chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & 3wk post vax pt devel a rash;no further details were provided;
Sore Arm Injected Arm; Pain on the Injection Site; Bad Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm Injected Arm), VACCINATION SITE PAIN (Pain on the Injection Site) and HEADACHE (Bad Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) for Asthma.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm Injected Arm), VACCINATION SITE PAIN (Pain on the Injection Site) and HEADACHE (Bad Headache). At the time of the report, VACCINATION SITE PAIN (Sore Arm Injected Arm), VACCINATION SITE PAIN (Pain on the Injection Site) and HEADACHE (Bad Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-264431 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received included outcome of all events updated to recovered.
Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported) had received an intramuscular, right arm injection of Daptacel, lot number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report, the patient had recovered from the event. The reporter in this case is the same as for cases 2006-00694, 2006-00693, 2006-00696, 2006-00697, 2006-00698, 2006-00699, and 2006-00700.
Developed vertigo the day after first dose - symptoms lasted 2 weeks and then resolved Then the day following second dose of Pfizer (4/23/21) , symptoms returned and felt very debilitated for two weeks - unable to walk comfortably, constantly dizzy and afraid to do much else other than get up from couch. Totally resolved after another two weeks
Patient received a pediatric pfizer booster by mistake. He was suppose to receive the adolescent/adult formulation booster of pfizer. Patient sat in holding pool for 15 minutes and did not have a reaction.
fainted; fell to the floor; hit his head; This is a spontaneous report from a contactable pharmacist. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 30Apr2021 at 12:15 PM (Batch/Lot Number: EW0172) as the 2nd dose, single for COVID-19 immunization. The vaccination facility type was reported as the pharmacy/drug store; the vaccine was not administered at the military facility. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. Relevant medical history included past experience with fainting on an unknown date. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had vaccination on 30Apr2021 and then proceeded to the front of the store to check-out. On 30Apr2021 at 12:20 PM, he fainted and fell to the floor and hit his head. The 911 was called immediately. The reporter checked the blood pressure and gave patient some water. The paramedics arrived and took over. The patient refused paramedic transport to hospital. The patient's father picked him up from the store. It was unknown if the patient has ever had an adverse event following any previous vaccine. The patient underwent lab tests and procedures, which included blood pressure with unknown results on 30Apr2021. The outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Faint cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
SHOULDER INJURY DUE TO VACCINE ADMINISTRATION: GIVEN TOO HIGH INJURING TENDON CAUSING TENDONITIS. IN EXTREME PAIN.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. No concurrent or medical history was reported. On 07-JUL-2015 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), dose, route, frequency and anatomical location were unknown. No adverse event was reported. Additional information has been requested.
Pt recv vax on 8/21/98; on 8/28/98 pt exp red/ swollen/ indurated vax site; tx=Claritin
Systemic: Fainting / Unresponsive-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient fainted about 5 minutes after received Covid vaccination. Hit head against soft chair and came to quickly with some initial confusion. Called 911 who responded within a few minutes and took away. No medications administered before EMS arrived as patient only started feeling tingling right before EMS arrived\r\n
Both injection sites with moderate redness, swelling approximately 3 inches in diarrhea.
I have had shingles before (10 years ago) and recognized it. Since then it is slowly spreading in a circle around the outside of my underarm on both arms; I started having a burning sensation in the underarm area of my left arm; I had a rash area develop in the underarm of my left arm.; This is a spontaneous report from a contactable consumer (patient) or other HCP. A 50-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: FA7485) dose number unknown via an unspecified route of administration, administered in the left arm on 04Sep2021 17:45 (at the age of 50 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included crohn's disease, anxiety, depression, palpitations (one chamber of heart beating out of rhythm with the others), shingles had shingles before (10 years ago). Patient had no known allergies. Concomitant medication(s) included escitalopram oxalate; fluticasone propionate; duloxetine; aspirin (acetylsalicylic acid), atorvastatin; clonazepam; melatonin; infliximab dyyb; nebivolol; trazodone and multivitamins start date and stop date was unknown. No other vaccines were given 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested COVID-19. On 05Sep2021 16:00 the patient experienced I have had shingles before (10 years ago) and recognized it, since then it is slowly spreading in a circle around the outside of my underarm on both arms, I started having a burning sensation in the underarm area of my left arm, I had a rash area develop in the underarm of my left arm. Therapeutic measures were taken as a result of I have had shingles before (10 years ago) and recognized it, since then it is slowly spreading in a circle around the outside of my underarm on both arms, I started having a burning sensation in the underarm area of my left arm, I had a rash area develop in the underarm of my left arm and included treatment with prescriptions for valacyclovir and gabapentin. All the events results physician office visit. The clinical outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
pt recv vax 14JUN96 & 16JUN96 pt exp weakness in rt arm & shoulder blades & lost the use of lt arm & hand;dx brachial neuritis;not that lt leg had an injury which subsequently resolved;
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 74 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2107 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
3 days later she experienced awful nerve pain; trouble moving her arm; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 70 years old female patient who 3 days later experienced awful nerve pain and trouble moving her arm after receiving vaccine Influenza Quadrival A-B high Dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza Quadrival A-B high dose HV vaccine of lot no: UJ925AB and expiry date: 30-Jun-2023; at a dose of 0.7 ml (strength, formulation, frequency, lot number and expiry date: not reported) via intramuscular route in the right deltoid as Immunisation.  On an unknown date, the patient developed non-serious event 3 days later she experienced awful nerve pain (neuralgia) and trouble moving her arm (limb discomfort) (unknown latency) following the administration of Influenza Quadrival A-B High dose HV vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for both events.  Outcome: Unknown for both events.
