chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to multiple unspecified patients. No information regarding their pertinent medical history, concomitant medications, drug reactions, or allergies was provided. Since 08-SEP-201 to 12-OCT-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route of administration, lot# and expiration date were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Celsius for 3 hours and 40 minutes. There was no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter. Follow up information was received from the medical assistant on 27-DEC-2016. She was going to fax the patients' identifiers, dates of vaccination, lot# and expiration dates. Additional information has been requested.; Sender's Comments: US-009507513-1610USA008206: US-009507513-1612USA014132: US-009507513-1612USA014130:
Have been receiving treatment for tendonitis developed after flu shot. Receiving iontophoresis w/dexamethasone for shoulder pain and limitation of movements as well as physical therapy.
On Wednesday, January 13, 2021, felt very cold starting around 11:00 am as the day went on felt very tired, went home was very tired, chills, low-grade fever 100, achy with a headache.  Took ibuprofen, went to bed at 7:30 pm slept through the night woke up feeling very good.
ON 1/8/21, DEVELOPED A MILD HEADACHE. TREATING WITH ACETAMINOPHEN.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Described as electrical feeling in left side of brain-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Second day after receiving vaccination, pt stated having a localized rash and itching at injection site area. On day 3, pt stated electrical feeling in left side of brain, was instructed to follow up with md to assess
at 3:00 pm, patient started to feel tingling around lips and mouth, felt foggy, could not focus, and slurring words. Vaccine clinic nurses were contacted shortly after to go assess the patient. Vitals were taken; BP 159/93, HR 94, O2 99%, RR 18, temp 98.7, IV was started for emergencies. Patient was layed down and then later sent to ER for monitoring
Patient came to the clinic for her booster dose of the COVID vaccine, with her mother. The front desk gave them the forms to fill out and then brought the completed forms to this RN. The MA then took the forms and gave the patient the Moderna booster vaccine. The MA noticed the patients age after the vaccine was given when she was putting the encounter in the chart. This RN called the patient's mother and advised her of the situation, provided information on what happened and what side effects to be aware of. Mother verbalized understanding.
anaphylactic reaction to the PROQUAD; Information has been received from a nurse practitioner concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history of the patient was unknown.   On an unknown date, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route, lot# and expiration date were not reported) for prophylaxis.  On an unknown date in April 2022, the patient had an anaphylactic reaction to the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Patient received diphenhydramine hydrochloride (BENADRYL) and was sent to the hospital. The outcome of anaphylactic reaction was recovered on an unknown date in 2022.  The event of anaphylactic reaction was considered to be related to the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  Upon internal review, anaphylactic reaction to vaccine was determined to be medically significant.   This is one of two reports received from the same reporter (linked case # US-009507513-2206USA002456).; Sender's Comments:  US-009507513-2206USA002456:
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, approximately one third of the patients who were vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and dose were not reported), subcutaneously in the arm (reported as deltoid) returned to the pharmacy complaining of redness swelling heat and pain at the injection site. The patients arm would often swell to a size of an orange. The patients sought medical attention, visited the pharmacy. The patients were advised to treat with ice packs, over the counter non-steroidal anti-inflammatories, the symptoms typically resolved with 2 weeks. On an unknown date (reported as with 2 weeks), the events of redness swelling heat and pain at the injection site was recovered/resolved. Additional information has been requested.
Received a booster dose beyond the use date (beyond 30 days at 2-8C). Beyond Use Date: 12/28/21 Notified manufacturer Moderna & State Immunize Manager.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warmth feeling in throat) and DYSGEUSIA (Metallic taste in mouth) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING HOT (Warmth feeling in throat) and DYSGEUSIA (Metallic taste in mouth). On 01-Mar-2021, FEELING HOT (Warmth feeling in throat) and DYSGEUSIA (Metallic taste in mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       N treatment and concomitant medications were reported.
Information has been received from a physician concerning a 9 year old female patient with environmental allergy (allergy to: dust mite, molds, fall pollen and "sorel") and a history of hot flashes (start date unspecified) after allergy shots (from 22-JAN-2008) to 02-OCT-2009, type and manufacturer unspecified) who on 21-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z, expired data 18-JUL-2011). There was no concomitant medication. The physician reported that the patient did not have any hot flashes between the stop of the allergy shots on 02-OCT-2009 (also reported as 02-OCt-2011) and the vaccination with PNEUMOVAX 23 vaccine on 21-MAR-2011. On 21-MAR-2011, patient developed the hot flashes. The hot flashed occur daily (at least one per day, sometimes more) and least for a few hours. The physician considered hot flashes as disabling as the patient could not tolerate the hot flashes and the hot slashes interrupts study at school. On an unknown date, the patient had consulted with an endocrinologist and a neurologist. X-ray and MRI test were done (results and details unknown). No treatments was given for adverse events. At the time of the report the patient's status was not recovered. Additional information has been requested.
