chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 20SEP95 & 21MAR97 pt devel chickenpox that consisted of less than 30 lesions;
Patient had a very large injection site reaction that night lasting for 3 days. It was very swollen and inflamed. She did not seek medical treatment. She stopped in pharmacy a week later to report and by then it was resolved.
Initial report was received 30 September 2011 from a healthcare professional which involved a cluster of four patients. Four elderly patients above 65 years of age, had received FLUZONE HIGH-DOSE, lot number UH452AA within a two week period. All of the patient had been fine while at the doctors office, but a few hours later after returning home, all developed symptoms of nausea, vomiting and chills. One patient was hospitalized. Unspecified laboratory testing confirmed it was an infection (not specified) and further testing was required. No additional information was provided and outcomes were not reported. Documents held by sender: None.
Info has been received from an LPN concerning an 8 year old white male, with no known allergies, who on 1/26/98 was vaccinated with a 1st dose, in the right arm of varicella virus vaccine live. There was no illness at the time of vaccination. On 5/5/05, the pt presented with 5 to 6 vesicular lesions on trunk. Unspecified medical treatment was sought and no treatment was required. At the time of the report, the pt was recovering. A product quality complaint was not involved. Follow-up info from an LPN indicated that on 5/5/05 at 13:00 PM, the pt had 5 to 6 lesions, with no fever and no other symptoms. It was reported that the pt recovered. Additional info is not expected.
stomach aches; chest aches; Exhaustion; Feeling unwell; Headache; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that an 84-year-old male patient received bnt162b2 (Pfizer COVID 19 vaccine, BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL3302), dose 2 via an unspecified route of administration on 12Feb2021 (Age 84-year-old at time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The historical vaccine included, bnt162b2 (BNT162B2, Batch/Lot Number: EL0142), dose 1 via an unspecified route of administration on an unspecified date (Age at time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunisation. The reporter stated that her and another best friend of hers went to take the shot last month and they were trying to find out, they still had different abnormal response to the vaccine after the second one. It has been 2 weeks since they had the second one and the still had tiredness and extreme fatigue, feeling unwell in Feb2021 and they were calling to see if there were suggestions, or something take or do after the second shot. She clarified she was calling about the second Pfizer COVID 19 vaccine. She said the patient was also on the line they went to together to get the vaccine and he was the other person; he was also on the call. She confirmed his first dose says EL0142 or the 2 could be a 6. And the second dose says EL3302. And the zero has a slash in the middle and that was on 12Feb2021 and it has AMC-S. She said the dates were the same for them because they went together on the same day to get both doses. She said he had been worse off than her. He was having feeling unwell, exhaustion, he had headache and stomach aches and his chest aches in Feb2021 and still had. Physically there was nothing wrong with him he has been to the doctor and had a physical and the doctor did not seem to be anything wrong with his physical being. The outcome of the event was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.
Muscles were really sore; It feels like the arthritis pain that he has in his hip, but all over his body; It feels like the arthritis pain that he has in his hip, but all over his body; It feels like the arthritis pain that he has in his hip, but all over his body; 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 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 11:30 (Lot number: EW0183) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis in hip", start date: Mar2021 (ongoing), notes: States he has had arthritis in his hip since Mar2021. The patient took concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 03Sep2021, outcome "unknown", described as "Muscles were really sore"; PAIN (non-serious), ARTHRALGIA (non-serious), ARTHRITIS (non-serious) all with onset 03Sep2021, outcome "unknown" and all described as "It feels like the arthritis pain that he has in his hip, but all over his body".  Additional information: Patient received the first dose of the Pfizer Covid-19 vaccine on 27Aug2021. Caller states when the vaccine was administered, he "didn't even realize he had received the shot because his arm didn't hurt". Caller states his "muscles were really sore," in which the muscle soreness started this morning. Caller was asking if muscle soreness was normal and if it usually takes this long for side effects to appear. Caller asked if he could take ibuprofen for the muscle soreness he was experiencing. Concomitant medications included the unspecified high blood pressure medication from 2000, unspecified heart medication from 2000 and unspecified blood thinner from 2000. Caller states that he was calling about the Pfizer product that was FDA approved. Clarified as the Pfizer Covid 19 Vaccine. Caller states that all of his muscles were sore. Asks if that it normal. States he took the vaccine last friday, does it take that long to have side effects. Caller denies any other medications or medical conditions relevant to events. Then he states he was on high blood pressure medication, heart medication, and blood thinners since 2000. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. Any AE(s) did not require a visit to Emergency Room and Physician Office. Prior Vaccinations (within 4 weeks), patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-up attempts are completed. No further information is expected.
arm pain after receiving Prevnar13; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient complained of arm pain after receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date and then needed 6 months of physical therapy. Outcome of the event was unknown.  No follow-up attempts are possible; information about the batch number cannot be obtained.
