chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upper arm soreness in both arms; it's like muscle strain; upper arm soreness in both arms; it's like muscle strain; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored Program. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration Date: not provided), dose 2 via an unspecified route of administration on 09Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (at the age of 68-year-old) for COVID-19 immunization. Patient received her second dose of the Pfizer BioNTech COVID-19 vaccine on 09Mar2021 and since then had been experiencing soreness of both her upper arms, which feels like muscle strain (Mar2021). She would like to know how long this side effect will last. The outcome of events was unknown.  Information on the lot/batch number has been requested.
The dpt shot was administered late morning on July 16, 2007.  By afternoon, our child was running a 104 degree temperature.  He awoke from his afternoon nap red and shaking.  His temperature was 105.  He was put in cold water to bring his temperature down.  He was given motrine continously, every four hours after receiving the shot.  We took him to see the doctor at 5:00pm.  His temperature and shaking had stopped and he was acting normal.  During the early am hours, our child awoke again with a nearly 105 degree temperature.  This time he was shake and having muscle spasms every 15 seconds. Some of these spasms caused him to bounce in his baby bed. (This lasted over an hour.)  We gave him more mortin immediately.  We called the doctor and spoke to a nurse.  We took patient to the emergency room, but by the time we arrived he was acting completely normal again and we were advised not to check him in, but to take him back home because he had no symptoms at that time.  The fever and muscle spasms were gone within 48 hours of the shot.  About a month later our son began to break out with hives.  They are telling us these are due to a viral infection.  My husband and I believe that the hives are due to this shot reaction.  He has had the hives for one month.  Milk, peanuts, and wheat now cause him to break out severely.  He had no allergies to foods prior to this shot.  The allergist says that the foods are unrelated, and that this will pass with time. He said it is a viral induced case of hives that could last 3 or 4 weeks or so. He has had them now for four weeks.  They keep coming and going.  He has taken almost four bottles of benadryl and is now taking zyrtec.  Some hive outbreaks are severe and cause his mouth to water. We are still waiting for the hives to resolve.
received an expired product with no reported adverse event; Initial information received on 17-Nov-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 16-year-old female patient who received an expired product with no reported adverse event after receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine.  On 16-Nov-2022, the patient received 0.5ml (once) dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (batch lot: U7140BB) (expiry date: 07-Nov-2022) via intramuscular route in the left deltoid (form, strength: unknown) for Immunization.  On 16-Nov-2022 the patient developed a non-serious event of received an expired product with no reported adverse event (expired product administered) (latency: same day) following the administration of Meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken with meningococcal vaccine (menactra) was not applicable.  Outcome: unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a licensed practical nurse and refers to multiple patient of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 degree F, time frame of 3.75 hours) of M-M-R II rHA, lot # L024268 with expiration date 01-JUL-2017 and lot # L027432 with expiration date 22-JUL-2017 (dose and route were not reported). No known adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
The father said that on his drive back after the vaccination, patient experienced a seizure like experience, his arm was seizing and his eyes rolled back, but he came to normalcy on his own. Parent called his pediatrician and was advised that if it persists to contact ER. Father said that the patient was okay for the next few hours.
a week after vaccination, patient developed fatigue and weakness, SOB, eye ptosis similar to her myasthenia flares. she was admitted for IVIG and discharged 1/31
w/in 10 mins p/inject was given had head congestion, stuffy nose, dizziness, flu-like sx started 3-4 hrs later; the next day c/o pain & ache in back;
Client received vaccines on 4/1/2004.  On friday, 4/2/2004.she spiked a temperature of 103, she was sent home from school and mother gave her Tylenol x1.  Over the weekend she continued to spike temperatures around 102.3.  Mother is giving child Motrin/Tylenol prn.  On Monday, 4/5/2004 client temperature 102.7, mother went to the ER, they told her it was a normal reaction to the vaccines she got, told her continue with Motrin/Tylenol,. On Tuesday the child was still spiking temps of 101 and 102.  Mother called her child's doctor.  They told her the same thing again.  VIS sheets were given to father at time vaccines were given and mother did tell the person filling out this form that she did read them.
have had both shots and just got over having shingles/Suspected Vaccination failure; just got over having shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both shots and just got over having shingles.  The patient asked so this ad was false advertisement. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting.
a red spot on her left eyelid; swelling around both corners of mouth; swelling of her knuckles on her right hand; shoulder was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA OF EYELID (a red spot on her left eyelid), CIRCUMORAL SWELLING (swelling around both corners of mouth), JOINT SWELLING (swelling of her knuckles on her right hand) and ARTHRALGIA (shoulder was sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ARTHRALGIA (shoulder was sore). On 20-Mar-2021, the patient experienced ERYTHEMA OF EYELID (a red spot on her left eyelid), CIRCUMORAL SWELLING (swelling around both corners of mouth) and JOINT SWELLING (swelling of her knuckles on her right hand). The patient was treated with PREDNISONE for Adverse event, at a dose of 3 dosage form; CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Adverse event, at a dose of 10 mg once a day and FAMOTIDINE for Adverse event, at a dose of 20 mg once a day. At the time of the report, ERYTHEMA OF EYELID (a red spot on her left eyelid), CIRCUMORAL SWELLING (swelling around both corners of mouth), JOINT SWELLING (swelling of her knuckles on her right hand) and ARTHRALGIA (shoulder was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient had been to emergency room and they prescribed medications and patient was discharged back home.
