chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; fatigue; mild muscle aches; Felt faint/ dizzy; hot; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and muscle pain. On 24th July 2019, the patient experienced felt faint and feeling hot. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the fatigue, muscle pain, felt faint and feeling hot were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, felt faint and feeling hot to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced soreness at the injection site. Next day, she felt faint, dizzy and hot, She had to sit down in a chair under a fan and the symptoms resolved after 10 minutes. The reporter consented for follow up. This case has been linked with the case US2019134725, reported for patient's wife.
Little bit weak today; sore muscle; body ache; had chills too; I would feel bad.; if I smell food, it would you know kind of sickening but I ate,; I had unwell feeling, like you getting the flu; This is a spontaneous report received from a contactable consumer (patient). A 77-years-old (reported currently 77 and half, 78 in august so) female patient received first dose of bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 22Jan2021 (age at vaccination: 77 years) as single dose for covid-19 immunisation. Medical history was not reported. The patient's height is about 5 (feet) 3 (inches) and right now her weight this morning was 116.7 (pounds), closer to 117 (pounds) (not captured in tab). Concomitant medications included vitamins once a day (multiple vitamins), calcium plus D (calcium, colecalciferol) per day, ciclosporin (RESTASIS) for dry eyes (in eye twice a day). On 22Jan2021, the patient had first shot and started having a sore muscle and the body ache and everything; on the same night she had little bit chills too, but side effects were mostly at night and then about (incomplete sentence). And then during the day she was fine, and it was just during the evening when she would feel bad. And then about Thursday (dates unspecified) when she woke up and she had unwell feeling, like getting the flu. And then at times like if she smells food, kind of sickening, but ate, had a good appetite. Sometimes she would get up and would feel better. The symptoms had gradually gotten better and went to a grocery shopping in-between the time, but it was sick, but now she would not be sick again and she was almost back to normal today. She was wondering is this normal to have this kind of symptoms for 2 weeks. When questioned about stop date of events, she reported that she was not feeling really bad right now, she just feels, just a little bit weak today (05Feb2021), feel like everything's going away. When questioned about outcome of event: consumer stated, she thinks she was recovering. The patient did not take any treatment. She did call her doctor and didn't seem to be concerned. She didn't take any Tylenol or anything else. She did not have the seizure; she did not have injection site swelling or redness or so. She reported alright and was going to have her next one. The outcome of event asthenia was unknown and for other events it was resolving.  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
1 hour , 45 minutes post vax pt returned to have her arm checked. Pt developed a quarter size pink area around injection site. No palpable knot felt, not excessively tender to touch and no warmness felt. Pt instructed to treat with Tylenol and cool compress. Symptoms resolved in one day. Fifteen days later the pt awakened with a half dollar size area of redness on upper arm. The area was warm to the touch, red and pt experienced decreased appetite and low grade fever.  Pt was concerned about an insect bite so was taken to a walk in clinic and given antibiotics for cellulitis and Benadryl for increased itching. Still unsure of cause of site.
At 1 year check up on 3/21/19 received MMR, Varicella and Hep A.  On 3/31/2019 had a cough and febrile seizure with fever up to 102 F and was diagnosed in ER with Influenza A and febrile seizure (mother had been sick with known influenza as well). Barack's seizure was felt to be a simple febrile seizure in the setting of influenza A infection. He has not had any more febrile seizures since that episode. Mom reports though that she is sure the MMR was the cause and would like it reported.
This 38 -year-old female patient reported that soon after she received the injections she napped and felt the nap was due to the vaccine. Then, at 1700 the patient was asked how she felt and the patient stated that she felt very very good.  In the morning of December 31, 2020, the patient reported pain at the injection site, the patient was then treated with Tylenol 650 mg at 0934 with positive results. On the evening the patient reported anxiety, a sore throat and pain to the left arm due to recently receiving her COVID vaccination. The patient was then treated with Hydroxyzine 25 mg PRN, Cepacol Lozenge, and Tylenol 650 mg; the medications were effective.
I tested positive for covid between vaccine shots.; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 35-years-old, via an unspecified route of administration in left arm on 15Mar2021 at 08:45 at single dose for COVID-19 immunization. The patient's medical history was not reported. She was not pregnant. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC) for birth control. She has no other vaccines in four weeks. The patient tested positive for COVID between vaccine shots. She believed she contracted it on 23Mar2021 on a flight. She started showing symptoms on 25Mar2021 and tested positive for COVID-19 nasal swab on 26Mar2021. The patient was told to come in for her second vaccine as scheduled as it would be her first day out of quarantine. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0150), via an unspecified route of administration in left arm on 05Apr2021 at 08:45 at single dose for COVID-19 immunization. The outcome of the event was unknown.