Patient is in the age group to have had the COVID Vaccine for 5-11 years old.  Instead, the patient received the wrong vaccine, being given instead the COVID vaccine for ages 12 and older. There were no symtoms at the time adminsitration.  Healthcare staff is trying to reach patient to notify parents of the error and check on patient.  Error was identified when the nurse started to document in system and recognized that the age and the vaccine lot number corresponded to the other age group.  The professional that administered the wrong vaccine is workign with the clinic to map out process cahllenges and make improvments to prevent another error from occurring. The patient and family will be offered the opportunity to have a follow-up appointment with a provider to discuss concerns or answer more questions.  It will be recommended, per guidelines, for the patient to recieve the second dose in 21 days.
Expired vaccine administered / a patient received a dose of VAQTA (R010369 3/25/2019) beyond its expiration date; No adverse effects have been reported; This spontaneous report as received from a medical assistant refers to a patient of unknown gender and age. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.   On 16-APR-2019, the patient received a dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5, injection, 1 dosage form, intramuscularly, lot number R010369, expiration date 25-MAR-2019, for prophylaxis, beyond its expiration date. No adverse effects had been reported.
Red, raised, bumpy welt at injection site, approximately 2-3 inches in diameter.  Palpitations, shortness of breath, weakness/lethargy, fever (102 degrees), headache
Non-healing ulcer of right ankle, unspecified ulcer stage. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Severe back spasm; This is a spontaneous report from a contactable consumer, the patient. A 63-Year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8727), via unspecified route of administration in right arm on 19Mar2021 at 02:00 pm (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included S/P bilateral mastectomy, H/O bilateral breast cancer, hypertension, GERD, eczema, anxiety/depression, recurrent HSV, H/O HPV 18 infection and back spasms. Concomitant medications include pantoprazole (MANUFACTURER UNKNOWN) at a dose of 40 mg and olmesartan medoxomil (MANUFACTURER UNKNOWN) at a dose of 40 mg on an unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. The patient was allergic to ceftriaxone, ACE inhibitors, zoloft, craw fish, environmental elements like dust mites, pet hair and pollen. The patient had H/O back spasms. After the Pfizer COVID-19 vaccine, on 20Mar2021, at 09:00 am, the patient suffered from severe back spasm. Severe back spasm occurred as soon as the patient stood up, real painful, pain rated 10. The patient had to immediately go back to bed to relieve the pain, because the pain was debilitating. The patient did not receive any treatment for the event. The clinical outcome of the event severe back spasm was recovered on 21Mar2021. No follow-up attempts are needed. No further information is expected.
I contracted COVID-19.  Two weeks before Christmas, I developed a dry cough. I thought I was coming down with a cold. The cough was persistent and I called my primary care doctor. He told me to stay hydrated and drink more liquids. However, the coughing continued. I started developing a fever around 100.2. I had no problems breathing and I still had my taste and smell though. I contacted my doctor again and I was later prescribed Paxlovid medication.
Swelling, tenderness, redness in the armpit of injected arm continuing at time of report.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 13 years old female patient with no pertinent medical history. The patient's drug reactions/allergies included CIPRO, ELMIRON and acetaminophen, and LORTAB. The patient's history of previous pregnancies and live births were not known. Thw patient was intramuscularly vaccinated with lot # (666595/0096Z) dose 1, 0.5 ml GARDASIL on 29-JUN-2012. No concomitant medications were reported. A urine pregnancy test at the Health Department on 29-JUN-2012 was negative. The patient contacted the nurse to inform her that, after she consulted with an unspecified OB/GYN practice, she has been determined to be pregnant. No problem reported. The LMP and EDD were not known. No treatment was given for AE. The outcome of vaccine exposure during pregnancy and no adverse event was unknown. Follow up attempt was performed to obtain pregnancy outcome information. There was no response, the case is lot to follow up. All telephone attempts to obtain follow up have been unsuccessful. Pregnancy outcome was unknown. Additional information is not expected.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. In 2013 the patient was vaccinated with the first dose of GARDASIL. On 05-FEB-2015, the patient would receive the second dose of the vaccine which was considered as inappropriate schedule of drug administration. No adverse effects reported. Additional information is not expected as we are not allowed to contact the reporter.
