chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included pain (Family History) (father), blister (Family History) (father), scab (Family History) (father) and shingles (Family History) (father). Previously administered products included Shingles vaccine with an associated reaction of injection site pain (on an unknown date received 1st dose and experienced tired, had soreness at injection site, felt a bit of tummy confusion refer case US2021AMR227225). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced nausea, vomiting, upset stomach and sleepiness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the nausea, vomiting, upset stomach and sleepiness were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting, upset stomach and sleepiness to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated 2nd dose was not as kind. The patient woke up terribly nauseous the next morning. Vomited, but she might had been okay if she had not been hit by the smell of the leftovers from dinner as she packed hubby's lunch, so partially her error. The patient's tummy upset rest of day, and slept a good portion of it. However, 24 hours of inconvenience, which was all it was, compared to possibly lasting pain, or worse. Not much questions as to the benefit of the vaccine. The patient would do it again. No contact details were available; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227225:same patient same reporter.
Narrative: Booster dose of pneumococcal vaccine administered 10/27/10. Patient states he went to work the morning of 10/28 and experienced shortness of breath repeatedly. A co-worked notified the (school) nurse and found his systolic BP to be 80 and HR to be over 100. Patient was seen in the emergency room for evaluation. States he received Benadryl and was told to apply warm packs to arm and take additional Benadryl if he felt he needed it. Redness and swelling from left shoulder to elbow along inside of the arm, 4-5 inches across. Patient stated on 10/29 that he felt the arm was improving.
Pt recv vax on 11/10/98; post vax pt exp dizziness & pale color x few min
Patient's father reported patient received first dose pediatric COVID Pfizer vaccine during drive thru vaccine clinic. Family was waiting  in the car during the required 15 minute monitoring time when patient became stiff and started to fall back, hitting head on back window of truck. Incident was witnessed by patient's father and patient's sister. Father honked horn to alert staff who responded to patient who was responsive and able to answer questions. Patient reported feeling dizzy and tired and was unsure what happened. Patient appeared confused about situation but remembered getting vaccine and was oriented to time and place. Patient's blood pressure was 98/60 and patient was provided a bottle of water to drink. Father reported patient struck back of head on back window of truck but it did not seem to be a hard strike. Patient reported no pain or discomfort to her head. Patient leaned back on seat, drank water, and had second blood pressure reading of 100/65 5 minutes after first check. Patient reported feeling very tired and wanted to rest while being monitored. Patient sat in front seat of truck with father and finished out a 30 minute monitoring at 16:48. Nurse explained to father possible cause of syncopal episode and to monitor child for the rest of the evening. Nurse also explained when seeking care at urgent care, emergency room, or healthcare provider may be appropriate if patient does not continue to improve.
EDEMA AND ERYTHEMA TO RIGHT DELTOID 16.25 CM x 16.25 CM. ADVISED PARENT ON APPLICATION OF COLD COMPRESSES, MED W\ KEFLEX 500MG BID #14
Severe headache - Excedrin Migraine - no relief - 11 hours; Nausea - no treatment - 9 hours; Exhaustion - rest and sleep - 14 hours; Soreness at injection site - 40+ still ongoing.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patients experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were recovered/resolved. It was unknown if the reporter considered the pain and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The healthcare professional (HCP) reported that he typically saw the patients got pain and redness, 24 to 36 hours after they receive SHINGRIX which went away 4 to 5 days later. The patient had denied permission to contact their physician. Did not speak to HCP, but spoke to a representative in inside sales but HCP stated that they did not want to be called back and did not want to provide any additional information. The HCP was making a general statement of what he had seen when administered SHINGRIX.
Went to bed around 10pm on 2/10, experienced right arm stiffness and hemiparesis. Lived by herself, unable to reach her until 1/11. Admitted with Left MCA infarct, several foci on left occipital lobe points to cardioembolic etiology.  No motor deficits, mixed aphasia. Central embolic etiology. No fam hx of coagulopathy.
no adverse event; HCP called to report AE for VARIVAX. Caller reported the HCP inadvertently gave the vaccine to a 6-month-old. Date of administration was 08/17/2023. Caller reported the patient is asymptomatic. No additional details provided. Patient demographic info; This spontaneous report was received from a nurse referred to a 6-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 17-AUG-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, as prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). The patient was asymptomatic. No additional adverse event (No adverse event).
