chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 34 years old and unknown gender patient and it was reported that  this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and  administered to patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error)  On 29-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (formulation, strength, route: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as Immunization    On 29-SEP-2022 the vaccine was  administered to patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event,  administered to patient with no reported adverse event).  At time of reporting, the outcome was Unknown for all.    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 the 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.
Day 14 itchy hive/welt approx 2-3 inches in diameter at injection site.  This is day 13, it remains the same.
SARS-CoV-2 ~COVID-19 rapid diagnostic test performed on 7/22. Test came back positive. Case investigation interview with patient has not been conducted as of the time of this interview.
About one week after shot, patient could not lift arm. Pt seeked therapy and 4 month later can now lift arm about 70 degrees.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient was given the vaccine at 513pm. She sat in the waitng area with her when, at 525pm, slumped into the arm of the chair and lost concsiousness.  A tech called 911 while I helped the father lower her to the ground and raise her feet onto a chair.  EMS arrived shortly after and took over care.  They sat her up and she lost consciousness again. She was taken with EMS to  Hospital.
Received Hib vaccine on 2/11/02 and on 2/12/02, mother states that whelps appeared on diaper area and extended to feet (both). Four or five hours, post vax, the child ran a temperature of 99F-102F (ax). Mother reported incident on 2/13/02 and was instructed to go to PCP. Had a temperature X 24 hours. MD saw child on 2/13/02 and did unknown lab work. PCP stated whelps were from vaccine reaction. Also states, child had virus on top of a virus.
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever of 101 degree F and then 102 degree F on the same day of receiving 2nd dose of Shingrix. The fever resolved on the next day. The reporter did not consent to follow-up. The outcome of the event recovered reported and the age group reported in the database was different with that reported in the source document where it was resolved with sequele.      Lab Comments: On an unknown date, the patient's body temperature was recorded as 101 and 102 degree F.
SKIN ALLERGY ON HANDS, ARMS AND FEET; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included do not have any history of food or chemical allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced skin allergy on hands, arms and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin allergy on hands, arms and feet was not reported. This report was non-serious.
This case was reported by a lawyer via a statement of injuries and described the occurrence of neck pain in a male subject of unspecified age who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown).  At an unspecified time after vaccination with Lymerix, the subject experienced pain in his neck and down his spine, knee pain, shoulder pain, fatigue, tingling in legs, and leg numbness. He underwent bilateral total knee replacements, and pain management included prescription narcotics and epidural injections. The statement alleged that the events negatively impacted his activities of daily living and enjoyment of life. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were was unspecified.
Information was received from a registered nurse, who reported that an unspecified number of patients (demographics not provided) received an improperly stored dose of VARIVAX lot number M006156, expiration date 05-FEB-2018 and lot number M033313, expiration date 13-JUL-2018, (dose number, dosage and route of administration not provided), for prophylaxis.  The outcome of the event is unknown.  No adverse effects reported. Temperature excursion reported as: Temperature: > 15°C but < -10°C; highest temperature -14°C. Time frame: 20 minutes. Previous temperature excursions reported as: -14°C for 10 minutes, -13°C for 40 minutes, -13°C for 4 hours 20 minutes, -13°C for 1 hour 40 minutes, -8°C for 3 hours 40 minutes, -9°C for 13 hours, -11°C for 63 hours. No further details provided. 17-FEB-2017: Lot #M033313 was determined to not be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007838:
630PM pt became very irritable-high pitched scream, could not reconcile; 8PM had temp of 102.2 R; mom gave PAPA; 930PM the fever broke; by 10PM pt was fine;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 23-NOC-2015 at time- 13:41, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 1.9 (units unspecified) respectively. There were not Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to 19 patients. The patients received M-M-R II (lot# reported as 0679AE; expired date: 02-APR-2014) that was reconstituted with expired sterile diluent (lot# reported as 6103Y; expired date: February 2012). The patients received M-M-R II sometime between 27-AUG-2012-31 to 31-AUG-2012. No concomitant medications were reported. Pharmacist stated their wholesaler sent them expired diluent. The patients were not experiencing known symptoms. Additional information has been requested.
1st dose in 2020 bc COVID did not get the 2nd; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: 1st dose in 2020 bc COVID did not get the 2nd). The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 10-Mar-2023 Reporter was a female patient that reports that she received her 1st dose of Shingrix in February 2020 (she did not have an exact date), and she was supposed to get her 2nd dose of Shingrix 6 weeks later, but Covid happened, and her pharmacy quit giving vaccines during this time.  The patient never got her 2nd dose of Shingrix. The patient also reports that she received her Pneumonia vaccine (unknown product and details about this vaccine were unavailable) at the same time as her 1st dose of Shingrix. The patient did not have a lot number or remember the location where the injection of Shingrix was administered. The reporter consented to follow up. It was unknown whether patient experienced covid or reporter meant covid situation. Therefore, conservatively capture as social problem event.
Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). On 25-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.
