chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 23-Aug-2021 from an Other health care professional via Agency (Reference number- 00735962) and transmitted to Sanofi on 23-Aug-2021.  This case involves a six-month-old male patient who was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), POLIO VACCINE INACT (IPV), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 20-Aug-2021, the patient received 0.5 mL (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ351AA and expiry date 09-Aug-2021] via intramuscular route in the right thigh for prophylactic vaccination.  It was reported, "Office manager reporting an expired dose of ACTHIB was inadvertently administered".  It was a case of actual medication error due to expired vaccine used (latency was on the same day).  At the time of reporting, patient had no adverse event.  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.
Jaundice, generalized weakness, lethargy over the past couple weeks. yellowing of her urine and diarrhea, abdominal pain.
muscular problems; chills; fever; nauseas; body pain; diarrhea; night sweats; didn't feel well; felt funny; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), MALAISE (didn't feel well) and FEELING ABNORMAL (felt funny) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Test was negative but he had all the symptoms for 6 weeks) on 31-Oct-2020.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (body pain), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), MALAISE (didn't feel well), FEELING ABNORMAL (felt funny), CHILLS (chills), PYREXIA (fever) and NAUSEA (nauseas). On 22-Feb-2021, the patient experienced MUSCULAR WEAKNESS (muscular problems). At the time of the report, PAIN (body pain), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), MALAISE (didn't feel well), FEELING ABNORMAL (felt funny), MUSCULAR WEAKNESS (muscular problems), CHILLS (chills), PYREXIA (fever) and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No treatment information provided    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
w/in 1hr of vax pt exp tenderness @ the inj site;pt devel an inj site rxn characterized by redness, induration & warmth;pt believes the inj was given subcutaneous;
Severe upper neck pain on both sides of the neck. Pain worsened about 30 seconds after neck moved. No tingling sensation or fever. Took 800mg ibuprofein over a few hours which did not lead to symptom relief. Eventually fell asleep and symptom had lifted when I woke up.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown ages and genders. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patient were vaccinated with improperly stored doses of ZOSTAVAX (dose, route of administration, injection site, lot # and expiration date were not provided) for prophylaxis. The vaccines were administered along with improperly stored sterile diluents (dose, route of administration, injection site, lot# and expiration date were not provided). The reporter stated that the vaccines and the diluents were placed in a cooler with an icepack and transported to the physician's office. Additionally, it was reported that the vaccines were improperly stored during "10 to 30 minutes" and there were no previous temperature excursions. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Information has been received for VARIVAX (Merck), a Pregnancy Registry product, from a physician concerning a 28 year old female with no drug allergy and no medical history who on 14-NOV-2011 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (Lot# not reported). There was no concomitant medication. The physician reported that the patient contacted her and informed her that she did a home pregnancy test and was pregnant. No adverse effect reported. There was no laboratory studies performed. The patient sought medical attention by contacting physician and was given no treatment for AE. It was also reported that at the time of the report, the patient had not recovered. Follow up information has been received from the registered nurse, who reported that the patient had a spontaneous miscarriage in the first trimester. The registered nurse reported there was no knowledge or information of any known congenital anomalies with the fetus. Upon internal review abortion spontaneous was considered to be a medically significant event. Additional information is not expected.
redness and soreness at the site of the injection; soreness at the site of the injection; rash under her left breast.; bubbles; itched; 5 to 6 raised areas; overly tired; red rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox, tuberculosis (had tuberculosis at one year of age), shingles (had shingles twice in the past), pain (The pain was so excruciating one time she was hospitalized for three days and put on an IV.) and heart rate high. Previously administered products included Zostavax with an associated reaction of herpes zoster (administered when she was 60 years of age and developed a case of shingles a few years after the vaccination.) and HEPATITIS VACCINE (had hepatitis at four years of age). Concomitant products included analgesic, nos (Pain Medication).   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site pain, rash, blistery rash, itchy rash, raised rash, tiredness and red rash. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the rash, blistery rash, itchy rash, raised rash, tiredness and red rash were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, rash, blistery rash, itchy rash, raised rash, tiredness and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed some redness and soreness at the site of the injection by the next morning but it resolved after a couple of days. She had surgery in January and was advised to speak to her doctor before proceeding with the 2nd dose, then Covid broke out. She was unable to get the 2nd dose until the end of May.   Then last week, she noticed a rash under her left breast and had bubbles on it and itched.   It was the size of a couple of quarters if you put them together in which there were 5 to 6 raised areas.   In the last few days, it seems to be going away and no more bubbles and the redness was lessening and was itchy. The patient has been using a cream on it to help with the itching. The reporter consented to follow up. This case US2020AMR108078 is a duplicate of US2020107171. All future correspondence will be submitted to US2020107171.
pt recv vax 23FEB96 & 25FEB96 pt devel a fever of 104, a stiff neck, muscle aches especially the lt side of neck, h/a, & nausea;pt self-medicated fever w/APAP;
After vaccine it was almost a month later, the bed was shaking and she was having a seizure. I tried to get her back on target and called the ambulance.  In the ER she started having a seizure again and I called the ER doctor. He said if that's what happened earlier and said its definitely  a seizure.
