chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac function test abnormal, Chest discomfort, Chest pain, Diarrhoea, Dysphagia
Clinical narrative: right upper quadrant pain; upper quadrant discomfort; Broke out in a rash; she developed a rash; Cardiac numbers are elevated; After she did her injection she started feeling bad; nausea; vomited; feeling sweaty; chest discomfort; diarrhea; gas; burping; She feels feverish; achy; Her temperature is 100.9ºF; chest pain; Numbness around mouth; Difficulty swallowing; This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch no/Lot number: not reported) via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization. Patient also received Inotersen sodium (TEGSEDI, injection) ongoing via subcutaneously on 29Aug2019 for hereditary neuropathic amyloidosis and diphenhydramine hydrochloride (BENADRYL ALLERGY) on an unspecified date for right upper quadrant pain and upper quadrant pain. ISSD (Integrated Syringe Safety Device) for unknown Indication from unknown therapy dates. Patient's medical history included as hereditary neuropathic amyloidosis. Concomitant medications were not reported. On 05Mar2021, patient experienced right upper quadrant pain, upper quadrant discomfort, broke out in a rash; she developed a rash, cardiac numbers are elevated, after she did her injection and she started feeling bad, had nausea, vomited, feeling sweaty, chest discomfort, developed diarrhea, gas, was also burping, she feels feverish, achy, her temperature is 100.9 F, chest pain, numbness around mouth and difficulty swallowing. Patient under lab tests and procedures which included cardiac function test and results noted elevated on 11Feb2021 and on 05Mar2021, body temperature increased results 100.9F. Outcome of the events Abdominal pain upper and Rash was not recovered, and other events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eructation, Feeling abnormal, Flatulence, Hyperhidrosis, Hypoaesthesia oral
Clinical narrative: right upper quadrant pain; upper quadrant discomfort; Broke out in a rash; she developed a rash; Cardiac numbers are elevated; After she did her injection she started feeling bad; nausea; vomited; feeling sweaty; chest discomfort; diarrhea; gas; burping; She feels feverish; achy; Her temperature is 100.9ºF; chest pain; Numbness around mouth; Difficulty swallowing; This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch no/Lot number: not reported) via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization. Patient also received Inotersen sodium (TEGSEDI, injection) ongoing via subcutaneously on 29Aug2019 for hereditary neuropathic amyloidosis and diphenhydramine hydrochloride (BENADRYL ALLERGY) on an unspecified date for right upper quadrant pain and upper quadrant pain. ISSD (Integrated Syringe Safety Device) for unknown Indication from unknown therapy dates. Patient's medical history included as hereditary neuropathic amyloidosis. Concomitant medications were not reported. On 05Mar2021, patient experienced right upper quadrant pain, upper quadrant discomfort, broke out in a rash; she developed a rash, cardiac numbers are elevated, after she did her injection and she started feeling bad, had nausea, vomited, feeling sweaty, chest discomfort, developed diarrhea, gas, was also burping, she feels feverish, achy, her temperature is 100.9 F, chest pain, numbness around mouth and difficulty swallowing. Patient under lab tests and procedures which included cardiac function test and results noted elevated on 11Feb2021 and on 05Mar2021, body temperature increased results 100.9F. Outcome of the events Abdominal pain upper and Rash was not recovered, and other events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, Rash, Vomiting
Clinical narrative: right upper quadrant pain; upper quadrant discomfort; Broke out in a rash; she developed a rash; Cardiac numbers are elevated; After she did her injection she started feeling bad; nausea; vomited; feeling sweaty; chest discomfort; diarrhea; gas; burping; She feels feverish; achy; Her temperature is 100.9ºF; chest pain; Numbness around mouth; Difficulty swallowing; This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch no/Lot number: not reported) via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization. Patient also received Inotersen sodium (TEGSEDI, injection) ongoing via subcutaneously on 29Aug2019 for hereditary neuropathic amyloidosis and diphenhydramine hydrochloride (BENADRYL ALLERGY) on an unspecified date for right upper quadrant pain and upper quadrant pain. ISSD (Integrated Syringe Safety Device) for unknown Indication from unknown therapy dates. Patient's medical history included as hereditary neuropathic amyloidosis. Concomitant medications were not reported. On 05Mar2021, patient experienced right upper quadrant pain, upper quadrant discomfort, broke out in a rash; she developed a rash, cardiac numbers are elevated, after she did her injection and she started feeling bad, had nausea, vomited, feeling sweaty, chest discomfort, developed diarrhea, gas, was also burping, she feels feverish, achy, her temperature is 100.9 F, chest pain, numbness around mouth and difficulty swallowing. Patient under lab tests and procedures which included cardiac function test and results noted elevated on 11Feb2021 and on 05Mar2021, body temperature increased results 100.9F. Outcome of the events Abdominal pain upper and Rash was not recovered, and other events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills and fever started from 15 hours after administration; Chills and fever started from 15 hours after administration; This is a spontaneous report received from a contactable other- health professional (in response to HCP letter sent in cross referenced case). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration on 10Feb2021 (at the age of 47-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. In Feb2021, the patient experienced chills and fever started from 15 hours after administration. The patient took 1 extra strength TYLENOL as therapeutic measure for both. Fever went away and did not repeat any other symptom. It was reported that the patient did not receive re-vaccination. Outcome for chills was unknown and for fever was recovered in 2021. Do you consider the Pfizer product had a causal effect to the adverse event: Yes.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Ear discomfort, Ear swelling, Swelling face, Tinnitus
