chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and a healthcare professional, via a GSK representative, and described the occurrence of nausea in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included MENACTRA (non-gsk); Sanofi Pasteur MSD given on 14 July 2011; ADACEL (non-gsk); Sanofi Pasteur MSD given on 14 July 2011. On 14 July 2011 (in the morning) the subject received 1st dose of CERVARIX (.5 ml, unknown route, right arm). On 14 July 2011, "a few minutes" after vaccination with CERVARIX, the subject experienced nausea and dizziness. The physician considered the events were clinically significant (or requiring intervention). On 14 July 2011, the events were resolved after a "short time" with the subject lying supine and drinking some water. Her blood pressure had been monitored. The physician considered the events were possibly related to vaccination with CERVARIX. Follow-up information was received via the physician on 10 August 2011. The subject's date of last menstrual period was 13 July 2011. She was not pregnant at the time of adverse events. Nausea and dizziness resolved on the day of CERVARIX administration, 14 July 2011, and no additional details were provided.
My daughter received pentacel for the first time along with Prevnar 13(which she previously had several doses of) for her 15 month check up. She was administered the vaccine at 3:30 p.m. on 08/15/2023. We stopped to pick up a few groceries on the way home and by the time I got her home at 5:30 to put her in the bath, I took of her diaper and saw huge whelts and hives localized to the lower left side of her back. We knew she had not been bit or strung, and that she had not had any new foods so we could rules out any of those things and knew it was a reaction to the new vaccine. She had a breath-holding spell upon adminsitration of the vaccine, was fussy in between the doctor's office and home. Once we identified the reaction, we sent photos to the after hours triage nurse and were told at first that itt probably wasn't a reaction since it was localized, however, then they asked us about the vaccines they did send the photos to the doctor and they advised ibuprofen, we also gave pt. benadryl because we knew she was having an allergic reaction based on other family member's history of anaphylaxis due to other sources. Pt. would not drink her milk that evening before bed. The next morning she seemd okay, but upon waking up from her nap at 11:45 a.m. Pt. seemed very dazed and confused, and her whole body was covered with hives, whelts and her face swollen. I called the doctor's office and they advised that I give her benadryl and take her to the ER since they could not see her right away. I gave her 6mg of benadryl. Upon arrival to the hospital her symptoms were subsiding however she had a 101.4 fever. They took her vitals and gave her the appropriate dose of ibuprofen. The ER doctor was able to rule out any other causes of the reaction and said that it was from the vaccine. However, he kept saying that she had a rash to us and in his notes even though the photos indicate hives and whelts, as well as a high fever. Upon discharging from the ER and returning home at 3:30 p.m., I took pt. out of the car and she was having an outbreak of welts and hives again on her legs and arms. I called the doctor's office again and they told me to give her another dose of benadryl since itw as almost 4 hours since she had it. The doctor then prescribed prednison to take for 6 days to help alleviate pt.'s symptoms.
Two days after receiving the vaccine I developed a rash on both sides of my torso, upper thighs, and arms. Went to urgent care.
17 year old female from vaccination area with possible LOC after Pfizer Vaccination.  Brought to observation area via wheelchair with mother.  Initial blood pressure of 71/56 66 12 99% RA O2 sat.  Mildly confused , diaphoretic. Placed on ground with feet elevated.  Patient A+Ox3 within one minute.  At 1020 patient sat up denying any dizziness.  At 1025 am , placed in regular chair and drank one 200ml apple juiceand ate some crackers.  Educated patient and mother about signs and symptoms to watch for and encouraged to perform slow deliberate body position changes.  Patient stated he felt fine and reported being asymptomatic and was discharged in charge of her mother.  NAD, MAEW WELL, STEADY GAIT A+OX3    Occurred at Vaccination Site(site supervisor aware of incident)     Reported that patient was anxious prior to vaccination  History of taking lexapro with no reported allergies
The following Friday, the signs and symptoms started. It started with pain on the neck on the left side, shoulder, and the left arm where the vaccine was administered.  An X-ray and physical therapy was done.  Voltaren and Norflex
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Patient developed large red area at injection site which was treated with KEFLEX then doxycycline - No fever - Reaction lasted over 5 days.
