chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the first dose, I experience a sore arm. Afer the second dose, I experienced muscle aches, fever, and fatigue.
Caller experienced Graves Disease after receiving both doses.; This is a spontaneous report from a contactable consumer or other non-health care professional. This consumer(patient) reported for himself that a 47-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on 27Mar2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration on 06Mar2021 (Batch/Lot number: Not reported) as dose 1, single for covid-19 immunisation. On an unknown date in 2021, caller experienced graves disease after receiving both doses. Patient was received treatment for event. It was reported that caller experienced Graves Disease after receiving both doses. He has received the necessary therapy. On Friday, he had the radio activated iodine therapy and he hopes it will improved. He has seen his endocrinologist and his primary medical doctor for this. Caller was being enrolled into a study at with several patients with this same type of issue that occurred after receiving the Pfizer COvid-19 Vaccine. Caller asking was this a side effect reported after having the Pfizer Covid-19 Vaccine and what was his next step. The outcome of event was unknown.  Information about batch/lot number has been requested.
Arm tenderness, arm ache (dull ache), loss of strength in arm, very limited range of motion. Loss of sleep due to ache.
I developed skin rashes on my left bum and left leg is now showing signs of rashes, also diarrhea. Also I have weird pain in my left hamstring/leg. I have not seen my doctor.
High fever, malaise, fatigue, inconsolable crying, fussiness, loss of appetite, dis-engaged, lethargic, green runny poops, developed ear infection, sinus congestion, coughing, depression, altered mood, irregular sleep, irritability.
Vaccine expired 11 days before patient got the vaccine shot; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired 11 days before patient got the vaccine shot) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired 11 days before patient got the vaccine shot) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired 11 days before patient got the vaccine shot) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired 11 days before patient got the vaccine shot).    No concomitant medication was reported.  Caller stated that his wife took the vaccine and he checked the LOT number online and it expired 11 days before his wife got the vaccine shot.  No treatment information was reported.
1/8/15 arm swollen in area of injection, warm, and hot. Size of 50 cent piece vaccine was given on 1/5/15 (Monday).
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 20-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
This is a spontaneous report from a contactable nurse. A child patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. Prepneumococcal titers were low and the child needed a booster dose. The nurse asked what was the earliest age or how far apart from the 1 year vaccination the booster dose could be administered to the child. Follow-up (06Aug2014): Follow-up attempts completed. No further information expected.
Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from Nurse. This case involves a 10 years old male patient who received IPOL which was from vial opened at 46.04 degrees for 34 minutes on 27 Jun 2018. Patient received two POLIO VACCINE LIVE ORAL in the past on an unknown date, other medical history was not reported. Concomitant medication was not reported. On 06-Jul-2018, the patient received a 0.5 ml single dose of suspect IPOL lot N1K931M, expiry date: 18-Nov-2019 via intramuscular route in the left arm. On 06-Jul-2018, the patient also received a dose of PREVNAR 13 and HEPATITIS B VACCINE. It was a case of actual medication error due to product storage error. It was reported that IPOL was from vial opened at 46.04 degrees for 34 minutes. It was not reported if adverse event occurred or not. 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 Directive and Module VI of the Practices. 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.
Admitted to the hospital AFib with RVR, mild troponin elevation and found to have COVID-19 pneumonia with acute hypoxic respiratory failure.  Tx.  remdesivir therapyand  oxygen.  home oxygen therapy as well as home health services including skilled nursing care, skilled physical and occupational therapy.
A report has been received from a Health Professional concerning a 9 year old, Male subject, who had been received Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started during Dec-2014. The patient experienced TESTED POSITIVE FOR FLU A, FEVER, BODY ACHES, HEADACHE, SORE THROAT, STOMACH ACHE and FATIGUED which started on 30-Jan-2015. The outcome of the event of TESTED POSITIVE FOR FLU A, FEVER, BODY ACHES, HEADACHE, SORE THROAT, STOMACH ACHE and FATIGUED is unknown. The report was considered to be non-serious.
Began with redness, swelling 10/27/12 - purulent discharge noted 10/28/12 - indistinct bordered area of warmth and redness on (L) upper thigh w/ tender palpable subcutaneous swelling approx. size of egg - drained by palpation about 8 cc purulent discharge. Mupirocen applied and sterile gauze and Rx for cephalexin 10/29/12.
