chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and 91 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sickness and sickness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the sickness and sickness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After both the vaccination in 2018, the patient experienced very sick for 2 days but the patient was recovered. In 2018, three months later, the patient experienced a mild shingles outbreak on the nose. The pharmacist told that, it was mild because the shringrix gave him some immunity.  Since then, the patient had gotten shingles 3 more times and at the time of reporting healing from the last episode, which began on 18th January 2019. This case was considered as suspect vaccination failure since the details regarding lab test confirming shingles was not unknown at the time of reporting. The GlaxoSmithKline claimed that, the vaccine was 90 percent effective so the patient guess that he was fallen under the radar into the 10 percent category that it did not work even though the patient suffered so with side effects. The patient was wondered if the 90 percent was accurate or if it was more like Merck's ZOSTAVAX 51 percent. The patient wanted to know, if any follow up testing indicate a lower success rate. The patient contacted to the CDC about his side effects but obviously they lost the information as they never followed up on the report he filed with them.
Pain in my arms, legs, and back - lasted 1 day Headache - lasted 1 day Diarrhea - lasted 1 day Nausea - lasted 1 day Metallic taste - ongoing
Possible secondary transmission of Rotateq from vaccinated infant to father. Father diagnosed at the clinic on 9-26-07 with rotavirus
On 4/7/2021, I experienced an early cycle, by 14 days. It was very heavy, heavier than it has ever been. It was not a miscarriage.
patient stated her arm became itchy on the one opposite of her vaccine and it traveled up her arm and lips felt tingly
25MAY95 pt fainted on arriving to waiting room from receiving MMR; taken by EMT to hosp; 5JUN95 pt reports visual vagal response;
Vaccine vial was diluted with 0.8 ml instead of 1.8 ml. the patient received the correct volume of a less diluted vaccine.  - Wednesday october 6, 2021 - patient received the dose at 11am - Wednesday October 6, 2021 - Patient was made aware of the mistake at around  1pm - Thursday October 7, 2021 - Patient reported some fever ( max 103.7F), repeated vomiting, chill, sore arm and being tied - Friday October 8, 2021 - Patient temperature was normal,  no more fever, no vomiting, no chill. patient's arm was still sore and patient remained "a little tied".
Clavicle and neck swollen; neck swollen; Vaccine administered too high on arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of bone swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (first dose received on an unknown date, refer case id US2023AMR051192).   On an unknown date, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced bone swelling (Verbatim: Clavicle and neck swollen), neck swelling (Verbatim: neck swollen) and vaccine administered at inappropriate site (Verbatim: Vaccine administered too high on arm). The outcome of the bone swelling, neck swelling and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the bone swelling and neck swelling to be related to Shingrix.     It was unknown if the company considered the bone swelling and neck swelling to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR051192   Additional Information: GSK receipt date: 03-Apr-2023  The patient received the second dose of Shingrix. After the second Shingrix vaccination, the patient experienced clavicle and neck swollen.  The consumer reported that the vaccine was given higher up on her arm and she commented to the administrator that she thought it was administered too high (wrong injection technique). The reporter consented to follow up. This case had been linked with US2023050865 same reporter. The patient received the vaccine too high on arm which led to vaccine administered at inappropriate site.; Sender's Comments:  US-GSK-US2023AMR051192:Same reporter US-GSK-US2023050865:Same reporter - husband case
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. Since 19-AUG-2014 doses of VARIVAX (Merck), which had been exposed to a supported temperature excursion, have been administered to unspecified patients on unspecified dates (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effect has been observed or reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Spoke with patient's wife, she is reluctant to give out information over the phone, she states her husband went to the doctor on 1/8/2009 with symptoms of a sinus infection, congestion. He was diagnosed with a sinus infection by his Physician (name refused by wife) and placed on an antibiotic, (name refused). He received the H1N1 vaccine injection while at the Physician's office. The next morning he woke with a headache, low grade fever (lasting for 2-3 days) and body aches all over. He continued to take the antibiotic and the headaches and bodyaches continued for a week. He is asymptomatic now. Wife is refusing to give any additional information, even after explaining VAERS reporting to CDC .
3 days after 1st vaccine...tingling in top of scalp my hair follicles hurt 1 week after 1st vaccine...spasms in left leg above knee cap [right hip was replaced in 2010 w/titanium hip] 8 days after 1st vaccine...lower lumbar pain left side  9 days after 1st vaccine...severe pain in upper thigh left side...could not walk...had to lay down for comfort took ib prophen 10-12 days later...left leg ached down to shin 13 days later...went to orthopedic dr...gave me steroid & muscle relaxer & stretches 21 days later...received 2nd vaccine...had to take it prophen for pain relief 26 days later...went to pain Dr  wanted an MRI but was declined...continued to stretch  Told both Drs about vaccine & nerve reaction but the didn't think it was related.  35 days later...absolutely no pain & can walk and sit normally
Patient received Pfizer first dose on 12/20/2020, lot # EH9899. Pfizer was the only manufacturer administered on 12/20. Patient was scheduled by the vaccinator for her second dose on 1/10 with an appt note "Pfizer 2nd dose." This appointment was subsequently cancelled and rescheduled to 1/11 with the same appt note. Patient no-showed for the 1/11 appt. On 1/12, the patient was scheduled for 1/26 with appt note "dose 2." 1/26 was a Moderna ONLY day. Moderna was documented as administered, lot # 032L20A. No adverse reaction, reporting as required by CDC.