per patient notes- "Was in pain, delirious and confused.  Severe stomach,head ache, and body ache. Wild dreams."
tachycardia; shortness of breath; sweating; A spontaneous report was received from a other health care professional concerning an unspecified age and gender patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tachycardia, shortness of breath/dyspnea, and sweating/hyperhidrosis.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date at a pharmacy, within minutes, the patient had shortness of breath, tachycardia and sweating. The events were considered to be life threatening.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pain in the legs and feet.  Same with my hands and fingers.  Fatigue. Night sweats. Unable to sleep.  Muscle pain in the back and chest area.  This started at bedtime around 11:00 pm, approximately 12 hours after the dose. Symptoms lasted a full 24 hours. Fatigue being the symptom lasting the longest.  As of now, all symptoms have subsided.
Tinnitus, began a little over 24 hrs after dose 2, continuing more than 48 hrs so far.  I have had very mild tinnitus for many years, maybe 1 or 2 on scale of 1 to 10, very tolerable.  Currently at maybe 5 or 6 level, with some intermittent fluctuations to higher levels.  No issues after first dose.
Nausea/vomiting and fatigue began at approx. 3pm the following day (about 30 hours following injection), treated with rest and Zofran, lasting about 24 hours.  Also decreased appetite. Muscle aches and pains began morning of 14 Jan 2021, approx. 46 hours following injection, treated with extra strength Tylenol and rest, lasting about 24 hours. As of 15 Jan 2021, currently no more adverse reactions.
Day after shortness of breath ER and gave a breathing  treat, blood  pressure and sweating , Ebrudarol breathing and ,  magnesium and fluids.
cannot move; terrible torn meniscus; fever of 100.8F; rash under the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (cannot move), MENISCUS INJURY (terrible torn meniscus), PYREXIA (fever of 100.8F) and VACCINATION SITE RASH (rash under the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Lupus-like syndrome. Concomitant products included HYDROXYCHLOROQUINE for Lupus-like syndrome.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (cannot move), MENISCUS INJURY (terrible torn meniscus), PYREXIA (fever of 100.8F) and VACCINATION SITE RASH (rash under the injection site). At the time of the report, MOBILITY DECREASED (cannot move), MENISCUS INJURY (terrible torn meniscus), PYREXIA (fever of 100.8F) and VACCINATION SITE RASH (rash under the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 (High) 100.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details was provided.
Breakthrough case of COVID-19 after being fully vaccinated; Breakthrough case of COVID-19 after being fully vaccinated; This is a spontaneous report from a contactable consumer.  An adult female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 both intramuscular, in Arm Right in Apr2021 at 09:00 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation in clinic. The patient medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced breakthrough case of covid-19 after being fully vaccinated on 19Jul2021 with outcome of recovered on 30Jul2021. The patient was not treated due to the event. The patient underwent lab tests and procedures which included SARS-CoV-2 Rapid Ag: Positive on 22Jul2021 (Nasal Swab), negative on 30Jul2021 (Nasal Swab), PCR: negative on 30Jul2021 (Nasal Swab). The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. Concurrent vaccination included MMR vaccine (non-gsk); Merck; subcutaneous; left arm given on 22 May 2012; varicella virus vaccine (non-gsk); Merck; subcutaneous; right arm given on 22 May 2012. Concurrent medications included CLARITIN. On 23 May 2012, one day after vaccination with KINRIX, the subject experienced swelling at injection site, hotness at injection site, injection site redness, and redness spreading. The subject was administered KINRIX and by the next morning he had swelling of ten centimeters, redness and heat at the injection site. The redness spared toward the subject's groin area and he was then seen in the office. The redness extended about three inches by two inches from the site toward the groin area. It was reported that the subject still had on the band aid from the date of vaccination. The subject was prescribed KEFLEX for 10 days. The reporter stated the KINRIX vial was used, by they do use latex band aids. At the time of reporting the swelling at injection site, hotness at injection site, injection site redness, and redness spreading were unresolved. This is the second of two reports regarding KINRIX; please see A0978807A.
Fever 100.3, chills, headache, arm soreness at injection site., fatigue
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M035141 exp date 03-AUG-2018) (doses and route were not provided). The temperature of excursion was -14°C for 30 minutes in a range > -15°C but < -10°C. There was no previous temperature excursion. A data logger issue was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the reporter does not want to be contacted. Sender's Comments: US-009507513-1702USA000288.
