chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and swelling at the shot site, significant pain at the shot site that lasted more than 2 weeks, significant lingering arm muscle pain when doing routine activities after the first two weeks passed,  overall feeling of having the flu for more than 5 days, significant all over muscle and joint pain, headache, upset stomach, fatigue all lasting more than 15 days, lingering arm soreness 3 weeks after the shot was administered. Red rash appeared in a band at the shot site on the second day after the shot and was visible for about 12 days. Overall significant impact on daily routine and mobility.
Sore arm; Red arm and hot to touch; So sick; Dry heaves; Sinus congestion; Dizziness; Ran fever; Headache; Body ache all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red arm and hot to touch), ILLNESS (So sick), RETCHING (Dry heaves) and SINUS CONGESTION (Sinus congestion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red arm and hot to touch), ILLNESS (So sick), RETCHING (Dry heaves), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PYREXIA (Ran fever), HEADACHE (Headache) and MYALGIA (Body ache all over). At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red arm and hot to touch), ILLNESS (So sick), RETCHING (Dry heaves), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PYREXIA (Ran fever), HEADACHE (Headache) and MYALGIA (Body ache all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Chills and fever (100.3)  Increased fluids, tried to stay warm, slept symptoms disappeared by 8 p.m.
Patient complained about rashes on the chest and she used Benadryl and she still break out
Redness, swelling, warmth to injection site - 4cm X 7cm surrounding injection site.  Provider instructed to place cold pack on the site and take ibuprofen as directed, if worsens to return to clinic.
The baby began to act fussy and felt warm a few hours after her IPV (Polio Vaccination).  Upon taking her temperature, we realized she had 102.7 degree fever.  Administered Motrin and Tylenol throughout the evening after consulting with the doctor.  Fever spiked overnight to a little over 103 degrees.  Fever lasted 2 days.  On the third day she broke out in bumps on her feet, arms, and bottom.  An office visit then indicated that she had developed Coxsackie Virus.  The rash was visible about two weeks.  1-2 days after the rash cleared, excessive bruising occurred witch lasted another 1-2 weeks.  Her blood was tested.  Platelet levels came back on the lower end of the spectrum at 148.
This is a spontaneous report from a contactable consumer reporting for herself based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (manufacturer reference number AR2016US00014709). This currently 61-year-old female patient reported that on an unspecified date in the past was extremely allergic to pneumococcal vaccine adding that she used to always get sick when  would get vaccines and was covered top to bottom in sores. The patient received pneumococcal vaccine for immunization at single dose. Outcome was not reported. No follow up attempts needed. No further information expected. Pfizer is the Marketing Authorization Holder of  pneumococcal 13-val conj vac (dipht crm197 protein) in the country of origin of the reporter. This report could be a duplicate in case another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) submitted the same report to the regulatory authorities. Follow-up (24Oct2016): This is a follow up report from a contactable consumer. A 56-year-old female patient received pneumococcal 13-val conj vaccine in Nov2011 at single dose; she had been hospitalized for rare pneumonia and was on low antibiotics (unspecified) and for these reasons she was vaccinated. Concomitant medication included fentanyl patch from 24Oct2011 (after surgery) until Apr2014. In Dec2011 the patient developed an allergic reaction to the pneumococcal vaccine and starting from May2012 she was treated with subcutaneous IgE. Since Jan2012 she was covered top to bottom in sores, due to which she was hospitalized soon after the first on her finger tips and treated with topical antibiotics and then with Z-PAK oral. On an unknown date she was  sick, and was hospitalized on the same date and treated with subcutaneous IgE, IgG human (HIZENTRA); IgE was helping her. Since an unknown date, she also experienced extreme fatigue and weakness, that were still present. If she was late on IgG, IgE subcutaneous treatments within 3 days she couldn't breathe. She got continual infections in skin with abrasions on back, shoulders, arms, legs, buttocks and sometimes face. The outcome of skin lesion was recovering; sickness, allergic reaction, fatigue and weakness not recovered; the outcome of breathing difficult and skin infection was unknown. Pfizer is the Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of origin of the reporter. This report could be a duplicate in case another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) submitted the same report to the regulatory authorities.
