chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RESIDUAL DISCOMFORT IN RIGHT HIP; LETHARGY; MUSCLE SORENESS; STIFFNESS IN RIGHT HIP; COULD NOT WALK WELL; COULD NOT SLEEP; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; DISCOMFORT WITH RIGHT LEG; A UNIQUE HIP PAIN/ WHOLE LOT OF PAIN AND FELT LIKE A PRONOUNCED, EXAGGERATED WHEN HIP GETS TIGHT; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic pain, and other pre-existing medical conditions included: Patient took muscle relaxer and NSAID for pain relief. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-SEP-2021, and dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced stiffness in right hip. On 25-SEP-2021, the patient experienced could not walk well. On 25-SEP-2021, the patient experienced could not sleep. On 25-SEP-2021, the patient experienced discomfort with right leg. On 25-SEP-2021, the patient experienced a unique hip pain/ whole lot of pain and felt like a pronounced, exaggerated when hip gets tight. On 25-SEP-2021, the patient experienced inappropriate schedule of vaccine administered. On 26-SEP-2021, the patient experienced lethargy. On 26-SEP-2021, the patient experienced muscle soreness. On 27-SEP-2021, the patient experienced residual discomfort in right hip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stiffness in right hip, had not recovered from muscle soreness, lethargy, and residual discomfort in right hip, and the outcome of could not sleep, a unique hip pain/ whole lot of pain and felt like a pronounced, exaggerated when hip gets tight, could not walk well, inappropriate schedule of vaccine administered and discomfort with right leg was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. The report refers to a 7 month old infant patient of unknown gender. On 19-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Chills, dizziness, sweating, light headedness, nausea without vomiting. No syncope occurred.
Information has been received from a physician concerning a 2-month-old patient who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  The physician reported that the patient subsequently developed severe vomiting six hours after being vaccinated.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
VERY sore arm, slight redness at site. Treated with acetamaphin, ice pack Lasted 3 days, then abated for 2 more. (much longer than any other vaxxes)
pain in back; headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in back) and HEADACHE (headache) 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 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced BACK PAIN (pain in back) and HEADACHE (headache). At the time of the report, BACK PAIN (pain in back) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment information not was provided.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.   In 2022, the patient received doseof mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome 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 ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant medication was not provided.  Pharmacist reported that 20 adult patients  received 0.25 ml instead of 0.5 ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.  Treatment information was not provided.  This case contains information for the 1st patient of twenty adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-662881:Patient14 US-MODERNATX, INC.-MOD-2022-663014: US-MODERNATX, INC.-MOD-2022-663016:Patient 1
Failed at vaccine table. EMS evaluated. P66 SaO2 98% R18 BP100/72 3:45 P 63 Sawyer 94% (cold finger) R16-18 BP 90/pulse 4pm P62 BP 118/Pulse SaO2 90% Husband came to take clientele. Drank 2 waters and had recent shoulder surgery
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers 33rd out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Upset stomach, headache, right fingers  cramp, chest pressure, forgetful, rashes in face and itching arms and neck, flushing
Transverse Myelitis relapsed. I was able to use a walker, now I am back in a wheelchair. I lost about 80% of my mobility overnight.
I was about 3 weeks pregnant at time of vaccination (Due date 9/3/2021). I experienced spontaneous abortion at 6 weeks gestation.  Uncomplicated, no doctors visits or hospitalization required (though I am a physician so tracked HCG levels throughout). G3P1, one prior missed spontaneous abortion  2017, one live birth 2019.
they felt a little sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (they felt a little sluggish) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-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 experienced SLUGGISHNESS (they felt a little sluggish). At the time of the report, SLUGGISHNESS (they felt a little sluggish) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2022-456314, MOD-2022-456291 (Patient Link).
