chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had a legal complaint. An attorney reported that a male infant, a quadruplet, received Acel-Imune and Tetramune vaccine from 1/13/99 to 3/10/00. It is alleged that as a result of the cumulative exposure to thimerosal in the vaccines the child experienced neurological damage in September 2000. He was also diagnosed with autism. The attorney alleges that all four quadruplets from this family experienced these events. See related cases HQ4074805SEP2002, HQ4142510SEP2002 and HQ4142610SEP2002. This case was considered serious since autism, thimerosal poisoning and neurological damage were considered medically important in this case. No additional info was available as of the date of this report. A 15-day follow up report received 01/12/2004 adds: Follow-up info received provided the pt's medical records. An attorney reported that a male infant allegedly received Acel-Imune and Tetramune vaccines between 01/13/1999 and 03/10/2000. It is alleged that as a result of the cumulative exposure to thimerosal in the vaccines the child was "exposed to toxic levels of mercury and suffered neurological damage in Sept 2000 and thereafter". The attorney reported that the child "suffered mercury toxicity, neurologic injury and is autistic." Medical history: The pt is one of a set of male quadruplets. A hospital discharge summary from after the pt's birth indicated that the pt was born prematurely, at 31.5 weeks. The infant experienced hypoventilation in the delivery room. Due to the premature birth, the pt experienced apnea of prematurity, anemia of prematurity, jaundice and respiratory distress. He also had a problem with slow feeding. Apgar scores were 8 and 9 at 1 and 5 minutes respectively. Product details: According to medical records, additional suspect vaccinations received during the alleged time period of 01/13/1999 and 03/10/2000 included: Synagis (MedImune), Engerix-B (GSK), Haemophilus influenzae b (manufacturer unknown), Diphtheria, Tetanus toxoids and Pertussis (manufacturer unknown), oral poliomyelitis virus vaccine (manufacturer unknown), Hepatitis B vaccine (manufacturer unknown), MMR-II (Merck) and IPOL (Aventis). Event details: According to medical records, on 12/20/1999, a neonatologist stated that the pt was "doing well developmentally in all areas except in his language development. This language delay is possibly due to prematurity..." On 02/01/2000, a psychologist reported that a diagnosis of autism was confirmed and at that time the pt had a mild to moderate level of impairment associated with autism. On 09/29/2000, a speech/language pathologist assessed the pt as having moderate delays in both receptive and expressive language skills. On 12/08/2000, a child neurologist stated that the pt probably has pervasive developmental disorder. On 01/19/2001, in an evaluation to assess the pt for pervasive developmental disorder, a psychologist reported that the pt "meets criteria for a DSM-IV diagnosis of Autistic Disorder." Medical records are on file. Related cases: The pt is one of a set of male quadruplets. All 3 of this brothers experienced similar event (see MCN HQ4142510SEP2002, HQ4142610SEP2002 and HQ4074805SEP2002).
Pt went to ER on the night of the vaccination with urticaria (over total body). Treated and responded to Benadryl.
Hard lump at the injection site, it is red and warm, and it is itchy, it also feels like something is still in my arm.
Sharp pain in heart; Sharp pain in left lung; Sharp pain in inner left arm; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Sharp pain in heart), PAIN IN EXTREMITY (Sharp pain in inner left arm) and CHEST PAIN (Sharp pain in left lung) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. NDC: 80777-0273-10) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sharp pain in inner left arm). On an unknown date, the patient experienced ANGINA PECTORIS (Sharp pain in heart) and CHEST PAIN (Sharp pain in left lung). On 02-Jun-2021, PAIN IN EXTREMITY (Sharp pain in inner left arm) had resolved. At the time of the report, ANGINA PECTORIS (Sharp pain in heart) and CHEST PAIN (Sharp pain in left lung) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: other (High) High blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent condition, medical history or concomitant medications were reported. On 24-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 16 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor was Product Quality Complaint (PQC) involved. This is one of several cases received from the same reporter. Additional information has been requested.
