chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching; Hives on her legs\  on arms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her legs\  on arms) and PRURITUS (Itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to insect sting (Bees), Anaphylaxis, Hypersensitivity reaction and Hives (Severe hives on legs and arms.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced URTICARIA (Hives on her legs\  on arms). On an unknown date, the patient experienced PRURITUS (Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 15-Mar-2021, URTICARIA (Hives on her legs\  on arms) and PRURITUS (Itching) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: In follow-up information patient demographics, vaccine Information, product dose details, event (i.e.: Itching), event's out come were updated.
Generalized hives 5-10 min after administration. Given Benadryl IM and 0.2cc Epinephrine SQ.
Anaphylaxis, Angioedema & CoughWheeze  Narrative:  WENT TO ER ON 3/5/2021, MEDICATIONS GIVEN IN ER, DO NOT HAVE AT THIS TIME
neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder and over to right ear; left arm sore; neck sore to left shoulder and over to right ear; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number EK4176, Expiry Date: Mar2021, via an unspecified route of administration on 21Dec2020 at a SINGLE DOSE then via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband was calling for his wife that had the second shot. He stated that she was a nurse. He stated that she came home from work with her arm and neck sore. He stated that the neck soreness was causing ear ache. He stated that her fever was 102.9 and stated that they put a cool rag on her head. He stated that she had the shot yesterday and stated that she had her first shot 21Dec2020. They stated that arm sore at 1:00 in morning and stated sore neck at 11:30 this morning. Fever started at 11:30 and was 99.7 and about 15 minutes later was 99.9 and stated that was with having three Aleves. She stated that it is back up to 102.9 and stated that the right ear ache started at 11:00am today. The patient underwent lab tests and procedures which included body temperature: 102.9 on 08Jan2021, 99.7 on 08Jan2021 and 99.9 on 08Jan2021. Therapeutic measures were taken as a result of fever (pyrexia). The outcome of events was not recovered.
On my way home from the doctor's office, I heard pinging in my ears. I didn't think much of it at the time because there wasn't any use dwelling on it. That evening, about an hour after falling asleep, I was awakened by an intense perceived ringing in my ears that was significantly louder than my previous baseline tinnitus. I would describe the ringing as higher pitched than my normal tinnitus, and about three times louder at minimum. I can say the ringing was three times louder because I had to increase the volume on the device I use for masking by about three times just to begin to mask the new level of tinnitus. This lasted all night, and has since lessened to a degree, but not to my previous baseline. The perceived pitch has changed, and the perceived loudness has gone up in the month since vaccination. My tinnitus has been present since at least June of 2021.
Sunday evening (date of vaccination 8/1/21), patient reported deep chills, body aches, spinning dizzy vertigo  and fever which lasted till today 08/5/21. Patient reported having the same symptoms she experienced when she had covid in Oct 2020.  She is still suffering from a severe, non-stop headache that she is still taking Tylenol for.
Pt has red swollen area left arm warm to touch, no pain, no fever, it was not hard and it was 35x38.
A report has been received from a Physician concerning a 1 year old, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced NOSEBLEED. The outcome of the event of NOSEBLEED is unknown. The report was considered to be non-serious by the reporter.
Facial swelling and hives, itching eyes, angioedema of mouth, tongue, and lips, truncal and extremity hives. Trouble breathing and talking.
Narrative:  Patient was inpatient MICU and died inpatient. Death was caused by: Pneumocystis Pneumonia in setting of HIV/AIDS, along with Mycobacterium TB complex Pneumonia, Psuedomonas Pneumonia with resultant acute hypoxic respiratory failure. Patient had received J&J covid vaccine on 04/12/2021 assumed at clinic although not properly recorded in patient chart. This death is not related to the COVID vaccine.
Pain, swelling and redness at the injection site involving the whole upper deltoid of the right arm.  On March 26, 2012 the colleague reported muscle pain and weakness in the whole right arm.
hive-like rash, no itch, initially on rt shoulder & arm;seen by MD @ urgent care ctr rx pred & DPH; 30APR98 rash over entire body, papular like a mosquito bite, no itching;
Information has been received from a registered nurse concerning an 18-year-old female who in August 2006, was vaccinated with a 0.5 dose of Recombivax HB. Within 15 minutes of vaccination, the patient experienced nausea; and within another 15 to 30 minutes she had a fever and sweating; one hour later she experienced sharp stomach pains with crying lasting for four hours. Subsequently, the patient recovered from nausea, fever, sweating and sharp stomach pains, and crying. No diagnostic studies were performed. No additional information to report. There was not product quality complaint involved. Additional information has been requested.
30 minutes post vaccination, numbness on entire right side of face. Resolved after about 3 hours, but all sensation has not returned.
Symptom consistent with gout. Appeared morning after vaccine, worse next day. Began to fade slightly 6 days after vaccine. 95% back to normal after 12 days. Symptoms were swollen, red, painful left great toe. Entire foot slightly swollen for a few days.
"My" lower jaw was numb, felt "my" teeth are going to fall off, felt "my" teeth are extremely sharp; Couldn't chew a gum and solid food. "I" still have hard time chewing a solid food; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 10Apr2021, a week after a first dose, the patient lower jaw was numb, felt his teeth were going to fall off, felt his teeth were extremely sharp, could not chew a gum and solid food. So, the patient switched the diet to liquid or soft food only. (liquid/soft diet from 10Apr2021 to 17Apr2021). As the time progressed the symptoms were improved but the patient still had hard time chewing a solid food. Numbness was gone. The patient had seen two dentist and a primary care since the first dose. His doctors found nothing wrong with his teeth. All teeth were perfect. The patient was fully vaccination at the moment. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events the patient lower jaw was numb, felt his teeth were going to fall off, felt his teeth were extremely sharp was resolved on an unknown date in 2021, whereas the event could not chew a gum and solid food was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Moderate problems. Headache, nausea, vomiting, diarrhea, stomach ache, pain where shot was given. Symptoms lasted for a week.
30 minutes later he developed somewhat of a sore throat that he describes as a throat tightness accompanied by very slight chest tightness. He denies any angioedema, SOB, DOE, wheezing, rash, itching, or hives.
Redness and possible swelling of 2 inch diameter around injection site. Late onset from date of injection. Itchy. Warm to the touch. Location is also somewhat hard/solid to the touch.
The day after the vaccine she started having chest discomfort, feels like a pressure that will not go away. She also noticed that her blood pressure has been elevated.
Lump under left arm (armpit); soreness; diameter approximately 2 inches.  Treatment - 2 Aleve tablets, heat.  Outcome - soreness continued (less than 24 hrs since treatment).
24 hrs of fever, aches and pains, chills. could not get out of bed. Day 3 fever blister occurs. Day 7 still feel very tired, headache, heavy arms/ legs. I just do not feel like myself.  Slighty blurred vision and brain fog.
This case was reported by a nurse and described a 26 year old male subject who experienced loss of vision subsequent to vaccination with hepatitis B vaccine recombinant ( Engerix B) for prophylaxis. The subject had no known allergies to medications or food. On may 13 2005, the subject received 1st dose of Engerix B in the left deltoid (lot AHBVB052AA). The nurse reported that approximately, one and one half hours after receiving Engerix B, the subject lost vision in left eye and was dizzy for 2 hours. After that, he was sick to his stomach and felt like vomiting and had a severe headache which lasted 5 or 6 hours, until he went to bed. The next morning on May 14 2005 he awoke feeling fine. The immunization series with Engerix B was discontinued. The nurse considered the events to possibly be related to vaccination with Engerix B. Comment loss of vision was considered medically serious by manufacturer (OMIC).
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. Dept. of Health notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from Dept. of Health are to notify all of the recipients that received an incorrect dose and submit a report for each.
Patient called and stated he experienced black out period. Doesn't remember leaving shot after shot and entire next day. Vaccine was given on left arm and right side of his body was in pain. Also experienced high fever, fatigue and sleeplessness.  He was totally fine with the first shot.  When the pharmacist was giving the shot he seemed kind off, was kind of sleepy and pharmacist asked if he was ok and he said he didn't had good sleep and was sleepy.
Parent relates that child began developing a "strange rash" slightly more than 24 hours after vaccine administration.  Rash was described as appearing on patient's legs, torso  chest, neck face and diaper area.  The rash on patient's legs was described as numerous raised red bumps,  Her abdomenchest area reportedly was more solid blotchy-red. The areas on her neck and face were red rasied on the edges with a small depression in the center.  Child was noted to scratch the rash in the area around the back of her ears. The rash on her diaper region where the elastic portion of her dipaer fit against was described as purply bruised looking. Rash began to fade within 48 hours after its appearance and was completley resolved 2 days later. Mom had administered 2 doses of Benadryl. Child was not seen by this provider at any time she had the rash.  There was no fever, child remained alert, ate slept and played as usual.
fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (over-react to certain medicine). Concomitant products included EPINEPHRINE (EPIPEN) for Drug allergy, VITAMIN D [VITAMIN D NOS] for an unknown indication.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient didn't take any treatment medicine.   This case was linked to MOD-2021-378347 (Patient Link).
Shingles; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's concomitant medications and medical history were not reported. The patient experienced shingles on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed. Information about Lot/Batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC same reporter/AE/drug, different patient
ADMINISTRATION OF VACCINE PAST EXPIRATION DATE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-OCT-2021, the patient experienced administration of vaccine past expiration date. The action taken with covid-19 vaccine was not applicable. The outcome of administration of vaccine past expiration date was not reported. This report was non-serious.
I got the first vaccination on Jan. 31, and the second one on May 16. Both times, I have come down with fever and shivering, between 99-100 degrees. The first time it began a couple of hours after the shot and lasted two days, and was debilitating. The second time began about 12 or 13 hours later, and is not quite as bad as the first time but I still need to leave work.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: pt diagnosed w/ a staph infection 2 weeks after first dose shot
Heart palpitations, extreme joint pain, extreme headache, nausea for 72 hours. Over the counter medicine of any kind did not aid in symptom relief.
