chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria, Wrong product administered
Clinical narrative: Hives, he had on face then on his neck; Arm is just sore; 2nd dose yesterday and it is Pfizer vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 21-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot Number: EN0167, Expiration date: Unknown) via an unspecified route of administration on 18May2021 as dose 2 (initial Pfizer dose), single and first dose of covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number was not reported, Expiration date: Unknown) via an unspecified route of administration on 21Apr2021 as dose 1, single for COVID-19 immunization. Medical history included urticaria from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Transferring agent stated on call ,"She was calling on behalf of her son, they were calling because they received from first dose of the vaccine not from Pfizer it was from Moderna on 21Apr2021 and 2nd dose yesterday (18may2021) and it was Pfizer vaccine and according to the mother, she mentioned that her son noticed that (statement incomplete), experiencing a hives in the skin and his son had previous hives, history of hives before, actually they know the reason before like that, so got hives but now at this time they don't if that was from Pfizer Covid 19 vaccine. When paraphrased the concern, Reporter stated, "He had them (hives), they kind of went away, he had on face then on his neck but he took a shower they seems like they going away but I don't know, should just took him to emergency or because I know even with each one of shot you could have some sort of reaction even that if it properly administered so we are just wondering. When clarified if event occurred after Pfizer Covid 19 vaccine, Reporter stated, "He just got hives today, he is experiencing anything now is his arm is just sore. He had little bit of hives on his face and on his neck (further not clarified). Reporter added, "I want to know, I mean your personal opinion do you think it worth taking him to emergency because there was just so much unknown about people receiving two doses, everyone kind of giving big answer about if anything should be done or not. Patient did not receive any treatment. The outcome for the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Nausea; Vomiting; Fever; Muscle pain; Fatigue; Swollen lymph nodes; Sore throat; This is spontaneous report from a contactable consumer. This consumer (patient) reported). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, administered on 28Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 13May2021, patient experienced nausea, vomiting, fever, muscle pain, fatigue, swollen lymph nodes, throat was just sore. The reporter stated, "I have like all the side effects and its been going on since Thursday of last week, like Thursday night its not getting better, not getting worse, just not getting any better." "I was taking like NyQuil and DayQuil, I try to break my fever with some Tylenol. I was also taking Theraflu. (Intent: Treatment)". The reporter also stated that I cannot understand you but nothing is worse, it makes me feel better and then I go back to feel like nothing in that 3 hours, like I have a fever." Nausea, Vomiting, fever, muscle pain, fatigue, swollen lymph nodes, my throat is just sore right now. I have like 7 problems in 7 days. I cannot break my fever with the Tylenol like I usually do, I do not get sick." The patient stated that, "I am supposed to go take it today but I am not sure if I should. I have my second dosage today and I do not know if I should go and take it." The patient confirmed, patient took Theraflu as a treatment for the side effects, stated, and also Tylenol, it (Tylenol) was supposed to break fever but it never worked. It didnt do anything." The side effects are coming through the vaccine that patient got. Patient cannot break fever with the Tylenol like usually do. Patient took the Theraflu because having the side effect from the Pfizer shot the Theraflu was the medicine that took, it was over the counter medication. The patient asked my second dosage today and I do not know if I should go and take it. The patient received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; Fever; Muscle pain; Fatigue; Swollen lymph nodes; Sore throat; This is spontaneous report from a contactable consumer. This consumer (patient) reported). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, administered on 28Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 13May2021, patient experienced nausea, vomiting, fever, muscle pain, fatigue, swollen lymph nodes, throat was just sore. The reporter stated, "I have like all the side effects and its been going on since Thursday of last week, like Thursday night its not getting better, not getting worse, just not getting any better." "I was taking like NyQuil and DayQuil, I try to break my fever with some Tylenol. I was also taking Theraflu. (Intent: Treatment)". The reporter also stated that I cannot understand you but nothing is worse, it makes me feel better and then I go back to feel like nothing in that 3 hours, like I have a fever." Nausea, Vomiting, fever, muscle pain, fatigue, swollen lymph nodes, my throat is just sore right now. I have like 7 problems in 7 days. I cannot break my fever with the Tylenol like I usually do, I do not get sick." The patient stated that, "I am supposed to go take it today but I am not sure if I should. I have my second dosage today and I do not know if I should go and take it." The patient confirmed, patient took Theraflu as a