After receiving vaccines the pt became fussy and could only be consoled if held. Pt was treated with Tylenol and recovered after four hours.
customer no other AE occurred; MMRII that was administered and expired; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported.  On 23-APR-2021, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (strength and route of administration was unknown, lot# was reported as s010707, but upon internal validation, it was changed to the valid lot# S010707, expiration date was 08-APR-2021) for prophylaxis (expired product administered). The patient had no other adverse event occurred, and the product did not experience any temperature excursions prior to administration.
This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 74-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Tingling in lips; Felt a bit itchy; This is a spontaneous report received from a contactable consumer, the patient. A 70-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 10:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate cancer and high blood pressure (HBP). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), aspirin 81 mg (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN), all for unknown indications on unknown dates. The patient's past drug history included allergic to sulfa. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 16Mar2021 at 10:00, the patient experienced some tingling in lips and felt a bit itchy. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events tingling in lips and felt a bit itchy. The clinical outcomes of the events tingling in lips and felt a bit itchy were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Headache; achy muscles; during sleep for a very short bit hot/sweating; This is a spontaneous report from a contactable consumer (Patient).   A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 09:00 (age at vaccination 49 years) as dose 2, single for covid-19 immunisation. Medical history included blood pressure high. Concomitant medication(s) included losartan (LOSARTAN); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); ibuprofen (ADVIL [IBUPROFEN]). The patient previously took demerol and experienced drug hypersensitivity. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (age at vaccination 49 years) as dose 1, single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility type vaccine was Workplace clinic. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021 23:30 the patient experienced headache, achy muscles, during sleep for a very short bit hot/sweating. The patient did not receive any treatment for reported events. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Caller states that a patient stated they initiated the GARDASIL9 series at age 25. Caller states the patient reports receiving 2 doses of GARDASIL9, but has not yet received the third dose; no addtional adverse event; This spontaneous report has been received from a pharmacist, regarding a 28-year-old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On an unspecified date (reported when patient was 25-year-old), she started the vaccine series with first and second doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliters (mL) (route of administration, formulation, strength, vaccination scheme, anatomical site of vaccination, lot #, and expiration date were not reported) as prophylaxis. Notwithstanding, patient had not received the third dose in the series at the reporting time (inappropriate schedule of vaccine administered). No additional adverse event was reported.
Ectopic pregnancy; Exposure during pregnancy; This spontaneous case was reported by a consumer and describes the occurrence of ECTOPIC PREGNANCY (Ectopic pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECTOPIC PREGNANCY (Ectopic pregnancy) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Exposure during pregnancy). At the time of the report, ECTOPIC PREGNANCY (Ectopic pregnancy) outcome was unknown and EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she was not pregnant at the time of this report. Relevant concomitant medications were not reported.  Treatment medication was not provided.  Company comment: This report refers to a case of exposure during pregnancy for mRNA-1273 (lot # unknown) with associated AE reported of ectopic pregnancy. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: This report refers to a case of exposure during pregnancy for mRNA-1273 (lot # unknown) with associated AE reported of ectopic pregnancy. Very limited information regarding these events has been provided at this time. Further information has been requested.
Patient reported rapid and immediate fatigue post vaccination and nose bleed. Patient oxygen saturation rate remained over 95% during 3 hours of monitoring post injection.  One hour post injection patient noted right sided frontal headache that did increase in severity.  Patient BP increase to 151/88 and was 130/80 at discharge
Pt states her arm starting hurting around 3 pm - took some Ibuprofen - didn't help much - in pain throughout the night - woke up this morning could not move arm.
Pharmacist administered pediatric Pfizer vaccine (0.2ml) to child without diluting it first prior to administration. Child received a higher dose than intended. Mom was advised the child would feel increased side effects including headache, fever, soreness. Patient's mom advised that patient will still need to be vaccinated with the second appropriate dose in 3 weeks. Pharmacist followed up with mom a couple days after the incident and mom reported that child is doing okay with no side effects except sore arm. Pharmacist instructed mom to continue to monitor for any other symptoms that may arise and to contact pharmacy/doctor as needed.
Patient administered Pfizer vaccine on 3/8/2021 and given Moderna vaccine on 4/16/2021. Patient has not reported any adverse events.
Rph administered expired vaccine because she misunderstood the time of expiration after the update indicating that it is good for 30 days. She thought it is good for punctured one as well. Pharmacy manager wasn't sure either. We have to find out from DM since the pharmacy manager wasn't sure.
Red, itchy, welted rash on injection arm (4.5 inches long, 2 inches wide) 8 days after injection
*Important* I was not given shots directly mom given shots 12-18-15 contact was 2nd hand as primary caregiver. Developed flu-like serious sickness 3 days after exposure. Cycle of head/chest cold, heart palpitations, pain in abdomen continued for 9 months, revealed to be Epstein-Barr. Unbearable EMF sensitivity continues now.