chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 6 year old female with no allergies or medical history who on 8/30/99 was vaccinated in the left thigh with her first 0.5ml dose of varicella virus vaccine live (lot # 631165/0712J). There was no illness at the time of vaccination. On 10/28/04 at 11:30 the patient was diagnosed with chicken pox characterized by a rash on her neck and shoulder, a total of only 20 lesions (one of which was in her mouth) and her temperature was 99.5 - no fever. No medical treatment was required. At the time of this report the patient was recovered. There was no product quality complaint involved. No further information is available.
he had his arm swollen; This is a spontaneous report received from a Pfizer-sponsored program Support via a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical and concomitant medications were not reported. Few days after taking the 1st dose, his doctor prescribed him an antibiotic as he had his arm swollen. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills and headache from 9:30am-3:30am; Lethargy and tiredness through 5pm
Menstrual irregularity. I cramped and bled for 15 days which has never before happened in my life.  Cycle is normally 5-7 days with 2-3 heavy flow days in the middle and intermittent cramping. Also experienced Mild nausea and sleepiness.
Hospitalized for pneumonia, COVID, COPD. Treated with baricitinib, Remdesivir,  dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
Injection site swelling; Injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling and injection site redness. On an unknown date, the outcome of the injection site swelling and injection site redness were unknown.   It was unknown if the reporter considered the injection site swelling and injection site redness to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-July-2022 Reporter's comment: The patient received the first dose of the shingrix vaccine 2 months ago from the date of reporting and experienced injection site redness and swelling.
probably received 50% of it, almost half of dose leaked out of arm; was dripping out of her arm; vaccine was dripping out of her arm; This case was reported by a physician via patient support programs and described the occurrence of accidental underdose in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2022, the patient received the 2nd dose of Shingrix 25 mcg/mg. On 8th June 2022, unknown after receiving Shingrix, the patient experienced accidental underdose, accidental exposure while administering drug and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, accidental exposure while administering drug and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's comment: This case was reported by a physician via patient support programs The patient mentioned she received 2nd dose of Shingrix on the reporting day.  The patient said that when the registered pharmacist administered the dose almost half of the dose leaked out of her arm and per the pharmacists at said she probably received 50 percentage of it in her arm. No other information was provided. The reporter consented to follow up. Additional supportive information: Th patient received the 50 percentage of the dose which leaked out of her arm, which led to accidental underdose, accidental exposure while administering drug and exposure via skin contact.   Case update: Case corrected as per information received on 17th June 2022. The information was as follow: The case duration was updated. The value for duration 0 was removed.
Approximately 3 days after became red and painful at injection site. Came into pharmacy on day 5, pain had not lessened or worsened. Still red and patient described area as "hard as a rock". Advised patient to see physician on following day.
Caregiver has reported symptoms of arm swelling/hardness at injection site that began on 1/14/22 post Covid-19 vaccine booster on 1/14/22 and worsened by 1/16/22. CG saw provider via Telehealth appointment, prescribed ABX for DX of Cellulitis and advised to apply warm compress to site.
Right away large lump at site of injection. The lump has decreased in size. Patient said certain movements cause pain in his whole arm and he feels like he is losing strength. Now has small red spot with white central raised bump. Area under red spot is indurated, no fluctuance.
Received vaccination on 7/8/19. Symptoms started around 7/23/19 of nausea, severe arthralgias and body aches, severe bilateral wrist pain and swelling, some numbness, tingling to the fingers of the right hand, decreased sleep because of severe pain, and generalized headache. Nausea has resolved. Has been using ice, tylenol, ibuprofen, elevation, compression, rest without relief. No injury, no rheumatological disease history, no excessive lifting. No fever, no rashes. Treating with prednisone and norco.
soreness that turned to discomfort on the lower part of her back, on her spine; A spontaneous report  was received from a consumer concerning a 31-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness that turned to discomfort on the lower part of her back, on her spine.   The patient's medical history was not provided by the reporter. Concomitant medications reported included protonix and synthroid; products used for unknown indication.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient experienced soreness that turned to discomfort on the lower part of her back, on her spine.    Lab details was not provided by the reporter.  Treatment for the event was unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, soreness that turned to discomfort on the lower part of her back, on her spine was recovered / resolved on 08 Jan 2021.; Reporter's Comments: Based on the information provided which includes a temporal association, a causal association between the reported event and the product use cannot be excluded.
Tested NAAT positive for COVID 10/14/21 after being fully vaccinated.
Constant loud ringing in me head. Cannot attribute to one ear in specific. Went to Doctor no ear issues reported or seen.
My left arm has lost full range of motion without some discomfort from where the vaccine was injected. The injection appeared too high at the time it was given, and since the time of receiving the vaccine, it has been clarified by another pharmacy that the injection may have been placed incorrectly in my shoulder. I have tingling in my arm at times when my shoulder is rubbed and can have pain if pressure is placed on my left arm for too long (sleeping). A few hours after receiving the injection, my arm was sore; a very typical symptom. However, about eight hours after receiving it, my arm began to throb with pain. I was unable to move my arm or hand at all without intense throbbing pain shooting down my arm. This pain lasted for about 5 days, with lessening pain each day. My arm has not felt "normal" since the date of the injection.