treatment for the side effects, stated, and also Tylenol, it (Tylenol) was supposed to break fever but it never worked. It didnt do anything." The side effects are coming through the vaccine that patient got. Patient cannot break fever with the Tylenol like usually do. Patient took the Theraflu because having the side effect from the Pfizer shot the Theraflu was the medicine that took, it was over the counter medication. The patient asked my second dosage today and I do not know if I should go and take it. The patient received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: headache; chills; fever 100.6; tired; Slept afternoon into next morning; achy all over; This is a spontaneous report from a contactable consumer. This 54-Year-Old female patient (non pregnant) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: EW0183), via an unspecified route of administration, in left upper arm on 19May2021, at 15:30, as DOSE 2, SINGLE for covid-19 immunization (age at vaccination: 54-years-old). 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 and since the vaccination, the patient was not tested for COVID-19. The patient concomitant medications included Probiotic, fermented ginseng, multivitamin and menopa within 2 weeks of vaccination. She reported allergy to Sulfur based ointments. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number:  ER8736), via an unspecified route of administration, in left upper arm on 28Apr2021 16:10, as DOSE 1, SINGLE for covid-19 immunization. On 20May2021, at 07:00, patient was achy all over. By 14:30, she had headache, chills with fever 100.6, and was tired. She Slept in afternoon till next morning and when she woke up her all symptoms were gone. The patient did not receive any treatment for the events. The outcome of the events was recovered in May2021.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: headache; chills; fever 100.6; tired; Slept afternoon into next morning; achy all over; This is a spontaneous report from a contactable consumer. This 54-Year-Old female patient (non pregnant) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: EW0183), via an unspecified route of administration, in left upper arm on 19May2021, at 15:30, as DOSE 2, SINGLE for covid-19 immunization (age at vaccination: 54-years-old). 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 and since the vaccination, the patient was not tested for COVID-19. The patient concomitant medications included Probiotic, fermented ginseng, multivitamin and menopa within 2 weeks of vaccination. She reported allergy to Sulfur based ointments. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number:  ER8736), via an unspecified route of administration, in left upper arm on 28Apr2021 16:10, as DOSE 1, SINGLE for covid-19 immunization. On 20May2021, at 07:00, patient was achy all over. By 14:30, she had headache, chills with fever 100.6, and was tired. She Slept in afternoon till next morning and when she woke up her all symptoms were gone. The patient did not receive any treatment for the events. The outcome of the events was recovered in May2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (lot number was not reported) dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced pain after administering the vaccine. The event took place after use of product. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Gait disturbance
Clinical narrative: My ankle through my toes just became horribly painful and my feet at the same time were very painful; I couldn't walk; I got a horrible headache that last throughout the night and took an Aspirin that didn't helped at all; Chills; Cough; Low grade temperature; My ankle through my toes just became horribly painful and my feet at the same time were very painful; This is a spontaneous report received from a contactable consumer (patient).  An 88-years-old patient of unspecified gender received first dose of BNT162B2 (formulation: Solution for injection, Lot number: EL0168 and expiry date: not reported) via an unspecified route of administration as DOSE 1, SINGLE on 17May2021 at 04: 30 in afternoon for covid-19 immunization. Medical history included: The patient had COVID in the last two weeks of Dec2020 and patient was told to wait at least 3 months before taking vaccination. The patient underwent an eye surgery on an unspecified date. Concomitant medications were not reported. On 17May2021 (about 4 hours later taking first shot of vaccine), the patients ankle through toes just became horribly painful and feet at the same time were very painful. The patient had terrible time, couldn't walk, and tried to rub and rub that lasted for a good hour and then dissipated slowly. The patient had a horrible headache that last throughout the night and took an Aspirin that didn't helped at all. The patient had chills, picked up cough and a very low-grade temperature, not a high temperature. Outcome of headache was not recovered, Events (ankle through toes just became horribly painful and feet at the same time were very painful and could not walk) were recovered on 17May2021 and outcome for all other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: My ankle through my toes just became horribly painful and my feet at the same time were very painful; I couldn't walk; I got a horrible headache that last throughout the night and took an Aspirin that didn't helped at all; Chills; Cough; Low grade temperature; My ankle through my toes just became horribly painful and my feet at the same time were very painful; This is a spontaneous report received from a contactable consumer (patient).  