chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A and 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.  Patient had been administered with the Moderna vaccine which were beyond the 30 day beyond use date.  Patient received dose 1 from lot 053C21A with BUD 01-Jul-2021 and dose 3 from lot 042J21A with BUD 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up received: Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX lot # N012615 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1708USA013567.
Headache ( (1-10), Nausea: 6 hours after influenza vaccine.  No treatment, resolved 48 hours.
armpit to swell; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: The patient got his/her shingles shot on Wednesday, the patient had to stay home yesterday the day before reporting with all the side effects happening. The patient was better on the day of reporting. The patient's armpit on the same side was swollen.  The reporter wanted to know if it was normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
I have a swollen node in my Left Arm pit, the size of half of a tennis ball
no additional AE/no additional information; PROQUAD that underwent a temperature excursion had been administered to the patient; This spontaneous report has been received from a healthcare business professional referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 25-MAY-2021, the patient was vaccinated with the improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) for prophylaxis (lot # T028298, expiration date 16-FEB-2022; strength, dose, and route were not reported), which underwent a temperature excursion at 6.96 Fahrenheit (F) for 15 min (product storage error). The temperature excursion was detected by a data logger. There was no previous temperature excursion. No additional adverse event or information was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA001672:
Information has been received from a medical assistant who reported that multiple unspecified patients on multiple unspecified dates were vaccinated with improperly stored ROTATEQ lot #M019706, expiration date 24-OCT-2017; lot #L035510, expiration date 13-MAY-2017; lot #L048854, expiration date 31-AUG-2017; lot #M025565, expiration date 06-NOV-2017 (dosages not provided); or VAQTA lot #M021124, expiration date 28-FEB-2018 (dosages and routes of administration not provided). No adverse effects reported.  Excursion information: Names of vaccines involved: ROTATEQ and VAQTA Temperature:  32.01°F Time frame: 18 Hours Previous temperature excursion: No  "Data logger" involved: Yes  No further information provided. Additional information has been requested.
14 years old boy felt nauseous, appeared pale. Complained of itchy rash on hands right after MENVEO vaccination. Also complained of feeling dizzy. Did not lose consciousness. No drooling. No wheezing. EPIPEN 1x injection was placed on his left thigh.
My COVID-19 symptoms started on 03/28/2023 in the afternoon.  I had a fever for day and half, cough, sore throat. I was symptom free on day 4. On 03/28/2023 I took 2 home COVID-19 tests which were negative. On 03/29/203  I took a another test which was positive. I called my on the same day and scheduled a telehealth visit for the next day for 03/30/2023. The next day I did a telehealth with my doctor since my symptoms subsided even though she prescribe me Paxlovid I didn't need it. I tested negative  04/08/20223.
Heart racing,sob, tongue felt heavy, face felt numb and tingly, right arm where i received injection was numb tingly and clammy. Started to itch all over, right eye began twitching. Took and antihistamine.
Beginning approximately 8.5hrs after receiving vaccination I experienced a severe throbbing headache/migraine, brain fog, dizziness, chills, fever, body aches, arm soreness.  The  fever, body aches and arm soreness lasted approximately 3 days.  The severe throbbing headache lasted 4 days. The brain fog and dizziness lasted for several weeks/months and is just now maybe getting better. I have continued to have headaches (most often not severe) nearly every day  since receiving the 2nd Covid vaccination. This is what has prompted ,me to finally file a VAERS report. These headaches occur especially when I wake up in the morning, but also off and on throughout the day.  I also experienced heart palpitations multiple times per day including one day while running  (approx 3 weeks after vaccination) which caused me to stop my activity.  Prior to the 2nd COVID vaccination I almost never had a headache nor heart palpitations. The palpitations do possibly seem to be becoming less frequent, but unfortunately I am concerned about these health effects which is making it difficult for me to enjoy the active lifestyle I had before COVID vaccination.
