chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore shot arms; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore shot arms), PAIN (achy) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore shot arms), PAIN (achy) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (Sore shot arms), PAIN (achy) and FATIGUE (tired) outcome was unknown.            No Treatment medications was available. No concomitant medications was available.
Information has been received from a woman concerning a her 7 year old son with no past medical history and no allergies who in 1996 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 02/14/2002 it was reported that recently in 2001 the pt "had caught the virus from a classmate." It was noted that the pt did not develop a fever but had about 100 lesions. The pt sought unspecified medical attention. Additional info has been requested.
I have developed a red rash around the injection site around 12 days after getting the shot.  It is an red oval patch that is 4? x 3?.  The site is warm to the touch and very itchy.
Cold sore; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (Cold sore). At the time of the report, ORAL HERPES (Cold sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included eye drops for glaucoma and blood pressure medication Treatment information was unknown.
6X8 cm area with redness - 3X3 center with light purple area, no tenderness or warmth. No treatment just observe.
Large swelling in armpit of the arm given the Moderna booster.  Much larger than I would expect after a vaccine.  About the size of my fist but was soft.  I could not detect hard lumps anywhere.   Internal burning sensation though.   Noticed it next morning after shot.    Still large after two days but burning sensation is subsiding.
pt recv 1st dose; 5 mins later, exp "choking episode" & found  it diff to swallow;
a patient received a Flu shot from an extended shipment of Fluzone Quadrivalent, no adverse event; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff).  This case is linked to cases 2019SA271944, 2019SA278134, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278140, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received a dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On 27-Oct-2019, patient received a dose from a multi-dose vial of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC), exp date: 30J-un-2020, (no dosing details, route and site of administration were reported).  It was of actual medication error case due to product storage error.  It was reported that a patient received a Flu shot from an extended shipment of Fluzone Quadrivalent.  At the time of report no adverse event was reported.  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 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.
12 year old received 0.2ml of Pediatric Pfizer formula. Inappropriate dosing for age. No adverse events or treatment noted.
1st and 2nd Pfizer COVID vaccine given instead of the the PFizer  BIValent Booster
Evening of vaccination, developed 2-3 cm area of burning, stinging vesicular rash, weeping. Left shoulder hurt, still hurts and rash persists.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 09-APR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to her mother of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. Approximately in December 2000 (reported as: "16 years ago"), the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dose number, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date the patient experienced pneumonia. Therefore on an unspecified date in November 2015, the patient was admitted to an unknown hospital. On an unknown date in 2015 (reported as: "9 days later") the patient recovered and was discharged from the hospital. Upon internal review, the event pneumonia was considered to be a medically significant event. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005477: US-009507513-1612USA005475: US-009507513-1612USA005476: US-009507513-1612USA005473: US-009507513-1612USA005474.
Very obese patient with large 6 in red, swollen, warm to touch, circular in appearance, tender and painful to touch. Spoke with Dr. patient to use cold compressed 10-15 min @ least 3-5 times a day and prescribed-Benadryl every 6-8 hr. After 24-36 hr call if no improvement or worsening of symptoms. Reaction is to Varicella
Narrative:  COVID infection following COVID vaccine series 06/01 Janssen, dose #1 12/27 SARS-COV-2 Variant Sequencing: pending 12/27 COVID swab, result: detected 12/24 pt cc: chills, cough, fatigue, fever, headache, myalgias, rhinorrhea, sore throat exposure: unknown 12/27 pt admit ED cc: LOW BACK PAIN / HEADACHE dx: CPVOD-19 infection LOS:  1 day
Developed papular rash under chin, initially under chin and now several more to face, mouth, hands  with mild excoriation and itching. Multiple sores to soft palate, hard palate, and tip of tongue (appearing like canker sores). Pustule to tip of left index finger.
Pt. states that after receiving the 1st dose Shingrix 07/29/2021, started experiencing symptoms 08/19/2021 developing rash along back side and under side. Primary visit 09/01/2021, Diagnosed with Shingles. Still experiencing symptoms.
redness and swelling at injection site; redness and swelling at injection site; This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, Solution for injection in pre-filled syringe) via an unspecified route of administration, in the arm, at single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced redness and swelling at injection site. It was reported that redness and swelling covered the entire upper portion of her arm. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020341566 same reporter/ drug/ event for different patients.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The unspecified patients were administered RECOMBIVAX HB (lot# L016427, expiration date 13-APR-2017; lot# L004754, expiration date 10-NOV-2016) (dose and frequency not reported), which were exposed to temperatures outside of the recommended range since 05-NOV-2015. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with first dose of GARDASIL (dose, route and lot number not reported). 4 weeks after receiving the first dose of GARDASIL, the patient developed headache, pain and tingling at the injection site. It was not specified if the patient sought medical attention. Additional information has been requested.
