chrisvoncsefalvay/vaers-outcomes huggingface dataset:
face was warm; face was warm, red; face was warm, red,swollen; face was warm, red,swollen, and itching; rash on face expanded/ A big rash appeared on left legbehind knee/Also a big rash on lower and upper back; The rash behind knee spread, and it was itching; The rash behind knee spread, and it was itching and red.; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 30Apr2021 at 09:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included rash on face. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of COVID-19 vaccine. On 01May2021 at 00:30 the patient experienced, the rash on face expanded, a big rash appeared on left leg behind knee. On the same day at 08:00, the patient experienced face was warm, red, swollen, and itching. Also, a big rash on her lower and upper back. On the same day, the patient experienced the rash behind her knee spread, and it was itching and red. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL 25 mg every 6 hrs, prednisone 20 mg x3 daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash on face expanded, a big rash appeared on left leg behind knee, face was warm, red, swollen, and itching. Also, a big rash on her lower and upper back, rash behind her knee spread, and it was itching and red was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
pt recvd 5 doses of Engerix-B & still did not seroconvert; reporting MD heard about this had no addtl info;
Loose stool day before - severe abdominal pain.  8/12/08 Received copy of letter from surgeon to PCP dated 7/14/08.  Patient had been seen in office on 7/9 s/p air enema reduction for IS approx 2 wks prior.  Was doing well & was d/c from further f/u./ss  8/15/08 Reviewed hospital medical records of 6/24-6/25/2008 FINAL DX: Intussusception Records reveal patient experienced intermittent abdominal pain x 1 day with one loose stool.  Temperature 100, pulse 120.  Peds surg consulted.  Admitted overnight for observation s/p enema reduction of IS.  Progressed well & d/c to home w/peds surg & PCP f/u.
DEATH.  Suffered Cardiac arrest, Acute Myocardial, and Anoxic Brain injury.  Less than one year after receiving the COVID-19 vaccine.
Multiple lesions were seen on neck, shoulders, upper aspect of arms, chest, anterior and posterior aspect of trunk also on all parts of arms, upper part of thighs and buttocks, amount of lesions were more than 100. Lesion were all stages of development, slightly raised vesicles that previously were ruptured lesions were circlar in shape ranging between 1/4cm to 1cm in diameter.
Paranoid behavior for several days (3): disrupted work temporarily (ie functionally/productivity at work).
pt states a couple of days after taking the covid vax she had developed a itchy light 2 1/2 x 3 1/2" rash on her left arm about an 1" below the injection.  She also has diarrhea that comes and goes.   She feels like the rash is getting some better but the diarrhea is not.
Client presented to the vaccination site on 12/04/2021. The client notified PHN that he received a first dose of Pfizer COVID vaccine on 11/13/2021 and is here for the 2nd Pfizer dose. Per patient developed mild chest pain and throbbing headache on the second and fourth day only after administering Pfizer. All symptoms subsided with the use of Acetaminophen taken on the fifth day and client did not follow up with primary care provider. Patient denies underlying conditions, no known allergies and not taking any medications. PHN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer 2nd dose. Approval to proceed with COVID vaccine Pfizer 2nd dose was obtained from medical consult team via text message from MD, Vaccine Operations Lead . Client received COVID vaccine Pfizer 2nd dose LOT: FF8841 on 12/04/2021. The client did not report any symptoms during the 30 minute observation period. PHN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 3:30pm, client left facility with a steady gait. VAERS and VERP completed.
Mother called the health department at 1:30 p.m. on 12/6/18 stating that she had picked her child up from school due to pain in the right arm with child stating she could not use a pen. States no edema or erythema or other abnormal signs at injection site. Mom states that she complained of it being a little sore last night after the shot yesterday and mom told her this morning that if it started hurting her to call and she would come and pick her up from school. Child called this afternoon complaining that she could not use a pen to write without pain in her arm. I consulted with our medical director who advised TYLENOL or MOTRIN, cold compresses and to see her doctor if symptoms worsen.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M007301, expiration date 19-NOV-2017, lot # M041766, expiration date 08-MAY-2018 (dose was not reported) for prophylaxis. No adverse effects were reported. The administered doses of ROTATEQ were stored in the temperature between 9 degrees Celsius and 25 degrees Celsius for 9 hours and 5 minutes. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006296: US-009507513-1707USA006295: US-009507513-1707USA006293: US-009507513-1707USA006294.
