chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few hours after Moderna COVID-19 Vaccine, the injection site started to get erythematous and tender.  About 15 hours after having Moderna COVID-19Vaccine, I started feeling pain in vertebral column  starting at T4-5 vertebras and irradiating first to cervical vertebras, finally toward cerebellum area. The pain was so intense that a given point I almost went to the Emergency Department (ED). Simultaneously, felt chills. A headache started that lasted several days. I have never in my whole life have felt the same vertebral spine pain that started with a few vertebrae and started moving up in a matter of minutes. It was a hot burning pain felt only in the vertebras and up to the cerebellum area. I have Multiple Sclerosis (MS) but most of symptoms I presented the next morning were not usual, even on a when I have MS relapses. The next day I woke with headache, difficulty walking (worse than usual), nausea, mental fog for an hour or so, joint swelling and tenderness (wrists, elbows, ankles and feet). Besides extremity weakness, felt generalized weakness and aches. I was not able to perform any task during the whole day. I have MS but I work. I had to take the day off. Injection site pain got bigger until it reached two-thirds of the arm dorsal aspect.  It was tender and warm too despite pain medications. The nausea went away with anti-nausea medication. Muscle pain, generalized fatigue, joint swelling & tenderness and headache still going on 3 days after COVID-19 Vaccine but slightly better than 2 days ago, except joint paint & swelling and muscle pain which still pretty strong.
Patient received the vaccination in the morning 10/17/19 and by the evening was feeling lethargic, achy, chills, feverish, general weakness and sick.  This continued for a few more days and symptoms peaked about 2 days after the vaccination patient reports.  She stated that she also got a whole body rash that seemed to "move around her body" during these few days after the vaccination was administered.
Received vaccines at 6mo wcc on 9/19. Medical Assistant administered Pediarix (Dtap/HepB/IPV) intramuscular on LT, also administered PCV13 IM on LT as well as RotaTeq oral by mouth. Rash/redness on Left thigh, site is warm to touch developed 9/20/22 noted swelling.  9/21 at 845a parents contacted the office to report their concerns and current sx. Patient was scheduled same day for evaluation with provider.  The provider documented that Vaccine Adverse Reaction- (pediarix/Prevnar) erythema to left thigh (blanchable). Parent information for supportive care and advise on when to return to clinic or seek care. Advised to f/u as needed.
7 x 3 cm red urticarial area of the (L) upper arm with only mild induration 3 days of 101.6 ax temp then afebrile.
Pt was given Yellow Fever Vaccine incorrectly using wrong diluent and wrong location IM and not SQ.  Pt was then correctly given Yellow Fever vaccine using correct dilutent and location.
Patient received dose of J&J COVID-19 vaccine at local vaccine clinic. Reportedly, a couple minutes later, patient experienced vasovagal syncope for which a Code Blue was called by clinic staff. 911 was also called. Patient was evaluated by ED physician on scene at the clinic, where patient had regained consciousness and responded to questions. Patient was then transported to ED next door by ED staff where patient was monitored and ultimately discharged home.
STOMACH ACHE; FEVER; TIREDNESS; HEADACHE; PAIN IN LOWER BACK; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, 1 total, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced pain in lower back. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021 12:00, the subject experienced stomach ache. On 26-MAR-2021 12:00, the subject experienced fever. On 26-MAR-2021 12:00, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and had not recovered from headache, fever, stomach ache, and pain in lower back. This report was non-serious.
Body aches; painful lymph node sweeling underarm; painful lymph node sweeling underarm; uncontrolled shivers; nausea; tired; just overall felt unwell; This is a spontaneous report received from a contactable consumer (patient). A 41-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:45 (at the age of 41-years-old) (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. Concomitant medication(s) included cetirizine hydrochloride (ALLERTEC) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265 and Expiration date was not reported) via an unspecified route of administration, in Arm left, on 12Feb2021 at 02:45PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 05MAR2021 at 03:30AM, the patient had experienced body aches, painful lymph node swelling underarm, uncontrolled shivers, nausea, tired, just overall felt unwell. The outcome of the events were recovering. The patient did not receive any treatment for the events.  No follow up attempts are possible. No further information is expected
a lump-sore to touch & when moved a certain way-sl red & warm to touch been in bed w/fever 101 since Friday evening;been taking Advil,APAP,fluids,no n/v
This spontaneous report as received from a physician refers to a 48 year old female patient with allergy to penicillin. The patient did not have any pertinent medical history. In January 1995 the patient was vaccinated with M-M-R II (lot # was reported as 1176A, expiration date on 15-DEC-1995, route and dose were unknown). The patient had positive titer for measles and rubella on 12-FEB-2013. The outcome of event was unknown. The patient sought medical attention via seeing the physician. This is one of several reports received from the same source. Additional information is not expected.