About 2 weeks after vaccination received, patient states he began to have more fluctuations in his glucose levels as well as heart palpitations. Reports that his glucose levels do not generally go above 180. As glucose levels kept increasing, patient began exercising more. In early July, started to have levels in the 400s. Started to feel more dizzy & weak and had polydipsia and increased frequency of urination. He went to the Emergency Room on 7/8/2021; glucose level was 373. He was given IV fluids and 6 units of regular insulin. Glucose level came down to 252 prior to being sent home and instructed to follow up with his Doctor. Patient had follow-up labs on 7/12/2021, which show hemoglobin A1c of 10.0% and glucose level of 272. Prior to vaccination, patient's hemoglobin A1c was 6.5% and glucose level 135 on 1/29/2021. Historically, this patient's A1c has been between 5.3 and 6.5 since 2014. His BMI is 28, actively exercises and has been adherent to his diabetes regimen of metformin 500mg twice daily.
10 Watery stools with blood over the last 3-4 days. Slight decrease weight, improved today. Feeding well, no fevers.
Patient had swelling of arm (right) that lasted about 3 days with pain. Was starting to subside when reported worse with PNEUMOVAX arm.
Patient developed impingement syndrome a week after receiving vaccine. She has muscle weakness, inability to grasp heavy objects, etc. Her doctor prescribed MOBIC for her, which she started today (4 weeks after the vaccine).
initially inconsolable & febrile (tactile) day of vax; following AM brief generalized sz x 4; (1 w/no fever); pt given Phenobarbitol; seen by MD;
In 30 seconds: Severe headache - a 10 on a scale of 1 to 10, severe Vertigo, severe Nausea, Shortness of breath, tight abdomen, throat felt like it was closing, profuse perspiration. No treatment action was taken at the clinic despite my report of a reaction. Went to ER much later in the day. Prescribed EpiPens by a ER doctor.
Low white blood cells, low lymph, no taste no smell, neurological  disorders, dizzy, fatigue ongoing for 7 weeks
Severe diarrhea .abdominal distention. cramping. Nausea.
entire lt arm inc red, hot, swollen, lt axillary has warm red lump approx 1x1inch noted;
fever up to 37.8 with sweating; fever up to 37.8 with sweating; CRP 90; Sedimentation rate 70; pain in left groin; This is a spontaneous report from a contactable physician.    A 88-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Right on 03Feb2021 09:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation  .  Age at vaccination :88 years.Medical history included Bilateral inguinal hernia Repair. Facility type vaccine: Unknown;No  other vaccine in four weeks; No Other medications in two weeks.  The patient experienced fever up to 37.8 with sweating (non-serious) on 03Feb2021 11:00 with outcome of not recovered ,  crp 90 (c-reactive protein abnormal) (non-serious) on 03Feb2021 11:00 with outcome of not recovered , sedimentation rate 70 (non-serious) on 03Feb2021 11:00 with outcome of not recovered , pain in left groin (non-serious) on 03Feb2021 11:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 37.8   on Feb2021   , c-reactive protein: 90   on 03 Feb2021   , red blood cell sedimentation rate: 70   on 03Feb2021  .  The action taken in response to the event(s) for bnt162b2 was not applicable.  The patient received treatments for all events: Acetaminophen and Celecoxib.The adverse events resulted in: Doctor or other healthcare Professional office or clinic visit.Addiitonal information :No covid prior vaccination. No covid tested post vaccination. The patient received dose 2 of bnt162b2 (Brand Pfizer) intramuscular, administered in Arm Left on 24Feb2021 11:00 (Batch/Lot number was not reported) as DOSE, SINGLE,  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
3 days after getting 1 dose of Pfizer vaccine I started I had pain in my left arm and was losing feeling from the injection site into my fingers--tingly feeling.  Joint pain in both hands--this subsided about 10 days afterwards.  13 days afterwards, my abdomen swelled--normal waist is 27--went up to 30/31 inches.  15 days afterwards (today) ankles swollen and tingly in both feet but the left worse than the right.  Period is also 10 days late as of today--I was regular before the vaccine.
