chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Vomiting
Clinical narrative: headache/headache that turned into a migraine; migraine/headache that turned into a migraine; vomiting/she is throwing up; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (reporter's mother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller spoken to safety before being transferred. Caller called on behalf of his mother. Caller stated my mom's got the second dose of the Pfizer Covid-19 vaccine. She developed a headache, migraine and vomiting post vaccination on 10Feb2021. Caller wants to know if it was safe to use excedrin an over the counter medication. Caller stated I was transferred several times. I had to give my information each time. His mom received the second shot of the covid vaccine. She woke up today with a headache which turned into a migraine. Now she was throwing up. Asking if it is safe to take generic Excedrin. He was on hold for a long time and was told we would be able to answer his question. He declined to complete a report and requested to be transferred to address question. The clinical outcome of events was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a Non-contactable consumer. A elderly male patient (age not reported; above 65 years) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown, whether prior to the vaccination, the patient was diagnosed with COVID-19 or since the vaccination, the patient had been tested for COVID-19. On 09Feb2021, the patient experienced fever. It was unknown, whether patient received any treatment. Outcome of the event was unknown. No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain
Clinical narrative: Generalized body pain; sharp aching joints; Fatigue; Chills; This is a spontaneous report from a contactable nurse (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EM9809, Expiration date was not reported), via an unspecified route of administration (administered on the left deltoid) on 09Feb2021 at 12:00 (at the age of 41-years-old) as dose 1, 0.3 mL single for COVID-19 immunisation. Medical history included known allergies to PCN (penicillin) from an unknown date, asthma and COVID-19 both from Nov2020. The patient has no other concomitant medications in two weeks. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 11Feb2021 at 01:30, the patient experienced generalized body pain, sharp aching joints, fatigue, and chills. Therapeutic measures were taken as a result of the events which included home symptom management and time off work. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Gastrooesophageal reflux disease, Hyperhidrosis
Clinical narrative: Fever 99.2; chills; joint aches & woke up in a sweat; joint aches & woke up in a sweat; Gastric reflux; This is a spontaneous report from a contactable nurse. This 44-year-old female nurse reported for herself. A 44-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3248) via intramuscularly in arm right on 08Jan2021 09:30 as dose 2, single (age at Vaccination: 44 years) for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, allergy from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL0140) via intramuscularly in arm right on 08Dec2020 10:30 AM as dose 1, single for COVID-19 immunisation. No Covid prior vaccination and did not tested covid post vaccination. On 08Feb2021, fever 99.2, chills, joint aches & woke up in a sweat, then gastric reflux for 3 days post vaccine. Treatment received was antacids & Tylenol. The patient underwent lab tests and procedures which included fever resulted 99.2 on 08Feb2021. The clinical outcome of the event gastric reflux on 11Feb2021 was resolved and the other events on Feb2021 was resolved.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 99.2; chills; joint aches & woke up in a sweat; joint aches & woke up in a sweat; Gastric reflux; This is a spontaneous report from a contactable nurse. This 44-year-old female nurse reported for herself. A 44-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3248) via intramuscularly in arm right on 08Jan2021 09:30 as dose 2, single (age at Vaccination: 44 years) for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, allergy from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL0140) via intramuscularly in arm right on 08Dec2020 10:30 AM as dose 1, single for COVID-19 immunisation. No Covid prior vaccination and did not tested covid post vaccination. On 08Feb2021, fever 99.2, chills, joint aches & woke up in a sweat, then gastric reflux for 3 days post vaccine. Treatment received was antacids & Tylenol. The patient underwent lab tests and procedures which included fever resulted 99.2 on 08Feb2021. The clinical outcome of the event gastric reflux on 11Feb2021 was resolved and the other events on Feb2021 was resolved.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Sinus congestion, Throat irritation
