chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Myalgia, Pharyngeal swelling
Clinical narrative: Closed throat; Couldn't breathe; Swollen tongue; Right calm muscle pain; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number Fd8020 or f48020), via an unspecified route of administration, administered in Arm Left on 23Oct2021 13:30 (at the age of 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and within 2 weeks of vaccination patient received: Albuterol, Wixela, Xanax. Medical history included covid-19 from an unknown date and unknown if ongoing If Covid prior vaccination: Yes, irritable bowel syndrome from an unknown date and unknown if ongoing IBS, drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Sulfa, food allergy from an unknown date and unknown if ongoing Known allergies: Several food products. Concomitant medication(s) included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) taken for an unspecified indication, start and stop date were not reported. On 23Oct2021 13:45 the patient experienced closed throat (medically significant), couldn't breathe (medically significant), swollen tongue (medically significant), right calm muscle pain (medically significant), headache (medically significant), fatigue (medically significant). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was treated with Epinephrine, benadryl, solimetrol (Prednisone). Therapeutic measures were taken as a result of closed throat (pharyngeal swelling), couldn't breathe (dyspnoea), swollen tongue (swollen tongue), right calm muscle pain (myalgia), headache (headache), fatigue (fatigue). The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Closed throat; Couldn't breathe; Swollen tongue; Right calm muscle pain; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number Fd8020 or f48020), via an unspecified route of administration, administered in Arm Left on 23Oct2021 13:30 (at the age of 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and within 2 weeks of vaccination patient received: Albuterol, Wixela, Xanax. Medical history included covid-19 from an unknown date and unknown if ongoing If Covid prior vaccination: Yes, irritable bowel syndrome from an unknown date and unknown if ongoing IBS, drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Sulfa, food allergy from an unknown date and unknown if ongoing Known allergies: Several food products. Concomitant medication(s) included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) taken for an unspecified indication, start and stop date were not reported. On 23Oct2021 13:45 the patient experienced closed throat (medically significant), couldn't breathe (medically significant), swollen tongue (medically significant), right calm muscle pain (medically significant), headache (medically significant), fatigue (medically significant). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was treated with Epinephrine, benadryl, solimetrol (Prednisone). Therapeutic measures were taken as a result of closed throat (pharyngeal swelling), couldn't breathe (dyspnoea), swollen tongue (swollen tongue), right calm muscle pain (myalgia), headache (headache), fatigue (fatigue). The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: has Covid-19; has Covid-19; This is a spontaneous report from a non-contactable consumer (patient) via company representative. This consumer (patient) reported for self.  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunisation; also received dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) 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 has Covid-19. Person had the Pfizer Covid-19 vaccine series in Apr2021 and now has Covid-19. Event took place after use of product. Outcome of the event Covid-19 was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate irregular, Neck pain, Pain
Clinical narrative: Within mins shooting pain on l side neck; Within mins shooting pain on l side neck; within 10hrs ER room severe chest pain; breathing issues; Severe sweeling l side of neck/chest/under arm; Severe sweeling l side of neck/chest/under arm; 2wks of breathing irregular heart beats; This is a spontaneous report from a contactable other health care professional (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), intramuscular, administered in arm left on 09Sep2021 14:30 as dose 1, single (at the age of 52-years-old) for COVID-19 immunization. The patient was not pregnant at the time vaccination. Medical history included COVID-19 (covid prior vaccination: yes). The patient concomitant medications were not reported. The patient previously took Compazine [prochlorperazine edisylate] and experienced allergy. On 09Sep2021 14:45, within 15mins the patient experienced shooting pain on l side neck. within 10 hours of emergency room the patient had severe chest pain, breathing issues, severe swelling l side of neck/chest/under arm. The 2 weeks of breathing the patient had irregular heartbeats. The patient Still had severe/neck/chest/under arm swelling with severe pain. The events resulted in emergency room/department or urgent care. The patient received steroids as a treatment for the events. The patient underwent lab tests and procedures which included Nasal Swab: negative on 19Oct2021. The outcome of the events was not resolved.  The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Swelling
