chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nerve pain and numbness in left hand developed approx 48 hours after injection.  extremely sensitive nerve (located between the main joint of the thumb and the index finger knuckled) nerve causing high level of pain from slightest touch.  numbness covering top and metatarsal area between middle and index fingers.   additional nerve pain developed approx 1 week later in right hand wrist upon extension of wrist joint outward.    no injury or event exist other than the vaccination preceding symptoms
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown 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 EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medication information was reported. Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients.  No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Case number PHEH2014US018204 is an initial spontaneous report received from a pharmacist (pharm D) on 09 Sep 2014. This report refers to a 50 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 27 Aug 2014. It was reported that FLUVIRIN was stored at a temperature of 49 degree F (9.4 degree C) for 2 hours. No adverse events reported after the maladministration.
On day 11 (2-1-21) red circle about size of half dollar, by next day it had doubled in size.  Went to doctor and was put on Cephalexin and Florastor.  It is still here on 2-4-21 and still on antibiotic.  Have contacted family doctor and clinic where I received vaccine
received an expired dose of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 14-JUN-2023, the patient received Infanrix. On 14-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Infanrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-Jun-2023 The reporter was a clinical supervisor. The health care professional (HCP) unaware of the patient details at that moment.  Patient received a dose of Infanrix, which was expired on 10th June 2023, which led to expired vaccine used. The reporter consented to follow up via email.
Lots of pain when walking in the right leg; Severe joint pain right leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Lots of pain when walking in the right leg) and ARTHRALGIA (Severe joint pain right leg) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lots of pain when walking in the right leg) and ARTHRALGIA (Severe joint pain right leg). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 800 milligram. At the time of the report, PAIN IN EXTREMITY (Lots of pain when walking in the right leg) and ARTHRALGIA (Severe joint pain right leg) outcome was unknown.            The patient indicated that the batch number for the second dose could have been either 046A21A or 096A21A, she was uncertain based on the handwriting.
Mother states when child got to vehicle after vaccination, she took off bandaid from vaccination site, saw a drop of blood on the bandaid, then became very white, started having convulsions with extremities shaking. Nurse called from Immunizations office, came to vehicle where client was sitting in front seat with eyes rolled back into head, responsive. Within 3 minutes became more alert, able to answer questions. Mother states child had nothing to eat today, and that once she fainted after having blood drawn.
DEVELOPED SWOLLEN THROAT GLANDS, SORE THROAT, SWOLLEN FACE, KNOT UNDER CHIN, PAIN AROUND NECK
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 07May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 027A21A), in right arm, on 01Apr2021 as dose 2, single (Lot number: 02821A), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: 033A21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEPRAZOLE(GSMs), start date: Apr2011; PROPRANOLOL(GSMs), start date: 14Jan2022; ESCITALOPRAM(GSMs), start date: Jan2014; ATORVASTATIN(GSMs), start date: Jan2014. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid from 30Jun2022 to 04Jul2022. Clinical courses is as follows: 5 days after completion of Paxlovid regimen, patient experienced rebound symptoms-mild body aches, scratchy throat and mild fatigue. Abbott BinaxNOW antigen self-test Positive at 4:40PM / 09Jul2022.
Soreness of arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021. The most recent information was received on 14-Jul-2021 and was forwarded to Moderna on 14-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Pain in arm (Patient stated she had the typical symptoms of a sore arm with any vaccine.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14-Jul-2021 and included Newmedical history (typical symptoms of a sore arm with any vaccine) was added in patient medical history.
Pt had swelling of both hands on following day, BENADRYL helped. Had received vaccine 8/12/09, notified us on 8/9/10 when seen for physical.
on 1/9/2021 -, 16 year old female was given Moderna vaccine.  10 minutes after injection, this was discovered. Pt reports no adverse reactions during the 15 minute observation period.  Telephone call on 1/10/2021 at 3:00 pm mother reports child had some arm soreness and a little dizzy yesterday but today feels fine.
Patient received a first dose of the pfizer covid shot in his left arm. About 5 minutes or less after receiving his vaccine he reported he was very dizzy.  I had the patient sit down and gave him a bottle of water. He complained he was still very dizzy and had difficulty breathing. I offerred to call ED but patient declined. Patient went to the bathroom and came back and stated he felt better. He then left the store.
