chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 64 year old female patient with drug reactions/allergies to Morphine and with no pertinent medical history. On 20-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006828, expiration date 14-SEP-2014), dose not reported, subcutaneous to prevent shingles. Concomitant therapies included Tylenol, Losartan potassium (manufacturer unknown), Ibuprofen, fish oil, Simvastatin (manufacturer unknown), Ubidecarenone, calcium (unspecified) and multivitamin. On 24-NOV-2013, the patient experienced shingles after received ZOSTAVAX. No lab diagnostics studies were performed. The treatments of Famciclovir and hydrocodone were given to the event. The outcome of the event was reported as not recovered. The patient had sought medical attention by office visit. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 58 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 at 08:00 as dose 1, single (Lot number: EL9264), in right arm, on 25Feb2021 at 09:00 as dose 2, single (Lot number: EN 5318), in right arm and on 18Jul2022 at 15:00 as dose 3 (booster), single (Lot number: FP7139), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "heart rhythm" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL; IRBESARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Oct2022) Positive, notes: Return of covid symptoms 7 days after completing course of paxlovid. Positive test for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid.
Patient described feeling flush after vaccination which then turned into dizziness and nausea.  This progressively lessened during 90+ minutes of observation.  Patient was instructed to have another individual drive her home and to rest and hydrate for the  next 48 hours.
Muscle aches, joint pain, swollen lymph nodes in neck, chills, sore throat/tonsils/back of tongue
Pt had numbness, couldn't move left arm, for a few hrs. Went to ER, but left before being seen. Next day pt doing fine, except for some pain. This was 2nd injection.
MEDICATION ERROR; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 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. No concomitant medications were reported. On an unspecified date, the subject experienced medication error, and expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and expired vaccine administered was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a 6-months old patient of unknown gender. The patient's medical history included chickenpox on an unspecified date. On an unknown date, the patient received the first dose of (Oka/Merck) VARIVAX (dose, route of administration, lot number and expiration date were not reported) at the age of 6 months. On an unspecified date at the age of 1 year, the patient received the second dose of (Oka/Merck) VARIVAX (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
First vaccine shot received 9am Tuesday 4/13 5.5 hours after shot and lunch, face reaction, red, hot, splotchy, tight skin feel Reaction only on face lasted 20min  Wednesday 4/14 - super nauseous and cramping 2:30pm last an 3 hours. Cramping lasted 30 min.   Friday 4/16 9pm - Face reaction - red, hot, blotchy, tight skin feel, sunburned feel Reaction during dinner lasted 1 hour.
I was getting ready for bed and I noticed I had chills, bumps on my arm and I was cold. Immediately I thought of COVID-19. Recently I had made a trip. I went to bed and woke up feverish and knew I was sick my temperature was one hundred and one when took my temperature, later in the afternoon I was positive for COVID-19. I called the night clinic and got a doctor online, he returned my call and asked when I tested positive and prescribed for me PAXLOVID and antibiotics for my cough.
Developed hives to the chest within 1.5hrs of taking the vaccine.  Home Tx: Ice to the affected area which resolved the hives She called her PCP who advised she should take benadryl; if it recurred.
Medium-High Fever 102 Muscular pain Inability to sit up for more than 1 hour Body shakes Neck pain
None- but he had previously gotten two doses of pfizer and lied and said he had never had a covid shot so he could get the full moderna dose instead of the booster dose
Congestive Heart Failure; other zoster-related conditions; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2010, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) as prescribed for the long-term prevention of shingles and zoster-related condition. Subsequently, on an unknown date, the patient was treated by healthcare providers for congestive heart failure and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The causality assessment between congestive heart failure, herpes zoster and other zoster-related conditions and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, the event of congestive heart failure was determined to be medically significant.
Developed flu like symptoms about 6 hours after receiving the vaccine. About 12 hours after receiving vaccine, I developed tachycardia. Saw primary care doctor the next day. About 2 days later, I developed pain in my right side. Bedford Memorial Hospital Dr. said it was a severe case of Shingles. A raised rash developed, but due to the antiviral medication the ER Dr gave me, it seemed to slow the rash and keep it from developing the fluid filled bumps. Where the rash is subsiding (after 2 weeks), I am still dealing with unbearable pain that wraps around the right side of my torso from my spine to my stomach. I was taking Morphine (Ibuprofen and Gabapentin) to control the pain, but because of severe gut issues, I stopped the Morphine & Ibuprofen. I'm currently taking the Gabapentin and Tylenol. However, my gut issues remain. I have no appetite and cramping and diarrhea . I'm heading back to the Dr tomorrow for more testing.
Left arm pain with limited range of motion and tingling extending to fingertips, developed around 3 weeks following the administration.
fever after getting the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (fever after getting the 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever after getting the 2nd dose). At the time of the report, PYREXIA (fever after getting the 2nd dose) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that patient had fever for 7-10 days after getting the 2nd dose.   This case was linked to MOD-2022-545561 (Patient Link).
psoriatic arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4290156-00 (Agency).  A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single and intramuscular, administration date 07Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) as unk (citrate free) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "recovering", described as "psoriatic arthritis flare up". The action taken for adalimumab was dosage not changed.The reporter's causality for the event(s) of psoriatic arthritis flare up with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of psoriatic arthritis flare up with Covid-19 Vaccine (Tozinameran) was a possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
utilized multiple vials for one dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (utilized multiple vials for one dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In June 2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (utilized multiple vials for one dose). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (utilized multiple vials for one dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. It was reported that 11 unidentified patients were affected.  These patients received a full 0.5 ml dose.
Two days post vax, this pt experienced fever, injection site swelling and redness of the entire upper arm. The pt was dxed with rule out cellulitis. He was treated with prednisone and cyproheptadine hydrochloride sesquihydrate and advised to notify the physician if the symptoms persisted.
dull injection site pain within 1 hour of injection. Moderate-severe injection site pain, minor chills, max temperature of 99.9F at 6 hours post injection.  At 15 hours post injection, moderate injection site pain and lethargy/discomfort were the only symptoms that remained. No redness or swelling at any point.
A non-serious spontaneous report of heart palpitations, swollen lymph node, sweating, nausea, headache, has been received from a patient/consumer concerning herself, a 47-year-old female, subsequent to receipt of H1N1, Intranasal. The patient had a history of Hashimoto's disease. Concomitant medications included numerous biological health nutrients, bio-thyroid, and bio-estrogen. On 09-Dec-2009, the patient received H1N1, Intranasal for an unknown indication. On 16-Dec-2009, seven days after the vaccine administration, the patient started experiencing symptoms of heart palpitations, swollen lymph node, sweating, nausea, and headaches. The outcome of the events was unknown at the time of reporting.
Red oval at injection site and another red patch roughly an inch below. Itches madly at times. This is the third day. Second spot developed today.
At 0430 (3/25/21) patient awakened with palms and soles of feet itching and rash.  Also, short of breath. Presented to ER with itching, rash of buttocks and short of breath.  Patient was hyperventilating and states had similar symptoms in past about a dozen times.  Patient allergic to PCN, suprax, sulfa and shrimp.  At 0544 patient was given Benadryl 25mg IVP, Pepcid 20mg IVP solumedrol 125mg IVP, Ativan 1mg IVP,. At 0619 Benadryl 25mg IVP,   Sent patient home with scripts for Decadron 6mg  1 po QD x 5 days, vistaril 25mg po QID, epipen, pepcid 20 mg 1 po Q12 hours x 5 days and instructed to followup with PCP
This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old male patient who received PEDIARIX (batch number L9L2K, expiry date 5th June 2016). Previously administered products included DTaP (dose 1), DTaP (dose 2), DTaP (dose 3), Hepatitis B (dose 1), Hepatitis B (dose 2), Hepatitis B (dose 3), IPV (dose 1), IPV (dose 2) and IPV (dose 3). On 11th November 2014, the patient received PEDIARIX. On 11th November 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered and inappropriate schedule of vaccine administered. On an unkown date, the outcome of the wrong vaccine administered and inappropriate schedule of vaccine administered were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate schedule of vaccine administered to be related to PEDIARIX. On 11 November 2014, a new medical assistant to the practice gave 3 patients a dose of PEDIARIX when they were all only due to receive DTaP. All 3 doses of PEDIARIX were from lot number L9L2K (expiration date on 05 June 2016). They were not due for the other components in the vaccine.
