chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 in once. and ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen. On 28-Aug-2022, the patient experienced COVID-19 (COVID). On 14-Sep-2022, COVID-19 (COVID) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  The reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event of COVID with adalimumab solution for injection was reasonable possibility.   Reporter did not allow further contact
I had a rash, doctor gave me some prescription cream for it and I still have the rash.
Arm hurt a little bit and patient a little fatigued other than that patient is fine and went to school today.
I was awoken with stomach pains and nausea.  Within a few minutes I began to projectile vomit for the next hour.  The pain was so bad i couldn?t hold myself up to vomit.  I curled up  and continued to vomit .  The rest of the day I didn?t feel well  tired no appetite and very tender in the stomach area.
high pitched , inconsolable crying starting around 3 pm until around 10 pm that night. swelling of the left thigh w redness at the site.  finally fell asleep between 10-12 pm.  when he woke up several hours later, ate and went back to sleep
This case was reported by a physician and described the occurrence of local swelling in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced local swelling, erythema, contusion and skin warm. On an unknown date, the outcome of the local swelling, erythema, contusion and skin warm were unknown. It was unknown if the reporter considered the local swelling, erythema, contusion and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Tuesday, the patient received SHINGRIX on unknown deltoid. The patient had possible reaction to SHINGRIX and wondered that if any immunization nurses had seen. On Thursday, the patient experienced large swollen area around diameter 8 cm by 6 cm over biceps and the area was sore like bruise and warm but muscle was not painful to use, so it must be fairly superficial. It was unknown whether the events were related to SHINGRIX or not as its edge was at least 4 cm below injection site. This is 1 of 4 cases, reported by the same reporter.
FOGGY BRAIN; RUNNY NOSE; RAPID HEART BEAT; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (FOGGY BRAIN), RHINORRHOEA (RUNNY NOSE) and HEART RATE INCREASED (RAPID HEART BEAT) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (FOGGY BRAIN), RHINORRHOEA (RUNNY NOSE) and HEART RATE INCREASED (RAPID HEART BEAT). At the time of the report, FEELING ABNORMAL (FOGGY BRAIN), RHINORRHOEA (RUNNY NOSE) and HEART RATE INCREASED (RAPID HEART BEAT) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment was reported for the events.
mom returned to clinic approx 1 1/2hr p/vax given w/pt stating that is broken out in a rash;examined infant-gen maculo-papular rash over trunk, face & extremities;referred to nearest MD office;
Mom reports today ( 07/08/05) that on 2/17/2005, patient "felt hot to my touch" and had a "little shaking, like a seizure".  This was approximately 7:30pm on 2/17/2005 and was approximately 9 hours after patient received immunizations.  Took patient to Hospital ER.  Patient given acetaminophen in ER with no further seizures or other symptoms occuring.  No temperature readings available.  ER MD recommended fever-reducing meds(tylenol and ibuprofen)with future immunizations.
Smooth red rash 2 inches radius (irregular borders) around injection site (total of 4 inches diameter rash) appeared 15 hours after vaccine administration--not itchy. Slept overnight for 6 hours, so don't know when the rash disappeared, but was gone by morning.
Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EJ1685), via an unspecified route of administration, on 18Dec2020 at 02:45 PM at single dose for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 42-years-old. No other vaccine was received in four weeks. Medical history included prior to vaccination the patient diagnosed with COVID-19 and known allergies were Penicillin (PCN), ephedrine, calamine, calendula, pollen. Concomitant medications included escitalopram 10mh. On 19Dec2020 at 07:00 AM, the patient experienced sore arm, nocturnal diaphoresis, generalized mild pain, fatigue. The events were reported as non-serious. The patient recovered in Dec2020 form the events. No treatment was received.
Patient unable to walk on left leg after 1 day after injection,  developed a macular rash around injection site. Patient able to walk currently.
During the monitoring period Pt complained of having a headache, dizziness and numbness to her feet.
swelling; pain; tender; welt at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site tenderness and injection site wheal. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site tenderness and injection site wheal were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site tenderness and injection site wheal to be related to Shingrix.  Additional details were received as follows: The age group adult selected as per vaccine specification. The patient experienced a big welt at injection site, tender to touch, painful.  Took 3 weeks to go away. The reporter did not consented to follow up.  No additional information provided.
