chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23 (lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for VARIVAX reconstitution was stored properly. Doses of VARIVAX was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of GARDASIL 9, ROTATEQ,  PNEUMOVAX 23, RECOMBIVAX HB, and VAQTA were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. Follow-up information has been received from the physician on 23-JAN-2018 referring to the male patient. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with agency and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. He was vaccinated with improperly stored doses of GARDASIL 9. The following initials are patients who received vaccines that were stored in refrigerator and these patients are being contacted to be re-vaccinated. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1801USA004018:
A wound that has not healed, the vaccine made a little wound with swelling  back in July, and as of OCtober 14 - still has not healed properly
Site pain and swelling for 6 days after vaccination. Day 7 post vaccination; redness, itching, edema at injection site, circular area, about 5 inches in diameter. Plus swollen, painful axillary  lymph nodes bilaterally.
Post vax, pt returned to ER with redness, swelling in area of inject 1/19. Dx cellulitis. TD possible cause. In-house stock of this lot sequestered.
TOOK LAST DOSE A WEEK AFTER THE THIRD DOSE; This spontaneous case report (PVX2019-2530) was received from a pharmacist on 09-Oct-2019. It described a consumer who "took last dose a week after the third dose" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took all the three doses of Vivotif according to the schedule. However, the consumer took the fourth dose a week after the third dose.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took last dose a week after the third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose a week after the third dose" was considered as not applicable.
Information has been received from a registered nurse concerning a 9 month old male who on 20-AUG-2008, 20-OCT-2008 and 17-DEC-2008 was vaccinated orally with a first, second and third dose of ROTATEQ (lot # 660376/0019X, 661037/0641X and 662884/1127X, respectively). It was reported that on 04-FEB-2009 the patient was seen by nurse and brought to emergency room and was diagnosed of diarrhea and dehydration. Reporter did not specify if the patient was admitted in the hospital. Emergency room demographics unspecified. On an unknown date, the patient recovered from diarrhea and dehydration. Follow-up information was received from the R.N. on 26-MAR-2009 which reported that the patient was not admitted in hospital. No further information is available.
Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number abxA87az, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 21-APR-2022 Reporter's Comment: The patient received an expired dose of Bexsero. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Bexsero which was already expired, which led to expired vaccine used. This was one of 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068144:Same reporter. US-GLAXOSMITHKLINE-US2022068148:Same reporter.
muscle aches; bone aches; nausea; vomiting; fever; massive migraines; felt bad; irritable bowel syndrome; This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine.   In March 2019, the patient received the 1st dose of Shingrix. In March 2019, 21 days after receiving Shingrix, the patient experienced irritable bowel syndrome. On an unknown date, the patient experienced muscle pain, bone pain, nausea, vomiting, fever, migraine and feeling bad. On an unknown date, the outcome of the muscle pain, bone pain, nausea, vomiting, fever, migraine, irritable bowel syndrome and feeling bad were recovered/resolved.   It was unknown if the reporter considered the muscle pain, bone pain, nausea, vomiting, fever, migraine, irritable bowel syndrome and feeling bad to be related to Shingrix.  Additional details were provided as follows: The nurse reported these adverse events were experienced by herself. The age at vaccination was not reported. Two months ago (from the date of reporting), the patient received 1st dose of the vaccine.  About 3 weeks later, the patient developed irritable bowel syndrome (IBS).  The patient had parasite testing as well as abdominal and pelvic ultrasound done. All results returned normal. Less than a year after receiving the 1st dose, the patient experienced muscle and bone aches, nausea with vomiting, fever and massive migraines and she felt bad. The patient remarked that she was very hesitant to get 2nd dose, but followed through with receiving it as she was a registered nurse and recognizes the importance of completing the series.  After receiving 2nd dose, the patient felt so bad as the first time and that she had to take a day off of work, for tolerance refer case US2019GSK086655.   The patient also commented that pharmacist really needs to highlight the horrible side effects of the vaccine.  No other details provided.      Lab Comments: On an unknown date, parasitic test, abdominal and pelvic ultrasound was performed.
Passed out; This is a spontaneous report from a contactable consumer (Patient's parent). A female patient of an unknown age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number FD0809 ), on Sep2021 as single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The patient received the vaccine dose in Sep2021 and she just passed out for like 10 minutes. The outcome of the event was unknown.  Follow up (17Sep2021): Follow-up attempts are completed. No further information is expected.
Inconsolable crying for 3-4 hours. Dad states she had no fever or other symptoms. Finally cried herself to sleep after 4 hours.