developed a rash of 4 inches by 6 inches; it was hot but not anymore. just for 2 or 3 days; itching; redness and sore; Redness and sore; A spontaneous report was received from a Consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site redness and sore, itching and developed a rash of 4 inches by 6 inches which was hot.  The patient's medical history was not provided. Concomitant medications reported were Simbastetin 10mg, Losartan, Baby aspirin, Vitamin C, Vitamin D, Multi vitamin, Calcium.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced redness and sore .   On 22 Jan 2021, the patient experienced itching .   On an unknown date, the patient developed a rash of 4 inches by 6 inches. It was hot but not anymore. just for 2 or 3 days.  Treatment details included Benadryl cream to keep it from itching.  Action taken with mRNA-1273 in response to the events was unknown.   On 25 Jan 2021 the outcome of feeling hot was resolved. The outcome of other events were considered to be unknown. ; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient was born healthy, but within days of being vaccinated he ran around screaming like he was in pain, banging his head and smashing things.  Over the next 3 months, he became speech delayed, getting stuck on three words: mama, dada, and hi.  These problems persisted and at age 5 Patient was diagnosed with Asperger's Syndrome, an autism spectrum disorder.  Patient also developed gastrointestinal problems including constipation and multiple food intolerances.  He is socially awkward and struggled through school, unable to get a high school diploma.  He is 24 now and still has this diagnosis.  We believe the MMR vaccine was the cause of this.
Patient had fever 1 week after vaccines.  Patient then developed febrile seizure.  Patient worked up for possible sepsis, sepsis exam normal except for elevated white count, blood, urine and CSF cultures were negative.
About an hour after the does I felt short of breath and had chest pain. It went away with Tylenol. I woke up the next day with a 103F temperature and was extremely fatigued. I had hives all over my body. Every day since then I have had a headache, dizziness, nausea, and fatigued/ tired.  I am currently working with my doctor to help with the symptoms
1/20/22  Pt is a 17 yr/o female who presents with complaints of depression.   Office called and therapist recommendation was to be seen in ER due to suicidal thoughts.  Admitted to hospital for depression/suicidal thoughts.  COVID positive test was incidental *CONST : no fever. Normal appetite *NEURO : no headache. No dizziness *MUSC/SKLT : No extremity pain/ swelling noted. *EYES : No eye discharge seen. No redness appreciated.   *HENT : No sore throat. No ear pain. *RESPIR : No respiratory difficulty. No significant cough *CARDIAC: No fast heart rate noted. No chest pain noted. *GI : No abdominal pain. Normal stools.  *GU : No change in urine output noted. No dysuria *INTEGM : No rash or wounds.  *HEME / LYMPH : No easy bruising/bleeding
9-15-06 mom reports red raised rash starting on face and hands, isolated macular, papular afebrile, L10 raised areas, areas viewed by this RN 9-19-06, areas crusted, no more break out.
heart failure; blood sugar was really high; This is a spontaneous case report sent by a Non-Health Professional which refers to an 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cardiac failure and blood sugar was really high.  The following drugs are known to have been taken by the patient prior to the event: Amlodipine ,atorvastatin, Breo, Diovan, furosemide, metoprolol, Xarelto, Trulicity  On  30-Jan-2021 the patient took the first dose of the Moderna COVID-19 Vaccine for COVID-19 infection. On the next day ('Sunday") her blood sugar was high and on Monday the patient developed heart failure and she is not attributing the heart failure to the vaccine but is wondering if her blood sugar is high due to the vaccine or CHF.  Gliperide and metformin are the treatment for symptoms.  Relevant laboratory results included. The hospital discharge summary was not available. The eventual diagnosis made on was cardiac failure . Patient wants to know that she should take second dose of vaccine.  The Non-Health Professional did not declare any relatedness between heart failure and Moderna COVID-19 Vaccine    Terse Narrative (for narratives and signal review) Brief 3 line summary of above for agency listing: Report Source- Non-Health Professional,  Age- 81 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- heart failure - Unknown,blood sugar was really high - Unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported events and the administration of mRNA-1273 is assessed as unlikely. Causality is confounded by the patient's underlying medical history suggestive in concomitant therapy.  Additional information has been requested.
Pt reported persistent (L) arm soreness on 9/24/06 with minor pain during day and more severe pain at night. Pt is tender mainly medial to lateral head of (L) triceps, well away from deltoid area. Improving.
Minor tics involving grimaces, head nods to the right, should shrugs, vocal tics-like a tongue click. Increased in frequency over next several days. Is now decreasing in frequency.
This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4,7 or 8 November 2011 the subject received a dose of FLULAVAL (.5 unknown route, unknown). On an unknown date in November 2011, several hours after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. According to the pharmacist, the hospital had a flu clinic between 04 November through 08 November 2011. Approximately 40 subjects were administered FLULAVAL from the same lot. Of the 40 subjects, five subjects experienced injection site redness, swelling and pruritus. This case was associated with a pharmaceutical product complaint. The pharmacist was suspecting a questionable batch of vaccine. She noted that a sister site had administered FLULAVAL with a different lot number and had no adverse events reported. At the time of reporting the outcome of the events was unspecified. This is four of five cases. See cases A0952517A, A0952520A, A0952521A and A0952523A for information regarding the other cases.
Erythema, swelling, tenderness at injection site. Erythema worsening 2 days later - treated as cellulitis given increased tenderness, and increasing erythema just started expect to recover.