An 88-years-old patient of unspecified gender received first dose of BNT162B2 (formulation: Solution for injection, Lot number: EL0168 and expiry date: not reported) via an unspecified route of administration as DOSE 1, SINGLE on 17May2021 at 04: 30 in afternoon for covid-19 immunization. Medical history included: The patient had COVID in the last two weeks of Dec2020 and patient was told to wait at least 3 months before taking vaccination. The patient underwent an eye surgery on an unspecified date. Concomitant medications were not reported. On 17May2021 (about 4 hours later taking first shot of vaccine), the patients ankle through toes just became horribly painful and feet at the same time were very painful. The patient had terrible time, couldn't walk, and tried to rub and rub that lasted for a good hour and then dissipated slowly. The patient had a horrible headache that last throughout the night and took an Aspirin that didn't helped at all. The patient had chills, picked up cough and a very low-grade temperature, not a high temperature. Outcome of headache was not recovered, Events (ankle through toes just became horribly painful and feet at the same time were very painful and could not walk) were recovered on 17May2021 and outcome for all other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Pruritus
Clinical narrative: Itching; This is a spontaneous report from a contactable consumer and nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient received co-suspect lenvatinib mesilate (LENVIMA), oral from an unspecified date (Batch/Lot Number: 1265572; Expiration Date: 29Feb2024) to an unspecified date, at 10 mg, 1x/day for uterine cancer. No known allergies and medical history were reported. Concomitant medication included nitrofurantoin; potassium; sodium bicarbonate; gabapentin; magnesium; pembrolizumab (KEYTRUDA); amlodipine besilate taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin g potassium, cipro [ciprofloxacin], iodine. The patient experienced itching on an unspecified date. It was reported that Patient got her COVID VACCINE 3 weeks ago and will get her 2ND one 5/22/21 and have been itching since getting the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on an unspecified date, blood pressure measurement: 121/71 on 28Apr2021, blood pressure measurement: 154/101 on an unknown date in 2021. The action taken in response to the events for bnt162b2 was not applicable, for lenvatinib mesilate was unknown. Therapeutic measures benadryl was taken as a result of itching which has made helped but made her sleepy and discussed alterative antihistamines. The clinical outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Hepatic enzyme increased
Clinical narrative: elevated liver enzymes; This is a spontaneous report from contactable consumer (patient). This consumer reported similar events for 3 patients. This report is for 1st of 2 other patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included megoblastic macrocytic anemia. The patient's concomitant medications were not reported. The patient did not had other vaccine in four weeks. The patient did not had no COVID prior vaccination and not tested for COVID post vaccination. On an unspecified date, the patient experienced elevated liver enzymes (Hepatic enzyme increased). On an unspecified date, the patient underwent lab tests and procedures which included elevated liver enzymes: unknown. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lipoma
Clinical narrative: poss lipoma; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 01Oct2021 and 06Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or other non HCP (patient). A 59-year-old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 intramuscularly, administered in Arm Right on 10Feb2021 at 12:00 (Batch/Lot Number: EM9809) as DOSE 2, SINGLE (at the age of 59-year-old) for covid-19 immunisation. The patient medical history and concomitant medications was none. Prior vaccination reported as none. Historical vaccine included first dose of bnt162b2 on 20Jan2021 at 12.00 (anatomical site of injection: Left Upper Arm (Below deltoid), Batch/Lot number: EL1283) (at the age of 59-year-old) for covid-19 immunisation. The patient experienced poss lipoma on 10Feb2021 at 14:00. The event caused physician office visit. The patient underwent lab tests and procedures which included Visual Inspection (by dermatologist) showed poss lipoma on an unknown date 2021. The event needed surgical removal. Therapeutic measures were taken as a result of event. The outcome event reported as not recovered.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, SARS-CoV-2 test
Clinical narrative: nose bleed; This is a spontaneous report from a contactable consumer. An 83-year-old (non pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: EL9264), via an unspecified route of administration, in left arm on 29Jan2021at 12:00, as DOSE 1, SINGLE for covid-19 immunization (age at vaccination: 83-years-old). The patient's medical history included heart issues and liver disease. Patient did not report any allergies. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: EN6201), via an unspecified route of administration, in left arm on 25Feb2021, as DOSE 2, SIN-GLE for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took her own medicines within two weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Post vaccination, nasal swab was done on 30Mar2021, and the result was negative. On 30Jan2021, at 02:30, after first dose patient experienced nosebleed. She stated that she had nosebleed after each shot. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cholelithiasis
