chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain
Clinical narrative: joint pain and body aches; joint pain and body aches; she had body and joint pain and exhaustion after the first dose; her left arm hurt; exhausted; sick; This is a spontaneous report from a contactable consumer (patient).   This is one of two reports. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, administered in left arm on 19Mar2021 09:48 (at the age of 57-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing Interstim Implant for Bladder from 2016, ongoing Inverted T waves all her life, clarifying she had issues since college, ongoing hypoglycaemia since high school, ongoing gluten intolerance (she stated in her 40s, she was told she had gluten intolerance, and another autoimmune issue referred to as leaky gut. She said she wasn't formally tested for leaky gut, but her leaky gut diagnosis was done by elimination), ongoing asthma diagnosed with moderate asthma as a child and Lobular Carcinoma-Right Breast from Dec2020 to an unknown date, she had a lumpectomy on her right breast in Dec2020. She said at that time, she was diagnosed with a lobular carcinoma that was not cancerous, but considered a high risk lesion, and was removed. The patient's concomitant medications were not reported. No any additional vaccine administered on same date of the Pfizer vaccine. No prior vaccination within four weeks. On an unspecified date in Mar2021, patient got sick. She said she had joint pain and body aches, and her arm, and all that stuff. She clarified the day she got her first COVID-19 Vaccine shot (on 19Mar2021), her (left) arm hurt, and she was exhausted. She said she went to bed at 7:00PM that night (19Mar2021), and the next morning (20Mar2021), she woke up with the joint pain and body aches, condition aggravated. She said the (left) arm pain, joint pain, and body aches hurt less the second day, and eventually went away. Patient stated she didn't go to her doctor because she kept thinking her joint pain would be gone soon, and it hasn't and took ginger (clarified as Nature's Way Brand Ginger Root 1.1g capsule), and turmeric (clarified as Solgar Curcumin) for her joint pain. Outcome of the event joint pain was not recovered and rest all events was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Malaise, Pain
Clinical narrative: pain in his body/body aches; little bit of headache; tired; Fever; was not feeling well; coughing; sneezing; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team.   A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0173, expiry date: unknown), via an unspecified route of administration, administered in left arm on 03May2021 at 10:30 (at the age of 33 years) as dose 1, single for covid-19 immunization in hospital. The patient medical history included ongoing deafness from an unknown date. Reporter confirmed her son was deaf and he could not explain his symptoms before treatment with the Pfizer COVID 19 vaccine when he was younger, he had an issue with his airways and one of the infections affected his hearing when he was may be 3 or 4. Concomitant medications included daytime Cold medicine (unspecified name) (lot number: 9LT3314 and expiry date: May2021) taken for an unspecified indication, on an unspecified date at 08.00 and stop date were not reported, so now she was giving ibuprofen. The patient did not receive any prior vaccine within 4 weeks. On 03May2021, the patient experienced fever and did not feel good. On 04May2021, the patient experienced pain in his body, little bit of headache and tired. On an unspecified date in 2021, the patient experienced coughing and sneezing. The reporter reported that her son got the Pfizer Covid 19 vaccine on Monday, since yesterday he had a fever and did not feel good. He took cough medication because he did not feel well. The reporter asked if it was normal that he still had a fever and how long would be it lasted. The patient ran a fever maybe 11 or 12 at night the first day, and he still has a fever today and has pain in his body and a little bit of a headache. Caller clarified the product her son took was Daytime Cold and Flu Multi Symptom. The patient was no not doing worse. He also had a temperature now but not worse. The body aches started on 04May2021 and he was tired and it was same as yesterday. He just woke up, and he could not explain it was very well. States might be the headache was also because of the fever, but it was a little better than yesterday. The patient took a pill for the coughing and sneezing, and she told him not to because Tylenol or Ibuprofen was only recommended. Events did not resulted in visit to emergency room or physician office. Patient was planning to get the second dose on 24May2021. Therapeutic measures were taken as a result of fever, pain in his body, little bit of headache, coughing, and sneezing. The outcome of events fever, pain in his body/body aches and tired were not recovered. The outcome event little bit of headache was recovering. The outcome of events sneezing, was not feeling well and coughing were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sneezing
Clinical narrative: pain in his body/body aches; little bit of headache; tired; Fever; was not feeling well; coughing; sneezing; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team.   