Clinical narrative: tinnitus on the left side; felt swollen on the left side of her face; gives me anxiety; my ear clogged and swell up; my ear clogged and swell up; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported; Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, she was calling to report some side effects that she had from the first dose of the Pfizer vaccine. She was scheduled for second dose on this coming Saturday, but she was hesitant to go. It only gives her anxiety that's how bad the reaction was. Almost immediately after receiving the vaccine her ear clogged and swell up. She has tinnitus on the left side and it started within an hour after the vaccine and it's been like that for 3 weeks. She spoke to three different doctor they keep saying it's not associated with the vaccine. She don't know why everyone keep denying it. She felt helpless. She know tinnitus was correlated with vaccine. She follow a group on social media which was called tinnitus from the vaccine. There's 500 people on the page who have reported this side effects. She got a bad tinnitus from the vaccine. The doctor just gave me anxiety pills and didn't do anything else. The patient also felt swollen on the left side of her face, it was the same side she got her shot in. The caller is almost 100% sure this was from the vaccine because she has never had tinnitus before in her life. The caller doesn't know what to do and she didn't know if this was reported from other patients. Response received form medical information team, stating that however these may not be all the possible side effects of the Pfizer BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer BioNTech COVID-19 Vaccine was still being studied in clinical trials. You should always talk with a vaccination provider, doctor, or other qualified health care professional about whether a specific treatment. They were in the best position to advise you about the suitability of a particular treatment as they have access to the details of your medical history, as well as to information on all medical products. The outcome of events was unknown at the time of reporting. The relatedness for the event of tinnitus on the left side was related with Covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Aggressiveness; soreness; Headache; fatigue; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9263) via intramuscular route of the administration in Arm Left on 17Feb2021 11:30 (age at vaccination: 74-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient didn't receive other medications within 2 weeks to post vaccination. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK 9231) via unspecified route of administration on 27Jan2021 11:30 in left shoulder as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced soreness on 28Jan2021, headache on 28Jan2021, fatigue on 28Jan2021, chills on 28Jan2021, aggressiveness on 17Feb2021. No Therapeutic measures were taken for the events. The outcome of the event aggression was recovered on Feb2021, the outcome of the event arthralgia, headache, fatigue, chills was recovered on 30Jan2021.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Neck pain, Pain in extremity
Clinical narrative: pain in his arm, neck, shoulder, and back; pain in his arm, neck, shoulder, and back; pain in his arm, neck, shoulder, and back; pain in his arm, neck, shoulder, and back; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 60 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 09:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included acetylsalicylic acid, butalbital, caffeine (FIORINAL [ACETYLSALICYLIC ACID;BUTALBITAL;CAFFEINE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced pain in his arm, neck, shoulder, and back causing pain in extremity on an unspecified date with outcome of unknown , arthralgia on an unspecified date with outcome of unknown, headache on an unspecified date with outcome of unknown.    Therapeutic measures were taken as a result of this with Fiorinal and Tylenol.  Follow-up (07pr2021): This is a follow up spontaneous report received from a contactable consumer (patient) reported that: Caller received first vaccine last week Tuesday. Caller took pain killers before for a headache and then after for his arm which was sore. Wants to know if that will decrease the efficacy of the vaccine.  Follow-up (17May2021): Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I only had a slightly sore arm after dose; This is a spontaneous report from a two contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Right, on 09Mar2021 (at the age of 60-year-old), as dose 1, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced slightly sore arm after first dose in Mar2021 and it was reported that it did not last long. No treatment received for the event. The patient recovered from the event in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Lip swelling, Paraesthesia oral, Pruritus
