chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-FEB-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L027282, expiration date: 21-SEP-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degrees Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Patient was given incorrect Vaccinations for 12 mo old.   no symptoms for patient  Patient was given wrong set of immunizations. 15mo child that received 2 vaccines that should not have been administered until the age of 4. Will have to call parent to inform of our mistake and have them come back in for correct vaccines.
I got the first Covid shot and got tinnitus approximately 2 1/2 after. I?ve never had any issues with tinnitus.
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ HYPOXIA 5/16/2022 -- RECURRENCE OF SAME SYMPTOMS
Saturday the same day of the first Pfizer shot: dizziness, 1st day after Pfizer shot: dizziness and weakness (all day in bed). 2nd day after the fist Pfizer shot: dizziness and weakness 2nd day after the first Pfizer shot: dizziness and weakness. 3rd day after the first Pfizer shot: severe headache, dizziness, weakness, nausea and vomiting. 4th day after the first Pfizer shot: acute headache, dizziness, weakness, nausea, vomiting, trembling in the body and extremities (arms, hands, and feet), strong palpitations, I felt cold and heat in my body, my menstruation came 14 days before, metallic taste in the mouth. I was treated in the clinic by a doctor. The doctor sent me to rest. 10 days after the first Pfizer the nausea and vomiting did not stop, I went to the clinic. I lost 4 pounds in 5 days. The doctor treated me for emergencies with intravenous treatment, to stop vomiting , dizziness and nausea and to hydrate me. He sent me to rest again for a few more days in recovery.
Passed out and had to go to emergency. My glucose level went high and my phrospherose and potassium level was very low
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the patient was over 50 years and the 4th dose (2nd booster) of the patient was administered on 02April2022.  No treatment medications was reported.   This case was linked to MOD-2022-532102 (Patient Link).
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was report that the patient inadvertently administered an expired FLUMIST quadrivalent dose on 08-Jan-2015. The outcome of the event of inadvertently administered expired FLUMIST quadrivalent to a patient is unknown. The report was considered to be non-serious.
This case was reported by a consumer and described the occurrence of joint paint in a 31 year old male subject who was vaccinated with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. There were no concurrent medications. The subject reported he had experienced headache and flu-like symptoms in the past with other vaccines. The subject received 1st dose of Twinrix in the summer of 2004. On 20 September 2006, the subject received 2nd dose of Twinrix (right arm). On 24 or 25 September 2006, 4-5 days after vaccination with Twinrix, the subject reported that his ankles, wrists, and elbows began to hurt and were swollen. He reported no visible bruises, however, his ankles and wrists felt as if they were bruised. He also reported his ankles, wrists, and the bottoms of his feet hurt when they were touched. The subject described the pain as a "nagging pain". On an unspecified date in September2006, after receiving Twinrix, the subject experienced fatigue, headache, flu-like symptoms, and his gums hurt. He described the fatigue as "extreme" and stated that "he felt as if he were 100 years old". The subject reported that when he ran for approximately 30 minutes on 09 October 2006, "the pain faded after running approximately 1/2 miles, however, it returned twice as bad after he showered and dressed". he stated he is usually pretty active but for the last few weeks, he has not been able to do much more than what he absolutely has to do to make it through the day. He reported walking has become easier. The subject was treated with Motrin twice a day. He reported "the bloodwork results were good". He is schedule to see his physician for a follow-up visit on 11 October 2006. At the time of reported, the flu-like symptoms, gums hurt and headache had resolved, but joint pain, swelling of joints, fatigue, and sensations of bruising were unresolved.
little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (TOUJEO), METFORMIN and DICLOFENAC for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (little sore arm). On 12-Mar-2021, PAIN IN EXTREMITY (little sore arm) had resolved.            concomitant medications include some heart medication. treatment to the events not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079306 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079306:Case for second dose
The patient felt numbness on left arm (injection site) after getting the vaccine.  Had patient rested for 30 minutes, pt started feeling her arm then left to work.
Patient was nauseous around 1am on 05/22/2021, vomited one and felt much better afterward. Patient stated that she is a little bit lightheaded and has little body ache. Her arm is a little sore but no swelling, no redness or any rash. Her fever was 98.9 Patient was informed  that vaccine was kept at room temperature for longer than 12hrs and to watch for any possible secondary infection as instructed by Pharmacist.
