chrisvoncsefalvay/vaers-outcomes huggingface dataset:
migraine; slight fever; body aches; This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 21Feb2021 (Batch/lot number not reported), as dose 1, single, for COVID-19 immunisation. In Feb2021, the patient experienced migraine, slight fever and body aches. The reporter was wondering how long the reactions will last. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Experienced syncope within 5 minutes of receiving vaccine. He bumped his head when he fell. Paramedics showed up and determined he didn't need emergency care. He was given an ice pack for his head and wasn't sure if he would go to urgent care after to treat his head. He denied experiencing any confusion or nausea after hitting his head.
2 high pitched screams in middle of noc (approx 14 hrs p/vax); 21 hrs p/vax had 2, back-to-back episodes of total body limpness followed by sleeping x 5 mins-disorientation x 2-3 mins full recovery t99.3;
Case number PHEH2014US014996 is an initial spontaneous report received from a Healthcare Professional on 24 Jul 2014. This report refers to a 17 year old female patient. She was vaccinated with an expired dose of MENVEO (batch number: M11075) via intramuscular route at a dose of 0.5 ml on 23 Jun 2014. No adverse event was reported following this administration error (expired vaccine used).
DIARRHEA; DIZZINESS; LEFT NOSTRIL PAIN; HEADACHE ON LEFT SIDE/ HEADACHE FELT THROUGH EAR; TEMP 102-103; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201821A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced left nostril pain. On 10-APR-2021, the subject experienced headache on left side/ headache felt through ear. On 10-APR-2021, the subject experienced temp 102-103. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache on left side/ headache felt through ear, diarrhea, left nostril pain, temp 102-103 and dizziness was not reported. This report was non-serious.
Woke up sweaty; was cold for about 30 minutes after; Mild tingling in left arm for about a minute after passing out; Mild numbness in lips for a few minutes after passing out; Passed out 25 mins after receiving vaccination; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 13Apr2021 09:15 (32-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not have covid prior vaccination and not tested for covid post vaccination. The patient passed out 25 mins after receiving vaccination (13Apr2021 09:40). Lasted a few seconds. Woke up sweaty (13Apr2021 09:45), was cold for about 30 minutes after (13Apr2021 09:45). Mild tingling in left arm for about a minute after passing out (13Apr2021 09:45). Mild numbness in lips for a few minutes after passing out (13Apr2021 09:45). Patient had no treatment for events. The outcome of the event passed out 25 mins after receiving vaccination and mild numbness in lips for a few minutes after passing out was recovered on 13Apr2021, woke up sweaty was recovering, was cold for about 30 minutes after was recovered on 13Apr2021 10:15, mild tingling in left arm for about a minute after passing out was recovered on 13Apr2021 09:46.
Patient given Pneumococcal vaccine developed fever, malaise, pain and swelling at inj site. Treated and resolved with no lasting effect. 7/25/06 Received medical records from hospital which reveal patient had hx of IDDM x 14 years & was recently diagnosed w/stage 4 bladder cancer & had been admitted for surgery.  Patient did not have PCP.  ID consult obtained due to fever, erythema & induration at LUE site of pneumovax injection.  Had also received flu vax in RUE on same date 1/24/06. Started on IV antibiotics but no resolution of s/s, in fact redness had extended.  Temp max of 102.5.  Unclear whether reaction was site infection or allergic reaction & diagnosis was fever & cellulitis of arm.  Antibiotics were changed & further x-rays were done to r/o collection of fluid.  Patient continued to improve & left arm s/s resolved by 1/29/06.  Continued to have swelling of LUE & outpatient studies done 2/28/06 revealed only considereable osteopenia.  CXR at same time revealed chronic TB.  Doppler sonogram of LUE revealed no DVT/ss
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. The temperature excursion and its time for administered doses of vaccine was unknown by the reporter. It was unknown if data logger was involved. There was an unspecified number of multiple ongoing excursions since April 2017. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011987: US-009507513-1709USA011988: US-009507513-1709USA011849.
Got 2nd shot, it itches; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-Jan-2023. Reporter's Comment: This case was received from consumer via interactive digital media. The patient got his/her 2nd Shingles shot but was itches. The follow up would not possible as no contact details were available.