My husband got the first shot but he broke out in, Like blisters, All over his body.; : This is a spontaneous report from a contactable consumer or other non hcp (patient's wife) for a male patient (husband). A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA 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 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported her husband got the first shot but he broke out in, like blisters, all over his body on an unspecified date. She asked was that happened to anyone else. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
previous temperature excursion for GSK vaccines and that those products had been administered to patients since that excursion in November of 2021 with no adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves adult and unknown gender patient, with previous temperature excursion for gsk vaccines and that those products had been administered to patients since that excursion in november of 2021 with no adverse event while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (dose, strength, lot number and expiry date:  not reported) both Solution for injection via unknown route in unknown administration site as prophylactic vaccination.  There was previous temperature excursion for gsk vaccines and that those products had been administered to patients since that excursion in on an unknown date in Nov-2021,with no adverse event (product temperature excursion issue) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. It was reported that multiple patients had received multiple vaccines and that the vaccines had been evaluated by GSK and determined to be supported by GSKs stability data. The names of the vaccines involved were provided. Caller unable to provide additional details. After the call upon looking up each vaccine this writer noted that MENACTRA and TENIVAC  were company products.  Action taken : not applicable.  At time of reporting, the outcome was Unknown
Generalized rash involving 2 scabbed papules at site of injection with 5 others on face, chest, and back.
Case number PHEH2016US021227, is an initial spontaneous report received from a pharmacist on 12 Aug 2016. This report refers to a male patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient received Influenza Virus Vaccine Seasonal (manufacturer unknown, batch number not reported) subcutaneously (Inappropriate route of vaccination) on unknown date in 1982 at unknown dose. The patient developed Guillain Barre Syndrome. Seriousness, outcome and causality of the event was not reported. Seriousness of the event Guillain Barre Syndrome was upgraded based on the Novartis Important medical event list.
This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patients did not have drug reactions. On unknown dates, the patients were vaccinated with improperly store doses of GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature exposure was 47-77°F (49°F) for 30 hours. Previous temperature excursion was not reported, and a data logger was involved. This is one of the several reports received from the same source. Additional information has been requested; Sender's Comments: US-009507513-1704USA003212: Original Case : 1704USA003069 US-009507513-1704USA003210: Original Case : 1704USA003069 US-009507513-1704USA003211: Original Case : 1704USA003069
patient recive two dose of Menactra vaccine; Initial information received on 05-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA217984.  This case involves a 13 years old patient who received 0.5 ml second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6204AA and Expiry date 08-May-2020) via unknown route in unknown administration site on an unknown date and first dose receive on Jul-2018.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due extra dose administered.   It was reported that patient came in today and received a Menactra vaccination. Caller says that the patient had previous received the Menactra vaccine from clinic in July of 2018 and they are not told by the family that the patient had received the vaccine.  At a time of vaccination it was unknown if any adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 is 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 has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
patient stated started feeling ill, dizzy and started having joint pains  not long after the vaccine was given, came to employee health for evaluation, joint pains progressed and became worse over the next 20 minutes or so, and he was taken to the emergency department for further evaluation.  Unknown outcome after the ED visit.
FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch no/Lot no. No concomitant medications were reported. On 28-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Vaccine 2- side arm, low grade fever 100, fatigue, body aches, headache, flu-like symptoms.
low grade fever 99.2 after taking Ibuprofen  headache  sudden hot feeling and then fast cooling off, almost chilled, but I am fine, very mild
There is no adverse event to report. This is an administration error. Moderna was given to this 17 year old.
Patient presented to our Vaccine Clinic and indicated she was here for her first Covid Vaccine dose. She signed a consent form indicating this. She received her vaccine and was monitored without incident for standard 15 minutes. When we entered her vaccination into the database, later that day, we saw this was her 10th Covid vaccine. She had received vaccine at a variety of other local pharmacies.  To our knowledg, she has not experienced an adverse event, but we wanted to report that this had occurred.