The pt had loss of head control; eyes rolling; crying; stopped talking (cooing); stopped playing with toys; very crabby and losing breath. Uncontrolled seizures. Per 213165, 60-day follow up, patient started to have seizures and now he has seizure disorder. patient's parents blame the shot for their son's condition.
Injection site is swollen, red, and tender to touch.  Arm feels numb, and tingly
Severe Joint Pain - 2 days Fatigue - 3 days Lightheadedness - ongoing (has lasted 7 days so far. Usually occurs when walking) Heart Palpitations - ongoing (has lasted 7 days so far. Usually occurs when walking) Mild Chest Pain - ongoing (has lasted 7 days so far) Shortness of Breath - ongoing (has lasted 7 days so far)
Approximately 5 minutes after injection while patient was in waiting area for monitoring, he lost consciousness and fell and hit his head. A few moments later he recovered but complained of head pain most like due to the impact after falling.  He then said his shoulders and neck were hurting.  Later in the day after MRI showed everything was ok, he still complained of neck spasms.  It seems like he is ok but it is unknown at this time.
On the day I received my second dose I had soreness in my left arm and could not lift it. I also had body aches, low grade fever, chills and night sweats that lasted about 12 hours. On 09/12/2021 I felt like I was cold and was having body aches and runny nose and congestion. My symptoms worsened for the next few days. I started having night sweats and chills and a fever of 100.1. On 9/15/2021 I have a virtual visit with my doctor, and they thought I had bad allergies and prescribed steroids. The next day I lost my sense of taste and smell. The fever had improved but I was still fatigued and having night sweats, congestion, and drainage. I got a COVID-19 test on 9/21/2021 and tested positive. At that point my symptoms were improving so I just isolated at home, drank fluids, and took Tylenol. I experienced brain fog and fatigue for another 2 weeks.  I learned several people I had been with all the same symptoms. Five of us in total. However, everyone else that was tested, tested negative.
Patient received flu vaccine into left low deltoid. Patient felt immunization missed the muscle.  About 4-6 hrs later, she noted swelling, pain, and redness at the site. This began to subside about 3-4 days later, and today, 1 wk later, has only 2" x 2" bruising at the vaccination site. She also noted a slight frontal headache beginning night of vaccination and lasting about 2 days. Of the most concern to the patient was the onset the day after the vaccination of abdominal cramping, bloating, and constipation. Mild nausea, but no V/D. Appetite is good. No melana or hematochezia. Better, but not completely well, today, 6 days after onset. No fever or other symptoms. She had a similar issue of injection site redness and swelling with last year's flu shot, but without the abdominal complaints.
itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back; itchy all the way down inner legs; right arm hot/right hand hot; body sore; fever; right arm swollen/right arm swollen; right arm red/right hand red; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back), PRURITUS (itchy all the way down inner legs), VACCINATION SITE WARMTH (right arm hot/right hand hot), MYALGIA (body sore) and PYREXIA (fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Allergy to animals (Allergies to cats,shelfish), Latex allergy, Allergy to molds, Grass allergy, Allergy to nuts, Drug allergy (Allergic to lisinopril, speralactose, tramadol, cipro, sulfur.), Multiple allergies (Allergic to rye, barley, cherries, chocolate, dust mites, roach feces.) and Penicillin allergy. Concomitant products included EPINEPHRINE (EPIPEN), BUMETANIDE, BUPROPION, CYCLOBENZAPRINE, PANTOPRAZOLE, PRAZOSIN, CARVEDILOL, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FLUTICASONE, RISPERIDONE, DICLOFENAC SODIUM, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), METFORMIN HYDROCHLORIDE (METFORMIN ER), MULTIVITAMINS [VITAMINS NOS], GABAPENTIN, LUBIPROSTONE (AMITIZA), CITALOPRAM, DICYCLOMINE [DICYCLOVERINE] and LEVOFLOXACIN HEMIHYDRATE (LEVOZINE [LEVOFLOXACIN HEMIHYDRATE]) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RASH PRURITIC (itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back), PRURITUS (itchy all the way down inner legs), VACCINATION SITE WARMTH (right arm hot/right hand hot), MYALGIA (body sore), PYREXIA (fever), VACCINATION SITE SWELLING (right arm swollen/right arm swollen) and VACCINATION SITE ERYTHEMA (right arm red/right hand red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY/COLD) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back), PRURITUS (itchy all the way down inner legs), VACCINATION SITE WARMTH (right arm hot/right hand hot), VACCINATION SITE SWELLING (right arm swollen/right arm swollen) and VACCINATION SITE ERYTHEMA (right arm red/right hand red) had not resolved and MYALGIA (body sore) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site discoloration in a 55-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 2nd June 2018 15:22, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd June 2018, immediately after receiving SHINGRIX, the patient experienced injection site discoloration, injection site swelling, injection site erythema and injection site burning. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the injection site swelling, injection site erythema and injection site burning were recovered/resolved. It was unknown if the reporter considered the injection site discoloration, injection site swelling, injection site erythema and injection site burning to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in the left deltoid at approximately 3:22 PM and she reported that the area on the muscle turned darker in color and she felt a burning feeling with redness and puffiness at the injection site. The patient experienced discoloration at the injection site, approximately the size of a half dollar coin. The patient felt the vaccine liquid when she received the vaccine as though the liquid was between her skin and the muscle. The patient had since received the 2nd dose of SHINGRIX with no side effects, however, the site discoloration remained.
