chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccinated with a lot number that just expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial was initially stored in the refrigerator on 09-Jul-2022. The vial did not underwent any temperature excursions.  Treatment information was not provided by the reporter.
patient fainted after receiving Janssen Covid 19 vaccine. Patient was sitting down after the vaccine but fainted about 5 minutes after injection. Patient loss consciousness for a minute and woke up after husband was calling her name. EMT arrived and escorted patient to hospital.
Flu vaccine given on 9/28/2011. Notified today 12/1/11 that he had received a previous Flu vaccine mid-September.
a physician prescribed a double dose of Twinrix / to an adult patient who has chronic cirrhosis; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a adult patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included hepatic cirrhosis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a physician prescribed a double dose of Twinrix (at the same time) to an adult patient with chronic cirrhosis and the patient did not receive any dose till the time of reporting, which led to intercepted product prescribing error. The reporter consented to follow up.
pt recvd vax 11:30; at 12:55, to mom & c/o diaphoresis, tremors;h/a & n;1:02 mom came to rn;pt was diaphoretic,cold,clammy, tremerous hands,feet & head; n;dizziness;BP 182/90;AP 110 w/ c/o dyspnea;meds given;sxs resolved;
pt recvd Hep B vax on 5OCT92 & 36 hrs following vax exp a seizure; 6OCT92 pt was seen in ER; adddtl details are being requested;
This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: period disorder, low iron, and allergy NOS. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. It was unknown if patient had any adverse reaction after Janssen vaccine (dose number in series 1). Non-company suspect vaccine included: Pfizer (dose number in series 2) (batch number: 33036BD, form of admin, route of admin was not reported) dose was not reported, administered on 21-JAN-2022 at 16:00 in left arm for prophylactic vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Pfizer vaccine. It was reported that patient was not tested and diagnosed with Covid-19. Concomitant medications included ascorbic acid for drug used for unknown indication, and iron for drug used for unknown indication. On 23-JAN-2022 at 07:00, the patient experienced sore throat and felt inflammation on her throat (dose number in series 2). Treatment medications (dates unspecified) included: paracetamol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammation in throat, and sore throat. This report was non-serious.
I woke up in the middle of the night with typical side effects of mild headache and aches. Ears were ringing and rang the entire weekend. Very loud on Saturday and Sunday. Monday it decreased but it was still there. I waited 3 weeks before I went to my doctor (11/20/2021) because I was afraid that it could become permanent. I went exactly 3 weeks after the vaccination. They put me on a steroid pack and suggested an audiologist and I have an appointment with an audiologist on Dec. 8, 2021.
Pain at injection site; Fatigue; Aches from head to toe; Could not sleep; Fever; Blotchy at injection site; Itchiness at injection site; Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included chicken pox vaccine.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, fatigue, general body pain, insomnia, fever, injection site macule, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, fatigue, general body pain, insomnia, fever, injection site macule, injection site itching and injection site erythema were recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the fatigue, general body pain, insomnia, fever, injection site macule, injection site itching and injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient stated that she never had chickenpox, however her doctor recommended that she should get the Shingrix vaccine anyway. The patient stated that she had blood work done and it showed that she was not immune to chickenpox. Approximately 2 months before the reporting date, the patient received Shingrix on the left arm. The patient stated that after receiving the vaccine, she developed pain at the injection site, fatigue, fever, achiness from head to toe and she could not sleep. The patient stated that she also developed a 3 inch by 3 inch area at the injection site that was blotchy, itchy and red. The patient stated that the symptoms lasted for approximately 4 days before resolving. The reporter consented to follow up. This case has been linked with US2019190822, reported by the same reporter. The outcome of the events reported in database was recovered while in the source document it was recovered with sequele.
pt recvd vax 25APR94 5PM 2 2AM devel fevers, chills, rigors;
rash over most of body;no fever;mom reports pt had spots in mouth;rash x 6 days;seen per MD on 3rd day of rash;mom states pt devel measles from vaccine;poss complicated d/t mom lack of immunity;pt had no immunity from mom;
patient tolerated vaccine fine and left. the next day, he woke up from a nap and noted his left arm was red, swollen, and tender from his shoulder down to his mid-forearm, with some redness/swelling spreading to upper left part of his chest. No trouble breathing, no chest pain, no fever, no aches, no chills. Arm muscle was sore. He came to office for evaluation on the 10th, and redness had resolved, but moderate amount of dependent edema remained to left forearm.
Injection site reaction lasting longer than expected.  Created a hard lump, hot to the touch, pain, swelling, & redness radiating out in a circle that became progressively larger over the next few days. At around day 3, the pain turned into itching underneath the surface.  Currently 4 days post- vaccine and the swelling and redness is about the size of a grapefruit, but seems stable.  Also experiencing significant tiredness.
