chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 days after his 2nd Pfizer COVID-19 vaccine, patient developed upper extremity weakness and paraesthesia.  From the discharge summary:    Pt had his second dose of Pfizer vaccine on 02/18/2021.  The patient complained of new onset of bilateral upper extremity tingling, numbness and weakness since 02/28/2021.  The patient denied lower extremity paraesthesia or weakness.  He has a history of chronic low back pain.  He denied any neck pain, back pain or radiation sensation.  He has no sphincter dysfunction or incontinence.  He has been using walker in the past.  Dr. of neurology did a nerve conduction and EMG recently.  The study showed the evidence of peripheral demyelination, peripheral neuropathy.  The patient was admitted for possible spinal tap and IVIG treatment.  The patient had a ground level fall 7 to 8 days ago.  He denied fever, chills, headache, dizziness, shortness of breath, chest pain, palpitation, abdominal discomfort, diarrhea, UTI symptoms or coughing. Pt had his last dose of IVIG yesterday. No side effects. Motor weakness improving and UE paresthesia nearly resolved.  No side effects to IVIG.  BMP normal.      Patient symptoms improved after 5 days of IVIG and he was discharged after being in the hospital  7 days
pt exp severe constipation/pain when having bowel movement; tx: changed formula; barium enema; rectal biopsy; Haleys MO; Kayro; rectal stimulation; Annual follow-up states the child has not recovered, and provided an address change. Information received from a follow-up states she is now 1-year-old and requires Milk of Magnesia 2x a day in order to have a bowel movement. At which times she cries when she have one.
pt recvd 2 doses of Engerix-B & on 20JUN92 devel GBS; poss still has sx;
Case number PHEH2013US020541 is an initial spontaneous report received from a nurse on 30 SEP 2013 with a follow-up received from the nurse on 14 JAN 2014. This report refers to a 34-year-old female patient. On 27 SEP 2013, she was vaccinated intramuscularly with FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) at a dose of 0.5 ml. It was reported that before vaccination. FLUVIRIN 2as placed in the shipping container at room temperature for 72 hours and later administered to the patient (incorrect storage of vaccine). It was reported that the vaccine was not refrigerated immediately when it arrived at the practice. No adverse event was reported following this medication error.  Follow-up received from the nurse on 14 JAN 2014: Updated dose of FLUVIRIN and comment from the reporter.
Dizziness/vertigo occurred within 2-5 minutes after receiving the 2nd dose of COVID19(Moderna) vaccine. I was told to consume fluids and eat without relief. I had to be driven home by a co-worker. My dizziness has persisted daily until present with no relief. I have also developed worsening anxiety within the last month.
Vaccine given expire on 11/30/22. Patient received dose on 12/01/22. No adverse events noted.
Woke up in the early hours of the next morning with my right arm throbbing. During the next 3 days physically I was so tired and dragging myself around. My right arm started with a slight rash and at the height, probably Saturday Sept 1, had extreme difficulty in raising my right arm and had a hot red spot covering about 4" around the injection spot. I slept for most of the time until Monday September 3rd. And until Wednesday I was mostly tired but forcing myself to stay away.   Today is Thursday September 6th my arm is still tender but at least I am awake. FYI I was also dehydrated for most of the time.
