chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 09 June 2011 from a health care professional. A 55-year-old male patient had received an intramuscular deltoid first dose injection of IMOVAX Rabies, lot number D1111 on 26 May 2011, and 20 minutes later, he developed numbness on the left side of his mouth which lasted 24 hours. This same event occurred after the patient had received their second and third dose. The events did not require a doctor's visit. The patient had no concurrent illness, no past medical history and he had not been taking any concomitant medications. The patient had not experienced any adverse events following prior vaccinations. No laboratory or diagnostic testing had been performed. At the time of the report, the patient was scheduled to receive his fourth dose vaccination. Outcome was recovered. Follow-up information was received from the healthcare professional on 18 July 2011. The IMOVAX Rabies lot number was clarified as 942320 (expiration 04 December 2011). The patient was vaccinated at 11:30, and the event occurred at 13:00 (previously reported as 20 minutes post-vaccination). Per the reporter, the patient was immunized due to possible rabies exposure, after having contact with a horse that tested positive for rabies. Documents held by sender: None.
golf ball - sized lymph node swelling in his right arm pit; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2019, the patient received the 2nd dose of Shingrix. On 26th October 2019, 1 days after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The reported stated that the patient experienced golf ball sized lymph node swelling in his right arm pit. No other symptoms reported. The reporter consented to follow up.
Pt was given Tdap, MENACTRA and GARDASIL, 5-10 mins after injections. Pt was at cashiers station. Mother said she says doesn't feel well. Then pt says can't see. Put pt in chair and rolled her back to clinic room. Put on exam table. Mother at side. B/P 100/60. Mother denied any problems prior. After 10-15 mins pt sat up says "feels better" walked out with mother.
9/15/05 around noon child had 102F temp. Advil given earlier. Acted fine all morning. Started seizure, eyes rolled back into head, limbs shaking. Lasted approx 1-2 minutes. Took child to ER. Sent via ambulance to health center. Saw physician there. Had lab work and CT done, all were normal. Child sent home. Had fever for 2 or 3 more days gave Advil routinely. No other seizure activity noted. As told by mother of child to this nurse.
Patient called next day with redness and swelling at injection site. Was instructed to use cool compress and pain management. Two days later she went to physician to check and Dr. said it was improving and to continue OTC treatment.
Information has been received from a medical assistant (MA) concerning a 41-day-old patient who on 08-Apr-2008 was inadvertently vaccinated with a 0.5ml dose of Hepatitis A virus vaccine inactivated instead of hepatitis B virus vaccine (MSD). It was unknown if medical attention was sought and no problems were reported. It was noted that this was not a case of product confusion. Additional information has been requested.
Employee reported a fever of 101.1 and fatigue post 24 hours after second covid vaccination. Was resolved by the next morning with a temp of 96.8.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccinated with unknown number of doses of GARDASIL, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that the GARDASIL lot # reported as J0112752 with expiration date: 21-APR-2016 and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of GARDASIL. The office was in the process of contacting the patients for revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 7 year old pt who on 01/14/1997 was vaccinated with varicella virus vaccine live. ON 12/26/2002, The pt experienced a breakthrough varicella. There were less than 50 lesions. . Unspecified medical attention was sought  no tx or hospitalization . the pt recovered. no product quality complaint is involved. This is one pt out of 40 reported. 39 other cases (WAES 0407USA01446, 0407USA01855, 0409USA01860, 0409USA01862 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additonal information is  not expected.
Craning around abdomine, very weak.  Headache. Loss of voice. Sore Throat
Stomatitis, posterior lesion seen 10-20-08 in office. Symptomatic Rxment improved. Came in 10-31-08 for scheduled Flu immunization seen by nurse, well -> gave immunization: 3 days later ataxia, seen at ER. Admitted-MRI +ve ADEM, hospitalized 11 days. I.V. steroid, acyclovir.   12/16/08 MR received for DOS 11/4-15/2008 with DX:  ADEM. Pt presented with fever, decreased appetite, and ataxia.  PE (+) for a fussy, sick looking irritable pt. Mild dehydration and refusal to walk. Pustule noted on L buttock. No ataxia reported in initial H&P. Admitted to r/o encephalitis. Neuro consult with Dx: ADEM presents with ataxia, somnolence, irritability, R facial palsy, Babinski's sign and brisk DTRs. Tx with abx, steroids, IVIG with improvement.
Patient developed hives on chest, arms, back and thighs at 1900 on 3-6-14. Given dose of BENADRYL and hives gone morning of 3-7-14. Hives started on forehead 3-7-14 at approximately 12 noon. Given dose BENADRYL - resolved by 1400 - will continue BENADRYL every 6 hours until hives gone x 24 hours.
Woke up at 11 pm the same night after dose with a 102.5 fever, chills, severe headache, fatigue, body aches, vomiting, dizziness, and pain at injection site. These symptoms including the fever lasted for 2 days.
A total of 8 pts had local reactions following immun; 6 of these 8 pts exp inject site react which included erythema, hot to touch, pain & swelling w/in 15 mins of immunization; dx allergic topical reaction;
Patient had swelling, redness and went to doctor and had cellulitis and received antibiotic.
Arm was sore at injection site after covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Arm was sore at injection site after covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore at injection site after covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Arm was sore at injection site after covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported  No treatment information was provided.
Three days post varivax immunization, developed one 5x5mm vesicle at injection site with 10x15mm erythematus base. Symptoms of itching. Vesicle still present on day 11 post immunization.
patient complained after vaccine later that evening she developed swelling in left arm, pain in left arm, swelling to left axilla, slight numbness left hand, "could not wear her wedding ring due to swelling in fingers", reported blurry vision the following day, fatigue and malaise which improved over the course of a few days, however pain in arm persisted and swelling in left axilla for over 5 days
Muscle spasms in left front upper leg. Muscle spasms in left upper arm both within 30 min of shot. Lasted one hour then stopped. Swelling around injection site (muscle in right shoulder).
Injection site reaction - redness, pain, fever began day after shot. Patient saw Dr. who prescribed antibiotic for suspected infection 2 days after shot given.
zoster related pneumonia; zoster related pneumonia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 09-SEP-2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions (prophylaxis). On an unspecified date (reported as subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation), the patient was treated by a healthcare provider at a hospital for zoster related pneumonia (varicella zoster pneumonia and herpes zoster). As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer 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. The outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, varicella zoster pneumonia was determined to be medically significant.
This spontaneous report was received from a pharmacist refers to a 93 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 20-OCT-2014 the patient was vaccinated with a dose of with ZOSTAVAX (dose, dose number and route were not reported) lot number J005721, expiration date 29-AUG-2014 and also reported as J001721 expiration date 29-AUG-2014. Co-suspect and concomitant therapies were not reported.   The pharmacist reported that on 20-OCT-2014, a patient received a dose of ZOSTAVAX that expired on 29-AUG-2014. The pharmacist reported that the expiration date was not noticed to be past at the time of administration because "the way that the lot number and expiration date was de bossed on the label, it was very difficult to read". The pharmacist stated the neither the nurse who administer the dose to the patient nor she could not discern the lot number of the dose of ZOSTAVAX. No adverse experience was observed or reported. Lot number J001721 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
I had my vaccine everything was fine I had to sit down for 30 minutes for observation. My heart started racing I checked my apple watch, and my palpitations was really high as if I was working out blood pressure was high. the moved me to do an EKG on site my heart wouldn't stop racing. I got really hot an ambulance was called.   After making it to the hospital they said I was running a fever. palpations. I had a bad migraine I stayed at hospital for 4 to 5 hours. stomach Inflammatory response syndrome (SIRS). Tachycardia  Doctor stated that my body was just reacting to the COVID 19 shot. I was very tired for about a week and had headaches.