Clinical narrative: Tingling in lips and they were slightly swollen; Tingling in lips and they were slightly swollen; Little hard to swallow for a while; Face and whole body was itchy; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included diphenhydramine hydrochloride taken for pruritus, start and stop date were not reported. Consumer stated, " patient had the Pfizer COVID-19 Vaccine the first dose this (reported date) morning and after a few minutes, patient just had like a tingling in patient lips, and they were slightly swollen. And then, it was just a little hard to swallow for a while and then patient was fine after 20 minutes. And then after a few hours, it kind of came back again and then patient whole body itched like patient was (incomplete sentence), patient face and whole body was itchy and then patient took a Benadryl and then seem to ease a little bit. Patient was just wondering, if patient should continue taking Benadryl and then, patient was just wondering if that was an allergic reaction to it." Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. When offered the contact# for Pfizer Medical Information, consumer stated, waited for few minutes on hold for this call, consumer can't do that again. When requested for permission to probe questions, consumer stated, "What is this for?. When informed about the need to probe questions for a safety report, consumer stated, "patient need to find out if patient having an allergic reaction or not. Patient don't care about that. This was not helping to patient at all. Patient just going to call patient hospital. Consumer hung up abruptly. Hence further probing could not be done. Hence, limited information was available over the call. Reason for no lot number: of COVID-19 Vaccine: Complainant hung up abruptly/transfer incomplete   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: pain in right arm where she had the injection for about 5 days; really, really bad pain in both arms; pain in joints; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date in Mar2021 as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia. The patient's concomitant medications and other Products were not provided were not reported. On an unspecified date, the patient experienced pain in right arm where she had the injection for about 5 days, really, really bad pain in both arms, pain in joints. It was reported that the patient got her first Pfizer Covid-19 vaccine around 11Mar2021 and they gave her all these papers and she experienced pain in right arm where she had the injection for about 5 days. She stated she has fibromyalgia and after about 11 days she had pain in joints. She stated she had really, really bad pain in both arms, right and left. She went to the doctor and they said because she has fibromyalgia that could have given her the reaction. They gave her anti inflammatory to take. Reportedly, it felt better but then it would come back again. The anti inflammatory they told her to take it once a day because it is not really that great to take. She was only taking one a day and then she would take the Tylenol. She stated the pain would get better but then it would come back. She was going for her second one on Thursday. She stated she wanted to know if it was okay to get the second dose, her doctor wanted her to take it but she wanted to get in touch with her rheumatologist but was unable to get in touch with him so she called Pfizer to ask if it is okay. She stated her doctor told her to get the second dose, she experienced more pain than other people and just wanted to make sure it was safe. This report is not related to a study or programme. Investigation Assessment was not provided. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: a nurse at the doctor's office said her grandmother had this with her first vaccine in the same area of her chest; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported. Reporter states a week after the vaccine the patient started feeling bad. On an unspecified date the patient experienced a nurse at the doctor's office said her grandmother had this with her first vaccine in the same area of her chest . States the doctor ordered a chest x-ray today because he heard wheezing, she has no energy and all that. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Rash erythematous, Rash pruritic, Vaccination site erythema
Clinical narrative: I have red bumps popping up on arms, torso and legs; typical redness by the injection site; started to have these itchy bumps on the arms and progressing down from there; It is like it is progressing through my body from head to toe; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had red bumps popping up on arms, torso and legs. Predominantly legs and arms. This started after 2nd Covid shot. Initially typical redness by the injection site, then started to had these itchy bumps on the arms and progressing down from there, it was like it was progressing through body from head to toe (condition aggravated). It was reported that now 17 days out and was still getting more annoying. Patient did not have this reaction after the first injection. Outcome of all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Rash, Vaccination site pain