1. Lost hearing in right side ear 2. Ringing sound in the right ear (Tinnitus) Symptom started on 8/13 and non stop since.
Less than 24 hours after receiving the injection in the left harm I woke the next morning with severe pain and burning in my skin in my right chest, under my right arm, and in my right shoulder blade down to about mid-back. This lasted for three days and eventually dissipated.
Left deltoid red, swollen, hot to touch. Cephalexin 150mg qid for 7 days. Benadryl 6.25 q 8 hours.
Breakthrough case admission after 3 vaccines Moderna 3/7/21 Lot# 030A21A;  Moderna 4/5/21 Lot# 006B21A;  Moderna 12/10/21 Lot# 013F21A
Symptoms after the vaccine: Severe chest pain and accelerated heart not sure if it is normal. I haven't gone to the doctor because I'm scared. I just want to know if the pain is normal.
Pt had itching at site of infection and scratched repeatedly starting 1 day after injection. 2 days later Pt developed cellulitis and was prescribed ABX and steroids in Left arm.
No additional AE reported; patient was administered an expired dose of PROQUAD; This spontaneous report was received from a Licensed Practical Nurse (L.P.N.) and refers to a patient of unspecified gender and age. Patient's pertinent medical history, concomitant medications and past drug reactions or allergies were not provided.  On 17-MAR-2022, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose on 0.5 milliliter (mL) (vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number T0318525 that was verified to be an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and does not match any company product as confirmed by lot verification team, expiration date reported as 16-MAR-2022) (expired product administered) for prophylaxis.  Also, it was confirmed that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had no temperature excursions. The reporter provided the supported disclaimer based on the "post expiry memo".  No additional adverse event (AE) was reported (no adverse event).
This spontaneous report as received from a healthcare worker refers to a 11 year old patient who had previously received 2 doses of VARIVAX (Merck) and M-M-R II. On 20-MAY-2014 the patient was inadvertently vaccinated with a third 0.5 ml dose of M-M-R II via subcutaneous route and VARIVAX (Merck) (captured in case #1405USA013780). No adverse effects were reported. No PQC. This is one of several reports received from the same source. Additional information has been requested.
2 hours after vaccination, arm with PNEUMOVAX vaccine became very red, swollen, itchy and heavy - Arm with flu vaccine was fine - high fever for days.
Have experienced bothersome and worsening  memory issues. Primarily an ability to recall info at times.
2 days post vaccine developed redness & pain at site - went to ER, differential diagnosis was vaccine reaction VS cellulitis ; tests included blood cultures and CBC ; had consult with infectious disease specialist and was treated with keflex X 14 days
This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the events was unspecified. This event occurred in 7 patients. Linked cases include A0746417A, A0746426A, A0746427, A0746428A, A0746429A and A0746430A. Follow-up identified a product complaint number. It was additionally reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse were recorded."
my arm is still very swollen; had a rash most of last night; it still hurts like hell where the shot was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 16Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset Nov2022, outcome "recovering", described as "had a rash most of last night"; VACCINATION SITE PAIN (non-serious) with onset Nov2022, outcome "not recovered", described as "it still hurts like hell where the shot was given"; PERIPHERAL SWELLING (non-serious) with onset Nov2022, outcome "not recovered", described as "my arm is still very swollen".  Additional information: the patient got the latest COVID-19 vaccine mRNA. The patient's arm was still very swollen and had a rash most on the night. Most of the rash has went away but the swelling was still there. The patient wanted to know if it was dangerous and will the patient will get hurt, if the swollen arm and rash was not going to kill the patient, or the patient's arm wont fall off and the if the patient will not have any real damage to the body just from having the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Has a 2 1/2 x 2 1/2 inch red area around injection site. Area is warm to the touch. Started on KEFLEX 500 mg p.o. QID x 10 days.
