chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild arm soreness / Tenderness at injection site; Redness at injection site; Arm felt heavy; A spontaneous report was received from a nurse concerning herself, a 36 old, female patient who experienced mild arm soreness [Injection site pain], her arm felt heavy [Vaccination site discomfort], redness at the injection site [vaccination site erythema] and tenderness at the injection site [vaccination site pain].  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28-Dec-2020, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28-Dec-2020, immediately after receiving the vaccine, the patient experienced some mild arm soreness at the injection site which went away. On 03-Jan-2021, the patient reported that her arm felt heavy. She experienced redness and tenderness at the injection site. The redness and tenderness were continuing at the time of the report and she believes the redness was spreading. Treatment for the events included ibuprofen and ice packs.   Action taken with mRNA-1273 in response to the events was not provided.   The event tenderness at the injection site [vaccination site pain] resolved on 28-Dec-2020. The events of redness at the injection site [vaccination site erythema] were not resolved as of the time of this report.   The event, Vaccination site pain beginning on 28-Dec-2020 was resolved on 28-Dec-2020. The events of redness and tenderness at the injection site were not resolved as of the time of this report. The outcome of the event, arm felt heavy, was unknown.; Reporter'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.
Patient called office to report reaction to Flu shot. Has been to doctor 3x and been on 3 rounds of antibiotics. Had lump in arm at injection site and felt bad that night and the next day. Lump went away and felt better but 2 wks later lumps returned and had major flu like symptoms. Achy all over body, arm hurt to move, pains all over body. Went to doctor put on antibiotics and felt better. Few days later started feeling bad again, chills, achy, lumps in neck at Adams apple, lymph nodes inflammed. Antibiotics again. Felt better but is still not up to par - Still has aches all over body lump in neck, on antibiotics till just before Thanksgiving. Ear hurts. Eyes water.
This spontaneous report as received from a registered nurse refers to five patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. The nurse reported that patients received improperly stored (Merck) PROQUAD (lot number L008353, expiry date 11-SEP-2016, 0.5 ml, subcutaneously). Four doses were administered on 17-AUG-2015 and one dose was administered on 20-AUG-2015. No adverse effects were reported. Follow up information has been received on 02-OCT-2015 that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received from the nurse on 08-OCT-2015. The nurse reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to a 4 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with the dose of improperly stored (Merck) PROQUAD. Temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested. The patient details and narrative was updated.
This spontaneous report as received from a registered nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored GARDASIL lot # K006117, expiration date 14-JAN-2017 and lot # K006124 expiration date 02-FEB-2017 (dose, route and site of administration were not reported). There were no adverse symptoms reported. No product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pain, swelling within a few hours lasting a few days. Rash on body, red painful, itchy rash on injection site 1 week post vaccination.
Nausea, dizziness, chest tightness, diaphoretic, short of breath. She did not report symptoms until later though at 2:30pm and was then sent to the ER.
I have been bleeding from my finger nail; This is a spontaneous report from a contactable nurse (patient herself).  A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration, on 22Sep2021 at single dose (dose number unknown) for COVID-19 immunization. No relevant medical history and concomitant medications were provided. On 22Sep2021, the patient has been bleeding from her finger nail. The outcome of the event wass unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Hemorrhage cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Moderate injection site pain, fever, chills, arthralgia, myalgias, fatigue
Patient woke up (10/9/12, 3:00 AM) with generalized muscle aches, a large fever blister (swollen) on top lip, and sharp pain in the cheek/eye area.  She called our pharmacy around 2:00 PM on 10/9/12 to tell us about the reaction.  We recommended that she see a doctor if the reaction gets worse or does not improve in the next day.