Clinical narrative: I got gallstones; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route of administration administered on left arm on 12Feb2021 1:00 PM (at age of 34 years) as a dose 1, single for COVID-19 immunisation. Medical history included endometriosis. Patient did not take any vaccine in four weeks. No other medications taken in two weeks. Patient had no Covid prior vaccination. Patient was not tested for Covid post vaccination. The concomitant medications were not reported. The patient previously took cefprozil (CEFZILL) and experienced allergy. Patient reported that "I am not sure if this was caused by the vacccine or not but I got gallstones on 09Mar2021 01:00 PM and had gallbladder removal surgery after". The patient underwent Covid-19 test (nasal swab) on 18Mar2021 and it was negative. The outcome of the event was reported as resolved with sequel.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other health care professional (patient, reported for herself).  A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: EW0178 and expiry date: unknown), via an unspecified route of administration, in left upper arm on 09Jun2021 11:50 AM (at the age of 38-year-old) as dose 2, single for covid-19 immunization. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: EW0186 and expiry date: unknown), via an unspecified route of administration, administered in arm left on 19May2021 11:00 AM (at the age of 38-year-old) as dose 1, single for covid-19 immunization. The patient's concomitant medications were not reported. Patient had not received any prior vaccination Within 4 weeks. Patient stated that she didn't experience any events for the first dose, but she got her second dose vaccine yesterday and she experienced headache, joint pain, tiredness, fever and chills, all on Jun2021. She confirmed that she took paracetamol (TYLENOL) and Ibuprofen as treatment, but nothing helped her. Patient stated that instead this morning, she was supposed to got to work today she didn't went to work. Outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Eyelids are swollen since four hours after the injection; Palpebral portion of my eyelids are swollen; This is a spontaneous report from a contactable consumer (herself). A 50-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: RW0180), via an unspecified route of administration, administered on left deltoid on 26Jun2021 12:30 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 50 years). Medical history included hypertension and thyroid ablation (thyroid disorder) from an unknown date and unknown if ongoing. Concomitant medications included METOPROLOL, levothyroxine sodium (SYNTHROID) and HYDROCHLOROTHIAZIDE taken for an unspecified indication, start and stop date were not reported; METFORMIN taken for hypertension, start and stop date were not reported. The patient did not have any family history of swollen eyes. No known allergies were reported. It was reported that the patient did not received any prior vaccination within 4 weeks. And also reported no Platelets Antibody factor IV Test done. The patient received the vaccine on Saturday, the 26th and the symptoms began within an hour of receiving the vaccination and had a reaction to her first Covid19 Vaccine, On 26Jun2021 her eyelids are swollen since four hours after the injection; palpebral portion of my eyelids are swollen. And persisting the same way for two days. The shot that was administered was her first shot and she had not yet had the second shot was due to receive second shot on Saturday, July17. Therapeutic measures were taken as a result of adverse events and included treatment with Zyrtec, the antihistamine, patient thought it is 10 mg but not sure, by mouth. The clinical outcome of the event was not recovered.   Follow up attempts are possible. Further information is expected.  Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Headache, Movement disorder
Clinical narrative: Severe body and joint pain; Severe body and joint pain; hard to move; dizziness; temp over 101; headache; This is a spontaneous report from a contactable nurse (patient). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 08Jul2021 at 16:00 (Batch/Lot Number: EW0185) as dose 1, single for Covid-19 immunisation. Medical history included a history (hx) of head injury from 1995 to an unknown date and known allergies to Sulfa. Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYTREC) taken for an unspecified indication, start and stop date were not reported; mometasone furoate (FLONASE [MOMETASONE FUROATE]) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination and was not tested post vaccination. The patient experienced severe body and joint pain so bad it was hard to move (literally every little joint), dizziness, temp over 101, and headache on 09Jul2021 at 06:00. No treatment was administered for the events. The outcome of the events was resolving.   No follow up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Severe body and joint pain; Severe body and joint pain; hard to move; dizziness; temp over 101; headache; This is a spontaneous report from a contactable nurse (patient). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 08Jul2021 at 16:00 (Batch/Lot Number: EW0185) as dose 1, single for Covid-19 immunisation. Medical history included a history (hx) of head injury from 1995 to an unknown date and known allergies to Sulfa. Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYTREC) taken for an unspecified indication, start and stop date were not reported; mometasone furoate (FLONASE [MOMETASONE FUROATE]) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination and was not tested post vaccination. The patient experienced severe body and joint pain so bad it was hard to move (literally every little joint), dizziness, temp over 101, and headache on 09Jul2021 at 06:00. No treatment was administered for the events. The outcome of the events was resolving.   No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Amnesia, Asthenia, Balance disorder, Body temperature, Chills
