chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 17 year old male patient (also reported as a child). On an unknown dates the patient was vaccinated with complete series of three doses of hepatitis B (manufacturer unknown) 5 mcg/0.5 ml once (doses, lot numbers and route os administration were not noted. The outcome of low antibodies levels were unknown. Relatedness between low antibodies levels and therapy with hepatitis B vaccine (manufacturer unknown) was not provided. Additional information has been requested.
Arm rash at and below vaccination site started day after and worsened through 4/14. Arm: warm raised patches of diffuse erythema, (+) TTP distal to deltoid.
9/30/03: Mother called office on 9/30/03 stating child was irritable and had a fever. Spoke to Dr. Mother instructed to continue Tylenol.
Shortness of breath, lethargic, swelling of lower extremities, fatigue, headaches
Patient experience CVA type symptoms and was found to have a subacute right corona radiata infarct.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9, lot number was L024993 and expiration date of 17-OCT-2017 (strength, dose and route of administration were unknown), which was stored at 49 Fahrenheit Degree for 8 hours and 9 Fahrenheit Degree for 39 hours and 20 minutes. Then, the vaccines were back in range. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
syncope 4 hours after chills 2-5 hours after body aches off and on for 7 days
I had headache, fatigue, congestion. I got a monoclonal antibody infusion, the symptoms lasted 4 days.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 10-AUG-2015, he patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L012038, expiration date 17-APR-2017, dose and route were unknown) instead of an intended dose of ZOSTAVAX. ZOSTAVAX was not administered. No adverse effects reported. No product confusion reported. This is one of two reports received from the same source. Additional information has been requested.
a 63 years old female patient received an expired dose of Flublok Quadrivalent, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA316754, 2019SA316760 and 2019SA316778 (same reporter).  This case involves a 63 years old female patient who received an expired dose (0.5 ml ) of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1824 and expiry date 30-JUN-2019) via intramuscular route in the left deltoid on 02-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting no adverse events was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a registered nurse concerning a 15 year old female patient with a history of motor vehicle accident in 2003 (CT scan at that time was normal) and minor head injuries due to sports that required stitches who on 03-MAR-2008 was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscularly, lot # 660387/1967U), and on 07-JUL-2008 the second dose of GARDASIL (0.5 ml, intramuscularly, lot # 660553/0070X).  On 10-OCT-2008 the patient experienced a petit mal seizure and on 18-OCT-2008 had a second seizure.  The nurse stated that each seizure lasted 2 to 3 minutes and it took 30 minutes post seizure for the patient to fully  recover.  Patient was seen in Emergency Room after the 2nd seizure because she bit her tongue which required treatment.  The 3rd GARDASIL dose was delayed pending neurologist's decision.  EEG showed bilateral seizure activity.  Patient is now taking TOPAMAX.  Upon internal review, petit mal seizure, and seizure were determined to be other important medical events.  Additional information has been requested. 12/29/08 Received ER medical records for 10/11/2008. FINAL DX: new onset seizures & hypothyroidism. Records reveal patient experienced HA followed by LOC & parent witnessed generalized seizure lasting approx 2-3 min followed by postictal period of approx 15-20 min.  Had 1 prior seizure on 10/10/08 & seen by PCP.  Referred to neuro.  No further seizure activity while in ER & d/c to home.  2/26/09 Received Neuro consut of 10/16/2008. FINAL DX: solitary seizure & migraines Records reveal patient experienced witnessed seizure activity w/tongue biting & postictal period & preceeded by emesis.  Tx w/meds & referred for EEG.  No further records available.  3/3/09 Received Neuro consult of 10/22/2008. FINAL DX: Epilepsy Records reveal patient had 2 generalized tonic-clonic events c/w epilepsy but unable to determine if partial onset or primary generlized.  Was to continue meds & obtain copy of MRI & EEG done at outlying hospital for review.  No further records available.