extensive right lower extremity DVT encompassing all vessels of the right leg extending up to the distal ivc; fibula fracture; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 16-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization.  The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "extensive right lower extremity DVT encompassing all vessels of the right leg extending up to the distal ivc"; FIBULA FRACTURE (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Cardiolipin antibody: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events deep vein thrombosis and fibula fracture and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
I received a vaccine at 4 PM on 2/23/21. In the middle of the night I started having the chills. I woke up around 6 AM the following day and felt extremely fatigued. Around 6:30 AM I became nauseous and very lightheaded. I had to brace myself against a counter so I would not fall down and faint. I rested all day then around 1 PM I got up and fainted. I woke up a moment later and had an intense ringing in my ears for several minutes. I felt fatigued the rest of the day.
Client reported feeling "fuzzy", ringing in his ears, voices "sounded far away", nausea and vomiting X 1, arm feeling "heavy" within minutes after leaving the vaccination area while participating in his school orientation. Case vomited in the classroom and was then escorted to the bathroom by his parent. Client's parent reported to this nurse that the client was resting on the floor in the bathroom. Upon assessment client stated he was feeling better.  Vitals within normal limits and client observed standing and walking without any further symptoms of syncope reported. Nurse requested client be observed for an additional 20 minutes . No fall or fainting reported. client was released from observation no follow up concerns reported by parent.
Information has been received from a physician concerning a 17 year old female pt with an allergy to Ceclor and no past medical history who on 10/04/03 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Lot # 643597/0895M). Concomitant therapy included sertraline hydrochloride (zoloft). Roughly two weeks post vaccination, on approximately 10/18/03, the pt developed a "breakthrough varicelliform rash" consisting of 12 mild lesions. Unspecified medical attention was sought, but no treatment was necessary. Subsequently the pt recovered. A product quality complaint was not involved. Additional information has been requested.
Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 23Sep2022; No Adverse event; vaccine was administered to patient past it's Beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered to patient past it's Beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 23Sep2022) and NO ADVERSE EVENT (No Adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Sep-2022 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered to patient past it's Beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 23Sep2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administered to patient past it's Beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 23Sep2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (vaccine was administered to patient past it's Beyond use date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 23Sep2022).    PNo concomitant information was reported. Product: Monovalent  Vail size: 2.5ml Date the vial was initially stored in the refrigerator: 22AUG2022. The vial did not undergo any temperature excursions. No treatment information was reported.
patient had to get the shot for work, and got sick every time; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 04-Dec-2020.  This case involved unknown demographic patient who had to get the shot for work, and got sick every time (illness), while received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, unspecified time after receiving the vaccine, patient had to get the shot for work, and got sick every time (illness). The shot might have changed since then, but since patient rarely get the flu, and the shot was no guarantee and won't get the flu, patient will pass.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
TIA (Transient Ischemic Attack) on 4/22/2022 affecting tongue only and for a total of about 45 minutes from onset to no symptoms remaining. Had been traveling via car when TIA occurred while a passenger. Had driven approx. 14 hours prior day and approx. 9 hours day of TIA. Went to walk-in next morning who referred to ER, who performed tests like CT scan, blood work, etc. They put a 30 day monitor on me and subsequently diagnosed A-Fib, and I'm now on Eliquis.