Clinical narrative: Consistent fevers and headaches 15 days and counting. 103.5-100.6F; Consistent fevers and headaches 15 days and counting. 103.5-100.6F; Loss of grip hand muscle strength; loss of balance; Muscle spasm (neck, legs); Short term memory loss; Stomach cramping; Chills; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 41 year old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number: EW0196, expiry date: not reported), via an unspecified route of administration in the right arm on 29Jun2021 10:00 (at the age of 41-years-old) as DOSE 2, SINGLE for covid-19 immunisation, bifidobacterium infantis (ALIGN, formulation: unspecified, Lot/Batch number: not reported, expiry date: not reported), at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. 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 COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number: EW0191, expiry date: not reported), via an unspecified route of administration in the right arm on 08Jun2021 10:00 (at the age of 41-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 29Jun2021 12:00, the patient experienced consistent fevers (103.5-100.6f) and headaches 15 days and counting, loss of grip hand muscle strength, loss of balance, muscle spasm, short term memory loss, stomach cramping, chills. Adverse event resulted in doctor or other healthcare professional office/clinic visit.The patient underwent lab tests and procedures which included body temperature: 103.5-100.6 Fahrenheit on 29Jun2021, sars-cov-2 Nasal Swab, Nasopharynx sars cov2 qualitative test negative on 01Jul2021.The treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gastrointestinal pain, Headache, Muscle spasms, Pyrexia, SARS-CoV-2 test
Clinical narrative: Consistent fevers and headaches 15 days and counting. 103.5-100.6F; Consistent fevers and headaches 15 days and counting. 103.5-100.6F; Loss of grip hand muscle strength; loss of balance; Muscle spasm (neck, legs); Short term memory loss; Stomach cramping; Chills; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 41 year old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number: EW0196, expiry date: not reported), via an unspecified route of administration in the right arm on 29Jun2021 10:00 (at the age of 41-years-old) as DOSE 2, SINGLE for covid-19 immunisation, bifidobacterium infantis (ALIGN, formulation: unspecified, Lot/Batch number: not reported, expiry date: not reported), at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. 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 COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number: EW0191, expiry date: not reported), via an unspecified route of administration in the right arm on 08Jun2021 10:00 (at the age of 41-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 29Jun2021 12:00, the patient experienced consistent fevers (103.5-100.6f) and headaches 15 days and counting, loss of grip hand muscle strength, loss of balance, muscle spasm, short term memory loss, stomach cramping, chills. Adverse event resulted in doctor or other healthcare professional office/clinic visit.The patient underwent lab tests and procedures which included body temperature: 103.5-100.6 Fahrenheit on 29Jun2021, sars-cov-2 Nasal Swab, Nasopharynx sars cov2 qualitative test negative on 01Jul2021.The treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 06-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves a patient of (unknown demographics) who experienced flu (influenza) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (one week) following the administration of INFLUENZA VACCINE.  It was reported "Over 36 years ago I received a flu shot. One week later I got the flu. I haven't had another flu shot since then and have never had the flu since then either."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event (influenza).  On an unknown date, the patient recovered from the event (influenza).  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Nasopharyngitis
Clinical narrative: severe cold; Initial information received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media.  This case involved adult male patient who developed severe cold (nasopharyngitis) after receiving vaccine INFLUENZA VACCINE.  The patient medical treatment, vaccination, concomitant medication and family history were not provided.  Patient use to never get a flu shot and was never sick, hardly ever even had a mild cold.  It was unknown if the patient concomitant disease or risk factor.  Then patient's wife had to start dialysis and her doctor told him he could kill her if he got the flu, so he began taking the flu shot ever year and every year.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious severe cold (nasopharyngitis) 14-days following the administration of INFLUENZA VACCINE.  It was reported ''patient wife passed away four years ago, patient quit taking the flu shot now patient hadn't got sever colds any more again.''  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the severe cold.  At time of reporting, the outcome was unknown for the severe cold.  There will be no information available on the batch number for this case for influenza vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination failure