The following day after receiving the COVID vaccine the patient took a hot bath in the evening and had redness from her ankles to her knees on both legs. She said it looked like a sunburn. She put lotion on it and went to bed and it was resolved the next morning. She did not think it was due to her water being too hot as she does that frequently and hadn?t had that occur before.
No additional AEs; Caller reported expired dose of PROQUAD was administered.; This spontaneous report was received from a licensed practical nurse (LPN) concerning a patient of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant medication were not reported.   On 27-JUN-2022, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter subcutaneously (lot #T037957, expiration date: 09-MAY-2022; strength and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Postherpetic neuralgia, vision problems and neurological issues; Postherpetic neuralgia, vision problems and neurological issues; Postherpetic neuralgia, vision problems and neurological issues; Information has been received from a lawyer regarding a case in litigation, referring to a currently 65 year old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 07-DEC-2015, the patient was vaccinated at a clinic with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not provided),for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a provided for the following injuries: post herpetic neuralgia, vision problems (visual impairment) and neurological issues (nervous system disorder). The patient claimed damages as result of injuries to themselves and economic losses. At the time of the report, the outcome of post herpetic neuralgia, nervous system disorder and visual impairment was unknown. The lawyer considered post herpetic neuralgia, nervous system disorder and visual impairment to be related to Zoster Vaccine Live (ZOSTAVAX).
SUDDEN ONSET BILAT  HAND REDNESS AND SWELLING. @1535-130/78-16-98%. A&OX4, SKINS W/D/P. RESP UNLAB & EVEN.  NO ADVENTITIOUS  LUNG  SOUNDS  NOTED. ALL SYSTEMS WNL. PT DENIES ANY THROAT ITCHING, SWELLING, OR ASSOC. S/SX NO URTICARIA NOTED.  BENADRY 50MG IM  L.D. GIVEN ( EST. 110KG) PER PROTOCOL. VSS. PT D/C'D HOME W/ HUSBAND WHO IS ALSO DRIVING HOME. AIRWAY REMAINS PATENT. PT AMBULATES TO  POV W/O INCIDENT.
The second day, the rash looked like measles; rash after the first day almost like dots through the skin; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH MORBILLIFORM (The second day, the rash looked like measles) and RASH (rash after the first day almost like dots through the skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MORBILLIFORM (The second day, the rash looked like measles) and RASH (rash after the first day almost like dots through the skin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH MORBILLIFORM (The second day, the rash looked like measles) and RASH (rash after the first day almost like dots through the skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.
Immediately following vax, pt had a seizure-like episode. Arms were flailing above head, eyes rolled upward for about 5 seconds. Pt stood up right away and sat on chair, complained of dizziness, face, lips appeared pale. EMS was called and pt was taken to the ER. Parents were not available.
Patient stated she was feeling and light headed after the 2nd does, also experience severe headaches , and arm had read spot at the injection site and pain as well, and her balance is off
Admitted through  the Hopsital ED with cough and SOB with symptom onset 12/10
This spontaneous report was received from a pharmacist via Pfizer company regarding to an adult patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, strength, frequency, anatomical location, route of administration, lot # and expiration date were unknown by the reporter), for prophylaxis. On an unspecified date, the patient experienced eye swelling. By the reporting time, it was unknown if the patient recovered from the abovementioned event. The causality assessment between eye swelling with PNEUMOVAX 23 was not provided.
Narrative: 1305: Vaccine administered Afluria/Moderna Bivalent. 1307: Patient experienced syncope and hypotension, Blood pressure 91/59, Heart Rate 69, O2: 100%, Interventions: Oral fluids given 1310: Patient alert and oriented x4 at this time 1325: Blood Pressure 111/74, Heart Rate 74, O2: 100% Patient denies any discomfort or symptoms. 1340: Blood pressure: 116/74, Heart Rate 72, O2: 100% Patient denies any discomfort or symptoms.
