chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red itch burning rash on her chest and neck; red itch burning rash on her chest and neck; red itch burning rash on her chest and neck; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red itch burning rash on her chest and neck), RASH PRURITIC (red itch burning rash on her chest and neck) and BURNING SENSATION (red itch burning rash on her chest and neck) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ERYTHEMA (red itch burning rash on her chest and neck), RASH PRURITIC (red itch burning rash on her chest and neck) and BURNING SENSATION (red itch burning rash on her chest and neck). At the time of the report, ERYTHEMA (red itch burning rash on her chest and neck), RASH PRURITIC (red itch burning rash on her chest and neck) and BURNING SENSATION (red itch burning rash on her chest and neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included- a cream for the dermatologist.
arms are currently swelling; Fever/ and 102 (reporter stated 102.4) temperature; ''aches like aching'' almost like a flu; ''aches like aching'' almost like a flu; This is a spontaneous report from contactable consumer (patient) via regulatory authority. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient mentioned that his arms were currently swelling right now and he had fever right now. The patient stated not always like, not swelling but it was like 'aches like aching' almost like a flu throughout the body and 102 (reporter stated 102.4) temperature. Patient wanted to know if he can take Tylenol or not because he was getting aggravated here because, he went through this over half an hour and now (voice overlap). Outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
had a sudden lightheadedness/a bit lightheaded; slurred speech; extreme sleepiness; feeling like was under anesthesia and unable to move the legs; unable to move the legs; Blood pressure dropped to 80/60mmHg and pulse was at 50; Blood pressure dropped to 80/60mmHg and pulse was at 50; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization in their facility. The patient's medical history and concomitant medications were not reported. It was reported that patient (doctor) in their facility received the vaccine and had a sudden lightheadedness, slurred speech and extreme sleepiness. Feeling like was under anesthesia and unable to move the legs. Blood pressure dropped to 80/60 mmHg and pulse was at 50. The episode lasted 2h and then became alert but a bit lightheaded and was normal next day. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
lt thigh area became swollen, hard, red @ inj site-size of quarter w/100 rt temp - infected hematoma @ inj site;
Information has been received from a medical assistant concerning a 65 year old female with no pertinent medical history or drug allergies, who on 16-OCT-2007 was vaccinated with a one time SC 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot# 657766/0620U) in the left arm. Concomitant drug therapy included Synthroid and vitamins (unspecified). On 17-OCT-2007, the patient experienced injection site pain, redness, itching, warmth on an inflamed 2 X 2 inch patch area. The patient called the physician's office and came into the office for a visit. The physician stated that it looked like a cellulitis reaction. No labs or diagnostic studies were performed. The patient was treated with anti-itch cream. The patient's outcome was not recovered at the time of reporting. There was no product quality complaint. Additional information has been requested.
Sporadic itching and hives all over my body that began one week and three days after receiving the Moderna booster. On days three through five of symptoms, took two Benadryl  tablets each day as well as applied Cortisone cream to affected areas. Went to Urgent Care on day six and was given a steroid shot, one Claritin tablet, and a prescription for Prednisone to begin the following day for the next seven days. Will follow up with PCP in two weeks.
Swollen eyes, fever, swollen throat, aches, difficulty breathing, Txt: prednisone & BENADRYL.
Tingling in the right foot only; Fatigue; Body weakness; Morning after booster felt low grade fever chills body weakness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the right foot only), ASTHENIA (Body weakness), PYREXIA (Morning after booster felt low grade fever chills body weakness), CHILLS (Chills) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 032B21A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced ASTHENIA (Body weakness), PYREXIA (Morning after booster felt low grade fever chills body weakness) and CHILLS (Chills). On 05-Nov-2021, the patient experienced PARAESTHESIA (Tingling in the right foot only) and FATIGUE (Fatigue). At the time of the report, PARAESTHESIA (Tingling in the right foot only), ASTHENIA (Body weakness), PYREXIA (Morning after booster felt low grade fever chills body weakness), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient developing tingling in her right foot along with fever and fatigue. The symptoms were ongoing.
Joint pain- hip, back, knees, shoulders, neck.  Intranasal Influenza Medimmune Lot 5000691P .2cc
After receiving the vaccine, I was fine with the exception of the expected injection site pain and achiness. I had a mild fever that night and a bit of tiredness for a few days but was ok after that. At then end of February or beginning of March, I got a blemish above my right eye towards the inner portion. That area became tender and tingly. As the days proceeded, I began to see more redness and blemishes appear. I eventually went to the Urgent Care as the redness and blemishes spread across my face toward my scalp and ears. I was experiencing mild pain and tingling. They prescribed Valtrex right away and the symptoms began to subside and went away all together after a few weeks.
Previous to receiving this vaccine I had only approximately 2 or 3 herpes outbreaks per year.  In the past 3 years, I have had 25 outbreaks.
From April 7-April 15, 2005, four babies were in for immunizations, Pediarix lot# GSKAC21A012BA was written on record of all four. It was found at a later date by inventory that there should have been only three left of that lot# of Pediarix. Therefore after consulting with immunizations representative at state we had all four babies return four weeks later for another dose of Pediarix.
Vertigo for 1 week starting on Friday May 7. Had to take off work the following Monday May 10 through Wednesday May 12. Multiple periods - May 2nd was the last day of my last period. Then I had a period from May 9 to May 11 - light bleeding. Then again from May 20 to May 25 - very heavy bleeding.
1st dose of DPT & PREVNAR was 7/11. On Tues 9/27 2nd dose of DPT & PREVNAR was given. Thursday night 9/29 baby was having absent seizures and all day on 9/30. Went to ER at Hosp. Was throwing up on Saturday 10/1/11 from 5:30A-12 noon. Still gets seizures. Have apt for EEG & MRI on 10/4 and have an apt with Pediatric neurologist on 10/5/11.
Urinary incontinence increased; This non-serious case was reported by a consumer via call center representative and described the occurrence of urinary incontinence aggravated in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included urinary incontinence.   On 12-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular). On 13-MAY-2023, 1 days after receiving Shingrix, the patient experienced urinary incontinence aggravated (Verbatim: Urinary incontinence increased). The outcome of the urinary incontinence aggravated was not resolved.   It was unknown if the reporter considered the urinary incontinence aggravated to be related to Shingrix.     It was unknown if the company considered the urinary incontinence aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023. Consumer was calling to asked if urinary incontinence was a known side effect of Shingrix.  The reporter stated that he did have urinary incontinence and that it became worse one day after receiving his first Shingrix dose.  The reporter referred to health care professional.  The reporter did not provide consent to contact his health care professional.  The reporter did not consent to follow-up.
~2wks following first injection, noticed a left submandibular lymph node swelling/tenderness. Following first injection, had occasional transient headache, lightheadedness. ~4 days following the second injection, had an episode of elevated resting and active heart rate for ~1.5hrs. (Normal resting HR is 60-70s, during episode was 100-110s with increase to ~140 with short walk). Following second shot, also had axillary lymph node discomfort, transient on/off headache, lightheadedness, chills, fatigue. My submandibular lymph node has not resolved but HR issue has (why reported as ?no? below).
44 y/o patient contacts Call Ctr on 06APR12 requesting waiver from all future vaccines. Reports "chills, felt warm, run down, tired, decreased appetite, general malaise" onset about 6 hours after receipt Tdap (LUE) & IPV (RUE) on Friday, 15JUL11. Stayed in bed all the next day (Saturday). Did not take any OTC medications for relief of sx. On Sunday, 17JUL11 felt like he was "hung over" but had not consumed any alcoholic beverages. Got up & around, but felt "off." Sx resolved spontaneously and he returned to work on Monday 18JUL11. On Monday, 25JUL11, he received AVA #5 in his left upper arm, IM. Arm got a little red at injection site and was sore, but denies large local reaction, erythema > 30 mm, warmth or induration at injection site. No adjacent joint pain or joint pain in any other part of body. No chronic HA's. States that AVA's # 1-4 all made his arm hurt, but no large local reactions or systemic malaise. On 29JUL11, patient received HEP B #1 IM in Lt arm on Friday, 29JUL11. Upon awakening on Saturday, 30JUL11, he noticed red spots, which looked like bug bites all over his body- face, neck, arms, chest, abdomen, genital area, back, legs, but not on palms of hands or soles of feet. The itching was not all that bad. By Sunday, 31JUL11, the red spots were quite a bit larger and merged together. His left eye was almost swollen shut, but he denied any lip swelling, tongue thickening, difficulty breathing or swallowing. He applied on OTC topical "anti-itch" medication (can't remember name) over all the affected areas. On Monday, 01AUG11, he returned to the Clinic and they gave him a Prednisone taper, which took effect right away. He has not received any other vaccines since the mentioned vaccines in July 2011. He will be mobilized for AD in June of 2012 x 2 weeks. He is not deploying and will remain in continent. He does Not want to receive another dose of HEP B or any other vaccines. PMH: No chronic disease, hospitalizations or surgeries. NKDA. No environmental, food, or chemical allergies. NO MEDS. SOCIAL Hx: Never has smoked. Very moderate Social ETOH. No illicit drug use. His MOS is currently Operational- sitting at desk, working at computer. His job during the week is as a Special Agent. He is married and has 2 boys. His 14-year-old son has Autism. His 12-year-old son is in good health, because they managed to "stop vaccines before he got damaged." Patient  expresses concern re + Family Hx of Auto-Immune Disease: Father (Deceased at 88) h/o RA since patient was born- as long as he can remember. Mother (Living, 83) in good health, no chronic disease. Likewise his elder Sister (Living, 47) is in good health, no chronic disease. Niece with asthma.
