chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Eye pain, Hypoaesthesia oral, Limb discomfort, Oropharyngeal pain
Clinical narrative: Tingly and numbing lower left side of my lip; numbing lower left side of my lip; Eye feel tired; Eye feel tired, low level pain behind them; slight sore throat on the left side; the standard arm feels heavy and a bit achy; This is an initial spontaneous report received from a contactable consumer. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 30Mar2021 16:00  as single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, seasonal allergy and allergy to animal from an unknown date and unknown if ongoing. Concomitant medications included metformin and dulaglutide taken for an unspecified indication, start and stop date were not reported. The patient experienced tingly and numbing lower left side of my lip, eye feeling tired, low level pain behind them, slight sore throat on the left side and the standard arm feels heavy and a bit achy on 30Mar2021 16:30. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tingly and numbing lower left side of my lip; numbing lower left side of my lip; Eye feel tired; Eye feel tired, low level pain behind them; slight sore throat on the left side; the standard arm feels heavy and a bit achy; This is an initial spontaneous report received from a contactable consumer. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 30Mar2021 16:00  as single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, seasonal allergy and allergy to animal from an unknown date and unknown if ongoing. Concomitant medications included metformin and dulaglutide taken for an unspecified indication, start and stop date were not reported. The patient experienced tingly and numbing lower left side of my lip, eye feeling tired, low level pain behind them, slight sore throat on the left side and the standard arm feels heavy and a bit achy on 30Mar2021 16:30. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested positive this past weekend and got her results on sunday 28Mar2021; This is a spontaneous case received report from a non-contactable consumer or other non hcp. A 30-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced she tested positive this past weekend and got her results on sunday 28mar2021 (sars-cov-2 test positive) (medically significant) on 28Mar2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Mar2021 Positive. The action taken in response to the event(s) for bnt162b2 was not applicable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Mood swings, Paranoia
Clinical narrative: Increased mood instability; paranoia; This is a spontaneous report from a contactable consumer. A 29-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 11:00 (At the age of 29-year-old) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included bipolar disorder, anxiety, post-traumatic stress disorder. Concomitant medication(s) included Effexor, Lamictal, abilify, trazodone. Allergies to medications, food, or other products: Sulfa drugs. On 29Mar2021 15:00 the patient experienced increased mood instability, paranoia. 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 has not tested for COVID-19, Since the vaccination. No treatment received. The seriousness was reported non-serious. The outcome of event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pyrexia, Upper-airway cough syndrome
Clinical narrative: cough; painful post nasal drip; headache; feel feverish but have no fever; This is a spontaneous report received from a contactable consumer. A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date was not reported), via an unspecified route of administration, in left arm on 24Mar2021 14:15 as single dose for covid-19 immunization. Medical history included PCOS, ADHD, chronic fatigue, and allergic to penicillin, egg, dairy. Concomitant medication(s) included methylphenidate hydrochloride (CONCERTA), patient received these medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. 6 days later patient experienced a headache, cough and feel feverish but had no fever. Patient also had a painful postnasal drip on 30Mar2021 14:00. Patient not tested for COVID-19 after the vaccination. No treatment received for the reported adverse events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Chills; sweats; headache; very tired, could not get out of bed; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported about a 44 year old male patient reported that the patient received the second dose of BNT162B2; Pfizer-BioNTech COVID-19 Vaccine; Lot number: EN6204; expiry date: unknown; Solution for injection);via an unspecified route of administration in the left arm on 28Mar2021 at 11:45 and received the first dose of Pfizer-BioNTech COVID-19 Vaccine; Lot number: EN6206; Solution for Injection) on 07Mar2021. The known allergies were Digestive allergies to Dairy and Gluten. The patient experienced chills, sweats, body aches, headache, very tired and could not get out on 28Mar2021 at 11:30 pm. The patient received Tetanus shot on 3/18, Prozac. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Headache; dizziness; nausea; feeling unwell; tired; for three days injection site pain. Injection site pain started immediately; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A 75-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 subcutaneous on 21Mar2021 11:00 as single dose for covid-19 immunisation.The patient's medical history and concomitant was not reported. 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 was not tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. On 30Mar2021 06:30, he experienced Headache, dizziness, nausea, feeling unwell, tired and for three days injection site pain. Injection site pain started immediately on 24Mar2021. The others 9 days later and may or may not be related to the vaccine. The outcome of all the events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; dizziness; nausea; feeling unwell; tired; for three days injection site pain. Injection site pain started immediately; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A 75-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 subcutaneous on 21Mar2021 11:00 as single dose for covid-19 immunisation.The patient's medical history and concomitant was not reported. 