chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fully vaccinated and boosted twice. Immunosuppressed, solid organ transplant. COVID breakthrough infection.
Received pneumococcal 7 valent vaccine left deltoid muscle 01/04/05 prn and developed low grade temp, swelling at site and headache 6 hours later.
Vaccine injection site appeared red, swollen and very tender to touch.  Baby cried continuously even during feedings. Symptoms resolved after 3 doses of Tylenol, left leg.
Left thigh edematous and erythematous most of erythema around injection site. No sign of infection.
Status post, 2nd Anthrax shot; had moderate local reaction with persistent 3cm X 3.5cm SC nodule.
Disorientation; brain fog for several days; fatigue; sore lower back; head pressure; general feeling of just being off; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 22Apr2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, acne and general anxiety disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included thyroid (ARMOUR THYROID), escitalopram oxalate (LEXAPRO), doxycycline (ORACEA) and spironolactone (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 11:15 the patient experienced disorientation, brain fog for several days, fatigue, sore lower back, head pressure and general feeling of just being off. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of sore back included treatment with chiropractic care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events disorientation, brain fog for several days, fatigue, sore lower back, head pressure and general feeling of just being off was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Moving L arm as I was driving home and began aching to the point that I had to hold the arm very still. The arm was better by bedtime but continued to periodically ache slightly for about 1 week. Currently, certain movements cause slight and fleeting discomfort
fever ( 102.8 ); stiff neck; swollen throat; pains in neck, shoulders, body; pains in neck, shoulders, body; pains in neck, shoulders, body; nauseous; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Lot number: 30145BA) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing), notes: HEART DISEASE; "Peanuts" (unspecified if ongoing), notes: Peanuts. Concomitant medication(s) included: COREG. The following information was reported: PYREXIA (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "fever ( 102.8 )"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "stiff neck"; PHARYNGEAL OEDEMA (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "swollen throat"; NECK PAIN (non-serious), ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 01Oct2021 20:45, outcome "not recovered" and all described as "pains in neck, shoulders, body"; NAUSEA (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "nauseous". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, musculoskeletal stiffness, pharyngeal oedema, neck pain, arthralgia, pain, nausea.  Additional Information: The patient treated was with Tylenol and pain medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received LASARTIN / COREG within 2 weeks of vaccination.The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient been not tested for COVID-19.  Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a nurse referring to a 47 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 06-AUG-2018, the patient was vaccinated with the first dose of VAQTA 50/1.0 U/ml intramuscularly for prophylaxis (dose, anatomical location, lot number and expiration date were not reported). Then on 21-DEC-2018, the patient was vaccinated with the second dose of VAQTA 50/1.0 U/ml intramuscularly lot number R027987 and expiration date of 09-AUG-2019 for prophylaxis (dose and anatomical location were not reported). No adverse effects were reported.
6:25 pm report: pt rec'd vaccine immediately c/o of not feeling well and had syncopal episode was given smelling salts then brought to recovery  vaccinator and Dr accompanied.  Pt laid on cot supine, feet elevated.  Assess: AAO, + nausea - dizzy, no complaints of pain of any kind. VS 146/94, heart rate 74 regular, resps 16 reg non labored, SPO2 97% RA  Mnitor 30 min. provided reassurance. Pt stated he felt better sat him at edge of cot 6:50 pm VS 152/92, heart rate 71 reg. resp 16 reg non labored, SpO2 98%. Encouraged fluids ok to exit. Encouraged him to follow up with primary MD. V-safe.  3/7/21 Followed up with phone call - pt stated he felt much better today.
This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 03Apr2021, the patient experienced severe rash on ankles. The events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of severe rash on ankles was recovering at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 23Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Redness at injection site; Tenderness at injection site; Peeling skin; Painful / Hurt like crazy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2019, the patient received the 1st dose of Shingrix. In June 2019, 3 days after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness, skin peeling and pain. On an unknown date, the outcome of the injection site erythema, injection site tenderness, skin peeling and pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, skin peeling and pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received Shingrix about three days later she had redness and tenderness at the site, which pharmacist states looked normal. Then about 7 days after the injection the patient experienced skin peeling at the site, which was painful and hurt like crazy. The pharmacist stated that the symptoms were resolved. The reporter consented to follow up. The pharmacist grants permission to follow up.
Fullness/swollen sensation of throat with mild lymphadenopathy; Fullness/swollen sensation of throat with mild lymphadenopathy; This is a spontaneous report from a contactable healthcare professional.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249), via an unspecified route of administration in Jan2021 as first single dose for COVID-19 immunization.  Medical history included COVID prior to vaccination from an unknown date. No known allergies were noted.  The patient's concomitant medications were not reported.  The patient experienced fullness/swollen sensation of throat with mild lymphadenopathy in Jan2021 with outcome of recovered on an unspecified date in 2021.  The patient underwent lab tests and procedures which included blood test/ antibody positive in May2020 and Nasal Swab/ PCR negative in Nov2020.  There were no treatments given for the events. The clinical outcome of events was recovered on an unspecified date in 2021.