This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was inoculated with ZOSTAVAX at a medical group as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and indication not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated at the same medical group for a blistering vesicular outbreak that was diagnosed as a severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Flu vaccine administered in left deltoid. Swelling around site about 100 mm with redness surrounding about 130 mm by evening. Sought opinion of PHN 10/6/14. Suggested icing swelling. Today definitely improving. No c/o of pain just itching.
Dry cough Tiredness Fever up to 103 body aches Arm soreness at injection site
sleepiness; weak; upset stomach; This is a spontaneous report from a contactable consumer or other non hcp.   A 65-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 18Jan2021 (Lot number and Expiry date was not reported) as 1st dose, single dose for COVID-19 immunisation (age at vaccination 65-years-old). Medical history included Penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was unknown if patient had COVID prior vaccination and unknown if COVID tested post vaccination. On 18Jan2021, the patient experienced sleepiness, weak and upset stomach for 4 days starting day of vaccination. Therapeutic measures not taken due to events. The outcome of the events was resolved (4 days starting day of vaccination) on 22Jan2021.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Blood Clot in left leg; This is a spontaneous report received from a contactable consumer or other non hcp.  A 59-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FL3302) via an unspecified route of administration in Arm Left on 22Jan2021 at 16:00 (age at vaccination 59-years-old) as dose 1, single for covid-19 immunization. The patient also received other Pfizer vaccine (batch number: EM9809) as dose 2 on 22Jan2021.The patient did not had any medical history. Concomitant medications included esomeprazole (ESOMEPRAZOLE), ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), ascorbic acid, calcium carbonate, calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX WITH C). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19.On 06May2021, the patient experienced blood clot in left leg. The patient received treatment blood thinning medication x 3 months for the adverse events. The patient had not yet recovered from the events.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning female nurse who in 2003 was vaccinated with two doses of Varivax. On 13-DEC-2006, the patient's titers were less than 0.91. No additional information to report. Additional information has been requested.
muscles shaking, quivering (left calf muscle and left thigh), lips go numb, and left arm in injection site still hurts
Rash; lump and fever at injection site; lump and fever at injection site; Pain at top of right leg; Slight bruise on leg; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-year-old non-pregnant female second dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration on 25Feb2021 (age at the time of vaccination 70-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 04Feb2021 11:30 AM (age at the time of vaccination 70-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Patient had known allergies. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. On 25Feb2021 16:45, the patient experienced Rash, lump and fever at injection site, Pain at top of right leg, and Slight bruise on leg. No treatment was received. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient came to pharmacy and got a dose of Janssen covid vaccine in the middle of Moderna series at a different facility
Agitation, Myalgia, Palpitations, ARM PAIN, DRY MOUTH, FACIAL SWELLING Narrative:  Other Relevant History:
This spontaneous report was received from a pharmacy intern and refers to a 60 year old female patient. No information about the patient's medical history, concomitant medications and drug reactions or allergies was reported. On 23-DEC-2016, the patient was vaccinated with ZOSTAVAX injection, lot # M014310, expiry date 26-MAY-2017 (dose, route of administration and anatomical location were not specified) and PREVNAR 13 (dose, route of administration, anatomical location, lot # and expiry date were not provided). On 24-DEC-2016, the patient began to experience swelling, redness and bruising at the injection site along with a rash that extended from the patient's arm down to her wrist. No treatment was given due to the adverse events. The patient did not seek the medical attention. The outcome of the events was reported as recovering (reported as "were getting better"). The reporter did not provide the causality assessment between the events and the suspect vaccines. Additional information has been requested.
Immediately following bandage application over site of yellow fever vaccination, patient lost consciousness and had a seizure lasting less than 2 seconds. Emergency services were contacted by another pharmacy associate, patient immediately started coming through, took about 2 minutes before he was aware of his surroundings. Patient was given some food and water while he was recovering. 10 minutes after vaccination, emergency services arrived, took vitals, and declared patient had no symptoms and all health information was normal. Parents elected to have them take him to hospital for further observation.