Clinical narrative: previous flu shot 3 did not work; Initial information received on 03-Oct-2021 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who reported did not work (vaccination failure) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and reported (unknown latency) did not work (vaccination failure).  This event was assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.; Sender's Comments: This case concerns an unknown demographic patient who reported did not work after vaccination with INFLUENZA VACCINE. The time to onset is unknown. However, there is no information regarding patient's condition at time of vaccination, immune status, vaccination details, event details and lab test confirming diagnosis or excluding alternate etiology. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: almost killed me; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves an unknown demographic patient who reported almost killed me (unevaluable event) after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious almost killed me (unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got mine in 1968, almost killed me, and they did it without my parents knowing, it also kept me from having children , so yeah , go get one ya morons , we dont need your offspring running around."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
Sex: U
Vaccine: FLU4
Symptoms: Haematoma, Limb injury, Wrong technique in product usage process
Clinical narrative: goose egg swelling; damaged left arm; Flu shot was given wrong; Initial information received on 03-Oct-2021 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.  This case involves a patient (unknown demographic) who experienced goose egg swelling (hematoma), damaged left arm (limb injury) after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was given wrong (wrong technique in product usage process).  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency, lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed serious goose egg swelling (hematoma) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event assessed as medically significant.  On an unknown date the patient had damaged left arm (limb injury) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   It was an actual medication error case due to wrong injection technique (latency: same day)  There were no lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.   It was not reported if the patient received a corrective treatment for the events (goose egg swelling, Flu shot was given wrong, damaged left arm).  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.  The patient was recovering from hematoma at the time of reporting (patient was glad as hematoma went down ).  The event outcome was unknown for limb injury.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns patient who experienced hematoma and limb injury after the vaccination with INFLUENZA VACCINE (unknown manufacturer) which was given wrongly. Time of onset is unknown. Further information regarding patient's past medical condition, previous vaccination tolerance and other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: got the flu every year; Initial information was received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced got the flu every year (influenza), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got the flu every year (influenza) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was not reported if the patient received a corrective treatment for the event (got the flu every year).  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination failure
Clinical narrative: Did not work well; Initial information received on 02-Oct-2021 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who reported did not work well (vaccination failure) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and reported (unknown latency) did not work well (vaccination failure).  This event was assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.; Sender's Comments: This case concerns an unknown demographic patient who reported did not work well after vaccination with INFLUENZA VACCINE. The time to onset is unknown. However, there is no information regarding patient's condition at time of vaccination, immune status, vaccination details, event details and lab test confirming diagnosis or excluding alternate etiology. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: severely ill; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced severely ill (illness) after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious severely ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I was really poorly from flu once so got the jab next Yr and think I will stick with flu. Made me severely ill."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Initial information was received on 05-Oct-2021 regarding an unsolicited valid serious case from social media via consumer/non-health care professional.   This case involves a patient (unknown demographics) who had pneumonia after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date in 2009, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.   It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event pneumonia.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a patient (unknown demographics) who had pneumonia after vaccination with INFLUENZA VACCINE (unknown manufacture). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.