chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; Wearing off effect; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and VACCINATION SITE PAIN (Vaccination site pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced PAIN (Pain) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, PAIN (Pain) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medications were reported. No treatment medication was reported.  In 2021, the patient experienced PAIN after receiving Moderna Vaccine, the week patient did not take her Humira and when took Humira shot the pain went away with Humira which was resolved on an unknown date. It was unknown if patient was enrolled in a COVID-19 Vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Shot # 1: Day 1- 7 Sleepy hardly can keep eyes open.  Sharp burning pain on right shoulder blade within  30 minutes of shot. highlighted all pain areas ie: I have a bad knee.. wasn't hurting that day till after the shot. It was alright durable. I also got alot of hotflashes.. even fans werent keeping me cool  Shot #2 Day one felt fine till 30 minutes after my hands weren't my hand felt felt like i had no control over them only my nubs (all i could see were nubs and my hands were see through" I don't really remember the ride home. The rest of the day i wasn't tired but felt like my body wasn't my body. at night i got a-lot of energy and couldn't go to sleep. (I could run a maraton with my energy). Day 2 my anxitey and mood level were at an all time high freaked out over everything and was ready to say something if someone said something wrong to me. At the end of this day i was burning up room tempure water felt like ice cubes on me. sat outside in the cold to cool down. Day 3 Im feeling alright still in the afternoon i feel like i get over heated. So far my close ones around me have noticed that I have a short temper since the first shot and my depression came back. I have a hard time remember things like i use to. like my phone number in times that i need to remember it, spelling and remembering what i was doing and where i just sat things down. Feels like early demetia. well see how day for goes
4APR96 2PM pt recv vax 205PM c/o redness & sl swelling @ inj site;erythema approx 5 1/2cm x 5cm;induration approx 2cm x 2cm;MD notified immed;
Developed  flu-like symptoms: 101 degree fever, mild nausea, aches, pains, and light headedness for about 24 to 30 hours. I gradually felt better.
Headache, Myalgia, CoughWheeze, Diarrhea, NauseaVomiting, burning sensation in lungs Narrative:
Patient began feeling dizzy, warm, and confused shortly after vaccination. The patient was helped to lie down on the floor. The patient remained there for 3 minutes and then pharmacy staff helped patient sit back up. Patient stated she was feeling better and remained in the area for 30 minutes to wait after immunization.  I checked in with patient 5 hours after vaccine and she felt fine.
About 6 hours after the vaccination, the area around the shot developed redness and swelling and became warm to the touch, resembling a circle. The swelling went down within 2 days; however, the  red circle became larger, eventually having a 3" diameter (and somewhat resembling a Lyme disease rash). The redness is gradually fading, but is still present as of this date.
Patient returned to ED later that day with dizziness, ringing in ears, and tight feeling in throat. Denied SOB, fever, chills, rash.
Information has been received from a physician concerning a patient who on 05-Mar-1997 was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot # 621192/1550D) Subcutaneously. It was reported that on 05-Jan-2004 the patient experienced fever 100.7 for 2 days, fatigue, chills, multiple lesions with red base, some vesicles and some papular, itchy scalp and ankles "very Pruritic additional information has been requested. This is in follow-up to report(s) previously submitted on 5/15/2009. Follow up information has been received from a Licensed Practical Nurse (L.P.N.) who reported that a 16 year old male patient with no pre-existing allergies or medical conditions was vaccinated on 05-MAR-1997 with the first dose of VARIVAX (Merck) (Lot # 621192/1550D) subcutaneously. There was no illness at time of vaccination. It was reported that on 5-JAN-2009 the patient experienced fever of 100.7 degrees F, multiple red lesions, fatigue, chills, itchy scalp and ankles and red hives papular. The patient had recovered on 11-JAN-2009. Additional information is not expected.
13 days p/vax pt exp varicella, pt exp rash & spread to entire body by 15mar99. no further info avail
Patient was given a high dose flu vaccine on accident instead of regular dose. No symptoms reported. Unable to get ahold of patient to confirm. Called patient, left voicemail.
