chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US017897 is an initial spontaneous report received from a pharmacist on 04 SEP 2014. This report refers to a 60 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145221) subcutaneously at a dose of 0.5 ml on 03 SEP 2014. It was reported that on the same day after vaccination, he experienced swelling under arm. The event outcome was unknown. The seriousness and causality were not reported.
Patient woke up with redness and swelling on the entire upper arm from elbow to shoulder. Treated with Hydrocortisone 1% Cream OTC and then received an Rx for Prednisone tablets. Pt reports swelling and itching had subsided, but still very red.
pt recv vax & exp nausea & fainted;the reporter noted 3 pt & WAES95081085 through 95081087 were assigned;no further details were provided;
Itching at the injection sight, I developed Erythema and developed patches. I had induration.
pt reported dizziness and mild throat discomfort approx 5-10 minutes after administration of vaccine. Narrative:  pt experienced slight dizziness and throat discomfort approx 5-10 minutes after vaccine administration. Pt provided with water and crackers, observed for an additional 30 minutes. Symptoms resolved and pt reported he was at his baseline with no further symptoms or concerns. Pt sent home with return precautions.
4 days post vax the pt experienced a cold with a running nose. 3 days later the pt experienced a pruritic diffuse rash that was bumpy and itchy all over arms and legs, headache, and low grade fever. The rash was not the pox kind with fluid yet. There were over 100 bumps on the extremities.
pt recv vax 11OCT96 & lab eval 17SEP97 revealed a lack of seroconversion (IgM of 0.49);
Information has been received from a physician concerning a 7 month old male who on 15-MAY-2007 received a first oral 2 ml, and a second dose on 21-SEP-2007 of Rotateq. On 31-OCT-2007, he developed intussusception. It was reported he was seen in the physician's office, was hospitalized, and underwent emergency surgical correction after he failed to respond to an enema. The patient was discharged and was to have a follow up visit on 09-NOV-2007 with his physician. No other symptoms or treatment was reported. A product quality complaint was not reported. No further information was available. The patient's intussusception was determined to be an other important medical event, and life threatening by the reporter. Additional information has been requested. 12/10/07-records received-for DOS 10/31-11/03/07-DC DX: Idiopathic ileocolic intussusception. Presented with vomiting and bloody diarrhea times 1 day. Abdominal ultrasound showed instussusception. Exploratory laparotomy mandual reduction of intussusception and incidental appendectomy.
11/1/12 Wrong strength of Hep B vaccine given to patient. Adolescent dose instead of Adult strength. Pt. has now completed Adult Hep B series as of 6/26/13.
10 days after MMRV developed mild fever and 1 to 3 mm papules pink on a flat pink base.  resolved in 3 days.
Extreme chills with twitching arms and legs. Twitching could be stopped with slow breathing and concentration. Twitching lasted about 30 minutes.
At 11:30 I awoke to burning and itching over my entire body from my feet to my hands. I then broke out in hives with the heaviest amount on the feet and hands, inner arms from wrist to shoulders, my back and my stomach.
Expired Dose Administered; Initial Report Received on 02-DEC-2022  This is a spontaneous report received from a registered nurse regarding a 18-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 29-NOV-2022, a dose of HEPLISAV B (Lot #935843, expiration date 08-OCT-2022, NDC # 43528-002-01), route not specified, was administered in the left deltoid for hepatitis B immunisation.   The dose was 52 days past the expiration date. No adverse events were reported by the patient.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
12 year old was administered Moderna 0.25ml instead of Pfizer as her 2nd dose in Covid series.  No reaction or adverse effects reported.
Pt experienced pain, swelling, bruise about 2 hours after administration of vaccine. Pt. saw her MD on Thursday AM and was given Abx. for 10 days. After 3 days, swelling decreased to half size.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Respondent and husband both got COVID-19 after getting the Pfizer Vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202200944614 same reporter/drug/event, different patient;
Patient received dose of Moderna instead of Pfizer due to scheduling error. No adverse reactions observed.
Increased Confusion, Increased  Brain Fog,  Decreased Short Term Memory and other executive function. Aphasia Debilitating Fatigue, Anxiety. Depressive features.   Differential diagnosis includes Psuedodementia or Frontal Lobe Dementia.
This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates in 2017, between 01-SEP-2017 and 25-OCT-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally (strength, dose, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis; and RECOMBIVAX HB (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. The temperature excursion occurred between 47° F and 77° F and 32° F and 35° F, for an unknown amount of time. The temperature excursion was call because of a data logger. No previous temperature excursion occurred before.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient developed shingles. At the time of the reporting, the outcome of the herpes zoster was unknown. The relatedness between the event and therapy with VARIVAX was not reported. Additional information has been requested.
area became swollen and red, several hours after administration of vaccine.  Area became painful.There was quite a bit of swelling around the entire upper arm.  I saw the arm on the 2nd day and it was still swollen and reddened.
Information received from a health professional concerning a 6 year old male patient who was vaccinated with a dose of varicella virus vaccine, live. Subsequently, on approximately 03/11/2004, the pt developed breakthrough chickenpox with 50-500 lesions. Follow up information indicated that " there was not a single report of adverse reactions following varicella vacciantion". The reporter indicated that 49 other pt's developed breakthrough cases of chicken pox (WAERS# 0405USA02615, 0405USA00572, 0405USA00573, 0405USA00574, 0405USA00575, 0405USA00576, 0405USA00577, 0405USA00578, 0405USA00579, 0405USA00580, 0405USA00581, 0405USA00582, 0405USA00583, 0405USA00584, 0405USA00585, 0405USA00586, 0405USA00587, 0405USA00588, 0405USA00589, 0405USA00600, 0405USA00601, 0405USA00602, 0405USA00603, 0405USA00604, 0405USA00605, 0405USA00606, 0405USA00607, 0405USA00608, 0405USA00609, 0405USA00610, 0405USA00611, 0405USA00612, 0405USA00613, 0405USA00614, 0405USA00615, 0405USA00616, 0405USA00617, 0405USA00618, 0405USA00619). No additonal information is expected.
Cold symptoms after 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms after 2nd dose) 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 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold symptoms after 2nd dose). At the time of the report, NASOPHARYNGITIS (Cold symptoms after 2nd dose) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient was administered the first dose of GARDASIL (intramuscularly 0.5 ml) on 05-OCT-2013, the second dose of GARDASIL (intramuscularly 0.5 ml) on 08-FEB-2014, and the third dose of GARDASIL (intramuscularly 0.5 ml) on 17-APR-2014. No adverse effects reported. Additional information has been requested.
The patient developed fever and chills the weekend following vaccination; resolved after 1-2 days. Then patient developed a lump to left deltoid that is not visible but is palpable. Lump is sore, however nontender to touch. Denies swelling and redness. Lump has lasted for almost 1 month. Patient advised to apply cool compress and take TYLENOL as needed for pain. Patient did not do either. Lump still present today.
Case number PHEH2014US014482, is an initial spontaneous report received from a healthcare professional on 17 Jul 2014. This report refers to an unknown age and gender patient. Past medical history and concomitant medications were not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on an unknown date. No adverse event was reported following this administration error.
Patient reported that about 4 hours after receiving injection, she began to experience her throat closing. She noted wheezing, tightness in the throat, trouble swallowing, and an uncomfortable feeling in her throat. She reported to the emergency room, where she was treated with a steroid, famotidine, and diphenhydramine. She was given a prescription for prednisone as well, and as of the next day, patient reported feeling better.
Ipsilateral axillary node swelling and tenderness beginning day 2; treatment - watchful waiting,; outcome - slowly improving tenderness, size unchanged on day 3  No reaction to first shot inseries.
chills & severe body ache the next day, extreme pain at injection site.  Rash beginning 3 days post vaccine
Swollen lymph nodes in left arm pit; This is a spontaneous report from a contactable consumer (reporting himself). This 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ep6955), via an unspecified route of administration in left arm on 17Apr2021 at 09:30 (age at the time of vaccination was 17 years) as a single dose for COVID-19 immunization. The patient had no known medical history. The patient previously took penicillin, ibuprofen, amoxicillin and experienced drug allergy. The patient's concomitant medication included calcium, colecalciferol (CALCIUM +D3) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccination with in 4 weeks prior to the COVID vaccine. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ep6955), via an unspecified route of administration in left arm on 27Mar2021 at 09:00 as a single dose for COVID-19 immunization. On 17Apr2021, the patient experienced swollen lymph nodes in left arm pit. The patient received 1 aleve pill (naproxen) as treatment for the event. The outcome of the event was resolving.
12 hours post shot- Cold sweats and chills. 16 hours post shot- Headache and fever.
A non-serious report  of dosing error has been received from a pharmacist concerning a seven-month old infant. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical and medication history were not reported. The patient received FLUMIST on 08-Oct-2008. There were no immediate clinical problems or adverse events noted from the dosing error. There was no immediate clinical problems or adverse events noted from the dosing error. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
On 06/07/2022 I had vaccination. I started to experience joint pain neck swelling tingling hands a fever that lasted 4 days and increased heart rate on 07/04/2022. I saw doctor on 07/5/2022 and I was COVID-19 negative. The fever went away. When I went on trip I started to get a rash on upper right side of neck and torso and was swelling. I visited urgent care on 07/12/2022. They gave me antibiotics and steroid shot. I came home and was still having sore neck swelling redness. Doctor did a blood panel on 07/20/2022 and I tested positive for Lyme's Disease. My neck is still swelling. He gave me 14 days of doxycycline. I am still having joint pain mainly in my neck on the back. I wonder if the vaccination has caused a reaction to my immune system with the Lyme's Disease.
is suffering with it right now and she was vaccinated/suspected vaccination failure; shingles; painful; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female 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), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's child. The age at vaccination was not reported. The patient was vaccinated with Shingles and was suffered with the Shingles at the time of reporting. As per the reporter, shingles were very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR183382, reproted by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183382:IDM response comment
arm hurt; shortness of breath; Diarrhea; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), DYSPNOEA (shortness of breath), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Headache) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt), DYSPNOEA (shortness of breath), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (arm hurt), DYSPNOEA (shortness of breath), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Constant tinnitus both ears started approximately 30 minutes after vaccination; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 01Sep2021 at 13:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis, postural orthostatic tachycardia syndrome (POTS), hashimotos, migraines and allergy to iodinized contrast dye. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dimethyl fumarate (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Sep2021 at 14:00, approximately 30 minutes after vaccination, the patient experienced constant tinnitus in both ears and continued to present date/time and will be scheduling appointment with physician. The constant tinnitus did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the constant tinnitus. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constant tinnitus in both ears started approximately 30 minutes after vaccination was not recovered at the time of this report.
Vaccine update 5/3/2007 at age 4. Next am Mom noted swelling right arm shoulder to elbow, radiating to right chest wall. Sought care at ER. Told vaccine reaction , to use Benadryl for 4 hrs until resolved. A braided areas at prior location of band aid edges, some minor redness , warm mid arm noted at 5/17/07 office visit. Band Aid area had been blistered per ER report.
Fever, body ache, HA, nausea, chills, tremors, O2 sat = 96%
pt devel fever 1wk p/vax which lasted for 5 day (not over 102);face swollen, enlarged lymph glands under both arms;generalized muscle aches & joint pain for 4-5 days;
felt faint/dizzy; and a little nauseous; Then after 30 minutes, she felt tightness in her throat, faint, and quite nauseous; gastrointestinal issues; This is a spontaneous report from a non-contactable consumer or other non hcp(patient).  A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), dose 1 via an unspecified route of administration on 14Mar2021 (Age at vaccination was 47 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 14Mar2021 the patient felt faint, dizzy, and a little nauseous. Then after 30 minutes, she felt tightness in her throat, faint, and quite nauseous. She also said she had gastrointestinal issues very immediately. Patient said she felt normal again after 24 to 36 hours and would like to know if this is a severe allergic reaction, and if she should go ahead and receive the second dose. The outcome of events was recovered on unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderna administered to patient less than 18 years old (i.e. 17 years old)
This spontaneous prospective pregnancy report was received from a 25 year old female consumer, concerning to herself. The patient's medical history included varicella (reported as when she was a child she had chickenpox). Her drug reactions or allergies were not provided. No information was provided regarding the patient's concomitant medications. On an unknown date, the patient was vaccinated with VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided) as prophylaxis. The patient became pregnant on 22-OCT-2018 (estimated date of conception). At the reporting time, the gestational age was 7 weeks; consequently the last menstrual period (LMP) was on 08-OCT-2018 and the estimated date of delivery (EDD) would be on 15-JUL-2019. On 04-NOV-2018, she was performed an unspecified titer test for work that did not show immunity to varicella (antibody test negative). The outcome of antibody test negative and its relationship with VARIVAX were not reported. The pregnancy outcome was pending.
FELT LIKE CRAP; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be. No concomitant medications were reported.  On an unspecified date, the patient experienced felt like crap, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like crap, chills, and headache. This report was non-serious.