chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: felling of SOB with normal sat; dizziness; nausea; abd pian; elevated HR; headaches; body aches; sore throat; This is a spontaneous report from a contactable consumer. This 41-year-old female (Non pregnant) consumer (patient) reported that she received second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, solution for injection, LOT: EL3302 Expiry date: unknown), via an Intramuscular route of administration in right arm on 27Jan2021 at 13:00, at a single dose for covid 19 immunization. Patient historical vaccine included she received first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, solution for injection, LOT: EL0140, Expiry date: unknown), via an Intramuscular route of administration in right arm on 06Jan2021 at 12:00, at a single dose for covid 19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not tested for COVID-19 since the post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included Clonazepam, fiber, but vitamin D3 and medical history included that 'Botox' done on 20Jan21 for hemifacial spasms on right side of my face. Patient had no allergies. On 28Jan2021 05:00 after received the second dose the patient was feeling dizziness, nausea, abdominal pain, elevated HR, felling of SOB with normal sat, headaches and body aches, on 3rd day better but now with a sore throat, headaches and every some often heart rate going fast. Patient didn't take treatment for the events. The outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: felling of SOB with normal sat; dizziness; nausea; abd pian; elevated HR; headaches; body aches; sore throat; This is a spontaneous report from a contactable consumer. This 41-year-old female (Non pregnant) consumer (patient) reported that she received second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, solution for injection, LOT: EL3302 Expiry date: unknown), via an Intramuscular route of administration in right arm on 27Jan2021 at 13:00, at a single dose for covid 19 immunization. Patient historical vaccine included she received first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, solution for injection, LOT: EL0140, Expiry date: unknown), via an Intramuscular route of administration in right arm on 06Jan2021 at 12:00, at a single dose for covid 19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not tested for COVID-19 since the post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included Clonazepam, fiber, but vitamin D3 and medical history included that 'Botox' done on 20Jan21 for hemifacial spasms on right side of my face. Patient had no allergies. On 28Jan2021 05:00 after received the second dose the patient was feeling dizziness, nausea, abdominal pain, elevated HR, felling of SOB with normal sat, headaches and body aches, on 3rd day better but now with a sore throat, headaches and every some often heart rate going fast. Patient didn't take treatment for the events. The outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Influenza, Nausea
Clinical narrative: dizzy; sensation of brief increased heart rate; Flu sx; nausea; This is a spontaneous report from a contactable nurse (patient herself). A 44-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982, Expiry Date: unknown) via intramuscular in the left arm on 25Jan2021 at 13:15 (at the age of 44-year-old) as a single dose for COVID-19 immunization. The patient medical history included asthma. The patient had no allergies to medications, food, or other products. Concomitant medication (within 2 weeks) included ascorbic acid (VIT C), ergocalciferol (VIT D), biotin, loratadine, calcium, silybum marianum (MILK THISTLE), paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Past drug included Claritin (patient was premeditated 1 hour before the shot). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284, Expiry Date: unknown) via intramuscular in the left arm on 04Jan2021 at 13:30 as a single dose for Covid-19 immunization. After receiving her second dose of BNT162B2 on 25Jan2021 at 13:15, within five minutes the patient experienced dizzy with sensation of brief increased heart rate, MD on site was notified. The patient was provided with water and snacks and went home after 30 minutes observation as the symptoms resolved and on an unspecified date in Jan2021 (day2-3), the patient had Flu sx (flu symptoms), Dizzy spell on and off existed till day 5 and nausea was still ongoing. Patient did not received treatment for the events. The outcome for the events sensation of brief increased heart rate was recovered, Flu sx (flu symptoms) and dizzy was recovered with sequel (reported as recovered with lasting effects) on an unspecified date in Jan2021 and nausea was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling tired.; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable female consumer (patient, self-reported).   A female unspecified age received the first dose of dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on 27Jan2021, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient did take a nap due to feeling tired, she had never called before. The patient stated that she was fine after the vaccination. 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: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from contactable consumer (patient) from a Pfizer-sponsored program. A female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 26Jan2021 as single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 27Jan2021, patient experienced diarrhea all day. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body pain; This is a spontaneous report from a contactable consumer, the patient.  