chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lip swelling, Pharyngeal swelling, Throat tightness, Urticaria
Clinical narrative: Sensation of throat closure; Localized injection site urticarial; hives/generalized urticaria (hives)- limited to face; an hour out with throat swelling had to take a drink to swallow. /her throat started swelling again but worse; Lip swelling; Difficulty breathing; This is a spontaneous report from a contactable other hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE), dose 1 intramuscularly, administered in arm (deltoid) on 02Mar2021 (Lot Number: EN6202) as dose 1, single at the age of 56-year-old for COVID-19 immunization. Medical history included environment allergy. The patient previously took Adrenaline (Epipen) and experienced allergy. No concomitant medications. The patient did not take any medications prior to the event being reported. No relevant test. No laboratory tests or diagnostic studies performed. The patient did not receive any vaccines for any other conditions prior to the event reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient experienced hives, an hour out with throat swelling had to take a drink to swallow. /her throat started swelling again but worse, lip swelling, difficulty breathing on 02Mar2021; sensation of throat closure, localized injection site urticarial on an unspecified date. Organ involved included respiratory yes: difficulty breathing (without wheeze or stridor) and sensation of throat closure; Cardiovascular: No; Dermatological/Mucosal: Yes generalized urticaria (hives)- limited to face and localized injection site urticarial; Gastrointestinal: No; Any other symptoms/signs: No. The patient did not require medical intervention. It was unknown if the patient seen in the Emergency Department. The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit. Treatment received for all the events which included benadryl and famotidine. The outcome of lip sweliing was recovered spontaneously on 02Mar2021. The outcome of hives/generalized urticaria (hives)- limited to face was recovered in 2021. The outcome of other events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Sensation of throat closure; Localized injection site urticarial; hives/generalized urticaria (hives)- limited to face; an hour out with throat swelling had to take a drink to swallow. /her throat started swelling again but worse; Lip swelling; Difficulty breathing; This is a spontaneous report from a contactable other hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE), dose 1 intramuscularly, administered in arm (deltoid) on 02Mar2021 (Lot Number: EN6202) as dose 1, single at the age of 56-year-old for COVID-19 immunization. Medical history included environment allergy. The patient previously took Adrenaline (Epipen) and experienced allergy. No concomitant medications. The patient did not take any medications prior to the event being reported. No relevant test. No laboratory tests or diagnostic studies performed. The patient did not receive any vaccines for any other conditions prior to the event reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient experienced hives, an hour out with throat swelling had to take a drink to swallow. /her throat started swelling again but worse, lip swelling, difficulty breathing on 02Mar2021; sensation of throat closure, localized injection site urticarial on an unspecified date. Organ involved included respiratory yes: difficulty breathing (without wheeze or stridor) and sensation of throat closure; Cardiovascular: No; Dermatological/Mucosal: Yes generalized urticaria (hives)- limited to face and localized injection site urticarial; Gastrointestinal: No; Any other symptoms/signs: No. The patient did not require medical intervention. It was unknown if the patient seen in the Emergency Department. The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit. Treatment received for all the events which included benadryl and famotidine. The outcome of lip sweliing was recovered spontaneously on 02Mar2021. The outcome of hives/generalized urticaria (hives)- limited to face was recovered in 2021. The outcome of other events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased
Clinical narrative: 12Mar2021 showing 1.06, on 19May2021 1.16 High, on 05Aug2021 1.10 High, on 16Aug2021 1.13 High, on 08Sep2021 1.29 High; This is a spontaneous report from a contactable consumer and a non-contactable consumer (patient).  A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular, administered in Arm Right on 09Apr2021 (Batch/Lot number was not reported) (at the age of 53-year-old) as single dose for covid-19 immunisation. Medical history included Hashimoto Disease. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not had covid tested post vaccination. Known allergies was not applicable. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in Left arm on 08Mar2021 (Batch/Lot number was not reported) (at the age of 53-year-old) as single dose for covid-19 immunisation and following her 08Mar2021 dose, (name withheld) went to the doctor and bloodwork was done on 12Mar2021 showing 1.06 high creatinine levels. (name withheld) has also reported pain near kidneys. Facility type Vaccine was Health Clinic. Concomitant medications included thyroid (ARMOUR THYROID); hydroxychloroquine sulfate (PLAQUENIL), all taken for an unspecified indication, start and stop date were not reported. Creatinine levels have increased since as follows after second dose: on 28Apr2021 1.06 High, on 06May2021 1.03 High, on 19May2021 1.16 High, on 05Aug2021 1.10 High, on 16Aug2021 1.13 High, on 08Sep2021 1.29 High. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had not received treatment. The outcome of the event was Not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Lip swelling, Periorbital swelling, Swelling of eyelid
