chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient age : 10 Years; Feeling warm at injection site for 10 min; arm soreness 1 day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 18:00 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Feeling warm at injection site for 10 min"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "arm soreness 1 day"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 19Nov2021 18:00, outcome "unknown", described as "Patient age : 10 Years". Therapeutic measures were not taken as a result of vaccination site warmth, pain in extremity.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient presented the next morning with a swollen area and pain around the injection site. She also found discomfort raising arm above her head. Recommended patient take some Diphenhydramine and contact her PCP for follow up. I have tried to follow up with her also with no response at this time.
This serious case was received on 26 March 2009 from a consumer (patient's parent). A 23 year old male patient with seasonal allergies received ADACEL (lot number not reported) "4 weeks ago". 24 hours post vaccination the patient developed chills, fever, heart was racing. Within a few days he later developed numbness in his arms and legs, weakness, loss of balance, vertigo, flashing lights in his eyes, a lump in his throat, and difficulty swallowing. These symptoms have decreased but are still present. The patient was out of work for four weeks. He was seen by his physician, a neurologist, and an eye doctor. He was started on Ativan and he is now calmer. GBS (Guillain-Barre Syndrome) was ruled out. No further information was provided. List of Documents held by Sender: none.
Headache; The needle had not been completely secured; I felt fluid rushing down my arm/solution ran down her arm/It ran to her elbow, she saw a collection of fluid at her elbow/ Two drops of medication leak down her arm; I had a lump on my arm the size of a large jaw breaker in my arm/hard lump at injection site/she had a hard lump the size of a large jawbreaker for about 5 hours; bruising at the site; This is a spontaneous report from a  contactable  consumer  reporting for herself and a nurse.    A 82-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine, via an unspecified route of administration in the left arm  on 29Jan2021 13:30 at single dose  for Covid-19 immunisation .  Medical history included anticoagulant therapy , bone disorder, vitamin D deficiency (vitamin supplementation), probiotic therapy, rhinorrhoea, lung congestion, dry eye .  Concomitant medication included acetylsalicylic acid (ASPIRIN 81), calcium carbonate, colecalciferol (CALCIUM 500+D3), colecalciferol (D3), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS), bifidobacterium infantis (ALIGN) , guaifenesin (MUCINEX), macrogol 400, propylene glycol (SYSTANE), metronidazole (METRONIDAZOLE).  The patient experienced the needle had not been completely secured  on 29Jan2021 with outcome of unknown ,  felt fluid rushing down her arm/solution ran down her arm/it ran to her elbow, she saw a collection of fluid at her elbow/ two drops of medication leak down her arm  on 29Jan2021 with outcome of unknown , i had a lump on my arm the size of a large jaw breaker in my arm/hard lump at injection site for about 5 hours  on 29Jan2021 with outcome of recovered , bruising at the site  on 29Jan2021 with outcome of not recovered , headache on 30Jan2021 with outcome of recovered.  The patient took Tylenol for her  headache. The patient stated that states her injection site was already black and blue when she got home and removed the bandage. Adds in her photo her whole shoulder is yellow and it looks jaundiced.  The nurse stated that the incident occurred on Friday 29Jan2021 , so they had multiple different type of syringes and needles that was using to administered and they had a vaccinator who was using a lower lock syringe in which you case you know you have to secure the needle by twisting in to that lower lock and when he went to administer the vaccine to the patient two drops of medication leak down her arm, so of course we are at that point the vaccinator realize the lower lock and that the needle had not been completely secured so we don't know how much vaccine the patient actually received.  Information about Lot/Batch number has been requested.
No Adverse event. Pt received Moderna as first dose per immunization registry. Pt signed up for pfizer and received pfizer vaccine as second dose.
Received Shingrix on 6/19/19 Returned to pharmacy on 6/21/19  MD visit with redness/swelling on arm  Given steroid shot and antibiotic
pt recvd vax; fever 101.5; high pitched cry, persistant crying for 4 hrs;a wheezing sound when breathing;"jumping" when moved that mom relate to tenderness, swelling in leg; MD said pt had pneumonia;
So a day later, I had hives and my scalp was very itchy and lots of fatigue.
Employee was given vaccine in right deltoid approximately 6 finger widths down from the shoulder. Approximately 3 wks after injection arm still sore. Saw MD no signs of any complications at site, just pain reported by employee. No fever, no redness, but employee reports pain with lifting arm above shoulder more in AM.
Erythematous, slightly raised area on deltoid surfaces bilaterally, (L) arm approx 4 in. diameter, (R) arm approx 3 in. diameter. Tender to palpation. Tx: BENADRYL, ice packs, ADVIL for fevers.
This case was reported by a physician and described the occurrence of seizure in a 4 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not known. The physician reported that she believes that the subject potentially had a urinary tract infection at the time of vaccination. In August 2006, the subject received the 2nd dose of Pediarix at 0.5ml. The lot number and expiration date were not reported. An unspecified amount of time following administration of Pediarix, in August 2006, the subject experienced a seizure and was hospitalized. The physicians felt that the subject potentially had a urinary tract infection at the time of Pediarix vaccination which could have been the cause of the seizure. In the physician's opinion, the event was not related to vaccination with Pediarix. The event resolved.
Injection site soreness and dark red circle for 3 weeks Severe chills 4 days Dizziness Headache Nausea
Developed mild tongue swelling and lips "felt funny". Took 1 Benadryl and symptoms improved slightly. Extended her monitoring time in clinic until symptoms subsided. No further report of symptoms.
It was reported 11/29/01 that Fluzone  (lot # Uo692AA) was administered on 11/27/01. On 11/29/01, recepient reported to school nurse with a local reaction of redness and swelling. Patient advised to see her physician for follow up 11/29/01. School nurse instructed to take either ibuprofen or acetomenophen for any side effects. PMH-sulfa allergies.
pt w/excessive crying & screaming few hr p/vax per parents;advised APAP drops, small, frequent feedings & hold pt frequently;recv vax 21OCT96 pt seen 22OCT & 23OCT96;
Bilateral lower extremity weakness, bilateral hand paresthesia, areflexia - diagnosed as Guillain Barre Syndrome by neurology team
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
body aches; muscle soreness; headaches; being tired; chills; throwing up; This is a spontaneous report from a contactable other healthcare professional (patient himself). A 47-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer -Biontech Covid-19, lot/batch number and expiry date were not reported), intramuscularly in the left arm on 19Jan2021 20:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included CHF (congestive heart failure). He was not diagnosed with COVID-19 prior to vaccination and did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 22Jan2021 17:00 he started to have body aches, muscles soarness, headaches, felt being tired with chills and throwing up about a week. No treatment was given. The events were reported as non-serious. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Immediate swelling/raised and red area with some itching. Day 9 increased itching/irritation, hot to the touch and still swollen and red raised area.
87 year old female with PMH of A fib, CLL, HTN, HLD, gout, pHTN, and OA who presented to the ED on 9/10 for weakness after testing positive for COVID on 9/9. Symptom onset was 9/9 - fevers, weakness, vomiting x 1. Patient was walked in ED and she de-satted <88%. CXR notable for cardiomegaly with pulmonary edema and possible superimposed infection. XR R hip/pelvis showed chronic L4 fracture. Spine X ray notable for chronic severe burst fracture at L4. Ortho consulted - non-op, will follow up in spine clinic outpatient. Admitted for monitoring of hypoxemia. Patient is hemodynamically stable. Fevered overnight on 9/10 and is on2L O2. Will trend inflammatory markers today.  -Wean O2 as needed - previously on 2 L up to 5 L on AM of 09/14; decreased to 3L and was satting at 93%
Moderna 6/3/21, 7/1/21. Positive on 2/12/22
Patient presented to emergency department on 7/24/2021 with complaints of shortness of breath, weakness, fatigue, bloody stool. Also reports having chills and has a mild cough.  Patient has COPD.
Injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Feb2021 (Lot number: EL3249, Expiration Date: May2021) at the age of 74 years as dose 1, single and intramuscular, administration date 09Mar2021 (Lot number: EN9581, Expiration Date: May2021) as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous, administration date Oct2020 (Lot number: 1156892) as 150 mg (1 in 12 wk) and subcutaneous, administration date 18Dec2021 (ongoing) (Lot number: 1156892) as 150 mg (1 in 12 wk) for psoriasis. Relevant medical history included: "Atrial Fibrillation", start date: 1996 (unspecified if ongoing); "Non-smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation; AMBIEN taken for insomnia. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 15Feb2021, outcome "recovered" (10Mar2021), described as "Injection site pain". The action taken for risankizumab was unknown.  No follow-up attempts are possible. No further information is expected.
Pfizer / BioNTech: Dose Number: 4; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 4; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Obese" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sulfa allery, reaction(s): "Known allergies: Sulfa"; Penicillin allergy, reaction(s): "Known allergies:penicillin" .The following information was reported: COVID-19 (medically significant) with onset 10Jun2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 4; Paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and covid-19 and BNT162B2.
evaluated for shortness of breath. Over the last 3 days, the patient has experienced progressively worsening shortness of breath with an accompanied productive cough
Left side facial numbness, intermittent eye and cheek pain, at times entire left side numbness, crawling feeling to left side intermittently
a reaction to the Moderna vaccine; A spontaneous report was received from a consumer about a reaction to the Moderna vaccine and some questions about the reaction   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   No Laboratory details was provided.  No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the event was unknown
C/O nausea, irritable, nervous, low grade temp with chills, headache. Slightly red raised localized reaction.
Fever GI tenderness, chills, shaking Narrative:  Treated with OTC tylenol and ibuprofen
Received flu vaccine in left arm on 10/25/16. Welted almost immediately and redness progressed, arm became swollen and red to the touch.
Muscle pain; muscle pain, they felt tense; Weakness in her legs; She feels "anguish" in the chest; Headache; Felt pricking on her legs; Nausea; This is a spontaneous report from contactable consumer. This 42-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 14:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19 one year ago (feeling the pricking on the legs). The patient's concomitant medications were not reported.  Patient had "too much" muscle pain, they felt tense, and she felt weakness in her legs. Besides, she felt "anguish" in the chest. She reported it had been six days. She also had a headache, felt pricking on her legs and nausea with outcome of unknown.    No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.