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 was not tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. On 30Mar2021 06:30, he experienced Headache, dizziness, nausea, feeling unwell, tired and for three days injection site pain. Injection site pain started immediately on 24Mar2021. The others 9 days later and may or may not be related to the vaccine. The outcome of all the events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: 7 days after vaccine I woke with leg weakness. 3 days later my arms are weak; 7 days after vaccine I woke with leg weakness. 3 days later my arms are weak; It is hard to walk or hold; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613) via an unspecified route of administration in left arm on 21Mar2021 18:30 as single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included covid-19 prior to vaccination and concomitant medications were not reported. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Patient had 7 days after vaccine I woke with leg weakness on 27Mar2021 08:00. 3 days later my arms are weak on. It is hard to walk or hold anything. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Both became positive with covid between doses.; Both became positive with covid between doses.; This is a spontaneous report received from a contactable Consumer.   This 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection, LOT NUMBER: UNKNWON) via an unspecified route of administration on an unknown date as a SINGLE dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On last Wednesday (24Mar2021), the patient tested positive of COVID-19 virus. The patient became positive with COVID between doses of the Pfizer vaccine. The second dose of BNT162B2 is scheduled for 07Apr2021; hence, the patient wanted to know whether the second dose of BNT162B2 could be rescheduled.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361947 same reporter/drug/event, different patient
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; fever of 102; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; very tired and exhausted; This is a spontaneous report received from contactable consumer. A 61-years-old female patient had taken BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955), via an unspecified route of administration at the right arm on 23Mar2021 18:00 at single dose for COVID-19 immunization. The patient's medical history included thyroid disorder, severe asthma, osteoporosis, heart disease (previous heart attack). The patient had allergies to penicillin, zpac, sulfa drugs, symbicort, hydrocodone, kiwi, shellfish. Concomitant medications included amlodipine besilate, simvastatin, levothyroxine sodium, fluticasone furoate. The patient had headache 1st 24 hours and very tired into the next 48 (on 23Mar2021), then 4 days later (on 27Mar2021) violent vomiting, diarrhoea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible migraine (not prone to migraines), was sick for about 36 hours and have been exhausted every since. It was reported that patient was homebound for the most part and no one in my house was sick but me. The patient was not diagnosed with covid prior vaccination not tested since vaccination. Outcome of events was reported as recovered with sequel.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Palpitations, Pyrexia, Tremor, Vomiting
Clinical narrative: headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; fever of 102; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing,  shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; very tired and exhausted; This is a spontaneous report received from contactable consumer. A 61-years-old female patient had taken BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955), via an unspecified route of administration at the right arm on 23Mar2021 18:00 at single dose for COVID-19 immunization. The patient's medical history included thyroid disorder, severe asthma, osteoporosis, heart disease (previous heart attack). The patient had allergies to penicillin, zpac, sulfa drugs, symbicort, hydrocodone, kiwi, shellfish. Concomitant medications included amlodipine besilate, simvastatin, levothyroxine sodium, fluticasone furoate. The patient had headache 1st 24 hours and very tired into the next 48 (on 23Mar2021), then 4 days later (on 27Mar2021) violent vomiting, diarrhoea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible migraine (not prone to migraines), was sick for about 36 hours and have been exhausted every since. It was reported that patient was homebound for the most part and no one in my house was sick but me. The patient was not diagnosed with covid prior vaccination not tested since vaccination. Outcome of events was reported as recovered with sequel.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hyperhidrosis, Vertigo
Clinical narrative: Metallic Taste in Mouth; Sweating; Vertigo; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Brand: Pfizer), dose 1 via an unspecified route of administration in Arm Left on 29Mar2021 16:30 (Lot number and expiry date was not reported) as single dose for covid-19 immunisation.  Medical history included hypersensitivity from an unknown date and unknown if ongoing Allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Mar2021 16:45, the patient experienced metallic taste in mouth, sweating and vertigo. Therapeutic measures were not taken as a result of adverse event. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain
Clinical narrative: Achy; Tired; Cough; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/Batch number: not reported), via intramuscularly on the left arm on 29Mar2021 04:15 pm at single dose for COVID-19 immunization. Medical history included diverticulitis. The patient was allergic to scopolamine. The patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. There was no COVID prior vaccination. Previously on an unknown date, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). Since the vaccination, patient had not been tested for COVID-19. On 29Mar2021, patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and on 30Mar2021 at 12 am, the patient reported that she was achy, tired and coughing. The patient did not receive any treatment for the events. The outcome of the events was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Vaccination site swelling
Clinical narrative: Soreness/swollen lymph node under left arm pit the morning after injection along with swollen arm at injection site. Soreness/swollen lymph node is still there 1 week later and has not gone down.; Swollen arm at injection site; Soreness/swollen lymph node under left arm pit; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP7534), via an unspecified route of administration in the left arm on 23Mar2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. The patient medical history included asthma. The patient had allergies to medications, food, or other products which included, shellfish, penicillin, biaxin, ceclor, sulfa, Cephalosporins. Patient reported that she took concomitant medications in two weeks as Mirabegron (MYRBETRIQ). The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 07:00 patient experienced Soreness/swollen lymph node under left arm pit in the morning after the vaccination along with swollen arm at injection site. Patient stated that the Soreness/swollen lymph node is still there 1 week later and has not gone down. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Reddish whole body rash with severe itching; Reddish whole body rash with severe itching; This is a spontaneous report from a contactable nurse (patient). A 64-year-old patient of an unspecified gender received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in Arm Left on 22Mar2021 09:45 (received at the age of 64-years-old) as single dose for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any vaccine within 4 weeks prior to receiving BNT162B2. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. Medical history included known allergies: sulfa. Concomitant medication included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9269), via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:45 (received at the age of 64-years-old) as single dose for COVID-19 immunization. The patient experienced reddish whole body rash with severe itching on 25Mar2021 03:30 PM. Therapeutic measures were taken as a result of reddish whole body rash with severe itching; the patient received oral Benadryl. Outcome of the events was not recovered. It was reported that events resulted into "congenital anomaly" (pending clarification).; Sender's Comments: Based on the information currently available and the product's known safety profile, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of "reddish whole body rash with severe itching" cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Headache, Illness, Pain in extremity, Pruritus
Clinical narrative: I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; Tuesday felt sick; itching; Crazy itchy once I itch it swells up; I'm broke out all over my arm. And face; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration, at arm left on 22Mar2021 12:00 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included high blood pressure. The patient had no allergies to medications, food, or other products. The patient received antibiotics within 2 weeks of vaccination. The patient concomitant medications were not reported. The patient got the shot and came home ever thing was fine then arm started hurting no big deal then the headache so bad I had tears. Carpet installer most of my life now that all happened Tuesday felt sick, we and things seemed instill till about the 26th started itching bad and it got worse and broke out all over my arm and face. Crazy itchy once I itch it swells up. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; Tuesday felt sick; itching; Crazy itchy once I itch it swells up; I'm broke out all over my arm. And face; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration, at arm left on 22Mar2021 12:00 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included high blood pressure. The patient had no allergies to medications, food, or other products. The patient received antibiotics within 2 weeks of vaccination. The patient concomitant medications were not reported. The patient got the shot and came home ever thing was fine then arm started hurting no big deal then the headache so bad I had tears. Carpet installer most of my life now that all happened Tuesday felt sick, we and things seemed instill till about the 26th started itching bad and it got worse and broke out all over my arm and face. Crazy itchy once I itch it swells up. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dysgeusia, Feeling abnormal
Clinical narrative: Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; her body started to feel strange/ just felt weird; This is a spontaneous report from a non-contactable consumer (patient). A 43-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in left arm, on 12Mar2021 at 02:30pm (at age of 43 years old), as a single dose, for COVID-19 immunisation. Medical history included migraine and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ondansetron (ZOFRAN) and oxymetazoline hydrochloride (CLARITIN ALLERGIC), Nurtec and allergy immunotherapy; all started on an unspecified date and for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the BNT162b2 vaccine. On 12Mar2021 (at 6:00pm), the patient experienced a metal taste in her mouth, mild on first afternoon but stronger tasting on next two days. On Day 2, it was reported that her body started to feel strange, could not quite describe feeling, further described as it was not really a tired feeling or a painful feeling, just felt weird. On 25Mar2021, the patient experienced Bells palsy. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the events metal taste in her mouth, body started to feel strange/just felt weird. The clinical outcome of the events, metal taste in her mouth, body started to feel strange/ just felt weird, was recovered on an unspecified date. The clinical outcome of the event Bells palsy was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: I am a moderate diabetic but after the injection I have had a considerable increase in fasting and postprandial blood glucose reaching 330.; This is a spontaneous report received from a contactable Health care Professional. A 81-year-old male Patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number and Expiration date: UNKNOWN ), via an unspecified route of administration in left arm on 27Mar2021 15:00 as a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included Metformin 850mg, gliclazide 60 mg, detusitol. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19.   On 28-MAR-2021 at 08:00, the patient stated, I'm diabetic, moderate, but after the injection I've been presenting high fasting and postprandial blood sugar level, reaching to 330. Patient was treated with Glicazide (dose increased). Seriousness of the event was not reported. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number unknown) via unspecified route on 05Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number unknown) via unspecified route on an unspecified date as SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported.06Mar2021, The patient experienced chills and headache. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, SARS-CoV-2 test
Clinical narrative: mid-cycle bleeding two weeks after my first dose; This is a spontaneous report from a contactable Nurse. A non-pregnant 45-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EK9231; Expiration Date: unknown), dose 1 via an unspecified route of administration, in Arm Left on 31Dec2020 09:15 as SINGLE DOSE for COVID-19 immunization. The patient received the second dose on 22Jan2021 09:00 AM in left arm (Batch/Lot Number: EL8982). Medical history included sulfa [sulfacetamide sodium; sulfadiazine; sulfadimidine; sulfamerazine]. Sulfa. The patient's concomitant medications were not reported.The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within 4 weeks.The patient did not receive any other vaccines within 2 weeks. In Jan 2021, the patient experienced mid-cycle bleeding two weeks after the first dose (metrorrhagia).The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 22Mar2021, sars-cov-2 antibody test: positive on 30Mar2021, sars-cov-2 antibody test: negative on 22Mar2021.The outcome of evet was recovering. No follow-up attempts are needed; Information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia
Clinical narrative: experienced left arm numbness after vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced left arm numbness after vaccine on an unspecified date. The outcome of the event was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstruation after 2nd dose/The following day after I received the 2nd shot I started to bleed heavily; This is a spontaneous report received from a contactable consumer (Patient). A 42-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6200 and expiration date not provided) via an unspecified route of administration, administered in right arm on 24Mar2021 02:00 PM as SINGLE DOSE for COVID-19 immunization. The patient's medical history was not provided. The patient's historical vaccine included first dose of BNT162B2 (Solution for injection, lot number EN6203 and expiration date not provided) via an unspecified route of administration, administered in right arm as SINGLE DOSE on 03Mar2021 2:00 PM for COVID-19 immunization. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25 Mar 2021, the patient had irregular menstruation after 2nd dose and it was reported that, following day after the patient received the 2nd shot and she started to bleed heavily. Heavy bleeding consisted for 5 days. On the 6th day it stopped. The patient assessed the events as non-serious.cThe adverse event resulted in emergency room. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On 31 Mar2021, the event was resolved.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID days before he was due to receive his 2nd dose of the Pfizer vaccine; contracted COVID days before he was due to receive his 2nd dose of the Pfizer vaccine; This is a spontaneous report from contactable consumer via Pfizer Sales Representative.  A 63-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  This healthy male contracted COVID days before he was due to receive his 2nd dose of the Pfizer vaccine. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Pain, Vaccination failure
Clinical narrative: Test COVID 19 test/Date 21Feb2021/Result Positive; Test COVID 19 test/Date 21Feb2021/Result Positive; Chills; achy; slight cough; This is a spontaneous report from a contactable consumer (patient's daughter). A 86-year-old female patient received second dose of BNT162B2 (Solution for injection, via intramuscular, administered in left arm on 13Feb2021 (Batch/Lot number: unknown) at single dose for covid-19 immunisation. Medical history included patient is diabetic, congestive heart failure, Oxygen 2 lpm. Concomitant medication was not reported. The patient had a past drug of BNT162B2 for COVID-19 immunisation on Jan2021 at the age of 86-year in left arm via intramuscular. The patient was laying in bed and had cough, achy, chills on 19Feb2021. Patient had both Pfizer COVID-19 vaccinations. The first date was unknown, but believed to be 3 weeks prior to last administration date of 13Feb2021. On 21Feb2021 patient tested positive for COVID-19. Outcome of the event cough, achy, chills was recovered on an unspecified date of 2021 and outcome of other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: PPV
