chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; Covid19; This is a spontaneous report from contactable consumer (Pfizer Colleague). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), dose 2, via an unspecified route of administration on 23Mar2021 as DOSE 2, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, single dose, both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Aug2021 patient tested positive for COVID (Drug ineffective). Fully Vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: tested positive on 10Aug2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Injection @ 1050. Started feeling nasal congestion @ approx 1700, feeling of scratchy throat and feverish. Took a vitamin @ 1730, returned to work and became hoarse, but felt better. Co-worker noticed blood shot eyes @ approx 2000. At approx 2100 no new symptoms, but pt had difficulty taking a deep breath in which had improved from 3 hrs previously. Arrived in ER @ 2115 noted to have high blood pressure. Received Benadryl injection which caused pt to feel worse, however the voice returned spontaneously. Illness deemed viral and pt sent home. Pt felt fine //// No other symptoms.
Wakened in noc with severe cough and runny nose, was ok by morning. This cough felt like I would choke and was prolonged over 2 hr period with episodes lasting 30-60secs or so. The runny nose was excessive down the back of my throat. Not clear if this could have been a reaction or not. I was fine the next day with the drainage continuing for 2-3 days without cough.
Swelling and redness around left deltoid muscle where vaccine was administered for approximately 3 days. Patient advised to take oral diphenhydramine on the third day following vaccination (when she presented to the pharmacy) and follow-up with primary care doctor if unresolved.
Itching; Big lump up there; Redness getting wider; When she touch it feels warm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SKIN MASS (Big lump up there), ERYTHEMA (Redness getting wider), FEELING HOT (When she touch it feels warm) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02C1Z1A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ), AMLODIPINE, SIMVASTATIN, METFORMIN, BENAZEPRIL, LEVOTHYROXINE and OMEPRAZOLE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (Itching), SKIN MASS (Big lump up there), ERYTHEMA (Redness getting wider), FEELING HOT (When she touch it feels warm) and PYREXIA (Fever). The patient was treated with LORATADINE at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching), SKIN MASS (Big lump up there), ERYTHEMA (Redness getting wider), FEELING HOT (When she touch it feels warm) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-105036 (Patient Link).
Information has been received from a RN concerning a pt who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The pt was noted to be ill prior to vaccination. The RN reported that the pt subsequently vomited after receiving rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). It was unk if medical attention was sought and no other symptoms were noted. At the time of this report, the outcome was unk. Additional information has been requested.
Pt describes tingling, burning in both ear lobes 8 pm 12/1/05, within 1 hour notice rash on trunk and under arms with itching. Rash progressed to raised hives on trunk 8" diameter - smaller hives under both arms. She took 50 mg benadryl around that time. By 12/2/05 7pm rash gone, all symptoms resolved.
Presented 1/4/03 with 5-8 varicella vesicles. Rx: symptomatic - Tylenol, Calomine lotion.
This spontaneous report was received from a physician regarding a 12 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2012 (5 years ago, as reported), the patient was vaccinated with second dose of GARDASIL (lot #, expiration date, dose and route were not reported), for prophylaxis. On an unknown date in 2012 (5 years ago, as reported), the patient experienced severe injection site reaction consisting of severe redness and swelling. On 09-AUG-2017, the patient went to physician to receive a dose of GARDASIL 9 as his third dose in the HPV series, but physician decided not to administer the dose. The outcome of injection site erythema and infusion site swelling was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
5days p/vax pt to hosp w/lethargy, poor PO intake & bilious vomiting; no bloody stools; tests confirmed intussusception; barium enema successfully reduced intussusception
Immediate dizziness, headache, nausea, injection sight pain.  Lessening but not resolution. Over next 4 days. Continued headache, cough, fatigue and weakness, along with injection site induration and pain after 24 hrs not resolved after 4 days. Symptoms lessened but not relieved by OTC medications.
9 hours after injection, all-over body exhaustion 10 hours after injection, convulsion-like chills & fever of 103.9  24 hours after injection, pressure on chest (like someone firmly pressing a hand into the center of my chest, affecting my breathing) and a cough develop 48 hours after injection, non-stop sneezing develops
sore arm; Leg pains; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (Leg pains) and PYREXIA (FEVER) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diarrhea.   On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (Leg pains) and PYREXIA (FEVER). At the time of the report, PAIN IN EXTREMITY (sore arm) and PAIN IN EXTREMITY (Leg pains) had not resolved and PYREXIA (FEVER) had resolved.            No concomitant medications were reported. No treatment medications were reported. Patient ended up with all the symptoms of COVID except diarrhea.
Fever, chills, tiredness, headache, body aches, sore lymph nodes, and nausea started approx 10 hours after shot. Took ibuprofen and acetaminophen for the duration of the symptoms Sunday night and all day Monday. By the time I woke up Tuesday morning (approx 42 hours after shot) the only remaining symptom was sore lymph nodes and more tired than usual.
Patient came in for a COVID booster vaccine without a COVID vaccine card. Patient informed me that she has receieved the initial first two COVID vaccine doses in 2021, and has not recieved a booster shot yet. Therefore, I administered the requested booster vaccination to the patient and was not able to mark a COVID vaccination card because she did not have one.
02/11/21: Left TMJ pain 02/12/21: Left TMJ pain; erythema, edema, itch Left upper arm at injection site 02/13/21: increasing  left TMJ pain; increasing erythema, edema, itch left upper arm 02/14/21: decreased range of motion mouth, unable to eat, pain TMJ; left upper arm problems resolving 02/15/21: to dentist - no diagnosis, source of TMJ problems.   Prescribed Flexeril, Medrol dose pak, but did not take as symptoms began to resolve.   02/16/21: no TMJ pain, normal ROM, just sore.  Not sure if related to vaccine, but thought I should report.
pt recv vax 11DEC95 & 5JAN98 pt exp 30 small gen pruritic pimple like lesions;no fever was noted;pt recovered;
Received 2nd vaccine dose 1/11 and started with GI symptoms 1/13. 1/14 had covid and flu test, tested negative for both. She had stool culture ? normal flora, negative for c-diff, camphobacter, shigella, echoli and salmonella.  Was started on flaggyl 1/20 and taking prescription strength probiotics.  Other than diarrhea having no symptoms. Had 5-6 episodes in a day, slowly reducing. Feels little bit weak and tired from the diarrhea ? has been doing BRAT diet. Rx viral gastroenteritis, babesiosis (likely latent). Travelled to upper Midwest in 2020. Energy and strength better + back to work on modified schedule with restrictions. Being treated currently for babesiosis.
Patient came into pharmacy to receive booster dose of Moderna vaccine. Patient had been asked if it had been 6 months since last dose and confirmed when scheduling dose. 2nd dose actually occurred 6/2/21. Was missed prior to administration of 3rd dose which was not actually due until 12/2/21 so administered 20 days early. At this time patient experiencing no adverse effects
With the exception of a sudden onset of sleepiness in the early afternoon (very rare for me), all went well until about 5:30 that afternoon when I noticed twinges when I raised my arm.  By 7 PM I was in severe pain with sharp pains radiating down my arm, not being able to raise my arm, and having much difficulty completing tasks requiring both arms.  The pain was reminiscent of tendinitis in the shoulder.
patient was given FLUZONE QIV T instead of FLUZONE HIGH-DOSE QUADRIVALENT with no AE; Initial information regarding an unsolicited valid non-serious was received from other health professional via Medical Information (Reference number- 00770131) and transmitted to Sanofi on 15-Sep-2021.  This case involves a 66 years old patient with unknown gender who was given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 15-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ705AA and expiry date: 30-Jun-2022) via unknown route at an unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) (wrong product administered).  It was reported "Nurse states that a 66 year old patient was given FLUZONE QIV T instead of FLUZONE HIGH-DOSE QUADRIVALENT and wanted to know if any additional protection was required for the patient. Caller asked if the patient needed an additional 0.2 ml since the FLUZONE HIGH-DOSE QUADRIVALENT contains 0.7ml per vaccine. Caller states that she is in the process of reaching out to the patient and wanted to know if she needed to have them return for a second vaccination."  It was a case of actual medication error due to wrong vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the legal guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Nose bleed right nostril; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730) via an unspecified route administration in the left arm on 28Mar2021 at 16:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient had as medical history of atrial fibrillation and allergies with penicillin, bee stings and mosquito bites. The patient received diltiazem (MANUFACTURER UNKNOWN) 120mg for day, melatonin (MANUFACTURER UNKNOWN) 10mg for day and cetirizine hydrochloride (ZYRTEC) within 2 weeks of vaccination. The patient had received erythromycin (MANUFACTURER UNKNOWN), tetracycline and cipro (MANUFACTURER UNKNOWN) in the past and experienced drug allergy. The patient had not received other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 15:45, the patient experienced with nose bleed right nostril, it was mild flow that she was able to stop by pinching her nose and she has not had a true nose bleed before. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported event. The clinical outcome of the event was recovered at the time of report.   No follow-up attempts are needed. No further information is expected
Pt called center on 4/22/21, Pt c/o dull headache since 04/18/2021. Pt concerned its possible s/e from covid 19 vaccine Pfizer that she got Ist dose on 04/16/2021. Pt speech clear, comfortable. Denies any emergency sx at this moment. Advised pt have enough rest, drink fluids and also notified pt if emergency condition arises call 911/go to closest ED, Pt assure understanding of education given. Also scheduled telephone f/u appt with MD today at 2pm for further evaluation and treatment. Pt stated Hx of hypothyroidism and taking levothyroxine daily.
