chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have had HSV2 for 10 years with minimal and minor outbreaks. This was the worst one ever. Had three blisters which merged, broke and scabbed on right buttocks. Immediately took Valtrex. Also had several red bumps appear on 12/8. After 4 weeks there is still a light red scar where the blisters were. Never had blisters before & a scar that is taking forever to go away. I was not under any emotional stress, but am positive that it stressed my system and gave me an outbreak. I have never had a reaction to a vaccine before including the old shingles vaccine 5 years ago. I would suggest that those with HSV2 should be warned to take Valtrex before getting the SHINGRIX shot.
This spontaneous report was received from a Nurse refers to a 4 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX Lot # H014074 (dose, route and frequency were not reported). The nurse reported that the on 24-OCT-2014, (Oka/Merck) VARIVAX was stored for -12.8 C for 4 hours. On 14-NOV-2013, the (Oka/Merck) VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the (Oka/Merck) VARIVAX was stored for -13.8 C for a total of 5 hours. Since the overall average for (Oka/Merck) VARIVAX was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA15842 and 1405USA008798 (same reporter link). Additional information has been requested.
Arm continues to be sore. Patient has a hard time lifting, driving and sleeping or putting weight on shoulder. Pt's left arm is the sore arm. Patient reports pain has not lessened since 10/6/2020 when shot was received in shoulder. Patient BELIEVES shot may have been inserted too high above deltoid muscle. Reports pain from shot in shoulder joint. Recommended patient call primary doctor. Patient reported that they will call Monday 11/9/20
Onset 11/22 evening Kw/ one lesion behind left ear. Developed increasing numbers of red bumps on trunk, one in right groin, one on scalp, all very itchy, over 11/23 and 11/24. Afebrile, no other symptoms. Lesions are all scabbed at time of exam.
Positive for COVID19 virus after 1st Moderna Vaccination; Felt like a sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID19 virus after 1st Moderna Vaccination) and SINUSITIS (Felt like a sinus infection) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced COVID-19 (Positive for COVID19 virus after 1st Moderna Vaccination) and SINUSITIS (Felt like a sinus infection). At the time of the report, COVID-19 (Positive for COVID19 virus after 1st Moderna Vaccination) and SINUSITIS (Felt like a sinus infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
Prior to bed, my hands and feet were very cold.  Went to bed about midnight, and could not get my feet or hands warm, even though I was using an electric blanket.  I started to get chills, got up and had a 102.7 temperature, blood pressure went to 190/110 and pulse was 110.  After calling my cardiologist, he recommended I go the emergency room.  I arrived about 2:45.  When the took my vitals, my BP dropped to 136/87, pulse was 96 and had a 100.7 fever.  The emergency room doctor recommended an EKG - all good, listened to my heart and lungs all good.  Doctor could not determine cause of  fever and chills
gerd; Pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (gerd) and VACCINATION SITE PAIN (Pain at injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (gerd) and VACCINATION SITE PAIN (Pain at injection). The patient was treated with VITAMIN D3 ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (gerd) and VACCINATION SITE PAIN (Pain at injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Omeprazole.
10cm x 5cm large circular erythematous itchy rash. which resolved with Benadryl but patient presented into office with right neck 1cm lymph node which appeared when the rash did.
severe abdominal pain, similar to labor; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (severe abdominal pain, similar to labor) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 20-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ABDOMINAL PAIN (severe abdominal pain, similar to labor). At the time of the report, ABDOMINAL PAIN (severe abdominal pain, similar to labor) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for event include omeprazole.
Patient presents to the ED for worsening edema of lower extremities and admitted to the hospital.  Patient noticed both legs appeared swollen since the end of August and her PCP started her on Furosemide 20 mg daily.  Patient with mild exertional dyspnea when she ambulates.
Pings sensation in back on left side; crawling sensation is on the left leg; nausea; malaise; disoriented; overall feeling unwell.
Patient developed hives and wheezing about 1 hour after DTaP and IPV injection. Treated at hospital ER.
This spontaneous report as received from a nurse refers to a 15 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # L007560. No adverse reaction was reported at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Low blood pressure, and to lay down shortly after vaccine while still at urgent care office. Took ,close an hour to recover.