Clinical narrative: injection site sore; rashes; Light headache; dizziness; This is a Spontaneous report from Pfizer Support program. A contactable female consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date in 2021, the patient experienced injection site sore, rashes, light headache and dizziness. The second dose was scheduled on 18Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu-like symptoms: fever, chills, and body aches; flu-like symptoms: fever, chills, and body aches; flu-like symptoms: fever, chills, and body aches; flu-like symptoms: fever, chills, and body aches; felt horrible; This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer Sponsored Program Support. A 50-years-old male patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ER8730 and Expiration date was not reported), via an unspecified route of administration on 03Apr2021 as dose 1, single (at the age of 50-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Apr2021 (from last 2 days), patient had flu-like symptoms, fever, chills, and body aches and felt horrible. Patient's mother asked how long patient flu-like symptoms will continue, and should patient think about getting the second COVID-19 Vaccine shot. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: dominant hand and wrist swollen up with extreme pain; dominant hand and wrist swollen up with extreme pain; Extreme pain; can't use that; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 29Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first of the vaccine on 29March2021 and during a night her dominant hand and wrist swollen up with extreme pain and the patient still have it and it has been 8 days now. The patient just wants to know that was that common. Oh there was my question. Was that patient's conditional side effect on receiving a shot. When consumer informed about Medical Information Department, consumer stated, "Well it was my right hand. The patient can't use the patient can't use that. The patient would not be able to write it down, could you help someone call me. Oh that was a person giving you my phone number, you can give that. The patient can't right with my hand. The patient wouldn't be able to report it. Can you send me message with the number. The outcome of the events was unknown.  No follow up attempts are needed. Information about Lot/Batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk, Illness, Pyrexia, Rash
Clinical narrative: my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; sick; moderate fever for 3 days; then a rash about a week about 10 days after; This is spontaneous stimulated report received from a contactable HCP. This contactable Female reported for her 6 months old baby (patient). A 6-month-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ER8727) via transmammary route of administration on 22Mar2021 at 10:00 AM as dose 2, single for COVID-19 immunization. Medical history included allergies to medications, food, or other products: penicillin, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) administered on 01Mar2021 at 10:00 AM for COVIID-19 immunization. Reported facility where the most recent COVID-19 vaccine was administered was Hospital. The patient's mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine, not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient's mother was not diagnosed with COVID-19. Since the vaccination, the patient's mother has not been tested for COVID-19. On 26Mar2021 at 12:00 the patient experienced sick, moderate fever for 3 days; On an unspecified date in 2021 the patient experienced a rash about a week about 10 days after. It was reported that her baby, whom she was breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later." The mother received no treatment for the adverse events. The clinical outcome of the events was not resolved.  No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021388307 same reporter/drug, different patient/event(mother case)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Back pain, Fatigue, Neck pain
Clinical narrative: Neck pain; low back pain; loss sense of taste 5 days after; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm on 02Apr2021 at 03:30 PM (at the age of 42-years-old) as dose 1, single for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and patient has not been tested for COVID-19 since the vaccination. On 05Apr2021, patient experienced Neck pain, low back pain, loss sense of taste 5 days after and extreme fatigue. No treatment was received in response to events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: redness in the itchy areas; itching all over my body with a rash; itching all over my body with a rash; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733, Expiration date: not reported), via an unspecified route of administration in arm right on 02Apr2021 at 14:15 (at the age of 51-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Allergies to medications, food, or other products was reported as no. The patient's concomitant medication received within 2 weeks of vaccination included amoxicillin 500 mg, taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6206, Expiration date: not reported), via an unspecified route of administration in arm right on 07Mar2021 at 14:15 (at the age of 51-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 06Apr2021, the patient experienced itching all over her body with a rash and redness in the itchy areas. Treatment was not received for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inflammation, Musculoskeletal discomfort, Neck pain
Clinical narrative: feel something different in her neck; pain in her neck; she can actually feel the injection go into the right of her neck, the middle of the back of her neck into her right breast and then into her right leg; feeling as discomfort and thinks it might be inflammation; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EN6207) dose 1 via an unspecified route of administration, administered in Deltoid Right on 19Mar2021 (at the age of 60 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced feel something different in her neck , pain in her neck, she can actually feel the injection go into the right of her neck, the middle of the back of her neck into her right breast and then into her right leg feeling as discomfort and thinks it might be inflammation. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Nasopharyngitis