Severe bloody nose multiple times today. Gushing blood from the nasal cavity. Bled through everything we tried to use to stop it including a tampon in a matter of less than a couple minutes.
had my first dose in 2019 and my 2nd dose last week; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient had received first dose of Shingrix in 2019).   In March 2022, the patient received the 2nd dose of Shingrix. In March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 25-MAR-2022 Reporter's Comments: The patient self-reported this case. The patient received second dose in last week prior to reporting date. The reporter wanted to know he/she required to take another dose. The reporter had not provided any contact information. Additional Supportive Information: The patient received 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccination schedule.
Resident had significant decline in condition on 11/21/2021, Resident passed away the morning of 11/22/2021.
PENTACEL, PREVNAR, Hep B and Rotavirus ordered. Patient received Rotavirus, PREVNAR, received only the DTaP/IPV of PENTACEL, received only the sterile diluent to be used with Hib. Patient did not receive Hep B or Hib.
arm got red from elbow to shoulder. Hands, Feet and Mouth develop blisters and peel. hands are raw and red
Chest pains in the left side and right side over the past 1.5 years.
Petechia; felt fatigued; This is a spontaneous report from a contactable physician. A 52-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 05Jan2021 to 05Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood cholesterol increased/high cholesterol and allergy to sulfa drugs. Concomitant medication included ongoing rosuvastatin calcium (CRESTOR) for blood cholesterol increased. The reporter stated that about 5 days later she noticed petechiae on her hands (10Jan2021). The patient also felt fatigue on Jan2021. She went to see her primary care doctor. She had lab work, blood count, clotting factors, and CMP done and states her labs were ok and the other test had unknown results on an unspecified date. The patient's weight ranges from 140-145 lbs. The petechiae has slowly faded. Outcome of the event petechia was recovering while outcome of the event fatigue was unknown.
Information has been received from a nurse concerning a 50 year old patient who "this week", on approximately 15-NOV-2009, was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665300/1214Y). The nurse reported that the day after being vaccinated, the patient developed redness from the shoulder to the elbow and fever. It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unspecified. Additional information was been requested. This is one of several cases reported by the same source.
Signs and symptoms of cellulitis 48 hours after immunization. Prescribed Omnicef 2tsp two times a day for 10 days with 48 hour follow up.
I received the 2nd dose at 730am and by 1130pm the following symptoms occurred dizziness, sweating, tingling in the feet, hands, and face; headaches rapid heart beats and I have these symptoms for 5 days now.
He developed a fever on 1/8, become unable to swallow and bedbound. He was already end of life and Hospice care at the time of the vaccine.
lethargic; Very chill to the point that used 5 blankets; a bit nauseated; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LETHARGY (lethargic), CHILLS (Very chill to the point that used 5 blankets) and NAUSEA (a bit nauseated) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced LETHARGY (lethargic), CHILLS (Very chill to the point that used 5 blankets) and NAUSEA (a bit nauseated). On 01-Jan-2021, LETHARGY (lethargic), CHILLS (Very chill to the point that used 5 blankets) and NAUSEA (a bit nauseated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication were reported   Patient did not took any meds.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: update to case On 09-Apr-2021: Information added for the second dose, verbatim updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On 4/17 I begin felling a little icky throughout the day, 18 and 19 as well.  But on 4/20 I woke up not feeling well with chest pain and tightness which progressed throughout the day.  I drove to the ER where  my BP was taken and was 240/120.  I was administered meds to lower my BP and once it lowered out of the danger level after some time and I was released.  My normal BP usually run 107/76 but has since began running 130/95 after this incident.  Resulting in an increased of my Lisinopril to 40mg daily which has helped but the BP still remains a little elevated to date
Within 2 hours of shot extreme soreness in arm, around 6pm shooting pain across forehead, nausea, chills, low grade fever, body aches.
For the first few days after felt fine and then a few days after developed a charley horse-like sensation in his upper arm.  There is no swelling or redness or warmth.  This has persisted.  With occasional numbness and tingling in his forearm as well.  Has never had a reaction like this to vaccines.
Approx 5 min p/immun-5 sec episode of eyes rolling back, ? leg & arm stiffening; alert & orientated immediately p/; Normal neuro exam;
Patient developed "heart palpitations following Moderna injection. VS 141/83, 95%, 64. Denied any shortness of breath. Reports "pinching" in chest but states this is not new and has "been going on for years". Denies any numbness or tingling. Ambulated with patient to exit. No assistance needed. Answers appropriate. Advised to call her PCP with any worsening of symptoms.
