chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager refers to a patient of unknown age. On 24-JUN-2016, the patient was vaccinated after the temperature excursion with VARIVAX (lot # M000996, expiry date 07-JAN-2018, 0.5 ml, subcutaneous). Temperature was 6 Fahrenheit for 17 hours. No adverse effects were reported. Additional information has been requested.
Pt came to the pharmacy on 7/23/13 w/her son for ZOSTAVAX immun. Recv'd electronic Rx on 7/23/13 for cephalexin 50 mg QID x 7 d. Nurse from dr's office called 7/26/13 450 pm to reported localized site reaction. Pt had "1/2 dollar sized, red, swollen area" which was hard. Pt was given cephalexin for possible cellulitis. Nurse also mentioned could be related to diabetes.
Had a fever for 8 days, highest temp 105 deg. He almost went into shock, we rushed him to the ER. His airway passages were inflamed he had chills, severe SOB. ER said he had bronchitis and fever.
Patient reported she woke up 4/18/21 with symptoms of "COVID arm" with redness and swelling around injection site.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 03-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L012480 exp date 10-APR-2017) that was exposed to 11 degrees C for 38.5 hours and 0 degrees C for 269.16 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
started with a red spot on neck 45 minutes after vaccine was administered patient spot then started to spread to neck back and torso was seen by provider in the office
palpitations; nausea; sore arm; fever; throwing up; eyes were hurting; This is a spontaneous report from a contactable consumer via medical information team. A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number was not reported, expiry date was not reported) via an unspecified route of administration on 30Aug2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Sep2021, the patient the patient experienced some side effects such as palpitations, nausea, sore arm, and a little fever. She said she was throwing up, and her eyes were hurting. The reporter wants to know if that was normal, and how long they last. She also mentioned that her granddaughter was already starting to get better. The outcome for the events was recovering.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
HA (headche); muscle ache; tiredness; fever; This case was reported by a physician via sales rep and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2021).   In June 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced headache, muscle pain, tiredness and fever. On an unknown date, the outcome of the headache, muscle pain, tiredness and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscle pain, tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix in early June 2021 and experienced headache, muscle pain, tiredness and fever. One month post 2nd dose, the patient still not feeling ok and still complaining of all the same side effects but not as severe as initial post dose 2. The reporter consent to follow up.
I received my first Pfizer vaccine on March 30, 2021 at the store. On April 5 I was woken up at 3 AM with a very loud ringing in my right ear. The ringing was so loud I couldn't sleep for 3 days. Since I've never had ear problems and had no hearing in my right ear I called my Dr. office. They referred me to an ENT Dr. He referred me to Audiology for a h earing test. The test showed my hearing in my right ear was greatly diminished compared to my healthy ear. I went to see my regular physician. He had me get an MRI at Hospital. Then I went back to the ENT Dr. and he is arranging a referral to have a BAER test to see if a hearing aid might help with this condition I'm suffering from almost 4 months after my vaccination. I still am having the nonstop ringing in my right ear. Dr.  implied that he thinks my hearing problem may be permanent. I'm still currently waiting to have my BAER test referral to appointment.
Patient reports having his flu vaccination in November 2020 and his Pfizer COVID-19 vaccination on 12/22/2020.  10 days later he noticed bilateral leg cramps subsequently leading to numbness in his feet, weakness in his feet, numbness on side of his legs, both hands and upper back.   2 to 3 days prior to admission on 1/2/21 he  has noticed right-sided facial weakness andhas noticed increasing shortness of breath on exertion.  He was initially seen by PCP who suspected Guillain-Barré syndrome and had a PFT done  which showed reduced tidal volume and FEV1 He was seen by neurologistand had EMG nerve conduction studies which confirmed demyelination &  patient has been sent to the hospital for IVIG treatment. Per PT note from 1/30: "UE ROM: WFL UE Strength: WFL, reports grip weaker from baseline LE ROM: WFL LE Strength: proximal WFL, ankle DF/ PF 2+/3-/5              Coordination: reports no deficits with finger to nose B  Sensation: numbness B hands; B feet numbness and reports weight bearing feels like standing on something squishy Balance: WFL over level surfaces, able to compensate with strength  Posture: midline Other: R side facial droop, able to close R eyelid Bed Mobility: mod independent Transfers: modified independent, no device; able to perform controlled eccentric lowering stand > sit  Gait Level of Assistance: Modified independent, requires aide device or extra time Assistive Device: None Distance Ambulated (ft): 10 ft Gait: pt ambulating in room without device, appears mildly unsteady with decreased heel strike with increased foot flat contact, mild increased lateral postural sway (increased with retrowalk). No frank LOB. Stairs: verbally reports has been performing stairs sineonset of symptoms, stairs are hard but able to perform, improved with UE support when available, requires increased time and fatigues quickly  Endurance: neuromuscular fatigue, requires increased rest breaks"  He was admitted to hospital from 1/28-2/2 for 5 treatmens of IVIG. He had improvement of his SOB and numbness but has not had full resolution of symptoms.
No additional AE/no side effects; an expired dose of PNEUMOVAX23 that was administered. It expired on 01-OCT-2023 but was administered to a patient today 02-OCT-2023; This spontaneous report was received from Pharmacist referring to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-OCT-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5ml/once, lot #W021636, expiration date: 01-OCT-2023 (Expired product administered), administered for prophylaxis (strength, and route of administration were not provided). Confirmed no prior temperature excursion, no side effects, no symptoms.
Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.
This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing spell) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing spell). At the time of the report, COUGH (coughing spell) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  Wife or reporter took booster and experience coughing spell after receiving bivalent booster.  No treatment medication reported by reporter.   Reporter did not allow further contact
Redness and itching, started 72 hrs after shot and 8 days later is extremely itchy, warm to touch and red approximately 3inches around vaccine site
Localized swelling R arm S/P HPV/Gardasil #3 vaccine.  Non-tender.
Pain at injection site Pain in armpit on injection arm Chills Body aches (pain in both arms and wrists) *all began 11 hours after vaccination*
Information has been received from a registered nurse concerning a 7 year old male with environmental allergies, heart murmur and no known drug reactions/allergies who on 05-APR-2000 was vaccinated with a 0.5 mL IM dose of Varivax (lot # 632368/1460J). Concomitant therapy included CLARITIN. On 16-MAY-2006 the patient developed varicella. The patient presented to the office on 19-MAY-2006 with a rash of 30-40 lesions on his abdomen and back. No laboratory tests were performed. At the time of the report, the patient's varicella persisted. There was no product quality complaint involved. Additional information has been requested.
Fatigue; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 0377A22B) for COVID-19 vaccination.     The patient had no allergies and never had COVID positive test or diagnosis.  The patient had no other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Obesity and Neurogenic pain (Neuro pain).    On 27-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient didn't seek medical care and the reporter doesn't know if the patient had experienced a similar event in the past. Reportedly, the symptoms cleared up after 24 hours.  The height of the patient was unknown.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-615224, US-MODERNATX, INC.-MOD-2022-615226 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615224:(sister case) US-MODERNATX, INC.-MOD-2022-615226:(Child case-Daughter case)
Patient's husband came into clinic today to report that patient has developed a hot red arm at the site of injection. This developed from the sore arm and general malaise the day after the vaccines were given. This has become larger overnight. Patient is being treated with Rocefin.
Concomitant products included USTEKINUMAB (STELARA) for an unknown indication.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received two 0.5ML doses of the Moderna COVID-19 vaccine the same day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received two 0.5ML doses of the Moderna COVID-19 vaccine the same day). On 11-Mar-2021, INCORRECT DOSE ADMINISTERED (Received two 0.5ML doses of the Moderna COVID-19 vaccine the same day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received two 0.5ML doses of the Moderna COVID-19 vaccine the same day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Patient was found to have abnormally low platelet count  of 12 two weeks after receiving COVID vaccine. In last few days leading up to ED visit and hospitalization, started to have bruising which prompted blood count draw. Patient has cancer and undergoing XRT, but is currently not on any chemotherapy or bone marrow suppression treatment. Patient was treated with prednisone 40 mg daily and platelets increased to 17 then decreased to 14. The patient subsequently received IVIG and nplate treatment and was discharged with follow-up set up with Hematology outpatient.
pharmacist called in to request information about how to proceed after administering an expired dose of Engerix-B in a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 06-SEP-2023, the patient received Engerix B. On 06-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: pharmacist called in to request information about how to proceed after administering an expired dose of Engerix-B in a patient).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-SEP-2023 The pharmacist reported the patient was administered with expired dose of Engerix B vaccine which led to Expired vaccine used. Th pharmacist wanted to know about how to be processed after the administration of expired vaccine. The vaccine administration facility was same as primary reporter. The reporter consented to follow up.
"After feeling needle prick in upper arm", pricking sensation continued up arm at approximately 1 intervals over shoulder, up neck fading out aroundtop of head; Vision blurry/unable to drive for approx 10 minutes; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included temporary vision loss (temporary vision impairment) from an unknown date, 50 years before. The patient was allergic to mild latex. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN); liothyronine (MANUFACTURER UNKNOWN), krill oil (MANUFACTURER UNKNOWN) and theanine (MANUFACTURER UNKNOWN); all for an unknown indication, from an unknown date and unknown if ongoing. The patient previously took Codeine (MANUFACTURER UNKNOWN) on an unknown date and experienced temporary vision impairment 50 years ago. 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 vaccination. On 26Mar2021 at 10:15, the patient felt needle prick in upper arm, pricking sensation continued up arm at approximately 1 interval over shoulder, up neck, fading out around top of head and vision blurry/unable to drive for approximately 10 minutes. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events felt needle prick in upper arm, pricking sensation continued up arm at approximately 1 interval over shoulder, up neck, fading out around top of head and vision blurry/unable to drive for approximately 10 minutes was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age and gender with psoriasis. On an unknown date, the patient was vaccinated with ZOSTAVAX. On an unknown date, the patient experienced a flare up of psoriasis. The outcome and reported causality of the flare up of psoriasis is unknown. No information regarding treatment, if any, was reported. No information regarding the patient's medical history or concomitant medications was reported. Additional information has been requested.
Stomach upset w/in 45 min of vax. Vomiting 3 hrs, 15 min later. Continued for 5 hrs, every 1/2 hr.  Only symptom.
Patient's husband stated that nite of 11-2 her arm was sore and red, next day she had soreness all down her arm.
Initially after receiving the vaccine I had tiredness, joint pain, and muscle aches. These symptoms were greater and lasted longer than the previous COVID-19 vaccines I've taken. 3 weeks after getting the vaccine I went to the ER. On May 2, 2022, I had to go to the ER because I had a very high fever. I was given and prescribed 650mg-700mg of Tylenol. I had a couple of days of tiredness with that as well. The fever resolved itself, and it went away.
Patient developed a fever the night of getting the shot that was adminsterd at 10am that morning with a temperature of 101.2. At first patient did no realize the development of a fever, but experienced chills and cold sensation. The fever fluctuated the next 2 days, with each day the fever geting lower. The fever typically was worse in the evening and was not significant in the afternoon. The patient did visit the physician 3 days later complaining of the fever which subseqeuntly subsided that day.
This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old male patient who received BEXSERO (batch number 157601, expiry date 31st August 2017). Co-suspect products included TRUMENBA. On 22nd September 2016, the patient received BEXSERO .5 ml. In July 2016, the patient received TRUMENBA. On 22nd September 2016, an unknown time after receiving BEXSERO, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown. Additional details were provided as follows: The patient received a dose of BEXSERO after receiving TRUMENBA, which led to an interchange of vaccine products. No further information was reported regarding the event. Follow up information was received from nurse on 30th November 2016. The patient stated that he had a bowl of cereal at around 9:45 am and had not eaten anything since then, on the day of vaccination. The patient experienced vasovagal response with slight nausea and lightheadedness after approximately 5 minutes after receiving BEXSERO (11:15 am). The patient was given sugar and placed lying down with legs raised. 10 minute after the onset of events the patient reported feeling better. On 22nd September 2016, the patient's blood pressure was noted as 111/64 mm  Hg, pulse rate was 76, and oral temperature was 97.7 degree F. The nurse contacted GlaxoSmithKline Biologicals and spoke with the doctor of Pharmacy and was told that no tests have been evaluated to determine the interchangeability of BEXSERO and TRUMENBA. The VAERS details were updated.
No Adverse Events noted. Patients PCP was notified Attempted to call patients mom -Left a message to return our call.
Child not acting like herself. Extremely irritated, fussy, runny nose, congestion, vomiting.
Presented with clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Presented with clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On an unknown date, the patient experienced THROMBOSIS (Presented with clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Presented with clots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Very limited information regarding this event has been provided at this time.  Further information cannot be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information cannot be requested.
-Tingling in roof of mouth without swelling then pt stated back of throat feeling numb & swollen
Information has been received from a nurse concerning a 22 year old female who on 08-JAN-2007 was vaccinated with Gardasil. On 12-Mar-2007 the patient received her second dose of Gardasil (lot #653938/0954F). On 12-MAR-2007 the patient experienced swelling at the injection site and pain at the injection site. It was reported that she sought unspecified medical attention. The events lasted about two weeks and subsequently she recovered from swelling and pain at the injection site. No further information is available at this time. Additional information has been requested. Initial and follow-up has been received from a licensed visiting nurse concerning a 21 year old female, with no pertinent medical history, who on 08-JAN-2007 was vaccinated with a first dose of GARDASIL vaccine. On 12-MAR-2007 at 9:00, the patient was vaccinated IM in the right deltoid with a
Hypnagogic Hallucinations; flashes of light between wakefulness and sleep.
Unexpected death shortly after administration of 3rd DTaP and 2nd Prevnar. 18 month old admitted to hospital for dehydration secondary to Rota virus on 1/25/04. Died 1/27/04 after being pronounced brain dead. Autopsy diagnosis was encephalitis with cerebral edema and uncal. herniation.
14 y.o. patient administered Moderna outside of approved age recommendations (Moderna currently approved for patients 18 y.o. and older)
This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored vaccine for children stock (reported as VFC stock) GARDASIL 9 (lot# M018810, expiration date 28-MAY-2018) (dose, frequency and route were unknown) for prophylaxis. At the time of report, the storage temperature and time frame were not determined. There was previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA006622: US-009507513-1612USA007532: US-009507513-1612USA007533: US-009507513-1612USA007534: US-009507513-1612USA007535: US-009507513-1612USA007536:
pt recv vax 15AUG96 10AM & devel rash 2PM;parents states throat closed up @ 6PM;seen by MD;bumps on lower arm both lt & rt;t97.0;h/a, sl dizziness;fine pinpoint macular rash;pt c/o SOB & throat swollen;hyperglossitis;