This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a pharmacist concerning an approximately 73 year old female with a history of shingles who on 21-MAR-2007 was vaccinated with a dose of ZOSTAVAX vaccine. Concomitant therapy was not reported. It was reported by the pharmacist that the patient was administered ZOSTAVAX (Merck) and was diagnosed with a case of shingles. The pharmacist administered the vaccination. Follow-up information was received by the consumer indicating that on "about" 22-APR-2007 she experienced pain and then developed shingles. She stated that she went to to an urgent care treatment center and they did not treat her as they said "She was one week too late for treatment". She stated that they put her on pain medication to help her with pain. In regards to recovering the patient stated that she was still having pain and some lesions. The patient stated that she had not seen her physician. No product quality complaint. No additional information was reported. Additional information is not expected.
Bone Aches/muscle pains, slight fever (did not measure), chills, sweating, cold feet, and fatigue began around 4PM 3/24 and lasted through 2AM 3/25, then fever broke, sweating.   The immediate rest taken, lots of fluids before fever broke resulted in the next day free of all symptoms, including fatique.  I felt fine.
swelling & redness in lt arm 3" x6" 4/10/99;T100 h/a pain in upper arm called MD to report reaction-seen by MD 4/12/99;prescribed zithromax (course of 7 pill for 5 days);MD said infect occurred;
No additional AE reported; Caller reports that a patient was administered a dose of PROQUAD on 30-JUL-2021 that experienced a termperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, lot number T034826 (rHA) expiration date 11-APR-2022 (route of administration were not provided) prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 9.12 degree fahrenheit (°F) for 1 hour and 6 minutes on an unknown date; another previous temperature excursions was reported of -6.5°F for 12 minutes.  The call was made due to a digital data logger. No adverse symptoms were reported.
For the last 3 weeks her hip has been hurting bad; pain at the injection site; the same night of the vaccine she had body soreness; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site), MYALGIA (the same night of the vaccine she had body soreness), HEADACHE (headache), FATIGUE (tired) and ARTHRALGIA (For the last 3 weeks her hip has been hurting bad) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site), MYALGIA (the same night of the vaccine she had body soreness), HEADACHE (headache) and FATIGUE (tired). On an unknown date, the patient experienced ARTHRALGIA (For the last 3 weeks her hip has been hurting bad). At the time of the report, VACCINATION SITE PAIN (pain at the injection site), MYALGIA (the same night of the vaccine she had body soreness), HEADACHE (headache), FATIGUE (tired) and ARTHRALGIA (For the last 3 weeks her hip has been hurting bad) outcome was unknown.            No treatment details were reported.   This case was linked to MOD-2021-235316 (Patient Link).
Swelling about 3" in diameter at point of injection.  Swelling is firm, slightly painful to touch, and has been present for more than 48 hours.  Overall body is itchy.
Intussusception diagnosed. History of vomiting for several days then had bloody stools. 03/20/2007 MR received for a 2 night hospital stay for several day history of vomiting. Over the course of the admission the infant developed bloody stools x2 as well as bilious vomiting. Review of systems on admission (+) for vomiting and lethargy.  PE: WNL except mildly difficult to arouse.  Intussusception reduced with air enema.  The infant was dicharged the following day. Discharge DX:  Intussusception.
High fever, 103 at 3am, fever 99-101 fluctuating from 5am -2pm.  Bad headache until 3pm
A few hours post injection, she noticed a lump and swelling. On 10/25/17 she noticed a baseball size lump, redness and warm.
Rash- Four blisters at onset, itches. Fussy. Slight fever.
Pt. had seizure like actions, lost consciousness for approx. 20 seconds, came around quickly. Cool compresses applied to neck and head. No nausea or vomiting. Dr. evaluated pt. Pt. waited for 15 minutes later, then left with mom and brother.
