chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; lot that had been expired was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient).    Patient age was reported as 68 Year 11 Months.  No concomitant medication was provided.  NDC ID number was reported.   Lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
TINNITUS; This spontaneous report received from a patient concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus was not reported. This report was non-serious.
Immediately after receiving the Moderna COVID-19 vaccine the patient began to feel nauseous, hot and her arm was hurting. I kept her in the immunization booth and monitored her. Within a minute of her initial feeling she stated that she was having trouble seeing and was "going to black out". She immediately lost consciousness, her eyes rolled back, and her head went limp and fell back. She then began a twitching movement, made a snorting noise and then all of her limbs went rigid and extended straight out. At the first sign of her reaction we paged management and then as soon as she had loss of consciousness we contacted 911. She regained consciousness and was able to start answering my questions within 30 seconds to 1 minute. We did get the patient water and began to fan her to help cool her off. She was able to tell me who she was, where she was and why she was here. We also gave her some chips and had her eat slowly and drink small sips. She had stated that she was very nervous at the beginning of our pre immunization questions. She told us after that she had not eaten a lot before coming for the shot, but did eat more than normal because she knew she was coming in. She contacted her parents to inform them of the situation. She was able to recount everything prior to her loss of consciousness. When EMS arrived she was able to answer their questions. They took her vitals and all were in normal range, BP=119/66, pulse=98. They asked her to stand and she was able to stand and maintain balance on her own, but stated her legs felt a little "shaky". She refused transport to the hospital by EMS, but did call her roommate to come pick her up. I had her wait in the COVID waiting area until her roommate arrived. I called her around 4pm (same day) to check on her and she said she is feeling much better. Her mom (a nurse) also came down to stay with her and was with her when I called.
13FEB-fever 103; sponge bath, temp reduced to 99, back up to 104 in 2-3 hrs; 14FEB fever 105.5; TC MD advised sponge bath, Tylenol; Seen in ER; dx viremia. 14FEB-present - Amoxicillin 3x/day, pediaprophen & pediatric tylenol.
The expected injection site swelling but then armpit of same arm(left) excruciating pain. Tylenol and cold compresses did nothing. Second week chills, diarrhea and body temp 95 which subside after two days. However, still have discomfort in armpit of injection arm. Seriously concerned about getting the 2nd vaccine due in two days. Just learned of your website.
Presented to ED with seizure-like activity in the setting of fever and recent vaccination. Mom reported patient "twitching of his arm... body shaking for 4 minutes."  Seizure-like activities resolved before EMS arrival. Patient at baseline, interactive and laughing prior to ED arrival. No history of seizures disorder in the family.
SICK IN BED FOR MONTHS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, and batch number were 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 patient experienced sick in bed for months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick in bed for months was not reported. This report was non-serious.
Patient received vaccine around 9:25am, and by that evening (~5:00pm) she had fever of 101, chills, headache, and dizziness. By the next morning, she noticed redness around the injection site which started out about dime size, then progressively got larger over the next couple of days to where it was widespread across her upper arm.  Patient visited her MD on 12/5 (the day after the vaccination) and he instructed her to use Benadryl. She then saw the doctor again today (12/9) and she prescribed a course of cephalexin and instructed patient to take Claritin.
About 2-3 hours after injection I noticed an achy low back pain. Not sure if related but my feet and nose were cold and hard to warm up.. The next day my main symptom was tired fatigued.  Arm soreness was more moderate than first injection.  Not sure if related but I had bouts of dizziness or vertigo. I had loose stools the next day.
The same day as the vaccine I developed a low grade fever and joint pain.  A few hours I developed severe esophagitis.  I do suffer from acid reflux.  I spoke to my dr who recommended acid reflux medication.  Symptoms ceased completely later that evening.
Flu like symptoms. Aches pains got cold and hot, sleepless night etc.
Redness and swelling, warmth in the area of injection site and stinging, itching, and burning pain (like an insect bite) 6 days following vaccination.  Symptoms lasted about 4-5 days.  Application of ice on the affected area, which helped the area feel better.  Then on the evening of February 17, the signs and symptoms reappeared.
The patient was given expired moderna.  The medication expired approximately 8 hours and 17 minutes upon administration.  No adverse effect so far
client complained of feeling palpitations and anxiety after receiving 2nd dose Moderna. EMT responded at 1508. Client was sitting in chair in front of EMT table and asked to be taken outside to patio. EMT observed client's hands were shaking, client was crying. First vitals: blood pressure 156/102, pulse 132, oxygen 96%. Client stated feeling tingling in limbs and palpitations. PHN joined at 1519. Upon arrival client sitting upright in bench, alert and oriented x4, crying, shaking hands. Client stated having history of anxiety and panic attacks. Medication: oral contraceptives. No known allergies. Client stated she was sitting in observation room and felt it was too small and felt her heart was beating fast. PHN coached client through breathing exercises. Client denied chest pain, shortness of breath, headache, blurry vision. 1520 vitals: blood pressure 138/80, manual pulse 120. Per client anxiety decreasing. Vitals at 1528: blood pressure 122/80, pulse 94, oxygen 97%. Per client feeling better, no palpitations. Last vitals at 1537: blood pressure 118/80, manual pulse 74. Client stated anxiety had resolved, denied palpitation. Client accompanied by friend, would drive today. Client advised to follow up with provider. ER precautions given. Client left facility with steady gait at 1540.
she suffered a stroke; blood clots after the 2nd shot; she lost her speech for a while; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (she suffered a stroke) and THROMBOSIS (blood clots after the 2nd shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, the patient experienced CEREBROVASCULAR ACCIDENT (she suffered a stroke) (seriousness criterion medically significant), THROMBOSIS (blood clots after the 2nd shot) (seriousness criterion medically significant) and APHASIA (she lost her speech for a while). At the time of the report, CEREBROVASCULAR ACCIDENT (she suffered a stroke), THROMBOSIS (blood clots after the 2nd shot) and APHASIA (she lost her speech for a while) outcome was unknown.            Concomitant medications was not provided by the reporter Treatment information was not provided  Company Comment : This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious events of stroke and blood clots. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Details are limited for the events and additional information is not expected.; Sender's Comments: This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious events of stroke and blood clots. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Details are limited for the events and additional information is not expected.
Rashes on my hands and dry scaly skin on multiple spots on my body that would worsen and abate intermittently as well as some headaches, and a little lymph congestion on my neck, and that went on for about 3 weeks. I used some topical skin cream, drank a lot of water, some Tylenol. I work as an acupuncturist so I did not seek medical help for this event, and just self treated.
Pinkish red firm tissue measuring 3 cm x 5 cm non tender, raised on (R) thigh.
Injection site was raised, bumpy, itchy red and painful. Patient took diphenhydramine.
rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Constant vomiting, diarrhea, horrible body aches, fever. Ended up going to the ER  for dehydration and pain.
Case number PHEH2012US018689 is an initial spontaneous report received from a health care professional on 05 Sep 2012, and with a follow up received on 16 Oct 2012: This report refers to a 16-year-old female patient. Her medical history included allergies to BACTRIM, SUPRAX, penicillin and latex. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) into the right arm on 31 Aug 2012 at 10 am. This vaccine had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. Vaccine was stable and okay to administer. Concomitant medication included influenza vaccine (batch number: M531AA) intramuscular, on 31 Aug 2012. No adverse event was reported following this administration error (incorrect storage of drug). Follow up report received on 16 Oct 2012: Updated patient demographics (height and weight), medical history, concomitant medication and vaccination site.
Reported 11/3/22 above vaccination She had around that time a febrile illness x 2 weeks with fatigue (possibly with onset prior to vaccination)  Then hospitalized 11/11 after 11/10 labs showed new leukopenia, given fevers.   During hospitalization, she was found to have pseudomonas bacteremia and acute diverticulitis in presence of isolated agranulocytosis . Treated with cefepime and flagyl. She had negative HIV and CMV testing, negative testing for endemic tick borne infections. Hematology had evaluated her with possibility of neutropenia due to acute infection, though also acknowledged the opposite causality.   On outpatient f/u, had recovered from above acute illnesses and has maintained normalized blood counts .
The patient was sitting in the observation area with his mother, when he began to feel short of breath and unexpectedly lost consciousness. The mother said he "slumped down in his chair". He came to within a minute, was laid down (and 911 was called immediately). He said he has never passed out from a vaccine before, but not longer felts out of breath or any other symptoms. A pharmacist (myself) retrieved a nurse and PA from the clinic across the hall who monitored the patient, who then had normal vitals. He denied the ambulance when they arrived and eventually left on his own accord.
COVID-19; COVID-19; Swelling; Pain; 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-163-4336952-00 (RA).  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Aug2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single and intramuscular, administration date 21Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at cf for ankylosing spondylitis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 01Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 01Mar2022, outcome "recovered" (Mar2022) and all described as "COVID-19"; PAIN (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Pain"; SWELLING (non-serious) with onset Feb2022, outcome "not recovered", described as "Swelling". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Mar2022) positive. The action taken for adalimumab was unknown. Causality for humira(adalimumab): the reporter's causality for the event(s) of swelling and pain with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of covid-19 with humira (adalimumab) was no reasonable possibility. Pfizer biontech covid-19 vaccine(tozinameran)(tozinameran), causality: causality as per reporter (drug/vaccine) given as not reported' for events swelling, covid-19, and pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: "Vaccination failure", "COVID-19", "Pain", "Swelling" and the suspect drug BNT162B2 cannot be completely excluded.  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.
Nausea,  headache and extreme chills. Did not occur until over 12 hours after getting the vaccine. Mostly recovered, still a headache and mild nausea
This case was reported by a other health professional and described the occurrence of swollen arm at the injection site in a unk patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. In 2014, the patient received FLULAVAL (intramuscular). On an unknown date, unknown after receiving FLULAVAL, the patient experienced swollen arm at the injection site and pharmaceutical product complaint. On an unknown date, the outcome of the swollen arm at the injection site was not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the swollen arm at the injection site to be probably related to FLULAVAL. It was unknown if the reporter considered the pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November 2014: This is one of the 5 cases received by the same reporter for the same vaccine (with the same lot number).
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering 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 will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Rash-erythematous, confluent, non-raised, pruretic. Face, neck, trunk (front and back), arms. Onset 0800 11/5/02. Tx with Benadryl, Medrol dosepack. Rash fading.
This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Aches joint and muscles, mood anxiety, blood pressure (high), high cholesterol, bursitis, concentration loss, difficulty trouble, Delirium, Depression with psychosis, Dry mouth, declining Energy, Hair loss, ringing in ears, Joint pain in right hip, Muscle and joint pain, Reflux, Rhinitis, rotating hot and cold spells, Insomnia, Sleep problem, feel not refreshed upon waking up, use medication to sleep, speech disorder, testicle problems, tinnitus, thyroid problems.
Syncopal episode 3-5 minutes after administration of TDap, Menactra and Gardasil, which lasted about 30 seconds. After episode she was fine.
C/o mild hives following H1N1 vaccine (Sanofi). EMS eval, administered BENADRYL.
1/18/21 begin muscle cramp starting at lower rib on rt side  1/19/21 next was deep, severe, debilitating  pain from mid front center to center back at level of last rib on rt Diagnosed w Shingles, no rash or blisters -severe debilitating nerve pain . Valacyclovir 2 grams a day for seven days 1/27/21 no rash or redness  ever developed but nerve pain continues,  skin still sensitive to touch,  less stabbing sharp debilitating pain  to now an aching nagging pain from mid center in a semi circle to mid back.
Report 20010066361 describes tingling and numbness (fingers) in a 14 year old female who received hepatitis B vaccine recombinant (Engerix-B). reportedly, the vaccinee had no allergies or medical history. Reportedly she had no illness at the time of vaccination. Concomitant vaccine: tetanus toxoid administered within four weeks of Engerix-B. On an unspecified date, the vaccinee received her unspecified dose of Engerix-B. subsequently, she experienced tingling and numbness in her fingers. Her symptoms resolved in two weeks. As of 03/13/2001, the vaccinee recovered.
Cough; Fever; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 17:00 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZINC; VITAMIN C PLUS [ASCORBIC ACID]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, Lot unknown=True, Lot unknown reason=Not available/provided to reporter at the time of report completion, DOSE 1, SINGLE), for covid-19 immunization. The following information was reported: COUGH (non-serious) with onset 13Sep2021 13:00, outcome "unknown", described as "Cough"; PYREXIA (non-serious) with onset 13Sep2021 13:00, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 13Sep2021 13:00, outcome "unknown", described as "Chills". Therapeutic measures were not taken as a result of cough, pyrexia, chills.  Additional information: No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Since receiving my fourth dose of Moderna, I have experienced increasing spinal issues. They have gotten a lot worse since I previously reported on my third dose. My cardiac issues have worsened as well, and I have been diagnosed with stage 2 heart failure. My cholesterol has risen dramatically from 198 to 230 and I have never had cholesterol issues in the past. My fibromyalgia pain has also increased. I have also been experiencing pituitary issues that had previously been resolved and am waiting on test results to find out more.