ON OCTOBER 21ST THE PATIENT CALLED THE PHARMACY TO EXPLAIN STARTING THE NIGHT OF REICEVING HER VACCINATION SHE EXPERIENCED CHILLS, FEVER, NAUSEA AND HEADACHE. IN ADDITION TO THESE COMMONLY KNOWN SIDE EFFECTS, THE PATIENT STATED SHE EXPERIENCED A SEIZURE FOR A SMALL DURATION OF TIME (UNDER A MINUTE) IN WHICH SHE FELT AS THOUGH SHE LOST THE ABILITY TO MOVE HER LIMBS. THE PATIENT STATED HER SYMPTOMS HAVE GONE AWAY AND THAT SHE HAS NOT EXPERIENCED ANOTHER "SEIZURE". THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH THEIR PRIMARY CARE PROVIDER TO LET THEM KNOW ABOUT THIS EVENT, AND TO GO TO THE EMERGENCY ROOM IF THIS HAPPENS AGAIN.
she woke up this morning with her tongue completely swollen.  she could barely talk because it was so swollen
This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of injection site induration in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). In 2014 the subject received a dose of INFANRIX (unknown details). In 2014, within weeks of vaccination with INFANRIX, the subject experienced injection site induration (described as "knots at injection site") and injection site redness. The reporter noted that "the timeframe was is the past 2 weeks." The reporter stated that after the subject received INFANRIX, the subject "developed huge red knots at the injection site." No other events were reported. It was unknown if the immunization series was discontinued. At the time of reporting the outcome of the events were unknown. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The medical assistant reported 4 other cases with INFANRIX. See A1060689A, A1060690A, A1060691A and A1060692A for details on the other cases. Follow-up information was received on 10 March 2014 via healthcare professional who reported the 6-year old male subject started to experience the events on 30 January 2014. The subject had no relevant medical history. The events were not attributed to medical history/concurrent illness, lack of efficacy, erroneous administration, suspected transmission of an infectious agent via medicinal product. No action was taken with INFANRIX, the series was not discontinued or delayed. The reporting healthcare professional did not consider the events to be serious. The events resolved on an unspecified date.
Information has been received from the authors in a published literature article and refers to a retrospective pregnancy report and concerns a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, anatomical location, lot number and expiration date were not reported) and hepatitis A vaccine (manufacturer unknown) (dose, route, anatomical location, lot number and expiration date were not reported) while being pregnant. The patient's last menstrual period, (LMP), estimated conception date and estimated due date were not reported. The patient gave birth to a baby, the infant was born without both lower limbs. This review of VAERS reports comprising more than 6 years of monitoring found no safety concern among pregnant women or their infants who received this vaccine during pregnancy, causality between reported AEs and GARDASIL vaccine was not specifically assessed. This is one of several cases from the same literature (1412USA009575 and 1412USA011729). Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of abdominal pain in a 65-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced abdominal pain, spleen enlarged and liver enlargement. On an unknown date, the outcome of the abdominal pain, spleen enlarged and liver enlargement were unknown. It was unknown if the reporter considered the abdominal pain, spleen enlarged and liver enlargement to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX in August or September 2018. On 5th December 2018 ultrasound abdomen was performed and it was note that liver was mildly enlarged and spleen was enlarged. The patient also experienced abdominal pain after 1st dose.
mildly immunocompromised; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19),  via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization, hydroxychloroquine sulfate (PLAQUENIL), via an unspecified route of administration from an unspecified date at unknown dose for mild rheumatoid arthritis for 15-20 years. The patient's medical history and concomitant medications were not reported. The patient experienced mildly immunocompromised on an unspecified date with outcome of unknown. The action taken in response to the event for hydroxychloroquine sulfate was not applicable.  Information about lot/batch number has been requested.
looked like she's going to faint; bones are aching; fever of 100.8'F; chills; tiredness; This spontaneous case was reported by a patient and describes the occurrence of PRESYNCOPE (looked like she's going to faint), BONE PAIN (bones are aching), PYREXIA (fever of 100.8'F), CHILLS (chills) and FATIGUE (tiredness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Bladder infection and Pacemaker insertion (cardiac). Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Bladder infection, OMEPRAZOLE, LEVOTHYROXINE, CARVEDILOL, WARFARIN, ISOSORBIDE, ATORVASTATIN, EZETIMIBE, AMIODARONE and ENALAPRIL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced BONE PAIN (bones are aching), PYREXIA (fever of 100.8'F), CHILLS (chills) and FATIGUE (tiredness). On 16-Mar-2021, the patient experienced PRESYNCOPE (looked like she's going to faint). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, PRESYNCOPE (looked like she's going to faint), BONE PAIN (bones are aching), PYREXIA (fever of 100.8'F), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 100.8 (High) 100.8'F. On 16-Mar-2021, Blood pressure measurement: 140/60 mmHg 140/60mmhg. On 16-Mar-2021, Heart rate: 94 per minute 94 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Is 17 weeks pregnant with her first child. I do not know her estimated date of delivery. She fainted approximately 5 minutes after receiving her vaccine and fell from a chair. She landed on her side face down, so we turned her face up so we could see her face. Her eyes were barely open, but she nodded her head the second time we asked if she could hear us. We took her blood pressure, and it was 107/71 with a heart rate of 85. EMS came, and she felt better, so she decided not to go with them. They asked her to stand up to sit back in the chair. When they left, she slowly progressed to walking around while talking on the phone with someone to come pick her up so she didn't have to drive herself. She told us this was the first time she had fainted in 3 years and the first time ever fainting due to a vaccine.
