chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 11-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002770: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769:
Pruritic rash on arms and trunk, onset 5 days after 1st Moderna Vaccine .    Discussed with allergy dept.  Possibly urticaria, currently reviewing with Dermatology consultant.  Meantime having patient take antihistamines meantime, and provided patient return precautions for continued / worsening of symptoms.
tinnitus; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73 years old female patient (pt). There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided.  On an unspecified date in 2017, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster) and tinnitus. The pt was treated by a healthcare due to the events. It was reported that the pt would continue suffer ongoing injuries, losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and tinnitus were not reported.   The reporter considered the herpes zoster and tinnitus to be related to Zoster Vaccine Live (ZOSTAVAX).
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications  were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No new information.
Initial information has been received from a registered nurse concerning a patient with an unspecified age, gender, pertinent medical history or drug reactions/allergies, who, on an unspecified date, received CERVARIX as the first dose of the HPV vaccination series. On 19-DEC-2012, the patient was in the office, and was vaccinated with the second dose of GARDASIL (dose, indication, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN HYPOTENSION ACUTE PULMONARY EMBOLISM
Daughter called pharmacy today (8/11/2021) and stated that her mother had developed cellulitis
Headache, Fever & NauseaVomiting Narrative:  Other Relevant History
ADMINISTRATION OF EXPIRED VACCINE GIVEN PAST THE 6 HOURS ALLOWABLE TIME LIMIT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced administration of expired vaccine given past the 6 hours allowable time limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine given past the 6 hours allowable time limit was not reported. This report was non-serious.
This spontaneous report was received from a physician via Medical Record referring to a 57 year old male patient. No information regarding the patient's medical history or concomitant therapies was provided. The patient's concurrent conditions included Non-smoker, abstains from alcohol, abstains from recreational drugs and eye disorder in 2001. On 02-FEB-2002, the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in July 2008, a removal of sperm ducts procedure was performed (spermatic cord disorder). On 21-AUG-2007, the patient was vaccinated with the second dose of PNEUMOVAX 23 (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in August 2011, an unspecified procedure to repair ruptured musculotendinous cuff chronic was performed. On an unspecified date in October 2011, the patient experienced latent tuberculosis by blood test. On an unspecified date in November 2014, a colonoscopy was performed (no results provided). On 19-JUL-2014, the patient experienced hypertension and on 24-MAY-2016, the patient experienced HIV infection. Health Maintenance: Annual alcohol and drug screen, colon cancer screening occult blood test, diabetes screening, depression annual screening, lipid screening, third dose of PNEUMOVAX 23 scheduled for 21-DEC-2024, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid second dose scheduled for 05-JUN-2015 and third dose scheduled for 20-OCT-2025, PREVNAR completed. At the time of the report, the outcome of latent tuberculosis, hypertension, tendon rupture, spermatic cord disorder and HIV infection was not provided. The reporter did not assess the relatedness between the events and PNEUMOVAX 23. Upon internal review HIV infection and spermatic cord disorder were considered to be a medically significant. All available medical records will be provided upon request. Additional information has been requested.
Developed a PPD allergy after being vaccinated, had never been allergic before.  Allergy got worse after I had a breakthru covid case in August.
Beginning on Day 3 after vaccine started with severe fatigue, pain in legs, numbness toes, headaches, feeling pulse in my head when laying down and ringing in ears. Fatigue has been unrelenting since, pain in legs getting more severe each day that passes.
Ear pain 10/17. Mouth/tongue sore 10/19, bleeding (L) gums 10/22 > resolved 10/22. Inability to wink (R) - 10/24. Bell's Palsy 10/25 - tx sought at urgent care - Dx with Bell's Palsy - placed on prednisone.
Awoke at 8 am with fever and knot in arm, ran fever and arm was red the size of baseball with huge knot, finally had to take to emergency room, had to be lanced and drained and packed and put on Bactrim and has to return to the doctor in 48 hours.
