chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Withing 1 minutes of vaccine. Headache, weird taste in mouth, shakiness, pounding heart. No treatment went to bed and when woke up 4 hours later s/s gone. 10/26/09 AM sudden onset N/V/D, low grade fever, sore throat x 1 week 11/2/09 increased temp, N/V, worse sore throat, rash. 11/3/09 rash worse with second type folliculitis type rash, low grade temp. 11/5/09 rash continues. 11/10/2009 PCP records from 11/2, 11/5 and 11/9/2009. Patient with c/o's fever, rash, facial swelling, nausea/vomiting, sore throat and hoarseness. Tx'd with ABX and prednisone.
SEVERE HEADACHES, NECK PAIN, BACK PAIN, CSF NORMAL, HEAD CT NORMAL, C-SPINE X-RAY NORMAL, CBC, CMP, UA NORMAL.
no additional adverse event; Drug administered to patient of inappropriate age; This spontaneous report was received from an office manager concerning a 6 months old patient. No information about the current condition, medical history or concomitant therapy was reported.   On 29-DEC-2021, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and lot# were not reported) was administered to this 6-month-old patient for prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported.
On 2/9/07 the child developed irritability, bilious vomiting, and bloody stool.  The child was diagnosed with intussusception.  Barium enema was able to partially reduce the intussusception.  The child required laparotomy, manual reduction and bowel resection of necrotic portion.  The child is presently recovering in the hospital.  02/16/2007 Rotateq added to vaccine list.  Provider stated to krk that an addendum with Lot #  0979F was submitted. 02/27/2007 MR received from treating hospital for admission for vomiting of dark green emesis, irritability, and lethargy. In the ER child had an episode of large, jelly-like bloody stool.  PE showed a slightly distended abdomen with hyperactive bowel sounds.  No palpable masses.  Taken to OR for Exploratory Laparotomy, Reduction of Intussusception, Appendectomy.  Limited right hemicolectomy. Post-operative DX:  Intussusception.  Final DX: Intussusception, with necrotic bowel.
Intermittent headache starting one hour post and persisting through the next day. Fever, back ache, fatigue, injection site tenderness, and swollen lymph node to right neck, started morning after vaccine and resolved by second day after vaccine. Took Tylenol twice.  Swollen lymph node under right arm, starting morning  after vaccination; has reduced but remains present.
Information has been received from a nurse referring to a 72 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On unspecified date of 2012 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, lot # 0468AE, expiration date 04-APR-2013, subcutaneously. Information regarding concomitant medication was not reported. On 27-FEB-2015 the patient was diagnosed with shingles. The patient was seen by her physician and she was prescribed an unspecified antiviral for treatment of the event on the same day. The outcome of the event was reported as not recovered. The causality was not reported. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 TEST POSITIVE (DELTA VARIANT); This spontaneous report received from a parent via a company representative concerned a female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Patients mother assumed the vaccination in the month of APR-2021. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure and tested positive for the other variant (covid-19 test positive). Patient was doing fine at the time of reporting. Patient oxygen and temperature both was okay and she was staying at home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive (other variant) and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186458; Sender's Comments: V0: 2021074085-COVID-19 VACCINE AD26.COV2.S-Suspected Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
At 36 hours after injection, lymph node under right arm became swollen and tender. On day 3, the swelling is the size of a tennis ball and tender.
Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 11-DEC-2014, at age 76, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
17 years old received Moderna booster. Monitored 30 minutes. No adverse reactions reported.
Caller is a nurse who reports inadvertent concomitant administration of PROQUAD and M-M-R II.; Patient received the dose today and has not had any adverse effects or symptoms from this dose. No other information available; no other AE/no PQC.; This spontaneous report has been received from a registered nurse concerning a 13-month-old patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 20-JUL-2022, the patient was inadvertently vaccinated with with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 mililiter (ml)/once, (lot number U006488, who had been verified to be a valid number, expiration date reported and established as: 26-FEB-2023) administered for prophylaxis, concomitant with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml/once, (lot number U017140, who had been verified to be a valid number, expiration date reported and established as: 28-NOV-2022) administered for prophylaxis, plus sterile diluent (DILUENT MRK) (strength, dose description, lot number, expiration date, were not provided) (accidental overdose). It was reported that, the patient did not experienced any adverse effects or symptoms for this dose.