Hospitalization, sever staphylococcus, MRSA, anemia, fever for over 80 days.
Initial information was received on 26 November 2008 from a health care professional. A female patient received an injection of FLUZONE SV 2008-2009 (lot number not reported) on 18 September 2008. On the day of vaccination the patient developed redness and swelling at the injection site and had swelling of the eyelid. The patient had a doctor's visit and was prescribed an antibiotic for the localized reaction. The recovery status was not reported. Follow-up information was received from a health care professional on 12 March 2009 which indicated that the patient had been hospitalized for five days. Based on this new information, the case has been upgraded to serious. The patient, a 67-year-old female, received FLUZONE SV 2008-2009 and PNEUMOVAX (Merck, lot not reported) on 18 September 2008. Approximately 48 hours post-vaccination, she developed swelling of the eyelid and injection site inflammation, and was subsequently hospitalized for five days. The event recovered. List of Documents held by sender: None.
4-12-21 10AM TC: PT STATES SHE HAS BEEN ITCHING. HAS NOT TRIED BENADRYL.  ADVISED TO CALL PCP IF BENADRYL DOES NOT HELP FOR OTHER OPTIONS.
10 minutes after vaccination patient became unresponsive, staring forward with stiff body, arms flexed and hands fisted. She required sternal rub without response.  She was incontinent.  Episode lasted 1-2 minutes. She had no recollection of the episode.  Paramedics assisted, with Temp 97.1, HR 80, B/P 122/80, pulse ox 98%, fingerstick 101. She was transported by ambulance to Hospital.  Laboratory assessment was unremarkable for for CMP, CBC, Troponin, Lactic acid. EKG, CXR and CT head were also unremarkable. She was discharged with diagnosis of possible vasovagal syncope episode and instructed to follow-up with her pcp.
Metal taste in the mouth; Felt like she would pass out; Soreness; Felt light headed; Upper lip felt numb; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed), HYPOAESTHESIA (Upper lip felt numb), DYSGEUSIA (Metal taste in the mouth), PRESYNCOPE (Felt like she would pass out) and MYALGIA (Soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DIZZINESS (Felt light headed), HYPOAESTHESIA (Upper lip felt numb), PRESYNCOPE (Felt like she would pass out) and MYALGIA (Soreness). On 29-Jan-2021 at 11:55 PM, the patient experienced DYSGEUSIA (Metal taste in the mouth). At the time of the report, DIZZINESS (Felt light headed), HYPOAESTHESIA (Upper lip felt numb), DYSGEUSIA (Metal taste in the mouth), PRESYNCOPE (Felt like she would pass out) and MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatments were provided.   This case was linked to MOD-2021-256808 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Updated patient email , second dose details and events.
Below is a description of the events from the incident at the event where we know that 1 individual was given an inappropriate vaccine.  The client, requested a vaccine and was assisted by the staff with filling out the consent form.  The client denied ever having received a COVID 19 vaccine before with the staff that assisted her.  The client was asked again by the vaccinator, and she again denied having received any prior COVID 19 vaccines.  She chose to have the Pfizer vaccine administered today.  When reviewing the paperwork with the staff after vaccination it was discovered that this same client had received a Janssen vaccine on 3/30/21 at a separate event.    When I arrived at the event today notified me of the event, and I went to speak with the client myself.  I found her among the crowd near the office.  When I asked her why she took another vaccine she informed me that "I wanted that shot and you have to give it to me because I'm the Chief" During this conversation it was clear to me that she was not mentally stable.  I did inform her that she could not receive any more vaccines and did my best to make certain that she understood.    When I came back to the office, I went through all the consent forms again screening for any other potential errors.   In this review another vaccination error was discovered.  I spoke with staff and the vaccinator, about the situation.  The scenario is very similar. This client filled out the consent form himself and wrote in a date of March 24 without a manufacturer in the question list provided that asked about prior covid vaccines and when the vaccinator, was with the patient she identified the date written in on the consent form and she questioned the client about it and he told her that it was a mistake and specifically denied having ANY prior COVID 19 vaccinations.  He also denied having any vaccine cards issued to him ever before.  She then appropriately drew a line through the mistaken date and initialed it.   She also confirmed with the patient that he wanted the Johnson and Johnson vaccine today and he stated he wanted the 1 shot vaccine (meaning the J and J).   I then looked the client up in the system and he is documented as receiving his first dose of Pfizer on 3/15/21.    The team is revising our operations for the vaccines and from this point forward all potential clients that request a vaccine at these events will be screened with the system prior to vaccine administration.
Mom states, pt inconsolable, decreased appetite, and bilateral swelling of legs noted at home, post vax. Mom called clinic in the afternoon. Pt was taken and seen by the doctor at 16:00.
UrticariaPruritus Narrative:  Patient complaining of torso,back, and bilateral arm pruritis and a splotchy rash after receiving second dose of COVID-19 Pfizer vaccine. Patient alert and oriented x 4. Denies shortness of breath, abdominal pain, nausea or vomiting. Vital signs stable. Patient was discharged home the same day.
Shingles vaccine given 8/20/13 - Itching and redness at site of shot, dermatologist applied Cloderm, redness enlarged that night and felt hot to touch.
Pt states that on June 23, 2004 (or 25th) while he was showering, he noted a "pea-sized" blister with clear fluid at the exact location of where he had received his smallpox vaccination about 1 year ago.  The lesion developed a scab in 3-5 days.  Pt states that he experienced malaise for 2 days immediately after first noticing the blister. The lesion was painful to touch, but otherwise caused no problems.  The scab came off after about 3 weeks (he states that he normally heals very quickly and that is the reason why he wondered if the lesion was somehow related to the smallpox vaccination he had received a year ago).  He denies a history of shingles and although he doesn't remember ever having chickenpox, he thinks he had it because all 5 of his children have had it and he never got sick while they were ill.  He had developed a major "take" reaction after the smallpox vaccination which developed a scab and healed without problems.
little swelling at the injection site on the axilla; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (little swelling at the injection site on the axilla) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE SWELLING (little swelling at the injection site on the axilla). At the time of the report, VACCINATION SITE SWELLING (little swelling at the injection site on the axilla) outcome was unknown.      No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-386035 (Patient Link).
Itching badly on upper torso/still itchy; Lips were tingly; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching badly on upper torso/still itchy) and PARAESTHESIA ORAL (Lips were tingly) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Allergic reaction to nettle) and Allergy to animal (Allergic reaction to scorpions).    On 31-Aug-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced PARAESTHESIA ORAL (Lips were tingly). On 31-Aug-2021 at 4:00 PM, the patient experienced PRURITUS (Itching badly on upper torso/still itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in 2021 for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching badly on upper torso/still itchy) had not resolved and PARAESTHESIA ORAL (Lips were tingly) outcome was unknown.            No concomitant medications were provided.  Patient was taking Benadryl every 3-4 hours and it helped a lot.
Information has been received from a licensed practical nurse concerning al 11 year old female who on 09/21/2001 was vaccinated with varicella vaccine. On 09/24/2001, the pt's mother called the office and reported that the pt had a sore throat, fever and rash. On 09/24/2001, the pt was seen in the office and was diagnosed with full blown chicken pox with over 100 lesions. The pt had no known exposure to wild-type virus. Subsequently, the  pt recovered from chicken pox. At the time of this report, the pt had not been seen in the office since 09/24/2001. Additional info has been requested.
This spontaneous report as received from a medical assistant refers to 12 months infant patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.