No additional AE information provided; VAQTA LOT T036739 that expired on 4/22/2022 was administered to a 22 year-old female patient today; This spontaneous report was received from a nurse prescriber and refers to a 22-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 26-APR-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1 ml, 50 units, lot # T036739 (route of administration was not provided) for prophylaxis, which expired on 22-APR-2022 (expired product administered). There was no temperature excursion. No additional adverse event information provided.  Lot number T036739 was assessed to be valid for V251 formulation vial.
Mother reports upset stomach and a general feeling of "not feeling well" for four days after vaccination. Mother states child was afebile, but blood pressure was 171/93 and pulse was 141 on 05/26/2008. Vital signs were taken by family RN when child complained of not being "feeling good". Site of vaccination has "red, hard, hot area the size of an egg". Parent advised to follow-up with family physician.
After receiving the Pfizer-BioNTech Covid-19 Vaccine EUA at 5:30 p.m on May 5th. I had injection site pain immediately.  Around 9 p.m. I began to feel pins and needles in my left arm extending down from injection site to fingers, tiredness, and headache.   The pins and needles feeling in my left hand makes it impossible to type, and I had to call in sick to work on May 6th.  Since waking on May 6th, I've also experienced muscle pain, chills, joint pain, a fever of 99.9 to 100.1 degrees F, and nausea.
This spontaneous report was received from a 90 year old female patient reporting on herself. The patient's concurrent conditions were not provided, the patient's medical history included allergy to morphine and penicillin. The patient stated that she was part of a study in 2004 for shingles prevention. In 2004, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (strength, dose, lot number and expiration date were not provided). Concomitant therapies included CARAFATE. The patient stated that in December 2014 she was diagnosed with shingles, which was followed by a severe postherpetic neuralgia. The patient described the sensation as 'stabbing pain' shooting through her skin. In June 2015, the patient was hospitalized for four days for severe dehydration and was unable to swallow. The patient stated that the "nerve endings in her tongue and throat" made it almost impossible for her to swallow (glossopharyngeal nerve disorder). The patient received a pain management. There was no PQC involved. The outcome of herpes zoster, vaccination failure, dehydration, pain of skin, postherpetic neuralgia, glossopharyngeal nerve disorder and dysphagia was reported as not recovered. Additional information has been requested.
Hospitalization following COVID-19 vaccination. Admitted to the hospital on 12/8/2021 with chief complaint of SOA, fever, HA since yesterday. O2 74% on 2L in triage. Wears 2L at baseline. 93% on 6L in triage.
Large itchy lump under the shin on left shoulder where the vaccine was administered. Also was flu like sick, weak, pukey, sweaty, chilled,  for days after receiving vaccine. Am now, 11 days later feeling a little better.
A physician reported that a 24 month old male received his 1st dose of Prevnar in 7/01 and 2 or 3 hours, post vax, experienced hives. His hives improved; however, the pt continued to experience generalized body hives and angioedema of the face, lips and eyes. His hives persisted for 2 months. As of the date of this report, no further information was available. Angioneurotic edema is considered "Medically Important. Follow up info received 2/11/02 indicated that at the time of this event, the pt had a complete blood count with differential, ANA, ESR and immunoglobulin testing and all results were normal. The pt's symptoms subsided 2 months later.
This spontaneous report was received from Registered Nurse, referring to a 19 year old male patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 17-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose and administration route were not reported) lot number N007931 and expiration date on 17-NOV-2019, for prophylaxis. On 17-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose and administration route were not reported) lot number N015087 and expiration date on 20-OCT-2019, for prophylaxis. No adverse effects were reported.
Chest tightness/pain, colchicine 1.2mg bid x 1 days, colchicine 0.6mg bid x 29 days
3/13/19 - Seen in office with complaint of  arm pain, weakness, difficulty with lifting, difficulty with pulling and pushing, redness and swelling.  Per MD, small patches of redness approximately the size of a quarter, warm, red and mildly tender. Doctor recommended - Ice, Benadryl and Motrin. 3/15/19 - Seen in office for complaint of redness, burning sensation in left arm and neck. Per MD, there were red round patches approximately quarter sized on right shoulder, chest and back. Suspect allergic reaction to vaccine, prescription given for Prednisone 5mg oral tablets, taper for 6 days.
Red, swollen area at site of injection, migraine, panic attack. 4-5 days after.
Red, swollen right arm. No pain or discomfort - just red, warm and swollen.
POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious.