Vaccinations for Tdap and Meningococcal given on 10-14-14. On 10/15/14, pt's arm was swollen and tender and warm to touch. Mother called our clinic on 10/16/14 and reports swelling has decreased, not tender or warm.
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot# M039904, expiration date 26-SEP-2018 and lot# M028130, expiration date 03-JUN -2018 (dose, route and site of administration were not reported). No adverse effects reported. Administered doses of vaccine experienced the temperature excursion between 9 to 25 degrees Celsius for 1 hour and 41 minutes. The vaccine experienced previous temperature excursion between 9 to 25 degrees Celsius for 25 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information is not expected, because there was no consent to contact the reporter.; Sender's Comments:  US-009507513-1706USA007129: US-009507513-1706USA007130:
Swollen and painful lymph nodes around right side  colar bone. I have not seen a doctor about this but I read that it should go away within 3 weeks.
Got my Second Covid shot on Tuesday at 1:00 pm When I woke up with the next day about 9 o?clock I felt terrible. My symptoms were: fever, extreme fatigue, bodyaches all over, headache, lack of appetite. I experienced these symptoms all day Wednesday until I went to bed that night at 10 pm.  I woke up Thursday morning around 7 AM. I still feel fatigue but in the longer I have the other symptoms. I have missed two days of work. I plan to go back to work on Friday. I took Tylenol to help control my fever. Which was a low-grade fever around 99.2 most of the time
Gave patient shot. He left the vaccination room. A few minutes later he tells me he is dizzy and his vision is blurry so I bring him back into the vaccination room, give him some water and tell him to relax. 10 minutes later I check his BP which is elevated along with his pulse. I check again another 10 minutes later and it has lowered (pulse 80). BP still elevated so I mentioned it could be due to the nervousness to the reaction or just that he has hypertension and he should get it checked out. After a while his spouse came into the vaccination room and he said he was better and they left.
On 10-11-11, pt experienced sudden weakness in body, left arm and hand paralysis, facial muscular collapse, difficulty walking & talking. Pt was hospitalized, diagnosed Guillain-Barre syndrome. Pt remains in hosp in rehabilitation wing. Pt is unable to close mouth completely, has difficulty speaking, eating, walking. Arm is "dead". Face resembles Bell's palsy.
Initial and follow-up information has been received from a nurse practitioner concerning a 23 year old female who on 24-Oct-2008 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot#661764/0650X) in the left deltoid muscle. On 24-Oct-2008 the patient experienced immediate pain at the injection site of the left deltoid muscle after administration of the first dose of GARDASIL. It was noted that the patient initially experienced the pain on the same day that she received the vaccination. The pain "subsided" without treatment in 2 days. The pain at the injection site "returned" on 10-Nov-2008 and was "now" accompanied by firmness" in the area. At the time of this report, the patient's pain and "firmness" at the injection site persisted. The nurse practitioner  added that the patient called the practice for medical attention. Additional information has been requested.
This case was reported by a lawyer and described the occurrence of autism spectrum disorder in a male pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. A physician or other health care professional has not verified this report. The pt received the 1st dose of Engerix B on 3/30/98 (2427A2). He received the 2nd dose of Engerix B (2567A9) on  10/9/98, six months after the first injection rather than the recommended interval of one month. On an unspecified date, he received his 2rd dose of Engerix B (2515A2). His attorney alleged that "as a result of the pt's exposure to thimerosal from the above vaccines, he sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder." The outcome of the event is unknown. Other medically serious report (OMIC).
I woke up with flat red patches on my upper arm for about an 8" radius around the site of the injection.
