chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an extra dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 4th September 2019) and Shingrix (received 2nd dose on 14th November 2019).   On 3rd March 2022, the patient received the 3rd dose of Shingrix. On 3rd March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's comments: Nurse reported that the patient received an extra dose of Shingrix. The reporter consented to follow-up. Additional Supportive Information:  The patient received 3rd dose of Shingrix, which led to extra dose administered. This case was linked with case US2022059685, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022059685:same reporter - 2nd patient
Itching; Huge, red spot reappeared at the injection site/red blotches on her arm; Left armpit hurt; Fever; Felt a little chilly; Huge, red rash injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), AXILLARY PAIN (Left armpit hurt), PYREXIA (Fever), CHILLS (Felt a little chilly) and VACCINATION SITE RASH (Huge, red rash injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives. Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Allergic to Cipro and neomycin.) since 2011. Concomitant products included VITAMIN D3, CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE RASH (Huge, red rash injection site). On 17-Feb-2021, the patient experienced AXILLARY PAIN (Left armpit hurt), PYREXIA (Fever) and CHILLS (Felt a little chilly). On 23-Feb-2021, the patient experienced PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Huge, red spot reappeared at the injection site/red blotches on her arm). The patient was treated with TRIAMCINOLONE ACETONIDE at a dose of unknown. On 23-Feb-2021, VACCINATION SITE RASH (Huge, red rash injection site) had resolved. At the time of the report, PRURITUS (Itching), PYREXIA (Fever) and CHILLS (Felt a little chilly) outcome was unknown, AXILLARY PAIN (Left armpit hurt) had resolved and VACCINATION SITE ERYTHEMA (Huge, red spot reappeared at the injection site/red blotches on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: ADR added
mom noticed red and bruised knot the size of a 50 cents piece on pt's leg;7jun95 noticed red streak going up pt's leg fr inj site;mom called MD;augmentin prescribed;dx:sterile abscess;12jun95,infect had subsided but knot still remained;
I developed a rash 11 days after vaccination in my private area that then spread to my neck and all over my body. The rash is itchy and in patches. I have to see an allergist.
she feels horrible, she doesn't feel well/ hasn't been feeling well; chills; low-grade temperature; she's just sick; pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included hip pain (she has hip pain where she always had it and for which she takes Tylenol and oxycodone), hip replacement, phlegm (she has a lot of phlegm (not new she always had it) When she gets bad colds, she can sometimes get an antibiotic for the phlegm and it does clear up. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient stated her breathing was okay, but other than that she feels horrible, she doesn't feel well. She also had an amazing amount of chills, she went to bed right away on Saturday, when she woke up, she got very scared. She hasn't been feeling well since she got the shot, had a low-grade temperature, she's just sick and can't explain it, she doesn't want to move, she was in so pain, she was feeling sick, and was scared. The outcome of the events was unknown.  Information about Lot/Batch number is requested. Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional concerning her 24 year old white daughter with thalassemia minor and sulfa allergy and a history of pituitary tumor surgery (1 1/2 years ago) who on 12/10/01 was vaccinated with 1 dose of varicella virus vaccine live (site unknown). On approximately 12/10/01, the pt experienced slight pain at injection site. On 12/23/01, the pt developed arm pain and redness at site. On 12/24/01, the pt developed a low grade fever, general achiness, arm swollen, 5 sores at site and severe nausea. The pt received treatment with ondansetron hydrochloride (Zofran) and acetaminophen (Tylenol). The pt was seen on 12/26/01 by a physician and the dx was reported as, "infection vs shingles vs allergic reaction to vaccines". The pt has continued on the medications. It was noted that the pt's immunity was depleted secondary to the pituitary tumor. Follow-up information from a physician noted that the pt developed an erythematous reaction to the varicella vaccine at the injection site. It was noted that it was not clear if this was an infection or allergic reaction. The pt received treatment with cefuroxime axetil (Ceftin) 250 mg. Additional information has been requested.
Received annual influenza vaccination 10/10/2018 at 0630 AM in left deltoid IM. Awoke on 10/11/2018 of 0500AM with left upper arm and under arm into left chest swelling with tenderness to touch, took Ibuprofen p.o. this morning still experiencing an odd uncomfortable feeling in arm. Swelling decreasing slowly.