Clinical narrative: Within mins shooting pain on l side neck; Within mins shooting pain on l side neck; within 10hrs ER room severe chest pain; breathing issues; Severe sweeling l side of neck/chest/under arm; Severe sweeling l side of neck/chest/under arm; 2wks of breathing irregular heart beats; This is a spontaneous report from a contactable other health care professional (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), intramuscular, administered in arm left on 09Sep2021 14:30 as dose 1, single (at the age of 52-years-old) for COVID-19 immunization. The patient was not pregnant at the time vaccination. Medical history included COVID-19 (covid prior vaccination: yes). The patient concomitant medications were not reported. The patient previously took Compazine [prochlorperazine edisylate] and experienced allergy. On 09Sep2021 14:45, within 15mins the patient experienced shooting pain on l side neck. within 10 hours of emergency room the patient had severe chest pain, breathing issues, severe swelling l side of neck/chest/under arm. The 2 weeks of breathing the patient had irregular heartbeats. The patient Still had severe/neck/chest/under arm swelling with severe pain. The events resulted in emergency room/department or urgent care. The patient received steroids as a treatment for the events. The patient underwent lab tests and procedures which included Nasal Swab: negative on 19Oct2021. The outcome of the events was not resolved.  The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Gastrointestinal disorder, Hepatobiliary scan, Migraine, Ultrasound scan
Clinical narrative: Migrane; GI/Digestion Issues - but had a recent flair-up; This is a spontaneous report from a contactable consumer. This 30 year old female consumer (patient) reported for herself that:   A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248; Expiration Date: Apr2021), dose 2 intramuscular, administered in arm left on 04Feb2021 (at the age of 30 years old) as dose 2, single for covid-19 immunisation. Medical history included gastrointestinal disorder from 24Aug2021 and ongoing Blood work ultrasound and HIDA scar performed to assess issues. The patient concomitant medications were not reported. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248 Expiration date: Apr2021), dose 1 Intramuscular, administered in arm left on 14Jan2021 as dose 1, single for covid-19 immunisation. On 2021, the patient experienced gi/digestion issues - but had a recent flair-up. On 05Feb2021, the patient had migrane. The patient assessed the events as non-serious. The patient underwent lab tests and procedures which included blood test: unknown results, hepatobiliary scan: unknown results, ultrasound scan: unknown results on an unspecified date. The outcome of the event GI/Digestion Issues - but had a recent flair-up was unknown and migrane was recovered on an unspecified date Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: covid test result Positive; covid test result Positive; This is a spontaneous report from a contactable consumer (patient). A 61 year old non pregnant female patient received BNT162B2 (Formulation: Solution for injection, Batch/Lot Number: EP6955), via intramuscular, administered in Left Arm on 25Mar2021 (Age at vaccination 61 year old non pregnant) as dose 2, single and intramuscular, administered in Arm Left on Mar2021 (Batch/Lot Number: EL3247) as dose 1, single for covid-19 immunisation. Facility type vaccine was Workplace clinic. Medical history reported none. The patient had no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 22Oct2021 at 12:00, the patient experienced covid test result positive and vaccination failure. The outcome of the event was recovering.  The patient underwent lab tests and procedures which included sars-cov-2 test positive ((NAAT)/RT-PCR Panther System) on 22Oct2021 as Nasal Swab.  No treatment received for the events.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Thrombophlebitis, Thrombosis
Clinical narrative: small superficial clots; thrombophlebitis in his left leg; This is a spontaneous report from a Contactable Nurse (wife). A 76-Year-Old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date were not reported), dose 3, via an intramuscular route of administration, administered in arm on 29Sep2021 as dose 3 (booster), single for COVID-19 immunization. The patient medical history and Concomitant medication(s) were not reported. Historical vaccines included first dose and second dose of BNT162B2 (Batch/Lot Number and Expiry Date were not provided), via an unspecified route of administration, on an unspecified date as dose 1, single and dose 2, single respectively for COVID-19 immunization. Reporter asked "does it matter which arm it got injected into", referring to the route of administration of the dose. The patient developed thrombophlebitis in his left leg and small superficial clots. The outcome of events was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  events Thrombosis 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Arthritic pain in hand and feet; This is a spontaneous report from a contactable Other HCP (Patient). This A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscularadministered in left arm (left shoulder) on 15Feb2021 at 08:30 am at age of 79-years-old (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included hypercholesterolaemia from 2004 and ongoing (pertinent details: Lowering cholesterol- zetia (cannot tolerate statins)), atrial fibrillation (AFib) from 2002 and ongoing (pertinent details: controlled by sotalol and atenolol), arrhythmia, high cholesterol, herpes prevention. Concomitant medications included sotalol taken for arrhythmia from 2002 and ongoing; atenolol  taken for arrhythmia from 2002 and ongoing; ezetimibe (ZETIA) taken for high cholesterol from 2004 and ongoing; valaciclovir hcl taken for herpes prevention from 2011 and ongoing. The patient experienced arthritic pain in hand and feet on 16Feb2021. Seriousness criteria was persistent/ significant disability/ incapacity. AE required visit to physician office. Treatment included pain medication, tylenol, lidocaine topical cream. The outcome of the event was recovering.; Sender's Comments: Based on the reported information ,a causal relationship between the event Arthralgia and suspected drug 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: Pain in extremity
Clinical narrative: pain in her legs; This is a spontaneous report from a contactable consumer. A 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 24Feb2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer states her mother received the Pfizer BioNTech COVID-19 vaccine yesterday and afterwards experienced pain in her legs. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal pain
Clinical narrative: severe pain in my muscle of my left shoulder blade and it radiated down into my elbow joint; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (left arm) on 30Jan2021 as single dose for COVID-19 immunisation. Medical history included diabetes. No Covid prior vaccination. No known allergies. No concomitant medications. No other vaccine in four weeks. He received other medication (unspecified) in two weeks. After dose number one, the patient experienced severe pain in his muscle of his left shoulder blade and it radiated down into his elbow joint on an unspecified date. Not Covid tested post vaccination. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in the arm where he received the vaccine; 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), dose 2 via an unspecified route of administration on Arm on 24Feb2021 08:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included ongoing chronic myeloid leukaemia (Treatment was ongoing by "Bosulif"). Concomitant medication included ongoing bosutinib (BOSULIF) taken for chronic myeloid leukaemia, start date was not reported. The patient only had a little problem which was pain in the arm where he received the vaccine. He would like to know since he had no other problems or much pain, if the vaccine will have almost no effectiveness. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: pain in the arm where he received the vaccine; 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), dose 2 via an unspecified route of administration on Arm on 24Feb2021 08:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included ongoing chronic myeloid leukaemia (Treatment was ongoing by "Bosulif"). Concomitant medication included ongoing bosutinib (BOSULIF) taken for chronic myeloid leukaemia, start date was not reported. The patient only had a little problem which was pain in the arm where he received the vaccine. He would like to know since he had no other problems or much pain, if the vaccine will have almost no effectiveness. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gout, Nausea
Clinical narrative: gout; nausea; This is a spontaneous report from a contactable nurse. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced gout and nausea on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: little uncomfortable for a day; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an 31Jan2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced little uncomfortable for a day on an unspecified date. The outcome of event was recovered on an unspecified date.  No follow up attempts are possible. Information about lot/ batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat; felt so tired; This is a spontaneous report from a contactable consumer (patient himself). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported), intramuscular, administered in upper Arm Left on 19Feb2021 12:00 (at the age of 74 years) as dose 1, single for covid-19 immunization. There were no concomitant medications and medical history. Patient had no prior vaccinations within 4 weeks. On 19Feb2021, the patient experienced felt so tired, on 22Feb2021, patient had sore throat and on an unknown date fell asleep. Patient had to go an hour and half to go get the vaccine. He got pretty tired driving home. He took a nap as soon as he got home. The next day, he became very tired. He was in fact so tired, he fell asleep while on a phone call with his friend. His wife asked him did he hear the question his friend was asking on the phone and the caller explained that he didn't answer the question because he was asleep. The tiredness was the first major side effect. The patient had the vaccine on a Friday. By Monday night, he was helping a friend out and as he was driving back home, he started having a sore throat that was like in the back of his neck. He did gargle some salt water. He mentioned that his son got COVID and he knows that a sore throat was his first symptom. However he has not seen his son in 4 months, so he knows that it wasn't from his son. The nurse he spoke to, she said it could be a possible side effect from the vaccine. He had no fever, or anything. On the same day he received the vaccine, he did get a Rapid COVID test and a PCR test and both came back negative. He needed to have the testing done to visit someone. He did not think he still has the tiredness. The tiredness was very strong the first 2 days. He could sleep easily no matter what, so he doesn't believe its still an issue. The sore throat lasted about a day and half until Wednesday. He clarifies he hasn't recovered completely, he believes he still has a little residual. However, he tends to be a nervous guy, so it could just be a memory of that. Clinical outcome of the event felt so tired was reported as unknown and recovering for sore throat.