PATIENT RECEIVED SECOND DOSE OF SHINGRIX IN JULY 2021. SHE CAME IN TODAY (JANUARY 28, 2022) FOR ANOTHER VACCINE AND REPORTED THAT THE SITE WE GAVE HER THE SHOT IS STILL SORE... SHE HAS A HARD TIME MOVING HER ARM.. SHE HAS MASSAGED IT, PUT A HEATING PAD AND IT STILL HURTS... SHE THINKS THE SYRINGE NEEDLE MAY HAVE HIT A NERVE IN THE UPPER ARM
Pt recvd 3 doses of Engerix-B on 2NOV89, 4DEC89 & 1MAY90; In APR92 titer lab check neg;
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45, ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. On 02-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experienced had been reported. This is one of 182 reports from the same source. Additional information has been requested.
After being fully vaccinated, I began having extreme headaches from scents and fragrances. I have never had any history of headaches related to scents nor has anyone in my family. As time progressed the head pain is now more and more intense, and begins if I am exposed to any scents of any kind. This includes, dyes, soaps, lotion, sprays deodorant, dish soap, detergent, and often times even the air - anything that has a scent or fragrance. The pain will continue to become more intense until I can remove myself from the area. If the scent is on my hands or clothes, I often have to use alcohol, or bleach to remove it. My significant other has been witness to this transformation, and has tried her best to assist. As a result we have had to throw away a couch, and furniture sets, dozens of clothes and coats in-order to remove items that have scents in them that cannot be eliminated. Before entering the house, we have a section where we have remove our clothes daily after coming home from outside. There we have to treat our clothes with an ozone machine in-odor to remove as much as the scent as possible before they are washed. If the scent cannot be removed the clothing eventually has to be thrown away. This newly obtained illness now prevents me from going out to theaters, restaurants, and seriously hampers any food shopping. Attending work is becoming extremely difficult, as I am in pain for most of the day, and on the worst days have to leave work and go home early. This illness is exacting, extremely pain full, and never ending. It begins as soon as I wake up and continues until I go to sleep. To this date there have been NO medications or treatments that have even slowed this process down. Based on my current levels of pain and sensitivity, I believe it is getting worse. THERE MUST BE A TREATMENT TO REVERSE OR STOP THIS PROCESS !!!!
This child was sitting in the lobby on the bench after about 5 minutes of receiving the Hep B, MMR, and PPD; when without provocation the child hyperextended back to neck. Dropping on the bench. Seconds later she was less rigid, she was asked to sit but she was still lethargic. 911 was called, the mother ran to find the father who is an RN assistant. The child totally recovered in 5 minutes. No illnesses were reported, the mother and father said she is a healthy child.
Pt to hospital and found to be positive for COVID; severe anemia and underlying COPD; pt had a long hospitalization; began to decline clinically and required intubation; no improvement; pt continued to worsen; family decided on de-escalation and comfort measures; pt remained GIP at hospital due to respiratory distress; pt passed away in the hospital
A physician report concerns an 8 year old male patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications. He received FLUMIST QUADRIVALENT (intranasal) on 06-Oct-2014. The patient initially complained of swollen elbow on 04-Nov-2014, then noted rash on ankles and developed abdominal pain and was diagnosed with Henoch-Schonlein purpura. The patient was treated with naproxen. At the time of reporting, the Henoch-Schonlein purpura (HSP) was ongoing. The reporter assessed the Henoch-Schonlein purpura (HSP) to be serious on the basis of hospitalization.