Approximately 5 minutes after receiving vaccine, patient felt anxious, face felt hot, felt like she "couldn't sit still".  BP 148/78  HR=66  O2=100% at 12:30pm.  BP 118/72  HR=71  O2=100% at 12:42pm.  Patient clinically stable.  Patient released from clinic at 12:45pm.
PEDVAXHIB underwent a temperature excursion and then was administered; No additional AEs reported; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 16-SEP-2021, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # T037648 with an expiration date on 20-JUL-2023), at a dose of 0.5 milliliters (strength, anatomical location, and route of administration were not reported) for prophylaxis which underwent a temperature excursion of 31.5 degrees Fahrenheit (°F) during a time frame of 13 hours and 10 minutes (product storage error).  No previous temperature excursions were reported.       No adverse events were reported.
Patient received Moderna booster dose too early. Facility was instructed to provide information about each recipient, when their 1st and 2nd doses were.  Information wasn't accurate (did not list his vaccination dates as being later) so pharmacy nurse administered. Upon realizing the error I contacted the facility and instructed them to contact the physician and guardians.
After 15 minutes of observation, patient complaining of dizziness, vital signs 155/94 (114), 18 RR, afebdrile, HR 82, 100% 02 on RA, glucose POCT 123. Pt went for full physical work up for her annual check up 2 weeks ago no problems. Stayed 25 more min, had water, and felt well
This spontaneous report was received from a medical assistant and refers to a 39 year old male patient. Concurrent conditions included HIV infection. Medical history, historical or concomitant drugs were not reported. The medical assistant informed that on the same unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 Injection, for prophylaxis (strength, dose number, dose, route, anatomical location, lot # and expiration date not reported), and a dose of PREVNAR for prophylaxis (strength, dose number, dose, route, anatomical location, lot # and expiration date not reported). No adverse effects reported.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, NDC/expiration: unknown, Lot: EW0173, Site: left arm), administration date: 07May2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (dose 2, NDC/expiration: unknown, Lot: EW0186, Site: left arm), administration date: 01Jun2021, when the patient was 31 years old, for COVID-19 Immunization, reaction(s): "Fever and chills for one day", "Fever and chills for one day". The following information was reported: HEAD DISCOMFORT (non-serious) with onset 12Dec2021, outcome "not recovered", described as "Pressure in head". Additional information: Patient stated he was calling about the Covid-19 vaccine, booster shot and got the vaccine last week. Patient stated it felt like a heavy pressure and it comes and goes and feels like a heavy pressure. The event did not result in Emergency Room or Physician Office. Family medical history was not provided. No relevant tests were reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 19MAY94 1030 to 11AM about 5PM rt leg became swollen reddened & very tender to touch p/630PM had emesis,was unable to sleep that noc due to tenderness in leg in spite of APAP x 3 doses; t101; poor appetite;
bilateral lower extremity paresthesias, R>L, started 6-7d after first shot, numbness tingling anterior R distal shin, no swelling, radiculopathy, now persistent, worsening
CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Polycystic ovarian syndrome (PCOS), and allergy (Bo), and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered on 06-MAR-2021 for prophylactic vaccination. Age at time of vaccination 25 years old. No concomitant medications were reported.  The patient additional received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, and route of admin were not reported, batch number: 031H21A, expiry: UNKNOWN) dose was not reported, administered on 17-NOV-2021 to left arm for prophylactic vaccination. On an unspecified date, the patient experienced covid-19 infection for which patient received Paxlovid as a treatment (coded as confirmed covid-19 infection) (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 17-JUN-2022 to 21-JUN-2022 for treatment of COVID-19. The patient was not receiving any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that, the patient tested negative on the last day (21-JUN-2022) of Paxlovid treatment, 3 days later (as of 24-JUN-2022) the symptoms came back overnight and then tested positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with Paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number requested.; Sender's Comments: V0:20220713757-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-JUN-2014, the patient was vaccinated with an improperly stored dose of GARDASIL  5 mg/0.5 ml injection, lot # J013777, expiration date 11-AUG-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to four separate temperature excursions (dates unspecified): the first lasting for 260 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius), the second lasting for 492 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius), the third lasting for 152 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the fourth lasting for 32 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 7 year old female who on 19-JUN-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). The date of the first vaccine as not reported. Concomitant therapy included Havrix. It was further noted that the patient received the Havrix on the same day, in the same arm. On approximately 19-JUN-2007 the patient experienced a rash that was red and hard around the injection site was well as hives. The patient was treated with Benadryl. The patient's outcome was not reported. Additional information has been requested.