Immunization in left arm. Site of injection sore to the touch (seems normal to me). Under arm pit is very swollen, sore and painful.  Not sure if it?s the lymph node but this is my guess. The only note on my health record states influenza quadrivalent preservative free im. I didn?t see this listed as an option
- 3 hours after vaccination: Tensing occurred around the injection site. Pain can be described as soreness that makes moving the muscles at and around the injection sight difficult. Pain lasted for 3 days. - 1430 of 2/25/2021: A headache occurred that lasted for approximately 24 hours. The headache got worse at around 1600.
Itches; more patient scratches it more it sores; sores; rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), SKIN IRRITATION (more patient scratches it more it sores), SKIN REACTION (sores) and VACCINATION SITE RASH (rash in the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE RASH (rash in the injection site). On an unknown date, the patient experienced PRURITUS (Itches), SKIN IRRITATION (more patient scratches it more it sores) and SKIN REACTION (sores). At the time of the report, PRURITUS (Itches), SKIN IRRITATION (more patient scratches it more it sores), SKIN REACTION (sores) and VACCINATION SITE RASH (rash in the injection site) had not resolved.            No concomitant medications were reported. Patient applied creams and ointments given by dermatologist to treat symptoms
Swollen soft palate, not to the point of difficulty swallowing, but visibly and noticeably, swollen.  Painful when eating.    Started noticing at 7PM, on day of 2nd vaccine, and it is ongoing.
This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored MMR II lot no. L032044/expiration date- 24-AUG-2017 (incorrect product storage). No concomitant medication was reported. No adverse event. It was exposed to temperature of 75.5F for 3 hour 7 minutes. Previously it was not exposed to temperature excursion. The call was because of a data logger. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. In September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a week after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness was unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the tiredness and pain in arm to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: On a Friday in September 2018, the patient received flu vaccine (name unknown) in the right arm. The patient experienced a very sore arm for about a week after receiving the flu vaccine. The patient was also tired for the entire weekend. The reporter did not consent to follow up.
Five severe episodes of vertigo after the third Moderno vaccine. Other slight episodes of vertigo over the past three months
congestion; achy feeling in body; Bad Headache; Got COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID after first dose), NASAL CONGESTION (congestion), MYALGIA (achy feeling in body) and HEADACHE (Bad Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced COVID-19 (Got COVID after first dose). On an unknown date, the patient experienced NASAL CONGESTION (congestion), MYALGIA (achy feeling in body) and HEADACHE (Bad Headache). At the time of the report, COVID-19 (Got COVID after first dose), NASAL CONGESTION (congestion), MYALGIA (achy feeling in body) and HEADACHE (Bad Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (abnormal) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was diagnosed with Covid-19 a week after receiving first dose of the vaccine. Concomitant medications were not provided. Treatment information was not reported.
pt recvd vax & had episode of dyspnea, perioral cyanosis & rhythmic shaking of hands & forearms; crying & irritability; pt taken to ER; cxr, lp, bc, cbc neg; remained febrile x 2 d; generalized exanthem;dx:febrile sz & viral illness;
Molluscum contagiosum around bottom area 5 days after receiving varicella. Molluscum spread to her trunk.
Resident observed with pale colored blisters noted on the underside of penis. No discharge, non tender on physical examination by NP  Treated with Valtrex 1Gm Tablet BID x 10 days and Betadine 10% solution on affected area BID x 5 days
administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
received a third dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) (batch number 4G95T, expiry date 23-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On 01-NOV-2023, the patient received the 3rd dose of Shingrix. On 01-NOV-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 2-Nov-2023 Pharmacy intern reported that a patient received a third dose of Shingrix, which led to extra dose administered. The reporter did not provide initials and date of birth of the patient. No additional details were provided. The reporter consented to follow-up
Just over 24 hours after receiving vaccine, began running low grade fever.  First recorded at 101.  Over the next 48 hours (approximately)  fever fluctuated between 99-101.  Also experienced pain at injection site and muscle soreness in left arm.  Issues resolved on their own without medication. V-SAFE 1st check in, did not occur until 4 days post vaccine, at which time, fever had resolved.
I experienced common symptoms for several days after receiving the shot (sore arm, mild fever, fatigue, etc.). I also had a red splotchy rash on my arm around the injection site, perhaps 2-3'' in diameter. I was outside the following week wearing a tank top with sunscreen, and I received a bad sunburn on my left arm on the same location as the splotchy rash - it was very unusual. I received the sunburn yesterday and it's very itchy and uncomfortable today.
inadvertently administered an expired dose of Daptacel with no reported adverse event; Initial information received from on 14-Jun-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-HCP.  This case involves a 1 years old male patient who was inadvertently administered an expired dose of daptacel with no reported adverse event , for receiving  vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Prophylactic vaccination; HIB VACCINE (HIB) for Prophylactic vaccination; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 14-Jun-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, once, ( lot: C5743AA ; expiry date: 06-Jun-2022)  via intramuscular route in the left vastus lateralis for immunization.  it was reported that  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE was  inadvertently administered an expired dose of daptacel with no reported adverse event (expired product administered) (onset date: 14-Jun-2022 ; expiry date: same day)  Action taken : not applicable.  Outcome: unknown   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 the 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.
This spontaneous report as received from a physician via a company representative refers to an 18 year old male patient with no pertinent medical history. The patient's drug reactions or allergies were not reported. On 20-SEP-2012 and 23-SEP-2013, the patient was vaccinated with the first and the second dose of GARDASIL 9 (dose, route, lot # and expiry date were not reported), respectively. On 01-SEP-2016, he was vaccinated intramuscularly with the third 0.5 ml  dose of GARDASIL 9 (lot # M018810, expiry date 28-MAY-2018).  Concomitant therapies included tuberculin purified protein derivative (PPD) and unspecified medication reported as "Mendeo". On 01-SEP-2016, immediately after getting the third dose of GARDASIL 9, the patient fainted, "fell head first from the table" and hit his head. Right after this event, in the office, they tried to wake up the patient by administering him oxygen and ammonia. The patient's blood pressure was measured twice in the office with the first result of 107/58 (unit not provided) and the second result of 117/68 (unit not provided). The office called the emergency number and the patient was sent to hospital on the same day. At the time of report, the patient was still in the hospital and he did not recover. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested
Patient states that a day after having the vaccine, he developed severe stiffness in his hips and shoulders, muscle aches, had a headache on and off, chills, felt tired, had night sweats, lost his appetite, and taste was off.  There symptoms lasted 10-12 days.  He was tested for Covid 19 on 2/28 with an antigen test and was negative and tested again on 3/2 with a PCR and was negative .  He is starting to feel better now.   Called his physician who felt that these symptoms were due to the vaccine, encouraged him to go ahead and get second dose.
Pinkish rash around injection site; Itchy sensation on rash about 2 inches by 2 inches; fever; Rash subside and come back again; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), INJECTION SITE RASH (Pinkish rash around injection site), RASH PRURITIC (Itchy sensation on rash about 2 inches by 2 inches), PYREXIA (fever) and RASH (Rash subside and come back again) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 13-Mar-2021, the patient experienced INJECTION SITE RASH (Pinkish rash around injection site), RASH PRURITIC (Itchy sensation on rash about 2 inches by 2 inches), PYREXIA (fever) and RASH (Rash subside and come back again). On 06-Mar-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, INJECTION SITE RASH (Pinkish rash around injection site), RASH PRURITIC (Itchy sensation on rash about 2 inches by 2 inches), PYREXIA (fever) and RASH (Rash subside and come back again) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9014) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: En6199), in left arm, on 27Mar2021 as dose 2, single (Lot number: Er8732), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: Ff3590), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: Fk9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2023) Positive. Therapeutic measures were taken (paxlovid) as a result of vaccination failure, covid-19.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/28/2023 UTI (URINARY TRACT INFECTION)
Headache, Myalgia, Arthralgia, Fever, dry mouth Narrative: Fever 1026, arthralgia, myalgia, headache, dry mouth. taking APAP/ibuprofen.