1. Acute left deep venous thrombosis in the popliteal, posterior tibial, peroneal, one branch of gastrocnemius veins. 2. Acute left superficial venous thrombosis in the great saphenous prox thigh to knee extending tinto a varicose vein at the proximal calf.  1. Pulmonary embolism with large thrombus burden bilaterally, right greater than left  ASA/heparin gtt started
4 cm rash c hives, pustules, erythema, pain and urticaria to injection site.
got vaccine 10AM 11/6 woke at 230 AM 11/7 with cold sweats, chills, arms felt heavy and hurt to move and whole body ache and numbness in arms now headache, nausea, pain left arm
Headache, All over body aches, Nausea, Chills, Lowgrade fever, Metal taste in mouth on the 3rd day, Fatique and weakness.
The dose was taken out of a vial that had been removed from dry ice on 5/19/21 and stored in refrigerator. Vial should have been discarded on 6/20/21 after being stored at refrigerated temperatures for more than 30 days. Vial was mixed and dose was drawn and administered on 7/12/21.
Right shoulder swelling, no pain, apparent on day 8; no medication taken,  patient gives  pain scale of 1/10.
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved. Not Provided      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 information was provided. No treatment medication information was provided   This case was linked to MOD21-068791, MOD21-068788, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068786, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711, MOD21-068713, MOD21-068716, MOD21-068785, MOD21-068717, MOD21-068718, MOD21-068721, MOD21-068722, MOD21-068723, MOD21-068724, MOD21-068727, MOD21-068729, MOD21-068731, MOD21-068732, MOD21-068733, MOD21-068734, MOD21-068735, MOD21-068736, MOD21-068738, MOD21-068784, MOD21-068739, MOD21-068768, MOD21-068769, MOD21-068770, MOD21-068771, MOD21-068772, MOD21-068774, MOD21-068775, MOD21-068776, MOD21-068778, MOD21-068780, MOD21-068781, MOD21-068782, MOD21-068783 (E2B Linked Report).; Sender's Comments:  MOD21-068791: MOD21-068788: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068786: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068785: MOD21-068717: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068784: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781: MOD21-068782: MOD21-068783:
Fever - 102 degrees - Tylenol given; lasted until morning of 10/01/2011 and then later that day slight rash.
This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a female patient who received Flu vaccine for prophylaxis. Previously administered products included COMPAZINE with an associated reaction of allergic oedema, FLEXERIL with an associated reaction of pruritus allergic, ibuprofen with an associated reaction of gastric perforation (drug allergy: gastric tear) and NSAIDs with an associated reaction of gastric perforation (drug allergy: gastric tear). On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Flu vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient had allergic reaction to the flu vaccines however, no reaction was listed.
Abnormally swollen, red, irritation to left and right thighs for 1 week. Advised to use cold compress and continue to observe. Call office if it does not resolve.
Can not really move; Lack of energy; Tired/ fatigue; Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of MOVEMENT DISORDER (Can not really move), ASTHENIA (Lack of energy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021) and FATIGUE (Tired/ fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021). On an unknown date, the patient experienced MOVEMENT DISORDER (Can not really move), ASTHENIA (Lack of energy) and FATIGUE (Tired/ fatigue). On 13-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose of the Moderna vaccine (Lot 048B21A ) on 26 Apr 2021 in his left arm. Patient received the 2nd dose(Lot 017E21A) in left arm on 13 Aug 2021) had resolved. At the time of the report, MOVEMENT DISORDER (Can not really move), ASTHENIA (Lack of energy) and FATIGUE (Tired/ fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. Pharmacist reports that the patient reported after the second dose,he has been experiencing tired, fatigue, lack of energy, and was unable to move.
Mom states next day p/shot 20MAR93 arm was a little red; Did not notice again until 24MAR93; @ that time arm had a 2" x 1" red warm streak;
My sense of smell and taste have been altered.; My sense of smell and taste have been altered.; I cannot eat without having a burnt taste in my mouth.; Many things I cannot smell; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 12:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Apr2021, the patient experienced sense of smell and taste had been altered and the patient could no longer enjoy any fried food, most meat, and a lot of grilled style foods, she couldn't eat without having a burnt taste in her mouth and many things she couldn't smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sense of smell and taste had been altered, burnt taste in mouth and many things she couldn't smell was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01May2022 as dose 4 (booster), single (Lot number: FJ6369) for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EP6955), on 01Apr2021 as dose 2, single (Lot number: EW0171) and on 01Oct2021 as dose 3 (booster), single (Lot number: FE3590) for covid-19 immunisation. The patient's relevant medical history included: "DIC" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 21Feb2023 to 25Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt stated that she had a little head ache and was achy and tired on day of vax.   On 2/7/21 pt woke up and had pressure in her right eye.  She went to her Retina Specialist and was given a shot since in the eye it was hemorrhaging.  Pt will go back in 4 weeks for FU and another shot.