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm; feeling "achy"; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included flu shot for immunization and experienced sore arm and feeling "achy". The patient received his first dose of the Pfizer-BioNTech Covid19 vaccine this past Tuesday, 23Feb2021. He reported a sore arm and feeling "achy" on Feb2021 which was what he expected and wasn't any worse than what he experienced with the yearly flu shot. He wanted to know, since he's had a reaction, why he would need the second dose. Also would like to know if you need to get the vaccine if you've had Covid and how long does the vaccine protect you. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Bad headache; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 77-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration in right arm on 23Feb2021 at 14:00 (age at vaccination: 77-year-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 25Feb2021 at 16:00 the patient experienced bad headache and nausea. The patient was not pregnant at the time of vaccination. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 1st dose: slightly sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 13:45 (Batch/Lot Number: EL8982) (at the age of 24 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient experienced slightly sore arm at injection site on an unspecified date after first dose, with outcome of unknown.   No follow-up attempts are Possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site reaction
Clinical narrative: white circles/splotches around injection sight, up her neck, onto her chest, back and down her arm to her elbow; white circles/splotches around injection sight, up her neck, onto her chest, back and down her arm to her elbow; This is a spontaneous report from a contactable pharmacist. A 57-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL3302), via intramuscular route of administration, administered in Arm Right on 24Feb2021, at 12:00 (Age at vaccination 57-years-old), as DOSE 2, SINGLE for covid-19 immunization. Patient did not receive other vaccine in four weeks. Patient did not have covid-19 prior to vaccination. After vaccination patient was not tested for covid. The patient medical history was not reported. Concomitant medications included zinc chloride (ZINC CHLORIDE), colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported. The patient had allergies from amoxicillin, augmentin bd, tetracycline, erythromycin. The patient previously received first dose of of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL3302), via unspecified route of administration, administered in Arm left on 03Feb2021 (Age at vaccination 57-years-old), as DOSE 1, SINGLE for covid-19 immunization. The patient experienced white circles/splotches around injection sight on 24Feb2021 at 20:00. The patient had white circles/splotches around injection sight, up her neck, onto her chest, back and down her arm to her elbow. they were not raised and did not itch. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event was recovering.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: aching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Feb2021, the patient was aching. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: a head cold 2 weeks after receiving the vaccine; This is a spontaneous report from a contactable consumer. This consumer reports same event for different patients. This the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a head cold 2 weeks after receiving the vaccine on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021214179 same reporter and product; same event; different patient
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL3247) as dose 1, single via an unspecified route of administration administered in left arm (at the age of 54 years old) on 25Feb2021 at 13:45 for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Atorvastatin calcium (LIPITOR), Sertraline (SERTRALINE). On 25Feb2021 at 13:00, the patient experienced diarrhea. The outcome of the event was reported as  recovering.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgraphia, Dysstasia, Gait disturbance, Gait inability, Muscular weakness
Clinical narrative: Has to take her time so that she does not fall, she can use her knees; weakness/feeling weak from her waist down/When she got ready to get in a chair she could not pull herself up; She could not use her knees; Unable to write clearly; not able to stand up; Had to crawl; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that:  An 87-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ELS263, Expiry date was not reported) via an unspecified route of administration on 22Feb2021 in the left shoulder/arm left at 12:00 (at the age of 87 years old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included High blood pressure from 2000 and ongoing. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on 01Feb2021 (at the age of 87-years-old) as DOSE 1, SINGLE for covid-19 immunisation/ first dose was administered 3 weeks before second dose approximately 01Feb2021. There were no concomitant medications. The patient has not received any other products. On 23Feb2021 she had onset of feeling weak from her waist down; unable to write clearly (unable to write checks), was not able to stand up, had to crawl, when she got ready to get in a chair, she could not pull herself up; she could not use her knees. Patient takes her time so that she does not fall, she can use her knees on 24Feb2021. She asked for information on why these events occurred relative to the Pfizer COVID-19 Vaccine. Patient stated that there has been no emergency room visit, hospitalization or physician's office visit relative to any of the adverse events reported. Patient has not received any investigation assessment. The clinical outcome of the event has to take her time so that she does not fall, she can use her knees was recovering while other events recovered with sequel.