A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0173, expiry date: unknown), via an unspecified route of administration, administered in left arm on 03May2021 at 10:30 (at the age of 33 years) as dose 1, single for covid-19 immunization in hospital. The patient medical history included ongoing deafness from an unknown date. Reporter confirmed her son was deaf and he could not explain his symptoms before treatment with the Pfizer COVID 19 vaccine when he was younger, he had an issue with his airways and one of the infections affected his hearing when he was may be 3 or 4. Concomitant medications included daytime Cold medicine (unspecified name) (lot number: 9LT3314 and expiry date: May2021) taken for an unspecified indication, on an unspecified date at 08.00 and stop date were not reported, so now she was giving ibuprofen. The patient did not receive any prior vaccine within 4 weeks. On 03May2021, the patient experienced fever and did not feel good. On 04May2021, the patient experienced pain in his body, little bit of headache and tired. On an unspecified date in 2021, the patient experienced coughing and sneezing. The reporter reported that her son got the Pfizer Covid 19 vaccine on Monday, since yesterday he had a fever and did not feel good. He took cough medication because he did not feel well. The reporter asked if it was normal that he still had a fever and how long would be it lasted. The patient ran a fever maybe 11 or 12 at night the first day, and he still has a fever today and has pain in his body and a little bit of a headache. Caller clarified the product her son took was Daytime Cold and Flu Multi Symptom. The patient was no not doing worse. He also had a temperature now but not worse. The body aches started on 04May2021 and he was tired and it was same as yesterday. He just woke up, and he could not explain it was very well. States might be the headache was also because of the fever, but it was a little better than yesterday. The patient took a pill for the coughing and sneezing, and she told him not to because Tylenol or Ibuprofen was only recommended. Events did not resulted in visit to emergency room or physician office. Patient was planning to get the second dose on 24May2021. Therapeutic measures were taken as a result of fever, pain in his body, little bit of headache, coughing, and sneezing. The outcome of events fever, pain in his body/body aches and tired were not recovered. The outcome event little bit of headache was recovering. The outcome of events sneezing, was not feeling well and coughing were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Influenza, Nasal congestion, Pyrexia
Clinical narrative: Coughing; feel congested; got sick with flu; fever; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable male consumer (Patient) of an unspecified age reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced coughing and feel congested, got sick with flu, fever. Patient and his wife will be having their second dose. They got sick with flu, fever and congestion on Tuesday of last week. Patient wanted to know if it was okay to take the vaccine on Wednesday. Clinical outcome of the events was reported as unknown for all the events.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Confusional state, Fatigue
Clinical narrative: Severe headache; 101 Fever; Chills; Sweats; Vomiting; Joint aches; Fatigue; Brain fog; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 19Apr2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroidism and metabolic syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) and progesterone (MANUFACTURER UNKNOWN), all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation and received codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 19Apr2021 at 20:00, the patient experienced severe headache, 101 fever, chills, sweats, vomiting, joint aches, fatigue, brain fog and confusion. On the same day, the patient underwent body temperature test and the result was 101 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, 101 fever, chills, sweats, vomiting, joint aches, fatigue, brain fog and confusion was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Severe headache; 101 Fever; Chills; Sweats; Vomiting; Joint aches; Fatigue; Brain fog; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 19Apr2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroidism and metabolic syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) and progesterone (MANUFACTURER UNKNOWN), all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation and received codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 19Apr2021 at 20:00, the patient experienced severe headache, 101 fever, chills, sweats, vomiting, joint aches, fatigue, brain fog and confusion. On the same day, the patient underwent body temperature test and the result was 101 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, 101 fever, chills, sweats, vomiting, joint aches, fatigue, brain fog and confusion was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: huge red area around the place the shot was given/She has a red mark around the area she got the shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-year-old female patient received first dose bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8732, Expiration date: Unknown) via an unspecified route of administration, administered in arm left on 29Apr2021 at 08:55 (age at vaccination 23 years) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 was administered was reported as clinic. Vaccination administered at military facility was reported as no. 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 vaccines administered on same date of the pfizer suspect was reported as none. The patient 's medical history and concomitant medications were not reported. Prior vaccinations within 4 weeks was reported as no. Adverse events following prior vaccinations was none. Patient's medical history including any illness at time of vaccination was none. Family medical history relevant to adverse events was none. On 30Apr2021, patient experienced huge red area around the place the shot was given/She has a red mark around the area she got the shot. Caller would like to know whether she should be concerned about her side effect or if she should see a doctor. She was asking the risks of the Pfizer-BioNTech Covid-19 Vaccine and what should she do about side effects. She reported on the Covid 19 vaccine and who explained she just got the 1st dose recently and experienced a huge red area around the place the shot was given. It was given on 29Apr2021 hasn't gotten better and she was calling to see if she should go to urgent care for this. She explained the red area was noticed the next day and it was about the same since it was noticed, not better or worse. Seriousness of the event was non serious. Investigation Assessment was reported as no. Relevant tests was reported as no. Adverse events did not result in Emergency room or physician office visit. The outcome of the event was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dysstasia, Feeding disorder