See vaccine schedule below.  48 hours after receiving YF and other vaccines on 5/1/06, and 4 hours after receiving Pneumovax and Menomune on 5/3/06, she developed shaking chills, and shoulder pain.  Today I received a phone message that she is hospitalized with fever 103 and stiff neck.
Information has been received from a consumer concerning his 74 year old wife, with no medical history and no allergies, who on 10/27/05 was vaccianted once with a 0.5ml IM dose of Pneumococcal 23v polysaccharide vaccine. Concomitant vaccine included a dose of Influenza virus vaccine unspecified. It was reported that, on 10/27/05, the pt had an injection site reaction with a large red mark, sensation of warmth, an inability to lift her arm for two days post dose, and with a transient lump that had moved slightly down the arm. It was noted that the pts reactions were resolving. there were no lab or diag test performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.
This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2 NOS), on 14Oct2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm 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 2023, latency 3 months 26 days 9 hrs after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Testing negative two consecutive days; (unspecified date) Negative, notes: Testing negative two consecutive days; (Feb2023) Positive, notes: tested positive three. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was tested positive three days after completing course with PAXLOVID and developed cold symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
forgetful; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (forgetful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (forgetful). At the time of the report, MEMORY IMPAIRMENT (forgetful) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sore underarm/ lymph nodes in vaccinated arm.  Sore, itchy, red, hard and swollen at injection site 8 days after vaccine.
Patient received 3rd dose of Moderna No adverse event happened. Patient did not disclose they had received a dose prior to receiving 2 doses of Moderna at a vaccine clinic. Patients daughter was mailed a vaccine card and received it 8/14/2021
First fluid filled blister started on head on 08/29/2021 ten days after getting first vaccine blisters went away by themselves. After getting second vaccine the fluid filled blisters re appeared this time in mouth on 09/27/2021 and  treated with Valtrex on 10/11/2021. Blisters in mouth went away however multiple fluid filled blisters under breast, torso and legs on 10/30/2021. Was seen by MD on 10/30/2021, 11/02/2021, 11/08/2021, 11/19/2021, and 12/02/2021. Was given 2 courses on antiviral medication 10/11 and 11/08/2021. Antibiotics because blisters got infected on scalp and torso and started to lose hair 11/02/2021. Referred to dermatology because viral swabs came back negative. Had skin biopsy and blood test done on 11/19/2021. Was put on prednisone on 11/22/2021 ( still on this medication).  Saw dermatologist again on 12/02/2021 with final diagnosis based on skin biopsy and blood work, I now have Pemphigus Vulgaris which is a rare disease.
3 hours after shot, got hives on midsection and shoulder. Persisted on face (mostly on) for 3 weeks as of now intense muscle soreness in neck and lower back started 3/24/15.
3-17-08 Soreness in arm that persisted till 3-27-08;  3-18-08 Loss of appetite that persisted till 3-21-08; 3-18-08 Tiredness that lasted till current; 3-18-08 Headache that persisted till 3-22-08; 3-22-08 Nausea that persisted till 3-23-08; 3-19-08 Low Grade Fever that lasted till 3-21-08.  On 3-19-08 The Health center was called and notified, their response was that it could not be from the immunization and not to worry.  On 4-01-08 when the tiredness continued family physician was contacted and child was placed on medication and we were told if symptoms did not clear in 2-3 days bloodwork and a chest x-ray would need to be done.  We are waiting at this point to see if this will need to be done.  Family Physician suggested filing this report.