This spontaneous report as received from a pharmacist refers to a 65 year old male patient. The patient's medical history included hip replacement, prostate cancer and unspecified reaction to penicillin. On 24-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date, route and site of administration were not reported). There was no concomitant medication. On 01-DEC-2014 (reported as a week after), the patient felt sick. No lab diagnostic studies were performed. The patient did not seek medical attention and no treatment was given. The outcome of event was reported as recovered/resolved on 08-DEC-2014 (reported as a week later). The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Rt arm, anterior upper arm red and warm goes all way to back. No fever. Within states she's putting cold compresses to site. Instructed to give Tylenol every hours for 48 hrs.
no adverse effect; one dose of improperly stored ROTATEQ was inadvertently administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-NOV-2019, the patient was inadvertently vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # 1658256 expiry date 18-NOV-2020, 1 dosage form for prophylaxis (route was not reported) (product storage error). The vaccine was stored at a temperature of above 9 degree Celsius (C) (9.4 degree C) for a time frame of 20 minutes. There was no previous temperature excursion. The digital data logger was involved. The patient did not experience any adverse effects.  This is one of the five reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA002785:
Case number PHEH2014US019578 is an initial spontaneous report from a health care professional received on 26 SEP 2014. This report refers to a 63-year-old female patient. She was vaccinated with FLUCELVAX 2014/2015 (batch number 012031A) at a dose of 0.,5 ml intramuscularly on 26-SEP-2014. It was reported that the vaccine received by the patient has reached 61 F for not more than 11 hours before administration. No adverse event reported following this medication error (incorrect storage of vaccine).
Sore arm; red 5-6 cm oval area at injection site on day 7/had flat edges and was hyperemic; more red than rest of the rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (red 5-6 cm oval area at injection site on day 7/had flat edges and was hyperemic) and RASH (more red than rest of the rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (red 5-6 cm oval area at injection site on day 7/had flat edges and was hyperemic) and RASH (more red than rest of the rash). On 12-Jan-2021, INJECTION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (red 5-6 cm oval area at injection site on day 7/had flat edges and was hyperemic) and RASH (more red than rest of the rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes cortisone cream.  Concomitant medication was not 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 the events 9 days after vaccination, a causal relationship cannot be excluded. Further information has been requested
Onset date is first observed date. Subject develops rash (red dots) around mouth while eating certain previously safe foods. With continued consumption of the problem foods, rash spreads across the face. Subject also displays unusual aversion to some of the problem foods. Rash begins within a few minutes of ingestion and gradually fades over hours. With repeated ingestion red marks remain on face for days. Two professional feeding therapists were first to notice the rash on the given date, and also had never observed subject to develop a rash prior to the vaccination (despite close contact over many months). Rash continues to appear more than a half year after first onset. On advice of GI doctor, most symptomatic foods are now avoided. Most reactive foods include common staples such as chicken, potatoes, apples, and various other fruits and vegetables, causing significant negative impact on subject's food intake variety.
dose was administered after published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered after published expiration date) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered after published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered after published expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Limited patient identifier was provided by the reporter. As per the reporter, it was unknown when the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursion.  No treatment information was provided by the reporter.   Reporter did not allow further contact
almost immed p/inject thigh became a little erythematous around the site, then swelling of the foot to the point of almost cyanotic; resolved w/in 2 hrs w/o tx;
Swollen lymph node base of neck on side the shot was given on. Currently waiting to see if the swelling goes down on its own. Follow-up with my primary care doctor again in 2 weeks.
Reported dizziness, facial flushing. Appeared pale BP 122/80, P 7. BENADRYL 25 mg p.o. given. no wheezing,No sob, no chest tightness noted. Called PCP and advised to monitor symptoms. Instructed to lay down in recliner. At 4:00 pm experiencing difficulty taking deep breath, used her PROVENTIL inhaler with relief. No SOB, no wheezing, no chest tightness noted. BP 124/68 - P 72 - facial flushing decreased, paleness gone. Discharged to husband at 5:30 PM - dizziness improved.
Patient had pain at the time of injection. She stated that she had worked out immediately before coming to the pharmacy and her muscle was tense. Later that night, when she went out to dinner, she started sweating and had muscle aches throughout her body. She felt restless all night and then a cold sore later emerged on her lip. Patient does have history of cold sores.