Rash around that area (gallbladder removal site) since getting the vaccine; Itching on his thighs, knee caps, and on torso (but not anywhere else in his body like hands etc); A little bit of headache; A little bit of tightness on throat; Slight shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (A little bit of tightness on throat), DYSPNOEA (Slight shortness of breath), PRURITUS (Itching on his thighs, knee caps, and on torso (but not anywhere else in his body like hands etc)), INCISION SITE RASH (Rash around that area (gallbladder removal site) since getting the vaccine) and HEADACHE (A little bit of headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C1A) for COVID-19 vaccination.     The patient's past medical history included Gallbladder removal (2 weeks prior to first dose of the vaccine) on 08-Apr-2021. Concomitant products included DOCUSATE SODIUM (STOOL SOFTENER) for an unknown indication.    On 22-Apr-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced THROAT TIGHTNESS (A little bit of tightness on throat), DYSPNOEA (Slight shortness of breath) and HEADACHE (A little bit of headache). On 23-Apr-2021, the patient experienced PRURITUS (Itching on his thighs, knee caps, and on torso (but not anywhere else in his body like hands etc)). On 27-Apr-2021, the patient experienced INCISION SITE RASH (Rash around that area (gallbladder removal site) since getting the vaccine). At the time of the report, THROAT TIGHTNESS (A little bit of tightness on throat), DYSPNOEA (Slight shortness of breath), PRURITUS (Itching on his thighs, knee caps, and on torso (but not anywhere else in his body like hands etc)) and HEADACHE (A little bit of headache) had resolved and INCISION SITE RASH (Rash around that area (gallbladder removal site) since getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had his first dose of the Moderna COVID-19 vaccine on 22-APR-2021 around 16:00 and was told from the vaccination site that he would experience something one hour later. After receiving the first shot, he experienced a little bit of headache, little bit of tightness on the throat, and slight shortness of breath, which went away. The patient reported that he had his gallbladder removed two weeks prior to getting his first dose of the vaccine and he started to develop a rash around that area since getting the vaccine.  On 23-APR-2021, the patient started itching on his thighs, knee caps, and on torso (but not anywhere else in his body like the hands, etc.), and stated he never experienced anything like it before but all symptoms had cleared up. The patient used Curel Itch Defense to treat the itchiness.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient DOB provided; onset dates of events and outcomes updated.
HPV given, after observing for 15 minutes. Pt got off exam table, walked out exam room door and complained of being "a little dizzy". Taken back into exam room. Lay back VS taken x 2. Dr examined pt.
Feeling tired the evening of vaccine. Started with fever 101.8 next day, along with headache, weakness, nausea. Injection site red and tender to touch. 5/28 started with fatigue and on 5/30 felt well.
pt felt dizzy, lightheaded 10min p/vax;c/o difficult breathing, hyperventilating, SOB when breathing;given epi;P 120, BP 150/100;
temperature/99.7; chills; body aches; headache; unable to eat; no interest in food; This is spontaneous report from 35-year-old contactable consumer (patient) reported herself. A 35-year-old female patient received second dose of bnt162b2 (BNT162B2, Lot Number: EP-6955) administered in left arm on 31Mar2021 13:45 as single dose for covid-19 immunisation. Medical history included chronic bronchitis, exercise induced asthma, Aspartame and Percoset allergy, had birth control ring. Prior to vaccination, the patient was diagnosed with COVID-19. Patient not pregnant at the time of vaccination. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING) for birth control; acetylsalicylic acid, paracetamol (EXCEDRIN BACK & BODY). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received first dose of dose bnt162b2 (Lot Number: EL-3247) in left arm on 10Mar2021 11:00, and experienced mild arm soreness, felt thirsty, mild headache, fatigue. When patient woke up around 5am the day after receiving vaccine (on 01Apr2021) with chills and body aches. She took Acetominaphin. Around 7am temperature was 99.7. She had temperature approx. every hour throughout the day, the temperature was in the 99s most of the day with 2 readings in the 98s. In the afternoon, she had a severe headache as well. Patient was unable to eat all day with no interest in food whatsoever. By 5pm the headache started to subside. Patient tried to sleep as much as possible. By the next morning the chills and fever were gone and did not come back. Some minor body aches persisted through the next day. The outcome of chills and fever was recovered, headache was recovering, other events' outcome was unknown. Patient had not been tested for COVID-19 Since the vaccination.  No follow-up attempts are needed. No further information is expected.
This study case was received from the investigator in a trial on 22 February 2012. A 45 year-old male subject with a past medical history of elevated cholesterol and diabetes (Type I or Type II) was found to have on 23 April 2009 "other, chest pain" three days after the subject had received on 20 April 2009 the following vaccines: ACAM2000 (lot number, route and site of administration not reported), an injection of TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 24 April 2009 and a normal ECG on 27 April 2009. Echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Patient experienced seizure like activity including eyes rolling, shaking, pale skin and sweating. After a few seconds, patient alert but experienced nausea and headache.  Patient was provided ice packs behind the neck, arms and groin. Once able to sit up, patient was provided with juice. After 30min, color back to baseline, no further nausea/headache. Patient able to sit up, stand slowly and ambulate  normally. Patient left the office with mom.