On the right arm all through tattoo surface a ?rash? appeared that was very itchy. No where else on my body did this occur. Treated with a steroid cream to calm the itching.
This patient had a varicella rash, noted on 03/31. Seen in the office today 04/03.
pt recvd vax; subsequently devel redness & swelling at inject site; also had a fever; dx of cellulitis was made but no tx;
coughing; difficulty breathing; dizziness; weakness; loss of appitte; lost 5 pounds; headache; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DECREASED APPETITE (loss of appitte), WEIGHT DECREASED (lost 5 pounds), COUGH (coughing) and DYSPNOEA (difficulty breathing) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (muscle pain). On 01-Mar-2021, the patient experienced HEADACHE (headache). On 02-Mar-2021, the patient experienced ASTHENIA (weakness), DECREASED APPETITE (loss of appitte) and WEIGHT DECREASED (lost 5 pounds). On 03-Mar-2021, the patient experienced COUGH (coughing), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency; BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Adverse event, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (muscle pain) had resolved. On 01-Mar-2021, HEADACHE (headache) had resolved. On 04-Mar-2021, ASTHENIA (weakness) had resolved. On 09-Mar-2021, WEIGHT DECREASED (lost 5 pounds) had resolved. In March 2021, DECREASED APPETITE (loss of appitte), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness) had resolved. At the time of the report, COUGH (coughing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Oxygen saturation: 88 (Low) 88. In March 2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This case was reported by a nurse and described the occurrence of hives in a 30 year old female pt who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis.  The pt's medical history was not reported.  There were no concurrent medications.  On 10/27/03, the pt received the second dose of Twinrix (Lot # HAB235A4).  On 10/29/03, 48 hours post-immunization, the pt experienced itching hands followed by hives, itching and redness over her entire body.  The events were unresolved as of 10/31/2003.  The nurse considered the events to be possibly related to vaccination with Twinrix.
Vaccine administered IM in the right deltoid on 4/4/01 and 24 hours later, complained of itching. Mom noted red, swollen area. No fever. Had emesis and decreased activity at 36 hours, post vax, with increased swelling.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient with drug hypersensitivity to Neomycin. On 22-SEP-2013 the patient was vaccinated with ZOSTAVAX (dose not provided), subcutaneous. On an unspecified date in 2013, after receiving ZOSTAVAX, the patient "felt a little sick". Patient reported to the pharmacist that this might be because she was allergic to Neomycin, which had manifested as contact dermatitis in the past. There was no treatment given for the adverse event. The outcome of felt a little sick was reported as recovered on an unspecified date. Additional information has been requested.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient's age could be 57 years or 58 years old. The patient reported that she received the first dose of Shingrix about 2 months ago. Afterwards she had a sore arm, which resolved. Consented to follow up. This case is linked to the case US2020AMR060549, reported by the same patient for the 2nd dose.