100.2 - 100.8 degree fever for two days which included chills, sweats, aches, headaches, difficulty concentrating and remembering
No adverse reaction at this time.  6 days later had inability to breathe, pains in chest - .04-29-21
I had two of my patients have retinal vasculitis after getting the Pfizer-BioNTech COVID-19 vaccine; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number and Expiration date was not reported),via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter, who worked in the clinic but was also involved in research, reported that the Pfizer-BioNTech COVID-19 vaccine has a design flaw because "they left the transmembrane domain in the mRNA and that can lead to cell damage. He had seen people lose their eyes, have immune activation, and have had patients die on me. He was going to the Post and the media and everybody to try and block full approval. He had already reached out to the FDA and asked to block approval but have not heard anything back yet. There was not enough thought, and testing done, and it was a mistake to use the whole spike mRNA. If you are immune and get the spike mRNA, it can cause a lot of damage. It gets stuck in the membrane and does not get secreted. It can cause T-call attack and antibody and compliment attack, and they can wind up with a lot of problems. There is a good chance this is the reason for the myocarditis seen in some young men, the pericarditis we have seen in quite number of patients, and vasculopathy with related clotting. He had two of his patients lose their eyes due to central retinal vein thrombosis after the second dose of the Pfizer-BioNTech COVID-19 vaccine. He had two of his patients have retinal vasculitis after getting the Pfizer-BioNTech COVID-19 vaccine. He was concerned if they go 6 to 9 months from now and tell people to get a booster of the Pfizer-BioNTech COVID-19 vaccine, we might see horrors. He had stopped recommending the Pfizer-BioNTech COVID-19 vaccine to all my patients and my family. I am very pro vaccine but think we need to be more vigilant with the Pfizer-BioNTech COVID-19 vaccine. The reporter refused transfer to Safety saying he was at the clinic right now and did not have time. He agreed to be contacted by Safety for follow-up if needed. The outcome of event was unknown.  Information about batch/Lot number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Retinal vasculitis and the suspect drug  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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.
Patient felt light headed and nauseous.  Monitored patient 30 minutes and nauseous went away but still feel light headed.
A little nauseated following injection. By that afternoon felt very ill. Took Tylenol and went to bed. Basically slept for the next 36 hours. High fever?Tylenol only brought down slightly and back up within a few hours, severe headache that Tylenol didn?t help, nausea to point of unable to eat or drink because felt like going to puke, dizziness whenever tried to get up, would also get short of breath whenever tried to get up, raised heart rate, fatigue?I was so out of it that my husband had to occasionally wake me to make sure I was still responsive, terrible body aches to the point that it hurt to move.
no severe fever reported; 4th Shot: Pfizer 27Aug; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Batch/Lot number: unknown) at the age of 25 years as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Sinopharm (Dose 1), administration date: 21Feb2021, when the patient was 25 years old, for COVID-19 immunisation; Sinopharm (Dose 2), administration date: 14Mar2021, when the patient was 25 years old, for COVID-19 immunisation, reaction(s): "Arm pain", "Fatigue", "Hotter Body"; Bnt162b2 (Dose 3), administration date: 25Jul2021, when the patient was 25 years old, for COVID-19 immunisation, reaction(s): "fever of 100.4", "Arm pain", "Fatigue", "Headache", "My heart raced". The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 27Aug2021, outcome "unknown", described as "4th Shot: Pfizer 27Aug"; PYREXIA (non-serious), outcome "unknown", described as "no severe fever reported".  Event Narrative: 1st Shot: Consumer got my first shot of (withheld) on 21Feb2021 and did not experience any side effects. 2nd Shot: Consumer got my second shot of (withheld) on 14Mar2021 and experienced arm pain, fatigue, and a hotter body (but my body temperature is normal). 3rd Shot: Consumer got another shot of Pfizer at 11:00 on 25Jul2021. Starting at 22:00 25Jul2021, Consumer developed a fever of 100.4, which lasted for about 24 hours. During this period, Consumer had severe arm pain, fatigue, headache, and her heart raced (her resting rate was usually 50-60 BPM but it reached 70-80 after the shot). 4th Shot: Pfizer 27Aug2021, no severe fever reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to the pharmacy with a fine red rash on her lower back on the right side and on the right side of her face. She was vaccinated in her left arm. Patient was not sure if this was related to the vaccine. She noticed it the morning after vaccination and suspected it could have been poison ivy as her husband had given her a back rub the night before. She was advised to apply hydrocortisone cream for itching, she could apply ice for swelling. She was advised that if it got worse or she developed any other symptoms to please seek medical attention.
Lumps in the left armpit and groins area. Bumps that turned into sores on both legs.