chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 days after receiving the Moderna Covid booster (3rd shot), I woke up with a severe rash, similar to hives, all over my body. The rash is incredibly itchy, and when I scratch it, it flares up and turns bright red and becomes even more itchy. Even if I lightly scratch anywhere on my skin, the skin turns red where I touched it, like dermographia. The rash moves around my body and is worse in different areas on different days. The rash is worst at night and after I shower. It has been 3 weeks and the rash has not gone away. I have taken a variety of antihistamines, including Benadryl, hydroxyzine, montelukast, famotidine, and Zyrtec. I take these in high doses every few hours, around the clock, which somewhat alleviates the itching, but not completely. I also have been lathering in cortizone cream and calamine lotion.  I did not experience any adverse reactions to the first two doses of the Moderna vaccine. Please contact with any questions.
13SEP91 day care facility reports that pt has red swollen area on thigh & is limping; does not have temp elevation;
Pt recv vax on 1/15/99; on 1/16/99 pt exp nausea, vomiting, fever (<102), body myalgias, erythema/induration at vax site-upper LA, arthralgias in knees/ankles, malaise
Patient came in with her mother and her sister for two vaccines. She was hesitant (anxious) to receive her vaccines, but eventually agreed. She received her Tdap in her left arm first, then we stood her up to flip the chair around and she sat down to receive her flu shot in her right arm.  A few seconds after she received her flu vaccines she lost consciousness for a few seconds which caused her to slump into the chair. I was able to place my hand  under her neck to support it. A second later she opened her eyes - they dilated and she arched her back out of the chair, fell forward and shook for a few seconds as I tried to lay her on the ground. She became alert immediately as I laid her on the ground and asked what happened. After that she was alert and oriented and had no other symptoms. Mom stated she has passed out from a vaccine before but she didn't shake in the past. She sat on the ground with her head between her legs as I administered her mom's and sister's vaccines. After that she was steady enough to leave. I called the mother a couple of hours later to check in and she said she was fine, no swelling at the injection site and no other adverse events after leaving the pharmacy.
Patient experienced itching and redness on both arms and hands. We provided diphenhydramine and observed for an hour. Patient did not progress to anaphylaxis or get any worse.
Covid arm developed on 3/20/21.   Day of vaccine 3/12 was tired , for 3 days after shot had sore arm and resolved , then Covid arm developed on day 8.  Took Zyrtec no response .  Had left  armpit pain on 3/17 & 3/18 but unsure if related.
16 days after receiving flu vaccine in 2005 (1st time ever receiving it) at 69 yrs of age, pt came down with a bad case of shingles, followed by RHN, which resulted in numb sole of foot and drop foot. He was seen in hospital for diagnosis, and neurologist was attending physician through several month's ordeal. Follow-up Information: Recovered from shingles but RHN remains - already 3yrs. Letter from patient: Thank you for affording me the opportunity to report the ill effects that might have been the result of the flu vaccine in October 2005.   1/5/09 Records received for 3 ER visits- 10/6/05 with Dx:  Acute shingles. Pt presented with 3 day hx of R leg pain, blistery rash and leg numbness. TX with Valtrex and pain meds. Returned 11/29/05 with c/o continued R leg pain 2' to shingles. DX: Post herpetic Neuralgia. Returned 12/5/05 with DX: Constipation 2' to pain meds. 2/18/09 MR received from neurologist for multiple OVs for post-herpetic neuralgia and Probable lower LS plexitis 2' to Zoster infection. Follow-up: Would love to know if you are seeing other cases of shingles, post flu shot. Post-Herpetic Neuralgia on sole of foot, which is the result of a very bad case of shingles. The patient, my husband developed shingles 16 days after receiving the flu shot; his first. I think it's very suspicious that after receiving the flu shot, which takes 14 days to take effect, that pt became very very ill with shingles. That can be proven documented in hospital and by his personal physician. Pt couldn't work for two months, and carried a cane for 4 months. Pain has subsided, but sole of right foot is numb and muscle in leg is weakened. Follow-up Information 09-DEC-2008: 16 days after recieving flu vaccine, in Oct of 2005, 69 yr old male recipient developed serious case of shingles. Neurologist was in chg. Physical therapy, because of derop foot prescribed for months and pain meds. Left w neuropathy from shingles, but foot is damaged.