Clinical narrative: sinus congestion/ stuffy head, nose and ears; stopped-up ears; scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN5318) via intramuscular on 30Jan2021 at 11:15 (at the age of 67-years-old) in right upper arm as a single dose for covid-19 immunization. Medical history included osteoarthritis, high cholesterol, and high blood pressure all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient had no known allergies. Prior vaccinations were reported as none. Concomitant medication included lisinopril (LISINOPRIL); loratadine (LORATADINE); rosuvastatin (ROSUVASTATIN); ascorbic acid (VIT C); cyanocobalamin (B-12) and Mult all taken for an unspecified indication, start and stop date were not reported. The patient experienced sinus congestion, stuffy head, nose and ears, stopped-up ears, and scratchy throat on 02Feb2021 at 08:00. The events were reported as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with sinus medication (sinus rinse pseudoephedrine oxymetazoline). The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/ Lot number: EN6200) via intramuscular on 20Feb2021 at 11:15 in left upper arm as a single dose for covid-19 immunization. Relevant tests were reported as none. The outcome of all the events was resolving.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hunger, Increased appetite, Malaise, Vitreous floaters
Clinical narrative: she had a rapid onset of floaters in her left eye; her appetite kicked in which is unusual for her; felt unwell; she felt extremely hungry which is very unlikely of her.; she experienced extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 26Jan2021 16:30 (Tuesday) as Dose1, SINGLE for an unspecified indication. The patient's medical history and concomitant medications were not reported. On 27Jan2021 (Wednesday), the patient experienced extreme fatigue. She was able to carry out her work duties. On 28Jan2021 (Thursday), the patient felt unwell, she felt extremely hungry which is very unlikely of her, her appetite kicked in which is unusual for her. On 04Feb2021, she had a rapid onset of floaters in her left eye. She went to the eye doctor. She wanted to know if it is safe to take the second dose of the Pfizer COVID-19 vaccine on 16Feb2021. The outcome of all the events was unknown. There was no product quality complaint (PQC) present.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Fatigue, Pyrexia
Clinical narrative: Chills; shakes; Slight fever (99.6 F); moderate fatigue; cold sweating; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 09Feb2021 11:00 (at the age of 28-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included one Kidney (his kidneys fused pre birth, fully funcitonal) and shellfish allergy. The concomitant medications for the patient were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 09:00 AM (at the age of 28-year-old) for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not receive other medication in two weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On 09Feb2021 23:00, the patient experienced chills, shakes, slight fever (99.6 F), moderate fatigue, and cold sweating. No treatment was given for the events. The outcome of the events was reported as resolving.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Chills; shakes; Slight fever (99.6 F); moderate fatigue; cold sweating; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 09Feb2021 11:00 (at the age of 28-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included one Kidney (his kidneys fused pre birth, fully funcitonal) and shellfish allergy. The concomitant medications for the patient were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 09:00 AM (at the age of 28-year-old) for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not receive other medication in two weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On 09Feb2021 23:00, the patient experienced chills, shakes, slight fever (99.6 F), moderate fatigue, and cold sweating. No treatment was given for the events. The outcome of the events was reported as resolving.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash spreading from left arm to neck, upper chest, and lower abdomen.; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an intramuscular route of administration on 02Feb2021 (Batch/Lot Number was not reported) as dose 2, single (at the age of 66 years old) for COVID-19 immunization. The patient's medical history included allergies with gadolinium contrast media (history of hives) and iodinated contrast media (causing anaphylactoid reaction); osteopenia, allergic rhinitis, and mild aortic regurgitation. Concomitant medications included butalbital, caffeine, paracetamol (FIORICET); sucralfate (CARAFATE), calcium carbonate (CALTRATE); and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH); all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2, intramuscularly on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility type vaccine where the patient received the vaccine was unknown. On 05Feb2021, the patient experienced itchy rash spreading from left arm to neck, upper chest, and lower abdomen. The result of the adverse event was doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as the result of the event included recommendation to take second generation antihistamine which the patient declined. Outcome of the event was recovered on Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable Other HCP (patient). A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL1283) intramuscular in left arm on 19Jan2021 at 09:00 (at the age of 43-year-old) as single dose for COVID-19 immunization at Doctor's office/urgent care. Medical history of the patient included depression and anxiety. Concomitant/other