Two days post vax pt developed a fever. Three days post vax pt experienced a blotchy rash. Four days post vax the pt got worse with hundreds of bumps on her face, chest and legs and she had a low-grade fever on and off. Follow up information indicated that the pt had a maculopapular rash on her face and trunk. The rash was greater on her upper extremities and the pigmentation on her buttocks increased. The pt also had scattered lesions on her palms.
Patient got 2nd shot 5/21 and prescription filled for cipro (5/22-pm). About 10 minutes after ingesting the cipro, he started having aggressive strange pains throughout the body, nerve endings felt like on fire. Haited till next morning and had to be admitted to hospital.
Left arm reddened and swollen. Warm to touch.Has had a headache since administration
Pt recvd shot in clinic in afternoon; Brought to ER  w/temp 104.7 r, mom stated eyes rolled back, started shaking & felt like he was getting hot;
Sever body aches And headaches . Dizziness.  Lethargic
I feel pain and weakness on my whole left side. Nausea Intermittent deafness on the left side Ears popping at times Numbness at times Headache Fatigue Sleeping Napping Lost trains of thought Lightheadedness
illness; inadvertently gave the Moderna Monovalent vaccine as the Bivalent dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (illness) and WRONG PRODUCT ADMINISTERED (inadvertently gave the Moderna Monovalent vaccine as the Bivalent dose) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2022 at 2:00 AM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Nov-2022 at 2:00 AM, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently gave the Moderna Monovalent vaccine as the Bivalent dose). On an unknown date, the patient experienced ILLNESS (illness). At the time of the report, ILLNESS (illness) and WRONG PRODUCT ADMINISTERED (inadvertently gave the Moderna Monovalent vaccine as the Bivalent dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Pharmacist reported that a technician inadvertently gave the Moderna Monovalent vaccine as the Bivalent dose to an adult male patient on 30-Nov-2022 around 2 PM. The customer wants to return to be vaccinated. What was the guidance. Treatment details were not reported by the reporter.
Woke up with welts and red splotches on abd, arms and back.  + itching.
Case number PHEH2013US010862 is an initial spontaneous report received from a nurse on 15 May 2013, with a combined follow-up received from a physician assistant on 11 Jun 2013 and 17 Jun 2013. This case refers to a 27-year-old male patient. His medical history was not reported and his concomitant medication included CONCERTA. He was vaccinated with MENVEO (batch number: X12025/A12025, expiry date: Jan 2015/Dec 2014) intramuscularly on 10 May 2013. On the same day, post vaccination, he developed fever. It was reported that within 24-48 hours after receiving vaccination, he developed high fever, neck stiffness, and headaches. He went to the hospital with headache, neck stiffness and fever greater than 103 degrees. He was hospitalized under the suspicion of meningitis where he was followed-up by an infectious disease physician. Lumbar puncture, spinal tap, x-rays, and laboratory testing were performed in ER, for which all results were negative for any infectious disease. The patient recovered from fever on 13 May 2013. The patient recovered completely from all the symptoms on unspecified date. He stayed in hospital for two to three days and was discharged in stable condition. Causality of fever was assessed as related to MENVEO. Combined follow-up was received on 11 Jun 2013 and 17 Jun 2013: Patient demographics, concomitant medication, events (neck stiffness and headache), hospitalization (tests performed in the hospital), outcome of the events and causality of fever were updated.
Patient states she gradually became  partial blindness and weakness . She states that she collapsed  a few times In addition to that she stated that she had a similar reaction when she received a flu shot but with Pfizer it was severe. Thank
Starting the next night my feet wer freezing when trying to lie down at night, could not get them warm unless wrapped in a blanket which is not normal for me, still ongoing but less intensity today 1-29 Ongoing fatigue and having to nap daily and if working go home and going to be early and sleeping about 10-11 hours a night, again not normal Improving daily but still ongoing
Large reddened area at injection site, fever 2 days after injection 100-101. Cellulitis symptoms, pain arm, shoulder.
nausea, fatigue, chills, sweats, muscle aches. No treatment. Cleared up on its own
Medical assistant reports patient was given liquid component of PENTACEL but not powder with no adverse event; Initial information received on 07-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a patient of unknown gender and age, medical assistant reports patient was given liquid component of pentacel but not powder with no adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (dose, strength, formulation, frequency: unknown) lot UJ670AA, U7256AB expiry date: 13-May-2023 via unknown route in unknown administration site as Immunization.  On an unknown date the patient developed a non-serious event medical assistant reports patient was given liquid component of pentacel but not powder with no adverse event (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (product preparation error).  At time of reporting, the outcome was Unknown for the event product preparation error.   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.
Vaccination of underage individual.  Mom indicated a false birthdate which was confirmed with the doctors office.
Information has been received from a consumer concerning her 83 year old mother with high blood pressure and rheumatoid arthritis who on 08-SEP-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route not reported). The consumer reported that her mother broke out in shingles on 23-FEB-2010 and on 13-AUG-2010. She stated that her mother had not recovered from the latest episode yet. The consumer reported that the rash was on the back. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The patient broke out in shingles (last episode) were considered to be disabling. Additional information has been requested.