chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant therapies were not reported.   On 26-JUN-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (lot # R022232, expiry date 16-APR-2020, 1 dose; route of administration and anatomical location not provided) for prophylaxis. The vaccine was properly stored. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R022232; expirationdate: 16-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Body aches; Fatigue; Headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 016M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Headache). On 19-Aug-2021, the patient experienced MYALGIA (Body aches) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   The patient received her booster dose on 27JAN2022   This case was linked to MOD-2022-465342, MOD-2022-465354, MOD-2022-465328 (Patient Link).
DIARRHEA; STOMACH PAIN; This spontaneous case (PVX2019-1336) report was received from a nurse on 24-May-2019. It describes a 39-year-old female consumer who had diarrhea and stomach pain, after the administration of Vivotif for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 23-May-2019 at 10 pm. On 24-may-2019, she had diarrhea and stomach pain at 6 am. She reported that, at 11 am both the events were continued. She had diarrhea and vomiting in every 10 minute. The nurse reported that there was no treatment medication reported for the events and she did not report any concomitant medications. She had no medical history related to the vaccine. She did not take any unhygienic food or water. Furthermore, she did not want to take other doses of Vivotif.   Action taken with Vivotif was unknown.  The consumer had not recovered from the events.  Company's Comment: In this case, it was reported that the consumer had diarrhea and stomach pain after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhoea and stomach pain are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had diarrhea and stomach pain after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhoea and stomach pain are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Stinging pain at the injection site.  Hurts more when pressed on and raising the right arm.    First felt while sleeping and laying on the arm with the injection site.  The pain continued for the rest of the night and during the next morning.   The site still stings during the time I was completing this report.   The previous vaccinations did not produce an adverse event.
The night after getting the shot, I could tell I wasn't reacting well.  I woke up Sunday morning with chills and later had a temp of 100.8 degrees F.  I had a bad headache & muscle aches and didn't feel I could eat without risking throwing up.  I laid in bed all day taking sips of water I felt miserable and not comfortable enough to sleep until about 10pm Sunday night. I was still tired and achy Monday morning including painful stomach cramps but gradually felt better by Monday evening and felt well enough to eat a normal dinner Monday night.  Prior to that I had one egg Sunday and one egg Monday and about a dozen wheat thins, then some banana bread about 3pm Monday afternoon
This spontaneous report as received from a pharmacist refers to a 69 year old male patient. Medical history and concurrent conditions were not reported. On 13-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX to prevent shingles (route, lot number and expiration date were not provided). Concomitant therapies included acetaminophen, NORCO and finasteride. On an unknown date approximately in January 2015, the patient was prescribed methotrexate and PLAQUENIL for arthritis. The patient contacted the pharmacist concerning the event. The outcome of arthritis was unknown. Additional information has been requested.
This spontaneous report was received from the patient's mother referring to her daughter, currently approximately 10 years old female patient. Concurrent conditions included methylenetetrahydrofolate reductase (MTHFR) gene mutation, gluten sensitive and milk allergy. The patient had no drug allergies. Information about concomitant medication and medical history was not provided. On an unknown date (reported as in infancy), the patient was vaccinated with M-M-R II series (strength, dose, route, lot # and expiration date were not reported) which was reconstituted with sterile diluent (STERILE DILUENT) for prophylaxis. On unknown date in the child stage (also reported as toddler stage (15 to 18 months)), the patient began experiencing failure to thrive and was treated with cyproheptadine hydrochloride(PERIACTIN). It was also reported on an unknown date when the patient was a toddler, she developed paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDA) or autoimmune encephalitis. The reporter stated the condition was not well known at that time, so the patient did see unspecified specialist for unspecified treatment and testing. On an unknown date, patient received PREVNAR 13 and it failed, meaning titers came back negative. The patient kept being sick with high fever that healthcare team stated was viral, so her parents provided comfort treatment like ibuprofen (ADVIL). On an unknown date, the patient did received therapy with montelukast sodium(SINGULAIR) tablet (strength, dose, frequency, lot # and expiration date were not reported) orally for an unknown indication. Action taken with sterile diluent (STERILE DILUENT) and montelukast sodium (SINGULAIR) was unknown. The outcome of failure to thrive, PANDA, autoimmune encephalitis, titers negative, being sick and high fever was reported as recovering. The causality was not reported. Upon internal review, the events failure to thrive and autoimmune encephalitis were determined to be medically significant.
