chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unconsolable immediately after immunization, and she has not been like this with routine immunizations, rash around mouth noticed at 4:15PM, fussy naptime, 5:45 PM mom called local Dr., recommended to be taken to Urgent Care. Had rash all over torso at this time (pea sized) was given 1/2 tsp Benadryl. Had 2 1/2 tsp doses on Fri as rash returned. Has been OK since. Drs thinking it might be egg allergy. Mom was encouraged not to get second dose of H1N1.
Tinuutis both ears, 24 hours after first shot Spikes came 2-3 days after both shots, lasted about 5-10 seconds
606 doses were given after expiration date; Vaccine expired on 13 Oct 2021 and placed in refrigerator on 04 Nov 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 04 Nov 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 04 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 04 Nov 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vaccine placed in refrigerator on 04 Nov 2021. Vial did not undergone temperature excursion. No any adverse event reported.  Treatment medications were not reported.
stiffness; bruising at the site of injection size of a quarter; beyond the 35 days recommended interval; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the 35 days recommended interval) and VACCINATION SITE BRUISING (bruising at the site of injection size of a quarter) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the 35 days recommended interval). On 03-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness) and VACCINATION SITE BRUISING (bruising at the site of injection size of a quarter). On 03-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the 35 days recommended interval) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness) and VACCINATION SITE BRUISING (bruising at the site of injection size of a quarter) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
sore throat and L ear pain about 22 hours after vaccination; sore throat and L ear pain about 22 hours after vaccination; This is a spontaneous report from a contactable pharmacist.   A 48-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# eL1284), intramuscular from 22Dec2020 15:45 to 22Dec2020 15:45, single for COVID-19 immunisation. Medical history was none.  The patient's concomitant medications were not reported. Vaccine location was left arm. No other vaccine was received in four weeks.  The patient experienced sore throat and left ear pain about 22 hours after vaccination on 23Dec2020 13:30. No treatment was administered. The action taken in response to the events for bnt162b2 was not applicable. The events outcome was unknown.
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-MODERNATX-MOC20230208000141 (Moderna).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID". Clinical information: Reporter states that they all had COVID in May2022 as well. Him and his wife have received the Pfizer COVID-19 vaccine so far but his son has received the Moderna COVID-19 vaccine with his most recent booster shot in Feb2022. Reporter that this was his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300062512 same reporter/product/event, different patient;
shingles; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3248), via an unspecified route of administration, by injection once to the left deltoid on 21Jan2021 at the age of 89-years-old as single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced shingles on 07Feb2021. The patient reported that she had the first dose of the PFIZER-BIONTECH COVID-19 VACCINE last 21Jan2021 and she had shingles. The doctor advised that she could have the 2nd dose on 22Feb2021 instead of 11Feb2021, which was 3 weeks later after the 1st dose. The patient wanted to know if she will take her doctor's advice to have the 2nd dose later than 3 weeks since she was now getting better. The patient wanted to know how long after the shingles go away can she get the second vaccine. The patient reported that she had shingles after having 4 shingles vaccine shots. The first was when it first came out, the second she thinks has been about 1.5 years ago. She would have to check records on that. She hasn't been out of the country. The patient reported that she thinks her shingles was better. She was on an antiviral drug valaciclovir (VALTREX). When reading the vaccine paperwork, the patient stated she has a hard time reading. The shingles was on her face and her eye was affected. Having had all the vaccines, this took her by surprise. There was no investigation assessment. The outcome of the event was recovering.
All started with nasal congestion, and headaches about 36 hours after vaccine administration.  After had to be absent to work for three days because had the above mentioned symptoms and tiredness, joint ache, and irritability.  I took tylenol every 6-8 hours and stayed in bed resting.  Took three days to completely recover.
Soreness and swelling at injection site; Soreness and swelling at injection site; Red spot at exact injection site; Soreness in lymph nodes at arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 15:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 23:00 the patient experienced soreness and swelling at injection site (7 days after the first injection), red spot at exact injection site and soreness in lymph nodes at arm pit. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events soreness and swelling at injection site, red spot at exact injection site and soreness in lymph nodes at arm pit were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, Arthralgia, NauseaVomiting,  chills, diaphoresis
No additional AEs were reported; Patient received PROQUAD after the expiry; This spontaneous report as received from a physician referring to a patient of unknown age and gender. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On 22-FEB-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), one dosage form (expiration date: 20-FEB-2022, lot, route of administration, anatomical location were not reported) for prophylaxis after the expiry (expired product administered). No additional Adverse event reported. No Product quality complaint. No Additional information provided.
palpable purpura both lower legs;hematuria-microscopic;arthralgia-pain around ankle;henoch scholein purpura;
Fully vaccinated not boosted.  COVID infection breakthrough with inpatient hospital stay, medical unit.
Muscle ache in my arms; This is a spontaneous report received from a contactable consumer (patient) reported for herself. This is the second of two report. A 81-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 81-years-old, via an unspecified route of administration, administered in upper left arm on 16Mar2021 (Lot Number: CN6205) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. patient received first dose of bnt162b2 (lot number: EL9267) at the age of 80-years-old on 15Feb2021 for covid-19 immunisation. Patient got the second shot and about 10 days later and started having a muscle ache in arms and neither one is gone away yet. Patient was just rubbing some Benadryl on arms because, because it hurts she was thinking about going to doctor make an appointment with the doctor and yet I was hoping it'd go away but so far not. Event outcome was not recovered.  No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427428 Same patient, different dose and event.
Local, redness and swelling @ injection site post Anthrax 1,2,3,4. Myalgia X 4 days post Anthrax #4, Flu-like symptoms post #4 anthrax lasting 4 days.