This spontaneous report as received from a nurse via company representative refers to a female patient of unknown age. The patient's medical history was not provided. In 2012, the patient was vaccinated with the third dose of GARDASIL (lot #, expiration date, route and site of administration were not reported) 0.5 ml and completed vaccination series with GARDASIL. The second and third dose of GARDASIL were administered to the patient one month apart, which is out of recommended series dosing schedule. No adverse effect was reported. Additional information is not expected because the physician cannot be contacted.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 01-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5mL SD-PFS-LLok wTip" which had the lot # K009874 with expiration date on 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 47 F (8.333333333 Celsius)for 40 hours (highest recorded temperature). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
stuffy nose; cough; This is a spontaneous report from Pfizer-sponsored program Pfizer First Connect. A contactable physician reported for himself that a 66-year-male received first dose (BNT162B2) , intramuscular at arm in Dec2020 at single dose for COVID-19 immunization.  The medical history included High Blood Pressure, Cholesterol and chills. The patient was a physician who reported being exposed to Covid 19 via his daughter. He completed a PCR test which was negative and received his vaccine at work  a few days later.  After receiving the vaccine he had a stuffy nose and cough and completed an antigen test which was positive in Dec2020.  He was given monoclonal antibodies the same day as his positive test.  He is supposed to take the second dose of the vaccine 11Jan2021. The background was on Thursday he had a PCR 5 days after possible exposure, so he stepped forward for vaccine on Monday, so he got the vaccine on Monday and usual chills and all that stuff that went away. He went to work on Tuesday and was little stuffy so he went downstairs to get the rapid test, he had cough too and they have been developing for several days. He went downstairs to go rapid test and it was positive and he didn't conform with the PCR. (word incomprehensible) around 9 percent so used to get 20 percent false positive so he got the infusion. The patient underwent lab tests and procedures, which included antigen test positive in Dec2020, PCR test negative in Dec2020. The outcome of the events was unknown.   The information on the batch number has been requested.
Information has been received from a certified medical assistant concerning a female with no pertinent medical history who in September 2007, "sometime last week was vaccinated IM into the right arm with 0.5 ml of a first dose dose of GARDASIL. There was no concomitant medication. In September 2007 "3- 4 days" after vaccination the patient developed blisters under her right arm. It was reported that the patient called the office to report she developed blisters under her right arm. Subsequently, the patient recovered from the blister under her right arm. Additional information has been requested.
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
I was visiting my mother in law on Christmas eve and they had an outbreak of COVID-19 in the nursing home. She was having COVID-19 symptoms and she was tested and the next day she was positive. That following Wednesday my wife started having symptoms and that next day I was having symptoms after taking a nap that afternoon and I tested positive the next day. I was lightheaded, my voice was horse, and I just felt like I was unwell- I was very tired and had mild muscular pain. After taking the COVID-19 Home Test we did have a telehealth appointment and they put me on a medication to help but it was altered due to my other health issues. I tested positive for about a week or so after that and was very tired and no engergy at all.
AFTER GIVING 1ST SHOT OF MODERNA ON LEFT DELTOID AND 2ND SHOT OF FLUBLOK ON RIGHT DELTOID, PATIENT FEELS FAINTED, LIGHTHEADEADED, DIZZY, AND LOSES CONSCIOUSNESS IN 1 MINUTE. PATIENT FEELS BETTER WHEN DRINKING GATORADE AND EAT CANDIES. BUT AROUND 3-5 MINUTES LATER, PATIENT FEELS TIRED AND DIZZY AGAIN AND ASK THE PHARMACY TO CALL 911. THE PATIENT PULSE FEELS STEADY AND STRONG; BREATHING NORMAL; BODY TEMPERATURE FEELS WARM.  PATIENT FEELS NORMAL WHEN THE EMS TEAM COMES AND HE LET THE EMS TEAM LEAVE THEN HE LEAVE THE PHARMACY. HE STATES THAT HE OFTEN FAINTED AFTER VACCINATION MANY TIMES ALREADY, EVEN THOUGH HE DIDNOT WRITE IT DOWN ON CONSENT FORM, AND JUST ANSWERED NO ON QUESTION OF FAINTING AFTER VACCINATION.
