chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized injection site reaction.  Redness and pruritis.  Patient self-treated with Benadryl cream.  On 02/10/2015 patient reported back to vaccinator for advice.  Patient was advised to take oral Benadryl and discontinue Benadryl cream.  Monitor for fever or other severe symptoms.  On 02/12/2015 patient was consulted by phone and stated her reaction had cleared.
Shocking pain in arm. Drifted in and out on consciousness. Unable to summon help. Bedridden for 3 days. Saw MD on 10/18/2013. Severe pain for further 7 day. Saw regular MD on 10/25/2013 he RX'd Prednisone. Currently pain when moving arm.
my back was sore; my back was sore; I could barely move; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 59 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Apr2021 10:30 (Lot number: EW0161) at the age of 59 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Herniated disc in lower back" (unspecified if ongoing), notes: years ago. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, Lot number: ER8732, Anatomical location: Left arm, Administration time: 10:30 AM), administration date: 25Mar2021, when the patient was 59 years old, for covid-19 immunization, reaction: "Intense low back pain". The following information was reported: BACK PAIN (non-serious), DISEASE RECURRENCE (non-serious) all with onset 17Apr2021 16:00, outcome "not recovered" and all described as "my back was sore"; HYPOKINESIA (non-serious) with onset 17Apr2021 16:00, outcome "not recovered", described as "I could barely move". The events "my back was sore", "my back was sore" and "i could barely move" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of back pain, disease recurrence and hypokinesia.  Additional information: Patient reported intense low back pain. She had intermittent issues with her back, her first shot was on a Thursday, and she woke up Sunday morning with back pain that she could not associate with anything. No heavy lifting or twisting that usually causes her bouts. She went to my primary, received a prescription for a MethylPREDNISolone pak, and felt better within 24-48 hours. Received the second shot on a Thursday, and by Saturday, her back was sore. Again, nothing lead up to the pain. By Sunday  she could barely move. Her episodes are never that close together. Went to an urgent care to get the steroids a day sooner and realized the timing of her events coincided with her vaccines. The patient had not received any other vaccine within 4 weeks or other medications within 2 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products.  No follow-up attempts are possible. No further information is expected.
This subject is a 70 year old female, who died while enrolled in a study. The subject received the study vaccine on 6/21/04. The study is blinded in the age group for this subject. The subject died at home 140 days post immunization. The cause of death is unknown at this time. There is no report of hospitalization. The death certificate will be provided up receipt from the subject's family. Additional information to be provided when available. The death was reported by the investigator as unrelated to the study vaccine. List of additional information received and available in source file: ISAEF, Telephone Contact; SAE Reports, SAE Fax Transmittal and Confirmation. Death Certificate states COD is acute coronary occlusion, coronary artery disease, diabetes mellitus and cardiopulmonary arrest.  Medical Records received on 11/23/2004 states the pt experienced diabetes mellitus, diabetic neuropathy, hyperlipidemia, elevated liver enzymes, adrenal mass, and hypertension.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported Pharmacist reported that they gave 26 doses after the 30-day use by date. Pharmacist would like to know if those doses were viable or not. Number of doses/vials: 26 Date the vial was initially stored in the refrigerator : 14Jan2022  Date(s) of administration of vaccine: 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.Vial did not undergo any temperature excursions.  No treatment information was reported.
Pt experienced a febrile seizure 9 days post vax. Pt also has thrombocytopenia.
Patient immediately felt dizzy after receiving vaccination.  Gave her a cold pack.  That seemed to help.  She moved to a different chair.  Within 2 minutes she passed out and fell out of the chair which resulted in a gash on her forehead.  Patient was unconscious and warm to the touch.  Paramedics were called.  She came to and knew who she was, where she was, but was very lethargic and groggy.  Paramedics took her to the hospital for evaluation.
consumer wants to know how long the arm is supposed to hurt after the 2nd dose; This is a spontaneous report received from a contactable consumer (Patient himself). A 85-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not provided) as single dose for COVID-19 immunisation. It was reported that "I have a patient on the other line reporting a side effect with PFIZER-BIONTECH COVID-19 Vaccine. He was 85 years old and he wanted to know how long his arm was supposed to hurt after receiving the second dose but I was not able to confirm specifically on how long his arm has been hurting but he just wanted to know that information and just to inform you, I did give him the answer to his question and I already referred to him to his HCP. I am just transferring him over to you, so that you can get more details about the reaction that he had." Patient experienced event was on an unspecified date. Outcome of event was unknown.   Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.
Report of event received on 2/25. Administered at 3:50pm and observed for 30 minutes.  At approximately 5:45p patient developed nausea and "slight" throat tightness with redness and swelling at site. 6:33p intense itching on neck and arm.  Took Benadryl 50 mg PO and Prednisone 20 mg  and felt better. 7:30p chills; 8:30p arm soreness;  8:50p intense itching  on soles of feet  9:00p N/V and hot flashes.  9:20p Benadryl 50mg and Pepcid 20mg; 9:30p itching on soles; 9:55p double vision and 10:00p itching soles at midnight went to the ER with throat tightness and was given Solumedrol IV and a mouthwash containing Maalox and lidocaine.  Diagnosed with Covid 19 vaccine dysphasia......she was discharged to home with steroids.
Tired for two days; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than 2 weeks after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient got his first dose of Shingrix about a week ago and felt tired for 2 days.  The reporter wish to know if it was safe for him to get his Covid-19 booster at the time reporting.  The patient wanted to remain anonymous and did not wish to provide any details.  The reporter did not consent to follow-up.  No health care professional information provided.
Noticed itching Friday the 12th, progressed from Friday to Sunday, it became a 6*4 red patch that was swollen, red, and hot to the touch.
Allergic reaction after getting the Gardasil 9; Per patient chart she will not be receiving any additional dose of Gardasil 9; This spontaneous report as received from the office manager referring to a 34 year old female patient with latex and yeast allergy. No information was provided regarding the patient's concomitant medications.     On 29-OCT-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # 1687293 that expierd on 30-APR-2023 for prophylaxis (dose and route of administration were not reported).  On an unknown date the patient, when to the emergency room for an allergic reaction after getting the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine.  It was not reported if the patient was admitted or if she was discharged from the emergency room.  It was noted that in the patient's chart was noted that she will not be receiving any additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration).  At the time of the report, the patient's outcome was unknown.  The causal relationship between the aforementioned event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Throat got swollen; Throat got tight; Diarrhea; Head felt like it was in a vice; Vomited; Headache was terrible; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PHARYNGEAL SWELLING (Throat got swollen), THROAT TIGHTNESS (Throat got tight), DIARRHOEA (Diarrhea) and HEAD DISCOMFORT (Head felt like it was in a vice) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high, High cholesterol and Glaucoma. Concurrent medical conditions included Ragweed allergy.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 22-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Throat got swollen), THROAT TIGHTNESS (Throat got tight), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Head felt like it was in a vice), VOMITING (Vomited) and HEADACHE (Headache was terrible). At the time of the report, PAIN IN EXTREMITY (Sore arm), PHARYNGEAL SWELLING (Throat got swollen), THROAT TIGHTNESS (Throat got tight), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Head felt like it was in a vice), VOMITING (Vomited) and HEADACHE (Headache was terrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that the patient normally gets reactions for flu shots.   This case was linked to US-MODERNATX, INC.-MOD-2021-078039 (E2B Linked Report).
Patient was looking to receive her 3rd booster shot for the pfizer covid vaccine, however there was miscommunication and patient had received their second  in August 13, 2021 and patient was not due until February 2022. Patient is preganet
severe fatigue, confusion, inability to have clear thought process (worst 4-8 hours after shot but is lessening with time)
Coughing; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for her sister. This is the one of two reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number and Expiration Date were not reported), via an unspecified route of administration on 29May2021 as dose number unknown, single for COVID-19 immunization. The patient medical history included COVID-19 from Sep2020 to an unknown date. Concomitant medications were not reported. The reporter states that, on unknown date in May2021, her sister having complaints of cough, her sister was 60 years old (Not confirmed hence not captured in tab). She had COVID last September (Sep2020). She and her sister got the covid vaccine on 29May2021 and both her and her sister were coughing, and still coughing like the cough occurred 5 days after getting the vaccine and they still have the complaints of the cough right now. The outcome of the event was not resolved.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021702539 same report/drug/AE, different patient
requested medical records but never received them; pt had a positive COVID test on 10/6/21; per death certificate, pt died in the nursing home with the causes of death being COVID infection, cardiopulmonary arrest, failure to thrive, dementia
he tested positive for covid after the first dose; he tested positive for covid after the first dose; This is spontaneous report from a contactable pharmacist. A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported) via an unspecified route of administration on unspecified date as a 1st dose single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient was due to take the second shot of the covid vaccine today but he tested positive for covid after the first dose. Reporter wanted to know should she still give the second dose to patient.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be excluded.
Patient complaining of achiness in joints the day after receiving vaccinations. Pt. also complained of rash on left arm and trunk. Denied shortness of breath, fever, or any respiratory symptoms.
Within 2 hours of receiving dose developed sore irritated thoat & then it progressed to laryngitis- lost voice for 2 days. History exercise induced asthma. Did not see doctor. Took asthma medicine & by 3/29 it had improved.
Patient came back to clinic at 1:20pm complaning of itching and facial flushing. Provider assessed and given Benadryl 25mg PO x 1 in clinic. Patient monitored for 1 hr and no severity of symptoms noted. Per patient itching is much lesser. Patient in formed to go to nearest ED if SOB or severe symptoms.
Adverse event: Vaccine was administered 3 weeks after beyond use date and is less effective. Treatment: Pt returning to our office for additional vaccine based on Pfizer and recommendations.
patient was administered ACTHIB that was not reconstituted with the supplied diluent and another diluent was used to reconstitute the vaccine with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics, and the patient was administered acthib (HIB (PRP/T) VACCINE) that was not reconstituted with the supplied diluent and another diluent was used to reconstitute the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (formulation, strength, route: unknown) lot UJ600AA, expiration date: 30-Nov-2022, in unknown administration site as Immunization.  On an unknown date the patient was administered acthib that was not reconstituted with the supplied diluent and another diluent was used to reconstitute the vaccine with no reported adverse event (incorrect product formulation administered) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  The patient was administered ACTHIB that was reconstituted with another diluent other than the supplied 0.4% Sodium Chloride ACTHIB diluent. Caller stated that she was doing inventory and there was an extra diluent left in the box, so she thinks that someone must have used another diluent to reconstitute the ACTHIB. She was not sure which alternative diluent was used and did not know which patient received the vaccine. This situation was reported as a medication error due to a patient being administered ACTHIB that was not reconstituted with the supplied diluent and another diluent was used to reconstitute the vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt arrives with shortness of breath, cough, and generalized weakness for 3 days. Pt is on hemodialysis. Pt has COVID-19 pneumonia with hypoxia.
Entire left side of body went numb on side of injection face, arm, abdomen, leg.; This is a spontaneous report from a contactable consumer (patient herself). A 19-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 07Apr2021 14:45 (Lot number and Expiry date was not reported) (age at vaccination 19 years) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included polycystic ovarian syndrome, high blood pressure and asthma. The patient was allergic to pineapple. Concomitant medications included bupropion (BUPROPION), montelukast (MONTELUKAST), spironolactone (SPIRONOLACTONE) and topiramate (TOPIRAMATE). All concomitant medications received within 2 weeks of vaccination. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient experienced entire left side of body went numb on side of injection face, arm, abdomen, leg on 07Apr2021 15:00. It was reported that since the vaccination, the patient didn't test for COVID-19. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for events. The outcome of events reported as not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Recieved 1st dose of Covid Vaccine Lot #EH9899 on 12/22/20.  Employee had tested positive for Covid 7/5/20 and had recovered from severe cough.  After recieving 1st dose of vaccine later that day, patient started having return of the cough.  , then also had HA and leg pain.  Received 2nd dose of Covid on 1/12/21 and immediately had  severe stomach pain, then had diarrhea.  Cough worsened the next day, developed sore throat, HA, runny nose, congestion, shortness of breath and would feel faint at times.
Headache, Myalgia, C/O INJECTION SITE SWOLLEN. Instructed to see primary care physician if promblems persist. Narrative:
Postural Syncope immediately following vaccine. Recurred again within 24 hrs. Flushed, nausea, dizzy when standing with orthostatic BP changes. No rash, no edema. Labs normal. Given IV fluids with symptom improvement.
The day after vaccination injection site began itching.  By the evening the site was hot with increasing redness and swelling. Patient went to private physician on Friday, 12/10 and was diagnosed with cellulitis.  Treatment with cephalexin 500mg bid for 10 days. 12/13/2010 is improving, arm remains red and swollen.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (dose, frequency and route were not reported) lot # M046004 with expiration date of 18-NOV-2018 or lot # M028547 with expiration date of 07-JUN-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion of the VARIVAX was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005174: US-009507513-1706USA005175: US-009507513-1706USA005176: US-009507513-1706USA005178: US-009507513-1706USA005179:
Information was received on 26-MAY-2017 regarding a case in litigation concerning a female (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 21-NOV-2007 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-JAN-2008  the patient was treated for a vesicular outbreak that was diagnosed as severe shingles. On or about 01-NOV-2010 the patient was treated for ongoing and worsening shingles that had persisted for several weeks. The patient was treated again on or about 11-NOV-2010 for chronic nerve pain from shingles outbreaks, which was diagnosed as post herpetic neuralgia. She was prescribed "lipoderm" patches for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
LOST HEARING IN LEFT EAR.   HAD FIRST STEROID SHOT THROUGH EARDRUM APRIL 15 SECOND STEROID SHOT APRIL 22 HEARING HAS BEEN RESTORED
After having second dose of guardrail vaccine had red dots appear on head of penis for several days and then they went away. They were no itchy or painful.