Clinical narrative: swelling under her right eye; swelling to both upper and lower eyelids and upper and lower Iips; swelling to both upper and lower eyelids and upper and lower Iips; inflammation; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Mar2021 for covid-19 immunization, took tacrolimus for dermatitis atopic. Patient was a 36-year-old female who was injected with a total of 1 ml of what she believes to be Restylane Kysse (Lot and exp Unknown) to tear troughs and upper and lower lips on 20Apr2021. She reported that she developed swelling under her right eye one day in Aug2021 and the next day she woke up with swelling to both upper and lower eyelids and upper and lower lips, she reported they were very inflamed. She saw the HCP who administered certisone injections to both eyes and lips and prescribed her with a 5-day course of oral prednisone, swelling resolved. After finishing the oral prednisone, the swelling returned (02Sep2021). She contacted the HCP by phone and sent him photos of the swelling and he prescribed her lisinopril 5 mg daily and advised she take cetirizine dihydrochloride and fexofenadine. She reported that she was reluctant to take the lisinopril because its for high blood pressure. Event has not resolved, still has swelling and inflammation both eyes and upper and lower lips. She reported that she was diagnosed with atopic dermatitis around the eyes 6 weeks prior to injections, she was treated with Tacrolimus ointment which she had stopped about 2 weeks prior to injections. No other medical history, allergies, or medications. Had the Pfizer Covid 19 vaccination 1st dose 15Mar2021 and 2nd dose 07Apr2021. No other vaccines, illnesses, or dental procedures in the last 6-12 months. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer. The reporter reported 3 reports, this is the 1 of 3 reports. This case was split from master case 202101198829 for a patient taking Bnt162b2 and experienced Bell's palsy.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization.Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bell's palsy. First, data reported in the Food and Drug Administration briefings suggest risk of Bell's palsy is greatest within 1 month of a second vaccine dose. The Pfizer briefing notes from dose 1 through 1 month after dose 2, there were three reports of Bell's palsy in the vaccine group and none in the placebo group. The outcome of event was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101207187 Same article, different patients with same drug;US-PFIZER INC-202101207188 Same article, different patients with same drug
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a literature report. This reporter reported 3 reports, this is the 2 of 3 reports. This case was split from master case 202101198829 for a patient taking Bnt162b2 and experienced Bell's palsy. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced bell's palsy. First, data reported in the Food and Drug Administration briefings suggest risk of Bell's palsy is greatest within 1 month of a second vaccine dose. The Pfizer briefing notes "from dose 1 through 1 month after dose 2, there were three reports of Bell's palsy in the vaccine group and none in the placebo group". The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101207186 Same article, different patients with same drug;US-PFIZER INC-202101207188 Same article, different patients with same drug
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Myocarditis
Clinical narrative: a family friend whose son had myocarditis; almost had a heart attack; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date consumer reported that, a family friend whose son had myocarditis, and almost had a heart attack. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Sep2021 08:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as dose 1, single for covid-19 immunisation and experienced nausea which lasted for a day. The patient experienced fever on 14Sep2021 20:00 which he classified as mild fever. However, patient did not have a thermometer to verify the temperature. The patient underwent lab tests and procedures which included body temperature: unknown results on 14Sep2021. Patient took Tylenol last night (14Sep2021) and today (15Sep2021) around 12:00 to treat post vaccination symptoms. Caller wanted to know if it was safe to take them. Caller also wanted to know if it was recommended to drink plenty of water to help alleviate the symptoms. The outcome of event fever was not recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: lack of efficacy- Fully vaccinated for CV19 with symptoms 14Sep2021 and positive CV19 test 15Sep2021; lack of efficacy- Fully vaccinated for CV19 with symptoms 14Sep2021 and positive CV19 test 15Sep2021; This is a spontaneous report from a contactable other hcp. A 41-year-old male patient of an received Second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: EL3247), via intramuscularly, administered in Arm Left on 15Feb2021 (age at vaccination was 41 years old) as DOSE 2, Single and first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: EL3247) via intramuscularly, administered in Arm Left on 26Jan2021 (at the age of 41 years old) as DOSE 1, Single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was unknown if diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Sep2021, the patient experienced lack of efficacy- fully vaccinated for cv19 with symptoms 14sep2021 and positive cv19 test 15sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive via Nasal Swab on 15Sep2021. Facility where the most recent COVID-19 vaccine was administered was clinic. The patient did not received any treatment. The outcome of the event was recovering.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reas-sessed once new information is available.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Musculoskeletal stiffness