medications received within two weeks included lamotrigine (LAMICTAL), fluoxetine hydrochloride (PROZAC), monascus purpureus (RED YEAST RICE), curcuma longa (TURMERIC), boswellia serrata (BOSWELLIA), acacia catechu wood, chondroitin sulfate sodium, glucosamine hydrochloride, hyaluronic acid, maltodextrin, methylsulfonylmethane, scutellaria baicalensis root (GLUCOSAMINE CHONDROITIN), VITAMIN D3, CHROMIUM PICOLINATE all taken for unspecified indications. No other vaccine was received within four weeks of suspect vaccine. Patient had no known allergies. Patient did not have COVID prior vaccination and was not tested for Covid post vaccination. On an unspecified date in 2021 after the first dose, patient experienced arm soreness and nothing else. Patient did not receive any treatment in response to the event. Outcome of the event was resolving.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Chills; headache; fever 99.5 deg.F; This is a spontaneous report from a non-contactable consumer (Patient). A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. It was unknown if patient received other vaccines in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19 was unknown, and COVID-19 tested post vaccination was also Unknown. On 10Feb2021, the patient experienced chills, headache, fever 99.5 deg. Fahrenheit. It was unknown if patient received treatment for adverse events. It was reported that colleague within the report communicated to me in informal conversation the AE post second dose for the COVID vaccine. His/Her understanding was his boost was on 09Feb2021 and presented with the symptoms in the document the following day, 10Feb2021. His/her awareness date was 10Feb2021. The patient underwent lab tests and procedures which included body temperature: 99.5 deg. fahrenheit on 10Feb2021. The outcome for the events was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Condition aggravated, Cough, Ear pain
Clinical narrative: feeling body aches; chills; low energy; symptoms started getting worse; sharp pains in throat; sharp pains in ears; coughing; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 22Jan2021 15:00(age at vaccination: 28 Years) as SINGLE DOSE for covid-19 immunisation (at pharmacy). Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history and concomitant medications were not reported. Patient had no allergies. Patient didn't had covid-19 prior to vaccination. On 24Jan2021 13:00 the patient experienced feeling body aches, chills, low energy, symptoms started getting worse, sharp pains in throat, sharp pains in ears, coughing. No therapeutic measures were taken for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05Feb2021 Covid test name post vaccination was Slava test. Patient was not tested to covid-19 to post vaccination. The outcome of the events pain, chills, asthenia, oropharyngeal pain, ear pain, cough was not recovered, the outcome of the event condition aggravated was unknown.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: feeling body aches; chills; low energy; symptoms started getting worse; sharp pains in throat; sharp pains in ears; coughing; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 22Jan2021 15:00(age at vaccination: 28 Years) as SINGLE DOSE for covid-19 immunisation (at pharmacy). Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history and concomitant medications were not reported. Patient had no allergies. Patient didn't had covid-19 prior to vaccination. On 24Jan2021 13:00 the patient experienced feeling body aches, chills, low energy, symptoms started getting worse, sharp pains in throat, sharp pains in ears, coughing. No therapeutic measures were taken for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05Feb2021 Covid test name post vaccination was Slava test. Patient was not tested to covid-19 to post vaccination. The outcome of the events pain, chills, asthenia, oropharyngeal pain, ear pain, cough was not recovered, the outcome of the event condition aggravated was unknown.  Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis
Clinical narrative: headache; head cold; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A 63-year-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 on 09Feb2021 (at the age of 63-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunization and advil [ibuprofen] for sinus headache/neck aches. On 09Feb2021, patient experienced headache, head cold. Patient again stated a week before his first Pfizer Covid vaccine, he was on a course of Advil to treat sinus headache/neck aches. He heard on the news that taking these medications could decrease the immune response and made the vaccine less effective. He wanted to know if this was true. Patient wanted to know if there would be a 3rd booster shot to take to address the new variants/strains of Covid 19 and inquired if he could take advil after the vaccine. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; aches/pains; chills; This is a spontaneous report from a contactable consumer (patient husband). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 09Feb2021 (age at vaccination 60-year-old) as dose 2 single for COVID-19 Immunization. Medical history and Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. It was reported that patient had fever, aches, pains, and chills after the second dose of the vaccine yesterday 09Feb2021. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Noticed face swelling; This is a spontaneous report from a contactable Consumer.  A 53-years-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL9267), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergy, covid-19. Other medical history none. Concomitant medication(s) included enalapril (ENALAPRIL); atorvastatin (ATORVASTATIN); hydrochlorothiazide (HYDROCHLOROTHIAZIDE). On 10Feb2021 21:00 patient noticed face swelling. No treatment for event. The outcome of event was not recovered.  Follow-up (17May2021): Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 20-year-old patient, of unspecified gender, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# EN6201, expiry date: unknown), at vaccination age of 20, via unspecified route of administration, right arm, on Feb 9, 2021, at 17:00, single dose, for COVID-19 immunisation. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# and expiry date: unknown), via unspecified route of administration, on unspecified date, single dose, for COVID-19 immunisation. Facility type vaccine was other. Medical history included peanut allergy, from an unspecified date and unknown if ongoing. Concomitant medications: none. There was no other vaccine in four weeks and no other medications in two weeks. On Feb 9, 2021, at 20:00, patient experienced rash over entire body. AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment given: Benadryl. Patient did not have COVID-19 prior vaccination, and was not tested for COVID-19 post vaccination. The outcome of event: recovering. Follow-up (May 12, 2021): Follow-up attempts completed. No further information expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Condition aggravated, Gait inability, Pain in extremity, Scan
Clinical narrative: Severe joint reaction; Can not walk because the pain she is in right now is excruciating; Can not walk because the pain she is in right now is excruciating; The flare occurred in the left knee; This is a spontaneous report from a contactable consumer or other non hcp. A 90-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 29Jan2021 (at the age of 90 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included arthritis and osteoporosis. The patient's concomitant medications were not reported. The reporter says she is calling for her mother who is 90 years old. She got her COVID vaccine on 29Jan2021 and says she is kind of concerned. She is unsure if it is from the vaccine or what. Her mother had a severe joint reaction. It did not happen in the first day, but about 2-3 days later after getting the vaccine. She took her mother to the orthopedic doctor yesterday to make sure that she did not have an injury. She has arthritis and osteoporosis and all the things, as she is 90 years old. She cannot walk because the pain she is in right now is excruciating. The doctor noted that she has some bone burs, which she has had for a while. One knee she has, has been treated in the past with cortisone before. Her other knee does not hurt as bad. The flare occurred in the left knee. They do not know what caused it. The x-rays and scans show nothing. She asked how they could know if this was a reaction to the vaccine. Her mother is supposed to get her next one on 19Feb2021. She wants her to get it, but she is concerned. The patient underwent lab tests and procedures which included scan: nothing, x-ray: nothing both on an unspecified date. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Severe joint reaction; Can not walk because the pain she is in right now is excruciating; Can not walk because the pain she is in right now is excruciating; The flare occurred in the left knee; This is a spontaneous report from a contactable consumer or other non hcp. A 90-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 29Jan2021 (at the age of 90 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included arthritis and osteoporosis. The patient's concomitant medications were not reported. The reporter says she is calling for her mother who is 90 years old. She got her COVID vaccine on 29Jan2021 and says she is kind of concerned. She is unsure if it is from the vaccine or what. Her mother had a severe joint reaction. It did not happen in the first day, but about 2-3 days later after getting the vaccine. She took her mother to the orthopedic doctor yesterday to make sure that she did not have an injury. She has arthritis and osteoporosis and all the things, as she is 90 years old. She cannot walk because the pain she is in right now is excruciating. The doctor noted that she has some bone burs, which she has had for a while. One knee she has, has been treated in the past with cortisone before. Her other knee does not hurt as bad. The flare occurred in the left knee. They do not know what caused it. The x-rays and scans show nothing. She asked how they could know if this was a reaction to the vaccine. Her mother is supposed to get her next one on 19Feb2021. She wants her to get it, but she is concerned. The patient underwent lab tests and procedures which included scan: nothing, x-ray: nothing both on an unspecified date. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Diarrhoea, Fatigue
