chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client reported chest pressure and itching status post 1st dose Pfizer COVID vaccine administered 04/13/2021 (LOT: EW0161, Expiration date 08/31/2021) She stated the itchy symptom began approximately 8 hrs after vaccine administration and the chest pressure began 1 day after vaccine administration. Client denied shortness of breath, headache, dizziness, , nausea, vomiting, diarrhea, swelling of lips, mouth or tongue. Client states chest pressure lasted 24 hrs and then resolved. She did not consult with her primary care provider regarding the pressure and itching. Client reported that she felt very anxious on the day of her 1st dose and was feeling anxious about 2nd dose as well. Client reported medical history of mitral valve prolapse which she takes propranolol daily, she also reported borderline hyperlipidemia which she takes Lipitor daily for. She denied allergies to medications/food/environment.
Measles like bumps for 3 days. She was fussy. She was given infant Advil.
Immediately following immunization, patient reported dizziness, paleness to skin, perspiration, weakness, and nausea followed by emisis
Accidental exposure due to syringe malfunction; A spontaneous report was received from a HCP concerning a 66-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental exposure due to syringe malfunction/accidental exposure to product.  The patient's medical history, as provided by the reporter, included diabetes and high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included metformin, metoprolol, atorvastatin, farxiga, clonidine, and amlodipine. A spontaneous report was received from a healthcare professional concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events accidental exposure due to syringe malfunction.  The patient's medical history was not provided. Concomitant medications reported were Metformin, Metoprolol 200mg BID, Atorvastatin 10mg daily, Farxiga 5mg daily, Clonidine .2mg BID, Amlodipine 10mg daily for drug use for unknown indication.  On 21 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 21 Mar 2021, the patient experienced the event(s) accidental exposure due to syringe malfunction.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 21 Mar 2021 the outcome of event(s), accidental exposure due to syringe malfunction was resolved.    On 21 Mar 2021, on same day of the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 21 Mar 2021, the patient was administered an invalid dose due to a syringe malfunction the patient and had accidental exposure. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was consider not reported.   The outcome of events, accidental exposure due to syringe malfunction was resolved on 21 Mar 2021.; Sender's Comments: This report refers to a case of expired product administered for mRNA-1273, lot #038A21A with no associated AEs.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 41-year-old female patient who received BOOSTRIX (batch number 594SR, expiry date 8th July 2019). On 24th July 2017, the patient received BOOSTRIX. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to BOOSTRIX. Additional details were provided as follows: The patient received a dose of BOOSTRIX on left arm and experienced pain in the same arm. It was unknown, how soon the event developed relative to receiving the injection.
sore arm from where vaccine was given down the arm, chills, stomach ache, fatigue
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound case of COVID19 following completion of Paxlovid. Symptoms began for second time three days following completion of Paxlovid series.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148548 Same patient/different product, different dose/event;
No other AE reported; Medical assistant reports administration of an improperly stored dose of VAQTA to a patient on 22-OCT-2021; This spontaneous report has been received from a medical assistant, concerning to 5-year-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On an unspecified date, the hepatitis a vaccine, inactivated (VAQTA) was improperly stored at below 36 degrees Fahrenheit (F) (34.7F) for a timeframe of 0 hour, 25 minutes and 0 seconds; below 36 F (35.4F) for a timeframe of 5 hour, 25 minutes and 0 seconds; below 36 F (35.6F) for a timeframe of 3 hour, 20 minutes and 0 seconds; below 36 F (35.9F) for a timeframe of 0 hour, 25 minutes and 0 seconds; below 36 F (35.7F) for a timeframe of 0 hour, 25 minutes and 0 seconds; below 36 F (35.2 F) for a timeframe of 3 hour, 20 minutes and 0 seconds; below 36 F (33.8F) for a timeframe of 18 hour, 20 minutes and 0 seconds; below 36 F (32.1F) for a timeframe of 23 hour, 45 minutes and 0 seconds; below 36 F (32.5F) for a timeframe of 9 hour, 35 minutes and 0 seconds (product storage error).   On 22-OCT-2021, the patient was vaccinated with the improperly stored hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliters (mL), "one time" (lot number T031201 has been verified to be a valid lot number, expiration date reported and established as 14-JUN-2022) as prophylaxis (vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported). No other adverse events (AE) reported (no adverse event).  This is one from several reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA003192: US-009507513-2111USA003125: US-009507513-2111USA003270:
Patient received Moderna Vaccine on 10/5/2021.  The shelf life expired on 10/03/2021. The vaccine expiration date 10/10/21.