Patient experienced an adverse reaction with her first dose of the Pfizer vaccine at our vaccine site. In order to prevent another episode happening, we administered the vaccine in our secluded first aid room so that she could be closely observed. Vaccine administered at 3:45 pm, first symptom of flushing and feeling warm began at 3:51 pm. Benadryl 25 mg PO was administered at 3:51 pm. At around 3:53 pm patient reported swelling of her throat. Patient appeared tachypneic, VS assessment completed. BP 128/76 P 69 RR 19 O2 99% RA T 98.3. EMS called at 3:53 pm, paramedics arrived on site at 4:00 pm.  Paramedics advised patient to go to hospital for further evaluation, patient refused and remained at our site for further observation for 45 minutes. Symptoms at time of adverse reaction include, swelling of throat, flushing, sweaty, shortness of breath, sensation of throat closing, itchiness in throat, wheezing noted upon auscultation and change in voice.  Applied ice packs and encouraged fluid intake.  Patient stated she felt better, was able to communicate all needs and ambulate independently.
I couldn't get my 2nd shot on time due to Covid; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   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 social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 04-June-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient wanted to know how long could he/she wait to get 2nd shingles shot and it still be effective. The patient couldn't get the 2nd shot on time due to Covid. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 4 patients. This is the first of four reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot number: S43277, expiration date: Sep2018, NDC number: 0005197101), via an unspecified route of administration on an unspecified date at single dose for routine vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as within the last 2 weeks), patient called into the office about experienced redness, swelling and a hard knot at the injection site lasting for several days. The nurse reported administering the product with possible quality issue to the patient. Outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017400617 same reporter, drug and events, different patients; US-PFIZER INC-2017400618 same reporter, drug and events, different patients; US-PFIZER INC-2017400619 same reporter, drug and events, different patients.
worsening  ringing in ears,  all waking hours, for several days. continues all waking hours through today and still quite loud and high pitched at times
Person received rabies vaccine #3 on 12/10/12. Called in PM 12/12/12 to say she had swollen neck glands. No other complaints from 1st & 2nd vaccine. Advised to see MD/ER. Person was called 12/13/12 in AM, said she was better and did not go to ER or see MD.
Rash, warmth and redness at the injection site,  I read that this has been seen after 5-9 days, but I am 16 days out. I am participating in the reaction tracker but my next check in is several days away.  I don?t think this is a serious problem but just wanted to report it.
On December 2, 2022, during the night I had a bad sore throat. It was so sore it woke me up. On Saturday December 3, 2022, my home COVID-19 test was negative. The following day I tested positive. I had a cough and some nasal congestion and a low-grade fever. I went to urgent care and received prescription for PAXLOVID. I had a horrible taste in mouth due to the prescription. In about two more days my other symptoms were gone. Also, on December 19 I had an event for AFIB, and my heart rate was 136.
Shivering, fever, vomiting, dyspnea that did not go away, nightmares, headache, chest pain, mouth and lip blisters, neck and back pain,
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dosage and route unknown for prevention of HPV). The patient was vaccinated with the second dose of GARDASIL (lot#, strength, dosage and route unknown in the left arm for prevention of HPV) series on unspecified date. On an unknown date the patient experienced "20 to 25 bumps" on the back of her arm following the 2nd dose GARDASIL that was administered. The patient was administered the 2nd dose of GARDASIL in her left arm and experienced the "bumps" on her right arm. The patient was seen by an unspecified dermatologist on an unspecified date and was informed by the dermatologist that the "bumps" were actually "warts caused by the GARDASIL vaccine." The dermatologist lasered to 20 to 25 bumps which the unspecified dermatologist stated were warts caused by the GARDASIL vaccine. The outcome of the events was recovered on an unknown date. Additional information has been requested.
was hospitalized and diagnosed with Guillain Barre Syndrome; Initial information received on 13-Feb-2023 regarding an unsolicited valid serious case received from a nurse.  This case is linked to case 2023SA053830(CLUSTER).  This case involves a 15-month-old female patient who was hospitalized and diagnosed with guillain barre syndrome after receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 20-Jan-2023, the patient received suspect influenza quadrival A-B vaccine at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date in 2023, the patient was hospitalized and diagnosed with guillain barre syndrome (guillain-barre syndrome) (unknown latency) following the administration of influenza quadrival A-B vaccine.   Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  Seriousness criteria: Medically significant and the patient was hospitalized for this event; Sender's Comments: Sanofi company comment dated 16-Feb-2023: This case involves a 15-month-old female patient who was hospitalized and diagnosed with guillain barre syndrome after receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV]. Additional information regarding condition at the time of vaccination, concomitant disease, concomitant medication would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Pt noticed itchiness and small bumps covering both forearms in early AM on 1/15, arms proceeded to worsen in redness, slight swelling with bumpiness around the edges, pt took 20 mg of prednisone around noon on 1/15. Pt woke up on 1/16 with rash now in right inner thigh, palm sized, as morning progressed pt noticed rash on top of butt/ lower back, extending up into the armpits on both arms, and on feet. Pt was in a lot of pain, pt took a hot bath, 40 mg of prednisone and 25 mg Benadryl. Pt took 50 mg of Benadryl night of 1/16. Pt awoke on 1/17 with worsened symptoms, pt repeated doses from 1/16.
Shot 2 Loss of muscle strength from neck down; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Aortic Valve replaced 2016", start date: 2016 (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no other medication in 2 weeks. Vaccination history included: Bnt162b2 (Dose 1, Shot 1, No Issues), for COVID-19 immunization.  The following information was reported: MUSCULAR WEAKNESS (medically significant), outcome "recovered", described as "Shot 2 Loss of muscle strength from neck down".  Clinical course: It was reported that after shot 2 patient experienced loss of muscle strength from neck down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201188088 Same patient, drug, and event separated in time;
Still has a lot of cough; Cant sleep enough because he wakes up with his cough; Dizziness; Feels disorientated; He is feeling worse; getting worse; saliva and runny nose with blood; cough sputum with blood; saliva and runny nose with blood; feeling sick; body aches; headaches; soreness on his arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021. The most recent information was received on 10-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), PAIN (body aches), HAEMOPTYSIS (cough sputum with blood), RHINORRHOEA (saliva and runny nose with blood) and EPISTAXIS (saliva and runny nose with blood) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045b21a and 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (feeling sick), PAIN (body aches), HEADACHE (headaches) and MYALGIA (soreness on his arm). On 29-Apr-2021, the patient experienced HAEMOPTYSIS (cough sputum with blood) and RHINORRHOEA (saliva and runny nose with blood). On an unknown date, the patient experienced EPISTAXIS (saliva and runny nose with blood), COUGH (Still has a lot of cough), SLEEP DISORDER (Cant sleep enough because he wakes up with his cough), DIZZINESS (Dizziness), DISORIENTATION (Feels disorientated), FEELING ABNORMAL (He is feeling worse) and CONDITION AGGRAVATED (getting worse). At the time of the report, MALAISE (feeling sick), PAIN (body aches), HAEMOPTYSIS (cough sputum with blood), RHINORRHOEA (saliva and runny nose with blood), EPISTAXIS (saliva and runny nose with blood), HEADACHE (headaches), MYALGIA (soreness on his arm), COUGH (Still has a lot of cough), SLEEP DISORDER (Cant sleep enough because he wakes up with his cough), DIZZINESS (Dizziness), DISORIENTATION (Feels disorientated), FEELING ABNORMAL (He is feeling worse) and CONDITION AGGRAVATED (getting worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided. His side effects are getting worse, and now he will be going to the emergency. He still has a lot of cough, it is a strong cough, and patient stated that he can't sleep enough because he wakes up with his cough, and that cough has more blood than before. He had to leave work. He has a bit of a headache, dizziness and he feels disorientated.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: New AE added
Client received her flu vaccine at 3:20pm & waited. She then left work & called a co-worker at 4pm stating she felt a "little shaky" & her (L) eye was puffy & red & she had "itching feeling" on her scalp. I called her back & she was at store getting BENADRYL & then was going straight home. Her mother lives very close she said & was aware of her symptoms. She had had dental work on 11/16/10 & was on Amoxicillin- no other meds & no allergies or medical conditions. No respiratory or throat issues noted although she has had sinus drainage recently & was clearing her throat. She stated she had eaten chili earlier in the day for the first time in many years so wasn't sure if it could be something related to that. She felt fine to drive but I encouraged her to have her mother come to get her. Her 11 year old daughter was with her. I gave her my number to call as soon as she got home. I spoke to her again at 4:25pm & she c/o her hands feeling itchy & the other symptoms remaining - she had taken a BENADRYL & was not shaky now & did not have any respiratory/throat s/s. She stated she had taken BENADRYL in the past (6 yrs ago) for poison ivy & it was usually effective although it made her sleepy. She also stated in addition to the dental work yesterday she had had a root canal last week for a broken tooth & the dentist had "hit a nerve" & her face was swollen & she was taking EXCEDRIN prn. I encouraged her to get a ride to an urgent care & gave her the name of flu shot given & to call me from the urgent care if needed. I spoke to her again at 4:55pm & she had returned from the urgent care & they could not determine if it was related to the injection, the dental work & anesthesia or the chili or a combination of the above. She received an anti itch cream & an oatmeal bath wash & was aware to call them or her doctor with any further s/s. No local site irritation noted. Left message on client's phone & contact persons's phone on 11/18/10 to follow up with client status. 11/19/10 3PM I reached patient and she said her eye swelling and itchiness resolved. She does have a "golf ball" size lump at injection site. Denies any other discomfort or problem.