Presented with SOB/body aches x3 days; dx Covid PNA: Labs: CRP 5.31; Ferritin 2113; CXR: R lung pneumonia Tx: Maxipime, Decadron, Heparin, Singulair, Zinc (no remdesivir due to ESRD); Initially on 3 LPM O2; up to 5 LPM and then back to room air at d/c
shoulder pain >4 weeks post vaccine Narrative:  developed shoulder pain after 1st vaccine which never went away; got 2nd dose same arm and pain persists (positional). was seen by ortho in the  private sector and told it's likely from vaccine. treated with naproxen.  Other Relevant History:
This case was reported by a consumer and described the occurrence of stopped growing in a 5-year-old female patient who received Hib vaccine. Co-suspect products included DTP (A or W not known), IPV, HepB, Pneumo, ROTATEQ, MMR and Varicella. The patient's past medical history included ear infection. Previously administered products included antibiotics, steroids, DTP, IPV, HepB, PCV-7, ROTATEQ (Batch number 0411F, expiry date 07 Dec 2007), DTP, IPV, HepB, PCV7, ROTATEQ, DTP, IPV, HepB, PCV7 and ROTATEQ. On an unknown date, the patient received Hib at an unknown dose. On 24th June 2007, the patient received DTP, IPV, HepB, Pneumo, ROTATEQ, MMR and Varicella. On 12th March 2011, unknown after receiving Hib and 3 years and 262 days after receiving Hib, DTP and HepB, the patient experienced stopped growing (serious criteria GSK medically significant) and stop developing. In July 2011, the patient experienced weight gain. In August 2011, the patient experienced learning issue. In October 2011, the patient experienced headache, In June 2014, the patient experienced sleep apnea, large tonsil and large adenoid. On an unknown date, the outcome of stopped growing, stop developing, learning issue and weight gain were not recovered/not resolved and the outcome of the sleep apnea and headache were unknown and the outcome of the large tonsil and large adenoid were recovered/resolved. It was not reported if the reporter considered the stopped growing, stop developing, sleep apnea, large tonsil, large adenoid, learning issue, weight gain and headache to be related to Hib, DTP and HepB. Additional details received from the reporter (patient's mother): her daughter was in 2 clinical studies. The patient received 3 injections but she did not know which vaccine the child received. The reporter believed that her daughter received Hib 3 times through clinical studies and 4 times through routine childhood vaccine administration. Unspecified time after pre-kindergarten shots the patient stopped moving forward with schooling and stopped developing. She was supposed to be in 3rd grade but she was testing on a 1st grade level. She acted like when was 4-5 years old. On 05 February 2014, the patient experienced weight gain in abdomen. The outcome of weight gain in abdomen was not recovered.
PT SEEN IN OFFICE ON 10/25/2007 FOR POSSIBLE VACCINE REACTION. PT RECEIVED TDAP AND VARIVAX ON TUESDAY, 10/23/07. ON 10/25/07 PT PRESENTED WITH LEFT ARM SWOLLEN, RED, AND SLIGHTLY ITCHY. PROVIDER NOTED THAT LEFT UPPER ARM WAS RED, INDURATED, AND WARM, AFFECTED AREA 3 X 4 CM, NONTENDER TO TOUCH. PT WAS ADVISED TO USE COOL COMPRESSES PRN AND HYDROCORTISONE CREAM PRN ITCHING. TO CALL BACK FOR INCREASED REDNESS, PAIN, OR SWELLING.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2014 the patient was vaccinated with a improperly stored dose of (Oka-Merck) PROQUAD (lot#, strength, dosage and route unknown). No adverse symptoms reported. The temperature excursion for the (Oka-Merck) PROQUAD was supported with in-house stability data. Additional information has been requested.
After three minutes patient reported feeling funny in her throat and feeling like she had phlegm in her nostrils.  She also stated her tongue felt like it was wobbly.  She was able to talk fine but cleared her throat a few times and asked for water.  Gave her a small amount of water and asked her to wait while we monitored her.  A little bit later when I looked her way she was gone (fifteen minutes had probably elapsed).  Pharmacy tech stated pt had reported feeling some itching before she left.
Pt received oral dose of Rotavirus. Mother said he had a choking spell turned pale. No cyanosis, no apnea.
Report 2001029413-1 describes leg pain in a female in her 50's who received hep B vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not specified. On 12/4/01, the pt received her first injection of Engerix B. For 20 minutes following the injection, the pt experienced nausea, which resolved without treatment. On 12/7/01, three days post-vaccination, the pt experienced pain in her legs and was seen by the reporter. She had no difficulty walking. The pt talked to her physician via the telephone. The pt indicated that she thought the leg pain was related to Engerix B administration.
