chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a Licenced Practical Nurse who put the 46 year old female patient on the line to provide details. The patient had no pertinent medical history and no drug reactions/allergies. Concomitant medications included hydrochlorothiazide (indication not specified).  On 04-APR-2017, the patient received a dose of RECOMBIVAX HB intramusculalry in her left arm for hepatitis B prevention (lot # N002914; expiration 04-NOV-2019). The patient developed pain all throughout her arm immediately following administration of the vaccine which lasted the rest of that afternoon and into that night. When she woke up on 05-APR-2017, her arm no longer hurt, but the pain had traveled into her left hand. The patient also experienced numbness and tingling in her left hand and reported the entire palm of her left hand was swollen, particulalry the joints between her index and middle fingers. Her hand was so swollen she could not make a fist. She had to tape her index and middle fingers together to kep them from moving around too much and causing pain as anytime she bumped those fingers on anything it would hurt really bad. The patient reported she was unable to use her hand very well as a result of these symptoms. She took ibuprofen but it did not help at all. The pain, numbness and tingling and swelling have "gradually subsided" and these symptoms were now isolated to her left index finger, but she still had difficulty using her left hand.  Causality assessment was not provided. Additional information has been requested.
Patient had waited the recommended 15 min post shot. Went home and his aunt told us that his eyes became blood shot, his throat started to close. He then proceeded to have 4 seizures. First one being at home, second in the car on the way to the ER, third once they arrived at the ER and fourth on the way inside into the hospital. Patients aunt called us 7/9 to give us the full details of the event. Patient spent the night in the hospital and is in stable condition.
39 yo female was noted ~40 minutes after vaccine to appear flushed. Her face, neck and upper arms were red. Upon questioning she reported she felt hot and itchy. Upon request she removed her jacket. Vital signs normal. She self-administered 25 mg of Benadryl. About 10 minutes later she reported developing a headache but otherwise reported some improvement in feeling hot and her facial/arm redness improved. She was originally given discharge instructions including home precautions and released to self, however a few minutes after leaving the patient walked back into the vaccination site and reported itching in throat with clearing throat.  Patient was administered epinephrine 0.3mg IM and transferred to ER via EMS.
Hives break out on top of foot, back of calf, above hips, belt line on belly.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 53-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th May 2018, 6 days after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved. The reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: At 13:00, the patient received the SHINGRIX. A week after her vaccination, the patient started to experience fatigue for the last week and a half. The registered pharmacist was transferred to medical information for additional assistance.
morning p/vax woke up w/URI lasting 2wk;became tired w/same thing in legs about 30MAR;sought med tx APR98 due to 8lb weight gain over 2wk;SOB;2X edema in legs;
Chills and body ache on the day after shot (all day) took 2 Tylenol 3X during the day/night. Symptoms subsided the second day.  on the 25th & 26th  I have a slight red rash in a 3 inch triangular patter around the injection sight. The rash is still ongoing.
Extreme arm pain starting two hours after vaccine, Headache, extreme arm pain, nauseous, chills, weakness, starting 7am the day after and lasting till 7pm.
After getting my second dose on 3/31 my under arm got extremely swollen. I called hospital to ask a nurse and was told the swelling should be gone by Sunday 4/4. As of today I still have swelling under my left arm.
vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022; Received first dose on 15-Mar-2022 and second dose on 17-May-2022; Patient Administered Expired Doses; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022), EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 15-Mar-2022 and second dose on 17-May-2022) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Bactrim).   On 15-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 15-Mar-2022 and second dose on 17-May-2022). At the time of the report, PRODUCT STORAGE ERROR (vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022), EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 15-Mar-2022 and second dose on 17-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   The caller was a health care professional who stated that they administered the Moderna COVID-19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The caller explained that since the expiration date was not written on the vial, they had not noticed it had already expired Vaccine was stored in refrigerator on 17-May-2022. The vial did not undergo any temperature excursions. Number of doses/vials are 26 doses  No treatment medication information was given.
Onset of Gout flareups (monthly). Treated with naproxen, colchicine, aleve, Voltaren, allopurinol. Uric acid levels when tested were 9.3 and 12.1
was administered only the diluent portion of Rotarix; was administered only the diluent portion of Rotarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4HN3, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 6th April 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 6th April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-Apr-2022 Reporter's comments: Certified medical assistant reported that the patient was administered with only the diluent portion of Rotarix, without being reconstituted. The consent to follow up was given. Additional Supportive Information: The patient received only the diluent portion of Rotarix without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.
Almost immediately, my peripheral vision became filled with moving shapes. And, though I typically do have the black floaters, these are different. Most were white, and looked similar to pinwheel fireworks. Later, I noticed that my peripheral vision started included 'moving patterns' with zig-zag shapes, and these patterns would move in random directions. Finally, there are the stationary patterns, where, again, in my peripheral vision,  random shapes  would appear to filled with  the zig-zag lines mentioned earlier, but the filled shape itself was stationary.
