chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling; Redness covers about a 3 inch area below the injection site; Bruise; Soreness; This case was reported by a consumer and described the occurrence of swelling in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received withe 3 months spacing and experienced very little reaction, refer inked case US2019AMR178056)  On 26th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced swelling, injection site erythema, contusion and pain. On an unknown date, the outcome of the swelling, injection site erythema, contusion and pain were unknown.   It was unknown if the reporter considered the swelling, injection site erythema, contusion and pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient refused to provide patient's information. On Thursday, the patient received Shingrix. The patient experienced bruise, swelling, redness, soreness and the redness covered about a 3 inch area below the injection site. The patient asked was this in the normal range or should the patient be concerned. The patient how long should the patient expect the swelling and redness to last following the vaccine.
Information has been received from a physician concerning a 1 year old white female with otitis media and no known medical history or allergies who on 09/25/01 was vaccinated in the right arm SC with the first dose of varicella virus vaccine live (lot 639128/0567L) with sterile diluent (639224/0829L). Concomitant vaccination the same day included a first dose of MMR II.
Fevers over 100; chest pain; hard time breathing.; Sore Joints; This is a spontaneous report from a contactable consumer.  A  non-pregnant 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for inejction), dose 1 via an unspecified route of administration, administered in left arm on 23Jun2021 13:00 (Batch/Lot Number: EW0217) as dose 1, single (at the age of 14 years old) for COVID-19 immunisation.  The patient had no medical history. The patient's concomitant medications were not reported.  The patient experienced fevers over 100, chest pain, hard time breathing and sore joints on 23Jun2021. The patient received TYLENOL. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.
Patient came to the clinic for a HEP a Vaccine. Patient was given Hep A. After injection, nurse noticed vaccine was expired on 06/18/2022.   Given at 10 AM. on 07/20/22
Fever, chills, tightness in chest, headache, painful eyes, nausea, allover general soreness, inability to sleep, shallow breathing. Fever broke about 6:00 AM the next day. Other symptoms resolved within 48 hours.
7 x 8 cm firm swelling at site of PENTACEL injection, (R) anterolateral thigh. No treatment.
Starting 3:30 am 8/5/21 woke with shooting stabbing pains in the shoulder of the left arm that proceeded to complete loss of feeling in the thumb of that hand that still has not returned as of 8/26/21.  Presumtive diagnosis of pinched nerve treated with NSAIDS and muscle relaxers, improoving but still can't feel my thumb
2-3 hours after injection-exp palpitations, weakness, HA, arm swelling, pain.
This spontaneous report was received from am office manager (other) via company representative concerning a female patient of unknown age. On an unknown date, the patient received her normal dose of (Oka/Merck) PROQUAD and then received a dose of (Oka/Merck) VARIVAX by mistake. No demographics were provided for patient, physician or reporter. Additional information is not expected as no reporter or physician contact details were provided.
no additional AE; temperature excursion for PROQUAD; This spontaneous report has been received from a medical assistant referring to a 4 years old male patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 25-MAY-2021, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (strength, route of administration and anatomical location were not provided; lot # T018275, expiration date reported as 23-NOV-2021) 0.5 ml for prophylaxis (product storage error). The vaccine underwent temperature excursion of max 80 Fahrenheit (F) for total 23 hours. It was reported that there were no previous temperature excursions. The digital data logger was involved in recording excursion details. At the time of report, there was no additional adverse event (AE).
Pt immediately after TD vaccination to right deltoid began to develop progressive deltoid pain and tenderness and ultimate inability to raise right arm above shoulder.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 21-MAR-2017 the patient was vaccinated with GARDASIL 9, first dose, (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis. Subsequently, on 21-JUN-2017 patient received GARDASIL, lot # K016966 (expiration date: 10-MAY-2017; exact dose and route of administration were not provided) for prophylaxis. No adverse effects were reported.
Arthralgia, Fever, NauseaVomiting, fatigue, chills Narrative:
patient described a rash of were she was injected, itchy, soreness, and warm to the touch
15 yr male c/o sore arm 6 hrs p/vax, temp to 102-103 several hrs later. In AM 11DEC90 arm bright red fr above elbow to upper shoulder, lateral aspect only -denies pain in this area. By noon 11DEC90 c/o neck pain esp chin to chest.
Per employee: Woke at 2am with thick tongue, dry mouth, itchy palm.
Patient received high dose flu vaccine 10/9/2020. No problem day of vaccination. The next two days (10/10 and 10/11/2020) "the pain was so awful I could not lift my arm." Continues to feel light throbbing pain at site of injection. At night she has to hang arm down on side of bed and it helps. Once in a while can feel throbbing down the right arm into fingers. Patient first reported above on 1-19-2021
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient "developed a chicken pox break out". Unspecified medical attention was sought. There was no product quality complaint involved. "No further information was provided about the patient". Follow-up from the physician indicated "no further information necessary". No further information is expected.
Fever, seizure activity same day as vaccines given details vague - caregiver doesn't remember details.
pt recvd vax 20SEP88 & lab eval was pos for surface antibody & neg for surface antigen; lab eval in 1989, 90, 91 & 92 revealed the same results; 4MAY93 lab eval again revealed pos surface antibody but was also pos for surface antigen;
PATIENT SAID SHE GOT A RASH FOR 1 DAY AND BLEEDING IN GUMS WHICH SHE STILL HAD SOME TODAY.
got the shot got the shingles/suspected vaccination failure; had it; This case was reported by a consumer via 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's brother/sister. The age at vaccination was not reported. The patient had the shot and then got the shingles. The patient also said how long were humans going to allow themselves to be fools. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Information has been received from an optometrist concerning a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not informed. In approximately 1996, reported as "about 20 years ago", the patient got chicken pox from another unspecified patient who on unknown date received a dose of ZOSTAVAX 19400 PFU, (lot #, expiration date, dose and route were not provided). Concomitant therapies were not informed. The outcome of the events was unknown at the time of the report. No product quality complaint (PQC) was involved. Additional information has been requested.
I developed hives all over my body after my booster vaccine. I saw allergist doctor one month after that. I developed hives on my chest, thighs, my lower back, stomach, glutes. Then about four weeks after I saw my allergist because hives was not going away. I also took Zyrtec and Allegra medication. I was also given Prednisone medication given by my primary doctor which this medication did not help me. Most recently I developed small patch under both breasts but it is not as bad as it was before. After my booster, I feel mostly tired and felt not as myself. I am considered myself a healthy person and very rare I get sick and now suddenly I feel sick at the times. I totally blame the booster shot of my symptoms.
Pt complained of pox appearing all over the right arm, chronic diarrhea and increased heart rate following vaccine
Had bivalent covid booster on Thur 11/3. Having continued swollen lymph node in armpit, bicep pain, numbness/tingling in arm that show was received in. Had flu shot in other arm at same time.
Received Moderna vaccines on 3/11/21, 4/8/21 tested positive for COVID by PCR on 3/4/22, diagnosis of COVID pneumonia Admitted to hospital on 3/12/22 w/ toe pain and discoloration, right distal foot ischemia and necrosis, subacute RLE DVT; thought to have bilateral foot hypoperfusion involving the microvascular circulation secondary to most likely embolic sources from aortic plaque or in the setting of COVID, will require amputation of right distal foot. Underlying Type II DM
Information has been received from a registered nurse concerning an adolescent female between 14 and 17 who was vaccinated with GARDASIL. The patient had an AE to GARDASIL that required the nurse to be trached. The patient was basically "brain dead". It was not reported whether the patients sought medical attention. Upon internal review brain dead and required to be trached were determined to be other important medical events. Additional information has been requested.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 6 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 6 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
pt acquired Miller-fisher variant & GB w/in 1 wk p/vax;
Moderna COVID-19 Vaccine EUA Received vaccine at Pharmacy My lower back aches extremely bad, upper thighs and my feet feel heavy to walk.  I'm very fatigued and feel the need to just sleep.
The nurse prepared FLUZONE vaccine for patient and another family member before interviewing patient. When patient and family member came into shot room, the nurse got distracted with talk about Tdap vaccine and forgot to ask patient about pregnancy status. The nurse proceeded to administer FLUZONE vaccine to patient. Just before finishing injecting the patient, the nurse got the sensation that the syringe was empty, but it was too late since she had already pushed the plunger to retract the needle. If that were the case, patient did not get the dose of FLUZONE. After patient left shot room, the nurse realized she should have prepared a dose of FLUVIRIN since the patient was pregnant.
Shingles/ it came on pretty severe all around her back, fore and front of the upper chest; Shingles/ it came on pretty severe all around her back, fore and front of the upper chest; This is a spontaneous report received from a contactable consumer (patient's child). An 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on an unspecified date (Lot: EN5318) as 1 st dose, single then on 27Feb2021 (Lot: EL9260) as 2 nd dose, single; both via an unspecified route of administration in left arm (at the age of 87-years-old) for covid-19 immunisation. Medical history included blood cholesterol, hypertension, heartburn and very small outbreak of shingles (35-40 years ago). Concomitant medications included amlodipine for hypertension; losartan for hypertension; omeprazole for heartburn and simvastatin for cholesterol. The patient had no investigation assessment. The patient had reaction after the second shot was shingles on 11Mar2021. The patient had shingles virus obviously in her system, viruses remain dormant, like that in the system. So her virus shingles was in her system. The patient's child guessed 35-40 years ago when she had a very small outbreak of shingles and then this time after the second shot it came on pretty severe all around her back, fore and front of the upper chest. The patient's child wanted to make sure that this was reported because he/she did think there was relation to it and think that people have them reporting the same thing. The patient's child stated, "She still has some facing from it I mean the shingles, I have not asked it anymore but she still has the after nerve sensation, you know that you get after shingles, yes; she still has some of the nerve sensation. That's common after shingles." On treatment for event, the patient's doctor called in a liquid medication that she took for a week for shingles, didn't have that name and bottle, also prescribed the pill that she could take in the evening if she need before bed called gabapentin was for when she had the nerve pain obviously standing on virus after shingle taken as needed prior to bed. Well the liquid was for to address the shingle that they were after shingle and the gabapentin was for her to take when she had that nerve pain obviously standing from the shingles virus, taken as needed prior to that. The outcome of the events was recovering.
minimal discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (minimal discomfort) in a 91-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (minimal discomfort). At the time of the report, DISCOMFORT (minimal discomfort) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-335308, MOD-2021-329830 (Patient Link).
pt recvd vax 1DEC92 & exp burning pain @ time of inject; exp burning pain @ the time of inject; 2DEC92 exp aching & heaviness in entire arm which persisted throughout the day; devel swelling in medial upper area of the inject arm;
Asthma; Not receiving second dose; Shortness of breath, couldn't breath with the mask on; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath, couldn't breath with the mask on), COUGH (Coughing), ASTHMA (Asthma) and PRODUCT DOSE OMISSION ISSUE (Not receiving second dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included POTASSIUM CHLORIDE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2011, the patient experienced DYSPNOEA (Shortness of breath, couldn't breath with the mask on) and COUGH (Coughing). On an unknown date, the patient experienced ASTHMA (Asthma) and PRODUCT DOSE OMISSION ISSUE (Not receiving second dose). At the time of the report, DYSPNOEA (Shortness of breath, couldn't breath with the mask on), COUGH (Coughing) and ASTHMA (Asthma) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not receiving second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included, using respiratory inhaler frequently, not other wise specified.
I felt violently ill.  I felt sicker than I ever have with any flu or other illness.   My symptoms included the following: Extreme weakness, could barely walk across the room. (12 hours) Very high fever (12 hours) Body aches (severe for 12 hours, consistently up to 6 days later) Extreme nausea and dry heaves (5+ days) Tear constantly pouring from eyes (few hours) Vibrations in leg (few hours) Very fast heartbeat (few hours) Severe headache with pain behind eyes and pressure in skull (2 days) Extreme tiredness and fatigue (5+ days) Tightness in calf muscle
Immun. 16Jan, about 330pm started /w runny nose(clear discharge) watery eyes, slightly puffy, lt > rt & sneezing, pt droopy, cranky, felt warm, gave Tylenol, sleeps more than usual, advised MD if S/S elevated, lt arm sore /w swelling
pt recv vax 19SEP96 & chickenpox dx 23FEB98;
Nurse is requesting employee immunization record related to PNEUMOVAX 23. Caller states the employee is currently in the hospital for an unspecified reason; This spontaneous report was received from a Registered Nurse (R.N.) concerning to a currently 70-year-old patient (also reported as "employee") of unspecified gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage regimen, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis.  On an unknown date, the patient was hospitalized for an unspecified reason (adverse event). It was unknown by the reporter if patient received treatment for the event.  At the reporting time, the outcome of the event was not provided. However, patient remained hospitalized (reported as "currently in the hospital"). Reporter was requiring patient's immunization record related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  The causal relationship between adverse event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
pt recvd vax 12JUN95 & 19JUN95 pt exp a rash consisting of approx 10 lesions;no further details were provided;
Individual with symptoms of SOB, body aches, and runny nose on 9/5/21. Tested covid positive on 9/7/21.  Advised to isolate from family in separate rooms until 9/15/21 and to callback when done.  Also, advised to callback if DOH contacts him.
Fainted; This is a spontaneous report from a non-contactable nurse via a Pfizer Sales Representative. A 20-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at 0.5 ml, single in his arm for immunization and influenza vaccine (manufacture unknown) via an unspecified route of administration in arm on an unspecified date at unknown dose for immunization.  The patient's medical history and concomitant medications were not reported. It was reported that they gave meningococcal group b rlp2086 and the patient fainted. Had got the flu shot at the same time in different arms. Happened a couple of weeks ago. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of TRUMENBA and the onset of being fainted cannot be excluded, considering the plausible temporal association and the known adverse event profile of the suspect vaccine.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 10:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 10:37 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 47.42 for dose administered on 22-Jun-2021. No concomitant medications were reported.  Batch number 008C21A administered on 22-Jun-2021 underwent temperature excursion with temperature of 35 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 27-May-2021 and beyond use date for the vial was reported as 26-Jun-2021. Product moved to clinic on 22-Jun-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.