Patient received vaccine and immediately felt light-headed and faint. He turned white upon standing and sat back down. He continued to have labored breathing and starting sweating. We were monitoring him and he informed us that it was anxiety related. He couldn't move his hands and started blacking out. When EMT arrived he started to feel better. They were able to rule out an allergic reaction and it was most likely anxiety related. Patient refused to go to the hospital and was walked out by EMT to make sure he could drive home.
VACCINE HAD EXCEEDED THE 6 HOUR PERIOD AT REFRIGERATION BEFORE ADMINISTRATION (BEYOND SPECIFIED TEMPERATURE RANGE); VACCINE STORED BEYOND SPECIFIED TEMPERATURE RANGE (EXCEEDED THE 6 HOUR PERIOD AT REFRIGERATION); This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced vaccine stored beyond specified temperature range (exceeded the 6 hour period at refrigeration). On 18-MAY-2021, the subject experienced vaccine had exceeded the 6 hour period at refrigeration before administration (beyond specified temperature range). The action taken with covid-19 vaccine  was not applicable. The outcome of the vaccine had exceeded the 6 hour period at refrigeration before administration (beyond specified temperature range) and vaccine stored beyond specified temperature range (exceeded the 6 hour period at refrigeration) was not reported. This report was non-serious.
Fainting, seizure like symptoms, limp/paralyzed limbs, slurred speech that lasted about 1 minute. With him in my arms went downstairs to get my cell phone to call 911 and all of the sudden he started acting normal again. Monitored him for the rest of the day and over night as the on call Dr had recommended. Made an appt with his pediatricians office following morning. They said it could have been a seizure and we made an appt to see a neurologist but appt isn?t until May 15!
This case was reported by a nurse and described a 32 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  The vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Approximately 3 weeks from receiving 2nd dose, onset of neck pain, and in the following week progressing to a rash, extreme arm & shoulder pain, extreme muscle weakness/paralysis/lack of ROM in that arm. At ER diagnosed with Left Brachial Plexitis / Autoimmune Plexopathy.  Began Prednisone.  Continued paralysis.
Shingles; Nerve pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th July 2019, 20 days after receiving Shingrix, the patient experienced shingles and nerve pain. On an unknown date, the outcome of the shingles and nerve pain were unknown.   It was unknown if the reporter considered the shingles and nerve pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The reporter did not have the lot number or expiration date but she would follow up with the pharmacy to obtain the information. The patient developed shingles with a very violent eruption of nerve pain. The reporter did not consent to follow-up and declined to give her treating physician's information. The GlaxoSmithKline (GSK) contact number and case number for follow up lot number and expiration date information was provided.
Blood pressure through the roof 185/125; heart racing; Pulse rate increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALIGNANT HYPERTENSION (Blood pressure through the roof 185/125) and PALPITATIONS (heart racing) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer, Palpitations (Heart palpitations), Blood pressure high and High cholesterol. Concomitant products included LOSARTAN for Blood pressure management, TAMOXIFEN for Breast cancer, PRAVASTATIN for Cholesterol, METOPROLOL for Palpitations, LEVOTHYROXINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MALIGNANT HYPERTENSION (Blood pressure through the roof 185/125) (seriousness criteria hospitalization and medically significant), PALPITATIONS (heart racing) (seriousness criterion hospitalization) and HEART RATE INCREASED (Pulse rate increased). The patient was hospitalized on 14-Jan-2021 due to MALIGNANT HYPERTENSION and PALPITATIONS. On 14-Jan-2021, MALIGNANT HYPERTENSION (Blood pressure through the roof 185/125), PALPITATIONS (heart racing) and HEART RATE INCREASED (Pulse rate increased) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 185/125 (High) Blood pressure through the roof 185/125. On 14-Jan-2021, Heart rate: 150 (High) Pulse 150.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The Patient reported that about 3 minutes post receiving her first dose of vaccine her heart was racing and blood pressure was through the roof (185/125). The patient also had an elevated pulse rate of 150. The patient reported that the symptoms subsided after 15 to 20 minutes and was feeling better however the patient was still taken to the Emergency Room.. The Centers for Disease Control suggested to the patient that she not receive her second dose of the vaccine.   No treatment was provided to the patient in the emergency room. The patient had an Electrocardiogram  (EKG) test completed but no results were provided.  Company comment - 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. However, the patient's past medical history may remain a contributing factors for this event.; 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. However, the patient's past medical history may remain a contributing factors for this event.
