chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The headache was (relative to a migraine) mild, and somewhat intermittent, but is combined with brain fog.; Fatigue; Felt a little washed out.; Slight pain at injection site for a few days; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old adult non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration in the left arm on 13Mar2021 at 14:45 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included Acyclovir (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN), lutein (MANUFACTURER UNKNOWN), all for unspecified indication and from unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: E19266), via an unspecified route of administration in the left arm on 20Feb2021 at 17:45, as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 14Mar2021, at 5:00 the patient felt a little washed out, slight pain at injection site for a few days, all these symptoms were still continuing by 20Mar2021 (Saturday) and on an unknown date, patient experienced fatigue and headache which was relative to a migraine, mild, and somewhat intermittent but was combined with brain fog. No therapeutic measures were taken as a result of the events. The clinical outcome of the event washed out, pain at injection site, fatigue and migraine headache was not recovered. No follow-up attempts are possible. No further information is expected.
Sick for 5 days; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2005006 (regulatory authority).  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Batch/Lot number: unknown) at the age of 66 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Sicca syndrome with other organ involvement" (unspecified if ongoing), notes: Sicca syndrome with other organ involvement; "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "migraines" (unspecified if ongoing); "partial thyroid removal" (unspecified if ongoing); "gall bladder removal" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; LIPOFEN; BOTOX; BUTALBITAL, ACETAMINOPHEN & CAFFEINE. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Sick for 5 days". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15 minutes after shot my ears began ringing .  the strong ringing continued for next 24 hours and has continued intermittently. I tried to find information from Pfizer website and there was a reference to ringing in the ears and it was advised to contact physician. I emailed our physician MD. He told me to submit this information to this reporting and to the Pfizer website which I have done. The ringing in my ears has improved and sometimes goes away but continues to return. I am still having it today 3/5/2021
Temperature increased to 100.1 F, blood pressure elevated 148/92, dizziness with fall, radial pulse rate increased to 120/min, shortness of breath, rash
dizziness, patchy rash-mildly picky/itchy, mild headache, lack of energy
1 day post vaccine, knee pain, swelling, rash, vomiting. Serum sickness including urticaria, angioedema, malaise, vomiting, arthritis both knees. Rx Zyrtec, motrin.
Patient experienced swelling in the arm 2 weeks after the vaccine then 4 weeks after the vaccine patient experienced swelling in the back of the neck.  Patient was told by the doctor that will go down over time.  Patient used massage to help go down,
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 14-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # M003434, expiry date, therapy type, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Feel Dizziness after 1 week till today; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic. Concomitant medications included metformin 500 (MANUFACTURER UNKNOWN) for an unknown indication from unknown date. The patient previously took sulfur and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 09:00 the patient experienced the feeling of dizziness after 1 week till the day of this report.  No therapeutic measures were taken as a result of this event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event dizziness was not resolved.  No follow-up attempts are needed. No further information is expected.
Headache occurred, body aches, chills, nausea, and fever of 99.4
She said that an hour after receiving her vaccine, she had experienced a numbness to her lips, jaw and chin. It lasted 15 to 20 minutes and resolved. The next day (May 15) she experienced similar symptoms towards the end of her work shift. She said it lasted 15 to 20 minutes and resolved itself.   She had called to notify us 06/07/2021 because she wasn't sure if she should keep her appointment for her second dose.
Fever of 102 deg. F for 48 hours, hives on both legs.
Patient ambulated to the clinic waiting area for observation immediately after vaccine was administered. Upon entering the room patient stated that she felt dizzy, patient was assisted to sit down, she immediately became verbally unresponsive to questions, her left arm and left leg became rigid, dorsiflexion of the left wrist occurred, she exhibited rapid horizontal eye movements bilaterally, approximately 15 seconds later patient was able to respond appropriately to questions and stated her name. Oxygen was placed via nasal cannula at 2Lpm, vital signs were obtained BP 118/75 pulse 79 oxygen saturation 100% on nasal cannula 2Lpm, patient was given orange juice and peanut butter cookies, blood glucose was checked by ancillary staff. patient was seen by the staff doctor and was cleared to leave. Patient's husband arrived and she left the clinic with him. She reported he would be driving her home. Oxygen was removed by the physician and she reported that the patient was stable on room air. Patient reported that she was feeling good. Patient left the clinic ambulatory without assistance with her husband.
Pt's left arm was swollen, red, tender to touch. Pt states arm was hurting the day of shot and has been taking Ibuprofen to help with pain. I recommended BENADRYL & Ibuprofen. (L) arm received PNEUMOVAX.
This spontaneous report as received from a medical assistant refers to 4 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 11-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609.