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 27Jan2021 at single dose for covid-19 immunization. The patient took vaccine earlier morning. Medical history was not reported. The patients concomitant medications an OTC aspirin 81mg for blood thinner. The patient experienced body pain. Patient took tramadol 50mg, and naproxen 500mg for his body pain. The outcome of the event was unknown.   Follow-up attempts have been completed and no further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for an 83-year-old female patient (Reporters mother) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Jan2021, as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. In Jan2021, after 2 or 3 days, the patient experienced headache and chills (non-serious events). The outcome of both the event was reported as unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: soar muscle at injection site; fatigue; This is a spontaneous report from a contactable other hcp. A 48-years-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she contacted initially for questions regarding the vaccine safety while on Dupixent shots for asthma and allergies, not to report side effects. She did not respond to first letter because that was not apply to her. patient clarified to 2nd letter, that she received both vaccines with no side effects at this time other than sore muscle at injection site and fatigue following 2nd vaccine which subside after a day or two. The outcome of events was reported as recovered.  It was notified that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; nausea; dizziness; aches; fever; This is a spontaneous report from a contactable nurse. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in right arm on 20Jan2021 17:30 (at the age of 45-year-old, Non-pregnant) (Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included migraine, essential tremor, fibromyalgia, arthritis and allergic to Sulfa. Patient has not covid-19. Concomitant medications included methylphenidate hydrochloride (CONCERTA), Propranolol, Tizanidine and Trazodone all for unknown indication. The patient experienced arm pain, nausea, dizziness, aches and fever on 21Jan2021 13:00. Since the vaccination, the patient not been tested for COVID-19. No treatment for events.Outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: achiness  in her body; This is a spontaneous report from contactable other health professional (patient) Pfizer via Sales Representative. A female patient of an unspecified age received BNT162B2 (Pfizer COVID 19 vaccine, Solution for injection), dose 2 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 previously took first dose of BNT162B2 for covid-19 immunisation. The patient had some achiness in her body after the second dose of the vaccine. Adds outside of that achiness, she felt fine. The patient recently received the second dose of the vaccine but was unsure of the exact date, time or the site. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain and tenderness at the injection site; This is a spontaneous report from a contactable other HCP (patient). A 26-years-old female patient received BNT162B2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 05Jan2021 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included autoimmune thyroiditis, appendicectomy, pyelonephritis from an unknown date and unknown if ongoing. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride, ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium taken for an unspecified indication. The patient previously took azithromycin and experienced drug hypersensitivity. The patient experienced pain and tenderness at the injection site on an unspecified date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.   Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable other hcp (patient himself). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E49899, expiration date not reported), intramuscularly, administered on the left arm on 26Dec2020 09:45 (at the age of 42-years-old) at a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient previously took aspirin and experienced allergy with aspirin. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced fever of 99.4 degrees, fatigue, muscle pain in left hip with radiating burning pain along posterior aspect of leg running from hip to calf , burning pain running across top of foot, blistering on left arch of foot, second, and forth toe; which was later diagnosed as shingles on 27Dec2020 19:30. The patient underwent lab tests and procedures which included body temperature: 99.4 degrees fahrenheit (fever) on 27Dec2020. Patient consulted a physician and treatment was received as a result of the event reported (reported as culture taken to confirm shingles). Events were assessed as non-serious by the reporter. The outcome of the event was recovered with sequalae.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Headache; Tiredness; Muscle pain; Chills; Joint pain; Swelling; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL8982) as single dose for an unspecified indication. Medical history included multiple sclerosis (Verbatim: MS), hypertension (Medical condition: Consumer stated, "High pressure") and covid-19 from an unknown date and unknown if ongoing (I had COVID in the last days of October around 21sth, 30 or 31st October). Concomitant medications included losartan taken for an unspecified indication. The patient experienced headache, tiredness, muscle pain, chills, joint pain, swelling, nausea, feeling unwell on an unspecified date. Patient had vaccination, Pfizer's dose, 20Jan2021 and should have my second dose of the vaccine on 09Feb2021 but had COVID in the last days of October around 21sth, 30 or 31st October and was diagnosed with MS (Later clarified as Medical history). Patient had very bad reaction the second day, I have the vaccination on Wednesday, didn't have any reaction in the moment or one hour or two hour but Thursday since the morning felt really bad with all the side effects that are listed in the paper that they gave me, I had everything, I had headache, tiredness, muscle pain, chills, joint pain, swelling and nausea, felling unwell." The action taken in response to the event for bnt162b2 was not applicable. The outcome of events was unknown.  Information about Lot/batch no has been requested.  Follow-up (05Feb2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Swelling
Clinical narrative: Headache; Tiredness; Muscle pain; Chills; Joint pain; Swelling; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL8982) as single dose for an unspecified indication. Medical history included multiple sclerosis (Verbatim: MS), hypertension (Medical condition: Consumer stated, "High pressure") and covid-19 from an unknown date and unknown if ongoing (I had COVID in the last days of October around 21sth, 30 or 31st October). Concomitant medications included losartan taken for an unspecified indication. The patient experienced headache, tiredness, muscle pain, chills, joint pain, swelling, nausea, feeling unwell on an unspecified date. Patient had vaccination, Pfizer's dose, 20Jan2021 and should have my second dose of the vaccine on 09Feb2021 but had COVID in the last days of October around 21sth, 30 or 31st October and was diagnosed with MS (Later clarified as Medical history). Patient had very bad reaction the second day, I have the vaccination on Wednesday, didn't have any reaction in the moment or one hour or two hour but Thursday since the morning felt really bad with all the side effects that are listed in the paper that they gave me, I had everything, I had headache, tiredness, muscle pain, chills, joint pain, swelling and nausea, felling unwell." The action taken in response to the event for bnt162b2 was not applicable. The outcome of events was unknown.  Information about Lot/batch no has been requested.  Follow-up (05Feb2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain in extremity
Clinical narrative: sore arm, from the injection, for only 1-2 days"; left arm discomfort; shoulder pain; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received bnt162b2 (PFIZER; Solution for injection; Lot number: EL3248) dose 1 via an unspecified route of administration, administered in left arm on 24Jan2021 as single dose for COVID-19 immunization. The patient's medical history included Chronic lymphocytic leukemia patient since Jul2015 and disrupt GI. Concomitant medications included ibrutinib taken for chronic lymphocytic leukaemia, meloxicam for arthralgia, flecainide taken for arrhythmia, aciclovir taken for antiviral treatment, guaifenesin, sulfamethoxazole, trimethoprim. The patient had a sore arm, from the injection, for only 1-2 days and was also taking meloxicam daily at the time. He then developed some "GI problems, due to the possible side effects of the meloxicam, and PCP told him to stop taking this medication. The patient stated that on day 8 the soreness reappeared and became worse each day, then on day 10 took a meloxicam and the arm pain was better. The patient stated that he can no longer take the meloxicam and he still had moderately sore. Upon follow up received on 05Feb2021, His oncologist recommended him to get it. 12 days after he got the vaccine his side effect came back. He got it in his left arm. He had left arm discomfort for a couple of days. The discomfort disappeared. He was also taking Meloxicam 7.5mg because he needs his hip replaced. It started to disrupt his GI, so he discontinued it. After he discontinued the Meloxicam, the arm soreness came back. He believes the Meloxicam was masking the shoulder soreness. He discontinued the Meloxicam, and 12 days later after the vaccine, his shoulder pain came back. He thinks once the anti-inflammation medication wore off it came back. His symptoms came back. He was just wondering how long people have been symptomatic after the injection. His next vaccine on 17Feb2021, and his arm was still sore from the first. He felt like this should have been more transient, and in a quicker time frame. The outcome of the events was reported as an unknown.   Follow up received on 05Feb2021: New significant information was received.   Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: Redness at injection site.; Slight itch; This is a spontaneous report from a contactable consumer (patient himself). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EM9809; Expiration Date: Unknown) via an unspecified route of administration in Arm Left on 04Feb2021 12:30 as single dose for COVID-19 immunization. The patient medical history included Cardiac and penicillin allergy. The concomitant medication included atorvastatin. The patient experienced redness at injection site and slight itch on 05Feb2021. The patient had not received any other treatments for adverse events. The patient was not tested positive since the vaccination. The outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Came down with shingles; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer or other non hcp (patient herself) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was supposed to get her 2nd dose on 02Feb2021 but came down with shingles on an unspecified date so her HCP advised her to not get the 2nd dose. She wants to know when she should get the 2nd dose. The outcome of the event reported was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles recently.; This is a spontaneous report from contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shingles (recently diagnosed, as reported) on an unspecified date. It was reported that "Had first pfizer covid shot. Due for 08Feb". Outcome of the event was unknown.     No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles on her body described as having rashes on her body; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Lot Number: EL3246) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with 2 doses of Shingrix on an unspecified date. On 06Feb2021 she had shingles on her body which she described as having rashes on her body. She went to the hospital, they said it was shingles. So, now she was asking whether there was a relationship with the vaccine and shingles. She was scheduled to have the second dose on 18Feb2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: hip started hurting; shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program A 72-year-old female patient received bnt162b2 (BNT162B2), first dose via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EL9269) as single dose (at the age of 72-years-old) for COVID-19 immunisation; and ibuprofen (MOTRIN [IBUPROFEN]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 1800 mg, daily as anti-inflammatory. Medical history included hypertension. Concomitant medication included amlodipine taken for hypertension, start and stop date were not reported.  The patient had her first Pfizer vaccination on 28Jan2021 and was scheduled for her next one in 18Feb2021. Days later she started noticing that she had no other symptom, she stated that "nothing happened to me, I didn't feel bad, my arm didn't hurt, I had no problems with the vaccine." A couple of days later, her hip started hurting and then just Wednesday (Feb2021) she went to her doctor and he said it was shingles and was given valacyclovir. No investigation assessment was done. The outcome of the events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling
Clinical narrative: Swelling; This is a spontaneous report from a contactable consumer(patient). A 75-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not reported) via unspecified route of administration on arm left at a single dose on 26Jan2021 15:00 for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. Patient received lisinopril(LISINOPRIL) as concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid -19 prior to vaccination. The patient tested for Covid-19 post vaccination. On 27Jan2021 patient experienced swelling that still hasn't gone down. No other adverse effects at all. Not painful. On 28Feb2021 patient had nasal swab resulted negative. Patient didn't received treatment for the event. The outcome of event was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I have shingles that started the day after the shot.  The shingles are on the left side of my neck, along the jawline, and behind the left ear.; This is a spontaneous report from a non-contactable consumer. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 17:30 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation.  Medical history included hypothyroidism. Concomitant medication(s) included rosuvastatin (ROSUVASTATIN); levothyroxine sodium (LEVOTHYROXIN); loratadine (LORATADINE).  The patient previously took clindamycin, and amoxicillin and experienced known allergies. On 27Feb2021, it was reported "I have shingles that started the day after the shot. The shingles are on the left side of my neck, along the jawline, and behind the left ear." Therapeutic measures were taken as a result of the event: given an antiviral medicine. The patient did not have COVID prior vaccination, the patient was not COVID tested post vaccination. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular disorder
Clinical narrative: Testes felt very tender; especially on the right side of my body; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot Number: MRN:70697732, Expiration date: unknown), dose 1 via an unspecified route of administration in left arm on 25Feb2021 at 12:30, as single dose for COVID-19 immunisation. The patient medical history included asthma. The patient did not had any known allergies. Concomitant medications included pseudoephedrine hydrochloride (SUDAFED) and ibuprofen (ADVIL). The patient did not receive other vaccine in four weeks. The patient did not had COVID prior to vaccine. Post vaccination, the patient did not had COVID test. On 25Feb2021 at 14:00, the patient experienced testes felt very tender, especially on the right side of his body. Therapeutic measures were not taken as a result of event. The outcome of the event was recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age BNT162B2 (Pfizer Covid-19 Vaccine), 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 mentioned that she was due for the second dose the next Tuesday at the time of reporting. She currently has shingles (onset date not specified) and would like to know if that would interfere with her second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate increased, Pyrexia