rash on injection arm, swelling & heat at injection site, intense pain in injection arm rendering arm immobile, fever, chills, nausea, fatigue, loss of appetite, body aches. flu like symptoms. all symptoms lasted approximately 4 days. swelling and arm pain lasted up to a week. a bump is still felt at injection site on arm 2 weeks later. Treated with ibuprofen q4hrs.
sweating,feet is sweating,sweating profusely,hands always sweating; underarm is awful; night sweats; stomach aches; headaches; puking; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating,feet is sweating,sweating profusely,hands always sweating), FEELING ABNORMAL (underarm is awful), NIGHT SWEATS (night sweats), ABDOMINAL PAIN UPPER (stomach aches) and HEADACHE (headaches) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0213c1a and 038c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included FISH OIL for an unknown indication.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced HYPERHIDROSIS (sweating,feet is sweating,sweating profusely,hands always sweating), FEELING ABNORMAL (underarm is awful), NIGHT SWEATS (night sweats), ABDOMINAL PAIN UPPER (stomach aches), HEADACHE (headaches) and VOMITING (puking). At the time of the report, HYPERHIDROSIS (sweating,feet is sweating,sweating profusely,hands always sweating), FEELING ABNORMAL (underarm is awful), NIGHT SWEATS (night sweats), ABDOMINAL PAIN UPPER (stomach aches), HEADACHE (headaches) and VOMITING (puking) had not resolved.            Concomitant product included supplements. Treatment medication was not provided. Patient reported that she was looking for receiving surgical treatment.  8 hours after vaccination with the second dose patient experienced puking, headaches, stomach aches. Immediately after vaccination with the 2nd dose patient had sweating, underarm  was awful,night sweats. The symptoms were ongoing.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: No new information. On 06-Dec-2021: Updated Patient initials.
Patient was given expired Pentacel. Expiration date was in the following form: 28Jan23, so the MA thought this was 1-23-28 because the other vaccines had exp dates in this form: YYYY-MO-DATE. Sanofi was notified today and the expiration date was confirmed to be 1-28-23. Adverse event was filed with Sanofi as well. Sanofi is going to send this to their Quality and Safety division to see about having the dates written in a different form so as to not be confusing.
pt c/o tightness feeling in throat. denies SOb. VS taken and stable, pt observed x 30 minutes. vs repeated WNL. Pt d/c home with return precautions. pt states understanding
This spontaneous report was received from a healthcare worker regarding an unspecified 6 patients of unknown age and gender. This report pertains to the patient who on 21-NOV-2013 was vaccinated with a dose of M-M-R II, (lot # J003002, expiry date 14-MAR-2015) (dosage regimen unspecified). The healthcare worker reported that 6 clients were vaccinated with the same lot of improperly stored M-M-R II. The healthcare worker reported details of a supported temperature excursion for M-M-R II that were exposed to temperatures of 47Fahrenheit (F) for 1 hour 48 minutes (min), 48.5F for 1 hour 13 min, and 48.5F 1 hour 13 min (also reported as the vaccine was not stored improperly, the products would not be adversely affected by this specific temperature excursion). No adverse effect reported. No further information was available. This case is linked to 1312USA010204, 1312USA010205, 1312USA010206, 1312USA010207 (Same reporter link). Additional information has been requested.
29OCT(3 pt c/o redness & tenderness of inject site lt deltoid; on exam redness & induration seen @ inject site; 25mm x 25mm area warm & tender when touched;
expected sore L shoulder resolved in 2+ days. 7-10 days later L shoulder started to be achy, Progressed to both shoulders, painful ache, much worse in morning. Difficult to raise arms, very difficult to put on shirt, sweater, jacket. Lessens over the day, but just as bad the next morning. I've worked out my whole life, this is not usual post-work out soreness- no precipitating exercise.
About 2-3 weeks after my second shot, I started to get episodes where I felt very hot and nauseous for 5-10 minutes...This happened 4-6 times a week until May 20th when I was rushed to Hospital with what diagnosed as a seizure.
she has seen similar cases being talked about online where people have experienced the same issues as her husband.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (she has seen similar cases being talked about online where people have experienced the same issues as her husband.) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she has seen similar cases being talked about online where people have experienced the same issues as her husband.). At the time of the report, IMMUNISATION REACTION (she has seen similar cases being talked about online where people have experienced the same issues as her husband.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.