Hot flashes; Profuse night sweats; Mood swings; Sleep disturbances; Memory difficulty; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Jan2021 13:06 (Lot number: EK9231) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer", start date: Feb2009 (ongoing), notes: Thyroidectomy, Radioactive, Iodine Tx; "Known allergies: latex" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Thyroid hormone replacement" (unspecified if ongoing). Family history included: "Cancer" (unspecified if ongoing), notes: Hx Cancer; "hypertension" (unspecified if ongoing), notes: Hx hypertension. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid hormone replacement therapy, start date: Feb2009 (ongoing); LORAZEPAM taken for anxiety, start date: Oct2011 (ongoing). Past drug history included: Ancef, reaction(s): "Known allergies: Ancef"; Lamictal, reaction(s): "Known allergies: lamictal"; Doxycycline, reaction(s): "Known allergies: doxycycline". Vaccination history included: Bnt162b2 (Dose number: 1, Time: 15:18, Vaccine location: Left arm, Lot number: EH9899, Route of administration: Intramuscular), administration date: 17Dec2020, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: HOT FLUSH (non-serious) with onset 17Jan2021, outcome "not recovered", described as "Hot flashes"; NIGHT SWEATS (non-serious) with onset 17Jan2021, outcome "not recovered", described as "Profuse night sweats"; MOOD SWINGS (non-serious) with onset 09Jan2021, outcome "not recovered", described as "Mood swings"; SLEEP DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Sleep disturbances"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "Memory difficulty". The events "hot flashes", "profuse night sweats" and "mood swings" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Feb2021) negative, notes: Nasal Swab; (03Mar2021) negative, notes: Other. It was unknown if therapeutic measures were taken as a result of hot flush, night sweats, mood swings.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
A few weeks after 2nd Pfizer Covid vaccination, I  became more tired, fatigue, short of breath on stairs.  Fainted/ blacked out once in August, and then in September  visited doctor and had very low pulse (30) low blood pressure and diagnosed with complete heart block between chambers.  Dual chamber pacemaker installed Sept 29, 2021 at Hospital.
This is a spontaneous report from a contactable pharmacist. A 60-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 24Feb2015 at 0.5 ml, single dose. Medical history included pain disorders. Concomitant medications included methadone 10 mg, oxycodone 30 mg, duloxetine 60 mg, Vitamin D 1000 IU, doxepin 100 mg, and gabapentin 300 mg. On unknown dates in 2015, the patient was not feeling well, fell down/could not get back up, and crumbled his leg. The events were serious for hospitalization. The clinical course was as follows: the patient said that he was not feeling well after the vaccine and he went to hospital. The hospital had sent him home. When he was at home, he fell and could not get back up. He was in hospital and they put a catheter in and he crumbled his leg. The patient stated that the hospital told him that this was due to PREVNAR 13. The clinical outcome of the events, patient was not feeling well, fell down/could not get back up, was not recovered. The clinical outcome of the event, crumbled his leg, was unknown. The pharmacist did not think the events, patient was not feeling well, fell down/could not get back up, and crumbled his leg, were related to the PREVNAR 13. The pharmacist mentioned that the patient was still in hospital.
12/22/21 The day after my injection, i had my third round of ?COVID arm.? This was my third Moderna shot and each shot gave me COVID arm and an injection site reaction. This booster also made my armpit lymph nodes swell up for about a week and a half.   12/30/21 Days after the injection was given, I began to itch all over. Slowly, I began to break out in hives all over my body. It started slowly then gradually increased to the point I was going into anaphylaxis after two days. My throat was tight, had trouble breathing, and my mom drove me to the ER. upon arrival they gave me prednisone which got stuck in my throat and told me to follow up with my PCP. Told me I probably ate an allergen? and that I wasn?t anaphylactic?  although I was in a complete wheeze. Didn?t make much sense to send me home but when every other patient was a COVID patient I guess they didn?t want me to get infected.   I?m not entirely sure if this reaction was from the Moderna vaccine but the woman who called me from Vsafe encouraged me to file this report. I hope this helps and I?m happy to do my part.
5-9-21 unknown exact time a headache started. ER diagnosed it, PCP followed up with her and told her it was a tension. with ringing in the ears in the mornings.
* 2X ENLARGEMENT OF BREASTS - PAIN   SEVERE ENLARGEMENT OF OVARY - APPROX 1 MONTH * EXTREME JOINT PAIN - MALFUNCTION-DISLOCATION W/ EXTREME MUSCLE PAIN LOSS OF RANGE OF MOTION * SEVERE MIDDLE PAIN * CONTINUES NO HELP FROM DOCTORS