chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: tiredness; headache; muscle pain; chills; injection site swelling; feeling unwell; swollen lymph nodes - Moderate-severe (Left axillary lymphadenopathy); injection site pain; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection. lot number: EL3249), via an unspecified route of administration on 21Jan2021 at a single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient was not diagnosed with COVID-19 prior to vaccination. No vaccines received 4 weeks prior to vaccination. The patient experienced injection site pain on 21Jan2021. On 22Jan2021 (24 hours after vaccination), patient experienced tiredness, headache, muscle pain, chills, injection site swelling, feeling unwell and swollen lymph nodes - moderate-severe (left axillary lymphadenopathy). All occurred for a duration of 24 hours, except for event swollen lymph nodes - Moderate-severe (Left axillary lymphadenopathy) in which reported duration was 48 + hours. The patient was treated with ibuprofen for the events. The patient was not tested for COVID-19 post vaccination. The patient has not recovered from the events.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: tiredness; headache; muscle pain; chills; injection site swelling; feeling unwell; swollen lymph nodes - Moderate-severe (Left axillary lymphadenopathy); injection site pain; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection. lot number: EL3249), via an unspecified route of administration on 21Jan2021 at a single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient was not diagnosed with COVID-19 prior to vaccination. No vaccines received 4 weeks prior to vaccination. The patient experienced injection site pain on 21Jan2021. On 22Jan2021 (24 hours after vaccination), patient experienced tiredness, headache, muscle pain, chills, injection site swelling, feeling unwell and swollen lymph nodes - moderate-severe (left axillary lymphadenopathy). All occurred for a duration of 24 hours, except for event swollen lymph nodes - Moderate-severe (Left axillary lymphadenopathy) in which reported duration was 48 + hours. The patient was treated with ibuprofen for the events. The patient was not tested for COVID-19 post vaccination. The patient has not recovered from the events.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: experiencing swelling in the armpit of the arm I was injected in; This is a spontaneous report from a contactable other healthcare professional, reporting for himself.  A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via an unspecified route of administration on 06Jan2021 at 15:30 (at the age of 56 years old) as a single dose in the right arm for COVID-19 vaccination.  Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included famotidine (Pepcid AC) for an unknown indication from unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of  BNT162B2, lot number: EJ1685 on 16Dec2020 at 11:00 AM in the right arm. On 08Jan2021, the patient experienced swelling in the armpit of the arm he was injected in. The patient did not receive treatment for the event. The event did involve doctor or other healthcare professional office/clinic visit. The clinical outcome of swelling in the armpit of the arm he was injected in was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphonia, Eye pruritus, Throat irritation, Vaccination site erythema
Clinical narrative: Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen circular hive/welt underneath injection site on left arm; pink and hot swollen circular hive/welt underneath injection site on left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient.  A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 07:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included seasonal allergies from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of  BNT162B2, on 31Dec2020 in the left arm. On 21Jan2021 at 09:30, the patient experienced  light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm. The patient did not receive treatment for the events. The clinical outcome of  light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen circular hive/welt underneath injection site on left arm; pink and hot swollen circular hive/welt underneath injection site on left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient.  A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 07:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included seasonal allergies from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of  BNT162B2, on 31Dec2020 in the left arm. On 21Jan2021 at 09:30, the patient experienced  light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm. The patient did not receive treatment for the events. The clinical outcome of  light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Malaise, Pain