Symptoms: Blood test, Computerised tomogram, Pneumonia, Pyrexia, X-ray
Clinical narrative: Pneumonia; Pneumonia; This is a spontaneous report from a contactable consumer (patient's husband). A 78-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unspecified), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got pneumonia on an unspecified date; the patient received Pneumonia vaccine a couple of years ago. It was not known the exact time the pneumonia started. It developed over a period of several day started with a mild fever and after the 2nd or 3rd day her fever spiked and that's when she was admitted to the hospital. No treatment done over the weekend, while she was in the nursing home. No treatment before going to the hospital other than calling the doctor and the doctor saying take her to the hospital. The adverse event also resulted in Emergency Room visit. The patient was hospitalized from 18Mar2021 to 26Mar2021. She had a lot of blood work done, a CT scan, an X-ray, the physicians have the result. The outcome of events was recovered on 24Mar2021 (as reported).  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information about lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Foreign body sensation in eyes, Headache, IIIrd nerve paralysis
Clinical narrative: Drooping and closed left eyelid/third nerve ocular palsy paralysis; Headache; Sandy eyes; This is a spontaneous report received from a contactable consumer (Patient) reporting for himself. A 73-year-old patient received second dose of BNT162B2 0.3ml on 26Feb2021 at 12:00 pm (Lot no: EN6203, Expiration date: unknown) via intramuscularly route of administration in right arm as SINGLE DOSE for covid-19 immunization. The patient does not have cardiovascular disease, he just had a blockage at one time. The patient had one stent put in and low dose to preventative for plaque buildup in veins. The patient's concomitant medications included Simvastatin for mild heart attack in 2013. The patient previously vaccinated with first dose of BNT162B2 on 05Feb2021 at 13:00 pm and 5 days later got sandy eye. It was reported that, on 04Mar2021 (3 weeks later of second dose) the patient experienced blurred vision and drooping, closed left eyelid which were diagnosed as third nerve ocular palsy paralysis on 08Mar2021.  It was reported that the patient still gets Headaches periodically. The outcome of the events was not recovered.  Follow attempts are requested. Further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: Stated that her knees are killing her. Clarified that her knees are hurting; This is a spontaneous report from a Pfizer-sponsored program XELSOURCE. A contactable consumer (patient) reported for herself that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 26Mar2021 as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ 5mg tablet, Batch/Lot Number: EH1886; Expiration Date: Jun2024), oral from an unspecified date 7 to 8 years ago to 26Mar2021 at 5 mg twice daily for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient previously took adalimumab (HUMIRA injection) for rheumatoid arthritis, started 15 years ago and stopped taking it 7-8 years ago permanently, unknown dosage injection to her arm every two weeks and she did not like the shot that she is a big baby; it quit working because she did not take it like she was supposed to. Patient was off of the tofacitinib citrate since last Friday (26Mar2021) since she got the Pfizer Covid vaccine. Stated that her knees were killing her, she could feel her knees when she bended and it was annoying. Clarified that her knees were hurting. It started Sunday night (28Mar2021) that she realized it. When she got up she could feel it. Stated normally she does not have any problems with her knees. When standing from sitting position that she noticed them. She should have said they were not killing her but that they were noticeable. This has been happening without the medication. Stated that she took the medication Thursday night to take the shot Friday morning. Stated that it was about three days later that they started annoying her. She would start back on it on Friday. The doctor wanted her off of it for seven days. The action taken in response to the event for tofacitinib citrate was post-therapy. Outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Lymphadenopathy
Clinical narrative: a lump in my lymph node; severe back pain; fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 for COVID-19 immunization on an unspecified date. In Mar2021, the patient experienced severe back pain, a lump in my lymph node and fatigue since receiving. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: I have pain in the armpit area that started on 3/30 in the evening; visional swelling on in the left armpit area above the breast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure/ allergies. Concomitant medication(s) included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient also received Desloratin within 2 weeks of vaccination. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination. Since 30Mar2021 17.30 (05:30 PM) evening, the patient had pain in the armpit area. The patient took Tylenol before going to bed. This morning (30Mar2021) there was visional swelling on in the left armpit area above the breast. Outcome of the event was not recovered.  No follow up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller stated a family member had the first dose of Pfizer's COVID vaccine and got COVID.; Caller stated a family member had the first dose of Pfizer's COVID vaccine and got COVID.; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), 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. On an unspecified date, it was reported that the patient had the first dose of Pfizer's COVID vaccine and got COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: got covid on an unspecified date. The outcome of the events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.