Clinical narrative: Achy; Unable to stand up; Nausea; Can't hold food down; Cold; Throwing up/Vomiting; Headache; Muscle pain; Joint pain; Slight fever; Chills; Unable to sleep; Very weak; Feeling unwell; This is a spontaneous report from a contactable consumer. This consumer reported for a 69-year-old female patient.  A 69-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch number: Not reported/Lot Number: EW0170, expiration date: Unknown), via an unspecified route of administration, administered in left arm on 01May2021 (Age at the vaccination 69 years), 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 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in left arm on 10Apr2021 (age at the vaccination 69 years), as DOSE 1, SINGLE for COVID-19 immunization and she had no side effects. On 02May2021 the patient experienced headache, muscle pain, joint pain, throwing up/vomiting, cold. On an unspecified date in May2021, the patient experienced chills, slight fever, feeling unwell, achy, unable to stand up, unable to sleep, very weak. On 04May2021 the patient experienced nausea, can't hold food down. The reporter was calling on behalf of his mother and stated that his mother had her second dose of the COVID vaccine on 01May2021. That same day, she had no symptoms. The day after she started coming down with a cold. Until now she had been getting worse. Yesterday she started vomiting. She can't hold food down. She had a headache, muscle pain, joint pain, and nausea. She was feeling unwell. She was vomiting. It was reported that the vomiting started yesterday noting that she cannot hold down any food or liquids. It was reported that she was very weak adding that right now she did not have a fever. Reporter started that 45 minute to one hour ago she vomited when she tried to have a piece of bread and some water. She was able to walk by herself today and not as achy today. Reporter stated his concern was being able to sleep and hold food down without vomiting. Reporter stated that his friends experienced the same thing, and it only lasted a day or two. She needed guidance on what to do next. She did not have a prescribing doctor. She got the vaccine at the local pharmacy. She got her first vaccine on 10Apr2021. She had no side effects after the first one. First lot: ER8737. She got both shots in her left arm. The outcome of the events headache, muscle pain, joint pain, nausea, throwing up/vomiting, cold, can't hold food down was not resolved. The outcome of the events chills, slight fever, feeling unwell, achy, unable to stand up, unable to sleep and very weak was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Malaise, Myalgia, Nasopharyngitis
Clinical narrative: Achy; Unable to stand up; Nausea; Can't hold food down; Cold; Throwing up/Vomiting; Headache; Muscle pain; Joint pain; Slight fever; Chills; Unable to sleep; Very weak; Feeling unwell; This is a spontaneous report from a contactable consumer. This consumer reported for a 69-year-old female patient.  A 69-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch number: Not reported/Lot Number: EW0170, expiration date: Unknown), via an unspecified route of administration, administered in left arm on 01May2021 (Age at the vaccination 69 years), 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 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in left arm on 10Apr2021 (age at the vaccination 69 years), as DOSE 1, SINGLE for COVID-19 immunization and she had no side effects. On 02May2021 the patient experienced headache, muscle pain, joint pain, throwing up/vomiting, cold. On an unspecified date in May2021, the patient experienced chills, slight fever, feeling unwell, achy, unable to stand up, unable to sleep, very weak. On 04May2021 the patient experienced nausea, can't hold food down. The reporter was calling on behalf of his mother and stated that his mother had her second dose of the COVID vaccine on 01May2021. That same day, she had no symptoms. The day after she started coming down with a cold. Until now she had been getting worse. Yesterday she started vomiting. She can't hold food down. She had a headache, muscle pain, joint pain, and nausea. She was feeling unwell. She was vomiting. It was reported that the vomiting started yesterday noting that she cannot hold down any food or liquids. It was reported that she was very weak adding that right now she did not have a fever. Reporter started that 45 minute to one hour ago she vomited when she tried to have a piece of bread and some water. She was able to walk by herself today and not as achy today. Reporter stated his concern was being able to sleep and hold food down without vomiting. Reporter stated that his friends experienced the same thing, and it only lasted a day or two. She needed guidance on what to do next. She did not have a prescribing doctor. She got the vaccine at the local pharmacy. She got her first vaccine on 10Apr2021. She had no side effects after the first one. First lot: ER8737. She got both shots in her left arm. The outcome of the events headache, muscle pain, joint pain, nausea, throwing up/vomiting, cold, can't hold food down was not resolved. The outcome of the events chills, slight fever, feeling unwell, achy, unable to stand up, unable to sleep and very weak was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Achy; Unable to stand up; Nausea; Can't hold food down; Cold; Throwing up/Vomiting; Headache; Muscle pain; Joint pain; Slight fever; Chills; Unable to sleep; Very weak; Feeling unwell; This is a spontaneous report from a contactable consumer. This consumer reported for a 69-year-old female patient.  