Clinical narrative: Flu like symptoms; Headache; Body ache; Chills; General malaise; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL 9261), via an unspecified route of administration in the left arm on 20Jan2021 at 11:15 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 21Jan2021 at 04:00, the patient experienced Flu like symptoms that lasted about 8 hours, headache, body ache, chills, general malaise. The patient stated he had no fever. The patient did not receive any treatment for the event. The clinical outcome of the Flu like symptoms, headache, body ache, chills, and general malaise was recovered on an unknown date in Jan2021.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Lip swelling, Pruritus
Clinical narrative: Within 20 minute of receiving the shot my face was very flushed and hot; Within 20 minute of receiving the shot my face was very flushed and hot; lips slightly swollen; Mild itching on face continues 20 hours later; This is a spontaneous report from a contactable consumer reporting for herself. A 72-years-old non-pregnant female patient received BNT162B2 lot number unknown, via an unspecified route of administration on 22Jan2021 15:45 (at the age of 72-years-old) as a SINGLE DOSE  in the right arm for covid-19 immunisation. Medical history was none.  It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications were none. The facility where the most recent COVID-19 vaccine was administered was provided as other. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Within 20 minutes of receiving the shot, the patient's face was very flushed and hot, lips slightly swollen on 22Jan2021 16:00. Mild itching on face from unspecified date in Jan2021 continues 20 hours later. No treatment was received for the events. The clinical outcome of within 20 minute of receiving the shot my face was very flushed and hot was not recovered It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Rhinorrhoea, Sneezing
Clinical narrative: her eyes are watering, she can't quit sneezing; her eyes are watering, she can't quit sneezing; her nose drips hot water; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Jan2021 as a SINGLE DOSE for COVID-19 vaccination. Medical history included spinal cord injury 14 years ago (2007) to an unknown date.  The patient's concomitant medications were not reported.  The patient experienced her eyes are watering, she can't quit sneezing and her nose drips hot water on an unspecified date in Jan2021. The clinical outcomes of her eyes are watering, she can't quit sneezing and her nose drips hot water was unknown.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Neck mass, Pain, Swelling
Clinical narrative: Swelling in the area at the base of the neck on the left shoulder; swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area); Soreness/tenderness in the area near the collarbone; Soreness/tenderness in the area near the collarbone; Pain in the left armpit; Swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELI283 and expiry date: unknown), via an unspecified route of administration on the left arm, on 18Jan2021 12:15 at single dose for covid-19 immunisation. Medical history included high blood pressure and seasonal allergies. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan potassium, naproxen sodium (ALEVE) and unspecified OTC allergy medications. There were no other vaccines received within 4 weeks prior to COVID vaccination. The patient experienced pain in the left armpit and swollen lymph node on 23Jan2021 11:30. On 24Jan2021 17:00, patient experienced swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area) and soreness/tenderness in the area near the collarbone. Patient had not recovered from the events and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Swelling in the area at the base of the neck on the left shoulder; swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area); Soreness/tenderness in the area near the collarbone; Soreness/tenderness in the area near the collarbone; Pain in the left armpit; Swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELI283 and expiry date: unknown), via an unspecified route of administration on the left arm, on 18Jan2021 12:15 at single dose for covid-19 immunisation. Medical history included high blood pressure and seasonal allergies. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan potassium, naproxen sodium (ALEVE) and unspecified OTC allergy medications. There were no other vaccines received within 4 weeks prior to COVID vaccination. The patient experienced pain in the left armpit and swollen lymph node on 23Jan2021 11:30. On 24Jan2021 17:00, patient experienced swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area) and soreness/tenderness in the area near the collarbone. Patient had not recovered from the events and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Throat irritation