Clinical narrative: Bone pain; Nausea; Fatigue; Headache; joint pain and muscle aches; joint pain and muscle aches; chills and sweating off and on; chills and sweating off and on; Diarrhea; she was bleeding after the person injected her; This is a spontaneous report from a contactable consumer (patient reported for herself). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269), dose 1 via an intramuscular route of administration, administered in Arm Left on 02Feb2021 at 16:45 (at the age of 32-year-old) as DOSE 1, SINGLE for covid-19 immunisation and prophylaxis. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Medical history included She did have a baby last February and covid-19 from an unknown date to Mar2020. Family medical history was none. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was none. On 03Feb2021, the patient experienced bone pain, nausea, fatigue, headache, joint pain, muscle aches, chills, sweating off and on, diarrhea and she was bleeding after the person injected her. The clinical details of the events as follows: she received the first dose and would like to report some adverse events. She had all the side effects listed and also had bone pain. She called her doctor and reported the symptoms to her. She was unable to confirm if it was given in the muscle but did note that she was bleeding after the person injected her. Injected in left shoulder unable to confirm if given in muscle. It was reported that Bone pain progressively worse with every hour. After 24 hours, she was taking Ibuprofen for symptom relief, but did not take anything prior to receiving the vaccine. ER or physician office required: tele-visit with doctor on 05Feb2021 and it was not her usual doctor and medical treatment provided. Relevant tests were none. She did have a baby last February and recently read where people had children had worse side effects. It was just an online article. She did not have any information on those people to provide. No Investigation Assessment was provided. She was very hesitant to get second dose and would like some guidance about that. The patient outcome of the events Nausea, Headache, and Diarrhea was resolving, the outcome of the events Bone pain, Fatigue, joint pain, muscle aches, chills, sweating off and on and the outcome of the event bleeding after the person injected was unknown at the time of this report.  Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Nausea, Vaccination site haemorrhage
Clinical narrative: Bone pain; Nausea; Fatigue; Headache; joint pain and muscle aches; joint pain and muscle aches; chills and sweating off and on; chills and sweating off and on; Diarrhea; she was bleeding after the person injected her; This is a spontaneous report from a contactable consumer (patient reported for herself). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269), dose 1 via an intramuscular route of administration, administered in Arm Left on 02Feb2021 at 16:45 (at the age of 32-year-old) as DOSE 1, SINGLE for covid-19 immunisation and prophylaxis. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Medical history included She did have a baby last February and covid-19 from an unknown date to Mar2020. Family medical history was none. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was none. On 03Feb2021, the patient experienced bone pain, nausea, fatigue, headache, joint pain, muscle aches, chills, sweating off and on, diarrhea and she was bleeding after the person injected her. The clinical details of the events as follows: she received the first dose and would like to report some adverse events. She had all the side effects listed and also had bone pain. She called her doctor and reported the symptoms to her. She was unable to confirm if it was given in the muscle but did note that she was bleeding after the person injected her. Injected in left shoulder unable to confirm if given in muscle. It was reported that Bone pain progressively worse with every hour. After 24 hours, she was taking Ibuprofen for symptom relief, but did not take anything prior to receiving the vaccine. ER or physician office required: tele-visit with doctor on 05Feb2021 and it was not her usual doctor and medical treatment provided. Relevant tests were none. She did have a baby last February and recently read where people had children had worse side effects. It was just an online article. She did not have any information on those people to provide. No Investigation Assessment was provided. She was very hesitant to get second dose and would like some guidance about that. The patient outcome of the events Nausea, Headache, and Diarrhea was resolving, the outcome of the events Bone pain, Fatigue, joint pain, muscle aches, chills, sweating off and on and the outcome of the event bleeding after the person injected was unknown at the time of this report.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseated; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (friend). A patient of unspecified age and gender received dose number unknown of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: 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 immunisation. The patient medical history and concomitant medications were not report-ed. On an unspecified date the patient experienced nauseated. Clinical course was reported as her friend received the Pfizer COVID-19 vaccine and became very nauseated afterwards. She would like to know if this is a common side effect. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A 28-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced fever, headache and left foot got hot; on an unspecified date. The outcome of the events: unknown. Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Migraine, SARS-CoV-2 test, Vertigo