Within 24 hrs, developed fever to 102 deg F, rash on face and neck, pain and swelling at site of vaccine. Had been inadvertently given pneumovax for second time-last fiven 11/01.
my face is like swelled up; hives on my face; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), first dose via an unspecified route of administration on an unspecified date, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Report not related to a study or programme. On an unspecified date, the patient experienced face was like swelled up, hives on face. It was reported that, yesterday "I got my first dose with Pfizer vaccine and I don't know if I am having allergic reactions to it because my face is like swelled up". When asked to specify the reaction, consumer stated, Like hives on my face. Further probing could not be done as consumer was unwilling to further answer the questions. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
An employee noticed two unopened vials of lyophilized vaccine component (ActHIB vaccine) without the liquid vaccine component (DTaP-IPV component). We cannot say with 100% certainty which two out of five patients were effected by the error and which MA is responsible. Vaccines with Lot #UJ876AA was entered into (EMR) on 06/21/2023. We narrowed our search down to the five patients that were given the Pentacel after 06/21/2023. Five vials come in a box. Two were missing the liquid component, one was given to a patient on the day the incident was discovered and two remained in the box. According to a report that was pulled, it shows commercial vaccines were given where state should have been given or it was documented incorrectly. An action plan has been put into place to prevent future errors. There will be inventory checks performed bi-weekly with an inventory check list and sign off for accountability. The staff is also keeping a log of vaccine administration to cross check the administration of the vaccines are accurate and match in the EMR. Dr. reviewed the patients chart and he needs to catch up most likely. Might need a HIB alone and a DTap alone if preferred by parents. The patient has a follow up appointment on 12/04/2023 to discuss further.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335  (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
AFTER THE IMMUNIZATION PT FELT FAINT  AND QUEASY. ASKED PT TO SIT WITH HEAD BELOW KNEES. GAVE COLD TOWELS , AND ICE PACKS FOR FOREHEAD AND NECK, GAVEW SIPS OF WATER. STAYED WITH HER MAKING SURE SHE DID NOT FAINT. AFTER ABOUT 20-25 MINUTES SHE FELT BETTERAND WELL ENOUGH TO DRIVE. CALLED HER ABOUT AN HOUR LATER AND SHE SAID SHE MADE IT TO HER DESTINATION AND WAS FEELING BETTER
FEVER 101 F; FATIGUE; HEADACHE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was 19 year old healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, administered on 29-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-NOV-2021, the patient experienced fever 101 F. On 30-NOV-2021, the patient experienced fatigue. On 30-NOV-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 30-NOV-2021, and had not recovered from fever 101 F. This report was non-serious.
Sat evening, 6/March 2021, when showering noted 'dime' size welt at vaccine injection site,  the following evening it had become 'quarter' size and slightly itchy,. Today Mon, it barely itches but is slightly larger, still just at the site
this is 1 of 2 patients reported by the same facility (see reports 895122002S);
Migraine headache - few hours after the shot Vomiting - 11:45pm Fever all day 4/27 Chills all day 4/27 Headache all day 4/27
Vaccine given at 9:10. Student came back to the Health Center with multiple whelps to lower extremities without Shortness of Breath or Swelling to face
The consumers son had side effects that were over in a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The consumers son had side effects that were over in a day) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (The consumers son had side effects that were over in a day). At the time of the report, VACCINATION COMPLICATION (The consumers son had side effects that were over in a day) outcome was unknown.            no concomitant drugs and treatment medications was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-155334, US-MODERNATX, INC.-MOD-2021-155959 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155334:Sister's Case US-MODERNATX, INC.-MOD-2021-155959:Same reporter
lethargic; No appetite; run down; severe diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), LETHARGY (lethargic), DECREASED APPETITE (No appetite) and EMOTIONAL DISTRESS (run down) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported ). Concomitant products included METFORMIN for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (severe diarrhea). On 05-Apr-2021, the patient experienced LETHARGY (lethargic), DECREASED APPETITE (No appetite) and EMOTIONAL DISTRESS (run down). On 05-Apr-2021, DIARRHOEA (severe diarrhea) had resolved. At the time of the report, LETHARGY (lethargic), DECREASED APPETITE (No appetite) and EMOTIONAL DISTRESS (run down) had not resolved. Not Provided          Treatment included Imodium and vitamin water.   This case was linked to MODERNATX, INC.-MOD-2021-067212 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-067212:crosslink
Received the Flu Shot at 7 am the morning of 11-29-2019. Went home after getting off of working a night shift and went to bed. Woke up 11-29-2019 around 4:30 pm and noticed some itching to both legs and arms around 6:00 pm. Applied some hydrocortisone 1 % she  had at home to both legs and arms for the itching. Made an appointment to be seen on 12/3/2019 by the CRNP.
Information has been received from a female who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (no lot number provided). On an unspecified date, the patient experienced shingles. At the time of the report, the patient had not recovered. No further information is available.
Initial case report received from a consumer on 18 NOV 2009. A caller stated that his mother was vaccinated i.m. for the first time with FLUVIRIN in late September. A week later (exact date not provided) she went to hospital with atrial fibrillation. The caller thought it was because his mum had a split tooth and because of the vaccine. His mother was hospitalised for 8 days before being released from hospital and upon release she began to experience night sweats. The patient's outcome was not recovered. Reference no.: NA09-008470.
Patient appeared faint and nauseous immediately following injection. Pt. started to slump in chair and complained that she felt hot and sick. Patient was told to lay on ground and was given water and ice. Pt. did not go into syncope or have any further reaction, and recovered after about 20 minutes.
Information has been received from a medical assistant concerning one of her cousin's female co-workers who on an unspecified date, was vaccinated with a dose of GARDASIL (lot number, dose and route not reported). The medical assistant reported that on an unspecified date the patient developed cervical cancer. The patient was vaccinated in the military. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. This is one of several reports received from the same source. Upon internal review, patient developed cervical cancer was determined to be an other important medical event. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of passed out in a 11-year-old male patient who received BOOSTRIX (batch number 2729X, expiry date 15th September 2017). Co-suspect products included HAVRIX pediatric (batch number F3J75, expiry date 18th November 2017), HPV vaccine (batch number L020015, expiry date 16th August 2017) and MENACTRA (batch number U5179AA, expiry date 19th January 2017). On 11th December 2015, the patient received BOOSTRIX, HAVRIX pediatric, HPV vaccine and MENACTRA. On 11th December 2015, less than an hour after receiving BOOSTRIX and HAVRIX pediatric, the patient experienced passed out (serious criteria GSK medically significant), confusion and unresponsive to stimuli (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out and unresponsive to stimuli were recovered/resolved and the outcome of the confusion was unknown. It was unknown if the reporter considered the passed out, confusion and unresponsive to stimuli to be related to BOOSTRIX and HAVRIX pediatric. Additional details were provided as follows: The patient received BOOSTRIX, HAVRIX pediatric, HPV 9 vaccine and MENACTRA and then nurse put on the band aids to the patient. The patient slumped over and did not respond. The event lasted about 5 seconds and the patient opened his eyes, but was looking confused.
Starting a few weeks after receiving the vaccine, I developed a significant outbreak of a now diagnosed lymphomatoid papulosis on my right forearm. I went to see the dermatologist who took a biopsy and then I was referred to an oncologist. After numerous tests, they determined it was not cancer and rather it was lymphomatoid papulosis. The same thing happened after the booster dose (10/21/2021) and that outbreak was worse. The lesion that formed is actually still present to this day in the right arm pit.
Initial information received on 12-Apr-2019 regarding an unsolicited valid serious case received from a non-healthcare professional (patient's mother) via phone. This case involves adult male patient of unknown demographics who experienced regress into autism, while he received vaccines MMR and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MMR not produced by Sanofi Pasteur (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious regress into autism and (Condition aggravated) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and MMR. This event was assessed as medically significant. It was reported that MMR was killing more children than the measles. It was also mentioned by the reporter that the measles outbreak which she believes was caused by the vaccine. No Lab data was reported. Final diagnosis was her son regress into autism. It was not reported if the patient received a corrective treatment. The patient was not yet Recovered / Resolved on an unknown date from autism. Documents held by the sender: none. Sender's Comments: Patient presented with autism after vaccination with DTAP and MMR vaccine. Time to onset is unknown. Moreover, further information including patient's medical history, concomitant medications, condition at time of vaccination, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of the vaccine cannot be assessed.
Leukocytoclastic Vasculitis rash; This literature-non-study case was reported in a literature article and describes the occurrence of CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis rash) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis rash) (seriousness criterion medically significant). At the time of the report, CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis rash) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis rash) to be related.    Concomitant, treatment medication information wasn't reported.  In our case report, we build on those findings with one of the first documented examples of vaccination-induced vasculitic rash in a previously asymptomatic patient.  Company comment: This literature case concerns a 59-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected AESI of Cutaneous vasculitis unspecified days after second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature case concerns a 59-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected AESI of Cutaneous vasculitis unspecified days after second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.