Colitis ulcerative aggravated; increased ulcerative colitis symptoms with rectal bleeding; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) till 2021 at 40 mg (40 mg (cf pen)) and second regimen subcutaneous from 27May2021 (Batch/Lot number: unknown) to 01Sep2021 at 40 mg weekly (40 mg, weekly (40 mg, 1 in 1 week)) for colitis ulcerative. Relevant medical history included: "COVID-19 Illness", start date: 01Jan2021, stop date: 15Jan2021. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Route of Admin: 1) Intra-muscular, Daily Dose: 1) First dose (1 in 1 Once)), administration date: 01Feb2021, when the patient was 69 years old, for COVID-19 Immunization. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 01Mar2021, outcome "recovered" (01Sep2021), described as "Colitis ulcerative aggravated"; RECTAL HAEMORRHAGE (medically significant) with onset 01Mar2021, outcome "recovered" (01Sep2021), described as "increased ulcerative colitis symptoms with rectal bleeding". The action taken for adalimumab was dosage permanently withdrawn on 01Sep2021. Therapeutic measures were taken as a result of colitis ulcerative, rectal haemorrhage. The reporter reported that, after receiving both doses of Covid vaccine on 01Feb2021 and 01Mar2021, patient started having increased ulcerative colitis symptoms with rectal bleeding. Patient's physician increased dose to weekly 40mg Humira. After symptoms continued, patient was instructed to discontinue Humira and patient had surgery to remove his colon on 01Sep2021.  The reporter's assessment of the causal relationship of the colitis ulcerative and rectal haemorrhage with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the colitis ulcerative and rectal haemorrhage with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Nurse gave dose from the Moderna 6 year to 11 year old COVID vaccine vial instead of the correct vial for Moderna 6 months -5 years old. Dose given was correct at 0.25 mL. Parent does not answer the phone and has not returned voicemail left for her regarding this matter.
Approximately 1-2 hours post vax, the pt cried in great pain for about 1 hour. Then the pt slept through the next morning. He was very lethargic that increased during the day. The pt vomited once, experienced abdominal cramping and pain. The pt was diagnosed with intussusception.
Information has been received from a health professional concerning a 17 year old female who on approximately 01-DEC-2007 was vaccinated intramuscularly with the first dose of Gardasil.  Concomitant therapy included FEMCON FE.  Two - three weeks post vaccination, the patient experienced a rash on her knees, elbows and back of her hands.  The patient visited her dermatologist who said it looked similar to Psoriasis.  The patient recovered from the rash on her knees, elbows and back of her hands.  Additional information has been requested.
Seemed to have pain in (L) leg 5/27/10 would not walk, erythema. 5/28/10 no pain, no erythema + edema. Pulses good. Able to walk today. Tx: continue to observe; Rx for BENADRYL given. 5/27/10 symptoms reported by parent.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THE  BEACH  ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
REDNESS; RASH / RASH WAS SPREADING FROM NECK TO THE UPPER PART OF CHEST; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a White Not Hispanic/Latino female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic skin condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced redness. On 13-MAR-2021, the subject experienced rash / rash was spreading from neck to the upper part of chest. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache on 15-MAR-2021, and had not recovered from rash / rash was spreading from neck to the upper part of chest, and redness. This report was non-serious..; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Confusion, anxiety, fatigue. Patient stated "I feel sick I do not know what is going on with me I am sleepy all the time".
This spontaneous report was received from medical assistant concerning to a 4 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 30-NOV-2017, the patient was vaccinated with one improperly stored dose of VARIVAX from lot number reported as N201582 with expiration date 09-AUG-2019, or lot number N014632 with expiration date 11-MAY-2019, or lot number N019131 with expiration date 22-JUN-2019, or lot number N019839 with expiration date 13-JUL-2019, or lot number reported as N019397 with expiration date 07-JUN-2019, or lot number N021317 with expiration date 07-AUG-2019 (route of administration and anatomical location were not provided); for prophylaxis. The VARIVAX was reconstituted with properly stored sterile diluent (MERCK) (lot # and expiration date were unknown). There was no previous temperature excursion and the data logger was no involved. The vaccines were exposed to temperatures between 47 F (Fahrenheit) to 77 F (Fahrenheit) during 10 hours and 18 minutes. No adverse effects were reported. Lot number N201582 is an invalid lot number for varicella virus vaccine live (oka/merck). Lot number N019397 is an invalid lot number for varicella virus vaccine live (oka/merck).