Patient presented to the ED and was subsequently hospitalized for pneumonia within 6 weeks of receiving COVID vaccination.
serious reaction to vaccine; This spontaneous report has been received from a registered nurse referring to a female patient of unknown age. No information was provided regarding the patient' medical history, concurrent conditions, drug and allergy history or concomitant medications.  On an unknown date in 1980, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route of administration, lot# and expiration date) and sterile diluent for prophylaxis. On an unknown date in1980, the patient experienced a reaction (adverse reaction) and she was hospitalized due to the reaction. The reporter stated the details of the "serious reaction" were not reported by the patient and were unknown at this time.  No additional AE reported. It was unknown if any laboratory diagnostic or studies were performed. Moreover, the event was not considered a cancer event.  Therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent were discontinued.  The outcome of adverse reaction was reported as recovered/resolved (exact date was not reported). The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent was not provided.  The reported considered the adverse reaction to be medically significant.
red face, throat itchy, hoarse voice, SOB while supine. Epipen given. resolution of symptoms
This spontaneous report as received from a Registered Nurse refers to an unknown number of patients. Patients might have received doses of GARDASIL (dose, route and lot # unknown) on an unspecified date which were exposed to 30F over the 3 months period. No adverse effects reported. Additional information has been requested.
Neck is very stiff and painful to perform range of motion. Very sore arm and shoulder at injection site.
Starting the evening the patient received the vaccine, she developed redness and swelling at injection site, fever, and rash covering body including legs.  Monitored by mother, patient advised by pharmacist to seek immediate medical care if any swelling of face, lips, or tongue occur, or rapid spike in fever, to take antihistamine for itching, ibuprofen or Tylenol to control fever, swelling, or any pain.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 38-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 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccines were stored in freezer and took out one to two vials and place in fridge each day as needed. No concomitant medications were reported. No treatment given.
This spontaneous report as received from a nurse who is also the female patient of unknown age. No medical history or concurrent conditions were reported. The patient was not pregnant. On 05-FEB-2013 the patient was vaccinated with ZOSTAVAX, intramuscular. No dosage information, lot number or expiration date was reported. No other co-suspects were reported. No concomitant medications were reported. On 06-FEB-2013, the patient developed "redness, pruritus, warmth and swelling about the size of an orange" around the injection site. It is unknown if the patient sought medical attention or received treatment for the adverse event. The outcome of redness, pruritus, warmth and swelling about the size of an orange around the injection site was reported as not recovered. No causality statement was provided by the reporter. No further information was provided. Additional information is not expected.
having a raise in heart rate/ heart rate was over a 150 beats per min; Heart racing; chest was heavy; having some heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old female patient received bnt162b2 (COMIRNATY), administration date 07Jan2022 (Lot number: FF8841) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (ongoing), notes: it does like exercise or allergy induced, so she does not take a normal inhaler; "fruit allergies" (ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer unknown, dose1), for Covid-19 immunization; Covid-19 vaccine (Manufacturer unknown, dose 2), for Covid-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious) with onset 08Jan2022, outcome "unknown", described as "having some heart issues"; TACHYCARDIA (non-serious), outcome "unknown", described as "having a raise in heart rate/ heart rate was over a 150 beats per min"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest was heavy". The event "having a raise in heart rate/ heart rate was over a 150 beats per min" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cardiac disorder, tachycardia, palpitations, chest discomfort.  Additional information: It was reported that the patient was having some heart issues which were "intermittent" started the day after she received the dose, since then she was having a raise in heart rate, then a week after that would raise again then another week will raise again after and so on and so fort. The patient visited ER this past week because her heart rate was over a 150 beats per min. Prior vaccination (Within four weeks) was none.   Follow-up attempts are completed. No further information is expected.
Client came in for her 4 year old shots and flu shot. Pain-ease spray applied to legs and shots given.  No crying at this time. About 5 minutes later client leaning against Mom's legs while standing and slid down her legs to the floor slowly. Client did not hit her head or loose consciousness. Mom picked her up and had her sit in her lap. Client was pale and then became nauseated, but did not get sick. She also complained of being hot. PHN also called into the room as standby. Had client lay on the exam table with feet elevated and drink water. Client appeared normal after 10 minutes (11:00). Client went home with Mom at 11:10.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious), HAEMORRHAGE (bleeding from forehead), EPISTAXIS (bleeding from nose), FACIAL BONES FRACTURE (nose is fractured), FALL (fell down from chair on the face down towards floor) and MALAISE (not feeling well) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criteria hospitalization and medically significant), HAEMORRHAGE (bleeding from forehead) (seriousness criterion hospitalization), EPISTAXIS (bleeding from nose) (seriousness criterion hospitalization), FACIAL BONES FRACTURE (nose is fractured) (seriousness criteria hospitalization and medically significant), FALL (fell down from chair on the face down towards floor) (seriousness criterion hospitalization) and MALAISE (not feeling well) (seriousness criterion hospitalization). At the time of the report, LOSS OF CONSCIOUSNESS (unconscious), HAEMORRHAGE (bleeding from forehead), EPISTAXIS (bleeding from nose), FACIAL BONES FRACTURE (nose is fractured), FALL (fell down from chair on the face down towards floor) and MALAISE (not feeling well) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not reported. Treatment includes IV; Sender'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.