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Feeling tired on the second day (27Feb2021) after vaccination of the 2nd dose.; A little bit muscle aches around the injection site and on the back; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Feb2021 14:30 (at the age of 35-years-old) as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were 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 did not receive any other medication within 2 weeks of vaccination. The patient did not received treatment for the adverse event. The patient received first dose of BNT162B2 on 05Feb2021 at 2:15 PM (lot number: EL3247, Location: left arm) for covid-19 immunization. On 27Feb2021 at 10:00 the patient experienced feeling tired on the second day (27feb2021) after vaccination of the 2nd dose and a little bit muscle aches around the injection site and on the back. The outcome of both the events was resolving. No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gingivitis
Clinical narrative: Gum infection; This is a spontaneous report from a Sponsored Program from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced gum infection. Reporter stated that her husband and herself were scheduled for their 2nd dose of the Pfizer Covid vaccine this week however her husband had a gum infection for which he requires penicillin. She would like to know if there was any interaction between penicillin and the Covid vaccine. It was unclear if this started before or after he received the 1st dose of the Pfizer Covid vaccine however caller did state that the 2nd dose was scheduled for this week. The outcome of the event unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Photopsia
Clinical narrative: she notices mild symptoms of withdrawal described as electrical impulses in finger tips and visual flashes (mild strobe like effect).; visual flashes (mild strobe like effect); This is a spontaneous report from a contactable consumer (patient) and physician. A 36-year-old non pregnant female patient received BNT162B2 (BNT162B2, solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in the left arm on 24Feb2021 (at the age of 36 years old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine administered was hospital. Medical history included Crohn's (has had ileostomy), allergies to medications, food, or other products: sulfa, feraheme & gadolinium contrast, PCOS (polycystic ovarian syndrome), depression, anxiety. Concomitant medication(s) included Humira, Methotrexate, Folic acid, Pepcid, Lo lo estrin, Depakote, Trazadone, venlafaxine & medical marijuana (cannabis). Patient previously received BNT162B2 (BNT162B2, solution for injection, Lot Number: EL8982), via an unspecified route of administration, administered in the left arm on 01Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 25Feb2021 08:00 the patient experienced she notices mild symptoms of withdrawal described as electrical impulses in fingertips and visual flashes (mild strobe like effect), visual flashes (mild strobe like effect). No treatment was received for events. Reporter stated that events was similar to what she's experienced when she's been a couple of hours late with a dose. The clinical outcome of the events was reported as recovering.  No Follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint stiffness, Muscle tightness, Pain in jaw
Clinical narrative: jaw tightness; right jaw tenderness; little tired; right jaw stiffness; This is a spontaneous report from a contactable consumer or non-health care professional (patient) via medical information team and from a sponsored program  Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in right arm on an unspecified date in Feb2021 10:30 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, after the first dose of the vaccine, the patient felt a little tired. The following day patient woke up and patient had some jaw tightness and jaw tenderness which occurred the morning after patient got vaccinated. Her right jaw was the one that felt tender when patient opened the mouth, patient could feel that it got affected. Patient also stated that felt like it was just hard to open her mouth and that lasted for about 12 hours and it was resolved or maybe 8 hours and that was resolved by Thursday night (unspecified date). Patient also had jaw stiffness on the side of the where the patient received vaccine. Patient wanted to know if what patient had experienced would increase patient's possibility of having Bell's palsy. Outcome of the events jaw tightness and right jaw tenderness was recovered on an unspecified date in Feb2021 and outcome of rest of other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I am only having soreness of arms.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female (patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: not reported) via an unspecified route of administration on 27Feb2021 (at the age of 69 years) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her first shot and she was due to see her primary care doctor on 10Mar2021 where she would get a Cortisone shot in her knee. She was wondering if that would cause any reaction with the COVID-19 vaccine. The second shot of vaccine would be on 20Mar2021. On an unknown date, the patient was only having soreness of arms. The outcome of event was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site vesicles