MENACTRA shot into the medical assistant's eye with no adverse event; administering Menactra, as she was pushing down on the plunger the needle popped off syringe with no adverse event; Initial information with live follow up regarding an unsolicited valid non-serious case from other health care professional and physician via Medical Information (MI) (Reference number- 00702860) and transmitted to Sanofi on 29-Jul-2021.  This case involves a 17-year old male patient for whom it was reported that MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] shot into the medical assistant's eye (accidental exposure to product) and administering the suspect vaccine, as she was pushing down on the plunger the needle popped off syringe (device issue) (lot number: U6951AB and expiration date: 06-Jun-2022) at a dose of 0.5 ml via intramuscular route in the unknown site for prophylactic vaccination.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications were not reported, and concomitant vaccination included HPV VACCINE.  It was an actual medication error case due to Accidental occupational exposure to product and device issue (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial report received from a healthcare professional on 10 OCT 2013, 9 patients were treated with expired FLUZONE ID . No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: None.
About 5-6 days after vaccination began having itching and redness in left eye. The issue spread to my right eye and I made an appointment with eye doctor. The doctor treated with sulfa which I reacted to exacerbating  the issue. I was then prescribed drops that cleared it up. Around the same time I began experiencing dermatitis eruptions on many locations on my body. I have followed up multiple times with dermatologist but have been unable to ascertain the cause of my break outs.
lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red and swollen; gums red and swollen; soft palate; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperthyroidism, menopause and COVID prior vaccination. The patient is not pregnant. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), dexamethasone (DEXAMETHASONE), methimazole (METHIMAZOLE), estrogens conjugated (PREMARIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE]), azithromycin (Z-PAK), and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient had no other vaccine in four weeks. The patient previously took Erythromycin (EES) and Levaquin and experienced allergies. The patient experienced swelling of lips, gums red and swollen, soft palate, lymph nodes in neck swollen/tender on 08Jan2021 at 10:00. The patient had not tested for COVID post-vaccination. No treatment was administered for the events. The events had not resolved.
Pt states her left side of face/head and neck felt numb. States symptoms are improving.
pt recvd vax 11NOV92 & 12NOV92 pt felt tired, weak, & lethargic & slept off & on all day long; stated that did not feel sick, but felt like could not move; 5MAY93 lab eval was neg for anti-HBs; No further details were provided;
Full body morbilliform rash.; Hives started on trunk and proceeded to limbs; Hives grew together to form plaques; plaques spread over all skin, including palms and soles of feet but did not enter mucous membranes.; Entire body turned red, like a sunburn.; The hive-to-plaque transition was very itchy.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the right arm on 15Apr2021 at 12:30 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included borderline high blood pressure (HBP). Concomitant medication included varicella zoster vaccine rge (CHO) (SHINGRIX) received on 26Feb2021 for an unknown indication. The patient's past drug included possibly azithromycin (unconfirmed) also the patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 18Mar2021 at 12:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 01:00, the patient had experienced full body morbilliform rash, hives started on trunk which proceeded to limbs that grew together to form plaques which had spread over all skin, including palms and soles of feet but did not enter mucous membranes, entire body turned red like a sunburn and the hive-to-plaque transition was very itchy. The rash cleared in five days, with minor flareups over two subsequent days. Therapeutic measure was taken as the result of adverse event which included treatment with diphenhydramine. The clinical outcome of the events morbilliform rash, hives started on trunk which proceeded to limbs, plaques which had spread over all skin, including palms and soles of feet, sun burn like rash and  hive-to-plaque transition was very itchy was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Developed an arthus type hypersensitivity reaction with thigh swelling starting 3-6 hours after vaccine and peaking at 24 hours with a fever of 104.2F, skin hypersensitivity with pain and difficulty ambulating
Arm where injection was received started to hurt 01/26/21 with swelling, redness, warm to touch and itching. Applied cortisone cream for itching with much improvement. States today redness, swelling, and itching is better but not resolved yet.
Evening after vaccine developed blurry vision, headache. Got worse every day. Developed dizziness, lightheadedness in the coming days. This transitioned to tunnel vision. Within 2 weeks I developed stroke symptoms, the right side of my face went numb. I was told to go to ER. Knowing my history if IIH I felt that it was related to that and that it had come back so I did not go to ER. Instead I called my PCP who then sent me to see my eye doctor and a neurologist. The eye doctor could not find a reason for my tunnel/blurry vision. Neuro ordered a STAT MRI to rule out stroke and that was negative. I was started on Diamox again, assuming it was my IIH again. Symptoms began to resolve after I went back on Diamox but still suffered from daily headaches, extreme fatigue, dizziness and lightheadedness for a few months after.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 04-DEC-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for the vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
4 year old who developed fever, right arm cellulitis, swelling, and itchiness after having a DTaP vaccine. Patient also had several episodes of vomiting on 8/20/18 and arm was warm to the touch. Mom reports the child had impetigo for 3 weeks about 1 month ago. Not sure if this is related.