Clinical narrative: itchy skin; itchy throat; Dizziness; This is a spontaneous report from a contactable nurse reporting for self.  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# E19261, Dose 1, via an unspecified route of administration on 22Jan2021 13:30 (at the age of 43 years old) as a single dose in left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination.  Medical history included asthma. The patient reported allergy to sulfa and amoxicillin sodium;clavulanate potassium  (AUGMENTIN). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 22Jan2021, the patient experienced dizziness within 5 minutes after vaccine that lasted 2 hours, itchy throat started within 10 min and itchy skin started 2 hrs post vaccine. As treatment for the events, the patient received diphenhydramine (BENADRYL) at home. There was no hospitalization for the events. The events were reported as non-serious. The clinical outcome of the events dizziness, itchy throat, and itchy skin was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Rash erythematous, Swelling, Urticaria
Clinical narrative: Hot painful red rash on abdominal area; Hot painful red rash on abdominal area; welts; swelling; This is a spontaneous report from a contactable other hcp.   A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration at single dose left arm on 23Jan2021 11:15 for covid-19 immunisation. Medical history included thyroid disorder, breast cancer female, migraine, allergy to sulfonamide and topamax, food allergy. Concomitant medications included levothyroxine, liothyronine (NP THYROID), multivitamin, plant based calci. The patient experienced hot painful red rash on abdominal area on 23Jan2021 18:00, welts on 23Jan2021 18:00, swelling on 23Jan2021 18:00. No treatment received. The outcome was not recovered. Information on the lot/batch number has been requested
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Head injury
Clinical narrative: Had a fall and hit his head; Had a fall and hit his head; This is a spontaneous report from a contactable pharmacist. A 83-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Jan2021 (age at vaccination: 83 years old) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient got the 1st vaccine dose "today" (23Jan2021)  but he had a fall and hit his head. Patient was now requiring TDAP. The clinical outcome of the event fell and his head was unknown. The reporting pharmacist was seeking information on the use with other vaccines, particularly the benefit vs risk of co-administering in an emergency case.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hyperhidrosis, Lymphadenopathy, Myalgia
Clinical narrative: Fever 102.7; severe myalgia/arthralgia; severe myalgia/arthralgia; sore throat; profuse sweating; Headache; swollen lymph nodes; This is a spontaneous report from a contactable nurse reporting for self.  A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 2, via an unspecified route of administration on 22Jan2021 16:30 (at the age of 37 years old) as a single dose in left arm for COVID-19 immunization.  The patient was not pregnant at the time of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included dyslipidemia, hypothyroid, bipolar type 2,and sleep apnea. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products.  Concomitant medications included atorvastatin, lamotrigine, and levothyroxine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1, as a single dose on an unspecified date for COVID-19 immunization. On 23Jan2021 01:00, the patient experienced fever102.7, severe myalgia/arthralgia, sore throat,headache, profuse sweating, and swollen lymph nodes. As treatment for the events, the patient received acetaminophen and ibuprofen. No hospitalization was required. The events were reported as non-serious. The clinical outcome of the events fever102.7, severe myalgia/arthralgia, sore throat, headache, profuse sweating, and swollen lymph nodes was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Fever 102.7; severe myalgia/arthralgia; severe myalgia/arthralgia; sore throat; profuse sweating; Headache; swollen lymph nodes; This is a spontaneous report from a contactable nurse reporting for self.  A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 2, via an unspecified route of administration on 22Jan2021 16:30 (at the age of 37 years old) as a single dose in left arm for COVID-19 immunization.  The patient was not pregnant at the time of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included dyslipidemia, hypothyroid, bipolar type 2,and sleep apnea. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products.  Concomitant medications included atorvastatin, lamotrigine, and levothyroxine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1, as a single dose on an unspecified date for COVID-19 immunization. On 23Jan2021 01:00, the patient experienced fever102.7, severe myalgia/arthralgia, sore throat,headache, profuse sweating, and swollen lymph nodes. As treatment for the events, the patient received acetaminophen and ibuprofen. No hospitalization was required. The events were reported as non-serious. The clinical outcome of the events fever102.7, severe myalgia/arthralgia, sore throat, headache, profuse sweating, and swollen lymph nodes was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test abnormal, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: On day 19 after the vaccine was given I tested them for antibodies to the virus, they both were negative for IgM and IgG.; This is a spontaneous report from a contactable Physician who reported similar events for two patients. This is the first of two reports.  An 84-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: eh9899), intramuscular in left arm on 29Dec2020 10:30 at single dose for covid-19 immunisation. Medical history included hypertension, benign prostatic hyperplasia, lipids increased. Concomitant medication included asa (ASA), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), finasteride (unknown manufacturer), fish oil (unknown manufacturer), hydroxychloroquine (unknown manufacturer), furosemide (LASIX), atorvastatin (LIPITOR), lisinopril (unknown manufacturer), levothyroxine sodium (SYNTHROID), vitamin b complex (unknown manufacturer), vitamin c [ascorbic acid] (unknown manufacturer), vitamin d3 (unknown manufacturer), zinc (unknown manufacturer). On 17Jan2021, day 19 after the vaccine, the patient was tested for antibodies to the virus, and was negative for igm and igg. Test was negative also on 18Jan2021, day 20 after their vaccination, the day before his second vaccination. No treatment was performed.  The outcome of the event was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021086757 same reporter/drug/event, different patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Racing heart; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL3249), via an unspecified route of administration in the left arm on 21Jan2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization.  Medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications included atenolol, bio-identical hormones and deplane (information presented as reported). The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 22Jan2021 at 15:45, the patient experienced racing heart. The patient reported that when walking she had to sit down to get heart back in rhythm, the patient was still experiencing the event, even when not walking. The patient stated it was a bit un-nerving and that the patient is a strong walker. The patient did not receive any treatment for the event. The clinical outcome of the racing heart was recovered with sequalae (reported as "Recovered with lasting effects") on an unknown date.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Periorbital swelling
Clinical narrative: a little pain between shoulder blade; baggy eyes; This is a spontaneous report from a non-contactable consumer. This male consumer (patient) reported that:  Narrative case summary and further information:  Originating AE Request: REQ-# Attachments: 1 Patient Age: unknown Reporter Subtype: Patient PQC Present: No AE Present: Yes  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller, male, received vaccine yesterday 22Jan2021 and only reports minor side effects (a little pain between shoulder blade and baggy eyes) and already filed safety report. Calling to see if there is any fish oil in the vaccine due to a squalene/fish oil allergy?  This is a spontaneous report from a non-contactable consumer, the patient. This male patient of unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 22Jan2021 as a single dose for COVID-19 immunization. The patient's medical history included squalene/fish oil allergy from an unspecified date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced only minor side effects, a little pain between shoulder blade and baggy eyes. The clinical outcome of the events numbness and tingling was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  This is a spontaneous report from a non-contactable consumer or other non hcp.  A male patient of an unspecified age started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration from 22Jan2021 to 22Jan2021 at SINGLE DOSE for an unspecified indication .  Medical history included food allergy from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient experienced a little pain between shoulder blade and baggy eyes (pain) (non-serious) on an unspecified date with outcome of unknown.  The action taken in response to the event(s) for bnt162b2 was not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Fatigue, Headache, Off label use, Pain
Clinical narrative: prod cough; SEVERE body aches; shortness of breath on exertion; inj site pain; exhaustion; headache; fever; patient received IMURAN concomitantly; patient received IMURAN concomitantly; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL 0142) via an unspecified route of administration in left arm on 21Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included Crohn's disease, migraine. Concomitant medication included azathioprine (IMURAN), propranolol, sertraline hydrochloride (ZOLOFT). The patient previously took infliximab (REMICADE) and morphine, both experienced drug allergy; received the first dose of bnt162b2 (Lot number: EL1284) in left arm for COVID-19 immunization and experienced severe body aches, headache, heavy feeling injection arm unable to lift it, cough and exhaustion. The patient experienced prod cough, severe body aches, shortness of breath on exertion, inj site pain, exhaustion, headache, fever, all on 22Jan2021 05:00. No treatment received for the adverse events. Reporter considered the events as non-serious. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Productive cough, Pyrexia, Vaccination site pain