Tinnitus, hyperacusis, numbness in limbs, tachycardia
Pt came to clinic 2 weeks after initial vaccine and reported that the day after vaccine was given his Left arm became red and mildly swollen from the deltoid, across the medial area of the arm down the bicep to the antecubital area. He also reported feeling some tingling at that time. He took his 'allergy medication' and the symptoms fully resolved within 5 days. He denies any further deficits from the vaccine.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT TURNED PALE AND FALLING TO ONE SIDE, SO WE STABILIZED HIM. WHEN THE EMS ARRIVED AFTER 15 MINUTES , HE SEEM LIKE HE WAS RECOVERING AND THEY TOOK AWAY ON A GURNEY. HE NEVER LOST HIS CONSCIOUSNESS.
6-7 hours after getting the shot, patient experienced tightness in the throat, started with the chills and high fever, feel very weak and couldn't stand up. Went to Dr the morning after. Per dr. pt is not tolerating HIGH DOSE.
Had initial reaction within normal expected limits (red, swelling, itchy arm at injection site); reaction lasted about 2 days then got better. Exactly one week after receiving the vaccine, arm started getting itchy again and I noticed the evening of March 15 that it was red, warm, swollen, and itchy again. March 16 the swelling intensified and itch got worse. Went into the doctor to let them look at it the morning of March 17. Slight tickle in throat, but that could be due to seasonal allergies. No fever.
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 01-DEC-2016, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113:
Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a four months old female patient who experienced low platelets two weeks after vaccines, while she received vaccine PENTACEL. No medical history was reported. No concomitant therapies were reported. On an unknown date, the patient received a dose of PENTACEL (lot number, expiry date dose details not reported) via unknown route in unknown administration site. On an unspecified date, two weeks after vaccination, the patient had low platelets. No lab data was reported. It was not reported if the patient received a corrective treatment. The patient outcome is not reported for low platelets two weeks after vaccines. List of document held by sender: none.
This case was reported by a pharmacist via call center representative and described the occurrence of eye irritation in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced eye irritation, inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the eye irritation was not recovered/not resolved and the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown. It was unknown if the reporter considered the eye irritation to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. During administration of SHINGRIX to the patient, some of the vaccine leaked out and squirted in the administering pharmacist's eye. The pharmacist was experiencing ongoing mild eye irritation. The pharmacist was no longer present in the pharmacy at the time of reporting. The lot and expiration was not provided.
red and blistered at the injectionsite; neck sore; Stiff neck; red at injection site; This is a spontaneous report from contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA) (Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 02Mar2021at 12:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications simvastatin (MANUFACTURE UNKNOWN), metoprolol (MANUFACTURE UNKNOWN), vitamin c (MANUFACTURE UNKNOWN), and vitamin d (MANUFACTURE UNKNOWN), zinc (MANUFACTURE UNKNOWN), reported for unknown indication from unknown date. On 17Mar2021 at 09:00 the patient experienced red and blistered at the injection site. Although it was looking like a burn, there was no associated pain. Also, not sure if related, but the patient also had a very sore, stiff neck all day that seemed to get worse instead of better as the day progressed. The patient experienced the small blisters turned into one large blister that broke and arm was still red at injection site, but neck is still sore but not as bad as previous day. No therapeutic measures were taken as a result of event. The clinical outcomes of stiff neck, sore neck, red and blistered at the injection site were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presented with a chief complaint of L Arm "Pain and numbness" that radiates to their L Distal Arm. Patient had normal gait with no complaint of difficulty breathing, no chest pain, no dizziness. Patient states the pain and numbness subsided 3 minutes  later, however, the injection site was still sore to palpation and general movement. A cold compress pack was applied to the patients L arm in a position of comfort. Patient was assessed every 10 minutes with continuing improvement of the L Arm  with no other complaint. Patient self ambulated to family vehicle.
