chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt cried instantly p/inject; mom then dressed pt p/approx 10 min pt becme somnolent-deep sleep,  arousable w/strong pain stimuli; PE-normal, pupils react normally; 3hrs later pt fine;
Arm hurts; When she woke up she doesn't feel good; She just feels terrible; Had diarrhea last night; A headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, MALAISE, FEELING ABNORMAL, DIARRHOEA, and HEADACHE in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 024M20A, and 0011321A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY, MALAISE, FEELING ABNORMAL, DIARRHOEA, and HEADACHE. The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL for Headache, at an unspecified dose and frequency and MELATONIN for Adverse event, at a dose of 10 milligram. At the time of the report, PAIN IN EXTREMITY, MALAISE, and FEELING ABNORMAL outcome was unknown and DIARRHOEA and HEADACHE had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Body temperature: 100 (High) little over a hundred degrees temperature.         No relevant concomitant medications were reported.
Papular Rash-infreq-Isolate lesion vesicular face -> trunk and erythematous
Felt heart racing, chest tightness, muscle fatigue, nausea, stomach /abdominal pain 2 days after 1st dose. Still having symptoms.
I did get COVID- 19. I was kind of head cold. I had nasal congestion and stuffiness in my head. I tested the next day; I was having a headache and it was getting worse. My wife has tested positive two days before. I was positive on 02/15/2023. I had chills and was very feverish, I called my doctor and they prescribed Paxlovid. I started to feel really sick that one day on the 15th.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "thyroid" (unspecified if ongoing), notes: thyroid; "known allergies: sulpha" (unspecified if ongoing); "known allergies: Cefzin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 05Oct2023 to 10Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329739 same patient/reporter, different drug/event (Paxlovid case);
Information has been received from a 65 year old female with diabetes who in July or August 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included LIPITOR and ACTOS. About 10 days ago the patient developed pain under her skin on her right side. The pain extends up to her breast and around her back. There are some red spots. The physician stated that the pain is caused by ZOSTAVAX (Oka/Merck) but it is not shingles. At the time of reporting the patient had not recovered. The patient was seen for an office visit. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a 16 year old female patient. Pertinent medical history was unspecified. On 29-NOV-2012, the patient was vaccinated with a dose of GARDASIL (Lot#,route, dose not reported). No concomitant medications were reported. ON 04-FEB-2013, the patient experienced lower back pain and hair loss. It was unspecified if patient received treatment. The outcome of lower back pain and hair loss was unknown. No medical attention was sought by patient. Additional information has been requested.,
Patient reported that 2 hours after the the immunization that she felt light headed and her left eye was twitching. Patient laid down for 20 minutes and then she did feel better just a little achey. Patient also reported a headache as well.
Mother reports patient had increased redness and swelling to the injection site on the left thigh. This was first noticed early morning on 05/18/18. Seen in ER 05/19/18 BACTRIM and KEFLEX started orally. Patient was then seen here in clinic on 05/21/18. Affected area remained red with mild induration. Border was outside of outlined area at that time. BACTRIM and KEFLEX discontinued. Clindamycin 300mg PO TID for 10 days initiated. Patient seen 05/23/18 for f/u redness and swelling have improved. Patient does not have a history of cellulitis in the past. Referral to Allergist done to look for further into possible allergies. Patient did not have fever at any time during this episode. ED diagnosed patient with Cellulitis.
JOINT PAIN; This spontaneous report received from a consumer concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (A glass of wine with dinner), and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug usage. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on 01-APR-2021 for prophylactic vaccination. No adverse events reported post vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered in first week of DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in DEC-2021, the patient experienced joint pain (dose number in series 2) and the reporter mentioned that the patient possibly sucked it out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of joint pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20211264134 and 20211240486.