I developed a rash on the outer left corner side of my mouth. Then I developed a sore right above the left outer side of my lip and also a rash on the outer right side of my mouth. The rash on the left corner of my mouth disappeared after about 2 weeks. I first thought it was a cold sore because it had blisters so I treated it with OTC Docosanol and  2 rounds of  Famciclovir.  That did help and the blisters have resolved but I still today have the sore. It dries up and skin flakes off and it's still pinkish in color. The rash in the corner of my mouth never developed blisters but it dries up.
No additional AE reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a physician and refers to a 4-year-old patient. Information regarding the patient's concurrent conditions, medical history and historical drugs was not provided.  Concomitant vaccinations included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) which did not experienced a temperature excursion.  On 27-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # U007471 and expiration date 08-MAR-2023 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 28.56 degree fahrenheit (°F) for 44 hours and 5 minutes on an unspecified date; no previous temperature excursions were reported.  No adverse symptoms were reported.
102 Fever, no appetite, vomiting, Diarrhea, chills, body aches.
really horrible pain in her right leg primarily hip and knee; really horrible pain in her right leg primarily hip and knee; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really horrible pain in her right leg primarily hip and knee) and ARTHRALGIA (really horrible pain in her right leg primarily hip and knee) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (really horrible pain in her right leg primarily hip and knee) and ARTHRALGIA (really horrible pain in her right leg primarily hip and knee). The patient was treated with PARACETAMOL (TYLENOL) for Pain in extremity, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (really horrible pain in her right leg primarily hip and knee) and ARTHRALGIA (really horrible pain in her right leg primarily hip and knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-075531 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075531:case for second dose
missed the third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first two doses on an unknown date in 2018).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, the patient missed the third dose of Twinrix. Till the time of reporting, the patient did not receive the third dose, which led to incomplete course of vaccination.  The reporter consented to follow up.
Jynneos was administered intramuscularly instead of subcutaneous; Case reference number US-BN-2022-001792 is a spontaneous case report initially received on 05-Aug-2022 from a health care professional via Communication and concerns one patient of unknown age.  The patients' relevant medical history and concomitant medications were not reported.  On 05-Aug-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) administered subcutaneously (explicitly coded as 'Inappropriate route of vaccination') at an unreported dose, or anatomical site for unknown indication.   At the time of this report, no further information was provided.   Additional information received on 08-Aug-2022 included local BN case ID.; Reporter's Comments: A patient of unknown age was vaccinated with Jynneos vaccine, administered subcutaneously which is considered as inappropriate route of vaccination, at an unreported dose, or anatomical site for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, no further information was provided. The patients' relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age was vaccinated with Jynneos vaccine, administered subcutaneously which is considered as inappropriate route of vaccination, at an unreported dose, or anatomical site for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, no further information was provided. The patients' relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
Approx 7 hours   (3pm) after vaccination dose 2 right upper arm began to hurt likened to feeling bruised.  Took  1 Aleve Around 6pm began to feel out of sorts and unwell.  Began to feel chilled and went to bed at 9pm.  12:30am woke with high fever. 102.4. Took 1 Aleve 1:30am  fever refused to 101.9  7:30 fever 100,  9am fever 99.9 Presently temperature 98.9 and feeling fatigue.
Patient developed palpitations, racing heart, and shortness of breath 4 hours after receiving Shingrix vaccine. Symptoms persisted and she presented to office for evaluation.
About 24 hours after the vaccine, I began to develop the following symptoms which seemed to reach their peak  by 9pm that evening. I had a 103 fever, severe fatigue, body aches (mostly in the lower body/ in the legs and aching joints) and chills (I could not get warm).  I was unable to function and perform my daily activities of living due to these symptoms. When I reached the 48 hour mark of receiving the vaccine, all the symptoms had subsided except for the fatigue.  These were the exact symptoms I experienced when I tested positive for COVID on December 10, 2020. Except I also had severe nausea for about 10 days and gastrointestinal distress when I had the virus.  FYI: I got my flu shot in November 2020.
Patient states that she had arm soreness and rash that radiated down her arm and continues to spread past her elbow. Also, stated she experienced warmth at the inject site. It was so hot that she had to site down the site of injection.