chrisvoncsefalvay/vaers-outcomes huggingface dataset:
here was a rash around her neck that feels like fire ants; it started it was burning red bumps, little teeny, tiny red bumps; it's burning; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Lot number: GJ2524) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary immunization series completed), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 3 (Booster)), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 4 (Booster)), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 19Oct2022, outcome "unknown"; RASH (non-serious) with onset 20Oct2022, outcome "unknown", described as "here was a rash around her neck that feels like fire ants"; RASH PAPULAR (non-serious) with onset 20Oct2022, outcome "unknown", described as "it started it was burning red bumps, little teeny, tiny red bumps"; BURNING SENSATION (non-serious) with onset 20Oct2022, outcome "unknown", described as "it's burning".  Additional information: Patient stated that, She had the "biochrome" formulation of the Pfizer BioNTech Covid 19 vaccine as a booster. (She could not 100% confirm that it was the new omicron bivalent gray cap booster). She was noticed there was a rash around her neck that feels like fire ants. Before she had two primary doses of the Moderna Covid 19 vaccine and then two boosters of the Moderna. Her physician told her it didn't matter if she could mix and match the booster and she got the Pfizer one because all they had was Pfizer. This was her third booster. She was just wondering how to got rid of it. She noticed it this morning, when it started it was burning red bumps, little teeny, tiny red bumps. She only had the rash, no other symptoms; no swelling of the throat or difficulty breathing. With the Moderna vaccines she had no side effects, she had nothing with the other ones.
Pt recv vax on 3/26/99; 1 hr post vax pt exp "room spinning", nausea, swollen arm; 12 hr post vax pt exp weak body, discomfort to move extremities, difficult to walk/hold head up, headache, stiff neck, sore throat
I feel twitching most of the times and sometimes burning and itching feeling. Have high blood pressure sometimes. It?s started about a month of  my vaccination.  Before my vaccination never had problems.
No adverse event reported.  Patient was under 18 and received a Moderna Covid 19 vaccination.  Have followed up with the patient, no issues reported.  Patient filled out the form on her own and knew she was receiving Moderna, unknown to the vaccinator.
A spontaneous report was received from a Healthcare Professional concerning a 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red spot just below the injection site with 4 to 5 cm in diameter, red spread and the area covered almost to the elbow, swollen and itchy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 15 Jan 2021, approximately 9 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient experienced red spot just below the injection site with 4 to 5 cm in diameter which was swollen and itchy. within 2-3 days, red spread and the area covered almost to the elbow. Treatment details included Antibiotics and anti inflammatory like Ibuprofen and Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s) red spot just below the injection site with 4 to 5 cm in diameter, swollen, itchy, red spread and the area covered almost to the elbow were considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
flu; Initial information received on 09-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "and it gave me the flu".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and HEADACHE (headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 035B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm) and HEADACHE (headache). At the time of the report, MYALGIA (sore arm) and HEADACHE (headache) had resolved.            concomitant and treatment drugs were not provided
I was 6 weeks pregnant at the vaccine, two weeks later I started bleeding and had a miscarriage. Exactly 2 weeks after the vaccine.  I left work that day to see the OB , had ultra sound, labs and a follow up a week later.
Pfizer-BioNTech COVID-19 Vaccine EUA Generalized rash
Swollen lymph node/gland in right armpit. Gland is visible from external observation and is roughly the size of a kumquat.
slept for a long time after their first dose of COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for a long time after their first dose of COVID19 vaccine) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (slept for a long time after their first dose of COVID19 vaccine). At the time of the report, HYPERSOMNIA (slept for a long time after their first dose of COVID19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitants products were reported no treatment drugs were reported; Sender's Comments: This case concerns female patient of unknown age with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of hypersomnia. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the event occurred after the first dose and there is no information about the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) to be not related.    Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
This was my son's second dose of the H1N1 flumist - He began feeling sick with a headache within 30 minutes of the vaccine. At 10:30 PM my husband woke him up and he had a 106 fever. We got him out of bed and layed him on top of the covers and gave Tylenol and retook his temperature - it was 103.8 - and it stayed in that vicinity for the next 2 hours - he then began with fairly severe diarrhea which has continued now for almost 24 hours. I am still giving Motrin for fever but his fever is now at the normal level on the Motrin - I was unable last night to break it beyond 102 even with alternating Motrin and Tylenol.
At 11pm had unbearable abdominal pain with chills. Passing gas, having a bowel movement and walking did not help relieve the pain. The pain lasted 4 hours. Every hour made me consider going to the ER because it hurt so bad. I finally passed out from not sleeping. When I woke up 2 hours later for work I was fine.
I was taking Benadryl, Zyrtec and Claritin to help with the rash obtained from the first dose. after the second dose, the next night I woke up with a rash all over my body and facial swelling. Brain Fog for 2 months after. I havecontinued breaking out in a rash if I don't take benadryl Zyrtec and Claritan daily. I also have shortness of breath and a cough related to the Covid 19 vaccine.
Information has been received from a registered pharmacist concerning 38 unspecified patients of unknown age. The patient's pertinent medical history and drug reactions or allergies were unspecified. On an unspecified date, about 38 patient were vaccinated subcutaneously instead of intramuscularly with a 0.5 ml dose of RECOMBIVAX HB, (lot # 668558/0894AA; Expiration date: 17-MAY-2013, and lot # 1740AA (MARRS#1209USA002375)), that was stored at -5 degrees to 10 degrees C from 11-JUN-2012 to 13-JUN-2012. It was reported that the patient's did not had any adverse effects. It was unknown of patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Per patient she had hives /rashes on leg and elbow-Mild
Vesicle like lesions appeared at the deltoid area 2.5cm around shot location. And 'extension' above left antecubital similar smaller area of erythema base w/slight rise of vesicle like lesions.
Vomiting, prolonged crying (>5 hours), hypotonic, hyporesponsive episode for about 3 minutes.
This case was reported by a physician and described the occurrence of swelling of limb in his 5 year old son who received diphtheria and tetanus toxoids and acellular pertussis vaccine for prophylaxis.  The patient has a history of allergies to casein, whey, gluten, soy, chicken, pork, beef, eggs, and milk.  The patient's concurrent medications were not reported.  On an unspecified date in May 2004, the patient received a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine.  Approximately 2 days later, on an unspecified date in May 2004, the patient experienced swelling of his limb, from his calf to his hip.  The physician stated that the area was swollen to basketball size, red, hot and inflamed.  Medical attention was sought and the patient was treated with acetaminophen and ibuprofen.  The event resolved.  Report received via Merck and Co.,Inc.
Pt vaccinated with Tdap to Lt deltoid - no erythema - c/o numbness to partial lower lip. Denies SOB. Voices under a lot of stress. Monitored x 20 min. Numbness resolved after 20 min.
80 y.o. female patient of local MD with history of chronic diastolic heart failure, COPD, diabetes mellitus, hypothyroidism, hyperlipidemia, hypertension, atrial fibrillation with pacemaker presented to Hospital with shortness of breath and cough.   Discharge Diagnoses:   Acute hypoxic respiratory failure Likely due to COVID viral pneumonia, COPD exacerbation Seen by pulmonology Currently on 2L O2 Home O2 arranged on discharge   Covid-19 Virus Infection Date of onset of symptoms: 1/14 Symptoms present on admission: Cough, hypoxemia, shortness of breath Date of covid positive test:1/17 Vaccination status: vaccinated in 2020, no boosters Imaging: Chest x-ray shows bilateral patchy interstitial infiltrates suggestive of atypical pneumonia and/or congestive heart failure Oxygen requirements on admission: 7 L Current oxygen requirement: 2 L Medical therapy: steroids (to complete 10-day course as outpatient, remdesivir (last dose 1/21/23) Consultants following: pulmonary Anticipated special isolation end date: 1/27   Acute exacerbation of COPD Not on Home O2 at baseline, no smoking history To complete steroids course as outpatient Discontinued azithromycin on 1/23 Bronchodilators provided Pulmonary consulted   Acute on chronic diastolic heart failure Most recent cardiac echo was in 2021 with left ventricular ejection fraction 54% with mild decrease in diastolic function Chest x-ray showed cardiomegaly BNP is markedly elevated Diuresed with Lasix   HTN Managed with beta-blocker and Lasix   Chronic Atrial fibrillation with pacemaker Continued home meds including Xarelto, currently with paced rhythm   Diabetes mellitus type 2 Type 2 held home meds Managed with correctional sliding scale insulin while hospitalized History of meningiomas No history of seizures, but is maintained on antiepileptic drugs   Obesity BMI 35.43 Weight loss advised
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N020014 and expiration date: 17-JUL-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported.  The vaccine was stored between 6 degrees Fahrenheit (F) to 14 F for 1 hour and 35 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion.; Sender's Comments:  US-009507513-1712USA001512:
4 hours after vaccine, began having severe stabbing abdominal pain and diarrhea. Next day had overwhelming fatigue and blurred vision. Blood pressure found to be 188/118 (I am a healthy fit individual whose BP runs 120's over 60's) Continued to have these severe spikes in BP for 3 weeks along with palpitations and blurred vision. Overwhelming fatigue persisted as well for about 2 weeks  Nurse follow up on 07/27/04 states: "Chest pain, Headache."
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 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), 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: "epilepsy" (unspecified if ongoing); "asthma" (unspecified if ongoing); "retinal (CRVO)" (unspecified if ongoing); "known allergies: mussels" (unspecified if ongoing), notes: known allergies: mussels. The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "known allergies: high doses of Ibuprofen", notes: known allergies: high doses of Ibuprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive, notes: Treatment of COVID-19; (Feb2023) Postive, notes: positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 treated with paxlovid started on 07Feb2023 and stopped on 12Feb2023.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Misadministration of Vaccine. Patient was scheduled for DTAP vaccine. Patient was given Tdap vaccine.  The Nurse Practitioner spoke with Pediatrician by phone, he informed her this would not hurt the child, if anything it would boost her immunity. Patient parent was notified by phone of this misadministration of vaccine. Parent states patient is doing fine, no problems with vaccinations.
Started 2 days after the immunization with rash/itching - persistent.  Later (after couple months) developed tingling/pain both intermittent.  By Nov. 8, 2007 developed swelling of same arm (2 cm > circumference than opposite are), increased sensitivity to light touch. 3/14/08 Spoke w/reporter who stated patient experienced shingles type rash at injection site.  Tx w/ topical cream.  Rash now resolved but arm remains swollen & extremely sensitive to touch or clothing.  Tx symptomatically w/pain meds.  MD expects complete recovery in time.
The patient received a Primary Moderna 6m-4yrs instead of a Moderna Bivalent 6m-yrs.
Bothersome itching occurred near vaginal opening the day after vaccine was administered 11/13/21 (early evening). Assumed the itching was just a coincidence and tried to ignore it. Itching and inflammation increased daily, and massive amount of thick, grimy, yellow discharge coating the entirety of the vaginal opening  was discovered on 11/17/21. OBGYN diagnosed symptoms as yeast infection. For the first and second doses of this vaccine, the only side effects experienced were a sore arm, pressure behind the ears, and a mild headache. This lead me to believe that I?d be experiencing similar side effects with my third vaccine. Through research, I discovered on a forum that other women have been getting this same side effect after receiving their covid vaccine (no matter the manufacturer). I felt it would be the right thing to inform you of this side effect, so it can be disclosed to potential vaccine recipients in the future, and you can include it in your records and statistics.
really tired; my muscles are sore; they kind of ache; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue (tired), myalgia (muscles are sore) and pain (kind of ache).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient stated she was really tired, her  muscles was sore and had a kind of ache.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Quadracel reached 33.5C; 14 years old patient received quadracel; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 14 years old patient (gender not reported) who was vaccinated with a 0.5 ml first dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5635AA and Exp. Date 18-Jun-2021) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant vaccine included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) received 0.5 ml dose via intramuscular route on 09-Jul-2019 for Immunization.  It was an actual medication error case due to inappropriate age at vaccine administration and incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.