A 69-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch number: Not reported/Lot Number: EW0170, expiration date: Unknown), via an unspecified route of administration, administered in left arm on 01May2021 (Age at the vaccination 69 years), 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 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in left arm on 10Apr2021 (age at the vaccination 69 years), as DOSE 1, SINGLE for COVID-19 immunization and she had no side effects. On 02May2021 the patient experienced headache, muscle pain, joint pain, throwing up/vomiting, cold. On an unspecified date in May2021, the patient experienced chills, slight fever, feeling unwell, achy, unable to stand up, unable to sleep, very weak. On 04May2021 the patient experienced nausea, can't hold food down. The reporter was calling on behalf of his mother and stated that his mother had her second dose of the COVID vaccine on 01May2021. That same day, she had no symptoms. The day after she started coming down with a cold. Until now she had been getting worse. Yesterday she started vomiting. She can't hold food down. She had a headache, muscle pain, joint pain, and nausea. She was feeling unwell. She was vomiting. It was reported that the vomiting started yesterday noting that she cannot hold down any food or liquids. It was reported that she was very weak adding that right now she did not have a fever. Reporter started that 45 minute to one hour ago she vomited when she tried to have a piece of bread and some water. She was able to walk by herself today and not as achy today. Reporter stated his concern was being able to sleep and hold food down without vomiting. Reporter stated that his friends experienced the same thing, and it only lasted a day or two. She needed guidance on what to do next. She did not have a prescribing doctor. She got the vaccine at the local pharmacy. She got her first vaccine on 10Apr2021. She had no side effects after the first one. First lot: ER8737. She got both shots in her left arm. The outcome of the events headache, muscle pain, joint pain, nausea, throwing up/vomiting, cold, can't hold food down was not resolved. The outcome of the events chills, slight fever, feeling unwell, achy, unable to stand up, unable to sleep and very weak was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash after each dose of the vaccine; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, NDC number/ Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as DOSE1, SINGLE for covid-19 immunization. The patient medical history included shingles (Shingles at a younger age) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient developed rash a day after each dose of the vaccine. It was reported that, the patient stated she developed rash a day after each doses of the Pfizer-BioNTech COVID-19 vaccine. She mentioned the day before getting the first vaccine, a medication she took and to which she had not reacted in the past was increased. She said 2 weeks after vaccination the rash was persisting, thus her doctor recommended her to stop the medication that was increased to see what would happen following the second dose of the vaccine. She specified the rash persisted and worsened after the second dose. She said it was been 4 weeks and the rash not going away. She described it as a crazy itchy rash travelling on her body, that was all over the place. She said it felt like a deep sort of pain and compared it to her previous experience of Shingles. She added she has a history of Shingles at a younger age. She specified both a cardiologist and dermatologist were consulted for her symptom.  She specified she may start a medication for Shingles today depending on her HCP's guidance. The outcome for the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable physician. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient also received upadacitinib (RINVOQ, Batch/Lot number was not reported), oral from an unspecified date to an unspecified date for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported.  It was reported that solicited report by a consumer of an adult female with an event of non-serious headaches after covid vaccine with RINVOQ (Upadacitinib). On an unknown date, the patient experienced headaches after covid vaccine. COVID-19 VACCINE was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer. Causality for RINVOQ(Upadacitinib). The reporters causality for the event of headaches after covid vaccine with RINVOQ(Upadacitinib) was no reasonable possibility. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: getting a tickle down at the bottom of our throat to our chest; coughing our heads off; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0172) via an unspecified route of administration in arm right on 27Apr2021 14:00 (age at time of vaccination 66-year-old), as single dose for COVID-19 immunization. Medical history included diabetic. The patient's concomitant medications were not reported. The patient historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0150) via an unspecified route of administration in right shoulder on 06Apr2021 (age at time of vaccination 66-year-old), as single dose for COVID-19 immunization. On 27Apr2021 at 15:00, the patient experienced getting a tickle down at the bottom of our throat to chest and coughing our heads off. The seriousness of the events was unspecified. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515082 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Ear discomfort, Urticaria
Clinical narrative: unpredictable hives ( burn skin reaction for whole body) almost every day, any time; Whole body has burning feelings, usually started with ears , hands and few minutes became everywhere; Whole body has burning feelings, usually started with ears , hands and few minutes became everywhere included the face; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that side effects (already after 1st vaccination, the patient did already 2). The patient was started to have unpredictable hives (burn skin reaction for whole body) almost every day, any time (can be nights, mornings, inside outside), which was not related to patient's food, or any make up (reaction can be after 16 hours, the patient did not eat anything). Whole body has burning feelings, usually started with ears, hands and few minutes became everywhere included the face. Never ever had anything like that before and would like to report it. After taking Benedryl sides effects gone (usually for 1 hour). Sometimes can be very very burning reaction, sometimes can be better only light burning. Thank you for any help and advice. The outcome of the events was unknown.  Information about batch no/lot no has been requested. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Muscle spasms