Heart rate spiked approximately 30+ bpm consistently for any movement, and 15 bpm at rest, per  data. (It may not be as accurate as medical testing, but is sufficient to show changes within its own data-set, which go back several years.) Heart rate would spike to 150 gently walking up a flight of steps. Drinking a soda also spiked my heart rate for 5-6 hours, which is abnormal.  (On the plus side, I now know how long before bedtime to avoid caffeine, since it apparently processes out of my system in 5-6 hours.)  Over four days, gradual improvement back to normal.  However, for the first two days, I couldn't do anything more than lay down and avoid anything even slightly stressful to avoid a dangerously high heart rate.  The simple act of standing took it up 15 points, to the area  it would normally have been if I was running up and down the steps with full baskets of laundry.   Shot was Sunday afternoon, reaction started shortly after midnight on Monday. I was woken up by my cardiac response, so this wasn't anxiety-induced. I also wasn't particularly worried about the shot so, again, not anxiety-induced. And I was doing slow breathing and such to calm my heart rate, so not anxiety-induced.   At about 3 am on Tuesday morning, I was laying down and my heart rate abruptly jumped 15 points out of nowhere, which was the final straw and I went to the ER. Of course, it was the final straw - my heart rate had started normalizing, so they found nothing on the ECG.  The next day, my heart rate was nearing normal. The day after (Thursday), it was seemingly completely back to normal.   However, if I had been TOLD that an extreme racing heart was a potential side effect and should normalize within 3-4 days, rest if it happened and see a cardiologist if it doesn't normalize within four days, take these precautions if it exceeds XXXX bpm, visit the ER if YYYYY happens, I would have been spared an ER visit.
Administered influenza vaccine. 30 secs later child laid back and began convulsing for 1 min. No clonic tonic but foamed at mouth & loss of bladder control. Pt recovered and sent via ambulance to hosp for eval.
received a third Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL) with a compromised immune system. Concomitant medication included PI3K inhibitor. The patient previously received dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. It was reported that the patient received second of two doses of the Pfizer vaccine in February. Patient since twice tested negative for the spike protein anti-body. On 24Jun2021, the patient received a third Pfizer vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Right thigh pain (non-bearing weight) 3 days post PPSV23 vaccination. Pt sent to ER.
Pain at the time of injection (greater than injections at other sites given at that time), redness and swelling started the next day just below the site and extended distally to the lower aspect of the deltoid by the time she was seen on 10/20 in ER.  Ice applied at home, no medications used.  Other sites of injection without reaction.  HPV first injection for patient.
I experienced abdominal pain about a half hour after receiving the shot. For the next two weeks the pain would come and go but was never totally gone. Some days were worse than others. On April 13th the pain was severe enough by 6:00pm that I knew something was wrong. By 7:00pm I was in tears the pain was so bad. I was vomiting, in pain, bloated, so much pain it was debilitating. I have a history of bowel obstructions and ovarian cysts and usually fight going to the hospital as long as I can and also refuse pain meds. But this was the worst pain I have ever felt and I was begging for morphine by the time we got to the hospital. After 7 hours, I left the ER still in pain and without any answers. I followed up with an obgyn, GI, colonoscopy, my primary. There was no answer as to what happened. I'm still having pain and bloating without warning.
Dose administered after exposure to room temperature more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature more than 24 hours) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature more than 24 hours). On 21-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
COVID vaccine breakthrough case. Moderna 1/7/21 011L20A, 2/4/21 012L20A and 12/9/21 029H21B
Patient received Covid 3rd booster shot on Friday 8/12. Then on Sunday, she started having fatigue, generalized weakness, and shortness of breath especially with exertion. She's found to have HR in 30-40 and ECG shows varying mobitz 2 type 2 and 3rd degree complete heart block.
12/10/2022 at around 02:00 began having sinus infection symptoms. Went to walk in clinic on 12/11/2022 and was tested for flu and COVID-19. Flu was negative and COVID-19 was positive. They prescribed cough meds but nothing else. Symptoms persisted for a couple days and began to subside. Symptoms completely resolved in 2 weeks.
He noticed rashes in both legs; itchy; headache; rash behind the right knee; at night, it starts to itch; pain in his head close to his eyes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (He noticed rashes in both legs), PRURITUS (itchy), HEADACHE (headache), RASH (rash behind the right knee) and PRURITUS (at night, it starts to itch) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included IBUPROFEN for an unknown indication.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (He noticed rashes in both legs), PRURITUS (itchy), HEADACHE (headache), RASH (rash behind the right knee), PRURITUS (at night, it starts to itch) and HEADACHE (pain in his head close to his eyes). At the time of the report, RASH (He noticed rashes in both legs), PRURITUS (itchy), HEADACHE (headache), RASH (rash behind the right knee), PRURITUS (at night, it starts to itch) and HEADACHE (pain in his head close to his eyes) outcome was unknown.            Treatment with Hydrocortisone 1%cream was provided for itchy events.   This case was linked to US-MODERNATX, INC.-MOD-2021-098384 (E2B Linked Report). This case was linked to MOD-2021-098321 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098384:Cross-linked
Tics started around the 4th day after vaccine. Patient has a similar reaction around 6 yrs old. We worked to build her immunity up with supplements and followed a strict diet. As of the past 2 years patient had been free from tics. After this meningitis vaccine, the tics started up again.