Clinical narrative: Intense migraine; severe vertigo; stomachache; This is a spontaneous report from a contactable Other HCP (patient herself). A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via intramuscular route, administered in right arm on 09Feb2021 11:00 (age at vaccination: 39-years) as dose 2, single for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 via intramuscular route, administered in right arm on 19Jan2021 11:00 AM (age at vaccination: 38-years) as dose 1, single for Covid-19 immunisation. Medical history was not reported. Patient had no known allergies. Concomitant medication included Sertraline 100 mg taken for unspecified indication. Facility type Vaccine was workplace clinic. Patient took no other vaccine in four weeks. On 10Feb2021 6:00 A.M patient experienced intense migraine, severe vertigo, stomachache. Patient did not have if Covid prior vaccination. She was tested for covid post vaccination. Patient underwent lab test which included nasal swab test, with unknown results on an unspecified date. No treatment was given for the adverse events. The outcome of events was recovering.   Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain in extremity
Clinical narrative: Diarrhea; Left arm pain; Nausea; This is a spontaneous report received from a contactable consumer (patient). This 60-Year-old female consumer reported for herself. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW2245) via an unspecified route of administration in arm left on 09Feb2021 10:00 AM as dose 1, single (age at vaccination: 60 years) for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine includes flu shot from an unspecified date Sep2020 to an unspecified date Sep2020. History of all previous immunisation with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunisations if dates of birth or immunisations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was none. On 09Feb2021, the patient experienced left arm pain, nausea. On 10Feb2021, had diarrhoea. It was stated that she was having a little bit of a side effect after receiving the COVID-19 Vaccine, her arm feels better, but she was nauseated and had diarrhoea. She knows she should go to her doctor if the side effects keep up and if there was anything else, she can really do for her COVID-19 Vaccine side effects, and will she go through the same side effects again with her second COVID-19 Vaccine dose in a couple weeks. Reported her roommate called to an emergency room to ask questions about her side effects, but the emergency room staff said they could not give her any information over the phone. Her left arm pain started at around 8:00PM last night, diarrhoea started this morning, and her last episode of diarrhoea was about an hour ago at 10:00AM. Treatment received was for the pain in her left arm she took aspirin and pain medicine. She said she put a warm water bottle on her left arm last night and left the warm water bottle on her arm all night. This really helped with her left arm pain. She took 2 Medline Ibuprofen 200mg (brown) tablets (NDC: Unknown Lot: WJO7688 Expiration: Mar2022) and gericare Aspirin 325mg as needed for pain (UPC: 5789690101 Lot: P120438 Exp: May2022) and had previously taken the Gericare Aspirin 325mg, as needed, for pain. Reported she goes to a clinic, and sees whatever doctor was available, so she does not have a set doctor. The adverse event did not require a visit to emergency room, physician Office. The clinical outcome of the event diarrhoea was not resolved and rest of the events was resolving.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Feeling abnormal, Inner ear inflammation, Vertigo, Visual impairment
Clinical narrative: Vertigo; Inner ear inflammation; vomiting; slight vision impairment; brain fog; This is a spontaneous report from a contactable consumer (the patient). A 51-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK5730; Expiration Date: Mar2021), via an unspecified route of administration, administered in upper left arm on 11Jan2021 09:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation (reported as to protect himself). Medical history included ongoing ulcerative colitis. Concomitant medication included mesalazine (APRISO) taken for ulcerative colitis from an unspecified start date and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK5730; Expiration Date: Mar2021), via an unspecified route of administration, administered in upper left arm on 24Dec2020 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. No additional Vaccines administered on same date of the Pfizer suspect. No other vaccine within four weeks of getting COVID Vaccines. On 11Jan2021 22:00, the patient experienced vertigo, inner ear inflammation, vomiting. On an unspecified date in Jan2021, the patient experienced slight vision impairment, brain fog. He had an adverse reaction to the Pfizer shot. He had bad vertigo and inner ear inflammation. He