Clinical narrative: severe joint aches; muscle spasms; severe diarrhea; severe pain in his knees; pain in his shoulders; cold; chills; fever; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support from a contactable consumer or other non HCP (patient) via medical information team. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 01May2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 08Apr2021 with no problems. The patient's medical history and concomitant medications were not reported. On 02May2021 the patient reports severe joint aches and muscle spasms and severe diarrhea. He says that he bent down at work and was in severe pain in his knees, and they didn't even want to push me back up and that he can be sitting, watching TV and if he moves, he can hear his knee joints grinding. He also reports pain in his shoulders. Patient experienced cold, chills and fever. He's been seen by his HCP and tested negative for Covid infection. The doctor told him that it will go away in 72 hours. He also asked the pharmacist at local store, and he was told that other people had cramps. He called in to know if it is normal and when it will go away or if other people experience the same. First dose of the vaccine was given 08Apr2021. He also mentioned that after the first dose he felt that he did not have the shot. The patient underwent lab tests and procedures which included body temperature results into fever on 02May2021, sars-cov-2 test results as negative on 03May2021. The outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: severe joint aches; muscle spasms; severe diarrhea; severe pain in his knees; pain in his shoulders; cold; chills; fever; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support from a contactable consumer or other non HCP (patient) via medical information team. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 01May2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 08Apr2021 with no problems. The patient's medical history and concomitant medications were not reported. On 02May2021 the patient reports severe joint aches and muscle spasms and severe diarrhea. He says that he bent down at work and was in severe pain in his knees, and they didn't even want to push me back up and that he can be sitting, watching TV and if he moves, he can hear his knee joints grinding. He also reports pain in his shoulders. Patient experienced cold, chills and fever. He's been seen by his HCP and tested negative for Covid infection. The doctor told him that it will go away in 72 hours. He also asked the pharmacist at local store, and he was told that other people had cramps. He called in to know if it is normal and when it will go away or if other people experience the same. First dose of the vaccine was given 08Apr2021. He also mentioned that after the first dose he felt that he did not have the shot. The patient underwent lab tests and procedures which included body temperature results into fever on 02May2021, sars-cov-2 test results as negative on 03May2021. The outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint and muscles aches/Joint and muscle pain lasting over a week/progressivenly worsening/Pain worsened; Joint and muscles aches/Joint and muscle pain lasting over a week/progressivenly worsening/Pain worsened; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EW0176) via an unspecified route of administration, administered in left arm on 28Apr2021 12:15 (age at vaccination 33 years) as dose number unknown, single for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). The patient had no known allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient experienced joint and muscles aches/joint and muscle pain lasting over a week/progressively worsening/pain worsened over the course of a week and seems to get worse daily on 28Apr2021 13:00. This was still occurring 7 days after receiving vaccine. The patient was not taking any treatment for events. Outcome of events was not resolved.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Haemoglobin, Pain in extremity, Vaccination site erythema, Vaccination site mass
Clinical narrative: my arms still red in that spot, feels like a knot; My face is red, nose, chin and cheeks; Arm sore and red and has a knot; arms still red in that spot, feels like a knot; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history included meniere's disease. This has caused her trouble in her left ear from hearing and was probably diagnosed in 2008 or 2009. Concomitant medication(s) included atenolol (ATENOLOL) taken for blood pressure. On an unspecified date patient reported that her arm was still red and the spot where they gave it to her still has a knot. The patient states that her face has also been red, like her nose and cheek and chin have been red.  The arm was sore and red and had a knot. The arm was really sore the first two days but it was like it went away or she did not really see it and then the last few days she sees it a lot.  Face was red for about four or five days. The patient adds that her arm was sore, but she saw redness, not quite as bad, not as bad as it was. It is worse now than when she first got the vaccine. The patient's nose, cheek, and chin on both sides were red. Investigations: The patient states she had lab work before she got the shot, because her blood was low. Her haemoglobin was low but it was back up to 11.5 before she got the shot. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No adverse events following prior vaccinations. The events outcome was reported as unknown.  No follow-up attempts are needed. No further information is expected. .