Clinical narrative: patient reports the stiffness has gotten worse, she doesn't think it could get any worse.; received her second dose yesterday 14Sep2021 and now her whole body is stiff.; This is a spontaneous report from a contactable consumer (patients fiance). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2588, Expiration date: 14Sep2021), dose 2 via an unspecified route of administration, administered in Arm Left on 14Sep2021 13:10 (age at vaccination 44 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Patient received historical vaccine Flu shot 2017 Flu Shot, ended up in the hospital because she got both strains of the flu. NDC, Lot, Expiration: Unknown Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: FA7485) via an unspecified route of administration on 24Aug2021 as single dose for COVID-19 immunization and experienced headache. The patient experienced received her second dose yesterday 14sep2021 and stiffness now her whole body is stiff on 15Sep2021, the stiffness has gotten worse, she doesn't think it could get any worse on an unspecified date. Reporter stated caller is calling on behalf of her fiance. Her fiance received the first dose on 24Aug2021 and had a headache after this that she still has from the first dose and received her second dose yesterday 14Sep2021 and now her whole body is stiff. And asking if this is a side effect. Patient not visited physician office or emergency room. The patient did not receive any treatment for reported events. The outcome of event was not recovered.  No follow up attempts are needed, No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Inappropriate schedule of product administration
Clinical narrative: started to flush slightly; First dose: administered on 05Apr2021/Second dose: administered on 14Sep2021; This is a spontaneous report from a contactable consumer (patient herself). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection and Lot Number: EW0185) via an unspecified route of administration in arm right on 14Sep2021 10:23 (age at vaccination 37 year) as dose 2, 0.3 ml, single for COVID-19 immunization. Medical history included Penicillin allergy and compromised immune system. The concomitant medications were none. Patient historical vaccine included hepatitis A for immunization which caused hives (several years ago). The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: ER8729) via an unspecified route of administration in right upper arm on 05Apr2021 at 15:30 as single dose for COVID-19 immunization and experienced with Pain at the injection site of her right upper arm, Severe flushing and tingling in upper lip and tongue. Initially he advised her against getting the second dose of the Pfizer COVID-19 Vaccine until there was more data available. Reporter stated with the new data coming out last month about safety of giving the second dose of Pfizer COVID-19 Vaccine after a patient has a reaction to the first Pfizer COVID-19 Vaccine that the physician felt it was safe to give her the second dose of Pfizer COVID-19 Vaccine. She was approved to get the second dose of Pfizer COVID-19 Vaccine with pre-medication. On 14Sep2021 at (Withheld) Hospital she was pre-medicated with 25mg of Benadryl and 20mg of Pepcid. She was administered second dose of Pfizer Covid-19 Vaccine on 14Sep2021 at 10:23. She started to flush slightly around 10:40. She was administered 25 mg of Benadryl and that resolved the event of started to flush slightly. She had no further incidents, was able to tolerate the second dose. She recovered completely from this event within about 24 hours also. They did not send her to the emergency room this time, they felt that the reaction was well controlled with the antihistamines. On 15Sep2021, the outcome of the event Flushing was resolved.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Rhabdomyolysis
Clinical narrative: Rhabdomyolysis; This is a spontaneous report from a contactable pharmacist. This pharmacist reporting same events under the same suspect product for 3 patients. This is the first of three reports.  A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC3180, expiry date: 16Sep2021), via an unspecified route of administration, administered in Deltoid Left on 15Sep2021 (at the age of 14-years-old) as dose 2, 0.3 ml single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC3180, expiry date: 16Sep2021,) via an unspecified route of administration, administered in deltoid left on 14Aug2021 (at the age of 14-years-old) as dose 1, 0.3 ml single for covid-19 immunization. The pharmacist was calling about the Pfizer covid 19 vaccine and went out to a facility yesterday on 15Sep2021, gave second dose and experienced Rhabdomyolysis within 20 minutes of the vaccine. It was a mild case of rhabdomyolysis and the patient did not have to stay in the hospital. The patient went to the emergency room but was never admitted as a patient. This event happened with the patients second dose. This patient was not a foreign exchange student. The pharmacist wants to know if Pfizer has any information on this. No Serious was reported. The patient had her CPK levels checked yesterday, on 15Sep2021, but did not have the results listed yet. The outcome of the event was not recovered.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between event Rhabdomyolysis and the suspect drug BNT162B2 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.