pt recv vax 6DEC95 & exp nausea, h/a & dizziness;sx resolved untreated in 24 hr;vaccination series was discontinued;
Pt recvd 1st dose Hep B vax 7MAR91 w/no adverse rxn; On 5APR91 pt recvd 2nd dose Hep B vax & devel erythematous rash w/swelling of fingers & toes; also h/a; tx DPH MD felt this was an allergic rxn to Hep B;
diarrhea, nausea, feeling faint, exhaustion, headache, eventually congestion and cough  initial symptoms cleared up by noon the next day, but the congestion and cough began the second day and have continued.
administered 1ml to five patients; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1ml to five patients) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (administered 1ml to five patients). On 30-Mar-2021, ACCIDENTAL OVERDOSE (administered 1ml to five patients) outcome was unknown. Not Provided      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.   No Concomitant medications were provided No Treatment information provided    This case was linked to MOD21-065824; MOD21-065792; MOD21-065826; MOD21-065852, MOD-2021-062195, MOD-2021-062261 (Patient Link).
Pt received vaccine went to observation for 30min d/t hx itching with # 1 vaccine 840 AM no SOB oral edema, vocal hoarseness lungs clear. BP 122/64 O2 Sat 97% RA HR 53 c/o urticaria at site given Benadryl 25mg oral solution at 850 AM 930 A no visible rash, no other symptoms
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: patient complaint of soreness/redness and extreme swelling in lymph node and trap muscle on arm.
got the shot/ shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and 3 years later still got shingles. The follow up would not be possible as no contact details were available.This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.
Information has been received from a physician concerning her 10 year old son who on 3/14/00, was vaccinated with 1 dose of MMR. Within 2 minutes, post vax, the child experienced a seizure, during which time he stopped breathing completely, was stiff and "completely out of it." He became cyanotic and his eyes rolled back, but he did not become incontinent. Medical attention was sought. The seizure lasted about ten seconds and the child started breathing on his own. His mother stated that no head injury occurred and that her son appeared to be normal following the seizure. There was no fever and the child's blood sugar and blood pressure were both normal. Upon medical review, it was determined that the pt's seizure was an "important medical event". No further information is available.  Follow up information from a nurse practitioner indicated that the patient's adverse experiences was a vasovagal response and not a seizure.  No further information is available.
Information has been received from a Licensed Vocational Nurse referring to a 4 year old patient of unknown gender. There was no medical history or concurrent condition reported. On 23-JUL-2015 the patient was vaccinated with one dose of (Merck) VARIVAX (dose and frequency were not reported; lot # K005426 with expiration date 15-APR-2016), which was stored in a freezer which had a max temperature excursion of 35.2 (unit unknown) on 16-FEB-2015 (incorrect product storage). The reporter did not known how long this was at this temperature not can she be certain if she pressed the right buttons on the fridge to obtain the readings as she did not be trained. The reporter stated that the freezer temperature was 0 Fahrenheit at 8 am and 3 Fahrenheit at 5 pm. The min/max temperature on that day was 2.4/11.8 Fahrenheit (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 13 year old female patient. On 13-MAR-2013, the patient was vaccinated with a first dose of GARDASIL(lot number, expiry date, route and dose were not reported).Approximately on an unknown date in March 2013, the patient developed stomach pain. The patient sought medical attention and no treatment was provided. Laboratory test performed was none. The event stomach pain was reported as not recovered/not resolved. This is one of the report received from the same reporter. Additional information has been requested.
Pregnant patient received fluzone, no AE; Initial information received on 09-Sep-2021 regarding an unsolicited valid non-serious case from an other health professional and physician.  This case involves pregnant female patient (unknown age) who was exposed to INFLUENZA VACCINE TRIVALENT (FLUZONE). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at unknown gestation period (exposure during pregnancy).  The date of last menstrual period was reported as 08-May-2021.  The estimated delivery due date was 17-Feb-2022.  The information on patient's previous pregnancy was unknown.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  It was unknown if the patient received concomitant medication.  The patient's past medical treatment(s), vaccination(s), and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUZONE (one dosage form, lot 477325SA and expiration date: 30-Jun-2022) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.