Patient was complaining of pain in her arm and discomfort radiating to her breast and back.
I received dose #2 of the COVID vaccine on  2/11/21 and experienced mild arm soreness (lasting approximately 36 hours) and slight tingling to my entire arm on side of injection, down to fingertip (lasting approximately 24 hours). I took Motrin 400 mg the morning of the vaccine, once at bedtime on the same day, and once in the morning of 2/12/21. On 2/13/21 through 2/16/21, I felt great with no symptoms at all.  On 2/17/21, almost a week after my vaccine, I woke up feeling dizzy, nauseated, and started having signifcant chills/sweats. Other symptoms included lethargy, headache, and loss of appetite. Per my employer's current protocol, I took a COVID test on 2/18/21 that was negative. On Friday, 2/19/21, my fevers were higher (101 degrees) and not responding well to over the counter Motrin. I was evaluated by a nurse practitioner in urgent care. Another COVID test was done that was negative. I was also tested for Influenza A and B, both negative.  Otitis media, migraine headache, sinusitis, and strep were also ruled out. Hearts and lungs were normal and not concerning. My fever and above noted symptoms continued until the morning of 2/21/21, after which fever had subsided. Likely due to dehydration, fatigue and headache remains present but manageable and improving with rest and fluids.
Narrative: COVID infection following COVID vaccine series 04/12 Pfizer, dose #1 05/03, Pfizer, dose #2 08/15 pt cc: chills, diarrhea, fatigue, fever, headache, loss of tast or smell, myalgias exposure: 08/19 COVID swab, result: detected 08/19 SARS-COV-2 Variant Sequencing result: pending 08/20 - 08/25 pt symptoms continue
Covid-19/Drug Ineffective; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), on 09Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 13Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: dust" (unspecified if ongoing); "Known allergies: poison ivy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 08Feb2022; OXYBUTYNIN, start date: 08Feb2022; VOLTAREN [DICLOFENAC], start date: 08Feb2022; ACID CONTROLLER. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Covid-19/Drug Ineffective"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Negative; Unknown results. Therapeutic measures were taken as a result of covid-19. Patient received the vaccine. Patient received other medications in 2 weeks which included atorvastatin, oxybutynin and voltaren all taken from 08Feb2022. Other medication in 2 weeks also included acid controller. After quick improvement of respiratory symptoms and mild fever, she tested negative twice and ventured out into the world. Then awful nausea/diarrhea for two days followed by full body rash, which Benadryl helped quell after two days. Lingering cough and chills. Still was glad she took Paxlovid and am not certain the later symptoms were related. As of yesterday cough and chills were gone. Tested negative again. PA put me on antibiotic 04May2022 to make sure cough did not go into Covid pneumonia. Patient received treatment which included 2 Benadryl every 4 hours, later antibiotic. Patient known allergies including Poison Ivy, Dust, Percocet. Other medical history included recovering from hip surgery 07Feb2022 (as reported).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from nurse regarding approximately 175 unspecified patients of unknown age and gender. There was no information on medical history and drug reactions or allergies. On an unknown date, the patients were vaccinated with ZOSTAVAX (strength, dose, route not reported) that were exposed to temperatures outside of the recommended storage range. No adverse effect reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
RESIDENT CONTINUED TO DECLINE ON HOSPICE SERVICES WITH COMFORT MEASURES IN PLACE. PASSED AWAY ON 12/22/21.
Experiencing neurological problems after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (Experiencing neurological problems after the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (Experiencing neurological problems after the vaccine). At the time of the report, NEUROLOGICAL SYMPTOM (Experiencing neurological problems after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient mentioned knowing other people experiencing neurological problems after the vaccine, specifically mentioned a friend of a coworker and other coworkers nice.   This case was linked to MOD-2021-403024 (Patient Link).
redness of the arm; flu like symptoms; anxiety; sore throat; weakness; irritability; trouble breathing; trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced erythema of extremities, influenza-like symptoms, anxiety, sore throat, weakness, irritability, difficulty breathing and difficulty sleeping. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the influenza-like symptoms, anxiety, sore throat, weakness, irritability, difficulty breathing and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, influenza-like symptoms, anxiety, sore throat, weakness, irritability, difficulty breathing and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient had her a dose of Shingrix about a month ago and afterwards she began to experience redness of the arm, flu like symptoms, anxiety, sore throat, weakness, irritability, trouble breathing, and trouble sleeping.  The patient was referred to health care professional and gave her medical disclaimer, advised as per package insert content.  Provided medical informer phone number for health care professional reference and offered after call survey. The reporter consented to follow-up.
I experienced a large red welt (4 by 3 inches) on my arm where the injection site was.  The red welt was painful and hot to touch.  It was also swollen and raised.  It is still present (3 days following injection site).
Sore arm, ache, headache for 2 days after vaccine. Vaccine site was firm to touch and slightly itchy for a week or so. As of 1/12/2021 a red ring approx. 2 inches in diameter appeared around the vaccine site. Began to fade as of 1/13/2021