Clinical narrative: rash around the injection site; blood blister where the injection site was; his arm started itching where he got his shot; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Husband) that:  A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 22Feb2021 (at the age of 74-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lymphoma (product injected into an arm that previously had lymphoma). The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, in right arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation with no adverse effect. Patient went a week ago to get his last COVID-19 shot(22Feb2021) and caller states that she didn't notice it before but last night (28Feb2021), his arm started itching where he got his shot, and the caller looked at it and her husband had a rash around where the shot was administered, and he had like a blood blister where the shot was administered (rash around the injection site and also he had a blood blister where the injection site was). Caller states that she put some coconut oil on it so that he would not scratch it anymore, and it was warm to the touch. Caller states that the coconut oil helped to stop the itching, but caller is concerned because her husband had lymphoma in that arm, and the VA did not ask which arm her husband wanted the shot in, they just gave it to him in his left arm. But caller states that her husband got his first dose of the product in the right arm. Caller is wondering if the vaccine will take if it was administered in the arm that her husband had lymphoma and he didn't have a lot of muscle mass in his left arm. Patient received treatment for event vaccination site pruritus. The clinical outcome of the event vaccination site pruritus was recovered on 2021 while other was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Trigeminal nerve disorder
Clinical narrative: Trigeminal neuropathy; Headache.; This is a spontaneous report from a contactable consumer or other non hcp (patient himself) via a sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration in left arm on 14Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history includes covid was in hospital for a month and trigeminal neuropathy from unknown start and stop dates. The concomitant medications were not reported. The patient experienced trigeminal neuropathy, constant headache on an unspecified date in 2021. He reported that he thinks the first dose triggered his condition, trigeminal neuropathy and the vaccine was administered on his left arm where his condition is most prominent. With this, he wants to know if it is still safe for him to receive the second dose. The clinical outcome of all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: after he had the second injection he has not had to use anything, it seems like it's gone; This is a spontaneous report from a contactable consumer (Patient).   A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: RN5318, Expiry date was not reported), via an unspecified route of administration on 30Jan2021 (at the age of 77-years-old) as dose 2, single for COVID-19 immunization. The Patient Medical history included arthritis from an unknown date and unknown if ongoing he had arthritis which was self-diagnosed it his hands for quite a while and he had been using copper infused gloves and sometimes if the pain was very bad, he would put cannabis cream on them to ease the pain, blood pressure abnormal from an unknown date and unknown if ongoing. The patient concomitant medications not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EL3246 and Expiry date was not reported), via an unspecified route of administration on 09Jan2021 (at the age of 77-years-old) as dose 1, single for COVID-19 immunization. The patient not received other products. Caller is calling about the Pfizer vaccine, the COVID vaccine. He had 2 injections on the 09Jan2021 and second on 30Jan2021. He did not have a adverse reaction, he had a positive reaction. He had arthritis which was self-diagnosed it his hands for quite a while, and he had been using copper infused gloves and sometimes if the pain was very bad, he would put cannabis cream on them to ease the pain. But after he had the second injection, on unspecified date, he has not had to use anything, it seems like it's gone, and he was wondering if there had been any other reactions like that where a condition seems to have improved. He says as long as there won't be 17 calls ahead of him. He says if it is, it is fine, he will drop it. He asks is it possible to have someone call him back. If he can be transferred to someone now otherwise. He had trouble on the web site sending something, he wanted to call but he doesn't want to make this his life's work. But after he had the second injection, he has not had to use anything, it seems like it's gone, and he was wondering if there had been any other reactions like that where a condition seems to have improved. Primary Care: The phone number is in his phone, and he is not able to get it right now. He thinks she is at. He thinks that is it. Patient details: he will be 78 soon. He used to be 6'3 he may be a little less than that now, they say you lose an inch every now and then, but he has good posture so maybe not. The only medication he takes if for blood pressure daily shouldn't have anything to do with that. He says he would rather have someone call him back since call handler does not know whether he would have to hold in a queue or not. The outcome for the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: The patient felt like she's been raped; This is a spontaneous report from a non-contactable consumer (patient) received via the Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she felt like she's been raped on an unspecified date, after being vaccinated. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.