chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low grade fever; bad headache; severe chills; diarrhea; flu like symptoms; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a via consumer non health care professional under reference number: US-SANOFI-00807408.  This case involves a 65 years old female patient who was experienced low grade fever (pyrexia), bad headache (headache), severe chills (chills), diarrhea and flu like symptoms (influenza like illness) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Reaction to preservatives.  On 07-Oct-2021, the patient received a 0.7 ml 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 prophylactic vaccination.   On 09- Oct-2021, the patient developed a non-serious low grade fever (pyrexia), bad headache (headache), severe chills (chills), diarrhea and flu like symptoms (influenza like illness) two days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "A consumer of FLUZONE HIGH-DOSE, reporting a possible adverse reaction to the vaccine, consumer states she never gets the flu but decided to get the High-Dose formulation because she turned 65 this year, she stated she received the vaccine on Thursday 07Oct2021 and by Saturday 09Oct2021"  She states she is hypersensitive to preservatives but understand there are not any preservatives in the shot, she has recovered form the symptoms but inquires if studies are being conducted regardless of gender, she states studies in the 1970 used to be conducted on men only Management of Adverse Events and Product Technical Complaints Pasteur AE Reporting Refunds/Credits will not be issued due to adverse events.   No laboratory data reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovered from all the events.  There will be no information on the batch number for this case.
101 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101 fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (101 fever). At the time of the report, PYREXIA (101 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 101 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
9 year-old patient inadvertently received a dose of Flublok quadrivalent/no AE; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 9 year-old patient who was inadvertently vaccinated with a dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number UJ448AA and expiry date 22-Mar-2021) via unknown route in unknown administration site on 05-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (Latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is 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 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.
Blurry Vision, headache, mild fever (99.5F)  and soreness.
Her first dose did not hurt as much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her first dose did not hurt as much) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis since an unknown date. Concomitant products included GABAPENTIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her first dose did not hurt as much). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 800 mg and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg. At the time of the report, PAIN IN EXTREMITY (Her first dose did not hurt as much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-036972 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her first dose did not hurt as much) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis since an unknown date. Concomitant products included GABAPENTIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her first dose did not hurt as much). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 800 mg and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg. At the time of the report, PAIN IN EXTREMITY (Her first dose did not hurt as much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-036972 (Patient Link).
He has been experiencing symptoms of COVID like the lost of taste and smell.; Lost of taste; This is a spontaneous report from a contactable consumer (patient) for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 14Jun2021 as 1st dose, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination the patient  had been experiencing symptoms of COVID like the loss of taste and smell. Reporter seriousness for events was unspecified. Outcome of event was unknown.  Information regarding the lot/batch number has been requested.
Fever; headaches; extreme muscle pain and extreme exhaustion; extreme muscle pain and extreme exhaustion; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 02Jul2021 at 17:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis, cardiac failure chronic, drug hypersensitivity (Known allergies: Penicillin). Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever, headaches and extreme muscle pain and extreme exhaustion on 02Jul2021 at 17:15. No treatment was received for the events. Outcome of the events was not recovered.  Information about lot/batch has been requested.
1610 c/o dizziness. VSS  HR 52 regular, BP 147/91, oxygen saturation 100%. She Reports history of hypertension and Dizziness. She takes metoprolol 100mg daily. Refused offer to be transported to the ER for evaluation. 12 lead EKG done by EMT.
Patient came into the pharmacy inquiring as to if the formulation of the shot been changed from the previous years. Patient states that about 3 hours after receiving the injection the site began to burn and turn purple and tender to touch. Patient stated that for 2 - 3 days he was unable to lift his arm above his head. Upon his trip today, he states that he has regained mobility, there is no tenderness, but was concerned with the large bruise that was still present.
Pt was given a Zoster vaccine instead of a PROQUAD vaccine. There has been no adverse reaction as of today.
hot and swollen red arm; hot and swollen red arm; hot and swollen red arm; Swelling radiating down to elbow; severe sensitivity to touch; pressure in arm; fever 103; body aches; fatigue; This is a spontaneous report from a contactable healthcare professional.   A non-pregnant 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 30Aug2021 (Batch/Lot Number: EW0171) as dose 1, single for COVID-19 immunisation.  Patient had no medical history (None, otherwise healthy).   There were no concomitant medications.  The patient previously took CECLOR and experienced allergies.  The patient experienced 5 days post-vaccine 03Sep2021 17:00, hot and swollen red arm. Swelling radiating down to elbow, severe sensitivity to touch or pressure in arm, unresolved.  24-48h maintain post-vaccine fever 103, body aches, fatigue, resolved after 2 days. Patient received topical biofreeze;  otc NSAIDs. No COVID prior to vaccination and has not been tested for COVID-19. The outcome of fever 103, body aches, fatigue  was recovered on 05Sep2021 and other events was recovering.   No follow up attempts are possible. No further information is expected.
pt recvd vax;grandma called stating 2 hrs p/vax started shaking;t 102;apap given;advised to take to er if cont shaking;grandma did not give apap as prescribed t inc to 103;gave apap & sxs stopped;
Pt recv vax on 8/27/98; 1 hr later pt exp nausea, difficulty breathing, pt went to E.R.; tx=Ventolin & Atrovent, Antihistamine injected, Medrol pack.
Red area at the injection site (quarter-diameter size) and moderate pain approximately 3 days after injection.
Pt recv vax on 12/30/98; on 1/1/99 pt exp rash on trunk; dx=virus
On the night of Monday 15, I started to have a fever over 102.2 degrees. Took Ibuprofen for the fever. At 3:00 AM of the same day started to feel weak. On that moment I lost consciousness and passed out. In my opinion, I experimented a down on sugar, which had never happened before. My husband was able to catch me and sat me on the floor. A minute after I recovered and my husband gave me fruit (Melon) to raise my blood sugar. On that moment I had lots of nauseas and diarrhea. I was feeling weak and dizzy all night and the next day. Today Wednesday March the 17 I have been feeling much better.
