chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm that she got the injection in, the left arm, the lymph node swelled/lymph node under her arm in her armpit was swollen; arm was hurting; chills; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8727, Expiration Date: 31Jul2021) at single dose in left arm on 01Apr2021 for COVID-19 immunization. The first dose was on 11Mar2021 (Batch/lot number: EN6206, Expiration Date: 30Jun2021) in left arm. Ongoing medical history included high blood pressure and high cholesterol. Ongoing concomitant medications included blood pressure medication; cholesterol medication; amoxicillin (tablet) from 24Mar2021 for tooth and the filling was painful, 21 tablets were prescribed. She did go to the dentist to have a filling in a tooth and the filling was painful and the doctor prescribed amoxicillin 875mg take one tablet two times daily. She started taking that around the 24Mar2021 she thought. It was 21 tablets. Prior vaccinations (within 4 weeks) was no. Patient experienced chills on 01Apr2021; arm that she got the injection in, the left arm, the lymph node swelled and arm was hurting on 02Apr2021. Patient reported she's been taking her blood pressure and cholesterol medication a long time. She didn't feel they were relevant. The adverse events did not require a visit to emergency room and physician office. Patient got her first vaccine and she didn't have any problems. She got the second Covid 19 vaccine and she had chills and in the arm that she got the injection in, the left arm, the lymph node swelled. Patient clarified that her lymph node under her arm in her armpit was swollen. Her arm started hurting on Friday, 02Apr2021 but she didn't pay attention. She thought it was just where the needle had gone into her skin. It was still hurting underneath her arm and as she went to take a shower she saw that the area under her arm was more even across instead of a dip. Meaning a dip like she had in her armpit. She reported the swelling had gone down some but right now it's staying about the same. The outcome of event chills was recovered on 02Apr2021. The outcome of rest events was not recovered.  No follow-up attempts are needed. No further information is expected.
Appears to be covid arm reaction. Appeared 7 days after vaccine.  First got a headache and fatigue. Woke up with red raised bump at injection site which grew over next few days. Went to doctor on 2/19/2021 and was told to put topical Benadryl on it. It slowly began to improve.
Atrial Fibrillation occurred numerous times that evening of the shot and on other occasions since then.  I have never had this condition prior to the vaccine.
31MAY95 knot in lt arm in area where inject w/MMR; 4AUG95 mom states she can still feel the knot pt does not seem to be distressed; 14AUG95 mom states small knot still there MD said;
I tested positive for COVID-19 and was sick for a week. I had tiredness, fever, sweats, chills, diarrhea and brain fog. I had fatigue for several weeks after.  I had some brain fog for a couple of months. I lost my sense of taste and smell entirely for 1 week. It slowly returned over the course of 4 months. Some fruits still have a sickly/sweet taste now.
Lost vision completely for 20 minutes diaphoretic hypotension  left pupil 4 x larger than right not responsive to light  short of breath
No additional adverse effects reported.; The patient was administered the second dose of GARDASIL 9 on 6/17/2020 at 15 years of age; This spontaneous report was received from a nurse referring to a 15 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided.      On an unspecified date in 2015 (when the patient was 10-11 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 17-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R003557, expiration date 20-NOV-2020; dose detail, strength and route were not provided) (inappropriate schedule of product administration). No additional adverse effects were reported.
Urticaria within 2-3 hrs of shot. Given Benadryl Elixir and resolved within 1-2 hrs.
Employee had migraines not relieved by IMITREX after vaccination. No additional treatment was needed.
Arm became red, swollen, warm and hard. This lasted approximately 7 days. Arm is still somewhat red, warm but has been improving 2 weeks after vaccination. Also had mild chills, body aches, temperature of 99 degrees F at night for 2 days following vaccine administration.
