chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delivery date; Nausea; Vomiting; Fever; Body aches; This is a spontaneous report from a contactable consumer. A 39-year-old pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ewo177  Solution for injection) via an intramuscular route of administration on 15Jun2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation (39 years at the age of vaccination.) Medical history was not reported and delivery date was reported. Concomitant medications were not reported.  The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ewo176) via intramuscular route of administration on 25May2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether the patient receive any other vaccines within four weeks prior to the vaccination. On delivery date, (Maternal exposure during pregnancy) and on 16Jun2021 the patient experienced nausea, vomiting, fever and body aches.  It was unknown if the patient received any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events nausea, vomiting, fever and body aches was recovered on an unknown date in Jun2021 and delivery date was unknown.   No follow-up attempts are possible. No further information is expected.
never completed the dosing series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 30th April 2016 with batch number 35G7C and expiry date 1st February 2019.).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Engerix-B and patient never completed the dosing series.  Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to the case US2021199896 and US2019215432 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021199896:same reporter US-GLAXOSMITHKLINE-US2019215432:same reporter
On approximately 2/5, this previously healthy 4-month-old male received his 2-month vaccines (HepB, RV, DTaP, Hib, PCV, and IPV according to the recommended immunization schedule). The next day, he went limp for several seconds and then returned to normal. He then started having increasing frequent episodes of arm stiffening for 30 seconds, falling asleep for 5-10 minutes, and then returning to normal. Between episodes, he was otherwise well, with no fevers, and acting normally. On 2/12, after breast-feeding, all of his arms and legs started shaking and his eyes rolled back. After about 1 minute, he fell asleep. He was taken to the ED, where he had 2 episodes of tonic-clonic seizures that were treated with lorazepam. A lumbar puncture, head CT, and chest X-ray were normal. During transport to SD, he had arm stiffening and received another dose of lorazepam. After arrival, he continued to have arm stiffening with blinking. He received a loading dose of fosphenytoin IV and started on an IV maintenance dose. He had a normal neurological examination and an unremarkable EEG. He was diagnosed with encephalopathy probably secondary to DTaP. He was discharged the next day on phenytoin. At a follow-up appointment on 3/17, it was reported that he had no further episodes of encephalopathy or seizures and a plan was made to wean him off phenytoin. Note: there is no family history of seizures or encephalopathies. Note: Encephalopathy has been more frequently reported with DTaP than with any other vaccine (CDC.gov). Summary: new onset seizure disorder in an otherwise healthy patient started 1 day after the 2-month vaccines that included DTaP; resulted in a 1-day hospitalization. Dx: encephalopathy possibly secondary to DTaP.
I had 2 minutes left from waiting my 15 min after receiving my first vaccine and all the sudden I got very flushed/hot. And then light headed. It lasted about 5 minutes and I ended up staying an extra 30 more minutes. Then I was fine. No other problems.
pt recd vax & exp arm soreness & aches; 24SEp92 & exp soreness, pain & aching down entire arm to bone;
3rd dose today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 7532P, expiry date 18-AUG-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd December 2019) and Shingrix (received 2nd dose on 10th February 2020).   On 01-AUG-2023, the patient received the 3rd dose of Shingrix. On 01-AUG-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose today). The outcome of the extra dose administered was unknown.   Additional Information: Receipt date: 01-Aug-2023 Nurse practitioner stated a patient came in to get her 2nd dose of Shingrix on the day of reporting, stating that she had only 1 dose previously. After the vaccine was administered, it was discovered that she had received 3rd dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received 3rd dose of Shingrix, which led to extra dose administered.
Appears to be a localized reaction, then became surrounded by an area of cellulitis. Area is red, warm to touch, itchy and tender to touch.
24hr p/vax pt noted red area on inside of lt upper arm;below & medial to inj site;10/15/99 redness, swelling & extreme pain across bicep below shot site;saw MD on 101/6/99 dx w/infect & placed on cephalexin;
Joint stiffness and aches, lymph swelling bilaterally in chest/neck. Took BENADRYL and TYLENOL. Started having Resp issues with wheezing, went to Urgent care that night.
Wrong dose given- Patient is 11 yrs and 12 + dose given in error.
induration of 5x8 cm @ site, very warm to touch & red;seen by MD on 12JUN95;
diarrhea on and off; soreness at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhea on and off) and VACCINATION SITE PAIN (soreness at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE, ATORVASTATIN, LISINOPRIL, SERTRALINE, GLIMEPIRIDE, PIOGLITAZONE, PANTOPRAZOLE, FLUTICASONE PROPIONATE (FLONASE) and TRAZODONE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea on and off) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, DIARRHOEA (diarrhea on and off) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient contacted her primary care physician regarding her symptoms. Treatment for the events included, Loperamide, Tylenol (Acetaminophen), and ice.
Pleurisy; This spontaneous case was reported by a consumer and describes the occurrence of PLEURISY (Pleurisy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PLEURISY (Pleurisy). The patient was treated with IBUPROFEN for Pleurisy, at an unspecified dose and frequency. At the time of the report, PLEURISY (Pleurisy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Mom noticed a few "hives" around pts diaper area on Sat evening 2NOV91; Sun AM pt was covered w/hives on back & front plus hands & feet were swollen w/hives; t99.2; pt played & ate nl; Pt taken to ER given DPH;
BILATERAL AXILLARY RASH, INTERMITTENT SINCE VACCINATION, ONGOING
Patient called at 10:00 am on 4/24/14 complaining that arm was tender to the touch. With a circle around the area where the shot was given.
Pt received Pneumovax on 9/19, and reported swelling, fever, and bruising at the injection site for a couple of days.  Received Prevnar13 last year with no issues.
Pt had received the Janssen Covid 19 vaccine and five minutes later had fallen out of the chair she was sitting in.  While talking to the patient she leaned forward and was held to prevent her from falling out of chair. She was very sweaty and was slow to regain full consciousness. Emergency services was called where she was evaluated and found to have had a vasovagal response. Paramedics had her lie down before she was sent home.
1008 - pt  c/o itchy spot on right side lower back. one hive noted.  bp 150/81, p 99, rr 20, sats 97.  25 mg of po Benadryl given 1017 - 128/75, p 87, rr 18, sats 98.  Pt reports I feel must better, no itching noted.
Info has been received from a physician concerning an approximately 3 year old female with no medical history or allergies who a 12 months of age was vaccinated SC with a dose of varicella virus vaccine live. There was no concomitant medication. In approximately 9/05 ("4-5 months ago"), the pt experienced breakthrough characterized by less than 50 vesicles on the extremities and trunk. Unspecified medical attention was sought and no lab or diagnostic tests were performed. Subsequently, the pt fully recovered. No product quality complaint was involved. Additional info has been requested.
Arm stinging/hurt for 1 week. Hot to touch, redness of 4 inches. Tylenol PNR.
healtcare worker came to our vaccine clinic for Pfizer COVID 19 vaccine booster and attested that they had Pfizer COVID 19 vaccine primary series at an outside facilty. we administered the Pfizer COVID 19 booster dose. after the fact the healthcare worker admitted that her primary series was Moderna COVID 19 vaccine.
Information has been received from a nurse practitioner concerning a 60 year old female with a history of drug allergies to clindamycin who on 14-MAR-2011 was vaccinated SC in the left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot number: 667610/1355Z; expiration date: 26-OCT-2011). Concomitant therapy included DHEA and "hormone cream" (manufacturer unknown). On 14-MAR-2011 (also reported as "24 hours after administration") the patient developed a "red welt" at injection site which tapered to a red area that looks like "a bruise". 3 weeks after vaccination, on approximately 04-APR-2011, the patient developed a varicella like rash on her left buttocks which was treated with Acyclovir and cleared 4 days ago, on 10-APR-2011. The patient sought medical attention by visiting physician in office. Upon the time of the report, the patient was recovering. Additional information has been requested.
I had a shingles vaccination Friday. I had a fever, nausea, diarrhea, headache the next day. 3 days later my arm is swollen, rash, red and hurts really bad.
Severe headaches, we went to the ER and they gave him tramadol and did a CAT scan.  Headache is primarily on his temples on the middle of his forehead.
No additional AE details available; vaccines were administered after experiencing temperature excursion.; Information has been received from a medical assistant referring to a 2 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 18-OCT-2021, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032317, expiration date 22-SEP-2022, dose, strength and route were unknown) for prophylaxis. The vaccine had experiencing temperature excursion between 6 to 14 degrees Fahrenheit (8.5 degrees Fahrenheit) for 18 minutes and between 6 to 14 degrees Fahrenheit (11.9 degrees Fahrenheit) for 1 hour (product storage error). There was no previous temperature excursion. No additional AE details available.
First shot my arm hurt like hell and I ran a temp 101 and got so weak when I tried to get out of be i fell to the floor.  Second shot arm not quite a sore but still a low fever 99.3 and general aches and pains.  weak but to so much I could not function.  No floor time.
Wheal and flared urticaria scattered throughout her body. Pt seen today in office for rash for 4 days. Treated with BENADRYL at home and prescribed PRELONE today. Nurse at Health Dept notified by phone.
fever of 102 that lasted about 12 hours, chills, severe pelvic bone pain, fatigue, nausea, severe headache that lasted 48h
had resolving bronchitis but cough and sob worse few hours after vaccination with bivalent vaccine
Humira pen misfire and the medicine dribbled outside leg with humira (adalimumab); Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and DEVICE ISSUE (Humira pen misfire and the medicine dribbled outside leg with humira (adalimumab)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Colitis ulcerative.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, CF. In 2021, the patient experienced PYREXIA (Low grade fever). On an unknown date, the patient experienced DEVICE ISSUE (Humira pen misfire and the medicine dribbled outside leg with humira (adalimumab)). In 2021, PYREXIA (Low grade fever) had resolved. At the time of the report, DEVICE ISSUE (Humira pen misfire and the medicine dribbled outside leg with humira (adalimumab)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: Low grade fever.         No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Approx. 5 min after vaccination patient started to feel dizzy. Technician went to retrieve ice packs and patient fainted. Pharmacist gently moved patient to her side on the floor and brought knees up to her chest while technician called 911. Patient regained consciousness after approx. 2 minutes before EMS arrived on scene. EMS took patient's blood pressure (hypotensive), administered saline drip in ambulance onsite then released patient to parents. Followed up with parents next day, patient was monitored at home and was feeling fine. Per EMS patient most likely was dehydrated. No prior history of event post vaccine.
Report 20010013551 describes difficulty breathing in a 24 year old female who received an injection of hepatitis B vaccine (Engerix-B). This report was received from the pt and has not been verified by a physician or other health care professional. There were no concurrent medical conditions. The pt has no known drug allergies. Concurrent medications include an unspecified oral contraceptive. The pt received her first injection of Engerix-B on 11/08/2000. Approximately two weeks later, around 11/22/2000, she developed difficulty breathing, difficulty swallowing, facial redness, and bilateral arm numbness and tingling. The bilateral arm numbness and tingling resolved after one week. The facial redness and difficulty breathing and swallowing persisted, and she was seen by her physician on 01/06/2001. Erythrocyte sedimentation rate, rheumatoid factor, antinuclear antibody titer, and C-reactive protein measured on 01/03/2001 were reportedly "all elevated." The pt received her second injection of Engerix-B on 01/03/2001. Approximately two weeks later, around 01/17/2001, she again experienced difficulty breathing, difficulty swallowing, facial redness, and bilateral arm numbness and weakness. On 01/17/2001, she was seen by her physician, who reportedly made a diagnosis of "rule out serum sickness." The pt was treated with propoxyphene, promethazine 50 mg daily, fluticasone (Flovent), and salmeterol (Serevent). as of 01/17/2001, the events were ongoing.
Diffuse swelling and small consistent blisters at site of Varicella vaccination. No erythema or fluctuation noted.
This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 28-AUG-2015, the patient was vaccinated with an improperly stored PROQUAD lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient has redness/irritation that has lingered for almost a month. Doctor is aware. She has been prescribed Triamcinolone topically.
Patient began having diaphragm issues following  2nd shingles shot, has required follow-up with many neurologists.
my arm has been red and hot; my arm has been red and hot; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, 5 days after receiving Meningococcal B vaccine, the patient experienced erythema of extremities and extremities hot feeling of. On an unknown date, the outcome of the erythema of extremities and extremities hot feeling of were unknown.   It was unknown if the reporter considered the erythema of extremities and extremities hot feeling of to be related to Meningococcal B vaccine.  Additional details were provided as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient received meningitis b vaccine and after 5 days from receiving it patient experienced red arm and hot arm. No further information reported.
PAIN IN HANDS; INJECTION SITE PAIN WITH COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (PAIN IN HANDS) and VACCINATION SITE PAIN (INJECTION SITE PAIN WITH COVID VACCINE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (PAIN IN HANDS) and VACCINATION SITE PAIN (INJECTION SITE PAIN WITH COVID VACCINE). At the time of the report, PAIN IN EXTREMITY (PAIN IN HANDS) had not resolved and VACCINATION SITE PAIN (INJECTION SITE PAIN WITH COVID VACCINE) had resolved.            Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient had admitted to already receiving 3 doses of Pfizer after receiving the first dose of Moderna for a total of 4 COVID vaccines. Patient received a full dose of Moderna as it was assumed it was the first COVID vacccination.
severe generalized burning type pain; pruritus in my feet, hands, extremities, & occasionally in the abdomen & back.; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 07Nov2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing), notes: Have you seen this response with other patients with SLE/other autoimmune diseases; "other autoimmune disease" (unspecified if ongoing), notes: Have you seen this response with other patients with SLE/other autoimmune diseases. Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE] taken for autoimmune disorder; BENLYSTA subcutaneous taken for autoimmune disorder. The following information was reported: PAIN (non-serious), outcome "unknown", described as "severe generalized burning type pain"; PRURITUS (non-serious), outcome "unknown", described as "pruritus in my feet, hands, extremities, & occasionally in the abdomen & back.". Therapeutic measures were taken as a result of pain, pruritus.  Additional information: The patient had autoimmune disease currently prescribed Cellcept and Benlysta. With the initial Pfizer vaccine and the 3rd booster dose (modified for defense against the omicron virus), the patient suffered from severe generalized burning type pain with occasional pruritus in feet, hands, extremities, and occasionally in the abdomen and back. These symptoms were unresponsive to over the counter (OTC) meds, partially responsive to oxycodone, and usually required short term use of prednisone. The patient reported symptoms occurred 6-7 days after the injection on both occasions. The patient asked if this response was seen with other patients with SLE/other autoimmune diseases or patients prescribed these immunosuppressants. The patient had minimal symptoms with the 2nd, 3rd and 4th doses; these symptoms only occurred with the 1st and the 5th doses. The patient asked was the fifth dose a totally modified vaccine. Patient also asked what would account for having such severe symptoms only with the 1st and 5th doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201287014 Same reporter/ patient/ event, different drug;
pt rcvd vax; pt exp a migraine headache for whole eve; pt took aspirin;