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report received from a contactable consumer (Patient wife) via Medical Information Team.  A male patient of unspecified age had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient had experienced fever and chills. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Illness, Influenza like illness, Nausea
Clinical narrative: flu like symptoms; fever of 99; chills; nausea; Ache; sick; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 23Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes patient previously took first dose of bnt162b2 for covid-19 immunization. Reporter is calling about the Pfizer Covid-19 RNA vaccine on behalf of her niece. Reporter stated she is calling for her niece who experienced side effects flu like symptoms fever chills, nausea 10 days after the second dose. she is 19 years old and caller wanted to know if side effects were reported 10 days later. The patient got the second shot on 23Apr2021 at her school. The patient started getting sick after 10 days. The patient had chills, ache, nausea and a fever of 99. The caller was looking online, and it indicates that side effects usually start 1-2 days after the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: flu like symptoms; fever of 99; chills; nausea; Ache; sick; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 23Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes patient previously took first dose of bnt162b2 for covid-19 immunization. Reporter is calling about the Pfizer Covid-19 RNA vaccine on behalf of her niece. Reporter stated she is calling for her niece who experienced side effects flu like symptoms fever chills, nausea 10 days after the second dose. she is 19 years old and caller wanted to know if side effects were reported 10 days later. The patient got the second shot on 23Apr2021 at her school. The patient started getting sick after 10 days. The patient had chills, ache, nausea and a fever of 99. The caller was looking online, and it indicates that side effects usually start 1-2 days after the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, SARS-CoV-2 test
Clinical narrative: Fatigue; Chills; Severe diarrhea: needed to use bathroom every hour or two, including throughout the nights; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 22Apr2021 at 12:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oxitriptan (5-HTP) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced fatigue, chills and severe diarrhea which needed to use bathroom every hour or two, including throughout the nights. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event diarrhea and included treatment with loperamide hydrochloride (IMMODIUM). Since the vaccination, the patient had been tested for COVID-19. On 30Apr2021, the patient underwent nasal swab test, SARS CoV-2 test and the result was negative. The clinical outcome of the event severe diarrhea: needed to use bathroom every hour or two, including throughout the nights was resolved on an unspecified date in 2021, after a duration of 5 days; while that of the events fatigue and chills were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Headache
Clinical narrative: Severe joint and muscle pain.; Severe joint and muscle pain.; Sore arm were shot was administered; Sore and swollen lymph nodes in the right armpit; Sore and swollen lymph nodes in the right armpit; Low-moderate fever; Chills/shivers; Headache; Lethargy/exhaustion; Lethargy/exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 29Apr2021 at 16:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, anxiety / depression, eczema and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine aspartate / amfetamine sulfate / dexamfetamine saccharate / dexamfetamine sulfate (ADDERALL), intrauterine contraceptive device (MANUFACTURER UNKNOWN) and loratadine (CLARITIN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received bupropion (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 30Apr2021 at 06:00, the patient had severe joint and muscle pain, sore arm where shot was administered, sore and swollen lymph nodes in the right armpit, low-moderate fever, chills/shivers, headache, lethargy and exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe joint and muscle pain, sore arm where shot was administered, sore and swollen lymph nodes in the right armpit, low-moderate fever, chills/shivers, headache, lethargy and exhaustion was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.