Clinical narrative: cold like symptoms; exposed to covid; This is a spontaneous report from a contactable consumer or other non-HCP communicated to a Regulatory Authority. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Lot number was not reported), as DOSE1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced cold like symptoms and exposed to covid. Patient received first dose 27Mar2021 and due for second 15Apr2021, had cold like symptoms and has been exposed to covid and currently waiting on results from Covid test. Patient would like to know what the protocol is if she tested positive. No unaddressed medical questions referred or forwarded to Medical Information. The patient outcome of the events was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient's friend). A 40-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unknown route of administration, on Mar 6, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medication not reported. On Mar 6 ,2021, patient experienced hives and rashes. The patient will be getting her second dose. The outcome of events unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crying, Pruritus, Rash, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient's friend). A 40-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unknown route of administration, on Mar 6, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medication not reported. On Mar 6 ,2021, patient experienced hives and rashes. The patient will be getting her second dose. The outcome of events unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Pain in extremity
Clinical narrative: pain in my arm and left arm aching; before midnight I had a fever/Had what she thought was a fever; fatigue; headache; loose stool; achy joints; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0158), via an unspecified route of administration on 08Apr2021 at 11:00 in left arm (at the age of 56-year-old) as single dose of for COVID-19 immunisation. The patient's medical history included covid-19 since Nov2020. Concomitant medication was reported as none. Patient was not received any other vaccine four weeks prior vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Additional vaccines administered on same date of the Pfizer suspect reported as none. Patient reported she took the first dose of Pfizer Covid-19 vaccine yesterday on 08Apr2021 at 11:00. She felt fine and about 3 hours after on 08Apr2021 at 14:00 her injection, her arm began to ache, and she took one Tylenol. Last night, she had what she thought was a fever, fatigue, headache, and loose stool she added not like diarrhoea she also reported her joints ache and it all started last night and is still happening. The case assessed as non-serious by the reporter. No relevant tests were performed. Patient was not visited to emergency room or physician's office for the events. The patient received treatment with Tylenol for event pain in my arm and left arm aching. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pain in my arm and left arm aching; before midnight I had a fever/Had what she thought was a fever; fatigue; headache; loose stool; achy joints; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0158), via an unspecified route of administration on 08Apr2021 at 11:00 in left arm (at the age of 56-year-old) as single dose of for COVID-19 immunisation. The patient's medical history included covid-19 since Nov2020. Concomitant medication was reported as none. Patient was not received any other vaccine four weeks prior vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Additional vaccines administered on same date of the Pfizer suspect reported as none. Patient reported she took the first dose of Pfizer Covid-19 vaccine yesterday on 08Apr2021 at 11:00. She felt fine and about 3 hours after on 08Apr2021 at 14:00 her injection, her arm began to ache, and she took one Tylenol. Last night, she had what she thought was a fever, fatigue, headache, and loose stool she added not like diarrhoea she also reported her joints ache and it all started last night and is still happening. The case assessed as non-serious by the reporter. No relevant tests were performed. Patient was not visited to emergency room or physician's office for the events. The patient received treatment with Tylenol for event pain in my arm and left arm aching. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This is a spontaneous report received from contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0150), at the age of 20, via an unspecified route, left arm, on Apr 8, 2021, at 12:30, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 8, 2021, at 15:00, patient had a full body rash (red dots covering her whole body). Patient stated the rash and itching was worse today. Patient did not go to emergency room/physician office. The outcome of itching: unknown; full body rash (red dots covering her whole body): not recovered. No follow-up attempts needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Hypoaesthesia, Pain in extremity, Pain of skin