Light headed/Dizzy; Throate tight; sore arm at the injection site; tired; swollen tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Light headed/Dizzy), SWOLLEN TONGUE (swollen tongue), THROAT TIGHTNESS (Throate tight), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Burning mouth (Burning mouth possibly from Actonel medication) from 15-Feb-2021 to 18-Mar-2021 and Cushing's disease (had Pituitary tumor surgery). Concurrent medical conditions included Drug allergy (Sulfonamide, Amoxicillin, Keflex, Levofloxacin, Cipro, Diflucan, Medroxyprogesterone Acetate, Drospirinone, Norenthindrone Acetate, Evista, Bactrim, Latanoprost Eye Drops, Travatan Z Eye Drops), Hypertension, Osteoporosis, GERD and Restless legs. Concomitant products included FAMOTIDINE for GERD, LOSARTAN for Hypertension, VITAMIN D3 for Osteoporosis, PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE [PRAMIPEXOLE DIHYDROCHLORIDE]) for Restless legs.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced SWOLLEN TONGUE (swollen tongue). On an unknown date, the patient experienced DIZZINESS (Light headed/Dizzy), THROAT TIGHTNESS (Throate tight), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form; LORATADINE (CLARITINE) at a dose of UNK dosage form; FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of UNK dosage form and PREDNISOLONE (PREDNERSONE) from 07-Mar-2021 to 24-Mar-2021 for Swelling, at a dose of UNK dosage form. On 24-Mar-2021, SWOLLEN TONGUE (swollen tongue) had resolved. At the time of the report, DIZZINESS (Light headed/Dizzy), THROAT TIGHTNESS (Throate tight), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient demographics added(Height, Weight), Historical conditions added, Treatment medications added, Outcome of the event added. Batch number of suspect product added.
PAPULAR LESION; red lesion; skin disorder; This case was reported by a physician via sales rep and described the occurrence of papular rash in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced papular rash, red rash and skin disorder. On an unknown date, the outcome of the papular rash, red rash and skin disorder were unknown.   It was unknown if the reporter considered the papular rash, red rash and skin disorder to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The physician stated that the patients experienced lesions that were popular, red, and pulsating with touch 2 weeks after receiving dose of Shingrix.  The physician had referred patient to dermatology.
Eventually, I went blind in the left eye. The doctor stated that it had an viral infection. I was given a viral drug, Valtrex. The kept on weeping and aching. I was sent to a Doctor. It was determined I had glaucoma and put on medication. Did not help, Had to put a shunt in eye. Pain stopped but still has weeping from eye from time to time.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of Merck sterile diluent. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Received flu shot 10:30am 9/30/09. 8am 10/1/09 severe pain across lower back. By afternoon swelling and pain left hip, bultic, upper thigh front leg. 1am 11/3/09 pain left side of belly. EM visit 11/3/09. X-rays done hip and spine. ALLEVE prescribed for swelling, heat for 48 hrs, then cold.
migraines, pain in arm cant lift arm ,extreme fatigue, light sensitivity fever at times.
Severe myalgia in all body muscles started in (R) arm in then affected all the other muscles x 24 hours, slept most of the day then got up Sunday did ALS walk and golfed.
Swelling and soreness, circulatory problems in the right arm, followed by tingling and color change to the affected arm, which has subsided. Numbness is slowling resolving over time (2 days since vaccine)
I received my booster dose on 11-22-2021. I started having low grade fever and a cough on 4-2-2022 and tested positive for COVID-19 on the same day by COVID-19 home test. I called and spoke with my doctor, and she prescribed Antiviral oral meds on 4-4-2022. My neighbor picked them up and I took them. I also ended up getting a sinus infection after completing the antivirals. I am reporting my breakthrough case of COVID-19. I am currently having headaches daily at this time.
01/31/21 approx 12 hours after receiving the second dose of Moderna vaccine I experienced blurred vision to right eye. Upon further eval I confirmed 30% loss of vision to right eye. No other symptoms noted. To date no change in symptoms. Since onset of symptoms I have been evaluated by various providers. 02/03 MD, 02/04 MD, 02/04 emergency room intake with blood work and MRI at hospital, 02/12 MD.
the patient was pregnant during the time of second dose of garadsilk 9; This spontaneous retrospective pregnancy report was received from a pharmacist regarding an approximately 19 year old female patient. The patient had no medical history, concurrent conditions and concomitant medications. On 11-MAY-2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # and expiry date were unspecified) (route of administration: intramuscular) to prevent HPV (human papilloma virus). On 11-JUN-2018, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # and expiry date were unspecified). It was reported that the patient was pregnant when she received 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vaccine exposure during pregnancy). Estimated date of last menstrual period (LMP) was approximately to be 2018. No laboratory/diagnostic tests were performed. The patient gave birth to a healthy baby. The outcome of the event was reported as recovered.
Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symptoms resolve within a half hour and patient was released to return to work
Two days after injections, this client developed raised, red, nickle size, bumps on both legs, groin and buttocks areas and chest. Went away over night and then reappeared the next evening only on the legs. The father is a doctor who cared for the client.
pt recv vax spring 1996 & 2wk p/vax pt devel a mild rash;25NOV97 pt devel another rash consisting of lesions on the trunk, arms, back & neck;
Lightheadedness within 10 mins of vaccination that lasted about an hour. Upon arriving home, I soon felt extraordinarily tired, and took a 2-3 hour nap! Woke up to a mild headache that lasted 4-5 days. The headache was manageable with tylenol, but very persistent.  The injection site was very sore, but not the whole arm.  On day 7, the injection site suddenly seemed extremely swollen, hot and red, measuring about 2inches x 3.5  inches in diameter. It was itchy at that time.
Patient was given Fluzone HD on 8/31/19, she came into the pharmacy on 9/5/19 after going to ER stating that her lips and face were swollen. She was given prednisone, famotidine and cephalexin (which she did not want the cephalexin so she did not pick it up).
Localized pruritis, swelling, tenderness and severe erythema at injection site, >70mm in diameter lasting approximately 10 days.
5-10 min after vaccine dose child complain of itching at site noted 10mm wheal, 2 x 3 cm erythema, and tenderness, no respiratory symptoms, vial signs stable, no distress within 30 mins, erythema subsided, wheal absent, 2x2 cm induration remained. Treated with ice, observation, rest.
24 hours after receiving the Pneumovax injection, I developed fever, rigors, body pain and tenderness with redness at injection site within 24 hours.  Fever and rigors not controlled with Tylenol or Motrin. Progressed with symptoms requiring hospitalization for 4 days.  Arm redness extended to elbow with swelling.  LFT's elevated upon admission, along with WBC's 17,000. Antibiotics started upon admission 7/20/2014.  Fever and rigors stopped by 7/22/2014.  Arm redness and swelling resolved by 7/26/2014 but tenderness and restriction of movement persisted for another 10 days.
tested positive /COVID 19 Treatment; tested positive /COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN; ROSUVASTATIN; LISINOPRIL/HCTZ; AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "not recovered" and all described as "tested positive /COVID 19 Treatment". The event "tested positive /covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient had no known allergies. Patient tested positive for on 02Aug2022. On 03Aug2022 patient had a video visit, prescribed Paxlovid for patient. COVID 19 Treatment included Paxlovid orally from 03Aug2022 to 04Aug2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The contributory role of the suspect product bnt162b2 to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Fever, chills, sore throat, earache, headache, sinus congestion, overall achiness and lethargy. Condition lasted 9 days.
Patient received first dose of COVID-19 vaccination series (Moderna) on June 05, 2021. Approximately 3 days later, patient states they were awoken in the middle of the night with extreme pruritus of the skin. The patient states they thought they were bitten by a spider in the middle of the night, but upon inspection noticed small, red, raised, itchy bumps on her forearm. The patient states within minutes the bumps were all over her body including arms and torso. The patient states they did not take Benadryl or any anti-allergy because it was not available at the time. The patient believes the bumps were hives. The rash lasted for approximately 7 days and resolved only after cleaning the skin with isopropyl alcohol as recommended by a family member. The patient states this provided relief almost immediately. The patient was questioned about other possible causes of the rash including poison ivy or poison oak but the patient denies possible exposure.   The patient also reports sore arm following the vaccination, but not in the area of the injection site. The patient states her hand was sore and she lost grip strength for 2-3 days following the vaccination.
This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported.  8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty.  Dx viral URI.  Sick family member.  RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days.  Dx viral gastroenteritis.  RTC 7/15, well child visit w/shots.  Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min.   ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor.  10/5/09 ER records received for 7/18/09 which had been previously received.