Per Dr. child develop a rash after being vaccinated on 7-31-08 with MMR, varicella, Hep A
Woken from sleep by painful shoulder. Pain is consistent with occasional throbbing in left shoulder joint and muscles above and around where vaccine was administered and does not respond to ibuprofen. Some response to naproxen @ 375mg per dose as needed per doctor visit on Sunday Nov. 13 when the pain became unbearable. Pain has led to sleeplessness, loss of range of motion, tingling in fingers, stiffness of joint and total loss of use of the left arm. A sling has been somewhat helpful.
This spontaneous report was received from the patient's wife and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received a second dose of PNEUMOVAX 23 (lot #, dose and route were not provided). No adverse effect was reported. Additional information is not expected, as no contact details were provided.
This spontaneous report as received from a pharmacist refers to a newborn patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 13-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L048849 expiration date 04-FEB-2018 (dose, dosage number and route of administration were not reported). No concomitant medications were reported. No product quality complain was involved. Additional information has been requested.
Patient had a red arm, painful, raised 2-3 inches. Onset of symptoms began 12/1/2021. Symptoms improved by 12/2/2021. Still circular and still red. Patient described it as "COVID arm."
Parent called on call doctor 6//2/2019 with a second episode of shortness of breath lasting 2-3 and throat tightness that resolved at time of phone call. parents concerned that it may be related to the vaccine, since had a similiar episode approx 45 minutes after vaccine administration on 5/30/2019.
Patient was given the inappropriate dose of 1.25 ml of Moderna instead of 0.25ml.  This was discovered after the patient had left but the provider called the mother to discuss the adverse event. Provider and Mom had thorough discussion and to this point the patient has not any reaction to the immunization dosage of 1.25 ml.  Mom was advised to report any side effects the child has.
Patient experienced red, warm, painful, spotty rash from elbow to shoulder in her left arm. Started 2-3 hours after vaccine. 10 hours post-vaccine, rash is subsiding and pain is decreasing.
Headache at about 20 minutes post shot. Took ibuprofen it worsened over the next hour. When that wore of off headache returned low throb this time. Mostly in the front. A low grade fever appeared.
loss of appetite; fatigue/completely drained/ragged tired; he got sick the next day/has been sick; whenever he tried to do something, he will break out in a cold sweat; This is a spontaneous report from a contactable consumer other non-health professional (patient) via medical information team.  A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, lot number: Unknown, Expiration date: Unknown), via unspecified route of administration on left arm on 28Jan2021 (age at vaccination 78-year-old) at 1st dose, single for covid immunization. The patient had no medical history. There were no other products. On 28Jan2021 patient took 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 29Jan2021 (day after) the patient experienced loss of appetite, fatigue, and completely drained. Reportedly on 29Jan2021 patient had been sick. The patient experienced ragged tired, totally drained, and whenever he tried to do something, he will break out in a cold sweat. Patient stated that he got a COVID shot on 28Jan2021 (last Thursday), and he had been sick ever since. Patient stated that the sickness does not seem to be going away, it was about the same, it did not seem to be getting any better. Patient was wondering how long this is supposed to last, and if there was something he could do. Patient wanted to know how long he will be experiencing these symptoms. The case was assessed as non-serious as per reporter. No investigation assessment was done. Reporter confirmed that he had no other vaccines on the same day as his COVID vaccine. Reporter did not have his COVID Vaccination card with him at the time to provide Lot number. The outcome of the event was not recovered for sick and unknown for all other events.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX (batch number 3Z53C, expiry date 13th March 2021) for prophylaxis. On 12th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: At the time of reporting, the patient was experiencing sore arm after getting a dose of SHINGRIX. Advised pharmacist to refer the patient to Healthcare professional. No further details were provided.