This is a serious spontaneous case reporter by other health professional and initially received on 18-Apr-2019, concerning a neonate patient of an unspecified gender. This was the patient's mother's first pregnancy. The father did not receive any medications prior to conception. There was no paternal or maternal history with major congenital malformation. The patient's mother didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The patient's mother did not use any other concomitant medications. The patient's mother's last menstrual period date was 07-Mar-2018. The type of pregnancy was singleton. On 20-Jun-2018, the patient's mother underwent nuchal translucency and no major congenital malformation was noted. On the same day, the patient's mother underwent first trimester screening and no major congenital malformation was noted. On 04-Sep-2018, the patient's mother underwent targeted ultrasound and no major congenital malformation was noted. On 05-Oct-2018, the patient's mother's underwent growth ultrasound, and intrauterine Growth restriction (IUGR) of the foetus was noted. On 10-Oct-2018, approximately 28 weeks gestational age, the mother received AFLURIA QUADRIVALENT (batch number: YF40208, route of administration, dose, anatomical location and expiry date: not reported) for an unknown indication. Days after vaccination, the mother delivered the infant at 30 weeks of gestation via emergency caesarean section due to IUGR and 2/8 BPP (as reported). The patient was admitted in neonatal intensive-care unit (NICU) and was doing well after stay in NICU. The patient's mother's estimated date of delivery was reported as 29-Dec-2018. This case was linked to 201805226, the corresponding maternal pregnancy report. Reporter's Comments: A neonate of unknown gender and underlying intrauterine Growth restriction (IUGR) was considered as premature baby, days after administration of AFLURIA QUADRIVALENT vaccine given at 28 weeks of gestation age. Despite the plausible temporal relationship between vaccination and reported event, there is no evidence for a biological mechanism that could cause the event and reported intrauterine Growth restriction (IUGR) of the foetus on ultrasound 5 days prior to vaccination appears to be more likely cause and therefore the event was assessed as not related to the vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Confusions; Dizziness; Weakness in lower extremities; Back pain; Tingling legs and arms; Brain fog; This is a spontaneous report from a contactable Other HCP (patient herself).  A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route administered in the arm, on 01Sep2021 (at the age of 32-year-old) at single dose for COVID-19 immunisation.  Historical vaccination includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route administered in the left arm, on unknown date at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included COVID-19 on unknown date (before vaccination). No known allergies. The patient did not have concomitant medications. On 09Sep2021 at 16:45, 8 days after the shot she suffering with confusions and dizziness. She was in the emergency room with weakness in lower extremities, back pain and tingling legs and arms. The events were reported as non-serious. It was reported that the events required also physician office visit. Therapeutic measures taken as result of events included intravenous (IV) fluids, dizziness medications, ketorolac tromethamine (TORADOL). Laboratory work was done but results were not provided. On 06Sep2021, a PCR Nasal swab was done and resulted negative. The patient was recovering from back pain while she had not recovered from the other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Back pain, headache and Lymphatic nodes severe swollen under the left arm and blower vision
I had a seizure. My wife found me on the bathroom floor convulsing. I was unconscious for  over an hour and a half.  I was taken to hospital  by ambulance. I have short term memory lost. All of the scans  were normal and all my vitals signs were normal .  I never had a seizure before and it was not signs of a stoke on the cat scan.
Injection site swelling & pain with radiation to axilla, subjective fevers & myalgias x 10 days. Pt. received no treatment, nor did she self treat.
Exceptionally healthy Patient suffered a stroke within  5-6 days after receiving the J & J vaccine.
Patient reported dizziness and not feeling well. Blood pressure taken at 9:27am 102/56 Pulse 48. 911 called at 9:30am Blood pressure monitored until 911 arrived at 9:41am. Patient transported to ER.
patient was administered 1 dose of improperly stored M-M-R II; No adverse effects reported.; This spontaneous report was received from a physician regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 26-JUL-2019, the patient received an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Lot No. R015165 and expiration date 29-MAY-2020 have been verified to be a valid) for prophylaxis (product storage error) (dose, route of administration and anatomical site were not provided). The vaccine was reconstituted with a properly stored Merck STERILE DILUENT. The temperature excursion was of 50 Fahrenheit degrees within a time frame of 4 hours. There was no previous temperature excursion and it was reported that the call was because of data logger. No adverse effects or product quality complaint were reported.
Diarrhea, gassy, bloating.  Lasted on and off for over a week.  Used several Immodium and finally got severe diarrhea under control. Lost 10 pounds.
Debilitating soreness, chills, and body aches.  So bad, Patient could barely move.  Spent most of her night and day in a chair sitting up, because no other position was comfortable.  Absolutely miserable.  Described as most sick she has ever felt
Pain and stinging upon injection. Followed by a strong burning sensation that lasted for approximately an hour and a half afterwards. 24 hours after receiving the booster, I had a low grade fever, chills, and was nauseous. My first two doses were Pfizer and I did not have any of these reactions with them.
Bells Palsy ...moderate symptoms next morning. Left facial. As of March 12 it is still somewhat noticeable. No treatment.  I had Bells Palsy in fall of 1999.