This spontaneous report was received from a licensed practical nurse referring to an unknown number of patients of unknown demographics. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies were not provided. On an unknown date, an unknown number of patients were administered improperly stored doses of ROTATEQ lot # N009948, expiry date: 21-OCT-2018. No adverse effects reported. The doses were stored at temperature of 47 degree F to 77 degree F (51.2 F) for 30 minutes. Data logger was involved. The outcome of incorrect product storage and no adverse event were unknown. No additional information provided. No product quality complaint was involved. This case is cross-referenced with 1708USA011751 (same reporter). Sender's Comments: US-009507513-1708USA011751.
3 am: Sleep disturbed, woke with night sweats. face hot, dry mouth, legs hot. felt feverish, had no fever. nausea. feeling hot/cold. headache, head pressure, eye pain, eye pressure. soreness of injection site. sleepy. slept most of the next day. symptoms resolved the following evening.
Received hep B vaccine at 1530 on 3/1/05.  Upon arising 3/2/05 c/o faintness & headache unrelieved by Tylenol.  Persisted throughout that day.  On 3/3/05 she was much improved.  Dr. was not contacted by mother for symptoms.  Was afebrile.
Had the shingles vaccine, got shingles/suspected vaccination failure; shingles in eye; shingles in ear; shingles. Scalp, ear and down left side.; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shingles vaccine and got shingles on scalp, eye, ear and down left side.  The patient said still glad, as he/she got the shot, might had been worse. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Pt. on 7/23/05-1445- after receiving immunizations on 7/21/08.  C/o pain in LUE.  Pts. LUE had an area of approx 5 in x 3 in around injection site that was red in color & warm to touch.  Small bubble where injection was.  Had received VARICELLA on LUE.  Saw PCP on 7/23/08- States reaction to VARICELLA.  7/25/08 no s/s left.
Lowgrade tiredness; Fever; Chills; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Achiness) and FATIGUE (Lowgrade tiredness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Achiness). On an unknown date, the patient experienced FATIGUE (Lowgrade tiredness). On 09-Nov-2021, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Achiness) and FATIGUE (Lowgrade tiredness) had resolved.            No concomitant medications were reported. No treatment medications were reported. Normal symptoms after second dose. Patient had low-grade tiredness, which lasted 2 and half days.
The pt developed an injection site reaction characterized by extreme redness, warmth, and swelling which extended to the elbow. The pt was treated with Benadryl and prednisone.
Slept for 15 hours straight; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERSOMNIA (Slept for 15 hours straight) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HYPERSOMNIA (Slept for 15 hours straight). On 09-Apr-2021, HYPERSOMNIA (Slept for 15 hours straight) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported     This case was linked to MOD-2021-118235 (Patient Link).
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received FLUARIX QUADRIVALENT. On 13th October 2017, the patient received FLUARIX QUADRIVALENT. On 14th October 2017, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On 15th October 2017, the patient experienced movement disorder and neck pain. In October 2017, the outcome of the injection site pain, movement disorder and neck pain were recovered/resolved. It was unknown if the reporter considered the injection site pain, movement disorder and neck pain to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced difficulty turning her head, and pain up the side of her neck, on the side of the injection site.
vomited @ 11:30PM on 19AUG98, coughed all noc while sleeping 20AUG98 drowsy & sleepy all day;7PM temp was 102 gave med for fever p/pt vomited again;21AUG98 parent reported pt was totally fine;
16 year old patient came to get 2nd of Pfizer vaccine. 1st dose given 3-8-2022, and nurse calculated the next dose interval wrong given the 2nd dose early (3-23-22). Monitored for 15 mins and no adverse reactions noted. Pt tolerated well.
new onset atrial fibrillation 02/27/2021 (hospitalization #1) pericarditis with pericardial effusion 03/12/2021 (hospitalization #2)
The patient is 12 years old and received a 5-11 Pfizer Covid Bivalent
Temp check 98 degree F BP 141/90 P86 - 10/13/2016 Left Deltoid area had a dermal allergic reaction to FLUZONE ID injection on 10/12/2016 onset two hours after the shot. 12.5cm by 12.5cm area of redness, skin was warm to touch, tenderness and small induration. Treatment: LORTISONE 1 % topical application.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 20-AUG-2014, 2 patients (1409USA007061) were vaccinated with a dose of MMR II (lot number, expiration date, dose and route were not reported) that was improperly stored to 48F for 39 minutes. No concomitant medications were reported. No adverse effect was reported. Follow up information was received from the Registered nurse who stated that she did not had any patient identifiers or dates of vaccine administration. The registered nurse reported the lot numbers and expiration dates: MMR II lot number reported as J010208 expiration date 23-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested.