chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a stroke; Minor heart attack the same day as the stroke; Did not feel right; Could not lift her arm, it felt like a thousand pounds; Could not get up, her right leg gave out; Kidney disease; Felt tired; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a stroke) and MYOCARDIAL INFARCTION (Minor heart attack the same day as the stroke) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Had a stroke) (seriousness criteria hospitalization and medically significant), FEELING ABNORMAL (Did not feel right), LIMB DISCOMFORT (Could not lift her arm, it felt like a thousand pounds), MUSCULAR WEAKNESS (Could not get up, her right leg gave out) and FATIGUE (Felt tired). an unknown date, the patient experienced MYOCARDIAL INFARCTION (Minor heart attack the same day as the stroke) (seriousness criterion medically significant) and RENAL DISORDER (Kidney disease). The patient was hospitalized from sometime in May 2021 to 28-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Had a stroke), MYOCARDIAL INFARCTION (Minor heart attack the same day as the stroke), FEELING ABNORMAL (Did not feel right), LIMB DISCOMFORT (Could not lift her arm, it felt like a thousand pounds), MUSCULAR WEAKNESS (Could not get up, her right leg gave out), RENAL DISORDER (Kidney disease) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Around 8:30-9:00pm, the patient did not feel right, could not lift her right arm, could not get up and her right leg gave out.  She was taken to the hospital where "they said she had a stroke."  She was hospitalized then and was released 28-May-2021. The patient would require rehab for next 6-12 months. Additionally, it was also reported that the patient suffered a minor heart attack the same day as the stroke. It was reported that the patient suffered two strokes, however, there was no further information about the second stroke.   At the hospital, in regards to patient's medical history, the doctors mentioned "kidney disease" and that the patient had "blood pressure" before.    Concomitant medication use included "blood pressure pills."  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Excursion - vaccine; Information has been received from a registered nurse concerning to a 12 month old patient (gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 21-DEC-2020, the patient was vaccinated with excursion temperature (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. T017688, exp. date 21-MAY-2022), 0.5 milliliter for prophylaxis.    Temperature: -13.3C Timeframe: 4 hours and 15 minutes Previous temperature excursion: No Call because of data logger
Hives - Benadryl, Pediapred, 2 tsp at am and noon and 2 tsp at pm x 5d.
After second dose, pain at site injection administration; Muscle and joint aches; Muscle and joint aches; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05May2021 at 12:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history included allergy to lysol and bleach. 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. The concomitant medications included loratadine (MANUFACTURER UNKNOWN), mometasone (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), clonazepam (MANUFACTURER UNKNOWN) and an unspecified medication; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 14Apr2021 at 12:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 18:30, after second dose, the patient experienced pain at site injection administration, muscle and joint aches, chills and headache. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at site injection administration, muscle and joint aches, chills and headache were resolved on an unknown date in May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got vaccine at 2:30 pm by 3:30 I was extremely tired - I had to go to bed. 3 days later I got a bad cold. Had to have Dr give me azithromycin - Z-PAK.
Rapid heart rate, chest pain, shortness of breath, fatigue, high blood pressure, tight muscles, dizziness, feeling like passing out, nausea, joint pain
Injection site has become red and itchy in an area about 3 inches in diameter.  Seems to be getting worse since yesterday.  It has been 8 days since injection.  Treating with icing so far.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (breast cancer in one breast treated with radiation). Concurrent medical conditions included immune system disorder (hyperimmune system).   In June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 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 patient received Shingrix in early June in the left arm and the only effect she experienced was a sore arm that resolved within several days. The reporter consented to follow up. Emergency room visit required. For tolerances of 2nd dose, refer case US2019AMR173490, reported by same reporter for the same patient.
Patient was administered monovalent Pfizer\BioNTech booster instead of the intended bivalent booster. Patient was notified by provider and advised about option to be boosted with bivalent booster after at least 2 months.
Information has been received from a health professional concerning an adult female with no reported previous medical history who on 12/12/05 at 11:00 am (also reported as 12/13/05, was vaccinated with a 0.5ml IM first dose in the deltoid area of Pneumococcal 23v polysaccharide vaccine (lot 651859/0877R). On 12/13/05 th pt developed a red blotchy rash and there was itching at the injection site. There were no treatments for the conditions. The status of the pt was reported as unknown. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been received from a registered nurse. The nurse reported that the deltoid area where the vaccine had been given to the pt became swollen to her elbow with a maculo papular rash and that her arm was very painful with a nodule. The pt went to the ER and was treated with oral prednisone. The pt recovered from the events on 12/19/05. Additional information is not expected.
Information was received on 14-MAR-2017 from a medical assistant regarding multiple patients. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, multiple patients were administered improperly stored doses of VAQTA (lot # M036459, expiration date 18-JAN-2018) and ROTATEQ (lot # M014731, expiration date 05-FEB-2018).  No adverse effects were reported. Temperature : between 32 degrees Fahrenheit and 35 degrees Fahrenheit Time frame: 10 minutes Previous temperature excursion: yes: 47 degrees Fahrenheit to 77 degrees Fahrenheit for 15 minutes Was call because of a "data logger"? no Lot # M014731 has been verified as valid for ROTATEQ. No further information is expected.
Initially: Arm Pain Slight Temperature Very strong abdominal/ GI pain,  had to go see a GI doctor, he was not able to understand the correlation to this vaccine because it was something he was familiar with, or able to comprehend.   Persistent, these issues have not resolved: Chronic Headache, forehead area pressure, insomnia as I wake up with headache regularly, Joint Pain, Chest Pain (Heart Area) , unexplained pain (intermittent), Fatigue,   Less frequent: Difficulty breathing  Least frequent: hypersensitivity to temperatures (warm water seems very hot)
Headache, Myalgia, Arthralgia, Fever, Diarrhea &  NauseaVomiting Narrative:  sore arm; chills; fever; vomiting; nausea; diarrhea; cold sweats; fatigue; tiredness; joint pain; stomach cramp
I received a tetanus shot in my right arm on Friday. By Saturday I'd experienced localized swelling around the area where the shot was administered and extreme pain when trying to raise that arm up to shoulder height.  Today is Sunday and the pain is excruciating, whether I move my arm or keep it still by my side. I can only sleep on my back so my arm can rest still by my side.
where shot was administered / is red; where shot was administered / is itches.; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix 3 days prior to the reporting and the area affected upper arm where shot was administered and was red and itches.
Tingling in left hand and numbness of forearm that has persisted. It will come and go periodically. In some instances, it gets close to fully numb and there is pain with the tingling.
After receiving Gardasil and waiting for 5 minutes, pt went to check out and she passed out and hit her head on door.  Couldn't stand by herself after 15 minutes, called ambulance and went to ER.  At discharge, mom went to get the car and child had a seizure.
This case was reported by a consumer via interactive digital media and described the occurrence of respiratory tract congestion in a female patient who received DTPa vaccine. In July 2015, the patient received DTPa vaccine. On an unknown date, less than a month after receiving DTPa vaccine, the patient experienced respiratory tract congestion and cough. On an unknown date, the outcome of the respiratory tract congestion and cough were unknown. It was unknown if the reporter considered the respiratory tract congestion and cough to be related to DTPa vaccine. Additional details were provided as follows: In the last week before the reporting time, the patient received the tdap booster. In July 2015, the patient experienced chest congestion and cough. The patient was wondering if the symptoms were a slight side effect of the vaccine. The patient's doctor did not inform her of the possible side effects after the vaccination.
Headache; heart beating really fast; trouble sleeping; This is a spontaneous report from contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in arm left on 14Sep2021, given around 13:00 (at the age of 38-years) as dose 2, single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient past drug event includes Anthrax. some 20 years ago, the patient 2002 or 2003 he had the anthrax shots and had a bad reaction to it. The patient was in the navy and had a booster at 6 months and then every 12 months. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: FC3182) (at the age of 38-years), via an unspecified route of administration, administered in arm left on 24Aug021 given around 13.00 as dose 1, single for covid-19 immunization. Caller reporting on the Pfizer COMIRNATY, the covid shot and who explains the patient took it yesterday and was told to call if felt anything afterward. It was his second dose. Last night the patient had trouble sleeping. Patient just hopes he was really tired to night and will be able to catch up on his sleep. His heart had been, the patient feel like he ran a marathon for 12-13 hours it had been beating really fast, which started around 22:00 last night, was about the same, the patient just feels like he ran a marathon, his heart was beating really hard and fasting. He drank water. Patient also had a slight headache which started about 9-10pm last night, it was about the same. The patient explains that he gets migraines so it was nothing like normally gets. He was treatment with excedrin. The patient did not visit in emergency. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reports the patient thinks he was doing fine but his heart was beating really fast. The patient underwent lab test: heat rate: elevated (heart is beating really fast). The outcome of the events headache and heart beating really fast was not recovered while the outcome of the event insomnia was unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
48 hours later bilateral eyes swollen. Saw dr. in office and treated  with steroid cream and allergy meds resolved without difficulties
Information was received from a pharmacist via a company representative concerning a patient (demographics unknown). The pharmacist reported that 5 or 6 months ago, the patient was vaccinated with ZOSTAVAX (dosage and route of administration not provided). One month later, the patient developed shingles. The outcome of shingles is unknown. Additional information has been requested.
This spontaneous report has been received from a pharmacist referring to a 65 year old female patient with drug hypersensitivity to sulfa and erythromycin. The patient's medical history included breast cancer with radiation. The patient received a dose of PREVNAR on 23-JUL-2018. On 23-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N022650, expiration date 31-MAR-2019, intramuscularly (strength, dose and frequency were not provided) for prophylaxis. On an unspecified date in July 2018, the patient complaint of pain underneath the arm where she was vaccinated. Moreover, the reporter stated that the patient did not have injection site pain. It was reported that the patient visited a doctor's office because of the event. The outcome of pain in extremity was reported as not recovered. At the time of this report, the causality between the event and PNEUMOVAX 23 was not reported.
Tested positive for Covid (home test). Symptoms were taxing cough without phlegm, and also stuffy/runny nose, and fatigue
I experienced COVID-19 99.6 fever; sore throat; body aches; & chills I am currently taking ibuprofen.
Complete sleeplessness Didn?t sleep a wink the night of shot Feel very energetic Heart rate is normal:66bpm Treatment: stayed in bed and read all night Please note that I had similar sleeplessness with both Pfizer shots Also please note that I have not experienced this sleeplessness in the past with any other vaccinations such as boosters for traveling
The 30-day beyond use date was 18Mar2022; patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received expired doses) and PRODUCT STORAGE ERROR (The 30-day beyond use date was 18Mar2022) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 012H21B and 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received expired doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The 30-day beyond use date was 18Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received expired doses) and PRODUCT STORAGE ERROR (The 30-day beyond use date was 18Mar2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vials were moved  from freezer to refrigerated condition on 24 Feb 2022. The vaccine vial was opened on 21 Mar 2022 at 4:00 pm.  No treatment medication was reported.   This case was linked to MOD-2022-521064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Significant follow up was received and patient demographics, suspect information were updated.
the allergic reaction started with a rash behind the legs that had spread across the body; low grade fever / High fever; This spontaneous report has been received from a consumer, who was also the patient's mother, referring to her 12-month-old daughter. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not reported. The patient had food allergies.   On 03-JUL-2007, the patient was vaccinated with the first dose of Haemophilus b conjugate vaccine (meningococcal protein conjugate) (PEDVAXHIB) (dose, route of administration, anatomical site of vaccination, lot number, vaccine scheme and expiration date were not provided) as prophylaxis.  On 01-MAY-2008, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (ml) once, administered subcutaneously (dose number, anatomical site of vaccination, vaccine scheme, lot number and expiration date were not provided) as prophylaxis.  The reporter did not know if it was varicella virus vaccine live (Oka/Merck) (VARIVAX) or not. On the same date, after the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) she developed low grade fever (pyrexia) and a rash that started on her leg and moved over her body. The patient sought unspecified medical attention; no lab diagnostics studies performed.  On 27-AUG-2008, the patient was vaccinated with the second dose of Haemophilus b conjugate vaccine (meningococcal protein conjugate) (PEDVAXHIB).   The causality assessment between the events and the suspect vaccines was not reported. The outcome of the events was not provided.   Follow-up information has been received from a consumer on 19-JUL-2021. On 01-MAY-2008, the patient experienced an allergic reaction that started with a rash behind the legs that had spread across the body (dermatitis allergic). Also, she experienced a high fever (pyrexia) during 4 consecutive nights. It was reported that treatment with ibuprofen (ADVIL) and paracetamol (TYLENOL) was provided for the events.   The reporter stated that the patient did not receive the recommended booster vaccine due to the allergic reaction, and reported that the patient had a titer test done and the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was still significant.  On approximately 06-MAY-2008 (reported as "by day 5 or 6") the patient recovered from the events.   The causality assessment between the event of dermatitis allergic and varicella virus vaccine live (Oka/Merck) (VARIVAX) was related.
3/21/21 - Pt emails MD that he'd had SOB + fatigue since 3/10 when given first dose of infliximab, no energy, sitting all day. smell ok. taste reduced. poor appetite. +dyspnea on exertion. no chest pain or edema. HR nontachy at baseline, to 105 ambulating to bedroom. BP 164/97. COVID test scheduled for 3/23, which returned negative 3/24. 3/28 - Pt went to healthcare facility for generalized weakness, worsening SOB over days, R pleuritic chest pain, diagnosed with bilateral pulmonary emboli, left popliteal vein DVT. Required 5L O2. echo w/o LV strain. At the time he stated it may have been going on for 4 months. during hospitalization also had altered mental status, MRI/neuro diagnosed with hypoxic brain injury 3/30 - transferred to another healthcare facility given IV abx, lasix, 2-4L NC,  4/11 - discharged to another healthcare facility.
This spontaneous report was received from a pharmacist referring to unspecified patient of unknown age and unspecified gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dose not reported). No other concomitant therapies reported. On an unknown date it was reported that ZOSTAVAX leaked from the injection site of the patient's arm therefore the patient only received half of a dose. The pharmacist reported that this patient ended up experiencing hives after receipt of the dose of ZOSTAVAX. The action taken was reported as not applicable. The outcome of the events was unknown. The causality of the event was unspecified. No PQC reported. Additional information has been requested.