SYMMETRICAL maculopapular RASH ON ARMS AND LEGS; DIFFUSE RASH COVERING ALMOST ENTIRE BACK. LOOKED LIKE A CLASSICAL DRUG REACTION. Onset within 24 hours of administration. I needed a two month course of prednisone treatment. As of 10/6 the rash is clearing and the itching is almost gone.
Soreness and headache; Soreness and headache; Two clusters of blister rashes appeared 5 days after itch started along chest nerve line.; Not painful- assumed mild case of shingles.; Itchy back and right side of chest.; This is a spontaneous report from a contactable consumer (patient).   A 36-year-old non-pregnant female patient second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 03May2021 10:00 (at the age of 36 years old) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8731), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:00 as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 11May2021, the patient experienced itchiness on back and right side of chest. Not painful- assumed mild case of shingles. Followed by blister rash on 15May2021 in same places. Two clusters of blister rashes appeared 5 days after itch started along chest nerve line. All right side of body. Patient also had Soreness and headache. The treatment received for the not painful- assumed mild case of shingles, itchy back and right side of chest, two clusters of blister rashes appeared 5 days after itch started along chest nerve line was Clobetasol and valacyclovir. The patient underwent lab tests and procedures which included Nasal Swab PCR test: negative on 14Apr2021. The clinical outcome of the events not painful- assumed mild case of shingles, itchy back and right side of chest, two clusters of blister rashes appeared 5 days after itch started along chest nerve line was resolving and events soreness and headache was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Very quickly spiking fever that left me uncontrollably cold and shivering.  I had to jump in the show and then the bath tub in order to stop shaking.  After taking some Tylenol the fever peaked and  I stopped feeling uncontrollably cold.  Slept poorly and was uncomfortable for a night of sleep.  Recovered the next day by resting and getting my sleep.  I was better after a day or so.
Information has been received from a physician concerning an 18 year old white female, student with no illness at the time of vaccination, whose reported weight was 131 pounds and whose reported height was 62 inches who on 30-JUL-2007, at 9:15 A.M., was vaccinated into the left arm with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), (Lot #658222/0927U).  It was reported that on 30-JUL-2007, the patient experienced a hot face for 5-7 minutes, post injection.  The patient had a brief syncopal episode.  The patient reported that she felt that she blacked out for about 30 seconds.  The patient's blood pressure reading was 86/50 mmHg.  It was reported that the patient felt well and within normal limits (wnl) after lying down for 15 minutes.  Additional information has been requested.
This spontaneous report was received from a consumer, who's a registered pharmacist refers to a 2 year old male patient. Patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date the patient was incorrectly vaccinated with GARDASIL strength, dose/frequency, lot # unspecified) (inappropriate schedule of drug administration). No concomitant medications were reported. Reporting consumer stated that they were going to be monitoring the patient's condition for adverse events. Additional information is not expected as the reporter did not wish further contact.
shortness of breath; lot of muscle pain like it was jumping; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and MYALGIA (lot of muscle pain like it was jumping) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021 at 8:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) and MYALGIA (lot of muscle pain like it was jumping). At the time of the report, DYSPNOEA (shortness of breath) and MYALGIA (lot of muscle pain like it was jumping) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Day 1: fever, Day 2 onset of spasmodic retrocollis and inability to walk; spasmodic retrocollis continued x6 weeks, currently still present but improved.
rash; swelling upper left arm; hardness upper left arm; headache; chills; body aches; felt hot; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 6 years ago). Previously administered products included Zostavax (received a few years ago).   On 13th September 2019, the patient received the 1st dose of Shingrix. On 14th September 2019, 1 days after receiving Shingrix, the patient experienced chills, general body pain, feeling hot and influenza-like symptoms. On 15th September 2019, the patient experienced headache. On an unknown date, the patient experienced rash, injection site swelling and injection site induration. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the chills, general body pain, feeling hot, influenza-like symptoms, rash, injection site swelling and injection site induration were recovered/resolved.   It was unknown if the reporter considered the headache, chills, general body pain, feeling hot, influenza-like symptoms, rash, injection site swelling and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient stated that, after vaccination with dose of Shingrix, had rash near injection site. The patient reported that upper left arm was swollen and hard. After vaccination with Shingrix, the patient had headache that came and gone. The patient did not received medication like Tylenol or Advil that seems to help with headache. No any additional information was provided. The patient consented to follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 71-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. On 21st April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: The onset date or specifics about the rash were not known at time of report.
Hepatic function levels high  during preventative care bloodwork, Alkaline Phosphatase 232 U/L AST 95 U/L ALT 104 U/L