chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness; heat; itchy; hurt at injection site; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced erythema, skin warm, pruritus and injection site pain. In June 2019, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the erythema, skin warm and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema, skin warm, pruritus and injection site pain to be related to Shingrix.  Additional details were provided as follows: One week before the time of reporting, the patient received a dose of Shingrix. The reporter told that, the injection was given into the muscle and it hurt the minute the needle was inserted. The patient had redness over 5 inch long and 5 inch wide. The call center called back to the reporter and asked additional questions regarding adverse event. The reporter did not have lot number and expiration date. The patient's physician was allergist.
p/vax T102.4 APAP given; later T102;tepid sponge bath given & APAP given again; T101.0; infant irritable;referred to pvt MD;
A minor got through the screening process at a vaccine clinic I was working at in county and I administered the Moderna vaccine to this minor unaware of his age.
Everybody's arms hurt after these vaccine; 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 PAIN IN EXTREMITY (Everybody's arms hurt after these 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 PAIN IN EXTREMITY (Everybody's arms hurt after these vaccine). At the time of the report, PAIN IN EXTREMITY (Everybody's arms hurt after these vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The caller states while reporting adverse events.Everybody's arms hurt after these vaccines.  No concomitant medication were reported  No treatment information was provided
Patient seen on 8/28/07 for physical. Given Varicella vaccine to LUE. When reading the PPD on 8/30/07. Patient noted to have redness and swelling to LUE. Seen by doctor diagnose when r/o side effect of vaccine vs cellulitis treated with Keflex for r/o cellulitis. No other symptoms.
48 hours after the vaccine was given, both hands developed red welts that lasted about 4 days, then hands have been peeling since. As of a week ago, I noticed that both feet began to peel as well as the continuation of hands peeling.
A few hours after receiving influenza vaccine at pharmacy, began to have shoulder pain, pain with ROM/difficulty with ROM. Symptoms persist to this day. feels better with NSAIDS. No numbness/tingling. No swelling, redness, fevers.
I woke up at 3:10 am feeling cold and chilling. I took by temperature and it was 98.4. I normally have a temperature of 97.1 - 97.7. I take it daily multiple times. My hands were cold. When I got up and started moving around I didn't have any more chills. When I got up at 6:30 am. I just didn't feel well in general. Slight feeling of sniffles, congestion.  I would get some aches that went away in a few seconds. They were at various points in my body, knee joints, muscles, and my head. They were simply a nuisance. I felt tired all day. My blood pressure was up 15-20 points on both numbers during the day. I've told my doctor when my blood pressure is higher, I'm having more aches and pains as though I'm fighting a virus. I tolerated the symptoms most of the day, letting my immune system try to work it out. My symptoms seemed worse at 5:45 pm, so I took two ibuprofen. My temperature was 98.9 at that point. The highest it's been. All my symptoms got better until 1:15 am. I woke up feeling like I was chilling, but not as bad as yesterday, so I took two more ibuprofen. I feel 50% better today and haven't taken any ibuprofen. Here is the really strange part. I had these exact symptoms and similar temperature ranges twic last year. In July and October I think. I didn't get tested last year because they were minor symptoms. They were just nuisance symptoms. I took ibuprofen right away last year.  I followed the masking guidelines, social distancing, etc. So, is it just coincidence I had similar symptoms last year two times, that I had when I getting the inactive Moderna vaccine? I had no reaction to the first shot.  I just wanted to provide the information in case it is helpful. Very strange. I expect no other symptoms in a couple of days.
R arm redness, soreness, itchiness. began over 1 week after injection. improving slowly without treatment
Left arm has a red, hot, itchy, hard area where injection was given.  Noticed it a few days after injection but it has not gone away.
CHILD WITH SWOLLEN ERYTHEMATUS LEFT ARM EXTENDING FROM THE SHOULDER DOWN TO THE ELBOW. MOTHER WAS ASKED TO APPLY WARM COMPRESSES TO THE AREA. THIS WAS FIRST NOTICED BY THE MOTHER WHEN SHE WOKE UP AT 7:15AM THIS WAS THE ARM WHERE HE RECEIVED THE DAPT.
Injection site pain started on 5/14. Woke up on 5/15 with the additional symptoms:  Low grade fever Body aches Chills  Headache Lasted thru most of the day, subsiding in afternoon. Feeling much better on 5/16.
Had ice pick stabbing on the left side of my head and ear which continued for 36 hours.  Stabbing stopped and a general headache stayed on left side and spread to the back of head; the head felt sore when  massaged.  This continued into the third day post injection.  Took aspirin initially for one day, then switched to gabapentin.  These two meds did nothing of note.  Headache was bad enough that I missed work for 2 days which includes today, as I am not feeling well.
Next evening-Headache to back of the head.   Saturday-Am with fever of 101, achy, not feeling well and no appetite. "Flu like"   Saturday evening -Tender to the Left Deltoid region.   Sunday-Am Swelling to Left clavicle,, shoulder very sore, fever of 104., could feel lympth nodes of axillary, Left side of the neck bruised.    Monday-fever gone.   X1week of not feeling well and swelling.     Opted not to go to MD.
Within one hour- flushing, headache,  and swelling and sore lymph node- right side.  Over nite and for 3 days fever of 100.2. Tired, skin hurt and sore throat- swollen lymph node lasted for 4 days.
Patient presented to the pharmacy on 01/01/2022 stating his left deltoid muscle was still hurting  from the injection received on 10/22/2021. Patient showed me his upper arm but I did not notice any redness or swelling at the injection site. Patient said he previously had a doctor's office visit but the pain in his arm has not resolved. He is scheduling another doctor appointment.
Tightness in chest after the first shot that subsided and then resumed after the second shot. Tightness continued for 5 months and ability to perform cardio exercise was limited.
the shingles on the right side of my face, extending from my right ear down to my chin, and up to my right eye.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729, expiration date: unknown) dose 1 via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 59-year-old) as single dose for covid-19 vaccination at Pharmacy or Drug Store. Medical history included penicillin allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, the patient had not been tested with covid-19. Concomitant medication included VITAMIN D [VITAMIN D NOS]. On 13Apr2021, after five days from vaccination, patient developed the shingles on the right side of my face, extending from my right ear down to my chin, and up to my right eye. He would like to know if it is possible that the Pfizer BioNTech COVID-19 vaccine could have "triggered" the case of shingles of that her husband experienced 5 days after receiving his first dose of the vaccine. Response was that there is no information to suggest that the vaccine causes shingles, shingles was not listed as a commonly reported side effect with the clinical trial participants, this list does not include all possible side effects with the vaccine. Also that they do not have the safety data to speak from since the vaccine has been released to the public. Her wife wanted to know if this was a common thing, Is it from vaccine, if he did get second dose, how soon can he get second dose. she also wanted to know With the Pfizer COVID vaccine, like with the flu vaccine, which has a flu component, does this also have a Covid component in the vaccines. Patient wanted to know wanted to know how soon can he get next COVID shot. Patient's second dose is due on 01May2021. His dermatologist advised he not have second dose. Dermatologist said not to get one on Saturday if the Shingles would clear up. Patient was not sure if he should get it. If so, how soon. Patient also reported that the first vaccine did trigger the shingle's because of whatever in his immune, is he at a higher risk for getting a worse case with second vaccine. Patient received unspecified treatment which was prescribed by dermatologist. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.  No Follow-up attempts are needed. No further information is expected
Comatose for approximately 16-18 hours; unresponsive to physical stimulation and verbal stimulation, eyes unresponsive to light when eyelids lifted.
STEVENS JOHNSON SYDROME SICK STOMACH TIREDNESS WEAKNESS RED RASH LIKE A SUN BURN IT DID EVENTUALY PEEL I WAS WEAK FOR TWO MONTHS AFTERWARDS
2nd dose interrupted by the covid pandemic; This case was reported by a physician via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date in December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self-reported this case, who was also a physician. The age at vaccination was not applicable. The patient reported that the 2nd dose of Shingrix was interrupted and delayed by the covid pandemic, which led to social problem . The patient enquired if he/ she could get the 2nd dose now or needed to restart the vaccine series.
