chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old patient inadvertently received a dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently received a dose) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No treatment medication information were provided.     On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently received a dose). On 29-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently received a dose) outcome was unknown.        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 medications were not reported. No treatment information were provided   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Possible NNI
Headache, rash 11-13-07; rash is fading 11/15.  Leg cramps 11-14-07; cramps continue.
After the first dose, I was just fatigued.  For the first 2 days after the second dose, it was just fatigue.  On the 3rd day, I started spiking temperatures as high as 103 off and on all night.  Then I had uncontrollable shakes/chills for about 1 1/2 hours as well as horrible headache.
27 year old male with medical history notable for exercise induced asthma who developed fevers, chills, myalgias, and chest pain shorter after second dose of Pfizer. Presented to ED and found to have elevated troponin, initially normal ECG. Admitted to hospital, experienced recurrent chest pain, rising troponin to 23750, and STE on ECG, and was taken to cath lab, with normal left heart cath. Then transferred to heart medical center for further eval and cardiac MRI. Felt by cardiology there to have myopericarditis potentially related to Pfizer vaccine. Cardiology also wondering if possible inflammatory bowel disease might increase his risk of myocarditis, though no established diagnosis (outpatient gastroenterology workup planned).
Information has been received from the registered nurse concerning to an approximately 66 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-DEC-2014, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K007824 with expiration date of 05-NOV-2015) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
PATIENT EXPERIENCED NEAR-SYNCOPAL EVENT POST-VACCINATION. WHEN ASKED, PATIENT STATED THIS WAS A KNOWN REACTION AND OCCURS WHENEVER SHE RECEIVES ANY INJECTION/VACCINATION OR BLOOD DRAW. PATIENT HAD NO FOOD OR DRINK TODAY.   PATIENT WAS EVALUATED, FULL SET OF VITALS WAS TAKEN AND PRESENTED WITHIN NORMAL RANGE. ORTHOSTATIC VITALS WERE TAKEN AND AGAIN PRESENTED WITHIN NORMAL RANGE. PATIENT AND PARENT DECLINED EMS EVALUATION AND FURTHER TREATMENT/TRANSPORT. PATIENT WAS HELD FOR 15 MINUTES AFTER INITIAL 15-MINUTE OBSERVATION TIME WITHOUT ANY FURTHER INCIDENT.   PATIENT AND PARENT WERE ADVISED TO INFORM VACCINATOR OF NEAR-SYNCOPAL HISTORY UPON SECOND VACCINATION APPOINTMENT.
Patient was given bivalent COVID vaccine instead of monovalent.  Pharmacy sent over the wrong vaccine, it was labeled as monovalent, and they sent over bivalent instead of the monovalent.  Monovalent was ordered from the pharmacy, not bivalent.
~3-5 minutes after receiving the vaccination, the patient started to appear to lose consciousness, displayed weakness, and wheezing and shortness of breath. The pharmacist carefully lowered the patient to the ground and had his staff contact 9-1-1 while he administered an Epi-pen injection to the patient's right outer thigh. The patient immediately responded to the injection, was alert and talkative. EMS arrived and took over. Patient left on his own thereafter (~15 mins). Patient was advised to reach out/follow-up with his physician for medical evaluation.
temp elevated by 19MAY92 around MN; In AM face blood red; t103, listless, whinning, sore throat, hurt to swallow, throat felt swollen, achy muscles, h/a;
HYPOTENSION ACUTE RESPIRATORY FAILURE 11/15/2022,  1/4/2023,  2/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient is 33 weeks pregnant with a high-risk pregnancy due to previous Pulmonary Embolism during pregnancy. The patient was vaccinated with her 1st dose of Pfizer COVID-19 vaccine at our facility on 8/26/21 and reported having no issues from the vaccine. On 9/16/21 the patient received her second dose of Pfizer and reported a long-standing needle phobia. She got her vaccine, then watched as her husband got his. She commented on the needle size and immediately started looking pale and reported feeling nauseous. I got her a water at her request and took her blood pressure. Her blood pressure was normal, but her heart rate was up to 119. She was worried due to her high risk pregnancy, so we called 911. Paramedics arrived and she began vomiting and reporting some mild Braxton-Hicks like cramps. She remained conscious for the duration and was transported to Hospital for follow-up.