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: got her first dose of the Pfizer BioNTech Covid-19 vaccine /Afterward, she breastfed her 14 month old son; got her first dose of the Pfizer BioNTech Covid-19 vaccine /Afterward, she breastfed her 14 month old son; Sore arm; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. This is 1 of 2 reports. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 15Sep2021 20:30 as dose 1, single for COVID-19 immunization. Patient got her first dose of the Pfizer BioNTech Covid-19 vaccine yesterday (15Sep2021) at about 20:30 afterward, she breastfed her 14-month-old son. Around 03:00 he started throwing up.   Stated she got the vaccine yesterday (15Sep2021) around 20:30. Around 03:00 this morning (16Sep2021) her baby started throwing up. Stated she had breastfed him after receiving her vaccine last night. Said she just had a sore arm for herself on an unspecified date in Sep2021. She stated that her son had no symptoms prior to this. The outcome of the event sore arm was unknown.   The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.  Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101218735 Same reporter/drug, different patient/event (mother/baby case)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 intramuscular on 03Mar2021 12:00 (at the age of 52-year-old) (Batch/Lot Number: E13247) as DOSE 1, SINGLE and bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Left on 24Mar2021 12:00 (at the age of 52-year-old) (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Known allergies to Penicillin and Celebrex from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) taken for an unspecified indication, start and stop date were not reported. After dose 2, the patient tested positive for covid 19 (vaccination failure) (medically significant) on 15Sep2021 12:00. The patient underwent lab tests and procedures which included covid-19 virus test (Nasal swab): positive on 15Sep2021. Patient did not receive any treatment for adverse events. Patient did not have pregnancy at time of vaccination. Patient did not receive any other vaccine in four weeks. It was reported that the patient had not been diagnosed with covid prior to vaccination. Outcome of events were not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up/vomiting; This is a spontaneous report from a contactable consumer. This consumer (patient) reported. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on Sep2021 as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Sep2021, the patient received second dose of Pfizer Vaccine almost an hours ago and started throwing up. So was not sure just if the patient need to go to the hospital or kind just waited out at home. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Deep vein thrombosis, Dyspnoea, Laboratory test, Loss of consciousness
Clinical narrative: pulmonary emboli - both lungs; DVT right thigh; shortness of breath; body weakness; passed out; syncope; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER COVID-19 VACCINE, Batch/Lot Number: EL1284), via an unspecified route of administration, administered in arm left on 16Jan2021 (at the age of 74-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included asthma and hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); fexofenadine hydrochloride (ALLEGRA); diltiazem; simvastatin (SIM), all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 (at the age of 74-year-old) as single dose for COVID-19 immunization. The patient experienced shortness of breath, body weakness, passed out 27Feb2021 at 13:00, March 2nd passed out - admitted to hospital, all negative tests, March 12 passed out -admitted to hospital again, March 12 - pulmonary emboli - both lungs, DVT right thigh - loop recorder implanted, on Eliquis 5mg twice a day. The patient was put on Celexa March 13 - 20mg - SSRI sometimes helps with syncope. The events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The events were considered as serious due to hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was hospitalized for 10 days. The patient also received treatment for pulmonary emboli included lovenax injections. Since the vaccination, the patient had been tested for COVID-19 with the type of nasal swab in ER on 12Mar2021: negative result. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) PFIZER INC-202101228425 same patient/vaccine, different dose, similar event
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test, Syncope
Clinical narrative: pulmonary emboli - both lungs; DVT right thigh; shortness of breath; body weakness; passed out; syncope; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER COVID-19 VACCINE, Batch/Lot Number: EL1284), via an unspecified route of administration, administered in arm left on 16Jan2021 (at the age of 74-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included asthma and hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); fexofenadine hydrochloride (ALLEGRA); diltiazem; simvastatin (SIM), all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 (at the age of 74-year-old) as single dose for COVID-19 immunization. The patient experienced shortness of breath, body weakness, passed out 27Feb2021 at 13:00, March 2nd passed out - admitted to hospital, all negative tests, March 12 passed out -admitted to hospital again, March 12 - pulmonary emboli - both lungs, DVT right thigh - loop recorder implanted, on Eliquis 5mg twice a day. The patient was put on Celexa March 13 - 20mg - SSRI sometimes helps with syncope. The events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The events were considered as serious due to hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was hospitalized for 10 days. The patient also received treatment for pulmonary emboli included lovenax injections. Since the vaccination, the patient had been tested for COVID-19 with the type of nasal swab in ER on 12Mar2021: negative result. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) PFIZER INC-202101228425 same patient/vaccine, different dose, similar event