Patient had influenza vaccine on 10-18-07. Complaints on 1/9/08 of numbness for 1-2 wks in arms/feet. 2/22/08 unable to ambulate. 3/2 Placed on vent. (1/21/08 had malignant lymphoma removed from tonsil). MD diagnosis Guillain barre, 2 lymphoma.  6/24/08 Death certificate states COD as respiratory failure with Guillain-Barre Syndrome & lymphoma. as underlying cause.    6/13/08 Reviewed hospital medical records for 2/23-5/16/2008. FINAL DX: diffuse large B cell lymphoma Records reveal patient experienced paresthesias of hands/feet, sore throat.  Had lump on tonsils removed & found to have diffuse large B cell lymphoma.  Weakness & paresthesias worsened & dx w/GBS.  Had very prolonged extensive hospital course complicated by multiple issues: chronic ventilator dependent respiratory failure; tracheostomy; PEG feeding tube; multiple septic episodes; pulmonary embolism; chemotherapy.  Condition worsened, developoed MRSA septicemia, became unresponsive.  Family requested comfort measures only, patient was extubated & expired 5/16/2008.  Patient had cancer and was undergoing chemo and radiation. This was cause of death.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (sore arm), DIARRHOEA (upset stomach/ diarrhea), PALPITATIONS (heart palpitations) and TINNITUS (Tinnitus) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for Blood pressure, ALENDRONATE SODIUM (FOSAMAX) for Bone injury, LATANOPROST for Glaucoma, LEVOTHYROXINE for Thyroid atrophy NOS.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache), PAIN IN EXTREMITY (sore arm) and DIARRHOEA (upset stomach/ diarrhea). On 02-Mar-2021, the patient experienced PALPITATIONS (heart palpitations), TINNITUS (Tinnitus) and INJECTION SITE REACTION (flash/current wave from injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 1 dosage form. On 28-Feb-2021, HEADACHE (headache), PAIN IN EXTREMITY (sore arm) and DIARRHOEA (upset stomach/ diarrhea) had resolved. At the time of the report, PALPITATIONS (heart palpitations), TINNITUS (Tinnitus) and INJECTION SITE REACTION (flash/current wave from injection site) outcome was unknown.            Reporter did not allow further contact
APPROXIMATELY  10 MINUTES AFTER RECEIVING THE VACCINE, PATIENT BEGAN TO EXPERIENCE ITCHING ON THE ROOF OF HER MOUTH  AND BACK OF HER THROAT, GENERAL FEELING OF MALAISE, LIGHT HEADEDNESS AND SLIGHT BLURRED VISION.  PATIENT REFUSED EPI SHOT,  BUT WANTED TO  TAKE AN ORAL DOSE OF DIPHENHYDRAMINE.  PATIENT TOOK 25 MG DIPHENHYDRAMINE AT APPROX 8:20.  DOSE WAS REPEATED AT 9:00.  AT 9:20, PATIENT STATED SYMPTOMS WERE DISSIPATING.  11:50 am PATIENT WAS SLEEPING, BUT STATED SYMPTOMS WERE WERE VERY LIGHT, NO MORE BLURRED VISION.   6:20 pm PATIENT REPORTED NO SYMPTOMS AND NO MORE DIPHENHYDRAMINE  HAD BEEN TAKEN .
Information has been received from a physician concerning a male with a history of shingles on his lower back three or four times a year, who was vaccinated with Zostavax. Approximately one month after being vaccinated, the patient developed shingles on his lower back. As of 10-SEP-2007, the patient was recovering. Additional information has been requested.
This spontaneous report was received from a female consumer of unknown age referring to herself.The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, site of administration, lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (manufacturer unknown) (lot # and expiration date were not provided) and acyclovir (ACYCLOVIR) (dose, frequency, lot #, and indication were not provided). The patient reported that she received ZOSTAVAX on an unspecified date while taking acyclovir (ACYCLOVIR) (manufacturer unknown).  It was reported that the patient's physician informed the patient on an unspecified date that the ZOSTAVAX was not effective because she was taking acyclovir (ACYCLOVIR). The outcome of the event was not reported. No adverse experiences were reported. No further information was reported. Additional information is not expected. as no contact details were provided and consent to contact was denied.