Arm hurt a lot; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-Jun-2022 Reporter's Comments: The patient was over the age of 50 years. The patient received 1st dose of Shingrix about 2 years ago in 2020. The patient held off getting the 2nd dose because her because her arm hurt a lot after that first dose. The reporter did not have patient date of birth and vaccination information like date, lot and expiry. The reporter consented to follow up via mail.
I woke up with terrible pain in left arm...radiating down into left hand..weakness developed to point where unable to move arm at shoulder. (My arm was sore from the evening of the injection, but flu shots generally do that...this became severe on 9/24/13).
FELT HOT, LOWERED HERSELF TO THE GROUND. BECAME UNRESPONSIVE OF LESS THAN 1 MINUTE.  ALERT AND ORIENTED AFTER.  STATED SHE WAS NERVOUS ABOUT VACCINE. OBSERVED
A LARGE RED CIRCLE AND PAIN APPERARED. IT WAS 6 IN, BY 4.5 IN. THE INJECTION SITE WAS 1.5 IN. BY 1 IN. IT WAS A DARKER RED. IT BECAME REDDER BY EACH DAY AND ON DAY 10 THE INJECTION SITE STARTED TO PEEL LIKE A BURN. I DO HAVE PHOTOS AND TILL TODAY I STILL HAVE A MARK FROM THE INJECTION SITE.
Right arm turned red, developed rash with itching. 24-48 hrs later, developed fever (102 degrees), chills with achy joints. She did not seek medical attention.
Outbreaks of shingles continued after having Shingrix shot; This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In August 2017, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 69 or 70 years old. The patient received 1st and 2nd dose with an interval of 2 months. The patient had 3 outbreaks of shingles per year which had continued after having two Shingrix shots.  The reporter asked whether a third dose ( or booster dose) could be given. The reporter agreed to follow-up. For tolerance of the 2nd dose, refer case US2021AMR200657 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR200657:Same patient, same reporter, same suspect, different dose (second dose)
Next day, muscle swelling at site of injection; 4-5 inch lump next day (2.5 weeks); muscle contractions over chest, neck, and upper back (lasted 8 hours).  Hot flashes (lasted 8 hours), and reddening in area of injection (lasted 2 days).
Patient stated shortly after receiving the vaccine, she started having severe muscle aches in her lower back, hips, neck and joints. Described the pain as an 8 out of 10 at onset. She was tired and achy. I spoke with her one week after receiving the vaccine and she still states she has pain all over, but it has decreased to a 6 out of 10. Says she was feeling fine prior to getting the shot.
Patient reported that 2 to 3 days after being vaccinated that his arm started to hurt, and the he has been having moderate to severe pain in his arm since then.  He is now going to follow up with his pcp
dizzy, lightheaded, nausea, headache, neck pain, fatigue.  hit me like a frying pan to the face 5 hrs after vaccination.
Patient developed redness with rash around injection site that is about 2 inch in diameter; oval shaped area around upper left arm. Patient didn't seek any treatment. She just asked about it but I told her I would report. Told her to watch for increase in size.
I developed first flu like symptom the day after vaccination and shortness of breath 3 days after vaccination
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8737), in left arm, on 21Apr2021 as dose 2, single (Lot number: ER8729), in right arm and on 13Nov2021 at 16:30 as dose 3 (booster) single (Lot number: 3230BD) at the age of 57 years, in right arm for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIOTHYRONINE. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19 Treatment/tested positive and Started Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of Covid-19. Additional information: Adverse event- Had symptoms but tested negative. Next day, tested positive and Started Paxlovid. (Calling this Day 1). Took full course (5 days) Paxlovid. Felt much better by Day 4 but still slight symptoms. Rapid test had bold line Days 1-6. Day 7 test showed very faint line. Day 10 got sick again, different symptoms (sinuses involved now), felt very fluey, had fever again, and rapid test showed bold line again. Felt better after several days. Rapid tests continued to be positive until Day 16 when I tested negative. Anti-viral details- Product-COVID 19 Treatment includes, Brand- Paxlovid. Treatment start date was 18Mar2022, Treatment stop date was 22Mar2022, Lot number-FW6343. Indication was Treatment of COVID-19. Adverse event start date was 27Mar2022, patient was recovered. Adverse event stop date was 02Apr2022.