Pt received 1st dose of Adult Pfizer 0.3ml Via IM at 1325. Pt reported feeling gonna faint. Pt  High BP noted 170/108 ,Pulse 90 , Resp 20. O2 100% . Pt verbally responsive and no facial color changes and no SOB noted. Vitals checked again BP 154/95, Pulse 83, Resp 18, O2 100% Fluids given and well tolerated. Physician contacted and pt evaluated by physcian and advice to contact PCP
After receiving the first vaccine my right arm was extremely sore and painful. Then after taking my second shot on March 10 my arm was still sore and painful. On March 11 I passed out after taking my allergy medicine, mometasone. I am still suffering from these side effects. The first shot was not given properly in my arm. Not in the muscle. The orthopedic refered me to see a physical therapist. I have been seeing the pt from March to the present. I am restricted from doing many things that I did before the shot.
The evening  of the first shot on February 5, I had a strong headache, muscle aches and was extremely tired for the next two days.  I had brain fog for the next 2 weeks.  Tylenol and Advil mostly relieved physical discomfort.    I had the second shot March 16.  The next day I had a severe headache, no energy, achy body,  chills and fever and on the second day after the shot my temperature was 101.4 - 101.8.  Tylenol and Advil relieved the symptoms.  Today, one week after the second shot I developed a pungent chemical taste in my mouth and a similar sense of smell.  The tip of my tongue is tingling, and while I can breathe in deeply,  my chest feels heavy, like I'm not getting enough oxygen.
8/12/08 call from mom at home.  Baby is having a seizure about 2 1/2 hours after vaccines were given.  Patient returned to office and given DIASTAT 2.5 mg via rectum and given O2.
congestion, rhinorrhea,  sore throat, HA started 1/31/22
She was diagnosed with Covid 19; She was diagnosed with Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She was diagnosed with Covid 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with Paxlovid. Caller states she has previously been vaccinated with Pfizer Covid 19 vaccine 2 doses and had her booster dose last Oct2022. She was diagnosed with Covid 19 and prescribed Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sore & achy shoulder (3 days; worst on 2nd day); headache (started about 2 hours after vaccine; 10 h after vaccine, took 2 tylenol, headache gone by night)
Face hot and tingly about 2 hrs after vaccine and lasting over 24 hrs while chilled elsewhere. Nausea and.lack of appetite for over 24 hrs since vaccine  Diarrhea about 19 hrs after vaccine Muscle and joint pain over 24 hrs since vaccine. Pain in trapeze on left size, same as shot, is crazy sore. Severe tiredness..slept from 9 pm (11.5 hrs after vaccine) til 2 pm next day. Still tired Headache 30 hrs after vaccine face is still somewhat tingly..like last stages of when novocain is wearing off after dental procedure) but not near as hot feeling.
Pericarditis: agonizing chest and back pains, frequent dizziness, shortness of breath
Information has been received from a physician concerning a 50 year old female who on 26-SEP-2008 was vaccinated with PNEUMOVAX (lot # 659487/1960U), mistakenly intradermally. On 26-SEP-2008 the patient experienced pain in arm, headache for a weekend, anxiety for long term effect possibility. The patient required emergency room or doctor visit. The outcome was unknown. No further information is available.
an expired dose of ROTATEQ was administered to a patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-DEC-2020 (also reported as 2020), the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S017634 exp date 08-DEC-2020) orally. There were no prior temperature excursions for the administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
FEVER UP TO 103 DEGREES FOR UP TO 3 DAYS, BODY ACHES, FATIGUE, SKIN ICHINESS, VERY SORE ARM,
Patient called pharmacy and complained of having trouble breathing/not feeling well. Pharmacist suggested she go to the hospital immediately. According to husband, she was admitted around 9PM to the hospital. She stayed one night on 11/4 and will stay at least 11/5 for one night for further observations.
Information has been received from the published literature article referring to a 5 year old male patient with allergy to fish, peanuts and eggs.  On an unknown date, the patient was vaccinated with a dose of MMR virus vaccine, live (manufacturer unknown) (dose, route and lot# were unknown), varicella virus vaccine live (manufacturer unknown) (dose, route and lot# were unknown) and DTAP-IPV (dose, route and lot# were unknown). Less than 30 minutes later, the patient experienced general pruritus, wheeze, cough and vomiting. The initial evaluation was performed in a clinic and the pediatrician provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 2. The patient was treated with epinephrine, oral antihistamine and antiemetic. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.
It choked my asthma (up) really bad. Heart speeded up - my whole body is weak, sick to my stomach and stiff body whole - headaches - dizzy headed. Hives big as silver dollars on entire body. Can't pick up anything with my arm they gave it in. Can't hardly walk.
This spontaneous report was received from a Nurse Practitioner and the patient's mother reporting to a 10 month old male. Medical history and concurrent conditions were not provided. On 08-APR-2016, the patient was vaccinated with a dose of RECOMBIVAX HB lot # L023387, intramuscularly (dose and expiration date were not reported). The patient had no concomitant medication. After the administration of RECOMBIVAX HB approximately in April 2016, the patient developed a stomach bug with dehydration on an unspecified date (also reported as on 22-APR-2016) for which the patient was admitted to the hospital on 22-APR-2016. The patient received unspecified intravenous fluids. Additionally, the patient developed elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels (units and values not provided) that were just above the normal range (on an unspecified date in April 2016). Then, the patient was subsequently discharged from the hospital (in April 2016). The patient was recovering from dehydration, aspartate aminotransferase increased, alanine aminotransferase increased and gastroenteritis viral. Relatedness between the therapy with RECOMBIVAX HB and the events was not reported. Additional information has been requested.
Patient passed out around 5:30 pm. Pt also reported headache. Pt went to ER at midnight and stayed for 12 hours.
Starting approximately 2 days after the injection I have experienced loss of voice approaching laryngitis, persisting to the present time. There is little or no discomfort, but speaking is difficult and my voice is severely restricted in volume, tone and clarity. I have had no  throat ailments for the past  several years. I have not experienced symptoms like this ever before, other than an occasional sore throat associated with colds or flu.
vomiting for 4 days, head ache, hot flashes, loss of appetite, thirsty, achy, eye twitches
Developed itching and then hives over entire body within hours of administration of Hep B vaccine.
Started out as severe tension in neck then came home . I was feeling very tired. Went to bed at 10 pm and woke up at 2 am with full body aches. I had no temperature but mild chills
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative through media concerned a patient of unspecified age, sex, race and ethnicity. 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: UNKNOWN and expiry: UNKNOWN) dose was not reported, 1 total administered in MAR-2021 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. The patient got vaccine 6 months ago (MAR-2021) and on 03-SEP-2021, the patient was found to have covid (suspected clinical vaccination failure and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000192350.; Sender's Comments: V0: 20210910659-covid-19 vaccine ad26.cov2. s- suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pain in arms and legs. Muscle twitching in arms and legs. Headache Tylenol helped. Seen back in the clinic the next day. PE was WNL.
Severe fatigue & back pain has been going on since he got the shot. On 10/19/2011 he had a seizure in the morning around 6:30 am which results in an ER visit. Since then, my son's back pain is worsen as well as his fatigue.   Needs further medical care but no one will help us. Dr refuses to believe these might be from the shot.
Lightheaded for about 20 minutes post injection. Did not alert staff , waited it out. Onset of lightheadedness was quick .
Fever of 101 to 102 for 2-5 days after vaccination onset 1-2 days after. Has recovered completely.
After giving the patient the shot, she opted to sit for 10 minutes before leaving. I watched her and saw her drop her head suddenly. Patient lost consciousness and fell to her right. She landed on her face and became tense.