Information has been received from a pharmacist concerning a 9 year old female who on an unspecified date was vaccinated with a dose of VARIVAX. "Three weeks post vaccination with VARIVAX," the patient started to develop pox on legs (20 pox), arms (5 pox) and head (3 pox). The pox were described as "larger mosquito bites" that were red and itchy. The patient contacted the pharmacist. The pharmacist considered this atypical breakthrough since none of the pox was on the trunk. At the time of the report, 30-OCT-2008, the patient had not recovered from the pox. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with OKA/Merck vaccine VZV strain. Follow-up information was received on 14-NOV-2008 from the pharmacist indicating that on 17-SEP-2008, the 9 year old female patient with no past medical history or allergies was vaccination in the left arm with a first dose of VARIVAX. There was no concomitant medication. The patient had no recent exposure to chickenpox or shingles. It was reported that the patient developed 35 lesions on legs, arms and head. Two samples of the lesion were collected from the vesicle on 31-OCT-2008. The PCR results revealed inadequate specimen, negative for B-globin, no strain identification. It was reported that the patient had recovered from the events. Follow-up information was received on 20-NOV-2008 via phone call from the pharmacist who reported that the patient's rash was an unusual rash due to the distribution on her legs, arms and head. He also reported that the rash had cleared. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 08Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Irritable Bowel Syndrome" (unspecified if ongoing); "Spastic colon" (unspecified if ongoing); "Seasonal Allergies" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Chronic Eustachian Tube Dysfunction" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "High Blood" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZETIA; HYDRALAZINE; ESTRADIOL TRANSDERMAL; OMEPRAZOLE; LIVALO; SINGULAIR; FLONASE [FLUTICASONE PROPIONATE]; CALCIUM CITRATE; VIT D3; MAGNESIUM; ZINC; VIT E [TOCOPHEROL]; VIT C; SUPER B COMPLEX [VITAMIN B COMPLEX]; VIT B2; QUERCETIN; TART CHERRY. Past drug history included: Macrodantin, reaction(s): "Known allergy: Macrodantin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Positive; (20Oct2022) Positive; (21Oct2022) Positive; (22Oct2022) Positive; (23Oct2022) Positive; (24Oct2022) Positive; (25Oct2022) Positive; (26Oct2022) Positive; (27Oct2022) Positive; (28Oct2022) Positive; (29Oct2022) Positive; (30Oct2022) Positive; (31Oct2022) Positive; (01Nov2022) Positive; (02Nov2022) Positive; (03Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  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.
Headache, muscle pain, nausea, body aches, itchy eyes, vision not normal need to blink few times to reset eye to read, point of needle entry is slightly red.
No adverse event; Patients received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent) 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 (Patients received 0.5 ml the Moderna booster as opposed to the bivalent).    No concomitant medication details was reported. It was reported that patient had 0.5 ml of a regular Moderna booster. No treatment medication details was reported.
Information has been received from a physician concerning a 12 month old patient who on 20-JUN-2008, 06-AUG-2008 and 01-OCT-2008 was vaccinated with the first, second and third dose of ROTATEQ respectively. On 07-APR-2009 the patient experienced rotavirus and was hospitalized. The patient had no long-term effects and recovered. It is unknown if the patient sought medical attention. Additional information has been requested.
Received vaccine on 1/4/2021 at 15:15 hours.  A few minutes after the shot, I felt a warm wave come over me , kind of felt like passing out but didn't, heart started racing and hands became clammy/shaky.  I sat down and after a few minutes it passed so I went back to work.  On 1/5/2021 I started to become slightly dizzy with a mild headache lasting all day.  On 1/6/2021 dizziness and slight headache persisted with slightly blurred vision.  On 1/7/2021 I felt slightly better in the morning but as the day went on the dizziness returned with slight headache and blurry vision.  At approximately 16:00 hours I was speaking with my NP,  and went over my symptoms.  She suggested getting my blood pressure taken.  It registered at 154/115.  I called my PCP and I was able to be seen the same day.  I was given clonidine and it came down but on morning of 1/8/2021 it was back up getting as high as 160/120.  Called my PCP back and he prescribed Olmesartan.  It seems to have stabilized my BP but he is unsure why the vaccine has caused this and why it is persisting.
Can't sleep on side with injection; experiencing pain in her arm after received the vaccine; swelling in her arm after she received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can't sleep on side with injection), VACCINATION SITE PAIN (experiencing pain in her arm after received the vaccine) and VACCINATION SITE SWELLING (swelling in her arm after she received the vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and GABAPENTIN for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INSOMNIA (Can't sleep on side with injection), VACCINATION SITE PAIN (experiencing pain in her arm after received the vaccine) and VACCINATION SITE SWELLING (swelling in her arm after she received the vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (Can't sleep on side with injection), VACCINATION SITE PAIN (experiencing pain in her arm after received the vaccine) and VACCINATION SITE SWELLING (swelling in her arm after she received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
On 12/23/02 c/o abdominal pain but not much change till sent out to hosp 1/2/03 due to ascending weakness. Dx by MD as Guillain Barr syndrome. Given IVIG 2 gram/kilo over five days. Returned to prison. Currently paralyzed but no breathing problems and can wiggle fingers and toes. Some improvement. Follow up: No additional information reported.