Anaphylactic reaction to the shot; Lips swelled up double in size; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylactic reaction to the shot"; LIP SWELLING (medically significant), outcome "unknown", described as "Lips swelled up double in size". Clinical course: His lips swelled up double in size and they happened like 3 or 4 days after the shot was taken. He didn't take anything this time, he didn't take anything since the first two. His doctor forbid for taking any more Covid shot.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300356951 same reporter/product, different patient/event;US-PFIZER INC-202300357098 same reporter/product, different patient/event;
Headache/ neck ache, dizziness, achiness, burning feeling on her tongue as if she burned it with a hot liquid.
The first one  go like my arm was going to fall off for 2 week the pain was unbelievable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose 1, single (Lot number: FM0773) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lung disease" (unspecified if ongoing); "Thyroid disease" (unspecified if ongoing), notes: I take stuff like that because I have thyroid disease. Concomitant medication(s) included: CALCIUM & VITAMIN D [CALCIUM LACTATE;CALCIUM PHOSPHATE;COLECALCIFEROL] oral taken for thyroid disorder. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The first one  go like my arm was going to fall off for 2 week the pain was unbelievable". Relevant laboratory tests and procedures are available in the appropriate section.  Additional notes: Calcium With Vitamin D: Calcium 600mg a day with vitamin D, Once a day, Tablet, By mouth. Patient had both doses of vaccine administered at the Right arm. Patient stated, she believe so, the first one go like my arm was going to fall off for 2 week the pain was unbelievable, second shot, she got sick. Two weeks of pain, throbbing pain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300135606 same reporter/patient/product, different dose/AE;
p/vax pt c/o lt shoulder, collar bone pain/ache;self administered ibuprofen w/minimal relief;c/o sleeping difficulty positioning;reports red flat rash to chest lt arm from shoulder to elbow x 2hr;
my arm is very sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (my arm is very sore) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm is very sore). At the time of the report, PAIN IN EXTREMITY (my arm is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.   Reporter did not allow further contact
small fainted redness were dose was infected / circle in shoulder were dose was infected; Immediately after getting better from booster, patient had UTI; circle in shoulder were dose was infected; so week; so sick; so sick that did not want eat or drink water; Patient attributed this to being dehydrated from sweating and not drinking water during possible side effects; dehydrated from sweating; small fainted redness were dose was infected; Patient felt fatigued, tired; with high fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFECTION (small fainted redness were dose was infected / circle in shoulder were dose was infected), URINARY TRACT INFECTION (Immediately after getting better from booster, patient had UTI), VACCINATION SITE REACTION (circle in shoulder were dose was infected), ASTHENIA (so week) and ILLNESS (so sick) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Primary vaccination series was with Pfizer vaccine). Past adverse reactions to the above products included No adverse event with Pfizer.    On 19-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 VACCINATION SITE INFECTION (small fainted redness were dose was infected / circle in shoulder were dose was infected), URINARY TRACT INFECTION (Immediately after getting better from booster, patient had UTI), VACCINATION SITE REACTION (circle in shoulder were dose was infected), ASTHENIA (so week), ILLNESS (so sick), FEEDING DISORDER (so sick that did not want eat or drink water), DEHYDRATION (Patient attributed this to being dehydrated from sweating and not drinking water during possible side effects), HYPERHIDROSIS (dehydrated from sweating), VACCINATION SITE ERYTHEMA (small fainted redness were dose was infected), FATIGUE (Patient felt fatigued, tired) and PYREXIA (with high fever). At the time of the report, VACCINATION SITE INFECTION (small fainted redness were dose was infected / circle in shoulder were dose was infected), URINARY TRACT INFECTION (Immediately after getting better from booster, patient had UTI), VACCINATION SITE REACTION (circle in shoulder were dose was infected), ASTHENIA (so week), ILLNESS (so sick), FEEDING DISORDER (so sick that did not want eat or drink water), DEHYDRATION (Patient attributed this to being dehydrated from sweating and not drinking water during possible side effects), HYPERHIDROSIS (dehydrated from sweating), VACCINATION SITE ERYTHEMA (small fainted redness were dose was infected), FATIGUE (Patient felt fatigued, tired) and PYREXIA (with high fever) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included Antibiotics for UTI.   This case was linked to MOD-2021-436309, MOD-2021-436372, MOD-2021-436373, MOD-2021-436543 (Patient Link).
Warm to touch; Harder than rest of my arm; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Harder than rest of my arm) and VACCINATION SITE ERYTHEMA (Red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, ROSUVASTATIN and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Harder than rest of my arm) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Harder than rest of my arm) and VACCINATION SITE ERYTHEMA (Red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant follow-up received included information about outcome of the events and was updated to recovered.