One week after receiving the Varivax vaccine, she developed a rash consisting of pink macules of varying size some ring like. Rash was on trunk, face and were portions of arms and legs. There was little if any pruritus. There were no systemic symptoms (no fever or joint pain). Rash was felt to be a hypersensitivity reaction possibly to the Varivax vaccine. She received some Benadryl. Phone f/u 3 days later indicated the rash was almost gone. There were no vesicles.
This spontaneous report was received from a consumer on behalf on his unknown age wife who is the patient. The patient's medical history or concurrent conditions were not reported. On 18-JUN-2015, the patient was vaccinated with the first dose of an expired PNEUMOVAX 23 lot # K009809, expiration date 16-MAY-2015. The dose and route were not reported. No other suspect or concomitant medications were provided. No adverse events were reported. At the time of reporting the patient's status was unknown. Additional information has been requested.
Upon arrival to incident,client was c/o of numbness to L ARM which was the site vaccine was given,vs stable.ice pack given.Benadryl po was given,pt was assisted out his car to more cooler location,pt stated was feeling better,food and water was given and after 30 minutes client walked to his car.
Brain tumor; Head swelling; This case was reported by a consumer via call center representative and described the occurrence of brain neoplasm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery. Concurrent medical conditions included deafness.   On 28th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced brain neoplasm (serious criteria GSK medically significant) and swelling. On an unknown date, the outcome of the brain neoplasm and swelling were unknown.   It was unknown if the reporter considered the brain neoplasm and swelling to be related to Shingrix.     Additional Information: GSK Receipt date: 28-Feb-2023 Reporter's Comment: Patient was deaf, and caller was using an interpreter to communicate during call. The reporter stated that before returning for his second dose developed head swelling and was diagnosed with a brain tumor. The patient stated he had surgery in September of 2022 and as a result missed the recommended time frame for getting his second dose of Shingrix.  The patient did not indicate whether or not he intended to get his second dose of the vaccine. The reporter did not consent to follow up.
having trouble breathing; After the first shot his symptoms were a little bit like the flu; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease and covid-19 in Jan2021. The patient's concomitant medications were not reported. On an unspecified date, after the first vaccination shot the patient experienced having trouble breathing and were a little bit like the flu. It was reported that, patient have had COVID in January, went out and had test done for blood, patient still had antibodies but they said he can still go ahead and had a shot, so patient had the first shot of Pfizer (Unspecified vaccine). Reporter stated that he got COPD and thought it was his medicine (unspecified medication), Patient thought it was inhalers. Patient realized today looking back that it was the medicine, honestly it was the medicine patient knew that. Patient went back into the doctor again this week and they have half his medicine, Patient was better the medicine seems to be working but that was what happened, and he went to the pharmacist, went to the pulmonary doctor today for his breathing and he could hardly go without anything and didn't know why this all happened. And his question was, was that going to came back. People that had this done since months ago had their help but all of this still came back. Patient was not upset with anybody, what he was upset with was said if his health was going to return okay that the question patient wanted to know. The outcome of the events was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 21-OCT-2012 06:03 the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 09-SEP-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K000456 and expiry date: 15-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
11:15 am while sitting at the observation area he complained that he was light-headed . Noted he was warm-flushed and pale lips. Then later on he was sweaty. Vital sings taken. BP initially was 84/54 mmHg; HR=88  O2 sat=96%  T= 97.8 . Instructed to lay down and gave him fluids. Denies any c/o N/V.  11:25 am BP 121/76  HR = 76. Still a little sweaty but feels much better . Less pale lips.  11:40 am Up and claims he is feeling much better. BP 113/72. No sweating noted. Color improved and requested to be discharged.  15:00 pm RN called him and stated that he went back to work and he was doing better.
Event occurred after 2nd Dose. This patient is an 84-year-old male with a history of Parkinson's disease, lymphoma, leukemia, kidney cancer, and cardiac dysrhythmia who was diagnosed with COVID-19 on 6 December.  He previous to that had a cough for 2 days  Casirivimab-imdevimab, Tylenol  Discharged home
Patient began experiencing left facial droop on 1/31/2021. Diagnosed with bell's palsy on 2/1/2021 and started on antiviral, PPI, and steroids.
24yo male trainee. On 12/23 he awakened with generalized weakness and soreness and in particular weakness and paresthesias of the feet and hands. Symptoms were progressive until he presented at clinic and was admitted on 12/28 with symmetric weakness/diminished reflexes. He gave a 3 week history of URI with yellow nasal drainage similar to many. EMG confirmed GBS.