DIZZINESS, NAUSEA, ANOREXIA ... ONGOING NOW FOR 2 MONTHS, 2 ER VISITS, MRI BRAIN,  CARDIOLOGY EVALUATIONS
Yes that's why I got the damn flu; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an adult and unknown gender patient who had flu after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the Initial information received on 17-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer.  This case involves Adult and unknown gender patient who had flu after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine  produced by unknown manufacturer(with unknown formulation, strength, dose, route, lot number , Expiry date and at unknown administration site) for flu (Influenza).  On an unknown date the patient was diagnosed with flu (influenza) (unknown latency) following the administration of Influenza vaccine.  No lab data were reported.  Action taken: not applicable.  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. patient received a  dose of suspect Influenza vaccine  produced by unknown manufacturer(with unknown formulation, strength, dose, route, lot number , Expiry date and at unknown administration site) for flu (Influenza).  On an unknown date the patient was diagnosed with flu (influenza) (unknown latency) following the administration of Influenza vaccine.  No lab data were reported.  Action taken: not applicable.  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.
Area of erythema & slight induration approximately 3 cm diameter around injection site (L) arm. Warm & tender.
Information has been received from a medical assistant concerning an 81 year old female patient, who on 26-OCT-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM. On 26-OCT-2010 the patient experienced redness, inflammation and pain in her right arm. The patient sought unspecified medical attention. At the time of the report the patient was recovering. Follow up information was received and indicated that there was no additional information other than the previously reported. This is one of several reports from the same source. Additional information is not expected.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: Ew0170), in left arm and on 07May2021 as dose 2, single (Lot number: Ew0176) at the age of 32 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Dec2021 as dose 3 (booster), single (Lot number: 028k21a), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: patient was treated with nirmatrelvir, ritonavir. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with nirmatrelvir, ritonavir from 08Jun2023 to 13Jun2023.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M017982 with expiry date on 13-SEP-2017; dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of -0.24 degree Celsius for 285.5 total cumulative hours. Data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Post vax, that night, pt's mother noted reddened left upper arm. It progressively became swollen, indurated and warm to touch and increasing in size. Pt was brought in 4/26/00 to get evaluated. PO antibiotics prescribed and told to elevate arm and observe for exacerbation or return to clinic.
had the vaccine and later tested positive for COVID-19; had the vaccine and later tested positive for COVID-19; This is a spontaneous report from a non-contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunisation.  Medical history included that the patient previously was positive from the virus COVID-19.  The patient's concomitant medications were not reported.  The patient that had the vaccine and later tested positive for COVID-19. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date (dates) those patients were vaccinated with RECOMBIVAX HB (dose, units, route of administration, anatomical location, lot number were not reported) that may had been stored improperly. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Received RECOMBIVAX on 3-15-14. On 3-27-14 called office stating on 3-26-14 had swelling to face, blotchy itchy rash all over. Began taking BENADRYL P.O. 25mg.
tired for several days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired for several days". Additional information:   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Three days after getting the booster, I started feeling tingling/burning sensations all over my body. When it became fairly intense (especially in my feet, legs and hands), I went to the ER. They did some blood work, etc., sent me home and told me to see my primary care doctor. When I returned home, I again ended up in the ER before I could get in to see my primary. My primary did a bunch of blood work and told me to see a neurologist. I am currently working with two neurologists trying to figure out what is going on with me. I have been through numerous tests and probably in for even more! Two months now and still in pain! On gabapentin for the nerve pain!
Had headaches and almost passed out after first dose. Started with the rest of the symptoms within 1-2 weeks after second dose. Headaches, migraines, positional/ high pressure headaches, dizziness, neck pain, blurred vision, palpitations, chest pain, presyncope, increased BP and pulse, anxiety, panic attacks, brain fog, and unsteadiness. I continue to have this symptoms.
This spontaneous report as received from a medical assistant refers to one unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant therapies were not reported. On 24-AUG-2016, the patient received a dose of improperly stored PROQUAD (lot # L033698, expiration date: 28-AUG-2017) (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. This is one of two reports received from the same reporter. Follow up information was received on 14-NOV-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: US-009507513-1609USA004115:, MERCK 1608USA015655:Mfr number.
Pt recvd 2nd dose of vax 15NOV90 & w/in 24 hrs devel severe h/a that were initially dx as sinus problem; tx meds; In JAN91 underwent ENT consult; CT inidcated pt did not have a sinus infect; dx poss vax related meningitis or encephalitis;