This case was reported by a consumer and described the occurrence of therapy non-responder in a female patient who received Flu vaccine. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced therapy non-responder, sinus infection and sickness. The patient was treated with Z-PAK. On an unknown date, the outcome of the therapy non-responder, sinus infection and sickness were unknown. It was unknown if the reporter considered the therapy non-responder, sinus infection and sickness to be related to Flu vaccine. Additional information received: A patient reported that her IgG level have increased, and that she has been sick all winter because of the flu vaccine lack of efficacy. She currently has a sinus infection. Her IgG level was in the mid-500's. Patient declined consent to be contacted. No additional information was provided.
Pt received her second dose of the Covid-19 Moderna vaccine on 2-18-21 and within a few hours developed a slightly raised, red rash on her lower back and complained of moderate  itching.  No other adverse symptoms reported. Pt saw primary care physician, and was given instructions to use a topical OTC Benadryl cream prn. RN from the health department, followed up with the patient of 2/24/21 via phone call and pt reported that the rash was still there but improving with the Benadryl cream. Company report filed and pt encouraged to follow up with physician if symptoms get worse and to call 911 if any anaphylactic symptoms present. Pt verbalized understanding.
Patient is complaining of shoulder pain since vaccination. Unable to lift arm about shoulder. Pain is bringing tears to her eyes. She has previously been treated for an injury to the shoulder vaccine was given in.
Syncopal episode immediately following administration of influenza vaccine.  Lasted ~5 sec.  Child observed in office. VSS. Discharged to home.
24 hours after the shot was given,  a hard, red, slightly raised area of approximately 2?x2? was noted 3 inches below the injection site. 48 hours after the injection the area tripled in size. It is still hard, red, and hot to touch. Soreness was expected, but it continues to be very sore despite taking ibuprofen/acetaminophen.
On 3/18 my arm started itching and had a knot at the vaccine site.  I also felt clammy/nauseous.  As the evening went on, the swelling grew and I just felt under the weather.  This morning (3/19) I went to UrgentCare.  The swelling is bright red and very hot to the touch.  The doctor thinks my arm is infected and has started me on antibiotics.
Profound weakness that occurred 14 hours after his 1st met during COVID vaccination.  He had marked weakness and was not even able to stand or crawl on the floor.  He does spend the night on the floor.  He was better during the day.  The following night, he had similar episodes when he got up in the middle the night.  Again had to sleep on the floor but was able to get back to bed.  Vaccine was 5 days ago.  This happened over the 1st 2 nights.  For the last 3 nights he has been find any feels back to his baseline.   CPK, 3/2/21 was 427
psoriatic arthritis; a C. diff infection; alopecia areatta; hay fever; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 20Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 2, Date: 08Sep2020), administration date: 08Sep2020, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "a C. diff infection", "psoriatic arthritis", "alopecia areatta", "hay fever", "vertigo"; BNT162b2 (Dose: 1, Date: 19Aug2020), administration date: 19Aug2020, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "a C. diff infection", "psoriatic arthritis", "alopecia areatta", "hay fever", "vertigo". The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "psoriatic arthritis"; CLOSTRIDIUM DIFFICILE INFECTION (medically significant), outcome "unknown", described as "a C. diff infection"; ALOPECIA AREATA (non-serious), outcome "unknown", described as "alopecia areatta"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "hay fever"; VERTIGO (non-serious), outcome "unknown". Therapeutic measures were taken as a result of psoriatic arthropathy.  Clinical information: Description of Event Outcome: Pfizer, I had two shots and a booster of your COVID vaccines as part of the clinical trial, starting in Aug2020 and booster in Jul2021. Since I began the shots I have been diagnosed with alopecia areatta, hay fever and, most recently, psoriatic arthritis. It's not been a good two years. I now need to see about getting a booster and, as you can imagine, I don't really want another Pfizer vaccine. Is there any problem to get a Moderna booster after 3 x Pfizer shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
prolonged vagal episode, no LOC;  BP: 116/72  HR: 62  patient rested lying down, apple juice; resolved at 10:15am
Patches of red hives on my body. Hives are located on my legs, stomach, hips, ribs, back, chest, neck, arms, and hands/fingers .; Patches of red hives; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 02May2021 at 13:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and ethinylestradiol, levonorgestrel (ALTAVERA); on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 03May2021 at 08:00, the patient experienced patches of red hives on body. Hives were located on legs, stomach, hips, ribs, back, chest, neck, arms, and hands/fingers. The patient did not receive any treatment for the events. The clinical outcome of patches of red hives on body and hives located on legs, stomach, hips, ribs, back, chest, neck, arms, and hands/fingers were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated treatment received as no for events.
Patient reports tinkling in her front and back and jaw tightness with pressure pushing her jaw to the side.  She also heard a "pop" sound in her head.  After about 45 minutes she reported feeling better but still had some symptoms.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of of unspecified demographics. No information regarding the patients' medical histories, concomitant medication and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot# M035935, expiration date: 09-AUG-2018 (dose and route of administration were not reported). It was reported that the vaccines were exposed to the temperature range from 9 Celsius degrees to 25 Celsius degrees for a time frame of 2 hours 14 minutes. The temperature excursion was recorded by a digital data logger and there were no previous temperature excursions. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information is not expected since there was no consent for further contact.; Sender's Comments: US-009507513-1705USA009556: US-009507513-1706USA003430: US-009507513-1706USA003431: US-009507513-1706USA003432:
1st shot on 06May2022, too late to get 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on 6th May 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     Additional Information: GSK Receipt Date: 3-Feb-2023  Reporter's comment: The patient stated that he/she had difficulty in getting the information even after requesting it several times. The patient wanted to know if it was too late to get the second dose and how he/she should handle it.  The patient did not want to get 3 shots. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Patient started feeling chills about 3 hours after injection. Uncontrollable shakes that lasted into the evening. He said he could not walk because his legs kept collapsing on him. It  lasted until the next morning. He did not report it to anyone. He said he didn't think he ran a fever.
Ichy, felt hot all of sudden, eyes watery and blurry, side of neck (injection side) felt thick/hot.
FLUBLOK was given to a 15 years old patient with no AE; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 15 years old male patient who received 0.5 mL dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: UJ497AA, expiry date: 03-May-2021) via intramuscular route on left deltoid site for prophylactic vaccination (product administered to patient of inappropriate age) on 09-Oct-2020.   The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant therapy receive by patient.  It was an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of reporting, patient had not experienced any 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 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.
2 DAYS POST SECOND MODERNA VACCINATION (4/30) PTNT BEGAN EXPERIENCING SHORTNESS OF BREATH AND CHEST PAIN. 6 DAYS POST SECOND SHOT (5/4) PTNT WENT TO PRIMARY DOCTOR WHO DID BLOOD WORK.  PATIENT WAS ADMITTED TO HOSPITAL ON MAY 19TH FOR CONFIRMED PULMONARY EMBOLISM TREATMENT.  PATIENT DISCHARGED FROM HOSPITAL ON MAY 20TH ON 6 MONTH COURSE OF XARELTO.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 02-NOV-2012 at 08:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperature below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
No ADR, timing ERROR, 2nd dose given 45days after 1st one  Narrative: No ADR, timing ERROR, 2nd dose given 45 days after 1st one.
Huge rashes started appearing on legs, ankles and continued darkening for a week; skin oozes liquid. After a week, sensation of pins and needles all over the body. Dry cough onsets after a week.
Pt recvd vax & had projectile vomiting, inter-shaking & flushing;
Fainting, dizziness, brain fog, shaking sensation, rapid heartbeat, abdominal pain, headaches.