Patient described unusual injection pain that lead to no sleep and then headache later, which patient states uncommon for her.
Patient rec'd DTaP 9-9-17 and reported rash and swelling to both deltoid area on 9-14-17. This was patients first visit to our clinic.
On Monday 07/18/2005 child received immunizations with noted problems.  Mom stated on the next AM around 09:00AM she noted his left arm swollen, hot red, she then applied cold compress, the heat decreased then returned she called the health department at 11:00AM 07/19/2005 and was advised to continue with cold compresses and call childs pediatrician.  They advised Tylenol and continue cold compresses, called back and infant was better.
WITHIN 10 MINS OF VACCINE REPORT FELLING HOT SHAKY, COLD HANDS, ANXIOUS.  VS CHECKED AT 0827 BP 131/83, HR 86, TEMP 97.7, RR 20.  REPORTED FEELING IMPROVED BY 0835. WHEN UP FROM CHAIR TO LEAVE OBSERVATION AREA AT 0915 FELT DIZZY AND NAUSEATED. LEGS WEAK AND BENT DOWN ON KNEES. GIVEN WATER ASSISTED TO ER VIA WHEELCHAIR AT 0930 . WENT TO ER AND C/O throat was closing some itching abdominal cramping.
This spontaneous report was received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions. drug reactions/allergies and concomitant medications were not reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of VAQTA lot # M031806, expiration date:30-MAR-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of - 1.7 Celsius degrees for 4 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013314: US-009507513-1703USA013315: US-009507513-1703USA013202.
per mom's report Hives all over body the next day. Shots given 5-9-19, rash began 5-10-19 and lasted for 24 hrs. 0 joint swelling or bruising. benadryl was given by mother.
This spontaneous report has been received from a consumer, via the Agency (413519) on 08-JUN-2017, concerning a 21 year-old female patient who, on 01-JAN-2010 underwent the administration of one dose of GARDASIL intramuscular (dose, frequency, lot #, expiration date and anatomical location were not reported) for prophylaxis, as per section above. On 01-JAN-2010, the patient experienced extreme pain at injection site (coded by the Agency as "pain") with temporary impaired mobility of the injected limb (not coded by the Agency in the dedicated section of the Regulatory form), dizziness, vertigo, myoclonus, asthenia, chronic fatigue (coded by the Agency as "fatigue"). The outcome of the adverse events was not available. The reported impact on the patients life quality was 8/10. The patient was contacted by the Local Health Unit by e-mail but she did not respond. At the time of reporting the patient was not a resident of the health district that received the report and the vaccination was not performed in the public vaccination health clinic. The reporter considered the events to be medically significant and the causality assessment between GARDASIL and the events to be related. Additional information has been requested.
Pt received vaccine on 9/2/10 and came in 12/10 reporting that shoulder/arm still ached and hurt to quite a degree. Advised pt that the needle may have hit a nerve and it is possible, but to follow-up if this pain keeps persisting.
My armpit lymph nodes was painful and became swollen; Went to Dr. 6 days later and was told that it could be due to vaccine; Still feel a little sore and swollen 2 weeks after.
Information has been received from a physician concerning a 60 year old female who was vaccinated with a 0.5mL dose of varicella virus vaccine live (Oka/Merck). After receiving the varicella virus vaccine live (Oka/Merck), the patient developed polymyalgia rheumatica and an elevated sedimentation rate. At the time of this report, the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Subcentimeter 7 mm nodular density at the left premandibular soft tissues, favoring to represent a reactive lymph node,
Pt got flu vaccination, then his wife was vaccinated. We chatted for several minutes afterwards & then they walked off. He was drinking a Capri Sun that I discarded for him. Several moments later his wife came back & said he fainted. We rolled him on his side & called 911. When he came to, he said this hadn't happened in about 15 years He was extremely pale, not disoriented. He said he had once fainted watching his wife get an injection and had fainted with other vaccinations but not the flu vaccine. We placed a towel under his head and used wet sponges to cool him down. He was clammy & sweating. His Blood pressure was 140/84 Pulse 58 He never mentioned prior to vaccination that he had previously fainted with other vaccines or that he had previously fainted watching his wife. EMS came and took over. I do not know if he actually went to the hospital or not.
Sore arm initially.  Tender hamstring muscle tendons 2 hours later.  Very sore, stiff, following morning then muscle aches mild fever, severe fatigue the following day.