PATIENT CHOSE TO WAIT 30 MINUTES AFTER VACCINE FOR OBSERVATION. AT 25 MINUTES SHE BEGAN EXPERIENCE A HEADACHE. PATIENT STATES SHE NEVER GETS HEADACHE.  SO THE EMS UNIT AT OUR LOCATION WAS REQUESTED. HEADACHE WAS RANKED A #2 FROM 1-10 PAIN SCALE.  PATIENT STATED HER HEADACHE MAY HAVE BEEN AUSE BY THE FUMES FROM THE PROPANE HEATERS IN THE GARAGE, PATIENT RECOVERED AND WAS RELEASED
305PM inj given pt went to front desk & apparently fainted, witnessed by MD;states pt came to self up on arrival;pt transported to a room to lie down & observed, VS taken;pt d/c 405PM;
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. No previous temperature excursion was reported. Concomitant therapy included properly stored DILUENT MRK INJ. On unspecified dates in 2018 (reported as from March-2018 to 20-APR-2018), the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD, therapy type: rHA, lot# N023969 (expiry date: 28-FEB-2019), (Oka/Merck) VARIVAX lot# N023960 (expiry date: 01-SEP-2019) and ROTATEQ lot# N012762 (expiry date: 04-FEB-2019) for prophylaxis (incorrect product storage). Temperature excursion of (Oka-Merck) PROQUAD and (Oka/Merck) VARIVAX was 6 degree Fahrenheit (F) to 14 degree F for 42 minutes whereas ROTATEQ was stored at or above 32 degree F up to 35 degree F for 52 minutes. ROTATEQ with same lot number in a different refrigerator was stored at or above 32 degree F up to 35 degree F for 3 hours and 48 minutes. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved.
Right leg was red, swollen, painful to touch. Pt was put on Augmentin, and told to f/u in 2-3 days.
No additional AE reported; Patient got additional dose (4th dose) of GARDASIL 9; This spontaneous report was received from a pharmacist referring to a 25 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided.  From 2009 to 2010, the patient completed the 3-dose series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). On 14-APR-2023, the patient was vaccinated with additional dose (the 4th dose) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # W011264, expiration date: 05-SEP-2024) 0.5 ml for prophylaxis (strength and route of administration were not reported) (extra dose administered). No additional adverse event (AE) or product quality complaint (PQC) was reported.
pain in arm tired next day woke with chills 2 days later and arm still sore 3 days later and a little sore 4 days later
Thrombosis of left greater saphenous vein at the knee and proximal leg.  Thrombosed superficial veins in the calf.  Thrombosed peroneal vein of calf on 2/1/21
PATIENTS HUSBAND CALLED THIS MORNING, STATES THE PATIENT WAS PREGNANT AT TIME OF VACCINATION, COMPLAINS OF HEADACHE AND STOMACH ACHES
TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-122) on 14-Jan-2019. The report describes a female consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer brought Vivotif home and took one dose. Then the vaccine was left on the counter for a week. She realized it had to be refrigerated when she took her last dose. She took all the doses according to schedule.   The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
very pruritic rash on the RIGHT upper arm/deltoid area as well as wart like eruption in the labia and raised papules/wart like eruption on the right radial aspect/volar aspect of the wrist and the left forearm/volar aspect.
Anaphylactic reaction; Vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) and VERTIGO (Vertigo) outcome was unknown.            Patient had an anaphylactic reaction within 10 minutes of administration and was administered an Epi Pen and Benadryl. Patient went to the ER and was discharged the same day. Since then, the patient has been experiencing vertigo intermittently.no history for the treatment of Vertigo was provided  Concomitant medications were not reported.  Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, the previous history of Vertigo is a confounder.   This case was linked to MOD-2021-076365 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, the previous history of Vertigo is a confounder. MOD-2021-076365:1st dose of vaccine
Phone call from patient stating she had lymphedema on left side. Patient diagnosed by primary care physician. through appointment.  Patient stated she just called her PCPs office and described the symptoms.  Swelling went into her left breast. Patient had lumpectomies in the past but only a needle biopsy on the left side.
Pt was given adult dose of Tetanus diphtheria in right thigh in the ER. Never reported.
Missed 2nd vaccine dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd vaccine dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd vaccine dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd vaccine dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
[Pfizer vaccine] use for COVID-19 under Emergency Use Authorization (EUA):Pfizer vaccine #2 on 4/2/21 - unsure if FDA approved at that time or not. Around 4/23 patient developed signs and symptoms of organizing pneumonia.
