chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; patient received 0.5 mL dose from a "child vial" Moderna COVID-19 Vaccine (2023-2024 Formula) (purple cap) instead of "adult vial" SPIKEVAX (2023-2024 Formula) for 12 yrs and older; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received 0.5 mL dose from a "child vial" Moderna COVID-19 Vaccine (2023-2024 Formula) (purple cap) instead of "adult vial" SPIKEVAX (2023-2024 Formula) for 12 yrs and older) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Sep-2023, the patient received dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) .5 milliliter. On 18-Sep-2023,  after starting mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024), the patient experienced WRONG PRODUCT ADMINISTERED (patient received 0.5 mL dose from a "child vial" Moderna COVID-19 Vaccine (2023-2024 Formula) (purple cap) instead of "adult vial" SPIKEVAX (2023-2024 Formula) for 12 yrs and older). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received 0.5 mL dose from a "child vial" Moderna COVID-19 Vaccine (2023-2024 Formula) (purple cap) instead of "adult vial" SPIKEVAX (2023-2024 Formula) for 12 yrs and older) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received 0.5 mL dose from a "child vial" Moderna COVID-19 Vaccine (2023-2024 Formula) (purple cap) instead of "adult vial" SPIKEVAX (2023-2024 Formula) for 12 yrs and older).    Information regarding previous COVID-19 vaccination doses were unknown. Patient did not receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as Unknown.  Treatment information was not provided.
Starting with a rash which develops over the whole body. Very strong measles rash. Lasts over 10 days already. Numbness in fingers, tired legs.
Client states area was reddened, hot to the touch, much more involved than when she presented to the clinic 11/4/15 @ 2pm where after taking OTC Benadryl the previous night, the site was 3x5" reddened, swollen and warm to the touch below the injection site.
BEFORE BE GIVEN FLUCELVAX, PATIENT STATED SHE IS NERVOUS ABOUT NEEDLES. PATIENT WAS ASKED IF SHE HAS GIVEN FLU SHOT IN THE PAST. SHE STATED YES; WITH NO PROBLEM. AFTER GETTING THE SHOT, PATIENT CAME OVER THE COUNTER TO SIGN PATIENT RELEASE. SHE STATED SHE DID NOT FEEL GOOD THEN PATIENT FELL DOWN. HIT HER HEAD ON THE COUNTER. SHE WAS LYING ON THE FLOOR. SHE HAD HER EYES OPEN; TALKED TO US. DID NOT WANT US TO CALL 911. AFTER FEW MINUTES, SHE SEEMED NOT TO FEEL WELL. ONE OF THE WITNESSES CALLED 911 WHILE WE TENDING TO PATIENT. SHE STATED SHE FEELING OK THEN STATED SHE HAVING LITTLE HEADACHE. SHE'S TALKED TO US TILL EMT ARRIVED. PATIENT WAS TAKEN TO HOSPITAL FOR FURTHER EXAMINATION BY AMBULANCE.
redness, swelling & itchy on the rt upper arm; poss abscess prescribed Amoxil
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3/24/21). Patient was admitted to the hospital for cough and wheezing and diagnosed with COPD exacerbation. Her COVID PCR was negative on 5/22 and 6/1 and then positive on 6/3. Patient now with cough and increasing SOB requiring 3L NC.
I felt suddenly feverish around 10pm that night and assumed it was a normal response to the vaccine. Around midnight, I woke my husband when my heart was racing and I was numb on my right side completely. My whole body was shaking and I wasn't cold, but I felt so sore and weak that I was scared for my life. My husband monitored me and got me water until my symptoms subsided after about 3 hours. The fever and soreness lasted through to the next two days.
Severe cramps to left lower leg lasting approximately 20 min. Treated by donor with walking, rubbing, oral fluids.
SHINGLES; This spontaneous report received from a patient via a company representative via social media concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-AUG-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles. This report was non-serious.
Fever; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) and MYALGIA (body aches) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (body aches). At the time of the report, PYREXIA (Fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided
fainted/Non responsive for short period of time; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SYNCOPE (fainted/Non responsive for short period of time) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 07-Nov-2023, the patient experienced SYNCOPE (fainted/Non responsive for short period of time) (seriousness criterion medically significant). On 07-Nov-2023, SYNCOPE (fainted/Non responsive for short period of time) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication information was not provided.  The patient received Flu and covid vaccines at the vaccination clinic offered at work. Reporter overheard saying her that, she laid down after she got the vaccinations but started feeling better, so she went back to her desk. She then went to get water and that is when she fainted. She was non-responsive for short amount of time. Paramedics arrived on site.  Company Comment   This spontaneous case concerns a patient of female patient of an unknown age with medical history of Co-suspect product INFLUENZA VACCINE who experienced the seriousness criterion medically significant unexpected event of syncope the same day after a dose of mRNA-1273.815 vaccine. Concomitant medication nor Treatment details were reported The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a healthcare worker referring to a 5 year old patient of unknown gender. There was no medical history or concurrent condition reported. On 17-SEP-2015, doses of VARIVAX (Merck) (lot # K010437, expiry date 22-JUL-2016) (dosage, strength and route were not reported) and M-M-R II (lot # K018965, expiry date 15-OCT-2016) (dosage, strength and route were not reported), which were exposed to a temperature excursion, were administered to the patient. At the time of the report, the patient had not experienced an adverse effect. Additional information has been requested.
Started having abnormal menstrual bleeding 14 days before my expected period. More than spotting, needed to use feminine products. Lasted for 4 days. From 4/23-4/26. Started to get menstrual cramps on 4/22/21.
Breakthrough COVID infection resulting in hospitalization. Symptoms are shortness of breath beginning around 4/18/22.
Fever 102, chills, malaise, papular rash on ankles (Also given PREVNAR at the same time).
Pfizer 0.2ml vaccine  for 6 months to 4 years old Ethan Khan 4 year old boy.  The boy  was sitting on his father lap. and the  Father was holding his son.  However son jumped and half of the Pfizer 0.2ml vaccine for 6 months old to 4 years went into his right deltoid and half of the vaccine ran down his arm..  Patient received Pfizer 0.1 ml in his right deltoid and half Pfizer 0.1ml ran down his right arm.
Patient asked me to look at her arm after vaccination. Had stated that it was sore at injection site area. Upon visually seeing her arm it appeared to be cellulitis. At that time I asked (co-worker) to please go see her pcp. She scheduled an appointment and started antibiotic for cellulitis later that day.
Pt had Tetanus listed as an allergy in her chart. She asked for the Tdap vaccine. She was aware of Tetanus in the vaccine and agreed to receive Tdap in office. No reaction while in office.
administration of PENTACEL that has expired on 12Oct2023 to a patient on 24Oct2023 with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves administration of pentacel that has expired on 12oct2023 to a patient on 24oct2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Oct-2023, suspect diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection lot UJ786AA, expiry date: 12-Oct-2023 via unknown route in unknown administration site for immunization (strength, dose: unknown) was administered administration to a patient with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  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.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-health care professional (Office staff). This case involves a patient of an unknown age and gender who received vaccine FLUBLOK QIV twice in error. The patient's past medical history, concomitant medication and family history were not provided. On 24-Sep-2018, the patient received a first 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number and expiry date not reported via unknown route in the right arm. On 24-Oct-2018, the patient received a second 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QSAA1804, expiry date 01-Jun-2019 via unknown route in the left arm. It was an actual medication error due to wrong vaccine administered and extra dose administered. It was reported that Patient received FLUBLOK QUADRIVALENT twice on 24-Oct-2018 and 24-Sep-2018. The patient was scheduled for different vaccines yesterday and was given FLUBLOK QUADRIVALENT in error. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
No adverse symptoms reported; The patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies.     On 04-MAR-2020,  the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (strength, dose and vaccination scheme were not reported; lot number 1660112, expiration date 18-OCT-2020), as prophylaxis (product storage error).  The vaccine involved was stored in a highest temperature above 47 degrees Fahrenheit (°F) (52.1°F) for 15 minutes. There was a previous temperature excursion above 47 degrees Fahrenheit (°F) (55 °F) for 21 minutes, as recorded by a data logger. No adverse effects were reported.
Thigh red, small area of bruising minimum if any tender, 8 cm in diameter.
The vaccine was given past it?s refrigeration expiration date, the date on the vial was still within date.  Patient had antibody testing done.
Lots of pain/Severe pain; She cold hardly walk; Back hurts; Collar bone hurts; Legs hurts; Eyes are burning (like where the socket is); Feels like something is wrong; Pain at the site of injection; Wrist hurts/Ankles hurts; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lots of pain/Severe pain), HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts) and PAIN IN EXTREMITY (Legs hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A, 003B21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced PAIN (Lots of pain/Severe pain). 27-Aug-2021, the patient experienced HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts), PAIN IN EXTREMITY (Legs hurts), EYE IRRITATION (Eyes are burning (like where the socket is)), FEELING ABNORMAL (Feels like something is wrong), VACCINATION SITE PAIN (Pain at the site of injection), ARTHRALGIA (Wrist hurts/Ankles hurts) and MYALGIA (Muscle pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, PAIN (Lots of pain/Severe pain), HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts), PAIN IN EXTREMITY (Legs hurts), EYE IRRITATION (Eyes are burning (like where the socket is)), FEELING ABNORMAL (Feels like something is wrong), VACCINATION SITE PAIN (Pain at the site of injection), ARTHRALGIA (Wrist hurts/Ankles hurts) and MYALGIA (Muscle pain) had not resolved.      No concomitant medication information was provided. Patient did not have this experience with the 1st two doses.
Breakthrough case admission after three vaccines: Moderna 1/20/21 Lot# 029L20A- Moderna 2/17/21 Lot# 003F21A- Moderna 8/23/21 Lot# 003F21A.
All over body aches within hours of shot, to the point of incapacity, muscle cramping and being unable to move. Upon waking at 0630 on 12/2: Fever of 102.7 that does NOT respond to fever reducing meds or fluids; fainting; chills; dizziness; fatigue; brain fog and mild confusion. As 2121 on 12/2, patient is sleeping following taking 440mg Aleve, 50mg Benadryl and 32 of gatorade.
it was an allergic reaction to the vaccine; left eye swollen; white part of the left eye turned yellow; left eye is red; pressure to the left eye; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EW0178; Expiration Date: 01Aug2021), via an unspecified route of administration, in arm left on 26May2021 at 11:00 (at time of vaccination was 35-years) as single dose for COVID-19 immunization. The patient had no relevant medical history. The patient did not receive any other vaccines within four weeks prior to COVID-19 Vaccine. The concomitant medications were not reported. On 27May2021 at 08:00, the patient had allergic reaction to the vaccine and experienced left eye swollen, white part of the left eye turned yellow, left eye is red, pressure to the left eye. The clinical course included: reporter stated that she got the Covid vaccine yesterday first round. Stated that her left eye was swollen and turned to yellow eye. Stated that it was the same side she got the shot on. Stated that her doctor told her that it was an allergic reaction to the vaccine and prescribed steroids. Stated that the pharmacist recommended not to get the second dose. The events left eye swollen, white part of left eye turning yellow resulted in Physician office visit. The outcome of the events was resolving.  Information on Lot/Batch number is available; Further information has been requested.
Leg weakness; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unspecified date, the patient experienced leg weakness. Treatment was not provided in response to the events. The outcome of the event was recovered on an unspecified date. The patient has not been tested for COVID-19 since vaccination.   Information about lot/batch number has been requested.
Information has been received from a physician concerning a 14 year old female with asthma who on 23-APR-2007 was vaccinated with a second dose of Gardasil dose of (lot 657617/0384U). Concomitant therapy included albuterol. On 24-APR-2007, the patient experienced numbness, pain, and weakness down both of her arms. The patient stayed home from school for three days. The patient did not seek medical attention. On 27-APR-2007, the patient recovered. On 17-AUG-2007, the patient was seen by the physician to receive the third dose of Gardasil. The patient's mother discussed with the physician the patient's experienced after the second dose of Gardasil, and the physician decided not to continue with the rest of the series. Additional information has been requested.
20 minutes post vaccine administration. Patient complains Redness notice to upper chest area below neck and numnbess to right hand (pointer finger and middle finger) .
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 49-year-old male patient 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 MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided.     This case was linked to MOD-2021-370455 (Patient Link).
Within 24 hours pt. vomited 7 times - White chunky (cottage cheese) in a clear liquid in conjunction with chronic diarrhea over the 6+ days.  6-10 bowel movements, per day, of 95% cream-ish liquid.   He did not experience any fever greater than 99.1 F and did not present with any rash or obvious body discomfort.  Maintains "normal" solid and liquid intake. No concerns of dehydration.
This case was reported by a nurse via call center representative and described the occurrence of decreased appetite in a male patient who received SHINGRIX for prophylaxis. On 21st September 2018, the patient received SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced decreased appetite, abdominal pain and nausea. On an unknown date, the outcome of the decreased appetite, abdominal pain and nausea were unknown. It was unknown if the reporter considered the decreased appetite, abdominal pain and nausea to be related to SHINGRIX. Additional details were reported as follows: The nurse practitioner (NP) said that a patient got a dose of SHINGRIX on Friday before the reporting date at the pharmacy and the patient contacted the NP on the reporting date to make an appointment because the patient was complaining of decreased appetite, nausea and abdominal pain.
experienced the same palpitation and dizziness; experienced the same palpitation and dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 27 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), DIZZINESS (non-serious), outcome "unknown" and all described as "experienced the same palpitation and dizziness".  Additional information:Caller wanted to know if Pfizer BioNtech Covid-19 Vaccine's reported AEs included dizziness and palpitations and if it would be possible that it would stay permanent.Caller wanted to know the efficacy of the Pfizer BioNTech Covid-19 Vaccine after one dose.Caller wanted to know where to access updated information on the efficacy of the Pfizer BioNTech Covid-19 Vaccine.Caller stated that she thinks the side effects for skinny people like her is caused by more dosage compared to other body types. Caller also mentioned that she researched that there are 3 million side effect cases for pfizer, moderna and johnson and johnson covid-19 vaccines and hoped for more access to information.Batch/lot number: Not Provided.Is report related to a study or programme: No.Expiry Date of COVID vaccine: Not Provided.Other Products: Not Provided.Patient History: Not Provided. Investigation Assessment: Not Provided.She has heard from her neighbor that the neighbor knows a guy who has a doctor and that 27-year-old doctor also experienced the same dizziness and palpitations that the caller has experienced.Reporter seriousness for also experienced the same dizziness and palpitations that the caller has experienced: Unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.