funky headache; getting cramps in the arm and hand that I got the shot in; ears were ringing loudly; muscles and joints ached badly; muscles and joints ached badly; felt tired and weak; felt tired and weak; Checked temp. was 100/temp was up to 104; cough; Felt like I was run over by a truck; Bottom line felt like I was having Covid all over; chills; upset stomachache/stomach was upset/waves of upset stomach; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:45 (at the age of 58-years-old), as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to Dec2020 and started with cough which she had horribly from an unknown date. There were no concomitant medications reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not receive any other medicine prior to COVID-19 Vaccine. The patient was tested COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 03Mar2021 15:00, the patient experienced chills, upset stomachache/stomach was upset/waves of upset stomach. On 04Mar2021, the patient also experienced, ears were ringing loudly, muscles and joints ached badly, felt tired and weak, checked temp. was 100/temp was up to 104, cough, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in. The patient underwent lab tests and procedures which included body temperature: 100 on 04Mar2021, body temperature: 104 on 04Mar2021 When I went to bed My temp was up to 104, body temperature: 100 on 04Mar2021 When I woke up Temp was 100, body temperature: normal on 04Mar2021. Treatment was received for chills and upset stomachache/stomach was upset/waves of upset stomach. Treatment was not received for ears were ringing loudly, muscles and joints ached badly, felt tired and weak, checked temp. was 100/temp was up to 104, cough, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in. The outcome of the events chills, upset stomachache/stomach was upset/waves of upset stomach, ears were ringing loudly, felt tired and weak, checked temp. was 100/temp was up to 104, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in were reported as recovering and for events muscles and joints ached badly and cough were reported as not recovered.  No follow-up attempts are possible. No further information is expected.
experienced psychotic episode, woke at 2am after wickedly violent dreams, hears voices yelling at me. my wife calmed me down. went back to sleep to awaken three more times after extremely violent dreams and I was yelling. Final dream I was partially awake and I heard someone tell me its time for you to go and had a vision of myself securing my firearm and shooting myself in the head. I have never had these experiences, I do not have have any type of mental illness and I am very happy and pretty stress free. I do not use drugs or alcohol.
pain in the arm on all doses/arm hurt for 2 days; slight grade fever; stuffy; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy), VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038CZ4A, 039K20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASAL CONGESTION (stuffy). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever). At the time of the report, NASAL CONGESTION (stuffy), VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Chest x-ray was clear.. On an unknown date, Laboratory test: normal (normal) normal. On an unknown date, SARS-CoV-2 test negative: negative (Negative) RT-PCR test - Negative. On an unknown date, SARS-CoV-2 test positive: positive (Positive) Antigen test(home) - Positive.         Concomitant medications reported includes, steroids.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-316515, MOD-2021-316581 (Patient Link).
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was inadvertently vaccinated with doses of RECOMBIVAX HB, in a series, (dosing details not reported). The first dose was administered on 26-FEB-2002, second dose on 26-MAR-2002 and the third dose was on 16-MAY-2002. No adverse effects and no product quality complaint (PQC) was reported. Additional information has been requested.
Warmth; Discomfort at the injection site; Injection site swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth), VACCINATION SITE DISCOMFORT (Discomfort at the injection site), INJECTION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Redness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE WARMTH (Warmth), VACCINATION SITE DISCOMFORT (Discomfort at the injection site), INJECTION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (Warmth), VACCINATION SITE DISCOMFORT (Discomfort at the injection site), INJECTION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Pt recvd vax & devel rt arm achiness; resolved w/in 24 hrs w/o treatment;
Swelling to left arm and below elbow.  Increased swelling to left axilla and chestwall.
Rash and itching for several weeks. Prednisone for 2 weeks, steroid ointment for 4 weeks, now treating for folliculitis in one area with solution.
patient developed itching to both forearms app. 20 min after receiving injection.  possible rash to same area. patient was immediately taken to be seen by physician in same building and was later seen discharged.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Three weeks after 2nd vaccine I experienced Rapid heartbeat  of 122 bpm. No event triggered it.  Spikes re-occurred  three times since first episode. Each spike lasts approximately one minute.
has complained of a dull frontal headache intermittently since receiving his first COVID-19 vaccine.  BP was 152/90, physical exam was normal.
We had patients who were administered the vaccine that underwent temperature excursion; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Product administration error; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error), PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 3:53 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 3:53 PM, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT ADMINISTRATION ERROR (Product administration error), PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Excursion duration was 1 month reported by reporter.   This case was linked to MOD-2021-402935 (Patient Link).