pt recv vax 7FEB96 & 7FEB96 pt exp fatigue & dizziness;pt was sleeping 22hr a day;pt exp soreness in arm immed p/vax;no further details were provided;
pt recv vax 11APR96 & was found to have an elevated LDH & SGPT;
She was coughing blood clots and I took her to the ER and she was diagnosed with blood clots in her lungs.
chronic vertigo - symptoms increased in duration and severity; fatigue; malaise; shortness of breath; transient muscle weakness; trembling; frequent digestive disruption; ranging from constipation to severe diarrhea, sometimes within a single day; supraventricular tachycardia; disorientation; memory issues; cognitive issues, frequently "disconnected" or "in a haze"; unusual clumsiness; anxiety  No treatments have been suggested for any of the symptoms beyond OTC medications for the digestive disruption, and migraine medications as a possible treatment for the vertigo (Xanax, Nurtec, Ubrelvy), all of which failed to help, or made my symptoms worse.
SWEATING, COULD NOT SEE(BLURRED VISION. PATIENT WAS SEATED AND OFFERED TO CALL 911 BUT PATIENT REFUSED. OFFERED COLD BOTTLE WATER WHICH SHE DRANK. SHE FELT MUCH BETTER AFTERWARDS. PATIENT STATED THAT SHE DID NOT EAT ALL DAY.
Weakness on both legs (she was taking small steps when she walked; Almost losing her balance; Feels tired; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness on both legs (she was taking small steps when she walked), BALANCE DISORDER (Almost losing her balance) and FATIGUE (Feels tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weakness on both legs (she was taking small steps when she walked), BALANCE DISORDER (Almost losing her balance) and FATIGUE (Feels tired). On 27-Feb-2021, MUSCULAR WEAKNESS (Weakness on both legs (she was taking small steps when she walked) and BALANCE DISORDER (Almost losing her balance) had resolved. At the time of the report, FATIGUE (Feels tired) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Information was also received from a nurse at this practice concerning a different patient who fainted after receiving GARDASIL vaccine (lot # not provided). No additional information was available. This is one of two reports from the same source (WAES# 0807USA03710) Additional information is not expected.
About 6 hours after the second dose my arm suddenly began aching and my heading pounding. I took an 800 mil. Ibuprofen and went to bed. Woke up the next morning with aches, headache, and chills. Took another ibuprofen.  By evening I had full blown flu like symptoms which caused me much discomfort. Fever, 101, chills, aches, headache. Another ibuprofen,  but not as much relief as previously. Finally got some sleep. Woke up this morning feeling like a truck hit me. Tired, but the aches have let up, and the headache and fever are gone.
Patient developed red/pruritic rash and induration to the right deltoid region. Induration is improving but rash persists.
Shortness of breath lasting over 1 week; Migraine/Severe Headache; Migraine/Severe Headache; This is a spontaneous report from a contactable consumer (patient).   A 30-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Left Arm on 09Apr2021 18:00, at the age of 30-years-old, (Lot Number: EP7534) as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history included endometriosis, seasonal allergy, and migraine. Concomitant medication included norethindrone; gabapentin; loratadine (CLARITINE); ibuprofen, all were taken for unspecified indication, start and stop date were not reported. Historical vaccine includes dose 1 of BNT162B2 administered on 19Mar2021, 05:45 PM on left arm (No reaction on previous exposure to vaccine).   The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 13Apr2021, the patient experienced migraine/severe headache, shortness of breath lasting over 1 week. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
1/10/2020 Left deltoid area of injection became itchy, red, warmth and welts appeared, small soft mass 2 by 3 cm.  Next morning still have soft mass, red and warm with itching.  No fever or swollen lymph nodes.
Dyspnea, swelling and dysphagia within 3 minutes of receiving the vaccine Received 0.3 mg Epi pen and 50mg Benadryl  PO Symptoms resolved after treatment
I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chills and an all over listless feeling that started about 18 hours after I received vaccine and still remains 4 days later
The day of vaccination, mother reports that the patient developed cough. The next day she also had rhinorrhea. The following day she had respiratory distress and was admitted to the hospital. She was tachycardic and breathing hard 32/min with intercostal retractions. She has pulse ox of 93% on room air and required 3LPM O2 by nasal cannula.
The patient is 4 years old and received the Pfizer vaccine for age group 5-11 years old.