got the second shot on 11Jan2021 at 9:30AM and that same day at 10PM everything started spinning and he started vomiting. He still has slight vision impairment, things are still slow, and he still has brain fog. It has gotten better, but very slowly. This has been a month now. It was reported that he went to a specialist an ENT after the fact. He was seen in the emergency room (ER) two days after the shot. When the hospital treated him they gave him anti-nausea medication and steroids for vertigo. He did not have the names of the medications. It was a seven day steroid course. When he went to the ER he was told that the Pfizer shot creates inflammation and it attacked the inner ear, so it is kind of same things as vertigo. On an unspecified date, the patient underwent lab tests and procedures which included tested his hearing: inflammation of the inner ear. Therapeutic measures were taken as a result of adverse events. The outcome of events inner ear inflammation and vomiting was unknown whereas the outcome of all other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vertigo; Inner ear inflammation; vomiting; slight vision impairment; brain fog; This is a spontaneous report from a contactable consumer (the patient). A 51-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK5730; Expiration Date: Mar2021), via an unspecified route of administration, administered in upper left arm on 11Jan2021 09:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation (reported as to protect himself). Medical history included ongoing ulcerative colitis. Concomitant medication included mesalazine (APRISO) taken for ulcerative colitis from an unspecified start date and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK5730; Expiration Date: Mar2021), via an unspecified route of administration, administered in upper left arm on 24Dec2020 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. No additional Vaccines administered on same date of the Pfizer suspect. No other vaccine within four weeks of getting COVID Vaccines. On 11Jan2021 22:00, the patient experienced vertigo, inner ear inflammation, vomiting. On an unspecified date in Jan2021, the patient experienced slight vision impairment, brain fog. He had an adverse reaction to the Pfizer shot. He had bad vertigo and inner ear inflammation. He got the second shot on 11Jan2021 at 9:30AM and that same day at 10PM everything started spinning and he started vomiting. He still has slight vision impairment, things are still slow, and he still has brain fog. It has gotten better, but very slowly. This has been a month now. It was reported that he went to a specialist an ENT after the fact. He was seen in the emergency room (ER) two days after the shot. When the hospital treated him they gave him anti-nausea medication and steroids for vertigo. He did not have the names of the medications. It was a seven day steroid course. When he went to the ER he was told that the Pfizer shot creates inflammation and it attacked the inner ear, so it is kind of same things as vertigo. On an unspecified date, the patient underwent lab tests and procedures which included tested his hearing: inflammation of the inner ear. Therapeutic measures were taken as a result of adverse events. The outcome of events inner ear inflammation and vomiting was unknown whereas the outcome of all other events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Hypoaesthesia, Inflammation, Swelling face
Clinical narrative: headache; an inflamed right side of the face /it is swollen enough to be noticeable; Feeling Numb /I felt like my face was numb in a weird way; one part of her face seemed a little more inflamed; my face got in pain on the right side /it kind of feel like I had an anesthesia and it was wearing off; This is a spontaneous report from a contactable pharmacist (patient). A female patient of (Age:32, unit not provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date on Jan2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, an inflamed right side of the face /it is swollen enough to be noticeable, feeling numb /i felt like my face was numb in a weird way, one part of her face seemed a little more inflamed, my face got in pain on the right side /it kind of feel like i had an anesthesia and it was wearing off on an unspecified date on 2021. The case was reported as non serious. Reported as, patient received the first dose of the Covid vaccine and states that she experienced the typical side effects of a headache, but also is experiencing "an inflamed right side of the face." She states that it was swollen enough to be noticeable and it feels as if she has received anesthesia and it was wearing off. She was scheduled to receive her second dose of the vaccine a day after. She was calling because she got the COVID vaccine a month ago on friday. She states that after she got it, a few hours later one, part of her face seemed a little more inflamed, and it felt like anesthesia was wearing off on one side. The feeling lasted a few days, and she felt it go down little by little. It took a few days to go away but I felt like my face was numb in a weird way. Not completely numb but just feel like coming off of anesthesia". Outcome of all the events were unknown.  Follow-up attempts completed. No further information expected.