Having inflammation in her lungs; difficulty breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient in her 70's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "metastatic breast cancer" (unspecified if ongoing), notes: 70's and has metastatic breast cancer that is in her lungs along with  other places. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), for COVID-19 immunization; Bnt162b2 (Dose 02), for COVID-19 immunization. The following information was reported: PNEUMONITIS (non-serious), outcome "unknown", described as "Having inflammation in her lungs"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a registered nurse concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a 0.5ml dose of PROQUAD (Merck) subcutaneously (lot # K009891, expiration date: 11-JAN-2016), which was post supported excursion. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was find during 30-minute post dose observation but upon getting home he was experiencing difficulty breathing, lips were blue, chills, pains in lower back and fever.  Patient called EMT and was taking to Hospital and treated then released same day.
Received shot on Friday with typical expected sore arm over the weekend. However,  while making dinner on Tuesday, I started feeling pain in my left hip. This pain continued to increase up until I sat down for dinner when I had a shooting pain so sharp I let out an audible yelp.  I have seen my PCM and a Physical Therapist.  They have stated swelling in the area and ordered an x-ray.  As of 4 days since onset of pain, I still have trouble walking due to pain with regular usage of naproxen.
24 later, patient had all over muscle aches, mildly sweaty/felt warm, bitter taste in mouth, loose stools x 2 days.
Seven days post vax, child seemed constantly inconsolable from 6:00 AM to 5:00 PM. It was different than a cry, no tears. Then he sleep for 2 hours. He re-started screaming from 9:00 to 10:00 PM. Then I gave him chamomile homeopathic and he slept ok. Woke up at 6:00 AM, screaming again for 15 minutes and resolved.
Vertigo, nausea and lightheadedness began on 9/12/2021 (continued for about two weeks).
Mother described over phone a red splotchy rash with raised area and central clearing occurred a few hours after MMR and Varivax and Hepatitis administered. Rash disappeared immediately after one dose of Benadryl
This patient developed hives after receiving the Flu vaccine after about 4 hours. There was no respiratory distress, nothing else new or different in her life. This was her first flu shot.
extreme increases in urine; This spontaneous case was reported by a consumer and describes the occurrence of POLYURIA (extreme increases in urine) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 203e23a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 23-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced POLYURIA (extreme increases in urine). At the time of the report, POLYURIA (extreme increases in urine) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741761:Same reporter, same product, different patient (spouse)
Lesion on back, swollen for 2 and a half months, chills everyday up to now, extreme rash, itching, difficulty breathing, vomiting, diarrhea.
This spontaneous report was received from a nurse practitioner regarding 2 unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L013827, expiration date- 21-APR-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Time was 1 hour, temperature 34.7F and there was no previous excursion. This is one of several reports received from the same reporter. Additional information has been requested.
First Pfizer shot was on  4/6/2021 and the follow up shot was on 5/4/2021. My period after my first shot started on April 21st as anticipated (I am very regular with light periods). This period was unusual - on the second day I experienced the worst cramps I have experienced since labor, I had to pull over my car on my way to work while I experienced close 8 back to back severe cramps in 5 minute period. It was like labor. Also had clots the size of quarters which I have never seen before .  The second and third day was extremely heavy and then the bleeding stopped. I am now on my first period after the second vaccine and I am once again experiencing heavier than usual bleeding on the second day with massive clots.
This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
sore arm and stuff like that; my heart rate was elevated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 2), for COVID-19 immunization; Bnt162b2 (DOSE:1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "sore arm and stuff like that"; HEART RATE INCREASED (non-serious) with onset Dec2021, outcome "unknown", described as "my heart rate was elevated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got booster shot yesterday, third shot of Pfizer booster and got the sore arm and stuff like that. Patient blood pressure was fine but heart rate was elevated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cold, very thirsty, shortness of breath, severe muscle pain, headache, nausea.
Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days; administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  It was mentioned in the report that the vaccines to be stored with 1 to 3 bottles in the fridge to thawout and to be ready for the patients when needed and at worst scenarios vaccines would have been in the fridge for about a week if no one came in to be vaccinated.  Treatment details were not reported by the reporter.
on April 11, 2021 my arm begin to itch and swell at the site where I received the vaccine. It looks like a shingle.  I put cortizone on it and doubled up on valtrex. It seems to be going away.
abdominal  (sharp and cramping) pain, nausea, vomiting.  Patient Is treated with morphine, ondansetron and IV fluids.
Aside from usual soreness of the site, near constant muscle twitches in nose and/or right thigh that were never present before. Just a minor thing that I figured was worth reporting due to it not being a listed side effect.
It was injected in her left arm in the muscle. It hurt.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 (Batch/Lot number: unknown, Expiration Date: 31May2021) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Jan2021, outcome "unknown", described as "It was injected in her left arm in the muscle. It hurt."  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021679424 same patient, different dose/AE
5 year old female had received a left arm injection of Daptacel, site not reported on 08/22/2005.  The following day she experienced left arm swelling in the length of the arm with tenderness and redness.  It was not reported whether the reaction occurred at the site of the Daptacel or Ipol vaccination.  She received corrective treatment with Benadryl and Tylenol.  The patient had not recovered from these events at the time of this report.
BODY ACHE; CHILLS; FEVER; EXHAUSTION; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced body ache. On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced exhaustion. On 2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 100 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, exhaustion, body ache, severe headache and chills was not reported. This report was non-serious. This case, from the same reporter is linked to
Spreading redness, and swelling in left upper arm, fever. Dr. has diagnosed cellulitis.