to appear overnight. He states that he lost a night's sleep worrying about it even though the paperwork he received said that swollen lymph nodes are a potential side effect. He is requesting more information about this side effect. The seriousness criteria of the event was reported as non-serious by the health authority. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained .
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: Body aches; Upset stomach; Chills; Head felt foggy; Arm got really sore; This is a spontaneous report received from a Pfizer sponsored program  via medical information team. A contactable consumer (patient's parent) reported for a male patient (reporter's son) of unspecified age that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date: not reported) via an unspecified route of administration on 23Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that on 24Apr2021, the next day, the patients arm got really sore. But on 25Apr2021, he had body aches, upset stomach, a little bit of chills and head felt foggy. On 26Apr2021, today he did not have the chills and enquired if there was something they did for it. He was not running a fever at that time and asked how long do these side effects last. Patient had experienced a lot of side effects and wanted to know if it was common to experience those side effects. It was unknown if the reporter was a healthcare professional and contact information was available. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. No unaddressed medical questions were referred or forwarded to Medical Information. Outcome was recovered for chills on 26Apr2021 and unknown for all the other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Influenza, Pain
Clinical narrative: Flu symptoms; Rapid heart rate; was achy with dizziness; was achy with dizziness; This is a spontaneous report from a contactable consumer or other non-HCP. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 14Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced flu symptoms, rapid heart rate, was achy with dizziness and reported that she gets rapid heart rate, the dizziness follows, and she is concerned about the second dose. The patient underwent lab tests and procedures which included heart rate: rapid in Apr2021. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Discomfort, Hernia
Clinical narrative: epigastric pain and discomfort; epigastric pain and discomfort; He said is felt like a hernia, with cramping and discomfort; He said is felt like a hernia, with cramping and discomfort; This is a spontaneous report from a contactable Physician. A 52-years-old male patient (physician) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Auto call back 26Apr2021 at 10:36am, caller was a physician who received his first dose of Pfizer-Biontech Covid19 vaccine this past Friday. On Saturday morning, around 10:30-11am, he started to experience increasing epigastric pain and discomfort. He said it was felt like a hernia, with cramping and discomfort. His symptoms have slowly resolved, and he stated that he was "back to normal" today. He reports that he had a "pretty high threshold" for pain, but these symptoms "stopped me" on Saturday. The outcome of the events was recovered.   No Follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Hyperhidrosis, Nasopharyngitis
Clinical narrative: Diarrhea; Stomach is upset; He's got a cold; On-and-off fever; Chills; Runny nose; Body aches; Hot-and-cold sweats; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162) dose 2 via an unspecified route of administration on 22Apr2021 as single dose for covid-19 immunisation. Medical history included single functional kidney (one kidney absent). The patient's concomitant medications was not reported. Historical medication included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: not provided) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. The patient experienced diarrhea, his stomach is upset, he's got a cold, on-and-off fever, chills, runny nose, body aches, hot and cold sweats. Patient asked how long do these last. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Diarrhea; Stomach is upset; He's got a cold; On-and-off fever; Chills; Runny nose; Body aches; Hot-and-cold sweats; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162) dose 2 via an unspecified route of administration on 22Apr2021 as single dose for covid-19 immunisation. Medical history included single functional kidney (one kidney absent). The patient's concomitant medications was not reported. Historical medication included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: not provided) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. The patient experienced diarrhea, his stomach is upset, he's got a cold, on-and-off fever, chills, runny nose, body aches, hot and cold sweats. Patient asked how long do these last. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: got a rash and itching all over both legs on inner thighs, both arms in the back and front of the arms; got a rash and itching all over both legs on inner thighs, both arms in the back and front of the arms; This is a spontaneous report received from a contactable consumer (reported for herself)  A 79-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24 APR 2021 patient received the first dose of the Pfizer vaccine, That night patient states, "I got a rash and itching all over both legs on inner thighs, both arms in the back and front of the arms., just wandered if it is okay to get the second shot?". The patient inquired stating "I had a side effect after the first dose of the vaccine. Should I get the second dose?". Seriousness and outcome of the events were not reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation
Clinical narrative: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via unspecified route of administration on 22Apr2021 as single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced bumps on her right arm (she is having bumps on her right arm. She wanted to know if this is normal since she never experienced this when she took her first dose). The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Flushing, Hypersensitivity, Mouth swelling, Pharyngeal swelling
Clinical narrative: Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); This is the spontaneous report received from a contactable other health professional. This other HCP (patient) reported for herself that a 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) at the age of 30-years, via an unspecified route of administration in left arm on 19Mar2021 13:00 at single dose for COVID-19 immunization, in hospital. Medical history included PTSD, anorexia, chronic migraines, bradycardia. Patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included propranolol, atorvastatin (LIPITOR), prazosin, alprazolam (XANAX). On 19Mar2021 13:15, the patient experienced allergic reaction-characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling). After medical treatment, hives continued for 3-4 days. The events result in doctor or other healthcare professional office/clinic visit. The patient received high dose diphenhydramine hydrochloride (BENADRYL) and epinephrine (EPIPEN). Outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Allergic reaction, Anaphylactic reaction. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); This is the spontaneous report received from a contactable other health professional. This other HCP (patient) reported for herself that a 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) at the age of 30-years, via an unspecified route of administration in left arm on 19Mar2021 13:00 at single dose for COVID-19 immunization, in hospital. Medical history included PTSD, anorexia, chronic migraines, bradycardia. Patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included propranolol, atorvastatin (LIPITOR), prazosin, alprazolam (XANAX). On 19Mar2021 13:15, the patient experienced allergic reaction-characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling). After medical treatment, hives continued for 3-4 days. The events result in doctor or other healthcare professional office/clinic visit. The patient received high dose diphenhydramine hydrochloride (BENADRYL) and epinephrine (EPIPEN). Outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Allergic reaction, Anaphylactic reaction. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: the fever was strong the night he received the vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 19Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced the fever was strong the night he received the vaccine on 19Apr2021 and has been less severe since then with a range of 37.8-38°C. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oral herpes, Vaccination site pain
