chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 19 year old female with no known drug or food allergies who in August 2008, was vaccinated with the first dose of GARDASIL, and two days later experienced a generalized rash. The rash had not yet resolved. The patient was being treated with BENADRYL. The patient sought medical attention and called the physician. Additional information has been requested.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: mild rash on right arm and spread to facial area , no shortness of breath. gave patient 2 benadry (12.5mg) chewable . patient was able to take the medication and was able to chew and swallow. called 911 at 12 45 am and they showd up in 5 minutes.
PT HUSBAND REPORTS "COMATOSE-LIKE" STATE - EYES CLOSED, NON-VERBAL
Frequent twitches every 2-3 min all night from 10PM-5AM; fever to 102 until 6AM 6MAR92;
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion. Total of 102 doses/vials were given for LOT  026C21A.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow up received contains non significant information: primary reporter address
The patient was to get the Moderna Bivalent; instead the Moderna Pediatric age 6-11 was administered
Pt COVID positive 11/21/21 and admitted to ED on 11/24/21 with cough and dyspnea  During her hospitalization, she developed MRSA pneumonia and was treated with a course of ceftaroline. She was on bipap until 12/04 when her respiratory statu declined and she required intubation. Her pressor requirement increased as did her oxygenation status and palliative was consulted for goals of care. She began to have acute renal failure likely secondary to sepsis, hypotension and increasing pressor requirements.  The family decided that the patient would have wanted to be DNR-CCA and code status was changed. The patient expired shortly after.
Flu like symptoms with aches, pains, fever up to 103, chills, headache the night of injection into the next morning. Then, a rash, hives started 5 days after injection
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 11:55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Diffuse bruising/black and blue surrounding site of injection, tender to touch. Lasted 10 days post-immunization.
Feeling weak after booster; Migraine after booster; Felt like fainting after booster; Terrible Headache after booster; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak after booster), MIGRAINE (Migraine after booster), DIZZINESS (Felt like fainting after booster) and HEADACHE (Terrible Headache after booster) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 16-Nov-2021, the patient experienced ASTHENIA (Feeling weak after booster), MIGRAINE (Migraine after booster), DIZZINESS (Felt like fainting after booster) and HEADACHE (Terrible Headache after booster). The patient was treated with PROPRANOLOL at an unspecified dose and frequency; DICLOFENAC POTASSIUM (CAMBIA) at an unspecified dose and frequency; BOTULINUM TOXIN TYPE A (BOTOX) at an unspecified dose and frequency; DICLOFENAC at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 18-Nov-2021, ASTHENIA (Feeling weak after booster) and DIZZINESS (Felt like fainting after booster) had resolved. At the time of the report, MIGRAINE (Migraine after booster) and HEADACHE (Terrible Headache after booster) had not resolved.            Concomitant medication details were not reported by the reporter.
Started with temp on Monday night 103.8, headache, chills, dizziness, sweats, fever, flutter in my chest off and on. Got worse Tuesday with the same symptoms. Took Ibuprofen to help with fever. Wednesday went to ER with flutter in chest. Was Frequent PVC?s. Had fever, headache, and dizzy until Sunday. So far today Monday 2-1-21 no fever just dizzy and flutter in chest off and on.
cold sores, canker sore on mouth; Lymph nodes; sore arm that itched; sore arm that itched; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (sore arm that itched), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes), ORAL HERPES (cold sores, canker sore on mouth) and VACCINATION SITE PAIN (sore arm that itched) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes, Hypertension and Surgery (heart surgery). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, METFORMIN, MONTELUKAST SODIUM (SINGULAIR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ACETAMINOPHEN and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP).    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (sore arm that itched) and VACCINATION SITE PAIN (sore arm that itched). On 04-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Lymph nodes). On 06-Mar-2021, the patient experienced ORAL HERPES (cold sores, canker sore on mouth). At the time of the report, VACCINATION SITE PRURITUS (sore arm that itched), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes), ORAL HERPES (cold sores, canker sore on mouth) and VACCINATION SITE PAIN (sore arm that itched) had not resolved.    No treatment information was provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Urticaria developed  EVERYWHERE except face and bottom of feet beginning by 12 hours post-innoculation .   Went to local hospital's Urgent Care Unit to seek care to reduce/eliminate adverse reaction.  Received methyPREDNISolone sod suc (PF) (SOLU-Medrol (PF) shot in RT Glute 29 hrs 38 min. after Bivalent Booster injection.  Was prescribed and have begun taking Prednisone tablet series.  By 18 hours post SSOLU-Medrol (PF) injection and first day's tablets of Prednisone prescription series, Urticaria has begun to subside. No additional adverse events have occurred yet.
Patient presented for "1st dose" covid vaccine.  Upon entry into State Immunization Information System after administration, it was discovered that patient had already received 2 doses of alternate mRNA vaccine.  Upon questioning, patients states that they wanted to get the alternate manufacturer to have better coverage and protection and have been reading articles about DRs doing this.
patient began shaking and breathing heavily,fainted and was out for approx 1 minute, came to and did not remember what happened. Three hours later patient feels okay, arm is sore
COUGHING; SORE THROAT; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ 1805020, and batch number: JJ 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced coughing. On 12-MAR-2021, the subject experienced sore throat. Laboratory data included: COVID-19 PCR test (NR: not provided) Negative, and SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. Treatment medications (dates unspecified) included: guaifenesin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the coughing and sore throat was not reported. This report was non-serious.
Soon after the flu shot was given my daughters arm became red, which is normal, but then it started swelling up and turning bluish. The swelling got worse within the next couple of days and it started turning a little more blackish with a red bulls eye type ring around the outside. It became a large area of bad bruising and swelling. Within hours of the shot my daughter was in extreme pain and was unable to move her arm for many days and the extreme pain lasted for several days. She also became very sick that day and was sick for weeks.
This case was reported by a healthcare professional and described the occurrence of an accidental overdose in a 1-year-old female subject who was vaccinated with HAVRIX for prophylaxis. Concurrent vaccination included MMR, PREVNAR and VARIVAX all given on 20 February 2008. On 20 February 2008 the subject inadvertently received 1st dose of HAVRIX at 1.0 ml (1440 elisa units). This was considered to be an accidental overdose. The same day, the subject became fussy. At the time of reporting, the event was resolved. Follow-up information was received on 12 September 21008 via a nurse, who reported that she had no further information to provide, as the incident did not happen at her clinic, nor was she involved with the incident. The nurse stated that she was only informed of the event via the subject's mother.
Patient felt a little fatigue, felt like her throat closing. Patient contacted md and was advised to take Benadryl. Patient felt a little better.
Vaccinated with influenza and PPV23 on 10/12/07.  Fever on 10/12 through 10/17.  On Sunday, 10/14/07 experienced fever of 102.8 degrees. By 10/14/07, reddened area at injection site - approx 2 cms progressing to reddened oval area from site to elbow of right arm (PPV23 administered in right arm subcutaneously).  "Passed outfor a few minutes" early Sunday, 10/14/07.  Presented on Sunday.  No meds given.
About three days after the injection, my right arm itched regularly with increasing intensity. I noticed a ring of redness that also intensified over the next days. By the following Saturday, it was swollen and by Sunday it hurt and itched enough to disrupt sleep. It has since faded but there is still a pale patch where the reaction occurred.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 78-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 as dose 5 (booster), single (Lot number: GJ3268) at the age of 77 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Sep2023 to 18Sep2023.  Additional information: The patient had no known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
The patient was supposed to receive  a flu (FLUARIX) vaccine, but she received a hep a-hep b (TWINRIX) vaccine. Then, when the error was discovered, the nurse called the patient's mother and explained the error and the patient returned to the clinic and received the flu vaccine. No injuries were sustained.
RECEIVED SHOT APPROXIMATELY 1145, WENT TO BED EARLY ~2100 NOT FEELING WELL, WOKE WITH "FEVER 102 F, 'EXTREME H/A,DIZZINESS,SHAKING'"; WAS FEELING BETTER BY ~1030.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown. The reporter considered the erythema of extremities and swelling arm to be probably related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The health care professional reported that the patient experienced redness and swelling of arm. The adverse events occurred lower on the arm where the vaccine was given. The health care professional was not sure if it had been resolved. This case has been linked with US2018102492, reported by the same reporter.