Information has been received from a physician concerning a 15 year old female who, on 19-JUL-2007 was vaccinated with a first dose of Gardasil. On 20-JUL-2007 the patient broke out with herpes like lesions, the patient sought unspecified medical attention. A culture of the lesions were taken and blood was drawn. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Pt developed a 4 inch area of redness around injection site, left thigh; warmth, tender and slightly firm; low grade fever.
This spontaneous report was received from a colleague of the company representative's daughter referring a their daughter, age not provided. Medical history, concomitant medications and concurrent conditions were not reported. On 19-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 or GARDASIL (dose, lot number and expiration date were not provided) and unspecified influenza virus vaccine (dose, lot number and expiration date were not provided) in the same time and in the same unspecified arm. On an unknown date, the patient started to experience pain in her legs. The reporter wanted to know if the event was a side effect of GARDASIL 9 or GARDASIL. At the time of the report the outcome of the event was unknown. The causal relationship between the event and GARDASIL 9 or GARDASIL was unknown. Additional information is not expected as the primary reporter did not provided details contact.
felt a little warm; shivering; headache; Achiness; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achiness), FEELING HOT (felt a little warm), CHILLS (shivering) and HEADACHE (headache) in an 82-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031897) for COVID-19 prophylaxis.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: RSV in September 2023 and Flu Vaccine on 06-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu Vaccine and RSV.   On 23-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 23-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PAIN (Achiness). On an unknown date, the patient experienced FEELING HOT (felt a little warm), CHILLS (shivering) and HEADACHE (headache). At the time of the report, PAIN (Achiness), FEELING HOT (felt a little warm), CHILLS (shivering) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was tumbling, rolling, turning, all night. It was also reported that patient had not taken any medications or treatments at this time. He had received 6 previous doses of COVID-19 vaccines but none Moderna.
Mother states infant received first immunizations on 01/24/2001. She says infant cried in car on the way home when at home 12 hr after immunization noted rash on trunk on belly. Infant nursed poorly that night, fussier, crying more and rash came and went. On November 2001 referred to dermatologist. Still has rash on trunk and neck.
This spontaneous report has been received from a other health professional refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA lot # N023953 with expiration date of 05-NOV-2018, (strength, dose, frequency, route, and anatomical location were not provided) intramuscular for prophylaxis. The vaccine was exposed to a temperature range of 9°C to 25°C (14.8 C), during a time frame of 2 hours and 47 minutes which was called by a data logger. No previous temperature excursions were reported.
The Moderna vaccine was taken out of the freezer and placed in to the refrigerator on 9/8/2021. The vaccine was administered beyond the 30 days of which the vaccine is recommended to be kept in the refrigerator.  No adverse reaction occurred during the 15 minute waiting period or reported after the clinic date.
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable physician. This physician reported similar events for 11 patients. This is the 6th of 11 reports.  A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown. The patent is not in a study or program.    Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Fever to 102.4 rectally, lethargic, decreased strength and tone, decreased appetite starting within 24 hours after administration vaccines.
fever, chills, headache lasting two days arm redness, arm warm, soreness lasting 5 days  Moderna Covid vaccine EUA
Patient called about 10 days after the shot and said she had a red circular rash on her arm where the shot was given to her. She said it was a little itchy and warm. She had it looked at to confirm nothing else was going on. I followed up with her today and she said that it has gone away.
Had a 100F fever around 7PM and continued until I went to sleep around 9PM on 3/19.  Fever had subsided on 3/20 and was able to resume normal activities.
Bilateral tinnitus; This is a spontaneous report from a contactable consumer reporting for self. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 01Mar2021 10:30 (Batch/Lot Number: EN6205) at the age of 52 years old as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced bilateral tinnitus on 12Mar2021 19:15. Event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures were taken as a result included Hearing test and ENT visit. Outcome of event was not recovered.
Swelling at injection site, tingling and numbness in injected arm and stiffness in shoulder joint of injected arm.  Pt reported being unable to lift her arm.
I woke up in the morning a week after the shot and I had a very itchy, inflamed, and red arm in the site of the injection. It was probably 3 inches around the site and I called a mobile medicine doctor and they came to me. They diagnosed cellulitis and prescribed an antibiotic but I do not remember the name. I discontinued the antibiotic after one dose.
Had to use bathroom a couple hours after shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Had to use bathroom a couple hours after shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Had to use bathroom a couple hours after shot). At the time of the report, ABDOMINAL DISCOMFORT (Had to use bathroom a couple hours after shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medication were provided.