chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen Lymph Node under the right armpit (Baseball size) after booster/The swelling was soft to the touch under right armpit. The swelling improved and went down to 2/3 today 28Jan2021; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph Node under the right armpit (Baseball size) after booster/The swelling was soft to the touch under right armpit. The swelling improved and went down to 2/3 today 28Jan2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 025A21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced LYMPHADENOPATHY (Swollen Lymph Node under the right armpit (Baseball size) after booster/The swelling was soft to the touch under right armpit. The swelling improved and went down to 2/3 today 28Jan2021). At the time of the report, LYMPHADENOPATHY (Swollen Lymph Node under the right armpit (Baseball size) after booster/The swelling was soft to the touch under right armpit. The swelling improved and went down to 2/3 today 28Jan2021) was resolving.            No Concomitant product use was reported.  The patient had swollen Lymph Node under the right armpit of Baseball size on 27-Jan-2021. The swelling was soft to the touch under right armpit and the swelling improved and went down by 2/3 on 28-Jan-2021, at the time of reporting.   The patient did not take any medications.
pt recvd vax & 2 days p/vax exp facial herpes zoster lesions w/pain; pt was seen by MD & was treated w/Zovirax, Darvocet-N & Motrin; Reporter indicated that the pt had recvd 3 shots of Novocain & Amoxicillin for a dental procdr 1 day a/sx
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent condition was provided. From 02-DEC-2015 to the time of this report, unspecified number of improperly stored doses of RECOMBIVAX HB (route, dose, lot # and expiration date were not provided) were administered to unspecified number of patients. No adverse effects were reported. This is the one of the several reports from the same reporter source. Additional information has been requested.
No adverse effects reported.; Medical assistant calling to report MMRII administered to patient after TE occurred.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-MAY-2023, the patient was vaccinated with an improperly storage measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, therapy type: rHA, valid lot #W021191, expiration date: 29-MAR-2024, administered for prophylaxis (strength, anatomical location and route of administration were not provided). Temperature excursion was reported as 73 Fahrenheit (F) for 51 hours and 30 minutes. No previous temperature excursion was reported. No additional adverse event was reported.  This is one several reports from the same reporter.; Sender's Comments:  US-009507513-2305USA008554: US-009507513-2305USA008288: US-009507513-2305USA008329:
Generalized body pains; swelling at the injection site; Tenderness at Injection site; fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized body pains), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (Tenderness at Injection site), PYREXIA (fever) and NAUSEA (Nausea) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PAIN (Generalized body pains), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (Tenderness at Injection site), PYREXIA (fever) and NAUSEA (Nausea). At the time of the report, PAIN (Generalized body pains), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (Tenderness at Injection site), PYREXIA (fever) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the events included paracetamol.  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.; 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.
Headache; Myalgia; Fever; Fatigue; The patient experienced chills overnight; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old no pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), intramuscular in left arm on 06Jan2021 17:45 at single dose for COVID-19 immunization. None Medical history included. Concomitant medication included sertraline and ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient experienced chills overnight (06Jan2021). On 07Jan2021 02:00 am, she experienced fever, headache, myalgia, and fatigue. Self-treated with Acetaminophen. The outcome of events was recovered at unspecified time on 07Jan2021.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), VACCINATION SITE PAIN (Arm aches), HEADACHE (Headache), EAR PAIN (Earache) and ABDOMINAL PAIN UPPER (Stomach Cramps) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches), VACCINATION SITE PAIN (Arm aches), HEADACHE (Headache), EAR PAIN (Earache) and ABDOMINAL PAIN UPPER (Stomach Cramps). The patient was treated with PARACETAMOL (TYLENOL) for Ache, Headache, Earache and Stomach cramps, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches), VACCINATION SITE PAIN (Arm aches), HEADACHE (Headache), EAR PAIN (Earache) and ABDOMINAL PAIN UPPER (Stomach Cramps) outcome was unknown.            Patient is taking blood pressure medication but unknown and been in bed consuming fluids.
Skipped 1st two periods, then menstrates every 20 days with very heavy flow.  Second day of period she has near black out episodes followed by crushing headache and bone crushing fatigue.  Also symptons include quivering of arms and legs.  This happens at almost anytime.