Immunizations given on 7/26/17, mom reports patient complained of headache since vaccines and dizziness. Woke up 8/1/17 with rash at injection site. Also complains of pain.
Flu like symptoms that lasted three days followed by ringing in the ears that has cause need for hearing aids.
a 63 year old patient recieved menactra, No AE; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case from a patient (non-health care professional).  This case involves a 63 years old female patient who was vaccinated with 0.5 ml of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiration date not reported), via unknown route in unknown administration site for prophylactic vaccination on an unknown date (PT:product administered to patient of inappropriate age) as per her immunologist's recommendation.  Concomitant medications included INFLUENZA VACCINE for prophylactic vaccination.  At the time of the event, the patient had ongoing Type 2 Immunoglobulin G deficiency .   It was an actual medication error case due to inappropriate age at vaccine administration (same day latency).it was reported that now the patient wants to know that if she can get the Menactra booster now even though.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is 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 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.  There will be no information on the batch number for this case.
Dreams have been very star game and vivid; heavy fatigue; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the right arm on 20Mar2021 at 14:15 (at the age of 43-years-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the right arm on 11Apr2021 at 15:00 (at the age of 43-years-old) as a dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient had dreams that had been very star game and vivid after both shots and also, heavy fatigue after both shots. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events dreams had been very star game and vivid and heavy fatigue were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Approximately 5 minutes after vaccination, the patient c/o "swelling in my mouth".  She was reclined and vital signs taken: BP 180/120, P 97, R 18, O2 Sat: 97%.  She also c/o blurry vision.  EMS was called and 50 mg Benadryl was given IM in the Right Deltoid.  She was able to swallow small sips of water.  Approx. 5 minutes later, she stated that she could feel the swelling receding in her mouth.  EMS arrived and she was feeling better, but her BP remained elevated at 180/120 and she was transported to Medical Center via EMS for elevated BP. The patient called us this morning 4/1/2021 to report that she is home. She was treated at the hospital for elevated BP and sent home when BP returned to normal.
Flu vaccine received IM deltoid, left arm on 2/3/11. 2/15/11 began onset of symptoms consistent with brachial plexus neuropathy/neuritis including: significant pain to shoulder & scapula, weakness when lifting items above shoulder height, constant tingling/numb sensation from scapula to elbow, significant stiffness when not using arm.
Pt received flu shot on 9/25/15. She stated she went to ER on 9/30/15 with heart flutter and low potassium levels. She was released the same day. She followed up with cardiologist; per pt cardiologist does not think it is related to flu shot but pt thinks it is and wants to be reported.
Pt. had a localized reaction about 3 inches around the sight of injection. Appeared red and slightly swollen. Presented me with symptom 2 days after vaccination.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-FEB-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
has not been doing well; extremely weak / Weak; very tired; This case was reported by a consumer via (Shingrix GSK) interactive digital media and..... and described the occurrence of weakness in a 85-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   Previously administered products included Shingles vaccine (Received 1st dose of shingles vaccine on an unknown date.).   On 31st March 2021, the patient received the 2nd dose of Shingles vaccine. On 13th March 2021, the patient received the 2nd dose of COVID 19 VACCINE. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced weakness, tiredness and unwell. On an unknown date, the outcome of the weakness and tiredness were recovered/resolved and the outcome of the unwell was unknown.   It was unknown if the reporter considered the weakness, tiredness and unwell to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by patient's wife. On 13th March 2021, the patient received 2nd dose of COVID vaccine. Less than a week after receiving Shingles vaccine and less than a month after receiving Covid vaccine, the patient had not been doing well the last week, but mostly the day before reporting. Less than 2 weeks after receiving Shingles vaccine and less than a month after receiving Covid vaccine, the patient had been extremely weak and very tired of 2 days. The reporter wondered if it could have anything to do with vaccines, as the patient received close together and stated that could this had anything to do with it all. It was unknown if the reporter considered the weakness, tiredness and unwell to be related to Covid vaccine. The follow-up would not possible as no contact details were available.
vaccine leaked around the hub of the syringe; underdose; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves patient who was vaccinated with a leaked syringe (Syringe issue), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. The lot number: UJ213AA and expiry date not reported.  It was actual medication error due to vaccine underdoes. It was also a case of Syringe issue.  At the time of report no adverse event was 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.
September of 2020 when he received his first dose; This case was reported by a consumer and described the occurrence of social problem in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in Septmber 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional information was provided follows:  The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, as the patient stated the reason for missing 2nd dose as he had his Covid - 19 vaccine too close to his scheduled appointment for his second dose of Shingrix. The VAERS details for 1st dose were provided. The reporter consented to follow up.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will consider revaccination
No adverse effects were reported; patient received one dose of improperly stored MMR II; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported.     On 26-JUL-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA, one dose, lot # R028526, expiry date 04-OCT-2020 via unspecified route. The vaccine was diluted in sterile diluent. Temperature excursion lasted 30 minutes, reached 47 Fahrenheit degrees and was recorded by digital data logger. No previous temperature excursions have occurred. No adverse effects were reported.
Right Deltoid 5cm X 5cm area is red and warm to touch. Hard induration, slight swelling. No fevers, cough, fatigue, muscle aches, Itching at site, rash or respiratory issues. No GI issues or loss of appetite. No relief from cold compress
8 pts recv vax 13JUN95 & 4 of the pts devel a gen morbilliform rash & fever greater than 102 24-48 hrs p/vax; a child who was not vax devel chickenpox w/in 24 hrs of contact w/one vax child;