No adverse event; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male 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 (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) 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 (Patient received expired vaccine).    NDC ID reported as 80777027398 and Person. Patient's age reported as 58 year 4 months. Concomitant medication was not provided. The lot # O70H21A had been received by patients between 08-Apr-2022 and 15-Dec-2022. A second past Lot #065F21A had also been administered after expiration to patients. Treatment information was not reported. Order date and Completion date reported as 10-Feb-2022.
HIGH BLOOD PRESSURE; FAST HEART BEAT; FELT LIKE BODY WAS SHUTTING DOWN; VOMITING; DIFFICULTY BREATHING; FATIGUE; GAS WENT BACK TO CHEST/CANNOT PASS GAS OR BURP; DIGESTION ISSUES; FELT ANXIOUS; COULD NOT SLEEP; This spontaneous report received from a patient, a 40-year-old female. The patient's height, and weight were not reported. The patient did not consume alcohol, did not smoke and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 02-APR-2021 at 14:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, at night, the patient experienced fatigue but, it was not extreme. On 03-APR-2021, the patient woke up vomiting, had difficulty breathing, fast heartbeats and felt like her body was shutting down following which her mother called the ambulance. On the same day, the patient was admitted to the emergency room (ER) of a hospital where her blood pressure was found to be very high and she was also given an intravenous (IV) as she had difficulty breathing. The patient was given Miralax (macrogol 3350) and was discharged on 03-APR-2021 itself. On 04-APR-2021, patient went to urgent care with the same symptoms. The doctor advised her to take magnesium citrate as she had digestion issues and the gas went back to her chest which made it difficult for her to breath. She could not pass gas/burp or eat whole foods. On an unspecified date in APR-2021, she felt anxious and could not sleep. At the time of report, her digestion issues persisted and the difficulty in breathing comes and goes. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure, and fast heart beat on APR-2021, had not recovered from difficulty breathing, gas went back to chest/cannot pass gas or burp, and digestion issues, and the outcome of fatigue, vomiting, felt anxious, could not sleep and felt like body was shutting down was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210417726.; Sender's Comments: V0: 20210417680-Covid-19 vaccine .ad26.cov2.s- Difficuty breathing, High blood pressure, Fast heartbeat, Felt like body was shutting down, Vomiting,. This event(s) is considered Unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210417680-Covid-19 vaccine .ad26.cov2.s-Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Right arm hurt when raised and drawn towards chest feels like pinched nerve and can't take shirt off over my head.
Received dose #2 of Pfizer COVID vaccine on 1/10/2021.  On 3/20/2021 developed headache,  rhinorrhea, cough, and body aches.  Tested positive for COVID.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (A little bit of nausea) 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 COVID-19 (went away after about 10 days) in August 2020.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (A little bit of nausea). On 17-Mar-2021, FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (A little bit of nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter Treatment information was not provided by the reporter
Information has been received from a nurse concerning a female "in her 70's" who on unspecified date was vaccinated SC with a dose of ZOSTAVAX (Merck) and got shingles three months after receiving the vaccine. The patient sought unspecified medical attention and was treated with "Anti-viral". At the time of the report, the outcome of the event was not reported. Additional information has been requested.
Patient was given Jansen Covid vaccine Lot# 1805029 Exp: 5/25/2021 to Left Deltoid at 10:40AM, by Rn.  Fact sheet was given to pt before and consent was signed.  Pt was escorted to lobby for monitoring per protocol.  At  10:55AM  pt begin to show signs of adverse reaction and was transported back to exam room via wheelchair by staff.  Pt was lethargic, flushed, warm and dry and had c/o SOB.  Pt was being accessed by Dr., vitals signs taken by staff at 10:56AM  BP was 157/69 HR 67  R18 O2 98% glucose reading 84.  Pt was offered juice and staff was attempting to arouse pt.  Per provider order pt was given IM Benadry 50mg to right deltoid lot# 070110 Exp: 7/31/2022 at 11:03AM by staff.   Vital signs rechecked at that time BP 137/68 HR 68  R 18 O2% 98.  Pt fully alert and oriented at 11:20am and was speaking to her daughter, daughter was explaining to patient the events that happened.  Pt vital signs recheck for 3rd time at    11:22AM  BP 11:10AM  HR 59  R 16  O2 98%.  Pt was transported to car via wheelchair by staff and was witnessed getting into car with no assistance.  Pt's daughter was contacted at 2:30PM by staff to check on pt and was told pt is feeling fine
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 10:30 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 49.42.  Concomitant products were not provided.  On 24-May-2021, Excursion time was 08 AM and 09 AM, temperature was 35 respectively, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18-May-2021, vial was moved to clinic on 24-May-2021. 03 vials were sent to clinic. Vaccine BUD date was 17-Jun-2021.  On 24-May-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 35, 10 AM: 42, 11 AM: 40, 12 AM: 40, 1PM: 39, 2 PM: 37, 3 PM: 37 and 4 PM: 32.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
4FEB97 t100.4 & confusion, malaise;4FEB97 RVC positive influenza A;3FEB97 med given x 21 days;