Pt was given the Covid-19 monovalent 12yrs and up instead of the Covid-19 bivalent 12yrs and up. Pt waited 15 minutes after injection and had no adverse reaction.
Extreme fatigue more or less 3 weeks- 1 month after injection of TD. Dizziness, chronic headaches, weakness in arms & legs, generalized muscle twitching. Referred to neurologist. Had URI- clear. Admitted to hospital 4/18/04 emergency room. Sensitivity to Thinerobal.
Patient developed Bell's palsy, hearing loss in right ear and tinnitus in right ear and change in vision
Pt admited to faility on 08172021 with c/o worsening sob, myalgias, fever, cough and generalized weakness x1 week. Her husband was dx with covid 8/8. Her symptoms started 8/11. loose stools have continued with frequent episodes of incontinence. O2 Sats ~85% on RA prior to transport.  Pt continues to be an inpatient at this time.
This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of M-M-R II with lot number N002337 and expiration date on 20-JAN-2019. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA012976: US-009507513-1708USA011949: US-009507513-1708USA012975: US-009507513-1708USA012972: US-009507513-1708USA012973.
Redness, swelling, tender to touch, warm, and itching at the injection site 3 hours after administration. Patient applied a cold compress to the area and we gave the patient diphenhydramine 50mg on 10/22/2015.
PATIENT RECEIVED  VACCINATION WHILE SITTING IN CONSULTATION ROOM.  SHE STOOD UP AND WALKED OUT TO WAIT IN CHAIRS AND FAINTED.
Tinnitus in right ear two days after first shot Continues to hear hissing sound.
On 2/17/99 and in 3/99, the pt received the first and second doses of Lymerix.  The pt's arm was very sensitive a the injection site after the first and second doses.  After either the first or second dose, she experienced generalized pain (neck, shoulders, lower back, right hip, and all over).  The most recent information received on 3/10/00, reports the condition of the pt as ongoing.
This case was reported by a healthcare professional to a sales representative and described the occurrence of the redness and swelling at the injection site in a 4-year-old subject (unknown gender) who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On an unspecified date in either in March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). The injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 April 2006, the subject experience redness and swelling at the injection site of Infanrix. The outcome of the events was not reported. The  nurse considered the events to probably be related to vaccination with Infanrix.
Hard time hearing; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer, the male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he got the Covid vaccine yesterday (27Jan2021) and has a hard time hearing on an unknown date in Jan2021. The outcome of the event was unknown.  No follow-up attempts are possible; Information on Lot/Batch cannot be obtained. No further information is expected.
Within the 15 minutes following vaccination client complained of feeling light headed, weak, and nauseated. He appeared very pale and diaphoretic. Reportedly may have  loss consciousness for few seconds per monitoring staff. While in his car his seat was inclined. His B.P. was 124/76 Heart Rate 63, O2 level was 93 % initially and increased to 97%. He reported improvement after being in inclined position for few minutes. However after 10 minutes he complained again of feeling light headed and nauseated, appearing pale. Blood Sugar level was 134.  MDs assessing client decided that it was best to have him further evaluated in the ER and therefore 911 was activated. With EMT clients Vital Signs were 130/80 HR in the 60's and O2 sats continued to go between 93%  and 97%. Client continued to be diaphoretic, pale, also shaky