Information has been received from a healthcare administrator referring to a patient of unknown age and gender. On 20-JUN-2016 the patient was vaccinated with improperly stored oral ROTATEQ (lot # L048854, expiration date 31-AUG-2017, dose not reported) orally. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 05-FEB-2018 the patient was vaccinated with improperly stored PROQUAD lot # N020620, expiration date: 23-AUG-2019, dose 1 for prophylaxis (product storage error). Concomitant therapies included sterile diluent(STERILE DILUENT). The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 127 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1810USA001739.
Right Chest discomfort, achy, and tightness. Goes into right shoulder. Right arm feels heavy
itchy all over her body/Itching in face, arms, neck, chest, and armpits.; Hives on face, neck, armpits, chest; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Parent) reported for a 20-year-old female patient received the first dose of BNT162B2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 07Jan2021 at single dose for covid-19 immunization. Medical history included High cholesterol, Apricots allergies. The patient's concomitant medications included Birth control, cholesterol meds. She works in a nursing home, she got the Covid-19 vaccine on 07Jan2021, she started getting high and really got itchy all over her body, especially in her face, in her neck, her armpits. Hives on face, neck, armpits, chest. Itching in face, arms, neck, chest, and armpits. The events occurred on 21Jan2021. No treatment received. The patient was no pregnant. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Information has been received from a registered nurse (R.N.) concerning a 4-year-old male with no pertinent medical history and no allergies, who on 25-JUL-2003 was vaccinated subcutaneously with a 0.5 ml first dose of Varivax (lot# 644091/1066M). There was no illness at the time of vaccination. There was no concomitant medication. On 29-NOV-2006, the patient developed vesicular lesions to the face and trunk and was diagnosed with a mild case of varicella. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. At the time of this report the patient had recovered as of 05-DEC-2006. No product quality complaint was involved. Additional information has been requested.
Combined initial and follow-up report received from a physician on 16 Jul 2010 and 19 Jul 2010, respectively: This patient had a dog bite on 19 Jun 2010. The assessment of the dog given by physician was animal bearing a "questionable vaccination status". The patient received first dose of RABIPUR (batch number 471011A) intramuscularly and BOOSTRIX (batch number AC 39802180) intramuscularly, on 21 Jun 2010. The patient received second, third and fourth dose of RABIPUR (same batch number) on 24 Jun 2010, 28 Jun 2010 and 05 Jul 2010, respectively. The patient tolerated first vaccination very well but experienced marked fatigue/exhaustion following dose second and third. The same occurred again after fourth dose and lasted for 2 days, but this time accompanied by generalized muscle fasciculation in all extremities which began one day after last dose. Ten days after fourth dose, this was followed by transient right hand-tremor amplitude (unspecified). On 15 Jul 2010 at about 8 p.m., the patient visited emergency service at hospital and reported about influenza-like symptoms with extreme fatigue, muscle pain, back pain, and amyostasia since last dose on 05 Jul 2010. In the evening of consultation day, the patient experienced a feeling of throat oppression. The clinical, physical and laboratory examinations showed normal findings. The diagnosis of suspected vaccination reaction was made. The recommendations included advice to reduce physical activity, immediate returning to emergency in case of worsening of complaints, and a new consultation with physician on the following day. Transient right hand-tremor amplitude resolved completely and there was improvement in respect of fatigue/exhaustion and feeling of throat oppression. Outcome for generalized muscle fasciculation in all extremities and amyostasia was reported as condition unchanged. No outcome was provided for flu-like symptoms, muscle pain and back pain.
Gave flu serum for 3 years and older. I believe .25 dose was givien.
This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 24-year-old female patient who received BOOSTRIX (batch number X2444, expiry date 8th October 2017). Co-suspect products included TWINRIX adult. Concomitant products included TWINRIX adult. On 14th July 2016, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On 21st July 2016, the patient received the 2nd dose of TWINRIX adult 1 ml. On 26th July 2016, 12 days after receiving BOOSTRIX and 5 days after receiving TWINRIX adult, the patient experienced generalized rash (serious criteria other: As per reporter). On an unknown date, the outcome of the generalized rash was recovering/resolving. It was unknown if the reporter considered the generalized rash to be related to BOOSTRIX and TWINRIX adult. Additional details were provided as follows: This case was previously reported to a doctor. The pharmacist reported that the patient received travel prophylaxis of TWINRIX adult. The patient's grandmother stated that her granddaughter broke out in a head to toe rash. At the time of reporting, the rash was getting better and resolving according to the grandmother. The reported lot number (X2444) for BOOSTRIX and (DX793) for 1st and 2nd dose of TWINRIX adult were not exist and was updated to XZ444 and DX7D3, according to sales database. The doses of vaccines were administered by 2 different people. It was not clear who administered which dose of the vaccines.