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non-HCP. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 31, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, he had a sore right arm/shoulder and a sore shoulder the next day. The skin on his forearm between his wrist and elbow went numb. He felt a spot on his hand, right above his thumb. He had another spot on his left arm and felt tingling there or like it was going to become numb. He felt something going on too where he wears his mask (cheek and an area of his jaw under his eyes). He reported he just got the Pfizer COVID-19 shot and his skin was numb on his arm, but he felt it on his other arm. He clarified it was not muscle pain, it is skin. He felt tingling on his face. The patient went to his doctor. Reportedly, it was not a stroke or a heart attack, but he didn't know what to think. He was offered an MRI and other tests. The patient reported the tingling started 4 or 5 days after the shot. He still felt the tingling after 3 or 4 days, and still has numbness on his arm where he got the shot. He added the feeling was down on the forearm and not at injection site. The outcome of the events: unknown. No follow-up attempts needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non-HCP. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 31, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, he had a sore right arm/shoulder and a sore shoulder the next day. The skin on his forearm between his wrist and elbow went numb. He felt a spot on his hand, right above his thumb. He had another spot on his left arm and felt tingling there or like it was going to become numb. He felt something going on too where he wears his mask (cheek and an area of his jaw under his eyes). He reported he just got the Pfizer COVID-19 shot and his skin was numb on his arm, but he felt it on his other arm. He clarified it was not muscle pain, it is skin. He felt tingling on his face. The patient went to his doctor. Reportedly, it was not a stroke or a heart attack, but he didn't know what to think. He was offered an MRI and other tests. The patient reported the tingling started 4 or 5 days after the shot. He still felt the tingling after 3 or 4 days, and still has numbness on his arm where he got the shot. He added the feeling was down on the forearm and not at injection site. The outcome of the events: unknown. No follow-up attempts needed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Gingival bleeding, Nausea
Clinical narrative: nausea; Bleeding gum; acne like on her face and her back.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unknown route of administration on 05Apr2021 at 15:45 (at the age of 38-year-old) in left arm as dose 1, single for COVID-19 immunization. Medical history included penicillin allergy. The patient had no known allergies. The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered at pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Apr2021 at 15:35, the patient experienced bleeding gum. On 05Apr2021 at 15:45, the patient experienced nausea immediately after getting vaccination. On an unknown date, the patient had acne like on her face and her back and Patient was asked that if needs to report these or is this something related to the vaccine and if needs to follow-up with patient's doctor. No treatment was received for the adverse events. The clinical outcome of nausea was recovered on 05Apr2021 at 16:45 while bleeding gum was not recovered, and acne like on her face and her back was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Malaise, Pruritus, Rash macular
Clinical narrative: the back of his neck felt itchy/ the itchiness spread all over his body; red welts, and red marks around his ankles that eventually spread all over his body as well; her husband has sensitive skin; dry skin itch; not feeling well; he experienced red blotches; Dates for his legs were peeling and he was just itching all over; This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 (at the age of 83-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced the back of his neck felt itchy/ the itchiness spread all over his body, red welts, and red marks around his ankles that eventually spread all over his body as well, her husband has sensitive skin, dry skin itch, not feeling well, he experienced red blotches, his legs were peeling and he was just itching all over. Reporter wanted to know when her husband will receive his 2nd dose of the vaccine. Patient went to the allergist dermatologist. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin, Skin exfoliation
Clinical narrative: the back of his neck felt itchy/ the itchiness spread all over his body; red welts, and red marks around his ankles that eventually spread all over his body as well; her husband has sensitive skin; dry skin itch; not feeling well; he experienced red blotches; Dates for his legs were peeling and he was just itching all over; This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 (at the age of 83-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced the back of his neck felt itchy/ the itchiness spread all over his body, red welts, and red marks around his ankles that eventually spread all over his body as well, her husband has sensitive skin, dry skin itch, not feeling well, he experienced red blotches, his legs were peeling and he was just itching all over. Reporter wanted to know when her husband will receive his 2nd dose of the vaccine. Patient went to the allergist dermatologist. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: she had vaginal bleed after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine; This is a spontaneous case received from a contactable female consumer (Patient). A 39-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733, expiration date: unknown), via an unspecified route of administration in arm left on 29Mar2021 14:00 (age at vaccination 39-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included thyroid and celiac. Concomitant medication included Synthroid 50 mcg, once a day by mouth. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional administered vaccines and prior vaccinations (within 4 weeks) was reported as none. Family medical history relevant to adverse events was reported as none. On an unspecified date in Mar2021, the patient had vaginal bleed after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine. The patient did not undergo any relevant tests. Adverse event required a Physician office visit. the outcome of the event was not recovered.  No follow-up attempts were needed. No further information was expected.