Clinical narrative: prod cough; SEVERE body aches; shortness of breath on exertion; inj site pain; exhaustion; headache; fever; patient received IMURAN concomitantly; patient received IMURAN concomitantly; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL 0142) via an unspecified route of administration in left arm on 21Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included Crohn's disease, migraine. Concomitant medication included azathioprine (IMURAN), propranolol, sertraline hydrochloride (ZOLOFT). The patient previously took infliximab (REMICADE) and morphine, both experienced drug allergy; received the first dose of bnt162b2 (Lot number: EL1284) in left arm for COVID-19 immunization and experienced severe body aches, headache, heavy feeling injection arm unable to lift it, cough and exhaustion. The patient experienced prod cough, severe body aches, shortness of breath on exertion, inj site pain, exhaustion, headache, fever, all on 22Jan2021 05:00. No treatment received for the adverse events. Reporter considered the events as non-serious. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headaches; This is a spontaneous report from a contactable nurse reporting for herself. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685/expiration date: not provided), via intramuscular route of administration, on 29Dec2020 07:45 AM (at the age of 53 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included multiple sclerosis (MS) and is a breast cancer (CA) survivor. The patient has known allergies to seafood and diazepam (VALIUM). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dimethyl fumarate (TECFIDERA), tamoxifen, and acetylsalicylic acid (ASPIRINE). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 06:00, the patient experienced severe headaches for a 1 month with no relief from acetaminophen (TYLENOL) or ibuprofen every 6 hours. The patient had to go to emergency room (ER) to get migraine treatment. The event severe headache was reported as non-serious and did not require hospitalization. The event severe headache required a physician office visit and an emergency room visit. The patient received treatment for the event severe headache which included acetaminophen, diphenhydramine (BENADRYL) toradol, prochlorperazine (COMPAZINE), and sodium chloride. The outcome of the event severe headaches was recovered on an unspecified date in 2021. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 19Jan2021 which was negative.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Injection sight tenderness; Fatigue; Severe headache; This is a spontaneous report from a contactable other HCP report for self. This 30-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) intramuscular at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included Asthma, anxiety, allergies to Acetaminophen (seizure like activity and fainting). No COVID prior vaccination. No other vaccine in four weeks. Concomitant medications include Fluoxetine, lorazepam, and Ibuprofen. Patient experienced injection sight tenderness, severe headache for 5 days, fatigue for 7-10 days after first dose. The outcome of events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; Chills; body aches; tired and slept all day; Tingling at fingertips; This is a spontaneous report from a contactable consumer(patient).  The 49-year-old female patient(not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot: EL3247), via an unspecified route of administration at left arm on 11Jan2021 16:30 at single dose for covid-19 immunisation.  Medical history included hashimotos disease, allergy to penicillin and sulfa, tree nut intolerance. There was no COVID-19 Prior to vaccination.   Concomitant medication included levothyroxine sodium (UNITHROID), ethinylestradiol/levonorgestrel (ENPRESSE). There was no other vaccination within 4 weeks prior to the COVID vaccine. On 22Jan2021, 04:00, The patient woke up with severe nausea and vomiting/diarrhea, lasted for the morning, she also experienced chills and body aches. By noon she was fine but tired and slept all day. She also experienced tingling at fingertips. That was all done by night. There was no treatment. Outcome of events was recovered in 22Jan2021. Events were assessed as non-serious. Since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vomiting
Clinical narrative: severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; Chills; body aches; tired and slept all day; Tingling at fingertips; This is a spontaneous report from a contactable consumer(patient).  The 49-year-old female patient(not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot: EL3247), via an unspecified route of administration at left arm on 11Jan2021 16:30 at single dose for covid-19 immunisation.  Medical history included hashimotos disease, allergy to penicillin and sulfa, tree nut intolerance. There was no COVID-19 Prior to vaccination.   Concomitant medication included levothyroxine sodium (UNITHROID), ethinylestradiol/levonorgestrel (ENPRESSE). There was no other vaccination within 4 weeks prior to the COVID vaccine. On 22Jan2021, 04:00, The patient woke up with severe nausea and vomiting/diarrhea, lasted for the morning, she also experienced chills and body aches. By noon she was fine but tired and slept all day. She also experienced tingling at fingertips. That was all done by night. There was no treatment. Outcome of events was recovered in 22Jan2021. Events were assessed as non-serious. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild arm soreness; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable male consumer, the patient. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) , dose 1, single dose via unspecified route of administration on 22Jan2021  for COVID-19 vaccination. Medical history and concomitant medications were unknown. On an unknown date, the patient experienced mild arm soreness. It was unknown if the patient received treatment for the event. The clinical outcome of mild arm soreness was unknown.   No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Nausea, Night sweats
Clinical narrative: fever; night sweats; chills; headache; nausea; administration date=21/01/2021. dose number=2/administration date=04Jan2021. dose number=1; This is a spontaneous report from a contactable physician (patient). A 34-years-old female patient (no pregnant) received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular on 21Jan2021 11:30 at SINGLE DOSE at left arm for covid-19 immunisation.  The patient received the first dose of bnt162b2 on 04Jan2021 for covid-19 immunisation. Medical history included gastrooesophageal reflux disease, allergy to Sulfa.  Concomitant medication included pantoprazole, spironolactone, and multivitamin.  The patient experienced fever, night sweats, chills, headache, nausea on 22Jan2021 02:30.  The patient received ibuprofen and acetaminophen for fever, night sweats, chills, headache, nausea. The outcome of events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; night sweats; chills; headache; nausea; administration date=21/01/2021. dose number=2/administration date=04Jan2021. dose number=1; This is a spontaneous report from a contactable physician (patient). A 34-years-old female patient (no pregnant) received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular on 21Jan2021 11:30 at SINGLE DOSE at left arm for covid-19 immunisation.  The patient received the first dose of bnt162b2 on 04Jan2021 for covid-19 immunisation. Medical history included gastrooesophageal reflux disease, allergy to Sulfa.  Concomitant medication included pantoprazole, spironolactone, and multivitamin.  The patient experienced fever, night sweats, chills, headache, nausea on 22Jan2021 02:30.  The patient received ibuprofen and acetaminophen for fever, night sweats, chills, headache, nausea. The outcome of events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Ear pain, Fatigue
Clinical narrative: vertigo/dizziness; vertigo/dizziness; Chills; body aches; extreme tiredness; bilateral ear pain; nausea; No appetite; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at let arm on 19Jan2021 17:00 at single dose for covid-19 immunization. The patient was not pregnant. The COVID-19 vaccine was administered at Hospital. The patient medical history reported as none. Concomitant medication included cimicifuga racemosa (BLACK COHOSH), curcuma longa (TURMERIC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 on 29Dec2020 07:00 at left arm for covid-19 immunization. The patient experienced Chills, body aches, extreme tiredness (slept for 30+ hours), bilateral ear pain, nausea - this all started 15 hours after 2nd dose on 20Jan2021 08:00, and then vertigo/dizziness started 4 days after 2nd dose on 23Jan2021, and also experienced no appetite from an unknown date in Jan2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vertigo
Clinical narrative: vertigo/dizziness; vertigo/dizziness; Chills; body aches; extreme tiredness; bilateral ear pain; nausea; No appetite; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at let arm on 19Jan2021 17:00 at single dose for covid-19 immunization. The patient was not pregnant. The COVID-19 vaccine was administered at Hospital. The patient medical history reported as none. Concomitant medication included cimicifuga racemosa (BLACK COHOSH), curcuma longa (TURMERIC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 on 29Dec2020 07:00 at left arm for covid-19 immunization. The patient experienced Chills, body aches, extreme tiredness (slept for 30+ hours), bilateral ear pain, nausea - this all started 15 hours after 2nd dose on 20Jan2021 08:00, and then vertigo/dizziness started 4 days after 2nd dose on 23Jan2021, and also experienced no appetite from an unknown date in Jan2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; This is a spontaneous report from a contactable consumer, the patient.  A 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EL3247), via an unspecified route of administration on 22Jan2021 at 09:45 (at the age of 74-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included a history of COVID-19 infection on an unspecified date. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) 150 mg and "Larsortin" 50 mg. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Jan2021 the patient experienced fever, chills and body aches. The patient did not receive any treatment for the events. The clinical outcomes fever, chills and body aches were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Malaise, Myalgia