I've had 3 Pfizer vaccines and 1 booster. Had 1st symptoms on 06Jul with pos. test. Started Paxlovid 07Jul and took last pills on 12Jul; I've had 3 Pfizer vaccines and 1 booster. Had 1st symptoms on 06Jul with pos. test. Started Paxlovid 07Jul and took last pills on 12Jul; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 82-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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) all with onset 06Jul2023, outcome "unknown" and all described as "I've had 3 Pfizer vaccines and 1 booster. Had 1st symptoms on 06Jul with pos. test. Started Paxlovid 07Jul and took last pills on 12Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2023) Positive, notes: Had 1st symptoms on 06Jul with pos. test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was an 82 yr female in very good health until Covid. She had 3 Pfizer vaccines and 1 booster. Had 1st symptoms on 06Jul with pos. test. Started Paxlovid 07Jul and took last pills on 12Jul. Initial bad symptoms cleared with Paxlovid immediately. By 14Jul symptoms began to return. Cough, nasal congestion, tiredness. She believed she stopped the med too soon. People are not reporting rebounds. The same thing happened to her husband last year. It's way more than you are recording.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253196 different patient, same drug and event;US-PFIZER INC-202300253197 same reporter, different patient, drug and event;US-PFIZER INC-202300253195 same patient, different drug and event;
This spontaneous report was received from a nurse and refers to a female patient of unknown age with hypertension, chronic kidney disease, asthma, rhinitis allergic, back pain, drug reactions/allergies to CIPRO, doxycycline and shellfish and with some other unspecified food allergies. The patient was not pregnant at the time of the report. On 05-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, dose: 0.65 ml, subcutaneously in the left upper arm (lot # and expiration date were not reported). Concomitant therapies included hydrochlorothiazide (manufacturer unknown), EFFEXOR XR and ergocalciferol. On 06-JUN-2015, the patient had pink/red colored, lemon sized rash/blisters at the injection site of left arm. On 08-JUN-2015 (reported as "today"), the patient came into the doctor's office. Rash/blisters were examined and the site was warm to the touch. No treatment was given and no lab diagnostic studies were performed. The outcome of adverse events was reported as not recovered at the time of the report. The patient sought medical attention - he came to the office. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
adverse effects; taking three to four naps daily; difficult to carry on daily activities; these shots have made my life unbearable; my feet feel like ice cubes/ her toes are like ice; one severe headache; severe chills all over my body/freezing all over; severe fatigue/tired all the time; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse effects), SOMNOLENCE (taking three to four naps daily), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to carry on daily activities), FEELING ABNORMAL (these shots have made my life unbearable) and PERIPHERAL COLDNESS (my feet feel like ice cubes/ her toes are like ice) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse effects), SOMNOLENCE (taking three to four naps daily), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to carry on daily activities), FEELING ABNORMAL (these shots have made my life unbearable), PERIPHERAL COLDNESS (my feet feel like ice cubes/ her toes are like ice), HEADACHE (one severe headache), CHILLS (severe chills all over my body/freezing all over) and FATIGUE (severe fatigue/tired all the time). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 1 dosage form. At the time of the report, ADVERSE EVENT (adverse effects), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to carry on daily activities), FEELING ABNORMAL (these shots have made my life unbearable), CHILLS (severe chills all over my body/freezing all over) and FATIGUE (severe fatigue/tired all the time) outcome was unknown and SOMNOLENCE (taking three to four naps daily), PERIPHERAL COLDNESS (my feet feel like ice cubes/ her toes are like ice) and HEADACHE (one severe headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient said that these shots have saved her life  Patient said that there were a lot of side effects     Patient stated that HCP was trying to set up a sleep test at the hospital for the fatigue  Patient stated she does not have a computer and requested information be mailed to her No concomitant medications were provided. No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up contains significant information event added as her toes are like ice.
Injection site soreness, redness and swelling, headache, muscle aches: onset approximately 2 hours post injection and continuing as of time of this report. Fever (100), chills and night sweats: onset approximately 5 hours post injection and continuing for approximately 12 hours. Has resolved. Treatments: Ibuprofen. I experienced the same reactions to the first injection received 13Mar2018.
~2/3 days after receiving shot on 11/4/17, I thought I injured my shoulder somehow but hadn't fallen or strained it or anything. Ground Zero of the pain was right where the shot was given but I didn't put it together at first and went to chiropractor with no relief. Certain motions caused extreme pain and  range of mobility was limited. Difficult to put on or take off shirts, shampoo or dry hair etc. It did not get better, only worsened to tingling in arm and hand/fingers, so went to family Dr. on Nov. 30. He diagnosed reaction to flu shot and prescribed Methylprednisolone 4mg DSPK, Gabapentin 300 mg and physical therapy.
Covid symptoms 20Jun2022 and testing positive again; Covid symptoms 20Jun2022 and testing positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1 , single (Batch/Lot number: unknown), in left arm and in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "unknown" and all described as "Covid symptoms 20Jun2022 and testing positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: still testing positive; (16Jun2022) Negative, notes: Tested again 16Jun2022 and was negative; (20Jun2022) Positive, notes: started having Covid symptoms 20Jun2022 and testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. patient received paxlovid as covid-19 treatment.  Clinical course: No other medication in 2 weeks. Took Paxlovid on day 1 of Covid 06Jun2022. Was told by Dr could return to work 12Jun2022, but work required negative test and still testing positive. Tested again 16Jun2022 and was negative. Scheduled to return to work 21Jun2022 but started having Covid symptoms 20Jun2022 and testing positive again.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Headache (ebb and flow all day), foggy brain, general fatigue, soreness around injection site (very hard to raise arm). Headache, brain fog, and fatigue cleared after 24 hours (including a 12-hour sleep after a day with the symptoms). Soreness around injection site mostly cleared, only mildly remains.