Systemic: she had a period start 2 days after and last for 1 week not supposed to get her period for 2 more weeks and she is normally regular-Mild, Additional Details: she started abnormal period bled for 1 week was 2 weeks early for period she will monitor since she got her second dose today
Wheezing, shortness of breath. Hives at and around injection site. Extreme soreness in arm.
Patient was complaining of vertigo at 11:05 am after vaccination about 10 minutes after; BP:106/60, P:72, R:22, O2:99% Reclined back in seat, gave snack/water, was better when patient closed her eyes. At 11;15, tried to move her outside of car to cot, was unable to move because was too dizzy. Was assessed by Dr., and vertigo got worse with position change and was seeing spots. Hx of migraines about every 3 months. By half an hour after her vaccination, she was unable to move, so family was called to pick her up from clinic. Advised to follow up with PCP today and discuss decision about dose #2.
patient was delivered adult dose of pfizer vaccine instead of pediatric dose, mother contacted about vaccine error. Patient is without present side effects per Mom
Feeling a under the weather; This is a spontaneous report received from Pfizer sponsored Program. A contactable female consumer (patient herself) of 78-year-old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left arm at 12:20pm on 06Feb2021 at single dose for covid-19 immunization. Medical history include needs a hip replacement and concomitant medications were not reported. On an unspecified date, patient felt like feeling under the weather and thought pain reliver might help. The patient took Tylenol prior to having the vaccine. It was further reported that she has heard a lot having to do with the use of Tylenol. It was reported that she takes 3000-4000mg of Tylenol for pain a day because she was waiting for a hip replacement. she cannot deal with the pain if she takes less than 1000mg a day. She wanted to know any recommendations with the use of any pain medication, Tylenol or Advil with the effectiveness of the vaccine conjunction, as she had no problem with the vaccine. The outcome of the event was unknown.   Follow up (09Feb2021): This is a follow up spontaneous report from a Contactable consumer. New information included relevant medical history, product details.
This spontaneous report was received from a pharmacy intern (healthcare student) refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot number not reported) 10 micrograms per milliliter (mcg/ml). No concomitant medications were reported. Pharmacy intern reported that patient was tested for hepatitis B antibodies and result showed negative for surface antibody and positive for core antibody. She could not confirm when or how many doses of RECOMBIVAX HB patient might have received. No additional information provided. Additional information has been requested.
Pt recv vax on 11/2/98;post vax pt exp sore Rt arm x 3 wk w/ tingling, joint &finger pain, headache,stiff neck,sensitive to light, blurred vision,muscle weakness,kidney pain,dec taste,unable to walk, rash,dec hearing;dx=yeast infection,carp Annual follow-up received on 10/25/00 states that the symptoms are slowly disappearing but some neurological damage still exists in right shoulder, armpit and arm. Taste has still remained affected and eyesight has possibly worsened and coular hypertension has been identified.
During the night after receiving her second Pfizer SARS-CoV-2 vaccine, pt developed subjective fever/night sweats, myalgias, and headache overnight, followed by nausea, diarrhea x1, and vomiting x1 this morning, prompting clinic visit.
Customer complained of arm stiffness and soreness two days after recieving flu vaccine. She expressed she could not move or lift her arm for several days. Appears to have resolved itself.
Pt was given PFizer Bivalent on 10/11/22 and then was given a second Pfizer Bivalent on 11/7/22
Patient given High Dose Quad Flu vaccine 3 days before his 65th birthday.