Healthy 49 yo female with no genetic disposition, no high blood pressure, no high cholesterol, not diabetic,  had a moderate to severe stroke with NIH stroke score of 19 upon admission to ER.  TPA administered,
Injection site pain, injection site and surrounding area swelling, injection site and surrounding area warmth, mild fever.
Back pain; Fever; Joint aches; Vomiting, not able to keep water or crackers down for 8 hours; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route in the left arm on 28Apr2021 at 16:00 hours (at the age of 43-years-old) as single dose for COVID-19 immunisation. Medical history of the patient included asthma. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other medications within 2 weeks of the vaccination. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route in the left arm on an unknown date as single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks of COVID vaccine. On 29Apr2021 at 05:30 hours, the patient had fever, back pain, joint aches and vomiting, and was not able to keep water or crackers down for 8 hours.  The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events of fever, back pain, joint aches and vomiting were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
On 4 OCT 2019, PT discovered that she has been in positive on urine pregnancy test after she received the smallpox on 24 SEP 2019.
2 Ulcers formed  in mouth, still swollen and not healed 7 days later.  Painful and swollen. No history of canker sores, cold sore, or ulcers in the mouth until after 2nd shot of the vaccination.
On  Saturday, April 17, 2021, patient received 1st Moderna vaccination from LVN working the COVID -19 Vaccination clinic.  Patient is 17 years of age.   On Monday, May 17, 2021, patient received 2nd Moderna vaccination from the COVID-19 Vaccination clinic.  Attempted to reach patient by phone to gather information regarding well-being after vaccinations, but  phone number listed belongs to someone else, not the patient.  Person who answered the call had no knowledge of the name.  Letter mailed to patient's listed address requesting patient call clinic regarding last visit.
Weakness, bilateral foot numbness (worsening).  Fall at home with increased weakness, unable to get out of bed his morning
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 14:00 as dose 1, single (Lot number: EN6205), in left arm, on 24Mar2021 at 14:00 as dose 2, single (Lot number: EN6205), in left arm and on 02Nov2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative twice; Negative, notes: tested negative twice; Positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Information: The patient has not taken any medications in 2 weeks. The patient took Paxlovid as a treatment drug for COVID-19. Treatment start date- 14Jun2022 and Treatment stop date- 19Jun2022. There were no known allergies and there was no other medical history reported. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 25-AUG-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot number J001698 with expiry date 08-MAY-2014. ZOSTAVAX was expired on 08-MAY-2014. Nurse stated the ZOSTAVAX did not have any previous temperature excursions. No adverse symptoms reported. Additional information has been requested.
Subject noted forehead swelling on 06/29/2005, the day following vaccination.  On 07/01/2005 he noted painful hives on both legs and on 07/02/2005, he developed bilateral ankle swelling.  On 07/06/2005, he sought medical attention at the local hospital where he received intramuscularly and by mouth Benadryl.  Information recieved from discharge summary states dyspnea.
broke out at site of injection all the way down arm. broke out in whelps face, and whole body, whole body is itching. pain in left foot
Visual disturbances 3 days after 2nd Pfizer dose - Floaters in the middle of my visual field wouldn't move and blurred my vision. Flashes/swirls of light. Struggled to read text. This lasted 2 hrs or so and finally gradually improved. I have NEVER had anything like this before. My mom had this EXACT same thing happen 2 days after her 2nd Moderna dose except hers hasn't gone away.
Initial misuse report received from a healthcare professional on 23 October 2013. The cases were received on 21 March 2014 at GPV. A female patient had received unknown dose of CAPTACEL; IPOL; PENTACEL; ACTHIB; FLUZONE; MENACTRA; MENOMUNE; ADACEL; TENIVAC for 1 hour 16 minutes and unknown dose TUBERSOL had been not properly stored and opened for more than 30 days. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender : none
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patient have been administered with a dose of MMR II (dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014065, 1507USA014066, 1507USA014067, 1507USA014068 and 1507USA013244). Additional information has been requested.
Felt tired and arm was heavy for a few hours right after then I went to bed around 11 pm and woke up at 1 am with my arm extremely itchy and swollen feeling like it does when I?m having an allergic reaction to my allergy shots (which I haven?t had in two weeks) so I got up to go check it out in the bathroom and then it looked fine so I sat down to go to the bathroom then felt faint so I moved to the floor and passed out for approx 20 seconds according to my partner then came to with a giant gasp for air and then drank a sip of water and threw up and felt dizzy for a bit after that
Prior to injection I had a normal sinus rhythm. Two weeks after, my rhythm changed to Left Bundle Branch Block.
01/17/22 presents to EC ED for "chest pain". PMHx of "DM2, HTN, HLD, asthma"
in a lot pain; The initial case was missing the following minimum criteria: no adverse drug effect. Upon receipt of follow-up information on (05Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or Other non-HCP (patient). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unknown route of administration on 28Jan2021 at single dose for covid-19 immunisation. Medical history includes Arthritis. Concomitant medications were not reported. The patient's wife reported, her husband had the COVID-19 shot 10 days ago. He has arthritis and has been on a Tylenol regimen for about a year. He stopped taking the Tylenol because he read on website that it might change the effectiveness of the COVID shot. Now he is in a lot pain from not taking the Tylenol. She confirms he received the Pfizer COVID 19 vaccine. The seriousness was reported as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Left shoulder still sore in the clavicle area above the shoulder from the first Moderna dose, 28 days later.  Patient ranked the soreness at a level of 2 to 3 on a scale of 1 to 10 with 10 being the worst pain ever and 1 being the least pain.  Pharmacist will notify Dr  and has advised patient to do so.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: On Wednesday (6-23-21) evening, the hives with rash and itchiness appeared on her lower back.  On Thursday, the hives on her back worsened and on Friday they spread to her hips, thighs and inner arms.
Received a booster (0.25ml) dose as a second dose in the primary series; Received Moderna as second dose after Pfizer first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a booster (0.25ml) dose as a second dose in the primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna as second dose after Pfizer first dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (First dose) on 04-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 23-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 23-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received a booster (0.25ml) dose as a second dose in the primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna as second dose after Pfizer first dose). On 23-Nov-2021, ACCIDENTAL UNDERDOSE (Received a booster (0.25ml) dose as a second dose in the primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna as second dose after Pfizer first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-406082, MOD-2021-406033, MOD-2021-406212, MOD-2021-405950 (Patient Link).
On Wednesday, August 18, 2021 around 2:00 pm I started smelling cigarette smoke that was not there. I would estimate that I smell it 9/10 breaths and I smell it everywhere (work, home, outside, in the car, grocery store, restaurants, and when I'm alone by myself), also, I don't smoke and neither does my boyfriend which I live with. I house have NEVER been smoked in. I have an appointment to see and ENT on August 31st.
Headache flu like symptoms Narrative: flu like symptoms about 13 hours after first dose of vaccine
Vaccine was given and within 1-2 minutes of receiving it patient reported itching on her legs. Leg was rechecked and redness and a small hive was noted so Provider was asked to come see the reaction and advise further. Ice pack was placed on the reaction site and reaction was monitored for 15 minutes to confirm there was no worsening or anaphylactic reaction. After this time patient reported the itching had stopped and she was stable to return home. Mom instructed on what to watch for and asked to return for any worsening symptoms.
This spontaneous report was received from one company via another company refers to a 50 year old female patient. The patient's concurrent conditions, past medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, dose number, vaccination site, route not provided). Concomitant therapies were not provided. It was reported that, the patient was allergic to vaccine. The outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was not provided. Additional information has been requested.