Pt left clinic after 15 minute observation period, however shortly returned to clinic stating she had tongue tingling and feeling of slight swelling near back of throat. States she has not had anything to eat yet, provided juice and crackers. States is not having trouble breathing, is taking in oxygen fine. Color was normal, pulse ox indicated oxygen lvl of 98-99 entire time. Provided 25ml PO Benadryl. Observed for approx 45 mins. After about 20-30 mins stated feeling of swelling went further down throat and was having trouble swallowing crackers provided. EMS personnel checked on pt, reported oxygen lvl was good, no trouble breathing. Offered to take to ER, but pt declined.  Pt left clinic reporting no worsening of sx or improvement of sx.  Stated was going to call PCP.
pt recv vax 10JUL96 & 12hr post vax pt exp an elevated AST (inc by 10 points), pain over the liver area, abd pain, vomiting, diarrhea & sl enlarged liver;no jaundice was present;pt was seen in a clinic;tx hydration;pt recovered;
Information has been received from a Registered Nurse (R.N.) concerning a female patient who was vaccinated with a dose of Gardasil. The nurse reported that on 27-SEP-2007 the patient experienced heavy menstrual bleeding. The patient's heavy menstrual bleeding persisted. No further information was available. Additional information has been requested.
Malaise and legs aching, weakness. Later before bed swelling of lymph glands under armpits, very painful on left side, not so pronounced on right side.  Vaccine was given on left arm.
Information has been received from a nurse concerning a female who on 30-Jun-2008 was vaccinated with a dose of GARDASIL. On the same day, the patient passed out in the office and experienced syncope. Subsequently, the patient recovered fully from syncope on the same day. The patient saw the nurse practitioner. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events were possibly related to vaccination with KINRIX.  This case corresponds to a pharmaceutical product complaint.  The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX.  At the time of reporting, no additional information was available.  This is case 6 or 15 (see case IDs A0860669A, A0860688A, A0860690A - A0860692A, A0860694A - A0860702A for the other reports).
Patient returned to the pharmacy 11/21/2018 and reported that the same night he received the SHINGRIX vaccination on 11/14/2018, he experienced redness and soreness at injection site, and by the next day he had heat and redness radiating down the upper arm towards the elbow. He felt that this may have been due to the fact that the pharmacist injected the vaccination slightly lower than the deltoid muscle area. He showed me his arm and it appeared slightly red with dry skin. I informed him that SHINGRIX is known to cause this reaction as one of its possible side effects even when administered perfectly. He said that his arm is feeling better than a few days ago, but just wanted to report this to us.
SEIZURES; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin 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, and batch number were not reported, expiry: unknown) dose was not reported, 1 total (first dose) administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  It was reported that " including children who had seizures w/in 24 hours of the vax in the clinical trial are lying? Are you that stubborn you can't even see any of the proof? ". On an unspecified date, the patient experienced seizures. The drug latency was reported as 24 hours The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220927816-covid-19 vaccine ad26.cov2.s- Seizures. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. 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: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210535199.
I had a blood test done, and the Dr. stated that my liver levels were up and he wanted me to see a specialist,  and when I did it was confirmed that I have Auto Immune Hepatitis.  I was given a Steroid called Prednisone, and Azathioprine, which I am about to stop taking the Prednisone  .  I had no symptoms to let me know that I had Hepatitis and was very shocked to here that I did.
Second day, March 5th muscle pain all over body, mostly on lower level, legs very painful feeling. Pain level 9 constant. Could not move or do much. Body aches.  Third day March 6- continue body pain and aches. Headaches long lasting - pain level continue at 9. Took Tylenol. Every 8 hours. Help for a little bit. Could not sleep headache came back, developed low fever and chills and body pain, legs muscles painful. Day 4- March 7- same as day prior.  Day 5- to now March 8-10. Chests pains, back of chests pains. Lung pain, sharp. Very hard to catch a breath, very painful in my longs, lost appetite, blurry vision,  my longs hurt while breathing. Difficult to breath. Will make appt with doctor. Pain level 9.
Spoke with patient today. He received the pfizer Covid-19 vaccine from us. The first shot was given on 4/15/21 (ndc: 59267100001, lot: ew0151, exp: 07/31/21; given in left arm/im) and the second shot was on 5/6/21 (ndc: 59267100001, lot er8736, exp: 07/31/21; given in left arm/im). After the second shot, he stated he began to have adverse effects. He says it started with dizziness and feeling underbalanced. The adverse effects continued to worsen to when he would turn his head left or right, he felt like he was in a fog and had to wait for his mind to caught up. And now within the last 2 weeks, he has had swelling on each side of his neck that is worse in the evening. He has checked with his primary care doctor. Patient reports that his doctor has done bloodwork, which was normal other than his cholesterol being elevated and the doctor did a CT scan of his head that has come back normal. Patient is now following up with an ENT. Patient and I called Pfizer today to get information on whether others have reported these same effects with the duration he is experiencing these effects. The reference number given to us by Pfizer was 51k4tadq.
(unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient reports that she took some Pepto-Bismol, but it's not helping.
Bilateral pulmonary thrombosis; hospitalized 2 day, given IV anticoagulant;
headache; fatigue; brain fog; This non-serious case was reported by a physician via sales rep and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced headache (Verbatim: headache), fatigue (Verbatim: fatigue) and brain fog (Verbatim: brain fog).  The outcome of the headache, fatigue and brain fog were not reported.   It was unknown if the reporter considered the headache, fatigue and brain fog to be related to Shingrix.     It was unknown if the company considered the headache, fatigue and brain fog to be related to Shingrix.   Additional Information: GSK receipt date: 25-Sept-2023 The physician reported that the patient had headache, fatigue and brain fog after getting Shingrix vaccine. The case was linked with case US2023132524, reported by the same reporter for patient's wife. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2023132524:wife case