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Hypertension, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: Stroke; Heart attack; High blood pressure; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Aug2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included sleep apnoea syndrome. The patient's concomitant medications were not reported. The patient experienced high blood pressure, stroke, heart attack on 19Aug2021 15:00. The patient was hospitalized for the events for 2 days. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events including medications. The patient underwent lab tests and procedures which included blood pressure measurement: high on 19Aug2021, Covid test (Nasal Swab): negative on 09Aug2021, Covid test (Nasal Swab): negative on 14Aug2021. The outcome of the events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: like she had something poured on her tongue as she was injected, patient stated that it was the weirdest thing and it was the nastiest tasting stuff; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN9581, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 05Feb2021 at 16:15 hours as dose 1, single (at the age of 68-years-old) for Covid-19 immunisation. Medical history included obese and flu (maybe 5 years ago from being in an elevator with little kids on vacation, she knows exactly where she got it and within no time, she had a fever and was sick) (all from an unknown date and unknown if ongoing). Patient had no relevant family medical history. Patient had no prior vaccinations (within 4 weeks). Concomitant medication(s) included rivaroxaban (Xarelto) taken as blood thinner (at this point, she had been on it maybe 2 years) from an unspecified start date and ongoing. Historical vaccine included patient received Polio vaccine (Batch/Lot number and Expiration date was not reported) via unspecified route of administration on an unspecified date for immunisation and patient stated that she does not remember when but, when they applied the Polio vaccine, they prick the skin and had no reaction. That was the way it was administered. She had no issues. Patient stated that she does not take vaccines and does not take the flu vaccine. Patient stated that she does not take them, she never had any of that stuff other than the Polio vaccine (when she was 6). On 05Feb2021 at 16:15 hours, when patient took the first dose, when they administered it, she could taste the vaccine immediately when it was injected in her right arm. She could taste the vaccine, like she had something poured on her tongue as she was injected, patient stated that it was the weirdest thing, and it was the nastiest tasting stuff. It lingered on her tongue and lasted for a good portion of that afternoon. It was the remainder of that first day. Patient stated that it did not happen the second time. No relevant tests were performed. The outcome of the event was recovered on 05Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Palpitations
Clinical narrative: constant chest pain; Heart palpitations; Fatigue; This is a spontaneous report from a contactable consumer reporting for husband. This report is not related to a study or programme. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced constant chest pain, heart palpitations, fatigue on an unspecified date. Reporter stated that patient received the vaccine on the 09 and he had this constant chest pain and heart palpitations and fatigue, and he was expensing on the EB. When probed for the confirmation of vaccine name as Pfizer COVID-19 Vaccine, Reporter stated that he had that since he got the first Pfizer COVID vaccine. Reporter was informed about the role of Pfizer drug safety. Reporter stated that she just wanted someone to report it and know what she needed to do from there. Reporter asked what Pfizer would recommend that they do with these adverse side effects. Reason for no lot number of COVID-19 Vaccine was caller unwilling to complete the report. Further probing could not be done as the reporter was unwilling to complete the report. Hence, limited information available over the call. Clinical outcome of events was unknown.  Information about lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Muscle spasms, Myalgia
Clinical narrative: Severe stomach cramping; Nausea; Bad headaches; Fatigue; Frequent urination; Muscle cramping; Muscles aches all over body; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient had no medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On an unknown date in 2021, the patient experienced severe stomach cramping, nausea, bad headaches, fatigue, frequent urination, muscle cramping and muscles aches all over body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe stomach cramping, nausea, bad headaches, fatigue, frequent urination, muscle cramping, muscles aches all over body was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pollakiuria
Clinical narrative: Severe stomach cramping; Nausea; Bad headaches; Fatigue; Frequent urination; Muscle cramping; Muscles aches all over body; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient had no medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On an unknown date in 2021, the patient experienced severe stomach cramping, nausea, bad headaches, fatigue, frequent urination, muscle cramping and muscles aches all over body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe stomach cramping, nausea, bad headaches, fatigue, frequent urination, muscle cramping, muscles aches all over body was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Presyncope, SARS-CoV-2 test