Acute narcolepsy. Suspected Guillain-Barre Syndrome. Could be related to concurrent-onset campylobacter infection.
Patient called today complaining her arm was red, sore, and hard. I told her to contact her doctor and inform him. Doctor called in fluocinonide 0.05% cream.
No additional AE; 2 year old was concomitantly administered PROQUAD and VARIVAX; This spontaneous report was received from a nurse practitioner referring to a 2-year-old patient of unknown gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 23-MAY-2022, the patient was concomitantly administered with 1 dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength and route not reported, lot # U029150, expiration date: 16-MAR-2023, therapy type: rHA) and 1 dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength and route not reported, lot # U016064, expiration date: 20-MAY-2023) for prophylaxis (overdose). No additional adverse event was reported.
total body hives-ears, eyes, nose trunk, extremities, no resp distress-DPH given
Tired for a few days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired for a few days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2*A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction to drug (Amifostine 20 years ago). Previously administered products included for an unreported indication: AMIFOSTINE (20 years ago) since an unknown date. Concurrent medical conditions included Cancer. Concomitant products included OLAPARIB (LYNPARZA) for Cancer.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired for a few days). At the time of the report, FATIGUE (Tired for a few days) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.     Concomitant medication included additional unspecified medications.  Treatment medication was not reported.   This case was linked to MOD-2021-027614 (Patient Link).
No adverse event; expired Moderna Covid-19 vaccine on February 22, 2023 lot number 015B22A expiration date February 12, 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine on February 22, 2023 lot number 015B22A expiration date February 12, 2023) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine on February 22, 2023 lot number 015B22A expiration date February 12, 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine on February 22, 2023 lot number 015B22A expiration date February 12, 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine on February 22, 2023 lot number 015B22A expiration date February 12, 2023).    No concomitant medications were reported. No treatment medications were reported.
first dose: loose stools; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP).  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 (Lot number: EL9263) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BENEFIBER FIBER SUPPLEMENT; PEDIALYTE [GLUCOSE;POTASSIUM CITRATE;SODIUM CITRATE ACID]; PREBIOTICS NOS; PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]. The following information was reported: DIARRHOEA (non-serious) with onset 05Feb2021, outcome "recovered" (Feb2021), described as "first dose: loose stools". Therapeutic measures were taken as a result of diarrhoea. Additional information: Patient's Medical History (including any illness at time of vaccination) and Family Medical History Relevant to AE(s) was None. History of all previous immunization with the Pfizer vaccine considered as suspect: First and second doses mentioned today, she confirmed no other history with the product. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations was None. She has been to both her primary care after the first dose and then a gastroenterologist after the second dose and he told her to increase fiber and she has been having fiber and nothing seems to be working. The first dose was 02Feb2021. The loose stools began about 4 days after the first dose. She says it probably lasted about 4-6 days. She also tried Imodium Multi-symptom for gas or bloating.  No follow-up attempts are possible. No further information is expected.
Inflammatory bowel disease; Condition aggravated; This case was reported in a literature article and described the occurrence of inflammatory bowel disease in a male patient who received Herpes zoster (Shingrix) for prophylaxis.    Concurrent medical conditions included inflammatory bowel disease.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced inflammatory bowel disease (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the inflammatory bowel disease and condition aggravated were unknown.   The reporter considered the inflammatory bowel disease and condition aggravated to be possibly related to Shingrix.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of an inflammatory bowel disease (IBD) exacerbation in a male aged between 50 and 81years, who was vaccinated with Shingrix vaccine (GlaxoSmithKline) for prophylaxis. The patient was a part of cohort study that aimed to monitor for IBD exacerbation after recombinant zoster vaccine (RZV-Shingrix) administration in a larger cohort of patients. The patient's concurrent condition included IBD. No information on patient's medical history or family history or concomitant medication were provided. On an unspecified date between February 2018 and November 2018, the patient received the 2nd dose of Shingrix vaccine injection (administration route and site unspecified; batch number not provided).  [In this study, most patients received the vaccine at their local pharmacy due to limited availability and insurance preference]. Age of vaccination was not provided. On an unspecified date, 3 days after vaccination, the patient had flare of IBD, as defined by requiring a change in medical therapy. Treatment was unknown. The outcome of the event was not provided. The authors stated, "There was a theoretical concern that patients with immune mediated diseases may develop worsening of their condition after RZV administration. Early results from this study suggest that RZV is safe in IBD patients on immunosuppressive medications. One patient (2% of the cohort) receiving his second dose of RZV had an exacerbation of his IBD. Larger studies with longer follow-up are needed to confirm that IBD and other immune mediated diseases are not worsened after vaccination with RZV."
Patient says was admitted to hospital with ovarian cyst after receiving GARDASIL. Reviewed hosp records. Patient admitted 11/9/10 to 11/15/10 for diabetic ketoacidosis and found on abdominal ct to have (L) ovarian cyst 3.5cm & several small mesenteric lymph nodes.
pt recv vax & exp 50 chicken pox lesions;no further details were provided;mom also reported an adverse event for herself which was assigned WAES96031478 & an adverse event for daughter WAES96031480
Chills, nausea, headache, overall aches and pains, loss of appetite, 100.4 fever - lasted 48 hours.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not provided) "two weeks ago", approximately on 25-OCT-2012 and vaccinated with another dose on 08-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Some of her friends reported feeling tired; feel discomfort at the injection site; sore arm; muscle soreness, like an ache "on and off"; had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group; having a tingling feeling off and on; some weakness to her hand on the side of her injection; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported), via an unspecified route of administration on 18April2021 as Second dose ,single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162b2  for Covid-19 immunisation. The reporter stated that she has friends who have experienced similar symptoms such as feeling tired, feel discomfort at the injection site, sore arm ,muscle soreness, like an ache "on and off" , had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group , having a tingling feeling off and on but that went away , some weakness to her hand on the side of her injection and picking things up and dropping things .The outcome of all events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684418 same patient/drug/similar event, different patient;US-PFIZER INC-2021687674 same patient/drug/similar event, different patient;US-PFIZER INC-2021687677 same patient/drug/similar event, different patient;US-PFIZER INC-2021687676 same patient/drug/similar event, different patient
Unwitnessed Cardiac arrest. ACLS protocols were performed.  Cessation of resuscitation was called in the field by Dr.
This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M018766, expiration date 15-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursions of 33.6 degrees Fahrenheit for 49.5 hours and 34.8 degrees Fahrenheit for 7 hours. There was no product quality complaint involved. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact physician.; Sender's Comments:  US-009507513-1610USA010976:
Mother states that the child has a seizure lasting approximately 5-10 seconds long.  This occured twice.  Seen by the doctor on Nov 5, 2001.
Chills; Body ache; Throat swelling; Sore throat; Fatigue; No appetite; Headache; Cough; Nausea; Cold; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; congestion; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration at the 73-year-old on 19Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medication were none. The patient stated, "she had her vaccine on the 19th and she developed very strong symptoms, chills, body aches, throat swelling, sore throat, fatigue, no appetite, headaches, cough, congestion, nausea in 2021. So, last Sunday her son took she to the walk in clinic and they put she on Azithromycin pack, the Z-Pak. She was still not a 100 percent and she was scheduled to get the second vaccine next Friday which was the April 9th. So, she understand the Azithromycin, the Z-Pak, she finish on Friday. But it will cover her for the next week. So, will it be advisable for her to get the second vaccine under the effect of the Azithromycin?" The patient further stated, "she waited for so long today and I had cold previously in 2021. But she just didn't wanted to keep postponing it." Patient stated, "she was 120 before she got sick. At this report, she thought that she had lost about 5 Pounds in 2021. she was not able to eat from her throat in 2021." Patient stated, "After she took the vaccine. After the vaccine, she got sick in 2021." Patient stated, "the treatment was when she went to the she gave Azithromycin, the Z-Pak. She just said that her throat was red in 2021."Patient  stated, "She had another question for the second vaccine. Did you think she would have lighter symptoms or the same". The outcome of events was unknown.  Information about Lot/Batch number has been requested.
SEVERE fibromyalgia symptoms that went on for 2 weeks until my doctor prescribed hydrocortisone which took 3 days to remove symptoms.
Breath holding spell with lips turning blue and skin pale following a crying spell about 4 hours following immunization. Baby gradually regained normal color but cyanotic episode was very brief. Subsequently had a normal exam in office.
Injection 15 min Stomach cramps/diarrhea. Severe itching (not at injection site - opposite side) lasted 2 days,  terrible deep cough, hurting in chest, throat closing up, violent jerking. Called pharmacy to see if could take BENADRYL - took 1 25mg capsule. After jerking bad headache, fever 102 degrees lasted about 12 hrs.
Rash over entire body, head and neck pain and was seen by dr on 7/25/18 and given steroid injection and prescribed Prednisone orally.
Started day after with lightheadedness foggy comes and goes increasing in frequency as days go by excluding while laying in bed. No nausea lasting each episode minutes to seconds. No sinus all other problems has lasted weeks. Blood sugar good BP 140/70.