RA flare/significant flare; all over" body pain / unmanageable; twisted her knee; This case was reported by a physician via other manufacturer and described the occurrence of rheumatoid arthritis flare up in a 73-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included etanercept (Enbrel) unknown for rheumatoid arthritis.   Concurrent medical conditions included rheumatoid arthritis and pain.   In October 2021, the patient received Hz/su + AS01B and Enbrel 50 mg at an unknown frequency. On an unknown date, less than 2 months after receiving Hz/su + AS01B, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant and other: serious as per reporter), general body pain (serious criteria other: serious as per reporter) and twisted knee (serious criteria other: serious as per reporter). The subject was treated with steroids nos (Steroids). Enbrel was continued with no change. On an unknown date, the outcome of the rheumatoid arthritis flare up and twisted knee were unknown and the outcome of the general body pain was not recovered/not resolved.   The reporter considered the rheumatoid arthritis flare up, general body pain and twisted knee to be possibly related to Hz/su + AS01B.  Additional details were reported as follows: The age at vaccination was not reported. No concomitant medications were provided. The patient received Enbrel with Single Dose Prefilled Autoinjector with co-suspect medication included Shingrix (varicella zoster vaccine RGE (cho)) on an unknown date in 2021. The patient had been on Enbrel for about seven weeks. On an unknown date in 2021, the patient twisted her knee and was using a walker to assist her when walking. The patient had Flare of RA (rheumatoid arthritis). It was reported that event of pain (RA pain) was prior to her Enbrel start. The patient also experienced body pain that described as  unmanageable. The patient was told by health care professional the benefits of the Enbrel may take up to six months to work for her. Treatment medication for event rheumatoid arthritis includes unspecified steroids.  The physician reported that the event rheumatoid arthritis were not related to Enbrel. The causal relationship between the event rheumatoid arthritis and Single Dose Prefilled Autoinjector was not provided by the physician. The reporter declined consent for follow up with physician. No follow up attempts was possible.  No further information was expected.
about 10-15 minutes after receiving vaccine pt complaine of dizziness, loss of vision, sweating, loss of consciousness, vomiting and of her left hand getting cold.
Expired vaccine reeived; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine reeived) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 1:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 1:17 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine reeived). On 24-Sep-2021 at 1:17 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine reeived) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. The patient did not experience any adverse event and did not require any medical attention.
Noticed pain in back on 02-13-1921 that patient thought was a kidney infection.  Treated at hospital emergency room on 02-18-1921 for infection and water retention and sent home.  Returned to hospital on 02-19-1921 and was diagnosed with a blood clot in her left lung and heart in A-Fib.  Was in Medical Center for 5 days.  Treated with Warfarin.
Patient had dose of vaccine that was expired by the time of administration. By the time the error was caught, patient had already discharged to different facility so immediate re-dose was not completed. RN was made aware that patient would need to be notified. No other adverse event occurred from administration.
Pt reports skin rxn 20 min after injection, left deltoid w/induration, site was plae, firm, 2x3 cm with area of redness around site. Pt c/o itching.
muscle aches; fever; nausea; Vomiting; This is a spontaneous report from a contactable other healthcare professional (patient).  A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, intramuscular right arm from 08Jan2021 to 08Jan2021 as single dose for COVID-19 immunisation. Historical vaccine includes first dose of BNT162B2 via intramuscular from 18Dec2020 to 18Dec2020 with lot number: EJ1685 on right arm. Medical history included allergies to sulfa drugs. Concomitant medication included metronidazole. The patient previously took Ciprofloxacin and Codeine and experienced allergies. On Saturday, 09Jan2021 at 07:00 AM, the patient developed fever, muscle aches, nausea, and vomiting. The outcome of the events was recovered on  Jan2021.  No treatment was given for the events.  No follow-up attempts are possible. No further information is expected.
No medical history information was provided.  Concomitant products included HYDROCHLOROTHIAZIDE, CARVEDILOL, SIMVASTATIN and ESCITALOPRAM for an unknown indication.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (102.2F fever). 12-Mar-2021, the patient experienced NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Headache in front of forehead) and VACCINATION SITE PAIN (Right arm of injection hurts). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, tid. At the time of the report, PYREXIA (102.2F fever), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Headache in front of forehead) and VACCINATION SITE PAIN (Right arm of injection hurts) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 102.2 (High) 102.2F fever.  The action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-Jun-2021 contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No adverse event; Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster).    This case contains information of patient 06th out of 20 reported patients.  No concomitant product reported by reporter.  Moderna monovalent vaccine was administered to approximately 20 patients from 11-Jan-2023 to 21-Jan-2023, instead of the Moderna bivalent booster.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704234 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704234:Master
Both hands extreme joint pain. Lathered them in over the counter arthritis cream and took Advil. Started making arrangements to see a doctor 10+ pain scale.