Customer got itchy once she received the vaccine.  This happened with the first vaccine as well.  No trouble breathing, just itching. Gave her 50 mg Benadryl and she waited 30 minutes until she felt comfortable to leave.
SOB, voice sounded hoarse, wheezing voice, bp=122/80, heart rate=128. School gave Benadryl. Two hours later no better, school called ambulance (couldn't reach parents), taken to ER. Hospital released on Tylenol 650mg with dx of anxiety. No airway restrictions noted and patient admitted nervous about shot. In school the next day.
Right leg red at site of immunization 9/28/17  Size of a quarter with surrounding lighter red. Pt acting normal. Very active. Not limping mildly tender to touch Denied fever. Site of DTaP Reassured local reaction.
ED visit for reaction to the COVID vaccine - Myoclonic jerking, Severe rigors, chills , malaise. Treated and released.
Got a flu shot, 3-4 days later seems to have come down with the flu, full blown symptoms not just achy. Wondering if vaccine was not fully inactivated. Have not been out of house or had contact with anyone other than going to pharmacy to get flu shot for 7 days.
Case number PHEH2014US019635 is an initial spontaneous report received from a medical assistant on 29 SEP 2014 and a follow up report from the medical assistant received on 31 OCT 2014. This report refers to a 34 year old female patient. Her past medical history and concomitant medications were not reported. On 29 SEP 2014 (at 11:54 am) she was vaccinated with an expired FLUVIRIN 2013/2014 (batch number: 1307701, expiry date: MAR 2014) at a dose of 0.5 ml in the right deltoid. The reporter stated that there was no harm to the patient. No adverse events were reported following the medication error (expired vaccine used). IT was reported that the box in which the vial placed stated batch number as 1412201 (expiry date: May 2015) but on the vial it was mentioned as batch number 1307701, expiry date: MAR 2014 and it was wrongly packaged.  Follow up report from the medical assistant received on 31 OCT 2014: Updated vaccination time, expiry date of the vaccine, does of vaccine and site of vaccination. Added event product label issue.
He got the vaccine, has had no problems ,then on 4/26/21 he got severe dry mouth, it's constant.  Then he started getting light headaches, and then his arms started jerking.  Then on Tuesday his feet went numb on both feet and he fell.  Now they keep going numb and okay and on and off.  It's like his nervous system and his motor skills have been affected.  He staggers now like he's drunk and had absolutely no symptoms or problems previously.   He is schedule d to see his PCP on 5/21/21.  Had an appointment for yesterday but had to cancel it.   He has taken some 81 mg aspirin but nothing else as he does not like to take any type of medicine.
Sickle cell disease patient with a history of Covid infection in Dec 2020, received first dose of Pfizer vaccine in April 2021 followed by second dose on  May 7th2021. He was admitted to the hospital on May 11th 2021 for a vaso-occlusive pain crisis. He then developed fevers, increased inflammatory markers, coagulopathy and significant tachycardia- echocardiogram, was done which showed coronary artery aneurysms raising concern for Mis-C. Retrospectively, his previous echocardiogram few years ago also showed coronary dilation although now it was slightly worse.  patient was given IVIG and steroids as treatment for Mis-C following which fevers resolved and his inflammatory markers improved. He is being followed with serial echocardiograms which shows stable echo findings.  He remains in the hospital still for treatment of his pain crisis.
I wake up it felt like I had interred ear trouble.  I felt dizzy and I felt like I was going to throw up. I stayed in the bed. My husband made me get up to eat.  When I tried to eat my soup, I did not have sense of taste and smell.  I went to pharmacy  for a Covid-19 test, which came back negative.  I also had the cold chills and brain fog. I feel fatigue.  I went to the local health department and did another Covid-19 test, came back negative.  I have high blood pressure when I went to the doctors. I have pain in my hands, in my arm, and left shoulders.  It feels like I been boxing all night.  I can not sleep on that side either.
Staff at hospital reported to pharmacy that patient was admitted with swelling in the face, hives and severe hypotension on 10/7/23 @ 5:45pm at the ER.