chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 4:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:21 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.54 and 40.62.  Concomitant products were not provided.  On 02-Mar-2021, Excursion time was 09 AM, 10 AM, 11 AM,12 PM, 2 PM, 3 PM temperature was 27, 29, 32, 33, 35, 36 total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 02-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM: 36, 2 PM: 35, 3 PM: 36, 4 PM: 37 and 5 PM: 37.  On 30-Mar-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  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 traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
We went and sat down right after the shot and shortly later he was complaining that his head was hurting. Then he said my head feels funny and my arm is throbbing and I said to give it a couple more minutes, then we talked to the nurse because he was really light headed. The nurse there at the site monitored him, he drank water and ate some crackers and checked his BP. Monitored all his vitals basically. He said he was able to get up and walk after about thirty minutes so we left after that.
Pt reported outbreak of shingles 3 weeks after receiving the ZOSTAVAX vaccine. Pt is associating her outbreak to the vaccine.
Mom and patient came to HD on 3/27/17 and stated that left arm started getting red and swollen on morning of 3/24/17. Around noon, blisters started showing. Mom took patient to PCP. 1 shot of antibiotic and 1 shot of steroid plus Rx for antibiotics. 3/27/17 Arm is still red, blisters gone.
While the pt was waiting in observation she reported feeling tingling in her right hand. Pt was evaluated by RN. Pt denied other symptoms. Well otherwise.  Pt denied EMS evaluation. Pt reported feeling better. The pt was given strict ED precautions. Pt verbalized understanding.
Coincidental - spontaneous fetal demise @ 14 wks occured four days after injection of H1N1 - again, probably just coincidental, but wanted to report, nevertheless
Had vax on 2/13/03 w/a major take, had an enlarged lymph node under left arm and minor fatigue that is still noted. On 4/5/03 started having severe pain in tail bone, but no memory of injury or fall. On 4/6/03 went to ER and a x-ray of the coccyx was done and showed no fractures but showed inflammation which was Tx'd with an injection and 2 prescriptions, Bextra & Percocet. Off from work on 4/7/03. On Wed, 4/9, went to family MD for routine 6 month blood work (has taken 20-40 mg Zocor for about 2 yrs, Levoxil, and INH for positive skin test since Jan. 03). Lab results showed Alk. P. 211 SGPT 874, and SGOT 666. Family MD and TB clinic MD recommended to stop all meds except Levoxil for Thyroid prob's (had Thyroid removed in 2001). Thyroid levels at blood work was w/in the normal range and Cholesterol level was 274. Due to return to family MD for repeat blood work on Wed, 4/16/03.
Flu like symptoms: Chills, body aches, muscle aches, bone pain, headaches, feeling like fever w/o fever. Lasting about 6-10 hours and occuring about once a week since vaccine taken. Not sure when this will end??
Pt immediately noticed some dizziness, HA, and tingling in both her hands. On 7/22 she noticed swelling and redness (8x7 inch) of her R deltoid around the injection site, fever, weakness. No pus drainage. Pain is worse with movement. No more hand tingling. Redness resolved w/ KEFLEX.
body have a reaction to the second vaccination shot; 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 VACCINATION COMPLICATION (body have a reaction to the second vaccination shot) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (body have a reaction to the second vaccination shot). At the time of the report, VACCINATION COMPLICATION (body have a reaction to the second vaccination shot) outcome was unknown.            NO CONCOMITANT DRUGS WERE PROVIDED. NO TREATMENT DRUGS WERE PROVIDED.
vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a hospital.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014, the patient was treated in a hospital, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
FEVER, CHILLS, VOMIT OVERALL SHE STATES SHE FEELS " WEIRD ".  SHE HAS TAKEN ADVIL PM 250 MG SO SHE CAN REST.
My white blood cell count is low (was never low before) My period stopped suddenly and hasn't started again I have severe hot flashes 20-30 times per day
Pt reports mild dizziness about 8-9 minutes following his first COVID Pfizer mRNA vaccine then later complained of throat swelling, dizziness, fatigue, light headedness, and nausea. Patient was kept in urgent care and stayed in observation for over 2 hours.
No additional AE reported; A four year old received an intramuscular injection of PROQUAD instead of subcutaneous; This spontaneous report has been received from a registered nurse, referring to a 4-year-old patient of unknown gender. The patient's medical history, the patient's concurrent conditions, concomitant therapies, allergies and drugs reactions were not provided.  On 17-MAR-2022, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) as prophylaxis at dose of 0.5 mL (lot number U022728 has been verified to be a valid lot number, expiration date reported as established as: 16-JAN-2023) and was given intramuscularly instead of subcutaneously (incorrect route of product administration). No additional adverse event was reported.
headaches; itchy; pain on the arm like it has been punched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (maybe 10 years before this report), for Immunization; Shingrix, for Immunization, reaction(s): "arms started to itch", "rash on her whole arm". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; PRURITUS (non-serious), outcome "unknown", described as "itchy"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain on the arm like it has been punched".  Additional information: Patient mentioned that she got the Pfizer Covid-19 vaccine "booster" yesterday. She said she never had a bad reaction to the Pfizer covid-19 vaccines. She only felt slight headaches. She wants to check if it is normal to feel itchy and have pain on the arm like it has been punched.  The patient mentioned that she got the Pfizer Covid-19 vaccine "booster" yesterday. She said she never had a bad reaction to the Pfizer covid-19 vaccines. She is looking to get the Pfizer RSV vaccine (Abrysvo). She wants to know if she should space out the vaccination. She also mentioned that her doctor told her to space them out and not get them all at once. Additional research is ongoing to further inform guidance on same-day administration of the RSV vaccine and other adult vaccines, including the COVID-19 vaccine. The patient had several questions regarding the pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), rsv vaccine prot.subunit pref 2v (ABRYSVO) and Pfizer Covid-19 vaccine for adults.  The patient mentioned that she got the Pfizer Covid-19 vaccine "booster" yesterday. She is planning to get the ABRYSVO vaccine a four more weeks after. She wants to know if it is okay to have it on her left arm where she got her covid-19 vaccine. The patient said she took the Prevnar 13 vaccine when it first came out and she doesn't know if she should take the Prevnar 20 vaccine now since she already has the Prevnar 13 vaccine. The patient is looking to get the Pfizer RSV vaccine. She mentioned that she had a reaction with the Shingrix, a shingles vaccine. She thinks the Shingrix vaccine is an adjuvanted vaccine because she had a reaction where her arms started to itch and there is rash on her whole arm. She went to the dermatologist and was advised to not take the second dose anymore. She wants to know if the Pfizer RSV vaccine is adjuvanted.
Light headedness, heart palpitations, tachycardia, elevated blood pressure (hyper tension or pre hypertension),  general symptoms of dysoutonomia, aphasia, migraines, and one possible transient ischemic attack
Reaction from Varicella on (R) arm 10 cm with scab urticaria on arm legs, back.
The night after her shot, patient had a hard time sleeping.  She experienced "crazy dreams".   She's had a fever, chills, headache, tiredness, pain at injection site, and a feeling of overall discomfort.  She has been resting and sleeping all day.
pain at injection site; redness at injection site; swelling at injection site; knees aches; body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 19-APR-2023, the patient received Boostrix (intramuscular, left arm). In APR-2023, several hours after receiving Boostrix, the patient experienced injection site pain (Verbatim: pain at injection site), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swelling at injection site), knee pain (Verbatim: knees aches) and general body pain (Verbatim: body aches). In APR-2023, the outcome of the knee pain and general body pain were resolved (duration 2 days). The outcome of the injection site pain, injection site erythema and injection site swelling were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, knee pain and general body pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, knee pain and general body pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-APR-2023. The patient reported that she received TDAP vaccine in left arm on 19 April 2023. The patient stated that hours later she had pain, redness and swelling at injection site that had not resolved.  The patient also experienced knees and body ached for 2 days, resolved now.  The patient referred to health care professional Reporter consented to follow up.
Extended length of time for soreness in arm - moved down arm with some weakness. Occurred with second injection.
Initially stored in refrigerator in December 2021 and administered vaccine on 4 mar 2022; administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Initially stored in refrigerator in December 2021 and administered vaccine on 4 mar 2022) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored in refrigerator in December 2021 and administered vaccine on 4 mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Initially stored in refrigerator in December 2021 and administered vaccine on 4 mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Vial was initially stored in the refrigerator approximately 26 DEC2021, actually 16 DEC 2021 and administered booster vaccine. The vial did not undergo any temperature excursions.   Treatment information was not reported.
Case number PHEH2014US025121, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 67-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
heart racing and pounding the night of the shot while in bed. In the subsequent days, my resting heart rate is back to normal (around 60) but when I'm up and walking around in the home, my heart rate goes up a lot, I feel breathless, and my heart aches. I'm not able to lie on my left side without feeling pain in my heart. Today my heart rate while mildly active is slightly better, but the pain in the heart is more pronounced.
Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pulse; extreme nausea; This is a spontaneous report from a contactable consumer (patient).  A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Batch/Lot number was not reported), at the age of 43 years, as single dose for covid-19 immunization. Medical history included fibromyalgia and t5 back fracture. The patient is not pregnant. Concomitant medications included pregabalin (LYRICA); buspirone and cannabidiol (CBD OIL). On 16Apr2021 at 2 AM, the patient fainted 12 hours later and fell down to the ground after using restroom.  She was cold, sweating, slowed heartbeat and pulse, extreme nausea. The patient did not receive treatment for the events. The patient had No COVID-19 prior to vaccination and had not been COVID-19 tested post vaccination. The outcome of the events fainted, fell down to the ground after using restroom, she was cold, sweating, slowed heartbeat and pulse, extreme nausea was unknown.   Information about lot/batch number has been requested.
12AUG93 pt recvd vax & approx noon pt collapsed & hit forehead on desk & back of head on concrete floor: turned blue from nose to chin & stopped breathing; eyes rolled back in head; ashy, waxy color, mouth-to-mouth for approx 30 times; rash
Likely, all a vasovagal event, but his symptoms were quite prolonged. Within about 20 seconds, post vax, while standing, pt fainted briefly. He came to and was sitting down and then fainted again after BP cuff deflated. We laid the pt down. BP was 90/60, then 108/60 after 2 minutes; then 130/80, 3 minutes later. No airway compromise or rash. Pt was scared and had cool and clammy extremities for about 45 minutes. O2 sats were more than 98%. Pt had full recovery and no medicines were administered.
She received the Prevnar 13 vaccine subcutaneously and not intramuscularly; Arm is super red; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), subcutaneous, administered in arm left, administration date 26Aug2021 (Lot number: CM113) at the age of 39 years as dose 1, single for immunisation; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), administration date 26Aug2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Does not have a spleen/asplenic person" (unspecified if ongoing), notes: asplenic person; "immunocompromised" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Aug2021, outcome "unknown", described as "She received the Prevnar 13 vaccine subcutaneously and not intramuscularly"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "Arm is super red".  Additional information: The patient was asking for the efficacy of the Prevnar-13 vaccine when given subcutaneously and any information on immunocompromised individuals. She also asked if she would have to repeat the dose given that she does not have a spleen and if there are any other side effects she should look for because her arm was super red. Patient was advised to seek medical attention if she feels it's necessary.   No follow-up attempts are possible. No further information is expected.
Patient was never evaluated by our office. Was admitted and evaluated in patient at hospital. 2014 healthy 15 year old girl. Cheerleader, tumble classes, normal social activity and average student. 11/2014 First HPV injection-became dizzy and nauseated within an hour afterward. Called doctor, they said it can happen to get her from school and let her wait it out. 12/2014 Began to complain about leg pain constantly. Missed tumble classes several times that month. 01/2015 First sign of tremors. Was at a New Years' party and dropped food because she couldn't hold it. Humiliated. Started to hide hand tremors due to embarrassment. Received the second injection of the HPV that month. Again it made her sick and very dizzy. Called the doctor and they said it was normal. 06/2015 Received third injection of HPV. Once again, made her feel horrible for two days. Continued to complain of pain and not feeling good throughout the year. Had to stop tumble classes. No energy. Never felt well. Never slept. 07/2015 On family vacation and tremors were very bad. We called her pediatrician and made an appointment for when we returned in the first week of August. 08/2015 First doctor's visit for symptoms. After a very extensive exam, pediatrician very concerned. Referred to a neurologist. 09/2015 First Neuro. appointment. Scheduled a sleep study. Initial diagnosis was Essential Tremor. Normally not showing in a person until after 40 years of age. Neurologist stated that something brought it out early in life. No sign of tremor in mother or father. Sleep study showed Sleep Myoclonus in head. 10/2016 Tremor episodes began daily. Had to stop driving, had to quit job and school. Became a homebound student for remainder of her junior year. Episodes so severe, went to ER and was admitted. After returning home, pain in legs increased. Became confined to bed. Could not walk without assistance. Has to use a wheelchair when going out. 01/2016 Tremor seizure like episodes stopped but leg pain and normal tremors continued. Had to keep increasing meds, which caused a lot of side effects. 03/2017 Diagnosed with Dysautonomia (POTS) by Primary Care Physician. Up to present: Pain is manageable but still all symptoms and randomly has other symptoms and problems arise, acute asthma, rare skin autoimmune disorder and the list goes on. Patient has been a patient of mine for the last two and a half years. Patient has recently been under my care and has been diagnosed with POTS Syndrome and Essential Tremors that began after receiving the GARDASIL shot.
1 of 3 pts who recvd vax exp inject site react;  pt exp a react 2 inches below the needle site resembling a rubber band around the arm; arm was red & swollen;