At 4:30 am WOKE EXPERIENCING CHILLS/SWEATS, MODERATE-SEVERE PAIN AT INJECTION SITE(LEFT DELTOID), MODERATE HEADACHE. MODERAE-SEVERE BODY ACHES/SHARP PAIN IN THE BACK, LEGS. SWOLLEN FINGERS. SLEPT ON/OFF FOR 2 HRS. TEMP AT 7AM 99.5. SYMPTOMS AND FATIGUE HAVE PERSISTED THROUGH AM.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (product storage error).    Concomitant medication was not provided.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication information was not provided by the reporter.  This case contains information for the 60th out of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Based on additional information received on 24 Feb 2015 from health care professional, this case is considered as medically confirmed. Initial unsolicited report received from a healthcare professional on 29 September 2014. A 56-year-old female patient with no medical history and concomitant medications of LIPITOR and "Meinforbazole" received an intramuscular dose of FLUZONE batch number: UI199AB (dose in series not reported), in right deltoid, on 27 September 2014 at 9:30am. On 27-Sep-2014 at evening 6pm i.e. 8.5hrs after vaccination the patient experience chills, muscle aches, sore throat, headache and temperature for 101. It was reported that on 29 September 2014 the subject was feeling better. Corrective treatment and laboratory investigations were reported as unknown. At the time of this report, the outcome of the events was reported as unknown. List of documents held by sender: none. Follow-up report received from a Physician on 24 February 2015. The patient was vaccinated with FLUZONE and not with FLUZONE as previously specified. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as hypercholesterolemia and also did not receive any other vaccinations within 4 weeks prior to Influenza vaccine. Documents held by sender: None. Follow-up information received from physician on 6 April 2015. It was reported that the patient was called on form request. No treatment needed. At the time of this report, the outcome of the event was reported as recovered. List of documents held by sender: None.
Malaise, vesicular rash x 2-3 days, lesions to extremities, trunk, scalp at hairline. Some lesions scabies, some vesicular. All lesions <0.5 cm.
Injection side swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection side swelling) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), HYDROCODONE and IBUPROFEN for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection side swelling). At the time of the report, VACCINATION SITE SWELLING (Injection side swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided by the reporter.
A physician reported that an unidentified 6 month old infant received a first dose of Prevnar (pneumococcal 7 valent conjugate vaccine ) vaccine (date not identified). Subsequent to vaccine administration, the child developed a rash. No further information was available at the time of this report.
9/7/06 Mother reports child has swelling right thigh with knot size of (golf-ball)  Reports child will not walk on leg without holding onto something.  Reports fever developed 4-5 hrs post vaccination and fever up to 102.7   9/18/06  Talked with nurse a physicians office.  She relates patient was seen on 9/07/06.  No treatment--continue with observation and administer tylenol/ibuprofen alternating for fever 9/20/06  Mother relates child doing well
Developed pruritic rash 6 hours after receiving immunizations.  Papular and non-erythematous
Injection site itchy, swollen red hard and hot when touched.  Area was getting larger and larger.
My son was injected in rear of his legs. Two shots in each let. Instantly swelling the size of golf balls on the back of each leg. I asked for a doctor to come look at my son. The doctor asked nurse who done this to this child? The nurse could of damaged my sons nerves and paralyzed my son. She injected in the wrong place of his legs.
This spontaneous report was received from an administrator and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of RECOMBIVAX HB (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided), were administered to an unspecified number of patients on an unspecified date, for prophylaxis. The vaccine had multiple unspecified excursions due to a data logger issue. The reporter provided information relevant to the temperature at which the vaccines were maintained, however it was explicitly stated that such vaccines were not administered to any patient. There was no product quality complaint involved. This is one of three reports received from the same source. Additional information is not expected as there was no information and consent to contact the physician.
The arm where PNEUMOVAX was administered was incredibly swollen, hot and red. I couldn't move it because of the pain.  I had fever for 24hrs (100F). I ingested 1,000 mg of  acetaminophen every 4hrs trying to decrease the fever.  I couldn't sleep because I couldn't take sides because pain on the arms. I have had this vaccine before and I never experienced something like this.  If fever and swollen persisted I was panning to go to the ER.   The arm where the  flu vaccine was administered was swollen and hot but not like  the PNEUMOVAX arm.
Tiredness, dizziness, headache. Rested for 15 min, given 2 bottles of water. Stable, released from vaccination site.
I developed a severe immune reaction/She also tried Embrel, which cross-reacted as well; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), route of administration, start and stop date, batch/lot number and dose were not reported for arthritis reactive. The patient medical history was not reported. Concomitant medication(s) included etanercept (ETANERCEPT) taken for an unspecified indication, start and stop date were not reported. The patient reported that his Rheumatologist recently prescribed Coscentyx. She (Rheumatologist) did so because, after the Covid vaccination, patient developed a severe immune reaction to Humira on an unspecified date. Patient was taking Humira for reactive arthritis. She (Rheumatologist) also tried Embrel, which cross-reacted as well. The patient received treatment for adverse event as Rheumatologist recently prescribed Coscentyx. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101364904 Same reporter/patient/suspect/different event
oral shingles. Currently hospitalized; This case was reported by a other health professional via sales rep and described the occurrence of oral herpes in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included throat cancer (had history of throat cancer).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced oral herpes (serious criteria hospitalization). On an unknown date, the outcome of the oral herpes was unknown.   It was unknown if the reporter considered the oral herpes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient was 50 years plus. The patient received a dose of Shingrix and developed oral shingles. The patient was currently hospitalized, not sure of condition. Offered Medical informer to person who reported the incidence. The reporter did not agree to follow-up from GlaxoSmithKline.