Clinical narrative: tiredness; sleepiness; muscle and joint pain; muscle and joint pain; nausea; lack of appetite; fatigue; feeling unwell; This is a spontaneous report from a contactable consumer, the patient.  A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number number number EX9231), via an unspecified route of administration on 30Dec2020 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included metastatic melanoma. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included prednisone (MANUFACTURER UNKNOWN), amoxicillin (AMOXICILLIN) and vitamins (MANUFACTURER UNKNOWN) all from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021, the patient experienced tiredness, sleepiness, muscle and joint pain, nausea, lack of appetite, fatigue and feeling unwell. The patient mentioned that he was unsure if this is from vaccine or "other treatment or cancer." The patient did not receive any treatment for the events. The clinical outcomes of tiredness, sleepiness, muscle and joint pain, nausea, lack of appetite, fatigue and feeling unwell were reported as not recovered.  It was additionally reported that the patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number E3246) on 20Jan2021 as a single dose in the left arm.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: tiredness; sleepiness; muscle and joint pain; muscle and joint pain; nausea; lack of appetite; fatigue; feeling unwell; This is a spontaneous report from a contactable consumer, the patient.  A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number number number EX9231), via an unspecified route of administration on 30Dec2020 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included metastatic melanoma. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included prednisone (MANUFACTURER UNKNOWN), amoxicillin (AMOXICILLIN) and vitamins (MANUFACTURER UNKNOWN) all from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021, the patient experienced tiredness, sleepiness, muscle and joint pain, nausea, lack of appetite, fatigue and feeling unwell. The patient mentioned that he was unsure if this is from vaccine or "other treatment or cancer." The patient did not receive any treatment for the events. The clinical outcomes of tiredness, sleepiness, muscle and joint pain, nausea, lack of appetite, fatigue and feeling unwell were reported as not recovered.  It was additionally reported that the patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number E3246) on 20Jan2021 as a single dose in the left arm.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site rash
Clinical narrative: woke up 1/23/21 with redness at injection site; a rash on the arm of said injection, right arm; a rash on the arm of said injection, right arm; This is a spontaneous report from a contactable healthcare professional who is the patient.  A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), intramuscularly on 22Jan2021 at 08:45 (at the age of 32-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included AV node re-entrant phenomenon. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246) intramuscularly in the right arm on 31Dec2020 at 8:30 AM.  The patient is allergic to morphine and "Celcor." The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ivabradine hydrochloride (CORLANOR) 5 mg half tablet twice daily with food. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient woke up on 23Jan2021 at 08:00 with redness at the injection site and a rash on the arm of said injection site (right arm). The patient did not receive any treatment for the events. The clinical outcomes of the events injection site redness and rash were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Nausea, Vomiting
Clinical narrative: splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mouth for 3 days.; This is a spontaneous report from a contactable other hcp, the patient. This 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), dose number 1, via an unspecified route of administration in the right arm on 29Dec2020 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus from 1974 to an unknown date (T1DM dx 1974) and aortic valve replacement from 1990 and unknown if ongoing (AVR 1990 and 1992). Concomitant medication included insulin (INSULIN), simvastatin (SIMVASTATIN) and lisinopril (LISINOPRIL). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 31Dec2020, the patient experienced metallic taste in mouth for 3 days. On 07Jan2021 at 13:00, the patient experienced splitting headaches, chronic nausea began and vomiting which was explosive and unpredictable. No therapeutic measures were taken as a result of the events. The clinical outcomes of the metallic taste in mouth for 3 days, splitting headaches, vomiting and chronic nausea were not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.