Low grade fever (100F), chills, severe muscle aches all over body, leg and back muscle cramping, severe headache, severe injection site pain, injection site swelling, and severe itching at injection site, moderate itching over entire body. All symptoms started around 4 pm and progressively got worse through the next day, starting to improve 24 hours after onset. Itching was managed by Benadryl (1 pill every 6 hours) other symptoms managed with ibuprofen  (2 pills every 6 hours). Symptoms still present, but at mild levels 48 hours post vaccination.
Right arm still sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Right arm still sore at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 09-Mar-2021, 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Right arm still sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Right arm still sore at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
pt called & stated area red & large knot ? react in clinic 14JUN94; pt w/local redness, warm to touch, edema, induration side of 7cm; tender to touch; malaise; c/o itchy;
No further adverse events; administered dose of expired PROQUAD; This spontaneous report was received from a medical assistant, referring to a 2-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 25-MAR-2022, the patient was vaccinated with 1 dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA, lot # T025506, expiration date: 23-JAN-2022, dose, strength and route were not provided) for prophylaxis (expired product administered).  No additional details provided. No further adverse events/no product quality complaints.
Pt right leg became red and swollen with a 2x2 knot with about 4-5 bumps after 7 days of receiving her varicella vaccine. Mom states the redness, swelling, knot and bumps have gotten better and are almost gone now.
Information has been received from a physician concerning a 32 year old male who is a resident doctor, with no known medical history or drug allergies who on 07/27/2001 was vaccinated with a dose of varicella. Concomitant therapy included Accutane. On 08/10/2001, the pt experienced a generalized rash and Valtrex was ordered. The pt was seen on 08/13/2001 and it was reported that his symptoms were subsiding. On 08/14/2001, the pt was seen again and it was reported that the areas were crusted over. No further symptoms were noted. Follow-up info received from the physician reported that the pt had complete resolution of his symptoms and no further work-up was done. No further info is available.
On Sept 21, 2007 I received the shingles  serum I was assured I would never get shingles and if I did it would be mild. On Sept 18, 2009 I had the shingles and it wasn't mild.  It's now Nov 10 and I still have the nerve pain. When I called the drug company,  they informed that in your 80s it's only 15% effective. Only doctor's visit I paid $215 for the shingles medicaire does not pay for the shot.
Itchy around injection site for a day or so, and then 2 inch diameter circle formed around injection site, still very itchy
patient wanted shingrix, flu, pneumovax 23--gave all 3 immunizations, pt was standing in checkout 20 minutes later and had intense hip pain.  came up behind him with chair and he had a few more shooting pains, gave water and 15 mins to rest , then felt perfectly fine---followed up the next morning and patient was "feeling fine"
Single hive at the administration site. Lasted 7-10 days. No lingering effects at this time.
pt recvd vax & exp flu-like sxs severe w/T102 worsened; 2 MD's dx PMR (polymyalgia rheumatica)
4/23/09 - reviewed PROTCOL questions with patient, denied steroid use  4/24/09 - patient came to pharmacy and showed pharmacist shingles-like rash.  MD notified & gave pt VALTREX and appt scheduled 4/27/09 Called pt 4/25/09 & she's feeling better on medicine.  MD said she had steroid epidural recently
Information has been received from a 70 year old consumer with allergy to indomethacin sodium (MSD) (WAES# 1202USA03612) who on 21-DEC-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 671611/1161AA, dose, route and expired date unknown), which was recommended friends. There was no concomitant medication. Consumer mentioned that 7 years ago he had "internal shingles" in the left hip area. He also mentioned that he always had some sensitivity after recovering from the first occurrence of shingles. Consumer did not have any "sensitivity" symptoms on the day he received ZOSTAVAX (Merck). He received a vial of ZOSTAVAX (Merck) from a pharmacy and took it to physician's office within 30 minutes to be administered (he was there in 5 minutes). On 22-DEC-2011, the consumer experienced left hip "sensitivity", burning, itching and severe pain. The patient got shingles again. No lab diagnostics study was performed. LYRICA and medications were given for "anti-reverse virus in system". The patient sought medical attention from unspecified physician and unspecified neurologist. At the time of reporting, the patient had 95% recovered. This is one of several reports received from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ZOSTAVAX (Merck). Additional information will be provided upon finalization of manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirement of the Center of Biologics Evaluation and Research and was released. No further information is available.
Approximately 11 hours post vaccine administration, patient woke middle of the night up with body aches, joint pain & chills. She self treated with Tylenol. Continued with joint pain, chills on 9/22/2021.  Was improved on 9/23/2021, back to normal on 9/24/2021.