GI symptoms within 24 hr causing ER visit.  subsequent chest pain within a week.  Pt saw me we did echo showing pericardial effusion and normal EF.  Treated with NSAID for a moth or so with partial resolution.  Blood work done thereafter to evaluate and troponin was positive.  Sent to ER for evaluation.  Cardiac Cath negative, EF stil normal of F/u.  Presumptive DX of myocarditis given.  F/U CMR confirmatory.
Narrative: Pt received vaccine the previous day, fell in dining room following day. Also being assessed for concomitant UTI.
It started the next day of getting the vaccine and I was extremely fatigue and I would sleep for the entire day. This was every day. Am not a person that sleep a lot. I am a very high energy person. I couldn't stay awake. It has been going on for a month. I just thought it was just a reaction. So I said, to let it run its course. But about 3 weeks later, it was still happening. I went to my doctor and she suggest Acupuncture and it went on for about two month. Each session was for about 45-50 mins. As it went on I start noticing that it was helping. I went for about three months and then I didn't need it anymore. The Acupuncture really help.
Expired Twinrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 18-APR-2023, the patient received the 2nd dose of Twinrix. On 18-APR-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Twinrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-APR-2023 The Nurse reported that patient received their second dose of Twinrix and the dose was expired. The reporter consented to follow up. The patient received an expired dose of Twinrix, which led to expired vaccine used.
Headache 10/19/07 AM; Dizziness 10/19/07 AM; Vomiting 10/19/07 8:15 AM.
red; hard; cellulitis at the injection site; hot; tender; itchy; This spontaneous case was reported by a patient and describes the occurrence of SKIN WARM (hot), PAIN OF SKIN (tender), PRURITUS (itchy), ERYTHEMA (red) and INDURATION (hard) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SKIN WARM (hot), PAIN OF SKIN (tender) and PRURITUS (itchy). On 22-Jan-2021, the patient experienced ERYTHEMA (red), INDURATION (hard) and VACCINATION SITE CELLULITIS (cellulitis at the injection site). On 15-Jan-2021, PAIN OF SKIN (tender) had resolved. At the time of the report, SKIN WARM (hot), ERYTHEMA (red), INDURATION (hard) and VACCINATION SITE CELLULITIS (cellulitis at the injection site) outcome was unknown and PRURITUS (itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient went to urgent care after her symptoms returned and started worsening. They diagnosed her with cellulitis at the injection site and prescribed her Bactrim topical ointment and doxycycline oral.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Additional information included further details regarding the events, and additional patient information.
APPROX AROUND 6:30P MY DAUGHTER COMPLAINED OF NOT FEELING WELL. SHE COMPLAINED OF ELEVATED HEART RATE (138 AND 143), HEADACHE AND FEELING COLD
urticaria; flu like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number JCU55-2273 ?, expiry date unknown) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 6th December 2019, the patient experienced urticaria. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the urticaria was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and urticaria to be related to Shingrix.  Additional details were provided as follows: The doctor reported that a patient developed flu like symptoms and urticaria after administration of Shingrix. The caller had no expiration date and he was not sure this was the lot  but it was the only number he could find at the time of the call.
Patient called today the 26th stating that she felt tingling all over her body from the covid vaccine administered yesterday. Patient said it worsened around 8 pm and had received the vaccine in the morning. She felt better today but it has not gone away. Patient was concerned with medical cost therefore doesn't want to see a doctor. Reassured patient that it is a rare but possible reaction. Advised patient she can continue monitoring and if the side effects are worrying and doesn't seem to go away in a few days to seek medical care.
Information has been received from a 76 year old male consumer who is a physician, with benign prostatic hyperplasia, hyperlipidaemia, radiculopathy and an allergy to cephalosporins who "about a year ago" (December 2006) was vaccinated with ZOSTAVAX and developed intermittent headaches after receiving the vaccine.  Concomitant therapy included dutasteride (AVODART), simvastatin (MSD) and clonazepam.  It was also reported that the headache onset was three days ago (approx 07-DEC-2007).  Medical attention sought was not specified.  There were no laboratory or diagnostics studies performed.  At the time of this report, it was reported that the patient had not recovered.  A product quality complaint was not reported.  This is one of two reports from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/26/2008. Information has been received from a physician and a 76 year old 139 lb. 60 in. white male consumer who is a physician, which benign prostatic hyperplasia, hyperlipidaemia, radiculopathy and an allergy to CEPHALOXPORINS who on 11-DEC-2006, was vaccinated with a first dose in the right arm subcutaneously of ZOSTAVAX (Merck) (lot# 652947/1212F) and developed intermittent headaches after receiving the vaccine. Concomitant therapy included AVODART, SIMVASTATIN and CLONAZEPAM. There was no reported illness at the time of vaccination. It was reported that the headache onset was 01-DEC-2007 (also reported as three days ago: approx 07-DEC-2007). It was indicated that the intermittent headaches were daily. generalized, but usually one sided. Medical attention sought was not specified. There were no laboraory or diagnostics studies performed. It was indicated that the headaches lasted for six weeks with no significant reoccurance. The physian reported that as of January 2008, the patient had recovered. A product quality complaint was not reported. This is one of two reports from the same source. Additional information is not expected.