Gave patient the Covid 19 Bivalent Booster and she should have received the 5-11 dose
Nausea, vomiting, pale, H/A, lightheadedness, incoherent.
Fever 100F taken 9/5 at 8 am, morning following vaccine. Lethargy/tiredness throughout day.  Some muscular and other aches left side of chest night of 9/4.
gas like cramps; aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (gas like cramps) and PAIN (aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included AMLODIPINE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (gas like cramps) and PAIN (aches). At the time of the report, MUSCLE SPASMS (gas like cramps) and PAIN (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were reported.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4289395-00 (RA). A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATOCHEZIA (medically significant) with onset Apr2021, outcome "recovered" (May2021), described as "Bloody stool"; DIARRHOEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Diarrhea". Causality for Pfizer BioNTech Covid-19 vaccine (tozinameran), Unknown: The reporter causality for the events Bloody stool & Diarrhea were reported as Possible. Causality for HUMIRA (ADALIMUMAB): The reporter causality for the events Bloody stool & Diarrhea were not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event bloody stools and diarrhea and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
In a few hours after my COVID shot, I had Intense chills that made my entire body ache, then a headache and a rapid heartbeat, with a 101.7 fever.
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided
On 11/25/01, had puffy and itchy eyes which spread to hives on trunk on 11/27/01. On 11/27/01, was seen by MD and prescribed Cortisone pills, saying reaction to Hep-B shot.
Information has been received from a registered nurse concerning a 62 year old female with drug reactions allergies to penicillin, aspirin, ibuprofen, Cephalexin, Doxycycline, Naproxyn, Voltaren, and indocin, herpes simplex virus, hypercholesterolemia, hypothyroidism, and hear murmur and a history of genital herpes and rheumatic fev who on 9/22/06 at 12:00 was vaccinated SC in the left arm with a 0.5 ml first dose of varicella zoster virus vaccine live, (lot 652965/0622F). There was no illness at time of vaccination.  Subsequently on 9/22/06 the pt experienced 3 vesicular lesions distal to the injection site which were red and itching. the diagnosis was herpes zoster vs allergic reaction. The pt was placed on Benadryl Acyclovir. At the time of the report, the pt was recovering. There was no product quality complaint involved. At the time of the report the patient was recoveringdditional information has been requested.  Additional information indicated that in the evening on 09/22/06 the patient developed reddened, vesicular lesions x 3 areas on the left arm posterior to the injection site. The patient had a prescription of acyclovir (ZOVIRAX) 400 mg and began taking. On 09/23/06 the patient was seen by the health care provider who continued treatment with acyclovir (ZOVIRAX) 800 mg TID for 5 days. It was reported that the patient had not recovered. It was reported that on 08/29/06 at 15:00 the patient was vaccinated with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot # 653335/0215F) given SC in the right arm and a frist dose of hepatitis A virus vaccine inactivated (+) hepatitis B virus vaccine rHBsAg (yeast) (TWINRIX) (lot #AHABB028AA) given IM in the left deltoid.   The patient experienced herpes zoster, hypersensitivity, injection site erythema, injection site reation, pruritis, rash vesicular, and skin ulcer on 22-SEP-2006.  The patient did not recover. Additional information has been requested.
COVID 19; COVID 19; breastfeeding a 2.5 year old; breastfeeding a 2.5 year old; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no Known allergies. There were no concomitant medications/No Other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; OFF LABEL USE (medically significant), PRODUCT USE ISSUE (medically significant), outcome "unknown" and all described as "breastfeeding a 2.5 year old". The patient underwent the following laboratory tests and procedures: COVID-19 treatment: Unknown results. Adverse event: The patient was breastfeeding a 2.5-year-old and no other outcome other than she says her milk is yucky for a few hours after each dose. She wanted to contribute to the data you have on the medicine and breastfeeding outcomes. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Anti-viral treatment and details included: Brand: Paxlovid, Treatment start date: 23Jul2022.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201007667 mother/baby case;
2-19-07 Patient was given ProQuad, Hep A and Prevnar and a prescription for amoxicillin. Developed severe hives over entire body 3-1-07. Now improving on 3-6-07.
Rash & UrticariaPruritus Narrative:  Developed erythematous and pruritic approximately quarter sized rash over injection site on the same day that lasted for about 3 weeks. Topical low dose hydrocortisone applied with slow resolution. No associated warmth, induration, sloughing, hives, or other adverse effects noted.