Started with sore feet and legs, felt like high tension wire/electric, tight and tingly-duration for 6 days; progressed to left upper thigh very painful woke from sleep at 3 a.m. with pain, was able to fall back to sleep; woke up at 4 a.m. to extreme pain in right shoulder and radiated to elbow and across back to left arm, neck, and into torso was told it was post-viral myositis  (11/28/09 ER visit); 11/28/09 Urgent Care visit for extreme pain; felt like a huge weight was crushing my chest. 11/30/09 ER visit numbness in right leg, shortness of breath, panic attack, could not lie back without having breathing problems and lots of pain, this dr agreed with the dr on the 11/2/09 visit. 12/1/09 pain management dr appt. initial visit, went through all the symptoms. 12/6/09 Urgent Care Dr. gives O2 bottle for night. 12/10/09 chest xray-shows elevated diaphragm, dr orders overnight oximetry and apnea link, also have tingling, pain in back arms, butt, front of legs. 12/10/09 CT scan abdomen upper and lower, atelectasis right lower lobe, no other findings. 12/11/09 legs buckle, slow, jerky. 12/14/09 labs discussed low testosterone and vit D, upper and lower limb weakness 12/17/09 Pain dr referred to rheumatologist, decreased testosterone levels. 1/4/10 ANA comes back abnormal. 1/12/10 appt with pulmonary specialist, sniff test and chest CT order, came back with the partially paralyzed diaphragm. 2/10/10 Osteopenia diagnosed via bone density test. Follow up appts and no new diagnosis. 6/3/10 lung function test comes back with a lung age of 63. I am still seeing multiple doctors, and plan on seeing a neurologist in the next few weeks.
Patient is not immunocompromised per form filled out, not over age 50, does not meet criteria for fourth booster shot at time of administration
Diffuse blanching erythematous macular rash. Some petechia on back. Multiple petechial palate. Platelet count 134: CBC drawn. Observation: pt improved.
I had cold symptoms in November of 2022 and got progressively worse. I was feverish and coughing. I was overseas. I received antibiotics. I was told it may be an allergy to pollution from the area. Back in the states, I had the same symptoms again but without a fever and lasted about a month. I tested negative for COVID-19 both times.
Fever  Chills Bad arm pain Lasted about 8 hours No treatment subsided after taking Tylenol and resting
From about a week from the injection I experienced elbow joint pain and swelling at the site. since the second week I have been experiencing muscle and joint pain in my right arm that makes it very hard to get a good night's sleep. In addition to a nagging muscle pain in my upper right arm. It also seems to have increased the arthritis pain in my right hand. The muscle pain in right arm has become chronic. I'd hoped it would go away with time but it appears to be getting slowly worse.
started having COVID-19 symptoms during the night that same day (sore throat); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (started having COVID-19 symptoms during the night that same day (sore throat)) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient had any medical history, allergy, concomitant diseases or risk factor. It was also unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 29-Apr-2023, 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 29-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (started having COVID-19 symptoms during the night that same day (sore throat)). The patient was treated with MOLNUPIRAVIR for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (started having COVID-19 symptoms during the night that same day (sore throat)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that patient was concerned that may be the vaccine lost efficacy due to COVID-19 and the treatment and wanted to know if the treatment blunted the vaccine response and diminished the vaccine induced antibodies.   This case was linked to US-MODERNATX, INC.-MOD-2023-724036 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724036:same reporter
7 year old patient was administered Adacel; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 7 years old patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that 7 year old patient was administered Adacel (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if the patient had any adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  Information on the batch number was requested.
Sore throat, then headache and nasal congestion with variable gastrointestinal upset
DONOR STATES APPROXIMATELY TWO HOURS FOLLOWING ADMINISTRATION OF VACCINE HE DEVELOPED A FEVER, BODY ACHES, CHILLS, AND A SORE THROAT. DONOR STATES SYMPTOMS LASTED APPROXIMATELY THREE DAYS.
A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis; A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 14 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (hospitalization, medically significant), MYOCARDITIS (hospitalization, medically significant), outcome "recovered" and all described as "A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis".  Clinical course: Description of Event: A 14 year old and An 18 year old were hospitalized at (withheld) in (withheld) for myocarditis/pericarditis. After hospitalization, symptoms resolved. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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
3 hours later arm and shoulder joint started hurting bad and stiffening in joint. Rest of night had pain, scrutiating couldn't move or lift it. Pain level was 9 to 10.
Had  1st dose  of Pfizer at 1715. Client approached this RN. Stated he felt " light-headed and nauseous.." Client brought to EMS room. Had water and crackers. Stated " I think it was the carpet." Patient stated he felt better at 1735, waited until 1740, walked around, stated he felt fine. This RN  walked patient out without incident. This RN suggested patient requests privacy room with second dose.
Altered sense of smell / various food items smell differently than before dose 2; Inappropriate Schedule of Vaccine; This case was reported by a consumer via call center representative and described the occurrence of altered smell sensation in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose on 16th January 2019, refer case US2019177086).   On 22nd August 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 26th August 2019, the patient experienced altered smell sensation. On an unknown date, the outcome of the altered smell sensation was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the altered smell sensation to be related to Shingrix.  Additional details were provided as follows: Four days after vaccination, the experienced an altered sense of smell. She reports that various food items smell differently than before administration of dose 2. This did not occur after 1st dose. The reporter did not consent to follow up.
Patient was given a vaccine that expired on 12/24/2021 by 9pm.
Redness, itching and swelling started at site of injection about 7 hours after the injection. She said the swelling didn't last long but the redness and itching continued. Patient stated she is now experiencing itching over entire body. She has not taken anything for the symptoms.
got rash 2 weeks after first shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (got rash 2 weeks after first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (got rash 2 weeks after first shot). At the time of the report, RASH (got rash 2 weeks after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment history was reported.
Sore arm, Exhaustion, heaviness, freezing couldn?t get warm, joint pain, achy,  nerve pain, swollen limp node in right armpit, diarrhea and upset stomach. Got Covid Arm(rash at the site of shot) 6 days after first dose.
Arm pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 59 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills; body ache; possible fever; This is a spontaneous report from a non-contactable consumer.   A 22-Years-old female patient (non pregnant) received first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), (Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 as dose number unknown single, (Age at the vaccination was 22 years old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Feb2021 at 04:00AM, the patient had experienced Chills, body ache and possible fever. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date in 2021, the outcome of the events were resolved.   No follow-up attemps are possible. Information about lot/batch number could not be obtained. No further information is expected.
The patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 4-year-old patient, gender not reported. The patient's medical history and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # S025608 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 18-AUG-2021) (strength, dose, route of administration and anatomical location were not provided), a sterile diluent properly stored, was used to reconstituted the vaccine (lot # S037030 has been verified to be a valid lot number sterile diluent, expiration date not reported, but establish as 18-AUG-2021).   The temperature of storage and time frame of the excursion were -12.50° Celsius (C) for 1 minute and -14° C for 1 minute.  A digital data logger was involved, and but there was no previous temperature excursion.
Aching whole body; Chills; Nausea; Fever; Feeling cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching whole body), FEELING COLD (Feeling cold), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, AMLODIPINE BESILATE, VALSARTAN (ASARTAN), CETOMACROGOL, PARAFFIN, LIQUID, PROPYLENE GLYCOL, WHITE SOFT PARAFFIN (VASELINE CETOMACROGOL CREAM), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LEVOTHYROXINE SODIUM (LEVOTIROXIN), LOSARTAN, PANTOPRAZOLE and FISH OIL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FEELING COLD (Feeling cold). On 22-Jan-2021, the patient experienced PAIN (Aching whole body), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, PAIN (Aching whole body), FEELING COLD (Feeling cold), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Pyrexia: 100.2 Farad (High) 100.2°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant med also include  "Naleda" 10mg daily,
I awoke the next morning with chills, fever, headache, nausea, dizziness, and extreme fatigue. The fever broke after about 5 hours with 800mg of ibuprofen and 1000mg of acetaminophen. The nausea subsided somewhat with 8mg of Zofran sublingual. The headache resolved about 01:00am on 01/10/2021. The dizziness and fatigue resolved significantly by 04:00am on 01/10/2021. Mild fatigue continued for another 24 or so hours, but seemed mostly resolved by 01/11/2021 and may have been exacerbated by my overnight (7p-7a) shifts.
12 hours post shot, muscle aches, headache, significant painful swelling at injection site.  24 hours post shot, chills, fever of 103, body aches, and general malaise.  36 hours to present, all other symptoms resolved, but now a cough that won't go away.