Fever (102), chills, headache, pain in neck, vomiting.  Over the course of 24 hours.
chills; fever; body aches; really bad nausea; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), NAUSEA (really bad nausea), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid activity decreased.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PAIN (body aches), NAUSEA (really bad nausea) and HEADACHE (headache). On 16-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, PAIN (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, NAUSEA (really bad nausea) had not resolved.            No concomitant medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea, headaches, chills and fever are consistent with the product safety profile
Patient received 2 Pfizer bivalent boosters. One on 10/19/22 and a second on 12/29/22.
Td on 07/26/2002; On 07/28/02 pm  s/s = Fever, chills, swelling in legs and feet, ER called it "serum sickness"
Hives on left thigh in the area of MMR and VARIVAX vaccines appeared within 10 minutes of receiving vaccines. Resolved after diphenhydramine by mouth.
Information has been received from a physician concerning a 19 year old female who on 12-OCT-2010 was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot # not reported). While the patient was checking out on 12-OCT-2010, she felt faint. The nurse then brought the patient back to a room where the patient's eyes rolled back in her head and she had involuntary muscle spasms". On 12-OCT-2010 the patient recovered before the physician allowed her to go home. Additional information has been requested.
Found on floor by EMS nausea, vomiting, diaphoretic. Felt need to have a BM. Patient considered hypovolemic and unable to increase bp with position. Patient transferred by EMS to nearest hospital
Optic nerve on left eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4261624, 3070-2088861690.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: OPTIC NERVE DISORDER (non-serious), outcome "unknown", described as "Optic nerve on left eye".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Migraine Auras (lightning bolt).  Although I would get 1 or 2 a year, since the vaccine I have had at least 1 every 2 weeks.
fever; chills; headache; feels sick all the time; opposite arm from where she received the vaccine is swollen; it like it was a burn and like beaten; it like it was a burn and like beaten; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 19Aug2021 as dose number unknown, single for covid-19 immunization. The patient medical history included breast cancer (she had breast cancer before where they took 14 lymph nodes in the right side), took 14 lymph nodes in the right side (she had breast cancer before where they took 14 lymph nodes in the right side). Concomitant medications were not reported. It was reported that, Patient is a consumer calling about her severe reaction with the vaccine. She said that she received the Pfizer Biontech COVID19 vaccine on 19Aug2021. She experienced fever, chills, headache, and that she feels sick all the time. She also said that the opposite arm from where she received the vaccine is swollen and that was the side she had breast cancer before where they took 14 lymph nodes in the right side. She stated that the shot was given to her left arm. She described it like it was a burn and like beaten. She also mentioned about a rumor going around in the pharmacy where the opposite arm from where they receive the shot is swollen. She wants to know how long would these last. The reporter assessed the seriousness as non-serious. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A nurse reported the occurrence of autism in a 25 month old male who was vaccinated with Infanrix and hep B vaccine (Engerix B) for prophylaxis. The subject had no relevant medical history. Concurrent conditions and medications were not reported. The subject received injections of Infanrix on 6/19/01 (995A2), 8/22/01 (983A2), and 7/23/02 (528F9). He also received an injection of tetanus and diphtheria toxoids and acellular pertussis vaccine (Tripedia) on an unspecified date, for the third dose in the immunization series. The subject received his first two injections of Engerix B on unspecified dates. He received his third injection of Engerix B on 2/4/02 (5214A2). Subsequently, on an unspecified date, the physician made a diagnosis of autism. The reporting nurse was "concerned about the preservatives in Infanrix and Engerix B potentially causing this." The autism persisted as of 5/13/03. The autism in this report is considered medically serious (OMIC). The most recent info was received on 7/22/03. The autism had "improved" as of 7/15/03. The reporter considered the autism to involve severe or permanent disability. The reporter considered the autism to be unrelated to immunization.
Day 1: soreness (L) arm at site of injection, progressing to stiff neck later the same day. Thirty-six hours after injection, (L) neck stiffness, swelling, headache. Instructed by PCP to go to emergency room. Treated with "steroid injection", BENADRYL & PEPCID. Given prescription for MEDROL Dose pack.
I have tongue sores.  Blister like with white surrounding them, very thick white film on tongue.
post herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-JUN-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced post herpetic neuralgia. On an unspecified date, the patient was treated by a healthcare provider for post herpetic neuralgia. The outcome of the event post herpetic neuralgia was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
A non-serious, spontaneous report of gave expired FLUMIST in a 33-month-old female patient was received from a nurse practitioner. On 11-Feb-2009, the patient received expired FLUMIST.  The office called the parent and explained that the child may no be fully protected;  however, the parents decided no to return to the office for re-dosing.  On 12 Mar 2009, the nurse practitioner confirmed that no adverse event occurred. There was no adverse event associated with this medication error;  therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with agency post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 12 Mar 2009 and the following information was added to the narrative: no adverse event occurred.  This is in follow-up to report(s) previously submitted on 02/11/09. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
pt recvd vax & devel a rash following vax w/MMR MAR94; No further details were provided;
Around 9:00 pm, possibly later, patient's pulse was very high (around 95), chest pain, felt like she was having trouble breathing, low back pain and said she just felt really strange and jerking.  Could not rest or relax.  Next morning was fine and back to normal except for the low back pain above and across the buttocks.
Received 3rd dose; Bloodshot eyes; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 3rd dose) and OCULAR HYPERAEMIA (Bloodshot eyes) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received 3rd dose) and OCULAR HYPERAEMIA (Bloodshot eyes). At the time of the report, EXTRA DOSE ADMINISTERED (Received 3rd dose) had resolved and OCULAR HYPERAEMIA (Bloodshot eyes) outcome was unknown.            No concomitant medications information were reported. Patient had 3rd dose of Moderna COVID-19 vaccine and experienced bloodshot eyes at the time of report. No treatment medications were provided.
Fever, difficulty breathing, large red sore area around shot area. Red sore spots away from shot area. Muscles aches. Coughing. Started trying to call MD 3rd day after shots. It was the weekend, MD called on Sunday asked for antibiotics and said that "If I has the flu- there was nothing he could do ". Monday his office called and said I could come in. I saw no reason to go in if there was nothing they could do. Both shots were given in same place. I don't know which one I had a reaction from.
Myalgias of the right lower extremities. Lasted several months. Now resolved. Started after receiving second dose of Moderna Covid vaccine series.
Patient awake at 2:50AM shaking and sweating. She began stuggling to breathe around 3:00AM. Mother took her to the ED where she received the medications listed in #19 & felt relief about an hour later.
Patient experienced palpitations and tachycardia approximately 36 hrs after receiving TRUMENBA (meningitis B vaccine).
This spontaneous report as received from a consumer refers to a patient of unknown age. The patient had a twin brother or sister. The patient medical history and drug reactions or allergies were not provided. 4 to 6 years ago, in approximately 2011, the patient was vaccinated with M-M-R II (route, lot # and expiration date were not provided). Concomitant medication information was not provided. Also 4 to 6 years ago, in approximately 2011, about two weeks after receiving M-M-R II, the patient became autistic and her or his other twin was fine. It was unknown if medical attention was sought for the patient. At the time of the report, the patient status was unknown. Additional information is not expected. No contact information was provided.
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 025C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022 at 9:40 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up received contains no new information
Tachycardia, HR up to 140 BPM upon standing, heart rate returns to normal upon sitting and laying down. Heart sounds loudest over the pulmonic area. Onset at 1:30 PM, approximately 20 hours after vaccine administration.
A 0.2 mL dose of Pfizer orange cap (5-11) was being administered to patient's left deltoid with VanishPoint 1mL syringe/needle. Vaccine leaked from around the syringe/needle base during administration.  The VanishPoint syringes are all one unit, there is no detachable needle hub. We assume this syringe unit was faulty.  A repeat, full dose of 0.2 mL, of the same Pfizer lot number was re-administered into the patient's right deltoid without incident. Patient was observed for 15 minutes following administration without any adverse issues noted.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) a pharmacist at a pharmacy recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 29-SEP-2015, a pharmacist at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 11-JAN-2017, the patient was treated by a healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.