chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: bad headaches; right  arm swelling/side of injection/Right arm is swollen up, has a knot and is painful; feverish/Fever; chills; nauseous; Feels awful; Feels like her kidneys are gone because she is hurting back there; feeling cold; sore neck; This is a spontaneous report received from a contactable consumer (patient). A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: EN6200) via an unspecified route of administration, in right arm on 04Mar2021at 13:30-14:00 (at the age of 66-years-old) as dose 2, single for covid-19 immunization. Medical history including diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity and respiratory illness. Concomitant medications included Levothyroxine at 50 mg every day from on an unknown date (taking it so long, forever). Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch no: not reported/lot number: EL9261) injection to left arm on 11Feb2021 at about maybe 13:30-14:00 (at the age of 66-years-old) as dose 1, single for covid-19 immunization and had bad headaches. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Patient was administered the second dose of Pfizer-BioNTech COVID-19 on 04Mar2021. She sat for monitoring after being administered the second dose of the vaccine and had nothing, no reaction. When she woke up on 05Mar2021 morning she has bad headaches again; chills; fever; feels awful; nauseous; right arm is swollen up, has a knot and is painful; Feels like her kidneys are gone because she is hurting back there. The events after the second dose of the vaccine are worse than they were after the first dose of the vaccine. Bad headaches as she cannot stand the headaches; she gets migraines, but she cannot take a headache, it kills her. Her head hurting was bad. Fever feels feverish, hot all over. When she first checked her temperature, it was 98 degrees Fahrenheit, then when she checked her temperature again it was 99.4 degrees Fahrenheit. She has been drinking water and everything. She has chills and feels cold, her feet are cold, hands are cold. received second shot of pfizer covid vaccine yesterday and woke up with bad headaches, right arm swelling/side of injection, sore neck, feverish, in Mar2021 feeling cold. chills. states with the first injection, he woke up next day with headache only but now after the second dose he has extra side effects. The patient underwent lab tests and procedures which included body temperature was 98 fahrenheit on and body temperature: 99.4 fahrenheit, both on an unknown date in Mar2021, mammogram test was performed on Feb2021 and results were came out great, they did not find anything. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Swelling face
Clinical narrative: I experienced a headache; a few hours later my face swelled up; This is a spontaneous report from a contactable consumer. This 23-year-old female consumer (patient) reported for herself that: A 23-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 25Feb2021 at 07:00 (at the age of 23-year-old) as single dose for covid-19 immunisation at Hospital. Patient was not pregnant at the time of vaccination. Medical history and concomitant medication reported as none. Patient had no known allergies. Patient not diagnosed with covid-19 prior to vaccination. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 04Feb2021 at 07:00 as single dose for covid-19 immunisation. Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient reported I experienced a headache and then a few hours later my face swelled up on 25Feb2021 at 18:00. Since vaccination patient not tested for covid-19. Event resulted to visit Emergency room/department or urgent care. This case assessed as non-serious by the reporter. Therapeutic measures were taken as a result of the events with steroids shot. Outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021251542 similar report from same reporter
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Swelling face
Clinical narrative: I experienced a headache; a few hours later my face swelled up; This is a spontaneous report from a contactable consumer. This 23-year-old female consumer (patient) reported for herself that: A 23-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 25Feb2021 at 07:00 (at the age of 23-year-old) as single dose for covid-19 immunisation at Hospital. Patient was not pregnant at the time of vaccination. Medical history and concomitant medication reported as none. Patient had no known allergies. Patient not diagnosed with covid-19 prior to vaccination. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 04Feb2021 at 07:00 as single dose for covid-19 immunisation. Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient reported I experienced a headache and then a few hours later my face swelled up on 25Feb2021 at 18:00. Since vaccination patient not tested for covid-19. Event resulted to visit Emergency room/department or urgent care. This case assessed as non-serious by the reporter. Therapeutic measures were taken as a result of the events with steroids shot. Outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021251542 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pruritus
Clinical narrative: areas on body that were inflamed; she felt more itchy; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) through a Pfizer-sponsored program via Medical Information Team. A female patient of unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunization. Patient relevant medical history included cut on fingers and insect bites. Patient experienced she had areas on body that were inflamed. Her cuts were inflamed on her fingers and she had insect bites that were inflamed. A few days after the shot it just seemed more inflammed and she felt more itchy but did not have a rash on an unspecified date in 2021. She was overall really itchy and things got more inflamed that were already inflamed but it has calmed down to where it was before. Patient stated she took the first dose of the vaccine and at that time it was very windy and the vials were blown away and were shaken but she did not confirm they were broken. She stated that shaken was not quite the right word and saw that it was important that the vials were not agitated. She stated that this happened right before she was going to get her shot. The entire cart blew over and she assumed the vaccine was on there. She stated that she had a side effect after the first dose. She stated she had areas on body that were inflamed. Her cuts were inflamed on her fingers and she had insect bites that were inflamed. A few days after the shot it just seemed more inflammed and she felt more itchy but did not have a rash. She was overall really itchy and things got more inflamed that were already inflamed but it had calmed down to where it was before. She asked about taking an anti-inflammatory patch for a knee. She stated a friend was saying something about not taking anti-inflammatories. She asked if it was okay to take anti-inflammatory vitamins like turmeric or an anti-inflammatory patch. She took the first dose last 23Feb2021. She would like to ask if it was ok to administer vials that were dropped on the floor. Any unaddressed medical questions were referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6202, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 as dose 2, single (at the age of 34-years-old) for COVID-19 immunisation. Medical history included allergy to adhesive, ankle surgery (in January), post-traumatic stress disorder (PTSD), attention deficit hyperactivity disorder (ADHD) and anxiety (all from an unknown date and unknown if ongoing). Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 at 11:00 hours as dose 1, single (at the age of 34-years-old) for COVID-19 immunisation. Patient had no other vaccine in four weeks. The patient's concomitant medications were not reported. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for the COVID-19, post vaccination. On 04Mar2021, patient experienced stabbing sharp lower left back pain, it takes her breath away and gives her chills it hurts so bad. Patient received no treatment for the events. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: I had some reaction to this, a little bit of pain at the injection site; I was tired; Very light headache; Little bit of muscle pain; Chills; Little joint pain; Fever; Little bit of nausea; I was feeling kind of unwell; soaking wet with sweat; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunisation. Medical history included atrial fibrillation, blood pressure measurement, all from an unknown date and unknown if ongoing. Concomitant medication(s) included carvedilol (CARVEDILOL) taken for blood pressure measurement, start and stop date were not reported; apixaban (ELIQUIS); amiodarone (AMIODARONE); tamsulosin (TAMSULOSIN); nystatin (STATIN [NYSTATIN]) all taken for an unspecified indication, start and stop date were not reported. On 04Mar2021 the patient experienced I had some reaction to this, a little bit of pain at the injection site, I was tired, very light headache, little bit of muscle pain, chills, little joint pain, fever, little bit of nausea, I was feeling kind of unwell, soaking wet with sweat. Clinical course was reported as 03Mar he got Covid vaccine his first shot at the (state name) hospital in (state name). Okay, he had some reaction to this, a little bit of pain at the injection site, he was tired, a very light headed, little bit of muscle pain but it was not lot, some chills, a little joint pain, a fever, no swelling though at the injection site no redness at the injection site, a little bit of nausea but nothing serious and he was feeling kind of unwell, no swollen lymph nodes and no swelling at the face or no fast heart-beat, no rash and no dizziness a little bit of weakness. He feels great now it's been almost 48 hours since he had the shot so he pretty much over it, but it has I let you know, did have little bit reaction. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered on unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: I had some reaction to this, a little bit of pain at the injection site; I was tired; Very light headache; Little bit of muscle pain; Chills; Little joint pain; Fever; Little bit of nausea; I was feeling kind of unwell; soaking wet with sweat; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunisation. Medical history included atrial fibrillation, blood pressure measurement, all from an unknown date and unknown if ongoing. Concomitant medication(s) included carvedilol (CARVEDILOL) taken for blood pressure measurement, start and stop date were not reported; apixaban (ELIQUIS); amiodarone (AMIODARONE); tamsulosin (TAMSULOSIN); nystatin (STATIN [NYSTATIN]) all taken for an unspecified indication, start and stop date were not reported. On 04Mar2021 the patient experienced I had some reaction to this, a little bit of pain at the injection site, I was tired, very light headache, little bit of muscle pain, chills, little joint pain, fever, little bit of nausea, I was feeling kind of unwell, soaking wet with sweat. Clinical course was reported as 03Mar he got Covid vaccine his first shot at the (state name) hospital in (state name). Okay, he had some reaction to this, a little bit of pain at the injection site, he was tired, a very light headed, little bit of muscle pain but it was not lot, some chills, a little joint pain, a fever, no swelling though at the injection site no redness at the injection site, a little bit of nausea but nothing serious and he was feeling kind of unwell, no swollen lymph nodes and no swelling at the face or no fast heart-beat, no rash and no dizziness a little bit of weakness. He feels great now it's been almost 48 hours since he had the shot so he pretty much over it, but it has I let you know, did have little bit reaction. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered on unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have a delayed rash, that may be related to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 16Feb2021 09:00 (Lot Number: Em9809) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported; no known allergies. Prior to vaccination, the patient was not pregnant and did not have COVID-19. The patient reported that she had a delayed rash that may be related to the vaccine and was wondering if it was ok to take Benadryl. It was a rash that she has had for a couple weeks on her upper chest and neck from 25Feb2021. No treatment was received for the event. Outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Eye discharge, Eye irritation, Eyelid ptosis, Vision blurred
Clinical narrative: Eyes Blurred vision; Ptosis; Eyes Irritation; Eyes Excretion; Blepharitis and dry eve disease, both minor but exacerbated after first vaccine/More intense after the second; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route, administered in Left Arm on 02Feb2021 at 12:00 (Lot Number: EL9263, 70-year-old at vaccination) as Dose 1, Single via an unspecified route, administered in Left arm on 23Feb2021 at 12:00 (Lot Number: EN6200, 70-year-old at vaccination) as Dose 2, Single, both doses for Covid-19 immunization. Facility type vaccine was reported as Other. The patient's medical history included blepharitis, dry eye. No known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with Covid prior vaccination. Since vaccination the patient was not tested for Covid. The patient had not received any other vaccine in four weeks prior to vaccination. On 04Feb2021 13:00, the patient experienced eyes blurred vision, ptosis, irritation, excretion, blepharitis and dry eye disease, both minor but exacerbated after first vaccine and more intense after the second. These AE resulted doctor or other healthcare professional office/clinic visit. The patient received Xiidra and lubricating drops as treatment medication for resulted events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: head to toe/full body rash; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 22Feb2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced head to toe/full body rash on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Shoulder pain that has persisted past 48 hours. Severe, aching pain has developed, and I can barely move my shoulder now; Bruising and swelling remain at the sight of the injection; Bruising and swelling remain at the sight of the injection; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) dose number unknown via an unspecified route of administration in Arm Left on 26Feb2021 15:30 (age at vaccination 54years old) as single dose for covid-19 immunisation. Medical history included cardiac disorder, drug hypersensitivity all from an unknown date and unknown if ongoing. 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 medication(s) included metoprolol (METOPROLOL); prasugrel (PRASUGREL) all taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. On 26Feb2021 at 15:30 the patient experienced shoulder pain that has persisted past 48 hours. severe, aching pain has developed, and I can barely move my shoulder now, bruising and swelling remain at the sight of the injection. The patient received treatment with Ibuprofen for the adverse events. The clinical outcome of the event was not recovered. Therapeutic measures were taken as a result of shoulder pain that has persisted past 48 hours. severe, aching pain has developed, and I can barely move my shoulder now, bruising and swelling remain at the sight of the injection.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Eye pain, Eye pruritus
Clinical narrative: very dry and itchy eyes, slightly painful to open; very dry and itchy eyes, slightly painful to open; very dry and itchy eyes, slightly painful to open; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 06Mar2021 15:45 (at the age of 43-years-old) as dose 1, single for COVID-19 immunization. Medical history included sleep apnea, and garlic and onion intolerance, from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not have any other vaccine in four weeks and no other medications in two weeks. The patient previously took Versed and experienced an adverse reaction of allergies. The patient reported that he woke up the next day with very dry and itchy eyes, slightly painful to open on 07Mar2021. The dry/itchy eyes lasted for about 8 hours. No treatment was received for the events. The patient has not been tested for COVID post-vaccination. Outcome of the events was recovered on 07Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash on chest and abdomen; This is a spontaneous report from a contactable other healthcare professional (patient). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 16:30 (Lot Number: EN6305) (at the age of 67-years-old) as dose 1, single for covid-19 immunisation. Medical history included heart ventricle fibrillation. The patient had no known allergies. Concomitant medications included atorvastatin; carvedilol; aspirin; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks of vaccination. The patient did not have Covid prior vaccination and was not tested for Covid post vaccination. On 03Mar2021 22:00, the patient experienced itchy rash on chest and abdomen. The patient did not receive any treatment for the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: itchy rash on chest and abdomen; This is a spontaneous report from a contactable other healthcare professional (patient). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 16:30 (Lot Number: EN6305) (at the age of 67-years-old) as dose 1, single for covid-19 immunisation. Medical history included heart ventricle fibrillation. The patient had no known allergies. Concomitant medications included atorvastatin; carvedilol; aspirin; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks of vaccination. The patient did not have Covid prior vaccination and was not tested for Covid post vaccination. On 03Mar2021 22:00, the patient experienced itchy rash on chest and abdomen. The patient did not receive any treatment for the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: felt like he was getting a rash on stomach on chest; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt like he was getting a rash on stomach on chest on an unspecified date. He stated that he hasn't gotten worse but hasn't gotten better either and was inquiring if he should get his second dose on 24Mar2021. Outcome of the events was not recovered.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: felt like he was getting a rash on stomach on chest; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt like he was getting a rash on stomach on chest on an unspecified date. He stated that he hasn't gotten worse but hasn't gotten better either and was inquiring if he should get his second dose on 24Mar2021. Outcome of the events was not recovered.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: bilateral forearm hives; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6202 and expiry date: 30Jun2021), via an unspecified route of administration, administered in left upper arm, on 05Mar2021 12:25 (at the age of 62-year-old), as dose 1, single, for COVID-19 immunisation in Department of Health. Medical history included Hashimoto's, heart arrhythmias, allergy to sulfa drugs, asthma, allergy to shellfish, blood pressure, thyroid, inhalation therapy. Concomitant medications included amlodipine taken for blood pressure; levothyroxine taken for thyroid disorder; albuterol sulfate taken for inhalation therapy; mometasone furoate (ASMANEX HFA) taken for an unspecified indication. The patient gets allergy shots for 30 years and would get puffy at the injection site. The patient gets the flu shot every year with no reaction. She doesn't have lot or expiry for any of the products she has received. The patient took bactrim and experienced hives all over and was reported that she might not be allergic anymore. Patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 05Mar2021 evening, the patient noticed bilateral forearm hives. She had a long-sleeved shirt and didn't notice it until that evening. One was on the right arm and the rest were on the left arm. She got the injection in left arm. She was not sure if there was something in the vaccine causing the hives. Two of the hives went right way. The others lasted two days. It was reported that, the patient gets heart arrhythmia from Benadryl, so the doctor told her to get Zyrtec without the D. The reporter doesn't have the lot and expiry for the Benadryl that gave her heart arrhythmias. The patient called her primary care doctor and talked to the PA. The PA said to call the number, take antihistamine, and if she started to wheeze go to the hospital. The patient wants to know if she should get the second dose after this reaction. The patient took Zyrtec: expiry: Sep2022, lot: BDC033 due to the event. The outcome for the event was recovered in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Chills; severe diarrhea for 3 days; no appetite; fever of 100.7 for two days; neck pain; joint pain; migraine; severe fatigue/Exhaustion; increased sense of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 01Mar2021 13:15 (Lot Number: EL9262) (at the age of 61-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension. Concomitant medications within two weeks of vaccination included venlafaxine hydrochloride (EFFEXOR); losartan potassium (LOSARTIN); both taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfur and experienced drug hypersensitivity, cipro [ciprofloxacin] and experienced drug hypersensitivity, iodine and experienced drug hypersensitivity. The patient did not receive any other vaccine within four weeks of vaccination. The patient did not have covid prior vaccination and was not tested for covid post vaccination. On 05Mar2021 19:00, the patient experienced chills, severe diarrhea for 3 days, no appetite, fever of 100.7 for two days, neck pain, joint pain, migraine, severe fatigue, increased sense of smell, exhaustion. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Neck pain, Parosmia, Pyrexia
Clinical narrative: Chills; severe diarrhea for 3 days; no appetite; fever of 100.7 for two days; neck pain; joint pain; migraine; severe fatigue/Exhaustion; increased sense of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 01Mar2021 13:15 (Lot Number: EL9262) (at the age of 61-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension. Concomitant medications within two weeks of vaccination included venlafaxine hydrochloride (EFFEXOR); losartan potassium (LOSARTIN); both taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfur and experienced drug hypersensitivity, cipro [ciprofloxacin] and experienced drug hypersensitivity, iodine and experienced drug hypersensitivity. The patient did not receive any other vaccine within four weeks of vaccination. The patient did not have covid prior vaccination and was not tested for covid post vaccination. On 05Mar2021 19:00, the patient experienced chills, severe diarrhea for 3 days, no appetite, fever of 100.7 for two days, neck pain, joint pain, migraine, severe fatigue, increased sense of smell, exhaustion. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Swelling under left armpit; Very sore to the touch; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 11:00 (at the age of 58-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included osteoarthritis. The patient had also known allergy to ZPac. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); paracetamol (TYLENOL ARTHRITIS); and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE); all were taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265), administered in left arm on 13Feb2021 04:30 PM (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. On 06Mar2021 03:00 PM, the patient experienced swelling under left armpit, and it was very sore to the touch. It was unknown if the patient received any treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 87-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 25, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced swelling, redness and pain in Mar 2021 (two weeks later). The patient did not receive treatment for the events. No history of COVID prior to vaccination and has not been tested for COVID post vaccination. Outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Pain in extremity, Peripheral swelling
Clinical narrative: Knee pain; Fingers swelling/pain; Fingers swelling/pain; Cramps in left leg; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (BNT162B2, Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 11:45 (at the age of 42-year-old) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism, metabolic myopathy and depression. Concomitant medications included levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC); fluticasone propionate (FLONASE); duloxetine; paracetamol (TYLENOL); and CBD (unspecified). No other vaccine in four weeks. No Covid prior vaccination nor tested Covid post vaccination. On 02Mar2021 15:00, the patient experienced knee pain, fingers swelling/pain, and cramps in left leg after 30 min of walking. The patient received no treatment for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Rash
Clinical narrative: Severe blinding headaches; dime sized rash on leg, & back; upset stomach; loose stool; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL3247, expiration date: not reported) via an unspecified route of administration, in right arm, on 02Feb2021 12:30 (at the age of 65-years-old), at dose 1, single as for covid-19 immunization from hospital. Medical history included known allergies to strawberries (hives). Concomitant medications included estradiol; montelukast; amlodipine; spironolactone. 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-19 vaccine. The patient has not been tested with covid-19 after the vaccination.  The patient had her second dose of vaccination on 25Feb2021. The patient experienced severe blinding headaches, dime sized rash on leg, & back, upset stomach and loose stool on 02Feb2021 16:00. No treatment was administered for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nonstop itchiness in her hand post vaccination on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood testosterone, Chills, Diarrhoea, Nausea
Clinical narrative: nausea; fever; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 07Mar2021 17:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure, low testosterone, and thyroid. Patient had no known allergies and was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. Patient had no other vaccine in four weeks. On 08Mar2021, the patient experienced nausea, fever, chills and diarrhea. No treatment was received for the events. Outcome of the events was not recovered. Patient had not been tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: nausea; fever; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 07Mar2021 17:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure, low testosterone, and thyroid. Patient had no known allergies and was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. Patient had no other vaccine in four weeks. On 08Mar2021, the patient experienced nausea, fever, chills and diarrhea. No treatment was received for the events. Outcome of the events was not recovered. Patient had not been tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Sneezing
Clinical narrative: Severe nasal congestion; sneezing; This is a spontaneous report from a contactable consumer (patient).  A 63-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: En 6205),  via an unspecified route of administration, administered in right arm on 07Mar2021 09:30 (at the age of 63-years-old) as dose 1, single for covid-19 immunization.  Medical history included hypertension.  Patient had concomitant medication. The patient experienced severe nasal congestion and  sneezing on 07Mar2021 18:00. No treatment was taken for the events. The outcome of the events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Fatigue; Headache; Low grade fever; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 07Mar2021 at 08:45 (Lot Number: En6204) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies and did not have COVID-19 prior to vaccination. Concomitant medication includes unspecified birth control. The patient was not tested for COVID post vaccination. The patient previously received the first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient experienced body aches, fatigue, headache and low grade fever on 08Mar2021 at 03:00. The patient did not receive treatment for the events. The outcome of the events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Vaccination site erythema
Clinical narrative: tired; shivering; Extremely itchy/ Still very itchy; large red area where the shot was given/ red, but less red than days before.; temperature was 100F-101.9F; This is a spontaneous report from a non-contactable consumer (patient). A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262), via an unspecified route of administration on 25Feb2021 (at the age of 95-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included transient ischaemic attack which started 16 months ago. The patient had no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient was extremely itchy and had a large red area where the shot was given on 26Feb2021. The patient was still very itchy, red, but less red than days before at the time of report. The patient temperature was 100F-101.9F on 26Feb2021 19:30. The patient called 911 and took acetaminophen, liquids, cool compress, get rid of electric blanket, and used wool and/or cotton blankets as treatment. The patient was shivering like she was all day on 26Feb2021. On 27Feb2021, morning, the temperature was 99 F, felt better and was very tired. On 28Feb2021 patient requested going out for a joyride. The outcome of event pyrexia was recovered on an unspecified date. The outcome of all other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: tired; shivering; Extremely itchy/ Still very itchy; large red area where the shot was given/ red, but less red than days before.; temperature was 100F-101.9F; This is a spontaneous report from a non-contactable consumer (patient). A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262), via an unspecified route of administration on 25Feb2021 (at the age of 95-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included transient ischaemic attack which started 16 months ago. The patient had no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient was extremely itchy and had a large red area where the shot was given on 26Feb2021. The patient was still very itchy, red, but less red than days before at the time of report. The patient temperature was 100F-101.9F on 26Feb2021 19:30. The patient called 911 and took acetaminophen, liquids, cool compress, get rid of electric blanket, and used wool and/or cotton blankets as treatment. The patient was shivering like she was all day on 26Feb2021. On 27Feb2021, morning, the temperature was 99 F, felt better and was very tired. On 28Feb2021 patient requested going out for a joyride. The outcome of event pyrexia was recovered on an unspecified date. The outcome of all other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: Rash; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 21Jan2021 15:00 (Batch/Lot Number: EL9261) (at age 55-years old) as dose 2, single for covid-19 immunisation. The first dose was received on 31Dec2020 (lot number: EL0142) (at age 55-years-old) on the left arm. Medical history included known allergies. The patient's concomitant medications were not reported.  There were no other vaccines within four weeks. The patient experienced rash that showed up on L side of face & neck & then sporadically over body on 10Feb2021 15:00. Rash continues to show up as of 08Mar2021 date. Treatment was given for the event that resulted in ER visit and physician's office visit. Outcome of the event was not recovered. Patient was not diagnosed with covid previously and had been tested post vaccination on 02Mar2021: nasal swab: negative.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Nausea, Pain
Clinical narrative: Diarrhea; Nausea; Dizziness; Fever; Chills; Aches; This is a spontaneous report from a non-contactable consumer (patient). A 23-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and unknown if patient had been tested for the COVID-19, post vaccination. On 05Mar2021 at 19:00 hours, patient experienced diarrhea, nausea, dizziness, fever, chills and aches. Patient received no treatment for the events. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; Nausea; Dizziness; Fever; Chills; Aches; This is a spontaneous report from a non-contactable consumer (patient). A 23-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and unknown if patient had been tested for the COVID-19, post vaccination. On 05Mar2021 at 19:00 hours, patient experienced diarrhea, nausea, dizziness, fever, chills and aches. Patient received no treatment for the events. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained