chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received for the Pregnancy Registry for VARIVAX (Merck), from a certified medical assistant concerning a 17 year old female patient with hypertension, anxiety and psoriasis, with no known allergies or drug reaction, who in 1999, was vaccinated with the first dose of VARIVAX (Merck) (lot # not reported) 0.5 ml, subcutaneously, and then, on 08-JUN-2011, she received the second dose of VARIVAX (Merck) (lot # 669227/1563Z, Exp. Date 11-NOV-2012) 0.5 ml, subcutaneously. Concomitant medication included "possible injections by dermatologist for psoriasis and topical creams for psoriasis". The certified medical assistant reported that on 02-AUG-2011 and on 03-AUG-2011, a home pregnancy test and a urine pregnancy test in the office were performed, respectively, which were positive. The patient's last menstrual period was on the week of 20-JUN-2011. Expected date of delivery was on approximately 26-MAR-2011. Follow up information has been received via complete questionnaire from an advanced registered nurse practitioner (ARNP) who reported that the 17 year old female patient had no previous pregnancies. On an unspecified date, the patient experienced strep throat. The patient was prescribed ARROX as treatment for strep throat during her pregnancy. On 11-AUG-2011 a serum beta-human chorionic gonadotropin test was performed (result: 20238 - positive). The ARNP also reported that on 13-AUG-2011 the patient had a miscarriage, before being seen by her OB/GYN. The patient was seen at the ER and it was determined that the patient was expecting twins. It was unknown if the products of conception were examined. It was reported that the patient was not tested for varicella antibodies before vaccination with VARIVAX (Merck) containing vaccine. It was also reported that the patient had no varicella or herpes zoster symptoms post vaccination. Upon internal review spontaneous abortion was considered to be an other important medical event. No further information is available.
pt developed blisters near injection site 4 days prior to seeking treatment on 4/16/2021. Pt diagnosed with Herpes Zoster. Acyclovir and Gabapentin prescribed
Information has been received from a medical assistant referring to a 13 year old patient of unknown gender. There was no pertinent medical history. The patient was allergic to penicillin (unspecified). On 18-NOV-2015, the patient was vaccinated with first dose of VAQTA (lot number L015460, expiration date 20-JUL-2017, dose and route unknown) in unspecified arm. Concomitantly, the patient received an unspecified flu vaccine (lot number, dose and route unknown). On the same day, the patient experienced a sore arm at injection site and red eyes later in the day of vaccination. The patient also had additional symptoms including a fever of 102F, sore throat and headache. The patient sought medical attention via contacting physician's office by the parent. No treatment was given for the events. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and VAQTA was unspecified. This is one of two reports received from the same source. Additional information has been requested.
SWELLING AROUND INJECTION SITE.  ERYTHMA, WARMTH SURROUNDING IMMUNIZATION INJECTION SITE RIGHT UPPER ARM (DELTOID).
Gardasil administered 4/16/08. On 4/20/08 fever at 103. Seen by primary care physician treated with Amoxicillin and then got a rash. Today 4/25/08 with low grade temp 101. Appetite slightly better. Has returned to school.
No additional AE information reported; 1 dose of PROQUAD and 1 dose of VARIVAX were accidentally administered to a patient concomitantly on 1/19/2023; This spontaneous report was received from a pediatrician and refers to a 1-year-old (reported as "1 year, 1 day old") patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 19-JAN-2023, the patient was accidentally administered one dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # W006412, expiration date 23-FEB-2024 (exact dose, route of administration and anatomical location were not provided) concomitantly with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) subcutaneous injection, lot # W024980, expiration date 05-FEB-2024 (exact dose, route of administration and anatomical location were not provided) as prophylaxis (accidental overdose). No additional adverse event information was reported (no adverse event).
PATIENT EXPERIENCED LOTS OF SWELLING IN THE ARMPIT NOT ASSOCIATED WITH LYMPH NODES
Clamminess, headache, swollen joints, fever, muscle pain, sweating, nausea.
A 6-MONTH-OLD PATIENT RECEIVED BEXSERO VACCINE BY MISTAKE. THE RECOMMENDATION FROM THE CDC STATED THAT, TYPICALLY FOR, VACCINES, SINCE THEY ARE ANTIBODIES, SHOULD NOT CAUSE ANY ADVERSE REACTIONS. HOWEVER, THE DOSE WILL NOT COUNT FOR FUTURE REFERENCES AND WHEN THE PATIENT BECOMES AGE APPROPRIATE.
Pain in my arm that went all the way up my shoulder and into my neck that gave me horrible headaches.  It also made my whole heart muscle ache and hurt It also made my hips ache and hurt and it has not gone away
Left arm bruising. Patient had hives prior to ED admission that resolved at home. Received Benadryl and Tylenol.
I felt dizzy and very unsteady on my feet when walking. When I went to lie down, I had a sensation of slight spinning. These events were ongoing, with the worst day being Sunday April 4 2021. The symptoms subsided at the end of Monday, April 5th and were completely gone by the following day. I called my doctor, however, by the time I had an appointment, the symptoms were gone.
Prior to receiving the Covid 19 vaccine, I was pretty much in remission with respect to interstitial cystitis ("IC").  Shortly after the vaccine, I have experienced a constant flare up.  I am in debilitating pain daily.  The only new thing, was the vaccine.  I have never experienced a flare up to last this long and not go away.   Everyday I now struggle with a stabbing pain in my bladder, constant urge to urinate.  There is no relief after urinating.  The pain is constant.  I have been tested and have no UTI.
fatigue; uncomfortable; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and discomfort. On an unknown date, the outcome of the fatigue and discomfort were unknown.   It was unknown if the reporter considered the fatigue and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced crummy fatigue and felt uncomfortable.  The reporter also stated, other patients have experienced this as well and was unable to quantify or provide details regarding other patients, refer case US2019GSK109123. The reporter consented to follow up and was ok to recontact.  No other details were obtained.
Pt given 4 year old vaccines at annual 4 year old well check. After administering, nurse discovered that pt had received same 2 vaccine injections on 9/12/2023. Have documentation from manufacturer noting there are no known risks associated with this, or need to repeat vaccines. Provider notified and reports no need for f/u visit if pt asymptomatic. Mom made aware and reports pt had fever of 102 on evening of 10/31/2023, but has not recurred after that date. Mom did not feel need for office visit at this time.
This spontaneous report as received from a licensed practical nurse refers to unspecified patients of an unknown age and gender. Concurrent conditions or medical history were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Hospital course Initially admitted for severe weakness suggestive of a UTI.  Transitioned to DNR/Comfort care and transferred back to LTC facility.  Same evening she became febrile, and tested positive for Covid 19 and sent back to hospital for isolation.   She became hypoxic and required oxygen supplementation and started on dexamethasone.  She died on 01/16/2022.
took your flu shot last fall and died about a month later from pneumonia\both illnesses that attack the lungs; both illnesses that attack the lungs; both illnesses that attack the lungs; Initial information received on 15-Sep-2023 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who took the flu shot last fall and died about a month later from pneumonia\both illnesses that attack the lungs.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient took flu shot last fall and died about a month later from pneumonia\both illnesses that attack the lungs (pneumonia) (illness) (lung disorder) (unknown latency).  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (pneumonia) (illness) (lung disorder).  Outcome was Fatal for the event pneumonia and was Unknown for the event illness and lung disorder No autopsy was done. The cause of death was reported as Pneumonia.  Seriousness criteria: Medically significant and Fatal for event pneumonia; Sender's Comments: Sanofi Company Comment dated 19-Sep-2023: This case involves an unknown age male patient who took the last flu shot on an unknown date and said to had fall on an unknown date and died about a month later from pneumonia\both illnesses that attack the lungs. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, with no time to onset, the role of the individual suspect vaccine cannot be assessed. Case will be re-evaluated post further update on the missing information; Reported Cause(s) of Death: took your flu shot last fall and died about a month later from pneumonia
My daughter had multiple seizures 10-11 hrs after her vaccines. We ended up in city. They sent us home I didn't say anything about vaccines due to her receiving the same at 2 months. She had another seizure at home I then went over paperwork from vaccines and it stated she received the MMR and Varicella vaccine when she shouldn't have.
no additional adverse effect; patient received a dose of improperly stored rotateq; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 03-JAN-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, dose number, lot # and expiration date were not provided) for prophylaxis. On 02-MAR-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660942 with expiration date 06-FEB-2020 (exact dose and dose number were not provided) for prophylaxis.   The multiple temperature excursions were below2 Celsius degrees (C) (1.28 C) for 2 hours and 30 hours. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported.
Initial unsolicited report received from a consumer (patient's mother) on 19-MAY-2017. This case involves a 20-year-old female patient who was vaccinated with a dose of TENIVAC (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 15-MAY-2017. Patient received a previous dose of MENACTRA on an unspecified date in 2015 and had a reaction as headache and memory issues in which she couldn't remember anything. Patient's Illness at time of vaccination was reported as none. Concomitant medications were not reported. On 15-MAY-2017, same day following the vaccination, the patient experienced left arm soreness. On 18-MAY-2017, three days following the vaccination, the patient began experiencing jaw pain. Lab data and corrective treatment were not reported. The outcome of the events was unknown (reported as 'Arm soreness and jaw pain continue to today, 19-MAY-2017'). List of documents held by sender: none.
pt received Moderna booster on 10/5 - seen in ED on 10/8 for swollen/painful lips; She was prescribed famotidine, diphenhydramine, and epi-pen; Follow up call on 10/11 - pt reports sx have resolved. Of note: She does report a new diagnosis of basal cell carcinoma on her face
At 0900, pt received 2nd Pfizer covid vaccine, chatted with staff, and sat down in a chair. At 0925, pt asked nurse, "Is it normal to have a headache after the injection? I feel warm and heavy all over." In response to the nurse's questions, pt stated that he had orange juice in the am, then stopped speaking. His eyes remained open and he continued to sit upright in his chair without slumping. Pt did not show any signs of distress (i.e., rapid breathing, diaphoresis, etc.).. A "team alert" was called for emergency response. Approx 4 mins after first sign of altered level of consciousness, pt started speaking "I don't know what just happened. I could hear you but wasn't able to speak." Pt denied losing consciousness. Denied any nausea, dizziness chest pain, itching, diaphoresis or sob. Vital signs: 152/89 bp, 70 hr, 18 resp, 98% O2 sat on RA. Response team accompanied pt to the ER for further evaluation.
Information has been received from a physician concerning a 7 year old male with on previous medical history who on 6/2/98 was vaccinated in the right arm with the first dose of varicella virus vaccine live (lot # 624778/1565E). Illness at the time of vaccination included an ear infection which was treated with azithromycin. The physician reported that on 4/11/04, after being exposed to a cousin who had chicken pox (WAES0404USA02562), the patient developed breakthrough chicken pox characterized by 25 lesions. There was no fever or other complications. Medical attention was not sought and no laboratory/diagnostic tests were performed. Subsequently, in 2004, the patient recovered from the breakthrough chicken pox. No further information is available.
My arm was very sore the morning after. Normally, my arm is a little tender but I didn't think anything of it. Then as days passed it got worse. I couldn't drive, brush my hair, change, lift things ETC. Eventually ended up getting an MRI. I got my results today (3/22/2016 - over 3 months after vaccine) they found tendinitis in my right shoulder along with a tear in my tendon. I attended PT 4 times prior to my MRI. PT did not help. I still to this day have limited range of motion.
Supraclavicular lymph node pain and swelling and axillary lymphadenopathy; Supraclavicular lymph node pain and swelling and axillary lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Sep2021 09:30 (Lot number: FC3184) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autoimmune" (unspecified if ongoing); "Thyroiditis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN; GABAPENTIN; SILENOR. Past drug history included: Sulfonamide for Sulfonamide:Allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Arm Right), administration date: 13Jan2021, when the patient was 36 years old, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9899, Location of injection: Arm Right), administration date: 22Dec2020, when the patient was 36 years old, for Covid-19 Immunisation. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 01Oct2021 23:00, outcome "not recovered" and all described as "Supraclavicular lymph node pain and swelling and axillary lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Injection site itching; Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling) had not resolved and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        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 for the events included was acetaminophen.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
pt recvd vax;fever in eve;noc started jerking;apap given;inc T x 2 days;fussy,coughing;bronchitis;some nasal discharge;
Information has been received from a female consumer who in 1994 was vaccinated with a third dose of hepatitis b vaccine. Subsequently, the pt developed a rash "all over her body." Two days post vax, the pt was hospitalized. It was reported that the pt was allergic to one of the preservatives found in the Hep B vaccine. Additional information has been requested.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in an 84-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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the onset date of the reported event of fatigue, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of fatigue, a causal relationship cannot be excluded.
tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of the mouth. Slight swallowing problem. High blood pressure, dizziness, shivering. Got some Benadryl ( chewing tablet) from the paramedic on site. Went to the ED got more Benadryl, steroids and pepsid IV. Tingling subsided after 2 hours and numbness in the mouth too. Next day had major vertigo and heart rate was high and heart palpitations . Had some PVC  which is still there. headaches come and go
The patient developed several blisters on the left ear 3 days after the vaccine followed by severe vertigo. She underwent multiple studies by ENT physician without any explanation; she eventually was treated with acyclovir for a total of 20 days several months later with complete resolution of the vertigo and was diagnosed with vestibular neuritis.
Patient received the first Pfizer COVID-19 Vaccine dose on 7/26/21 and the second dose of Pfizer COVID-19 Vaccine on 8/16/21. For unknown reason (not documented in chart) patient also received a third booster dose on 11/23/21 which is 99 days after the second dose. The recommended waiting period between booster and second dose is 168 days (7 days/week x 4 weeks/month x 6 months). There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Patient is experiencing dizziness, nausea, erythema, myalgias, and swelling at the site of injection. Events began about 24 hours after injection. Symptoms have since persisted for the following 48 hours.
hives on hands, ears, back of neck, body, legs and foot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives on hands, ears, back of neck, body, legs and foot) in a 59-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.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced URTICARIA (hives on hands, ears, back of neck, body, legs and foot). On 08-Apr-2021, URTICARIA (hives on hands, ears, back of neck, body, legs and foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Zyrtec as treatment drug . o concomitant drug is provided.