This spontaneous report as received from a nurse refers to a 2 unspecified patients of unknown age and gender. On 03-NOV-2015, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # L019127 and exp. 27-MAY-2017. No adverse effects reported. Additional information has been requested.
Face swelled / with eyes almost shut; eye almost shut; This case was reported by a nurse via call center representative and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies (unspecified allergies).   On 19th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced facial swelling and swelling of eyelid. On an unknown date, the outcome of the facial swelling and swelling of eyelid were unknown.   The reporter considered the facial swelling and swelling of eyelid to be related to Shingrix. Additional details were provided as follows: The patient was reporter's mother. The patient had a medical history or unspecified allergies The age at vaccination was not reported. The patient was vaccinated with Shingrix and her face swelled. The reporter showed the GSK representative pictures of patient's face which was swollen and her eyes looked, in the picture, to be almost shut. The nurse was asking the sales representative if her mother should get the 2nd Shingrix shot or not. The reporter consent to follow up. No further information was provided.
Morning after immunization, lower right leg had rash mottled red in color- not raised.  Next day bilateral lower legs had rash.  Over next 2 days, faint rash climbed up back to nape of neck.  No rash on chest.  Also, child had onset of clear, runny nose and mild cough that lasted about 5 days.  Benadryl helped rash slightly.
11:24am- Patient complained of "a little bit of tingling around lips".  B/P 128/70, P 67, pulse ox 98% on room air. Monitored.  12:05pm- wheezing now present, increasing tingling to lips and complaining of dryness to mouth. Benadryl 25mg PO given, Continue to observe for another 30 minutes. 12:1pm- B/P 186/92, HR 124, 98% room air.  12:33pm- 166/88, HR 106, 26 breaths per minute, 98% on room air. 12:40pm-  B/P 156/92, HR 106, 98% Room air.  NO wheezing, no stridor; Denies tingling of lips, continue to complain of dry mouth.  Plan agreed upon with nurse, patient, and husband; husband will drive patient to ER. Report called in to ER.
The patient received the incorrect manufacturer for her second COVID vaccine dose. Patient did not have her card with her and she indicated she received Moderna for the first dose. When she got home and found her card she realized she received Pfizer COVID vaccine lot number EN 6198 for her first dose on 2/20/21 and called us with this information. The patient did not experience any adverse effects from either of the two vaccinations.
Chills; Muscle ache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on 22Mar2021 at 12:30 in left arm (at the age of 53 years) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ADVIL for an unspecified indication. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in left arm on 01Mar2021 at 10:30 (at the age of 53 years) as a single dose for COVID-19 immunisation. On 22Mar2021 at 14:00, the patient experienced chills and muscle ache. No treatment was received as a result of adverse events. The clinical outcome of chills and muscle ache was resolving.   No follow-up attempts are needed. No further information is expected.
invalid dose administered to two patients; This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (invalid dose administered to two patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (invalid dose administered to two patients). On 17-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (invalid dose administered to two patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  The syringes were drawn in the afternoon on 16Mar2021. The syringes were kept in the refrigerator. On the morning of 17Mar2021, the nurse administered vaccines to patient from the syringes that were drawn on 16Mar2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-051994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051994:MOD21-058166 Crosslinked no  with Patient
Hospital employee had been given TDAP and next day had extreme flu like symptoms, fever, body aches, chills.
Right arm pain day of the immunization characterized by "extreme muscle pain" when "reaching or lifting ". Scale 0-10, 0 = no pain, pain can be up to a "6".
No additional AE/PQC was reported; improperly stored VARlVAX was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 01-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T006347, expiration date 20-FEB-2022) for prophylaxis (product storage error).Temperature excursion was 18.1 Fahrenheit degree for 408 hours 0 minutes and 0 seconds. Previous temperature excursions were - 7.0 Fahrenheit degree for 0 hours 20 minutes and 0 seconds; 7.7 Fahrenheit degree for 0 hours 15 minutes and 0 seconds; 5.4 Fahrenheit degree for 0 hours 5 minutes and 0 seconds. No additional AE/PQC was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003330: US-009507513-2109USA003761: US-009507513-2109USA003762:
This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 04 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-2017 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Ashen color, tunnel vision, pins and needles hand, lethargic, sweaty and nausea as per mom. Mom called us on 9/15/08 to inform us. Patient not seen in office.