Initial report was received from a consumer, who was also the patient, on 19 June 2012. A 40-year-old male patient had received a dose one injection in the right deltoid of TENIVAC, sanofi pasteur Ltd. (lot number unknown) on 14 June 2012 and an unspecified amount of time later experienced a sore right arm, "like getting punched". The sore arm resolved on 17 June 2012. On 18 June 2012, the patient was sitting in a chair when he began to jerk, lost consciousness and was incoherent for 10 minutes. A friend of the patient stated the seizure lasted for 10 minutes. The patient was transported by ambulance to the hospital. The patient was seen in the emergency room (ER). A CT scan of the head, blood work and EKG were done. The physician told the patient "all tests were clean" and referred him to a neurologist. The patient was receiving wound care at the time of vaccination. The patient had no known allergies (NKA). No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
This spontaneous reprot as received from a nurse practitioner refers to a 7 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 16-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a female consumer of unknown age regarding herself. The patient's concurrent condition and medical history was not provided. The patient's drug reactions/allergies included penicillin and codeine. On an unknown date in January 2015 (reported as second week of January 2015), the patient was vaccinated with ZOSTAVAX 1 single shot, injection (route and dose unspecified). On an unknown date in January 2015 (reported as one hour after receiving ZOSTAVAX), the patient experienced a long red rash on her arm that lasted 7-8 days. After the rash went away, the patient experienced cold sore on her bottom lip that lasted for 5-6 days on an unknown date in January 2015. On an unknown date in January 2015 (reported as lasted for 5-6 days), the cold sores went away. On an unknown date in 2015, the patient developed a cluster of white sores on the inside of her mouth that spread to her tongue. Patient stated that the sores had healed (Recovered/Resolved with Sequelae) but the left side of her tongue remains sore and swollen. The outcome of the event left side of her tongue remains sore and swollen was reported as not recovered. The patient sought medical attention reported as visited the physician. The reporter causality was not provided. No product quality complaint was reported. No further AE information was provided. Additional information has been requested.
Within 30 min child returned c/o H.A., nausea and slight dizziness, hives to upper chest and back-throat red-swollen with white patch L side-c/o slight itching off and on-beginning to scratch-Mom contacted-arrived-50 mg BENADRYL IM L deltoid-hives and rash becoming less noticeable-sent to ER with Mom-Dx as allergic reaction to H1N1-placed on steroids and BENADRYL with FU x 5-10 days.
Swollen lymph nodes in neck which caused migraine, this lasted a day, then swollen lymph nodes in armpit still persisting today, but has improved since yesterday.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored VARIVAX (lot# N034559, expiration date: 05-DEC-2019, strength, dose, frequency and route were unknown) for prophylaxis reconstituted with well stored sterile diluent. The vaccines had temperature excursion of 15 degree F to 46 degree F (18.9F) for 7 hours 18 minutes. Previous temperature excursion was 15 degree F to 46 degree F (14.5 F) for 48 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality compliant involved.
09/03/22 presents to ED for "abnormal labs". PMHx of "end-stage renal disease on hemodialysis, Lynch syndrome, seizure disorder"
First 24 hrs = swelling, warm, itchy, sore. Then: pain.down whole arm, weakness, loss of range of motion (now 3 weeks out).
General tiredness, injection site pain.  Tiredness started roughly 6 hours after injection. Resolved with a nap. Injection site soreness remains 28 hours after shot. Tylenol is helping.
Started with itching and by day four after the injection I had a severe trunkal rash - started around my neck and moved south eventually covering all around my neck, chest , abdomen and down both legs and both armpits; red raised rash that blistered in some spots.  One of my colleagues (a surgeon) looked and me and prescribed. Treatment was antihistamine and steroid DosePac . The rash may have improved with  the treatment; however, the blisters took awhile to heal and I'm still itchy. Swings in temperature  -in the room, or in the water or anywhere it swings - the itching gets worse. I crawl up my skin for the itching. I've tried cremes and calamine lotion and oatmeal baths.
Sore throat, muscle ache, congestion, wheezing for 9 days.
Between 24-48 hours began have reactions not expected. Pain in LEFT foot and toes. Severe pain in LEFT hand, fingers, wrist, and forearm. Then pain in BOTH wrists, hands, feet, and then lower back pain. The pain moved from scary levels to dull pain over the 2 weeks post-vaccination. I expect the pain will go away soon. The use of my hands was affected. Walking was affected. It felt like the lymph nodes around my ears, neck, face, eyes, chest, arms, abdomen, legs were all swollen. Can swollen lymph cause carpal tunnel like symptoms? Foot pain? Lower back pain? Began to have allergic like skin reactions 5 days post-vaccination. Burning eyes, itchy skin. Still experiencing itchy skin with red/warm face 13 days post-vaccine. Antihistamine relieves most symptoms.  This vaccine does not seem sustainable for me as a yearly vaccine. (I had red palms after the 1st vaccine within hours. I am not sure if this was a reaction to the vaccine. I began taking antihistamine before the 2nd vaccine and did not get red palms. I have no idea if red palms were an early hint that I would be hyper sensitive to the vaccine.)
Patient had a fever when he woke up in the morning. He was given ibuprofen for the fever. Approximately 45 minutes after waking, he had a febrile seizure.