I was having trouble breathing/she had to use her inhaler more than once; Felt nauseous in the morning; I felt fuzzy; My heart began beating rapidly (not normal for me); This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: en6208), via an unspecified route of administration, administered in left arm on 15Mar2021 16:30 (age at vaccination was 63 years) as dose 1, single for covid-19 immunization at Public Health Clinic/facility. Medical history included asthma, osteoporosis, sciatica. Patient Allergies to medications, food, or other products included Penicillin, Prozac, Darvon, Erythomycin, Codeine, Percoset, Bactrin Sulphur drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported and Clonazapin taken for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 16:45, after receiving vaccine patient stayed for 30 minutes since had a history of allergic reactions, she was fine and felt nauseous in the morning and as she worked through the day, she had to use her inhaler more than once. She had Asthma and felt fuzzy and decided to close her store early. Before leaving at 5 PM, her heart began beating rapidly (not normal for me), when she finally got into her car, she had trouble breathing. she always kept and EPI pen in her car and her bag. she injected into her thigh and within minutes, she could breathe again, and the pounding stopped. The EPI saved her life. Therapeutic measures were taken as a result of Asthma and trouble breathing and Patient received treatment for the events included inhaler more than once, while Treatment received was reported as no for all other events.  The events were recovered on unspecified date in Mar2021.
Death Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient found decreased at home on 3/3/21. No apparent cause of death. Telephone appt on 2/10/21 was unremarkable other than patient having mild shortness of breath and chest discomfort. Comorbidities include COPD, HTN, HLD, and age of 74.
Pt vaccinated with DTP/OPV had unusual prolonged crying, also had colic first 3 months of life.
PRETTY BAD SHAPE; This spontaneous report received from a patient via a company representative concerned  9 decades of unspecified sex. 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced pretty bad shape. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pretty bad shape was not reported. This report was non-serious.
My mouth was very irritated. Gums were red. Entire mouth felt like I had burnt it with Hot coffee. Under my tongue was red and hurt. Very uncomfortable. It started the day after the shot and went away when the rash on my arm went away.
Pt's left eyelid filled with fluid, skin highly irritated and red. Swelling lasting for 3 days so far.
Injection site red, tender, and swollen. Temp was 100.4 even with over the counter medications. Provider sent in KEFLEX 500 mg BID x7 days.
Universal hair loss: scalp, eyelashes, eye brows, pubic hair; Universal hair loss: scalp, eyelashes, eye brows, pubic hair; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686A) at the age of 51 years-old via unspecified route of administration on 08Jan2021 in left arm at single dose for COVID-19 immunization in the hospital. Medical history included GERD (Gastroesophageal reflux disease). The patient had no allergies to medications, food, or other products. Concomitant medication included VITAMIN D NOS. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) at the age of 51 years-old via unspecified route of administration on 20Dec2020 at 01:00 PM in left arm for COVID-19 immunization. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 15Jan2021 patient experienced universal hair loss: scalp, eyelashes, eyebrows, pubic hair. No treatment received for the adverse events. Since the vaccination, the patient has been tested for COVID-19. Post vaccination patient underwent labs and procedure on 19Jan2021 included PCR (Polymerase chain reaction): negative, Nasal swab: negative. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
muscle fatigue; pain; skin feels tight over the injection site; she could not lift her arm without severe pain; This is a spontaneous report from a contactable Consumer reported for herself.  A 33-year-olfd female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on unknown date. Relevant medical history and concomitant medications were not reported. On unknown date the patient stated the shot felt like a flu shot at first then at bedtime the muscle fatigue increased and her pain was a 7 out of 10. After taking Tylenol, her pain was a 5-6 out of 10. No rash or redness but the skin feels tight over the injection site. Caller complains of severe soreness. When she woke up, she could not lift her arm without severe pain. The outcome of the events was reported as unknown.   Lot/Batch number has been requested.
Shaking from chills and fever, extreme thirst followed by vomiting, moderate headache, body ache, kidney area pain. Fatigue following. Missed work the following day.
A non-serious spontaneous case was received from a consumer involving flu, sore throat, high fever, lethargy, and loss of appetite concerning a six-year-old male.  No relevant medical or drug history information was reported.  The patient received FluMist on 06-Nov-2007.  The patient woke up on the following day with influenza, sore throat, high fever, lethargy, and loss of appetite.  No outcome for the events was provided by the reporter.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Pt reports swelling and pain in left armpit and down into rib area. Visit to PMD at 05/25/2004 area of swelling enlarging down into abdomen and groin area. MD feels exaggerated reaction to Td. Tx: with ice and Motrin. Phone call to school nurse who reported incident to check condition. Swelling gone (it actually went down to his thigh) but area still tender to touch. Has seen MD 3 times over last several days.