In the pharmacy I work in, we have given someone a booster shot as a second dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (In the pharmacy I work in, we have given someone a booster shot as a second dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (In the pharmacy I work in, we have given someone a booster shot as a second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (In the pharmacy I work in, we have given someone a booster shot as a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (In the pharmacy I work in, we have given someone a booster shot as a second dose).    No concomitant medicine were reported. No treatment medicine were reported.
Suspected vaccination failure; Patient developed shingles; patient experienced nerve pain in her breast; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (The patient was a breast cancer survivor).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Patient developed shingles) and post herpetic neuralgia (Verbatim: patient experienced nerve pain in her breast).  The outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-OCT-2023 The doctor reported a previously vaccinated 78 year old female patient experienced nerve pain in her breast. The patient developed shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Left arm became painful, swollen, red, and warm to touch, unable to move arm. Right arm red and swollen as well but became better.
Patient advised to seek treatment for diagnosis and medical treatment. Diagnosed with cellulitis and treated with Keflex
Fever Axillary temp 103.  Next day rash on trunk and arms.  Same continued for three days.  Rash also extended to face and inner arms as well as chest.  All cleared 4/4/10.
I developed a massive headache approximately 7 hours after the injection and chills, fever, all over body pain, joint pain 15 hours after the injection.  These symptoms lasted for 2 1/2 days followed by extreme exhaustion and headaches. Mostly recovered to date but extremely anxious about getting 2nd dose for fear of more extreme adverse reaction.
Narrative: COVID infection following COVID vaccine series 03/27, Pfizer, dose #1 04/19, Pfizer, dose #2 08/23 COVID swab, result: detected 08/18 pt cc: COUGH, FATIGUE, RHINORRHEA, DYSPNEA exposure: unknown
Left arm swollen, warm and red for 2 days following flu vaccine. Given Motrin & Benadryl with no relief.
Case previously recorded as MA2009-4608. Case report received from a health care professional, via Novartis Medical Communication, on 18 NOV 2009. 3 year-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 1009224P) i.m. on 17 NOV 2009, an off-label indication. No adverse event was reported. MedCom reference no.: NA09-008431.
Employee received H1N1 on 11/4/09. States she woke up this AM left side of face is swollen and has raised macular rash. Consulted her PMD. Employee is on histamine blockers and prednisone.
By the end of the day, my arm was sore to the touch. The next morning, I had a 6 inch red, goose egg on the inside of my left arm, running from my elbow to armpit. While the swelling and tenderness subsided by the following Monday, I continued to have a series of sharp pains and dull aches in my left arm for weeks. I contacted the provider who thought that I had reacted to the preservative in the vaccine. After about 6 weeks of the ongoing pain, I had x-rays, saw an orthopedic doc, had an MRI, saw the orthopedic doc again, was referred to a pain management specialist (he wanted me to have another in-depth MRI with dye on my shoulder), have had massage therapy, seen a reflexologist twice, seen a chiropractic provider four times and now working with a kinesiologist twice a week to get my arm retrained and strengthened. I had absolutely no underlying health issues before the vaccine and following my visit with the pain management doc, he too believes my issues are directly related to this vaccine. Believe me, if I'd had any indication this would occur, I would never have agreed to this vaccination. Subsequently, I have had two Moderna vaccinations in the past 6 weeks with absolutely no side effects other than a bit of soreness in my arm the following day.
MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; Initial pregnancy information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA266135, 2019SA266138 and 2019SA266136 (same reporter).  This case involves a 25 years old female patient who was mistakenly exposed to preservative free vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of preservative free INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant.  Patient's gestation period at onset and gestation period at exposure was 3 weeks, the date of last menstrual period was 13-FEB-2019 and the estimated due date is 07-DEC-2019.  The patient's past medical history, previous pregnancy/ies, medical treatment(s), vaccination(s) and family history were not provided.  Patient received DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) as concomitant therapy on 20-Sep-2019 in the left deltoid.   On 20-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number 16-DEC-2019 via unknown route in the right deltoid.  It was a case of actual medication error due to wrong vaccine administered (Wrong product administered).  It was reported that patient did not experience any adverse event at the time of reporting.  Additionally, at time of reporting, the outcome of the pregnancy was unknown because patient's delivery due date is on 07-DEC-2019.  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.