Initial report received from the literature article on 18 June 2014. A 2-year-old patient (gender not reported) had received fourth dose of TDAP vaccine (dose, lot number, route and site of vaccination not reported) on an unspecified date. The patient had received all previous three doses on unspecified dates. The patient had a reported medical history of rhabdomyosarcoma and respiratory syncytial viral coinfection. The patient underwent prolonged ECMO course including necrotizing pneumonia and tumor progression. After fourth vaccination of TDAP, the patient underwent chemotherapy. On an unspecified date, the patient developed pertussis. The patient died on an unspecified date. Time to death from illness onset was 78 days. The autopsy results were evident for pulmonary hypertension and fibrosis, metastasis to lung and pericardium, but no trace of ongoing infection found. Documents held by sender: none.
I experienced extreme nausea, fatigue, and headaches for 3 days. I did not seek care from a doctor or ER because the symptoms subsided over time. I started feeling fatigue, nausea, and headaches but not as bad as I did after receiving the vaccine.
March 2021, I found swollen lymph nodes near  left armpit (vaccine site), June 2021, Diagnosed Lymph Cancer,- B-CELL lymphoma From July 2021, I am under chemotherapy.
Approximately 15 minutes after the vaccine was administered, the patient reported feeling lightheaded and tingling sensation of the face; patient also stated that she "feels like tongue is swollen." Patient vital signs were taken by EMS on site. Vital signs were within normal limits.
feeling sore arm/arm soreness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the 2nd of 2 reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced feeling sore arm/arm soreness the same day he got the shot on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513266 Same reporter, drug and event; different patients
After patient received the vaccine, epxerienced a syncope episode. , had some lightheadness. (-) for N/V (-) for cx/px. Patient able to respond to verbal commands. Vital signs taken for sequence of 4x's. Pt elvaluated. Alert and oreinted. Refused transport to ER. Ambulatory without assistance. Patient left with family.
Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.
Case number PHHY2014US025025, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 78-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reporting following this medication error.
A nurse reported the occurrence of an injection site reaction in a 14-month-old male who was vaccinated with diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS.  The subject had no relevant medical history, concurrent conditions, or concurrent medications.  On 08/20/2002, the subject received his fourth injection of INfanrix (lot number DTPA553A2) into the right leg.  Subsequently, on 08/20/2002, the subject developed an injection site reaction characterized by swelling and redness.  The reporter stated that the injection site reaction was possibly related to Infanrix administration.  The injection site reaction resolved.  Comment: This report has been linked to report A0379054A & A0381019A due to the same reporter.
Information has been received from a consumer concerning her 11 year old son with a drug reaction/allergy to soy and peanut, who on 01-APR-2008 was vaccinated with a dose of VARIVAX (Merck).  On 02-APR-2008 the patient had an injection site reaction that was the size of a half-dollar.  The area was red and raised.  No further information was available from the consumer.  Unspecified medical attention was sought, spoke to nurse.  There was no product quality complaint.  Additional information has been requested.
One week after the injection in my left arm  the area swelled, reddened, warmed , became itchy and hives developed. I?ve taken ibuprofen  for symptoms. 24hrs later site remains reddened, warm and itchy but remains manageable with ibuprofen. No office visit.
The next morning, throat felt dry. Tried to eat but could not move her tongue, pain and felt like a ball, no feeling on the left side of tongue. It progress in the morning, she called EMS, because she felt pain in her jaw. Looked in her mouth, saw swelling in her mouth. Took her to Medical Center. She was transferred to Hospital.
PT completed the requested 15 minutes and left the vaccination site. Twenty minutes into driving he began to experience the following reactions : dizziness, nausea, lightheadedness, left arm begin to feel extremely heavy. NP and EMS attended to PT. PT symptoms resolved and was cleared by EMS and NP.
PT. displays a fever of 100.9, aches in legs and arms, and abdominal cramps. PT states having felt this way from his second dose of TwinRX dose in JUN 2021
Patient had nausea, vomiting several hours after getting vaccine. The morning after receiving the vaccine she awoke with "hives" that resolved. She then presented to the emergency room with only symptoms of vomiting/diarrhea
raised red rash 3 in diameter at location of the vaccines, flu-like symptoms ( fever, body aches, in bed for a few days )
Hypothermia 95.7 - 96.1F; chills; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1685/expiration date) via an unspecified route of administration on 11Jan2021 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included negative PCR nasal swab on 15Dec2020. Concomitant medications were not reported. The patient received the vaccine in a hospital. She did not receive other vaccines within 4 weeks prior to COVID vaccine. She was not diagnosed with COVID-19 prior vaccination and was tested for COVID-19 since vaccination (PCR, unknown result). The patient experienced Hypothermia 95.7 - 96.1F and chills on 12Jan2021. No treatment was received for the events. The outcome of the event was recovered. The reporter assessed the events as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  hypothermia and chills  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate