chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed w/I 24 hours a rash accompanied w/ a large localized nodule. The patient describes the nodule as softball size and bruised.
right upper eyelid edema, started about 24 hrs post-vaccine, still present on day 4
MD saw pt 19AUG92 t99.5; no sz like activity noted by parent at all; pt slept more than usual starting 18AUG92;
A fter the vaccine, I initially felt fine. During a bike ride I began to feel weak, tired and my heart was racing. When I got home I tried to take my blood pressure and the machine said error. I was very tired and weak. Before I went bed feeling quite nauseous and felt overall weak and felt ill. Blood pressure was 85/65. During the night I was up often trying to vomit. I had some slight vomiting but mostly dry heaves. I was laying on the bathroom floor. My husband woke up and took me to the hospital. I was admitted for severe dehydration to the point it affected my kidneys. I had IV fluids throughout the day and was able to go home late that afternoon. The weakness continued for about another day and a half. Still a bit off but better as of 7/16/21
pt stated on 16NOV92 devel hives on legs, neck, in scalp which improved w/DPH & pred; 19NOV92 stated hives worsened; went to hosp ER 19NOV92; when dyspnea worsened & devel swelling of soft palate; 21NOV92 had more resp distress, swelling;
PT. TRAVELING 7/18/08. PT. RECEIVED THE FOLLOWING TRAVEL VACCINATIONS ON 7/2/08:        TWIN RIX # 1 - GSKB EXP. 5/15/10 LOT# AHABB116AA 1 CC IM LEFT DELTOID                                            TDAP - SANOFI PASTEUR EXP. 07/25/10 LOT# C2966AA  0.5 CC IM RIGHT DELTOID         TYPHIM VI - SANOFI PASTEUR  ESP. 10/02/09 LOT# A0923 0.5 CC IM RIGHT DELTOID.    PT. CALLED 7/7/08 @ APPROX. 4:00 PM TO SAY SHE HAD A RASH ON HER ABDOMEN AND LEGS THAT STARTED ON SAT. 7/5/08. PT. DENIES ANY OTHER REACTION. PT. ADVISED TO TAKE ORAL BENADRYL. PT. STATES SHE HAS BEEN APPLYING TOPICAL BENADRYL. ADVISED TO STOP TOPICAL AND BEGIN ORAL. IF RASH DOES NOT IMPROVE IN 48 HOURS TO SEE PCP.  PT. VERBALLY AGREED VIA PHONE.
Enlarged painful lymph nodes near collarbone in the crevice of neck, treated with warm compress, acetametaphine, and 14 days of doxycycline
mom reported by phone that pt devel local rxn of rt deltoid w/pain, swelling, warmth & induration; mom took pt to clinic 10APR92;
Pt exp brief sz 12 hrs post vax; hx of febrile seizure 1 wk prior;
Pt admitted 8/13/2021. She is undergoing tx for extensive stage SCLS originally dx 10/2019. Pt was SOB/fatique. Swabbed Monday for COVID pos on 8/13/2021 prior to arrival at ED.   Pt remains inpatient at this time.
heart speeded up to about 84-94 bpm; felt a little dizzy; sick to her stomach; headache; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart speeded up to about 84-94 bpm), DIZZINESS (felt a little dizzy), NAUSEA (sick to her stomach), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M2(orZ)20A) for COVID-19 vaccination.     The patient's past medical history included Degenerative disc disease and Heart disease, unspecified. Concurrent medical conditions included Penicillin allergy. Concomitant products included HYDROCODONE, METOPROLOL SUCCINATE (TOPROL) and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HEART RATE INCREASED (heart speeded up to about 84-94 bpm), DIZZINESS (felt a little dizzy), NAUSEA (sick to her stomach), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore at the injection site). At the time of the report, HEART RATE INCREASED (heart speeded up to about 84-94 bpm), DIZZINESS (felt a little dizzy), NAUSEA (sick to her stomach), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Heart rate: 84-94 her heart speeded up to about 84-94 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported. On 01-Feb-2021, the patient took vaccination at01:30 PM.
IMOBILE; MIGRAINE; SLEPT FOR A WEEK STRAIGHT; COULD NOT TALK; SORE ARM; TIREDNESS; NO ENERGY; This spontaneous report received from a patient 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: 206A21A expiry: UNKNOWN) dose was not reported, administered to left arm on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient suffered from a severe headache and slept for a week straight since patient was unable to move or open eyes, it felt like a migraine. The patient was imboile. Patient could barely move to the bathroom, could not talk, that could not watch television, and had to stay in a dark room. Patient also had sore arm and it was still there event after two months of vaccination. Patient also had tiredness. The patient's headache had finally gone away, but still didn't have any energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from sore arm, and no energy, and the outcome of tiredness, migraine, slept for a week straight, imobile and could not talk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210726165- COVID-19 VACCINE AD26.COV2.S-Imobile. 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).
5mo 4day old Pt at clinic for immunization update. Pt needed Dtap, IPV, Rotavirus, Hib, and PCV13. Rotavirus, HB, and PCV13 administered correctly. Administered Dtap-IPV KINRIX on RT IM. KINRIX not recommended for this age. Separate Dtap and IPV should have been given. Recorded immunizations in IR, but was unable to select KINRIX. Called former coworker to advise on how to document. Former coworker said the KINRIX could not be selected due to Pt age. I then called Dr. to notify her of med error. Med lot number and expiration noted. Dr. contacted manufacturer for recommended action. GSK reports dosage of the vaccine components are the same as that in individual vaccines and are age appropriate. Though not FDA approved, some studies have been completed in the age range of this child and the only adverse effects noted were redness at the injection site, irritability, and rarely fever (same as for the individual vaccine components). CDC recommendations for inadvertently administered dosage is to count these doses. Notified mother by phone of incident. Unable to reach, but left voicemail regarding manufacturer recommendations to count vaccine as valid. Left office number for parent to call if there are any other questions or concerns. Will follow up with IR tomorrow for recommendations and complete any other GSK requirements. Received phone call from grandmother with concern for med error. I apologized and restated the manufacturer guidelines and that I had reported the error to our doctor. Received call from Pt peds office. They stated the mother would like another phone call as she has questions. I reached mother by phone and again explained the error and the manufacturer recommendations. Mother stated she understood, and I told her to call me again if she has any other questions or concerns.
This spontaneous report as received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 04-SEP-2014, the patient was vaccinated with a dose of (Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The register nurse reported patient experienced 26 patients received doses of (Merck) VARIVAX (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse experiences reported. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Tiredness Headaches Chills Joint pain Nausea Feeling unwell Took Motrin Ate light Slept Kept moving All side effects ceased after 24 hours except tiredness.
I started to get red bumps on face and my back that were itchy sometimes. I went to the dermatologist, and they diagnosed the rash on my back as milia. They prescribed me triamcinolone acetonide ointment which helped with my back. I went to another dermatologist for my face, and they said it was Perioral. I also got a cream for my face, and I was told if it did not get better in 6 weeks to call. I have been taking the cream for my face for 2 weeks and it has not gotten better.
I had been outside all day and I was coughing. I was still coughing the next day and I felt unwell. I then started to have body aches and started to run a fever. I tested positive for Covid-19 and they identified the Delta Variant. I was given an antibody infusion the next day which was three days after the first symptoms. I felt really out of it for a week. I had no balance and my fever was coming and going. I felt like I had a foggy brain and I was extremely fatigued. It has been seven weeks and I still have some fatigue and I feel like I am hyperventilating sometimes. I can still breath deeply but it feels like my heart is beating fast. I have to stop and take a break for a few minutes. The cough was really bad for four weeks.
NOTHING OCCURED TO CHILD, CHILD WAS GIVEN 0.1ML OF PFIZER
Pt received first dose of Pfizer vaccine at age 11.  Pt and father presented for second dose and was declined due to age.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified date the patients were vaccinated with improperly stored VAQTA (lot N016805 expiry date 04-SEP-2018) or (lot M033611 expiry date 02-MAR-2018) or (lot N005796 expiry date 26-MAY-2018) for prophylaxis. No adverse effects reported with any patients. The vaccine was exposed to temperature of 0°C to 1°C for a time frame of 6 hours 7 minutes. Previous temperature excursion was reported. The call because of a data logger. No PQC involved. No further information provided. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1708USA008709: US-009507513-1708USA008708: US-009507513-1708USA008710: US-009507513-1708USA008711: US-009507513-1708USA008711.
June 4, Became largic, could not speak aloud, but understood. could not swallow hardy even water shock head to answer, only last day, very little response Prior to that, was feeding self, carried on good conversation and was enjoyable to visit with
Patient stated he began to get congestion, fever as high as 102, general aches and pains, small amount of hives/itchy patches on arm that was vaccinated beginning 1 or 2 days after the vaccination and lasting 5 days so far.
Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0L0M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, (lot #L031273, expiration date: 19-NOV-2016), (dose and frequency were not provided). Concomitant therapies were not reported. On 12-AUG-2015, the pharmacist noted that the vaccine administered was improperly stored. No adverse effect was reported. Additional information has been requested.
Within 24 hours of receiving the second COVID-19 vaccine, I had the normal aches/fever/fatigue but then I developed shortness of breath, and felt like my heart was beating irregularly. My heart rate would also go from 60s resting to 140s-150s from either climbing up or down a few stairs. I run 10-15 miles/week so this is completely out of the norm for me.  I called our clinic and was advised to increase fluids and rest and if it didn't get better, to go to the ED. I got my vaccine on a Tuesday, felt this way from Wednesday through Friday and then Saturday morning, I felt back to normal. During that time, I was not able to walk/run/or do any physical activity. I sat in a recliner and napped most days.
Patient presented to hospital on 10/30/21 for monoclonal antibody treatment however she had a syncopal episode and was hypoxic. Patient was transferred and admitted to hospital for treatment of hypoxia due to COVID. Previously fully vaccinated with Pfizer on 4/24/21 and 5/15/21. Patient was discharged on 11/3/21.
Information has been received from a certified medical assistant (CMA) referring to a patient (3) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant medications was provided. On 10-JAN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown). The vaccines were stored under 34.5 F (Min) and 36.9F (Max) for 24  hours. There was no previous temperature excursion. IT was called because of a "date logger". No adverse effects were reported. This is one of the several reports received from the same reporter.
Tintinus ! from 10/21 - Now 1/22 My experience I did not have any adverse effects until I got my first cold. My last vax was 2/20/21, but I got a cold in October of 21 - and my ear started ringing from the onset of the cold. I had never had a problem with my ears in 55 years of life, and feel that my body reacted differently leaving me with this ringing in my left ear. It has been ringing from then until NOW - Jan of 22 and I see no signs of it stopping. I would joke that it was the vax, but then I read that other people have been experiencing tintinus since the vax as well. I am very alarmed by this.
2 hours after the 2nd Pfizer Covid vaccine my LEFT EAR went NUMB. It's still numb 53 hours later I can't tell if I'm hearing worse or the same, but hearing SEEMS to be intact  I hear some "whooshing" noises from time to time but thankfully not all the time It does not hurt It feels like had local anesthesia that won't wear off
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unspecified dates since 14-AUG-2015, the patients were vaccinated orally with improperly stored doses of ROTATEQ oral liquid (dose, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
BLOOD CLOTS IN LEG; This spontaneous report received from a consumer 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 not reported) 1 total, 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 patient had blood clots in leg and was in and out of the hospital but still had the clot (at the time of this report).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210644769-JANSSEN COVID-19 VACCINE-Blood clots in leg. This event is considered unassessable. The event 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.
Double vision post 2 days after SHINGRIX vaccine. Patient seen in urgent care and was given Prednisone 20 mg. Patient advised to go to E.R. but went other.
Information regarding PREVENAR was received from a healthcare professional regarding a 10-week-old female patient who experienced UTI and a little fussy. At 10 weeks of age, the patient received a dose on 19-Jun-2009. The patient experienced a UTI in 2009 and a little fussy on 20-Jun-2009. The irritability and urinary tract infection persisted. It was reported that the infant had been otherwise healthy. The reporter noted that the UTI caused the fever. No additional information was available at the time of this report.
Irregular menstrual cycle that has still not resolved, 6 months after 2nd dose of vaccine. Patient was entirely regular, her whole life, before the vaccine. Now, cycles vary from 1.5 weeks early to 2 weeks late each month, but never on time.