This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching from waist up), HAIR DISORDER (something in his hair follicles) and THYROID DISORDER (thyroid due to some findings in his blood works within the last month) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 003B21A, 041B21A and 039D21A) for COVID-19 prophylaxis. The patient's past medical history included Non-Hodgkin's lymphoma (for which patient had 2 sets of chemotherapy). Previously administered products included for Product used for unknown indication: Flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included AFib, Blood pressure high (now maintained) and Cholesterol (now maintained). Concomitant products included APIXABAN (ELIQUIS), METOPROLOL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching from waist up), HAIR DISORDER (something in his hair follicles) and THYROID DISORDER (thyroid due to some findings in his blood works within the last month). The patient was treated with TRIAMCINOLONE (topical) at an unspecified dose and frequency; DOXYCYCLINE at an unspecified dose and frequency and LEVOTHYROXINE at an unspecified dose and frequency. At the time of the report, PRURITUS (itching from waist up), HAIR DISORDER (something in his hair follicles) and THYROID DISORDER (thyroid due to some findings in his blood works within the last month) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Skin test: there is no lymphoma now. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that he applies Triamcinolone 1% Cream every day on different sites. He was also on Doxycycline for a month currently midway as his dermatologist thought there must be something in his hair follicles. He stated that these medications were not helping. He was also started on Levothyroxine for his thyroid due to some findings in his blood works within the last month.
Got a good nights sleep which she usually does not get; feeling tired; dizzy; This is a spontaneous report received from a contactable consumer, the patient via Pfizer sponsored program Pfizer first connect. A female patient of an unspecified age received first dose of BNT162B2 (COMIRNAT PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, NDC number and Expiry Date: unknown) via an unspecified route of administration on 25Jan2021 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was feeling tired and dizzy after the first shot. Patient got a good night sleep which she usually did not get. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
2nd dose of vaccine given too soon.  Parent advised to repeat the dose in 3 weeks.
Diagnosed with a kidney infection-- very high fever, back pain, extreme nausea, extreme migraine-- that was treated with antibiotics and then went away after 5 days
Passed out; Cannot make it on the second dose schedule; missed from receiving her second dose; She has vomitted; she is still sick; can't keep her head up and has headaches; Feeling sick; She cannot eat; This is a spontaneous report from a contactable consumer (reported for herself). The female patient (80 unit not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot no: not reported) on an unknown route of administration on 06Mar2021 as SINGLE DOSE for COVID-19 immunization. Patient's medical history included Diabetes. Concomitant medications were not reported. It was reported that the patient had the first dose of the vaccine on 06Mar2021 and now can't keep up with herself. The patient has vomited and can't keep her head up and has headaches. and stated she knew the vomiting goes on for 14 days but today was 23 days and she was still feeling the same. Patient was due for her second dose of the vaccine and wanted to know if she should still get her second dose or if she should wait a couple weeks until she feels better. Upon follow-up (29Mar2021, on an unknown date the patient had passed out, cannot make it on the second dose schedule; missed from receiving her second dose, cannot eat, vomiting, Feeling sick. The patient reported that she experienced different symptoms like she passed out and was in IV fluid (as treatment) after the first dose. Now the patient cannot make it on the second dose schedule. The patient was reported that the treatment was advised by her physician because the patient passed out and missed from receiving her second dose. The patient cannot eat, vomiting and she was still sick, up until now, that is why she cannot go to get the second dose of vaccine. Limited information was available over the call. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Bleeding for 20 days. Once her period started again, it did not stop; Sometimes heavy flow with several medium sized clots a day; Some slight soreness/cramping; Some slight soreness/cramping; She did not have a period for 65 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 (Lot number: 33130BA) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing); "Shrimp allergy" (unspecified if ongoing). The patient had not experienced Covid-19 prior vaccination. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (First dose, Lot. EW0170. Location of injection: arm left), administration date: 22Apr2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Second dose, Lot. EW0187), administration date: 27May2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant), outcome "unknown", described as "Bleeding for 20 days. Once her period started again, it did not stop"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Sometimes heavy flow with several medium sized clots a day"; DYSMENORRHOEA (non-serious), DYSMENORRHOEA (non-serious), outcome "unknown" and all described as "Some slight soreness/cramping"; AMENORRHOEA (non-serious), outcome "unknown", described as "She did not have a period for 65 days". The events "bleeding for 20 days. once her period started again, it did not stop", "sometimes heavy flow with several medium sized clots a day", "some slight soreness/cramping" and "she did not have a period for 65 days" were evaluated at the physician office visit.   Clinical course was the following: patient's period completely changed after receiving her booster shot. Her last cycle ended on the 28Dec2021, the day she got her booster, and then she did not have a period for 65 days. Once her period started again, it did not stop. She had been bleeding for 20 days. Sometimes heavy flow with several medium sized clots a day and some slight soreness/cramping. There were no signs of her cycle changing before the booster. She contacted her doctor to check in and to schedule an appointment at the beginning of the week.   Post the vaccination, the patient has been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Mar2022) negative, notes: Abbot BinaxNOW Antigen Self Test, Nasal Swab; (08Feb2022) negative, notes: iHealth Antigen Rapid Test, Nasal Swab; (04Jan2022) negative, notes: SARS-CoV-2 RNA (NAA/RT-PCR)(NAA), Nasal Swab. It was unknown if therapeutic measures were taken as a result of heavy menstrual bleeding, heavy menstrual bleeding, dysmenorrhoea, dysmenorrhoea, amenorrhoea.
Fever, cough, sore throat, rash on night of 12/8 still sick when called Health Dept on 12/11/14. Advised client to seek medical care.
Body ache, flu-like symptoms that rapidly progressed. Was diagnosed with polymyositis and desquamative interstitial pneumonitis. The discharge summary states polymyositis, pulmonary fibrosis, pneumonia, staph aureus, bacteremia, cholecystitis, respiratory failure, anxiety disorder, and leukocytosis. The 60 day follow up received states polymyositis, interstial lung disease-receiving chemotherapy and steroids. Required to use oxygen 24/7. Readmitted to hospital-3 wk stay-8 days in ICU on ventilator. Must now consider medical retirement. The follow up received on 3/31/03 states, "triggered: polymyositis, interstitial lung disease, MRSA, respiratory failure, original diagnosis congestive heart failure, 94 days in hospital."
Acute inflammatory demyelinating polyneuropathy for about 3 months. Treated with IVIG and physical therapy.
Narrative:  Patient recently received his 4th moderna COVID immunization. He has not had any issues/concerns/reactions to previously administered vaccines. After receiving this 4th vaccine the patient and his wife noted that he was more fatigued than usual and they report that this fatigue resulted in him falling twice. These falls both occurred within the week following the vaccine administration. Patient is an elderly man who receives help from his wife with daily cares as well as is a part of home based primary care. There are multiple additional reasons for why the patient could have been fatigued and fallen. Patient also has diabetes and takes multiple medications that put him at increased risk for hypoglycemia which can cause fatigue and falls as well. The report noted that this reaction was only being reported as an adverse event in case the patient wanted to receive another booster in the future then the providers would know to educate on how to avoid falls. Patient as not had any documented falls since this event and has now expressed interest in receiving the bivalent booster.
Headache, Sedation, Myalgia, Arthralgia & NauseaVomiting Narrative:  Awoke evening of 1/12/21 with headache, myalgias and arthralgias. Fatigued, yet unable to sleep. Noted emesis on 1/13/21. Symptoms resolved after 36 hours, with the exception of a mild lingering headache. Missed work on 1/13/21. History of COVID positive test ~ 12/25/20.
shingles/herpes zoster; Initial information has been received from a lawyer and a currently 74 year old patient (gender unknown). The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or 03-DEC-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) for the long-term prevention of shingles and zoster-related conditions at a pharmacy. Subsequently, on an unspecified date, the patient was treated by a health care provider at a medical center for the following injury resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles/herpes zoster. At the reporting time, the outcome of the event was unknown. The reporters considered shingles/herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).