mild sore arm for about 2-3 days; feeling a little more achy; had a low grade fever of 100; a bit of a headache; I don't feel very ill just a little under the weather; This is a spontaneous report from a contactable nurse, who is also the patient.  This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Dec2020, the patient experienced mild sore arm for about 2-3 days and about a week out she started feeling a little more achy and she had a low grade fever of 100 and a bit of a headache but she didn't feel very ill just a little under the weather. The outcome of the events was unknown.  The information on the lot/batch number has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 3:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 3:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.  Age of patient was reported as 35.32 for dose administered on 28-APR-2021.  Batch number 007C21A underwent temperature excursion on 28-APR-2021 with temperature 33 degrees Fahrenheit at 9.00 AM. Condition of vaccine prior to administration was not frozen and number of vials sent to clinic were 4. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 28-APR-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degrees Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.
DEVELOPED COVID 7-4-2022. SCRATCHY THROAT FEVER VARIABLE FOR 2 DAYS 100.3 DEGREES TO 103 DEGREES WEAKNESS, MALAISE BED-RIDDEN 2 DAYS OUT OF WORK FOR 8 DAYS ALSO LOSS OF SMELL & TASTE. SMELL & TASTE STILL  DIMINISHED AS OF 10-5-2022
That evening began experiencing swelling and discomfort of entire L arm. Came to the doctor's office this morning for evaluation, still with marked swelling, discomfort, minimal erythema and warmth.
Developed intermittent itching and swelling around vaccination injection site.  Lasted approximately 3 days.
Right arm pain after her PNEUMOVAX injection on November 8, 2017. Her arm was initially just sore.   By suppertime at 6:30 p.m. the pain worsened in her right shoulder. She was unable to move the right arm and needed the assistance of her daughter to help her brush her hair. She rates the pain at a 9/10 on the numeric pain scale and describes the pain as shooting with attempts at moving her arm. From the right shoulder to the right elbow the pain is sharp and constant. From the right elbow to the right wrist, the pain is different. She has tingling in her fingers and she states her hand and fingers feel cold to the touch in comparison to the left side. She also reports numbness in the right arm. She has tried ice and heat, neither helped more than the other. She has also tried ibuprofen and Icy Hot without relief. She reports disrupted sleep due to the pain. Patient is right hand dominant. Work excused provided. At this time, symptoms appear to be localized reaction to the immunization. Five day course of prednisone as prescribed. May use acetaminophen, ibuprofen or Naproxen once course of prednisone is complete. Work on range of motion of the right shoulder and arm. Exercises provided. had follow up visit on 11/15/2017 and released back to work with a restriction to not lift more than 25 lbs. and a tapering dose of prednisone given, and to follow up again in 2 weeks.
expired vaccine from last years flu season '22-'23 was given (exp 6/30/23) no ADRs occures.
Injection site pain; This is a spontaneous report received from a contactable reporter (Pharmacist).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left upper arm - red rash that is painful to the touch, located on anterior portion of deltoid.  Rash is not raised, nor does it contain bumps.
Nausea, rash (large areas of body), muscle weakness and trembling. SOB. Primary care physician thinks the flu shot triggered an auto immune response.
Patient received Gardasil and Menactra.  Remained seated for approximately 5 - 10 minutes and was discharged.  Became clammy and faint when walking to check out of office.  Mother noticed she was very pale and asked if she was all right - the child said not.  Mother lowered her to the floor.  At that time the child's eyes rolled back and her lips and mouth were drawn back.  She lost consciousness for a few seconds and then came to on her own.  She was examined by a physician who came immediately.  Her pupils were slightly dilated, her B/P was slightly lower than normal.  When asked if she knew where she was she responded + and she also remembered what had gone on before her syncopal episode.  The patient left the office on her own without further difficulty.