Chemical taste in mouth; recalled similar symptoms after taking now-forgotten antibiotics ~decade ago. Persisted throughout the day, after eating, brushing, etc.
Fever,  Night sweats so bad have to change several times in the night. Some chest tightness and uncomfortable feeling  Nauseous and burning feeling upper stomach  Diarrhea  Headaches  Weakness and tingling in body  Hands and feet falling asleep  Face twitch - just a little
Severe chills and body aches, for 48 hours Severe ringing in right ear started at hour 33. That lasted about 5 hours.
Information has been received from a certified medical assistant concerning a 22 year old female with an allergy to gluten or wheat who on 02-JAN-2007 was vaccinated intramuscularly with a 0.5 ml (first dose of Gardasil) (lot 654389/0961F). The CMA reported that the patient's tongue felt numb for several days after her first dose of Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
received the recall batch of Shingrix that GSK issued on 02/10/2021; received the recall batch of Shingrix that GSK issued on 02/10/2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number TT2JF, expiry date 28th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the recall batch of Shingrix that Glaxosmithkline issued on 10th February 2021. The reporter stated that, the lot number was not 9LH3Y and was not sure if this the lot number from one of the vials. The reporter stated that, the vaccine was administered to the patient before the recall of drug. This case was 1 of 8 linked cases, reported by same reporter for different patients. The reporter consented to follow up via email.
This case was reported by a consumer via other manufacturer and described the occurrence of serum total protein increased in a male patient who received SHINGRIX. Co-suspect products included PREVENAR 13. On an unknown date, the patient received SHINGRIX at an unknown dose and PREVENAR 13 at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced serum total protein increased. On an unknown date, the outcome of the serum total protein increased was unknown. It was unknown if the reporter considered the serum total protein increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter refused to provide full demographics of the patient. The patient declined to participate in the adverse event report. The reporter was the patient's wife who reported that the patient experienced a high unspecified active protein count when getting blood work done after taking SHINGRIX and PREVENAR 13. It was unknown if the reporter considered the serum total protein increased to be related to PREVENAR 13. No product quality complaint was reported. No additional adverse event information was provided.
Atrial fibrillation. First possible onset Jan 6th. Diagnosed in ER January 20, 2022 and a second trip to ER January 22, 2022.   Still having issue and swing a cardiologist.
11 day p/MMR pt had rash, fever over 102, s&s gone p/ 2 days but pt slept alot, was fussy, walking "funny" as if legs hurt; very pale skin, anxious & fussy; hosp for dehydration;
I got a sore throat on 10/19/22 and I knew I had been exposed to COVID-19 on 10/15/22. By 10/20/22 the sore throat was worse and I started getting the sniffles, but the home COVID-19 test was negative. By 10/21/22 I was much worse and the home COVID-19 test came back positive. Over the weekend I developed a cough, chest congestion but I did not have a fever, violent sneezes. By Monday 10/24/22 my symptoms started to get less and as of today 10/26/22 I still have an occasional cough and runny nose. The doctor and I discussed medication but since my symptoms were mild we both felt it best that we let my body beat COVID-19.
Patient was given the pediatric dose.  Dr. stated he can have another pediatric dose to make a complete adult dose. In total, 2 pediatric doses were given
Narrative:  73yo male died on 8/4/2021. He had received covid-19 vaccinations on 3/21/21 & 4/11/21. Pt did not receive care, medications or vaccines from medical facility. No information available regarding pt's death. Likely not related to pt's death given length of time from vaccine administration.
No AE; HCP called to report that a dose of PNUEMOVAX 23 was given to a patient after a TE that was not supported. No further AE information available. No PQC.     ?    Names of vaccines involved (including lot/exp) PNUEMOVAX 23 Lot: W007035 Exp: 10/20/202; Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 10-AUG-2023, the patient was vaccinated with and improper storage dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5ml/once, lot #W007035, expiration date: 20-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided).  The vaccine had a temperature excursion of 49.44 Fahrenheit (F), during a time frame of 75 hours and 35 minutes. It was confirmed that non previous temperature excursions occurred.