Report A0373064A describes hives in a 4 year old female who was vaccinated with hep A vaccine inactivated. The subject had no known allergies. Medical history and concurrent conditions were not provided. The subject had experienced no adverse events following previous immunizations. On 6/25/02, the subject received her first injection of Havrix (721A2). On the same date, she received injections of MMR II and diphtheria and tetanus toxoids and acellular pertussis vaccine (manuf unk). Post-immunization, on 6/27/02, the subject "broke out in hives from the waist down." The subject was seen by a physician, who prescribed Benadryl. The reporter stated that the event was probably related to Havrix administration. The hives resolved on 6/27/02.
On the evening of October 17, 2008, patient and his wife came into the pharmacy for vaccination services. We discussed which vaccinations he needed by attempting to call where they suspected his last PNEUMOVAX vaccination took place. They could not provide that information, and they were not sure when the last PNEUMOVAX vaccination had taken place. It was decided that he would get both the Flu vaccine and PNEUMOVAX that evening. They were administered together the Flu in the left arm and the PNEUMOVAX in the right, at about 5pm. Universal precautions and standard IM injection techniques were used. The patient's wife called me on October 24, 2008, at 11:50a.m. to inform me that the patient had been admitted into the hospital on October 23, 2008, at about noon. She informed me that after leaving the pharmacy the couple had gone to dinner, and around 7:00 on the 17th he was experiencing an ill feeling and pain at the PNEUMOVAX injection site that she described as excruciating pain. They called the phone number provided on the VIS and were informed to take aspirin and apply ice to the injection site. Then at 10:00 p.m. they called the ER and were informed to do the same thing. She informed me that on Monday the swelling and redness on the arm was going down, but that he was having swelling in his legs and his ears were plugged. Their primary doctor started the patient on antibiotics. She informed me that he took the antibiotics and that still Thursday the arm was still swollen, red, and painful and thus, he was ordered to enter the hospital. Upon her request I called the physician and left a message with his staff that I was available for any questions and explained what vaccines were given. This was done at 12:24 p.m. October 24, 2008. I have not been contacted as yet by the doctor. On October 27, 2008, I contacted the wife to inquire on his status, and she informed me that he still had arm pain, but that he was coming home from the hospital that day, she thought.  12/24/08-records received for DOS 10/23-10/27/08-DC DX:Phlebitis, right upper arm. Right shoulder hematoma, deltoid, post vaccination for flu. Decreased range of motion right shoulder, post vaccination for flu. Presented with C/O severe pain in right shoulder consistent with phlebitis and hematoma. Admitted for intravenous antibiotics.
8-28-13 onset of fever - 101 max - rash started around injection site on 8-30-13 - varivax vesicles at site of injection only.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Date of refrigeration was reported as 05 Jul 2021.
Client states she became lethargic and could not move her arms or speak. She was taken by ambulance to the ER, The doctors could not find any indications of a stroke or other complication. Dr stated he dose not believe this incident was related to the flu vaccine.  12/19/06 Received hospital records which reveal patient admitted 11/14/06 for observation after feeling paresthesia, sleepiness, dizziness & speech impairment s/p flu shot.  Overnight observation. Improved & d/c home in AM 11/15/06. Final DX: possible adverse reaction fo flu vaccine w/hyperventilation.
Metallic taste, throat discomfort, dry mouth, hard to swallow Took 25mg Benadryl
On 3/4/00 the pt experienced severe abdominal pain for 10 hours. On 3/5/00, the pt experienced nausea and again on 3/8/00.  On 3/5/00 - 3/8/00, the pt experienced a body rash, blurred borders and itching, and dark amber urine. On 3/7/00  - 3/8/00, the pt had pale stools. On 3/5/00 the pt experienced a tender liver. On 3/4/00 - 3/8/00 the pt experienced fatigue. On 3/6/00, the pt was referred to family MD. The family MD ordered bloodwork.
Fever of 103, Parents gave Tylenol for Fever & tepid bath. Temp was taken via  non-contact skin thermometer. advised if temp reaches 104 or above seek medical attention or call PCP. Also on 06/08/2017 & 06/09/2017 had skin rash to upper torso, both limbs seen by a provider. given steroid. Per mom.