Pt states area red, hot to touch, et has a rash all at the injection site. Pt states had flu like symptoms on Tuesday. Ice 20 min/1-2 hours, MOTRIN 800mg TID with food until seen, cancel appt if resolves.
4 year old boy had classic febrile seizure consisting of one minute of shuddering  and unresponsiveness followed by 15 minutes being subdued (per mother, it was midnight) which occurred 30 minutes after she called about a high fever (Tmax 105 degrees per mom) and child complained of headache,  and administered 5 mL = 100 mg ibuprofen on my instructions. Child's weight is 14.8 kg (very small four year old). Spoke to mom in follow up the next morning, child did well the rest of the night. Complained once of headache after he woke up (this is not a normal complaint for him), Temp was 99 degrees F with no further antipyretic. Completely back to baseline at 10 AM on 11/10.
eye pain; eye pain and swelling/eye is swollen; chills; headache; This is a spontaneous report from a contactable pharmacist via a Pfizer-sponsored program Pfizer. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given COVID vaccine today and was experiencing a side effect that caller believed has not seen documented, the patient was experiencing eye pain and swelling on 13Jan2021. The eye pain started 6 hours after receiving the vaccine. The patient got a headache, chills, and eye pain on 13Jan2021. On 14Jan2021, the chills subsided, the headache was minor, eye pain was the same, and today on unspecified date, the patient has no more chills and no more headache, but still has eye pain and now her eye is swollen. The eye swelling is now hurts to blink. The first dose was 21 days from Wednesday on unspecified date. The patient was not given vaccination cards, the only thing she was given was information. The caller has hasn't seen vaccines cause eye problems. The causality for chills and headache was unknown. The outcome of the events chills and headache was recovered on unspecified date. The outcome of the remaining events was not recovered.  Information requested on Lot/ Batch number of suspect product.
For 48 hours starting 2/9/21 I was extremely exhausted, body aches and headache. I did return to work on 2/11/21.
BROKE HER FEMUR; FAINTED; This spontaneous report received from a consumer via a company representative concerned a female patient of an unspecified age, race and ethnicity. 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 administration not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient got vaccine and she fainted because of it and broke her femur. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted and broke her femur was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211115201.; Sender's Comments: V0: 20211114927-covid-19 vaccine ad26.cov2.s-broke her femur,  fainted. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I had server chest pain.  Slight SOB called 911 because of previous heart attack.  They took me to the hospital.  They did blood test, Chest x-ray, CT scan, Covid-19 (nasal and blood) and MRI.  Covid-19 test came back negative. They told me it was not a heart attack.  They said it might have been anxiety or tissue got stuck under rib. They did keep me overnight for observation.
Information has been received from a 20 year old female, for the Pregnancy Registry for GARDASIL, who was vaccinated with her third dose of GARDASIL.  Shortly after the vaccination, the patient became pregnant.  The patient saw the physician.  Pregnancy test was performed.  Follow up information has been received from the consumer who stated that in approximately November 2008, she was vaccinated with her third dose of GARDASIL (lot# not reported).  She said that the only problem she had with her pregnancy was that she started "dilating early- after 5 months in her pregnancy".  She was put on bed rest at home and carried the pregnancy to term.  She had a vaginal delivery of a healthy normal girl, two weeks before her due date.  The consumer's condition was considered to be disabling.  Additional information is not expected.
Patient stated that she had a fever that began about 2 hours post vaccination, and resolved about 12 hours later
gave patient a dose from an expired vial; gave patient their 3rd vaccine dose; Extra dose adminstered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial), OFF LABEL USE (gave patient their 3rd vaccine dose) and EXTRA DOSE ADMINISTERED (Extra dose adminstered) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder (Kidney issues.).    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial), OFF LABEL USE (gave patient their 3rd vaccine dose) and EXTRA DOSE ADMINISTERED (Extra dose adminstered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial), OFF LABEL USE (gave patient their 3rd vaccine dose) and EXTRA DOSE ADMINISTERED (Extra dose adminstered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Vomiting; she is miserable; Cold chills; Allergic reaction; patient had second dose of the Pfizer Covid-19 vaccine but having a bad reaction reaction to it like there is, her wife had allergy with metal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Metal allergy" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. Vaccination history included: Bnt162b2 (Dose Number: 01), for Covid-19 Immunization.The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomiting"; FEELING ABNORMAL (noserious), outcome "unknown", described as "she is miserable"; CHILLS (non-serious), outcome "unknown", described as "Cold chills"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction"; UNEVALUABLE EVENT (non-serious), outcome "unknown", described as "second dose of the Pfizer Covid-19 vaccine but having a bad reaction to it like there is, her wife had allergy with metal (further not clarified) and then he put metal on the injection site it sticks in to it aside".  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Mother calls to report child with 4/28/07 onset of flushed (red/ hot/ face/ neck, facial eye swelling ("like when you get up in the morning with eyes narrowed secondary to swelling). No fever (T= 97.6), gagged/emesis with H2O today only. No respiratory/breathing problems, decrease appetite (sl), sl decrease activity level. Has appointment to see PCP (Doctor got pet turtle4/18/07 today).
expired on 11/9/21 given on 11/10/21 Moderna provided lot assessment that validated effectiveness
This spontaneous report as received from a physician refers to a female patient of unknown age. On 25-MAY-2013 the patient was vaccinated with GARDASIL 0.5 ml, intramuscular. The patient did not receive her second dose until 07-JUN-2014, and third dose on 19-AUG-2014 (inappropriate dosing schedule). The physician reported that the patient did not experience an adverse event. Additional information has been requested.
Felt like he drank a lot of coffee and was all hyped up; can't stay asleep/Could not sleep for more than 2-3 hours /couldn't sleep well; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Felt like he drank a lot of coffee and was all hyped up), POOR QUALITY SLEEP (can't stay asleep/Could not sleep for more than 2-3 hours /couldn't sleep well) and HEADACHE (slight headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PSYCHOMOTOR HYPERACTIVITY (Felt like he drank a lot of coffee and was all hyped up), POOR QUALITY SLEEP (can't stay asleep/Could not sleep for more than 2-3 hours /couldn't sleep well) and HEADACHE (slight headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PSYCHOMOTOR HYPERACTIVITY (Felt like he drank a lot of coffee and was all hyped up), POOR QUALITY SLEEP (can't stay asleep/Could not sleep for more than 2-3 hours /couldn't sleep well) and HEADACHE (slight headache) outcome was unknown.            No relevant concomitant medication was reported.   This case was linked to MOD21-044585 (Patient Link).
Information has been received from a physician concerning a 12 year old female who was vaccinated with Gardasil. Concomitant therapy included DPT and Menactra. Subsequently the patient experienced dizziness and a lightheaded woozy feeling after receiving therapy with Gardasil. Subsequently, the patient recovered from dizziness and lightheaded woozy feeling. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial information has been received from a physician and a licensed practical nurse concerning a 11 year old female who on 16-MAY-2007 was vaccinated with a first dose of GARDASIL (lot # 655620/0171U). On 16-MAY-2007, concomitant therapy included IM dose of DTP, IM dose of MENACTRA and IM dose of hepatitis A virus vaccine (manufacturer unknown). On 16-MAY-2007, experienced dizziness lasting about 15 minutes. On 16-MAY-2007, the patient recovered from dizziness and the lightheaded woozy feeling. Additional information is not expected.
Fatigue-slept Wed night thru Sun night on and off. Sore throat- 6 days. Nausea, night sweats, muscle aches, extreme soreness at injection site- some redness. Runny nose and stuffiness x2 weeks with sinus pressure muscle aches have not subsided-even with mag ox as secondary of other symptoms dx URI.