After administration of Influenza, uticaria , hives noted to body after five minutes of administration . Follow up call by provider 2 hrs after, uticaria resolved after administration of Benadryl at home.
This case was reported by a consumer and described the occurrence of ever in a 5-year-old female patient who received KINRIX (batch number T325H, expiry date 17th February 2017). Concomitant products included PROQUAD. On 21st January 2015 16:30, the patient received KINRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 22nd January 2015, 1 days after receiving KINRIX, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were not recovered/not resolved. The reporter considered the fever and pain in arm to be related to KINRIX. Additional information: Caller reports that her daughter received a KINRIX and PROQUAD vaccination yesterday. This morning she was complaining that her arm hurt and she didn't look very good. She was given TYLENOL to treat the pain and she went to daycare. While at daycare she just laid on the floor. When she was picked up from daycare she was burning up with fever. The caller has not had a chance to take her daughter's temperature, but she feels in is greater than 102 F, just based upon touch. The caller feels the fever is more likely caused by KINRIX because she has had a previous Merck MMR vaccine with no reaction. Her daughter has a history of running high fevers when ill.
'excessively' sick; Chills; fever; aches and pain in her whole body.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9267), via an unspecified route of administration on 18Feb2021 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from Oct2020; diabetes, high blood pressure, and a heart disease from an unknown date and unknown if ongoing. The patient had unspecified concomitant medication. On 19Feb2021, the patient experienced chills, fever, aches and pain in her whole body. She wanted to know if this was normal, if she should expect the same reaction or worse for the second dose, and if the previous COVID-19 could have caused the reaction she experienced. She needed to know if she was going to be excessively sick as she was after the first shot if she got the second shot. Therapeutic measures taken as a result of the events included ibuprofen and acetaminophen. Outcome of the events was unknown.   No follow-up attempts are possible. No further information expected.
Patient experienced vasovagal reaction approximately 3 hours after receiving first vaccine. Patient was standing in the hallway, squat down and then when he stood up, he felt lightheaded and fell over (not hitting his head). He does not recall the event. Remembers a another individual helping him to sit up.
I had a infalmmation of bladder wall/bladder pressur existed approximately 1 month; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS NONINFECTIVE (I had a infalmmation of bladder wall/bladder pressur existed approximately 1 month) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048AZ1A and 0006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Pepcid), Drug allergy (Sulfa), Drug allergy (Minocycline), Drug allergy (Foxin), Drug allergy (Amatiza), Drug allergy (Macrobid) and Latex allergy. Concomitant products included DENOSUMAB (PROLIA) for Bone density abnormal, MULTIVITAMIN [VITAMINS NOS], BIOTIN, VITAMIN D [VITAMIN D NOS] and CALCIUM for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced CYSTITIS NONINFECTIVE (I had a infalmmation of bladder wall/bladder pressur existed approximately 1 month). On 17-Apr-2021, CYSTITIS NONINFECTIVE (I had a infalmmation of bladder wall/bladder pressur existed approximately 1 month) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Treatment information was not provided.   This case was linked to MOD-2021-028461 (Patient Link).
She said she had bump/lump at injections site for 4 days.  She said it cause slight discomfort and she would rub it until it went away.
weak; problem with his jaw/muscle related; unable to open his mouth all the way; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), ASTHENIA (weak), JAW DISORDER (problem with his jaw/muscle related) and DYSKINESIA (unable to open his mouth all the way) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm), ASTHENIA (weak), JAW DISORDER (problem with his jaw/muscle related) and DYSKINESIA (unable to open his mouth all the way). At the time of the report, INJECTION SITE PAIN (sore arm), ASTHENIA (weak), JAW DISORDER (problem with his jaw/muscle related) and DYSKINESIA (unable to open his mouth all the way) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Chest pain, difficulty breathing, swollen lower lip, bloodshot eyes, rash on face, difficulty remembering/recalling personal information i.e. birthday and address.
I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath.  Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine.  I was discharged to home at approximately 1130 on 01/05/2021.  Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00.  All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue.  My weakness, fatigue are still present today 01/07/2021 at 0945.
about 8hr p/vax pt began having trouble breathing;states lungs felt like filling up w/water;went to ER for heart attack;tx w/steroids;observed in hosp from 11PM to 7AM was told allerg rxn to vax;