Suddenly felt dizzy and loss of hearing, sweaty and arms and legs felt tingly. He turned pale. We laid him down and placed ice pack on his forehead and neck. BP initially was 84/50 repeat in 10 min was 105/54. He felt better after 10 min. Felt back to normal at 30 min when he was released to his mother
ADVERSE REACTION NOS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced adverse reaction nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction nos was not reported. This report was non-serious.
Severe headache 48 hours after administration of Zostivax and pneumococcal vaccines.  Redness to site of zoster vaccination.
Feeling ill for a long time; Side Effects; This case was reported by a nurse and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (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 feeling unwell and adverse drug reaction. On an unknown date, the outcome of the feeling unwell and adverse drug reaction were unknown.   It was unknown if the reporter considered the feeling unwell and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter inquired, whether anyone reading patient forums on the side effects from Shingrix. The reporter stated, she was scared by hearing about some people feeling ill for a long time due to Shingrix. The reporter heard from so many people that say that will not be getting the second shot due to the horrible side effects. The reporter consent to follow up. This is 2 of the 2 cases reported by the same reporter.
A large red area on my arm. Sore in general and to touch. Just started today - one week and two days after the shot was given.
This spontaneous report was received from a medical assistant referring to a 13 month old female patient. The patient had no pertinent medical history, nor concomitant medications and no drug reactions/allergies. The patients concurrent conditions were not reported. On 22-AUG-2016, the patient was vaccinated with a dose of VARIVAX injection, (which had a lot number reported as M022103 with an expiration date on 04-MAY-2018) dose 1, subcutaneously (dose, concentration and frequency were not reported). On 26-AUG-2016, 5 days after onset of therapy the patient experienced injection site erythema and injection site reaction. The patient sought medical attention as she went to the physicians office on an unspecified date and did not receive treatment for the above mentioned adverse events. There was no product quality complain involved (PQC). No laboratory diagnostic studies were performed. Furthermore, it was reported that there was no intervention to prevent serious criteria, the patient was not hospitalized, there was no significant disability or incapacity and the patient did not died. At the time of reporting, the outcome of injection site erythema and injection site reaction was reported as recovering. The primary reporter did not provide the causal relationship between VARIVAX and the events. Additional information has been requested.
Case was vaccinated for Covid in March 20212, then was hospitalized for Covid in January 2022. Hospitalized at:   COVID-19 virus infection Assessment & Plan Positive on admission screen 1/22/22, then developed hypoxia requiring supplemental O2. He was vaccinated back in May 2021 with J&J vaccine but has not gotten his booster. Improved with decadron and remdesivir (received 5 days of both). On day of discharge, O2 saturation was stable on room air. Patient was given instructions to quarantine/isolate through Monday 1/31.
Child fell asleep around 4pm 9/22/2022 and didn't wake up until I woke him up at 7:30am 9/23/2022. His whole body was covered in small red dots. The red dots didn't go away for 4 days. No other symptoms noticed.
Upper Right Deltoid very swollen, red, hot, and painful. Seen in the Emergency Room. MD prescribed pain medication and antibiotic for localized reaction with possible early localized infection.
Patient given PfrPediatric dose 5-11, 0.2ml.  Instead of correct white label, 0.3ml.
and per pt: "15 hours after the vaccine I fainted while washing my hands after having been up for several minutes. I became very dizzy and lost my balance and vision while reaching to turn the water off and fell. I recovered quickly.    This happened for the first vaccine, as well, about 20 hours after the first Pfizer shot. For that time, I became dizzy while stretching and standing and then collapsing, but quickly recovered."