Information has been received from a Registered Nurse for the pregnancy registry for human papillommavirus vaccine concerning a female with a penicillin allergy who on 12-FEB-2007 was vaccinated with the first dose of GARDASIL (Lot #654741/1208F).  The patient received the second dose on 01-MAY-2007 (Lot #655205/1426F) and the third dose on 15-AUG-2007 (Lot #657622/0388U).  The patient became pregnant after her last menstrual period of 08-NOV-2007.  No adverse effects were reported.  Follow up information was received from a licensed practical nurse concerning a Caucasian female with no history of previous pregnancies, who on 12-FEB-2007, 01-MAY-2007 and 15-AUG-2007 was vaccinated with the first, second and third dose of GARDASIL respectively.  Concomitant medication included TANDEM DHA.  The LPN reported that on 06-MAR-2008 an ultrasound was performed for size and date.  On 26-AUG-2008 the female patient gave birth to a normal male (weight 8 pounds 11 ounces and length 20.5 cm).  It was reported that there were no complications during pregnancy and none during labor/delivery.  The baby presented sleep apnea noted at 3 weeks.  Last menstrual period was 08-NOV-2007.  Estimated delivery date was 14-AUG-2008.  No further information is available.
That evening I was exhausted, fever peaking at 103, chills, body aches, congestion and developed a cough later that evening.  Went to doctor., Gave me an IV with fever and pain meds.  Fever, chills and body aches lasted 3 days.  Bad diarrhea 1 day.  Symptoms subsided on days 4 and 5 with no fever, and body aches gone.  fatigue and cough lingered.
Information has been received from a physician via company representative concerning a female patient in her 20's who on an unknown date was vaccinated with a dose of GARDASIL (lot number, route were not reported). The physician reported that the patient fainted and vomited after receiving GARDASIL. At the time of the report, the patient outcome was not provided. Additional information has been requested. This report is linked to MARRS case 1308USA08732, same reporter.
Breakthrough case after 2 vaccines Janssen 3/30/21 Lot# 1808978;  Moderna 11/10/21 Lot# 004F21A
Exacerbation of existing Benzodiazapene Injury Recover Symptoms - marked increase in skin burning, muscle/joint pain, cognitive confusion, panic, heart palpitations, insomnia, stiffness in extremeties, neuropathy, tooth pain, hives in scalp, malaise, facial blephrospasms  Addtionally there was significant pain at the site of injection with headache and nauesa that were not preset before vaccine
breakthrough covid +, asymptomatic except fatigue and weakness which may be attributed to underlying Esophageal adenocarcinoma  Poorly differentiated neuroendocrine cancer. As of 9/2/2021 will be transferred to higher level of care within health system.
Sudden onset at bedtime on Wednesday 9 November of severe shaking chills and Shortness of Breath, global pain in every muscle of respiration.  Went to ER shortly after MN Thursday  10 November, said I was afraid I was having blood clots in lungs from booster. Traveling ER Doctor thought I was hyperventilating, declined to do d-dimer (which both ER nurse & I requested), gave IV Valium.  Did CBC, BMP, EKG, said all was normal,  and sent me home.  Chills were gone and pain localized in left flank. I used pain pills previously prescribed on Friday 11 November, severe coughing most of day.  Saturday morning 12 November I returned to ER where was diagnosed with widespread pulmonary emboli
Chest pain. It is described as tightness and aching. It is described as located in the right chest, central chest and left chest area, right shoulder and left shoulder. It is described as located in the back. No radiation. This started today about 1 1/2 hours ago and is still present. Onset during rest. At its maximum, severity described as mild. When seen in the E.D., severity described as mild. Modifying factors. Not worsened by anything. Not relieved by anything. The patient has had nausea. No vomiting or diaphoresis. No additional chest pain. Similar symptoms previously. None. Recent medical care: The patient was seen recently in the office.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 09-FEB-2016, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Vaccine adminstered 4/9/2008, late afternoon; Upon injection of vaccine, pt reported burning and pain.  Pt states that arm soreness continued in evening, progressed to pain under ribs, rash to legs, fever, "flu-like feelings," headache, dizziness.
Vaccination noted in item 4 was my second Moderna booster. I was exposed to a COVID-positive person on 6/30/2022 who tested positive on 7/1.  I had a scratchy throat on 7/3 and tested negative, became more symptomatic on 7/4 while on a flight.  My antigen test was positive on 7/5; symptoms were cough, achiness and lethargy. No fever although on ibuprofen for achiness. Tested positive again on 7/6 and began Paxlovid through 7/10. Symptoms lessened on 7/7 but remained mildly symptomatic (cough, lethargy) through 7/9. Began feeling "normal" on 7/10.  PCR test on 7/11 done via local Health was positive.  Remained afebrile and cough subsided 7/10.
Patient developed (R) deltoid swelling, tenderness, induration and erythema 2 days after receiving IM PNEUMOVAX 23 and FLUZONE HD in same (R) deltoid. Seen by PCP on 8/19/14 - no rash, fever or chills, severity noted as 4/10. Diagnosed as cellulitis/possible reaction to shots - treated with sulfamethoxazole/tmp DS BID x 7d. Pt subsequently had a cutaneous blistering reaction to antibiotic which lead to hospitalization.
Myalgia, Fever, CoughWheeze, sweats, chills, lethargy Narrative:  Other Relevant History:
petechial rash, maculopapular rash spreading from legs, abdomen, chest, back, and arms
Burning Pain; This case was reported by a other health professional via interactive digital media and described the occurrence of pain burning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain burning. On an unknown date, the outcome of the pain burning was unknown.   It was unknown if the reporter considered the pain burning to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had burning pain.
This spontaneous report as received from a physician's via company representative refers to a baby of unknown gender and age. The patient's current conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ vial (dose, route, lot and expiration date were not reported). On an unknown date, the patient experienced vomiting and diarrhea and was seen in an unspecified emergency department on an unspecified date. The baby tested positive for rotavirus and was diagnosed with another gastrointestinal virus. The reporter stated that she did not believe that the patient had active rotavirus infection. At the time of the report, the patient was recovering from gastrointestinal virus. Additional information is not expected.
This spontaneous report as received from a physician refers to a patient of unknown age. On 07-FEB-2012, the patient was vaccinated with the first dose of GARDASIL (lot # not reported) (intramuscular, strength and total daily dose not reported). On 03-APR-2012, the patient was vaccinated with the second dose (lot # not reported) (intramuscular, strength and total daily dose not reported). On 07-MAY-2013, the patient was in the office to receive a third dos eof GARDASIL (lot # not reported) (intramuscular, strength and total daily dose not reported). No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Patient became disoriented with time (Dementia symptoms). Went into kidney failure and was admited into the hospital with mental confusion (dilerium).
Information has been received from GlaxoSmithKline and was assigned manufacturer report number: 2011-05840, concerning patients who on unspecified dates were vaccinated with doses of PROQUAD (Merck). There was an issue with seizures, so they went back to use MMR II separate from VARIVAX (Merck). At the time of reporting, the patients' outcomes were unknown. It was unspecified if the patients had sought medical attention. Upon internal interview, the seizures were determined to be other important medical events. This was originally reported by a physician. No further information is available.
Extreme itchiness all over body, welts/hives, swelling of hands, feet, throat, shortness of breath,  hives/redness/swelling at injection site, fatigue, cough from swelling of throat
day of vax pt began to audibly wheeze. seen again in exam room w/wheezing & poor a/e into bases and + use of accessory muscles. given nebulizer treatment
Initial unsolicited report received from a consumer on 24 Oct 2016. This case involves a male patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, site and route not reported) on an unspecified date. Patient medical history and concomitant medication was not reported. On an unspecified date, post vaccination; the patient experienced flu (got deathly ill). Case was consider serious due to life threatning event flu. Lab data and corrective treatment was not reported. Patient's event outcome was not reported. List of documents held by sender: none.