Chills, Fever, sore throat, running nose, constipation, Diarrhea, shortness of breath, muscle cramps in both legs, muscle aches in all parts of body.  Each symptom was not severe except muscle cramps.  Muscle aches and shortness of breath still happening.
My daugters left leg has been swelling up since Monday.  Redness, swelling, and extremely high temperature at the injection site. The swelling has been so severe that the back of her thigh started to get dimples, and there is a noticeable difference in the size of her thigh. Her appetite has also greatly decreased and she is more tired since the date of the vaccinations. And she has been very fussy since the shots.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 23-SEP-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 10-APR-2017 and to date continues to have reoccurring outbreaks and permanent nerve damage. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the events to be related to ZOSTAVAX. The events of Shingles outbreak/continues to have reoccurring outbreaks and permanent nerve damage were considered to be disabling. Additional information has been requested.
PATIENT EXHIBITED ERYTHEMA, PAIN AT THE SITE OF INJECTION AND SLIGHT SWELLING. PATIENT WAS INSTRUCTED TO APPLY A COLD COMPRESS AND TAKE ACETAMINOPHEN FOR THE PAIN (NSAIDS WERE NOT AN OPTION FOR THIS PATIENT). AWAITING FINAL OUTCOME OF TREATMENT FOR SYMPTOMS.
A bit of expected soreness around the injection site, and fatigue lasting up to 30 hours after the injection
Still with sore arm a week later; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The case was reported by the patient himself who was the registered pharmacist. The health care professional stated that he received the dose of Shingrix a week before reporting and still had a sore arm a week later till the time of reporting. The reporter did not agree to follow up from GlaxoSmithKline.
12 hours after  the injection. Developed "cold feeling" and muscle aches/join pain. no chills, no fever. no GI/Resp symptoms. lasting for about 30 hours and resolved completely
I am unable to locate my vaccine card for that information but the adverse event started about a week after my vaccine. So after I had the second dose, my blood platelet count dropped dramatically, also my ammonia levels were elevated. Normal ammonia levels are 11-32 MM/L and my ammonia levels spiked up to the 70s on 4/29/2021. My vaccination was received on the 19th of April I think, I am not positive. So my levels spiked and I became hallucinogenic. It was quite an event, I had three police officers in my house. So we have had problems controlling my ammonia levels since then. My iron levels are also elevated and my platelet count is way way down as well. The vaccine may have triggered some sort of autoimmune response is kind of what my DRs are thinking right now. Once we get more information on that then we will be able to see why my body reacted the way it did. I went to the ER on 4/29/2021 and they did tests and then they sent me home. I have follow up appointments with DRs.
06/10/98 pt exp nausea;06/11/98 h/a, hot,sweaty & dizzy. 06/12/98 pt called MD. Weak & dizzy when up, h/a cont. Temp to 100 night of 06/11/98.06/13 cont fever 99.5, weak. 06/14 sx gone.
Pt c/o itchiness to tongue and face 26 mins after receiving her first dose of the vaccine. She noted that she has hx of allergy to PCN, Medrol dose pack, A. Fib for which she had ablation and takes Eliquis, hyperlipidemia for which she takes atorvastatin, GERD for which she takes Nexium. She was assessed and monitored by NP, EMT and Paramedic. She had no difficulty breathing, throat swelling or rash. Initial BP- 178/81, HR - 69, O2 sat- 97% on RA. Subsequent BPs: 174/86, 166/76, last 140/86. She took a dose on 25mg Benadryl that she had in her purse. She was kept until she reported that she felt better and had no complaints. She was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to call 911 and go to the ED, follow up with her PCP, register with V-safe. Also instructed to avoid driving and operating equipment until tomorrow due to possible drowsiness from the Benadryl. She verbalized understanding and willingness to comply. She left site with daughter who noted that she will be driving her home and staying with her. She left in no acute distress, awake, alert, oriented to person, place, time and situation.
This spontaneous report was received from a nurse and health professional and refers to a 4 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
mom reported pt had a sl fever <100 w/swelling about the size of a quarter in the rt thigh; also stated inc fussiness & crying the area was pink-warm to touch & very firm;
Received call to the Advice Line from daughter at 10:47 am. Daughter was called back at 11:20 am by the Advice Line nurse. Reports some nausea yesterday after patient received the COVID-19 vaccine. This morning the patient was barely walking, dizzy, nausea, stomach hurt. Around 9:30 am vomited bright red blood. No fever, cough, chest pain, difficulty breathing. Recommended daughter take patient immediately to the ER.