Patient described feeling lightheaded immediately after getting the vaccination, but walking in outside in the cold weather improved sx.  She was able to drive home safely and didn't experience any other sx until 8pm that evening.  She reports that the lightheadedness, anxiety, feeling hungry and "out of sorts."  The patient reports no sx over the next two days, but woke up today with a milder version of previous sx.
pt recvd vax; 3 days after vax pt devel neuropathy & arthralgia in both legs;
Delayed local reaction, red, warm, tender, itchy, swollen -about 50 cent size.
This spontaneous report received from a registered nurse who is the patient. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown). The patient reported that she got the ZOSTAVAX vaccine and had a reaction. On 31-JUL-2012 her arm got really red and swollen and she developed a rash that spread down to her arm. Also the patient's injection site had redness and was warm to the touch. The patient went to the doctor for medical attention. No lab diagnostics studies were performed. The arm swollen was considered to be an important medical event since the patient did ice packs to keep her arm from swelling. The outcome of the events was reported as recovering. Additional information has been requested.
got the flu; Initial information received on 22-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non health care professional via social media.  This case involves an adult patient who got the flu (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. Concomitant medication(s) and family history were not provided.   On an unknown date, the patient received first dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (Influenza), unknown latency following the administration of INFLUENZA VACCINE. It was reported patient got flu shot every year. Patient did not think that was from the shot. It was unknown if the patient experienced any additional symptoms/events  There were no lab data/results available.  Medication Details and reason for taking the medicine was: Flu   On an unknown date, the event outcome was unknown.  There will be no information available on the batch number for this case.
Patient was receiving Moderna Bivalent Booster vax. While getting the vaccine, the needle dislodged from syringe.  Shot giver inserted the needle into pt's arm. At the time of pushing the plunger, shot giver and pt felt being splashed by the vaccine. The needle was on pt's arm and syringe was empty on shot giver's hand. Shot giver removed needle from pt's arm. Shot giver and pt are not sure on how much vaccine was injected.  Patient described as she heard a pop when it happened and then felt the splash on her face and dripping on her arm. Pt. stayed at observation for 15 minutes, she was feeling fine before leaving.
Initial unsolicited literature report received from a physician ion 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus 12 (0.2 percentage) neonate patients had developed 5 minute Apgar less than 4. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
7 days after the vaccine, a two inch circle around the vaccination site suddenly became really red,swollen,and itchy. By day 8 the swelling had gone down
pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (got the 1st shot for shingles got shingles 3 years later) and Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date, refer case US2021AMR206627).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient got the new two shots but it had been a year and a half and he/she still get pain at night. The patient take medivations for the pain.  The patient stated that this pain was a walk in the park compared to having full blown shingles. He/she pray for all those going through this sickness its horrible.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206627:same patient
Pain from neck to fingers, difficulty sleeping within 24 hrs after administration. Steroid shot 10/15.
- Bruising and pain at injection site  - After returning home , pt reported  feeling  lightheaded, sweats , and nauseous.  These symptoms  have impaired slightly , but still remain.
Pt received booster dose, then later that night vomited 6 times, throat burning, dry cough.  Progressively got worse, then tested positive for Covid 19.  Had loss of taste, smell, and headache over temples for 1 week
Patient presented to the pharmacy counter about 5 minutes after injection with a rash on chest and left arm.  At first I gave her 50mg of oral Benadryl. She started to mention she was having a hard time swallowing.  I grabbed the Epipen and administer it into left thigh.  At that time I also called emergency and EMS came.  They evaluated her and took her to the emergency room.  When she left she was able to breath and talk.