My arm for the last two weeks has been very sore, it is hard to move around like above my head; My arm for the last two weeks has been very sore, it is hard to move around like above my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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), INJECTED LIMB MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "My arm for the last two weeks has been very sore, it is hard to move around like above my head". Therapeutic measures were not taken as a result of pain in extremity, injected limb mobility decreased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, fever, aching muscles, headache, sore arm, nausea , light headedness and fainting
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-DEC-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N004815 and expiration date 07-OCT-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017 and 16-NOV-2017 was 47 degree Celsius for max 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Headache; Fever/fever reaching 99.7F; Chills; pain in the arms; I am a bit nervous in getting the second dose that I am getting palpitations; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 13Jan2021 (Batch/Lot Number: EH9231) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Mar2020 to Mar2020. The patient had the covid virus in Mar2020. The patient's concomitant medications were not reported. It was reported that she has a question, if a person had the covid virus earlier last year is it still okay to get the Covid vaccine. The first dose was given 13Jan2021. The patient had the covid virus in Mar2020. Caller clarifies that she is actually the patient in this case, and she is speaking about herself. Caller had the covid virus on Mar last year, relatively mild infection. She received the Pfizer vaccine last 13Jan2021. She spoke to a nurse last week since she started experiencing side effects, and was wondering if it was safe that she got vaccinated in the first place considering she had the covid disease prior. Caller mentioned experiencing side effects after the first dose of the vaccine, including severe headache, fever reaching 99.7F, chills, and pain in the arms (akin to getting the flu vaccine but worse). These symptoms have calmed down in a couple of days. She talked to her HCP about this who gave her tylenol but apparently did not do much in managing it. She wants to know if these side effects were expected from the vaccine. Patient was a bit nervous in getting the second dose that I am getting palpitations. Outcome of the events was unknown.
Neck pain; Pain in nerve endings; weakness; Join pain on the left side of the body; fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), NEURALGIA (Pain in nerve endings), ASTHENIA (weakness), ARTHRALGIA (Join pain on the left side of the body) and PYREXIA (fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Neck surgery. Concomitant products included GABAPENTIN, OMEPRAZOLE, SIMVASTATIN and VENLAFAXINE for an unknown indication.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced NECK PAIN (Neck pain), NEURALGIA (Pain in nerve endings), ASTHENIA (weakness), ARTHRALGIA (Join pain on the left side of the body) and PYREXIA (fever). At the time of the report, NECK PAIN (Neck pain), NEURALGIA (Pain in nerve endings), ASTHENIA (weakness), ARTHRALGIA (Join pain on the left side of the body) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol and Ibuprofen.  Action taken with response to the events are not applicable.
Systemic: Fever-Medium, Systemic: LOSS OF TASTE-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Complaint of cough, chills, elevated temperature, headache, runny nose/congestion, malaise and nausea/vomiting.
pt recv vax 11APR96 & 24APR96 pt exp 3 1-2cm area of induration, itching & erythema @ the inj site;there were no vesicles;MD felt that the exp was not a varicella-like rash;
Pt reported aches and pain and fatigue. General not feeling well. Reported on 11/6/23 and patient said from time of vaccine until he informed us.
daughter reports  a few hours after receiving vaccine eye felt "bubbly" then became cloudy and then developed a black spot.  received shot on 3/23/21 and daughter reported to pharmacy on 3/27/21.  they were instructed to go to urgent care
I developed redness, itchiness, swelling and pain just below the injection site 8 days after vaccination
56 yo woman Received t-dap booster on 6/26/2023 from PCP wellness appointment. Side effects have not subsided since receiving vaccine which include muscle, soreness, skin sensitivity all over body, especially down the back, chills, overall malaise.
10JUL96 mom called reporting pt awakened w/jerking like movements w/occasional tremors;recommended go to MD;pt had sz & ear infect;d/t febrile illness (t102);
12/13/2007 approx. 5 pm pt had onset of chills and temp of 101.5. 12/14/2007 r arm with redness from site of injection moving down past elbow. r arm hot to touch. Pt called pcp and was started on antibiotic for cellulitis
expired ACT HIB was administered with no adverse event; Initial information received 05-Aug-2021regarding an unsolicited valid non-serious case from the other health professional via Global Medical Information (Reference number- 00712064).  This case involves a seven-month-old male patient who was vaccinated with the expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 24-Jul-2021, the patient received a third dose of suspect HIB (PRP/T) VACCINE (lot number: UJ359AA and expiry date: 11 Jun 2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was also reported that, "expired ACTHIB was administered and wanted to know if it's safe for the consumer. Should the consumer be re-vaccinated?"  At time of reporting, 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 the 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.
Inpatient hospitalization on 01.31.2022, post vaccination Moderna (03.05.2021 & 04.02.2021).