Clinical narrative: Sever chills; Fever off and on for 30 hours\Temperature 99.8 - 103.2 for 6 hours; Heart rate increased; This is a spontaneous report received from a contactable consumer (Patient). A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 intramuscular, administered in Arm Left on 23Mar2021 13:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing (Had a similar reaction to shingles vaccine). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1, administered in Arm right on 02Mar2021 18:15 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. Concomitant medication included metoprolol succinate 25 mg and diltiazem hydrochloride 120 mg (DILTIAZEM CD). On 23Mar2021 05:30, the patient experienced sever chills, Fever off and on for 30 hours\Temperature 99.8 - 103.2 for 6 hours and heart rate increased. The patient underwent lab tests and procedures which included body temperature: 99.8 - 103.2 on 23Mar2021 (Temperature 99.8 - 103.2 for 6 hours), heart rate increased: 100-120 on 23Mar2021 (Heart rate increased to between 100 -120 / bpm for 6 hours). The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was recovered.  Follow-Up(03May2021): Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information which included: Deleted the event "Temperature 99.8 - 103.2 for 6 hours LLT: Body temperature" and subsumed to existing LLT: Fever.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight sore arm; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6206) via an unspecified route of administration in the right arm in Mar2021 as a single dose for COVID-19 immunisation. Medical history included lung cancer several years ago, surgery, multiple sclerosis, mild chronic obstructive pulmonary disease (COPD), arthritis, and irritable bowel syndrome, all from unknown dates and unknown if ongoing. Concomitant medications included phenazepam and nitrazepam, both from unknown dates for unknown indications. The patient reported she received her first dose on a Wednesday, three weeks earlier as of 05Apr2021, and only had one side effect, a slight sore arm. The patient received her second dose on 31Mar2021 at 08:30 for COVID-19 immunisation. The patient inquired if she should get a booster when it comes out. The clinical outcome of slight sore arm was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Lymph node pain, Pain in extremity, Peripheral swelling
Clinical narrative: dominant hand and wrist is still slightly swollen; dominant hand and wrist is still slightly swollen; her dominant hand and wrist is still slightly swollen and still hurts to use it.; her dominant hand and wrist is still slightly swollen and still hurts to use it.; slight pain under her arm in her lymph node; This is a spontaneous report received from a non-contactable consumer (patient). A 67-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient had slight pain under her arm in her lymph node but that went away pretty quickly. It had been 8 days and her dominant hand and wrist were still slightly swollen and still hurt to use. The outcome of slight pain under her arm in her lymph node was recovered. The outcome of dominant hand and wrist were still slightly swollen and still hurt to use was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Dysphagia, Fatigue, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: some fatigue; throat is very sore and very dry; throat is very sore and very dry; it is difficult to swallow; his throat does still feel "a bit swollen."; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer Sponsored Program. This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported receiving his first dose of BNT162B2 on 29Mar2021 and that his second dose had been schedule for 12Apr2021 which was 14 days and inquired if this was okay as he knew the recommended interval was 21 days. He reported that after his first dose, he did not experience any side effects initially, just "some fatigue." However, he stated that this morning (as of 05Apr2021) his throat was very sore and very dry and reported that it was difficult to swallow. He stated that it had been a couple of hours and he felt a bit better but reports that his throat still felt "a bit swollen." The patient inquired if the side effects he was experiencing with his throat were common with the vaccine of if he could just be getting a cold. He stated that he did read that "there is an issue with lymph nodes" and thinks that the throat is a common area where lymph nodes are. The clinical outcomes of fatigue, throat is very sore and very dry, it is difficult to swallow, and throat does still feel a little bit swollen were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: heel pain; This is a spontaneous report from a contactable consumer (patient). This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he had an appointment tomorrow (as of 05Apr2021) with a podiatrist for heel pain that his podiatrist said he could give him a shot for; the patient assumed it would be a cortisone injection. The patient inquired if he could take the steroid injection. The patient stated his second dose was due 14Apr2021 and that he would probably wait for the injection until after he'd received his second dose. The clinical outcome of heel pain was unknown.   No follow-up attempts are needed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report from a non-contactable consumer (patient). This patient of unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient called regarding pain experienced on an unspecified date. The clinical outcome of pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Off label use, Product dose omission issue
Clinical narrative: received the first dose on January 14 and due to a cardiovascular condition her Physician recommended to wait until her cardiovascular condition was monitored; cardiovascular condition; received the first dose on January 14 and due to a cardiovascular condition her Physician recommended to wait until her cardiovascular condition was monitored; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient wanted information about dose 2 of BNT162B2 because she received the first dose on 14Jan2021 and due to a cardiovascular condition her physician recommended to wait until her cardiovascular condition was monitored. The outcomes of received first dose on 14Jan2021 and cardiovascular condition were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue
Clinical narrative: tired; coughing; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced coughing two days prior to reporting (03Apr2021) and was very tired on an unspecified date. It was reported that patient did not have any fever and was taking Tylenol for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372956 Same reporter/drug, different patient/event.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Nausea, Pain
Clinical narrative: her lower back started hurting; It makes her feel like throwing up; She got chills and aches 14 hours later; She got chills and aches 14 hours later; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This female patient of 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 in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she got her first dose on Wednesday (as of 05Apr2021). She got chills and aches 14 hours later. She reported that on "this Saturday" (as of 05Apr2021) her lower back started hurting, also reporting it made her feel like throwing up. The outcomes of she got chills and aches 14 hours later, her lower back started hurting and it made her feel like throwing up were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Peripheral coldness, Pyrexia
Clinical narrative: Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-year-old on 12Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. patient has gotten her first shot of the Pfizer Covid 19 vaccine last 12Apr2021 and on 17Apr2021, she experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts. Asking if this is normal and as to how many days it usually lasts. Outcome of headache and fever was not recovered, outcome of chill was recovered and outcome of cold feet was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Lethargy, Malaise
Clinical narrative: headache; feel fatigued/super worn out; pretty lethargic/Lethargic as all get out; kind of almost flu-like feeling; arm pain/soreness like "someone punching me in the arm."/arm hurt; Not feeling too good; This is a spontaneous report from a contactable consumer (patient). A contactable 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 32-year-old, on 15Apr2021 at single dose for COVID-19 immunization. Medical history included COVID (Patient had COVID probably within the first few months of COVID being a thing, so that was a while ago). Concomitant medication was not reported. patient received his first Pfizer Covid vaccine dose on 15Apr2021. The following day (16Apr2021) he experienced arm pain/soreness like "someone punching me in the arm." On 18Apr2021 he states he started to feel fatigued, "super worn out", and a headache (19Apr2021). Patient asked if it was normal to experience. He is not feeling too good and doesn't know if that is from the Pfizer Covid-19 Vaccine. Caller's wife got the Moderna shot and caller got the Pfizer Covid-19 Vaccine shot on 15Apr2021. It seemed like his arm hurt on Friday. Saturday it seemed like he was alright. Sunday (18Apr2021) he felt pretty lethargic and kind of almost flu-like feeling, today (19Apr2021) just severe headache and just lethargic as all get out, walking to refrigerator is kind of a task. He was wondering, he heard of like the day after, but if it is a normal thing to have these events a few days after the Pfizer Covid-19 Vaccine. He does not feel like he needs to be rushed to the hospital. Outcome of arm pain was recovered on 17Apr2021 and outcome of other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: headache; feel fatigued/super worn out; pretty lethargic/Lethargic as all get out; kind of almost flu-like feeling; arm pain/soreness like "someone punching me in the arm."/arm hurt; Not feeling too good; This is a spontaneous report from a contactable consumer (patient). A contactable 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 32-year-old, on 15Apr2021 at single dose for COVID-19 immunization. Medical history included COVID (Patient had COVID probably within the first few months of COVID being a thing, so that was a while ago). Concomitant medication was not reported. patient received his first Pfizer Covid vaccine dose on 15Apr2021. The following day (16Apr2021) he experienced arm pain/soreness like "someone punching me in the arm." On 18Apr2021 he states he started to feel fatigued, "super worn out", and a headache (19Apr2021). Patient asked if it was normal to experience. He is not feeling too good and doesn't know if that is from the Pfizer Covid-19 Vaccine. Caller's wife got the Moderna shot and caller got the Pfizer Covid-19 Vaccine shot on 15Apr2021. It seemed like his arm hurt on Friday. Saturday it seemed like he was alright. Sunday (18Apr2021) he felt pretty lethargic and kind of almost flu-like feeling, today (19Apr2021) just severe headache and just lethargic as all get out, walking to refrigerator is kind of a task. He was wondering, he heard of like the day after, but if it is a normal thing to have these events a few days after the Pfizer Covid-19 Vaccine. He does not feel like he needs to be rushed to the hospital. Outcome of arm pain was recovered on 17Apr2021 and outcome of other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: her energy level went slower; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient) reported for herself. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient got the 1st dose of the Pfizer Covid-19 Vaccine this past Monday (12Apr2021). After getting the vaccine her energy level went slower. She would like to confirm if that reaction is normal. Outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.