atrial fibrillation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer.), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 31Mar2022, outcome "unknown".  Clinical course: Caller mentioned "latest booster" and "booster" only but was not able to specify which formulation of the vaccine he received. After checking PI and providing response, caller stated that he had his booster last "30Mar", had atrial fibrillation the next day, and had regular rhythm the next day. Caller also stated he received "another booster morning of 30Sep" and had arterial fibrillation at 4 in the afternoon. Caller said Pfizer booster and the last one put out for type omicron when asked to read name product. Unable to clarify formulation of Pfizer booster. He was needed information and asking has there been any indication that the booster can cause an atrial fibrillation event and it was said as Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe tremors; fell out of bed; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 13:30 as dose 4 (booster), single (Lot number: J 32777) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Non Hodgkin's lymphoma in remission" (unspecified if ongoing), notes: Non Hodgkin's lymphoma in remission; "sjogrens" (unspecified if ongoing); "ITP" (unspecified if ongoing), notes: Other medical history: ITP; "hypothyroidism" (unspecified if ongoing); "adrenal insufficiency" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "lymphocytic colitis" (unspecified if ongoing); "capillary leak syndrome remission" (unspecified if ongoing), notes: capillary leak syndrome remission. Concomitant medication(s) included: LOMOTIL [LOPERAMIDE HYDROCHLORIDE]; LISINOPRIL; HYDROCORTISONE; TIROSINT. Past drug history included: Plaquenil, reaction(s): "Known allergies: Plaquenil"; Flagyl, reaction(s): "Known allergies: Flagyl". Vaccination history included: Bnt162b2 (Other vaccine same date product=Pfizer,, Other vaccine same date lot number=FC3181,, Other vaccine same date dose number=3,, Other vaccine same date vaccine location=Left arm.), for COVID-19 immunization; Bnt162b2 (Other vaccine same date product=Pfizer,, Other vaccine same date lot number= EL9266,, Other vaccine same date dose number=2,, Other vaccine same date vaccine location=Left arm.), for COVID-19 immunization; Bnt162b2 (Other vaccine same date product=Pfizer,, Other vaccine same date lot number= EL 3249,, Other vaccine same date dose number=1,, Other vaccine same date vaccine location=Left arm.), for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 17Oct2022 at 22:30, outcome "recovered" (Oct2022), described as "Severe tremors"; FALL (non-serious) with onset 17Oct2022 at 22:30, outcome "recovered" (Oct2022), described as "fell out of bed". Therapeutic measures were not taken as a result of tremor, fall.  Additional information: Patient reported severe tremors for 1 hour, found on floor in am fell out of bed and don't remember falling or my son picking me up to put back in bed. Facility type vaccine include Pharmacy or Drug Store. No other vaccine in four weeks. No Covid Prior Vaccination. No Covid Tested Post Vaccination. Other medications in two weeks included Lomotil, lisinopril, hydrocortisone, tirosint and verspam.
devel intermittent, vomiting, fever & lethargy which started noc of 29MAY98;10 days p/vax devel bright red rash 8JUN98 vomiting stopped 9JUN but cont to be anorexic, febrile & lethargic;16JUN found to have blood sugar of 840;
arm was red initially; itchy; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red initially), PRURITUS (itchy) and VACCINATION SITE REACTION (Covid arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and FAMOTIDINE.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm was red initially), PRURITUS (itchy) and VACCINATION SITE REACTION (Covid arm). At the time of the report, ERYTHEMA (arm was red initially), PRURITUS (itchy) and VACCINATION SITE REACTION (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
sore arm; symptoms; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (symptoms) and ABDOMINAL DISCOMFORT (upset stomach) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (symptoms) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (symptoms) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  The reporter reported that most of his friends had a sore arm, symptoms for a day, upset stomach after receiving Moderna COVID-19 vaccine.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Headache-Medium
On 11/13/2009, two days following administration of the injectable H1N1 vaccine, the patient went into cardiac arrest. The patient is currently hospitalized and on life support. 12/11/2009 patient to ER 11/13/2009, Dx cardiac arrest, patient had  sudden onset seizure activity and became unresponsive, went into full cardiac arrest, heart rate V-fib, pupils fixed and dilated, cyanotic . Tx: intubated, CPR, epi  and atropine, defibrillated , placed on ventilator, blood gases, Dopamine drip, transferred to another facility for continued care12/14/2009 MR, H&P, for 11/15/209 transferred with episodes of V-tach, to PICU, concern for viral myocarditis, tx'd with IVIG and IV ABX, pacemaker placed 11/20/2009
pt recv vax & reported that pt awakened on 13NOV98 & appeared lethargic & listless when tried to walk, could take only 1 or 2 steps a/falling or collapsing;
Nausea swelling Joint pain Headache Fever Chills Vomiting Swelling
I just had the sore arm; I can even lift it hardly; I just had the sore arm; I can even lift it hardly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series , manufacture name unknown), for COVID-19 Immunization; Covid-19 vaccine (1st booster dose), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "unknown" and all described as "I just had the sore arm; I can even lift it hardly". Therapeutic measures were taken as a result of pain in extremity, muscular weakness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient felt normal after the injection and for the remainder of the day. She woke up in the middle of the night to use the restroom and fainted in the bathroom. She then returned to bed where she felt like she "blacked out for a short period". Her husband reported that she was shaking uncontrollably and her eyes were darting back and forth (this lasted about 10 sec). She was encouraged to be examined by a physician for any further issues. She stated that she is currently feeling ok.