Clinical narrative: fever blister; swollen lymph nodes; injection site soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 on an unknown date. The patient's concomitant medications were not reported. Approximately on unspecified date in Apr2021 (After receiving the vaccine), the patient experienced a fever blister, swollen lymph nodes and injection site soreness. Caller stated that she called to report these symptoms and stated: "I've had covid before and want to take every precaution possible". Should she get the second dose of the vaccine. The clinical outcome of the events was unknown. No PQC involved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Nephrolithiasis
Clinical narrative: Kidney stone; feel pretty bad; Felt like he had the flu for a day; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient stated that he received the first dose of the Pfizer Covid-19 vaccine on 06Apr2021 and he was scheduled to receive the second dose this Friday (30Apr2021). Stated that the first dose made him feel pretty bad and he felt like he had the flu for a day. He would like to know for how long he may reschedule the second dose as he currently has a kidney stone and he would go into surgery if the kidney stone does not pass during the weekend. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Petechiae
Clinical narrative: bruises after 4 days, and these "red spots on right forearm" faded away in 3 days; another red spot on forearm; This is a spontaneous report from a contactable pharmacist (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration was not reported) dose 1 via an unspecified route of administration, administered in arm left on 02Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced bruises after 4 days, and these "red spots on right forearm" faded away in 3 days. Then, 11 days after that, in Apr2021 another red spot on the forearm appeared which faded away until a couple of days too. The outcome of both the events was recovered in Apr2021. The patient asked if it would be okay for her to get the second dose and as she had a side effect after the first dose of the vaccine, should she get the second dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Illness
Clinical narrative: The infection got worst, different physicians have diagnosed the patient with herpes; Felt sick; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via unspecified route of administration on 10Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. It was reported that the patient had received the first dose of the Pfizer COVID-19 vaccine on 17Feb2021 and shortly after was diagnosed with a severe yeast infection and received treatment for this. On 10Mar2021 the patient received her second dose and the infection got worst, different physicians have diagnosed the patient with herpes. Due to this reaction the patient had to be transferred to the emergency room a couple of times. The patient felt sick and went to emergency room stated she had herpes. The outcome of the events was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood glucose, Blood glucose decreased, Dysarthria, Dysphagia
Clinical narrative: Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; Slurred speech an difficulty swallowing; Slurred speech an difficulty swallowing; Feet felt super heavy and awkward; Significant urination; muscle aches; low-grade fever; very tired; Slight headache; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; blood sugar plummeted; This is a spontaneous report from a contactable consumer (patient).  A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:45 (Batch/Lot Number: CR8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Type 1 diabetes, Some allergy medications like zyrtec, topamax, Nortriptyline, allergic asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG); bisoprolol (BISOPROLOL); fexofenadine hydrochloride (ALLEGRA). Historical Vaccine included product=COVID 19, brand=Pfizer, lot number=EP7533, administration date: 04Apr2021, administration time =04:00 PM, dose number =1, vaccine location =Left arm for covid-19 Immunization. Reported Event: About 3 hrs after 2nd dose, lower back pain for 20 minutes followed by numbness in tongue, throat, lips, cheeks, hands, feet, slurred speech an difficulty swallowing. Extreme difficulty thinking. Feet felt super heavy and awkward, like they were bricks. She was a type 1 diabetic and her blood sugar plummeted. She had to stop her basal delivery for an hour, then she halved her basal rate for several hours. After laying down for a few hours, symptoms improved, but worsened when standing. Significant urination every 40 - 60 mins for several hours. In the morning, muscle aches throughout body, low-grade fever, very tired. Slight headache. Adverse event start date: 25Apr2021, Adverse event start time: 06: 30 PM, No treatment for AE. Lab data included blood sugar: plummeted on 25Apr2021. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Hypoaesthesia oral, Limb discomfort
Clinical narrative: Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; Slurred speech an difficulty swallowing; Slurred speech an difficulty swallowing; Feet felt super heavy and awkward; Significant urination; muscle aches; low-grade fever; very tired; Slight headache; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; blood sugar plummeted; This is a spontaneous report from a contactable consumer (patient).  A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:45 (Batch/Lot Number: CR8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Type 1 diabetes, Some allergy medications like zyrtec, topamax, Nortriptyline, allergic asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG); bisoprolol (BISOPROLOL); fexofenadine hydrochloride (ALLEGRA). Historical Vaccine included product=COVID 19, brand=Pfizer, lot number=EP7533, administration date: 04Apr2021, administration time =04:00 PM, dose number =1, vaccine location =Left arm for covid-19 Immunization. Reported Event: About 3 hrs after 2nd dose, lower back pain for 20 minutes followed by numbness in tongue, throat, lips, cheeks, hands, feet, slurred speech an difficulty swallowing. Extreme difficulty thinking. Feet felt super heavy and awkward, like they were bricks. She was a type 1 diabetic and her blood sugar plummeted. She had to stop her basal delivery for an hour, then she halved her basal rate for several hours. After laying down for a few hours, symptoms improved, but worsened when standing. Significant urination every 40 - 60 mins for several hours. In the morning, muscle aches throughout body, low-grade fever, very tired. Slight headache. Adverse event start date: 25Apr2021, Adverse event start time: 06: 30 PM, No treatment for AE. Lab data included blood sugar: plummeted on 25Apr2021. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.