Clinical narrative: Contining to have near pass outs; 3rd dose 20Aug2021; 3rd dose 20Aug2021; This is a spontaneous report from a contactable consumer (the patient). A 75 -year-old non-pregnant female patient received the third dose of BNT162B2 (PFIZER COVID-19 VACCINE, Lot Number: FC3181) via an unspecified route of administration, administered in Arm Left on 20Aug2021 10:45 at age of 75 -year-old at single dose for COVID-19 immunisation. Medical history included asthma, hypertension and diagnosed with CML on 06Aug2021. The patient was not diagnose with COVID-19 prior to vaccination. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), fexofenadine hydrochloride (ALLEGRA), diltiazem, and simvastatin (SIM) all taken for unspecified indication(s) from unspecified date(s). The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration in left arm on 28Dec2020 10:45AM at the age of 74-year-old for COVID-19 immunization. The patient previously took the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in arm left on 16Jan2021 at the age of 74-year-old for COVID-19 immunization and experienced shortness of breath, body weakness, passed out 27Feb2021 at 13:00; 12Mar2021 - pulmonary emboli - both lungs, DVT right thigh; and syncope. It reported the patient had 3rd dose 20Aug - continuing to have near pass outs in 2021. The patient had 3 episodes of near pass outs this week. The event resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The event was considered as serious due to hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Hospitalization not prolonged. The patient was hospitalized for 10 days. Nasal Swab in ER was negative on 12Mar2021. Since the vaccination in 2021, the patient had been tested for COVID-19 (unknown result). The outcome of event "contining to have near pass outs" was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt as sick; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (reported for a patient). A 5-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and experienced no adverse event. On an unspecified date, the patient experienced felt as sick. It was reported by the reporter that two people that she knows got their first dose of the Pfizer BioNTech Covid 19 vaccine and were fine, but after their second doses, they said they felt as sick as they did when they had COVID (prior to vaccination). They both recovered Both female, one about 20 years old (college student who lived with her grandparents), one in her 40's. She asked if we could explain why they were that sick, and if they get the booster dose, will they get as sick again. The outcome of the event was reported as resolved on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101224549 same reporter/drug/AE, different patients
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Illness, Pain in extremity
Clinical narrative: made her arm sore; symptoms of covid -19/tested positive for covid-19; I believe the Pfizer vaccine got me and my 12 year old daughter sick.; This is a spontaneous report from a contactable consumer reported for herself and her daughter, this case is for herself. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Aug2021 14:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at age of 41 years old. Medical history was none. Concomitant medication included semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported. The patient reported that that prior to her first covid Pfizer shot on 26Aug2021, she had a negative covid test. Prior to vaccination, the patient was not diagnosed with COVID-19. The shot made her arm sore on 06Sep2021 at 12: 00, and on 06Sep2021 she started to get symptoms of covid -19. She tested positive for covid-19 on 09Sep2021. She believed the Pfizer vaccine got her and her 12 years old daughter sick. The events were serious per life threatening and required physician office visit. No treatment received for the events. The patient underwent lab tests and procedures which included Covid 19 test (Nasal Swab): negative on 17Sep2021. The outcome of the events was resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Dyspnoea
Clinical narrative: made her arm sore; symptoms of covid -19/tested positive for covid-19; I believe the Pfizer vaccine got me and my 12 year old daughter sick.; This is a spontaneous report from a contactable consumer reported for herself and her daughter, this case is for herself. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Aug2021 14:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at age of 41 years old. Medical history was none. Concomitant medication included semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported. The patient reported that that prior to her first covid Pfizer shot on 26Aug2021, she had a negative covid test. Prior to vaccination, the patient was not diagnosed with COVID-19. The shot made her arm sore on 06Sep2021 at 12: 00, and on 06Sep2021 she started to get symptoms of covid -19. She tested positive for covid-19 on 09Sep2021. She believed the Pfizer vaccine got her and her 12 years old daughter sick. The events were serious per life threatening and required physician office visit. No treatment received for the events. The patient underwent lab tests and procedures which included Covid 19 test (Nasal Swab): negative on 17Sep2021. The outcome of the events was resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.