chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About a week and a half or two weeks ago he broke out in a rash on his stomach/ Rash are worse; Diagnosed with shingles; He had burning sensations on his skin; Back pain; Pain in his hip; rash is also painful; This is a spontaneous report from a contactable consumer or other non HCP.    A 33-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FE3592), dose 1 via an unspecified route of administration, administered in Arm Left on 07Sep2021 (Batch/Lot Number: FE3592) as dose 1, single for covid-19 immunisation. Medical history none. There were no concomitant medications. No Prior vaccination with in four weeks. It was reported that, Caller stated about the Pfizer Covid19 vaccine and got the 1st shot about three weeks ago and about a week and a half or two weeks ago he broke out in a rash on his stomach; states he left the rash alone and is a pretty healthy 33-year-old and has no medical history and does not go to the doctor and does not take Advil or Motrin and left the rash alone. States he was working and took the vaccine because of the mandate forced him to get the vaccine or they would fire him. States he took the 1st shot of the vaccine and was breaking out with a rash and finished the workday and had a day off and was scheduled for the 2nd dose of the vaccine today but did not get the 2nd dose. States he wanted to call to report this information because he went to the urgent care yesterday and was diagnosed with shingles. The outcome of the event back pain was recovered, and the other events was not recovered. The patient underwent lab tests and procedures which included investigation: shingles on 27Sep2021 he went to the urgent care yesterday and was diagnosed with shingles. Therapeutic measures were taken as a result of about a week and a half or two weeks ago he broke out in a rash on his stomach/ rash are worse (rash), diagnosed with shingles (herpes zoster), he had burning sensations on his skin (skin burning sensation), back pain (back pain), pain in his hip (arthralgia) , rash is also painful (pain). Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Pt. had immediate fainting spell.  Recovered for 2 minutes then had seizure like movements for 10 seconds.  Eyes rolled back into head, cold & clammy skin - ashen color, decreased BP & decreased P.  Once recovered had no memory of fainting or falling from chair.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Within 15 minutes of giving the vaccine, the patient developed itching around the site of injection and gave water and 25 mg of benadryl. Patient also had mild dizziness and responded well to water and crackers. Observed the patient for additonal 30 minutes. Spoke with the patietn over the phone one hour later, she reported that her symptoms are improved. Of note the patient got fluad quad in the previous year 2021 with no issues reported.
My adverse reaction began, I went to the ER March 19th 2021 around noon, I had woken up that morning with a bumpy rash starting across my right buttocks and wrapping around my right ride and down the right side of my leg and also on the top of my right leg. I had thought a spider bit me and I am allergic to spiders but at the ER they did not know if it was an insect bite or something else. They gave me a cortisone shot. I have Medicare and I could not see my Doctor so I waited until Monday and saw him at 4pm. He gave me an antiviral for ten days and it did not do anything for the pain, the rash turned to blisters. I talked to my sister and she had found a topical cream that may help so I started using this derma-change and that really helped. I did not start taking Lyrica until two weeks later. So I had over one week of agony. I have been tapering down my dosage and am down to one 75MG capsule in the morning. My dose period is that I have relief for about 5-6 hours, then I will take another dosage. I expand in my dosage time at the end of the day so I can take one before bed. I might wish this shingles on my very worst enemy but that is it, just one person and it it really is horrible.  It starts out as an itch and then it goes to huge blisters and you have to be very careful because it can spread all over your body. So this is my complication after receiving the Moderna vaccine.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 04Aug2022 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: MASS (non-serious) with onset 06Aug2022, outcome "unknown", described as "lump on her upper arm"; RASH (non-serious), outcome "unknown", described as "big rash; rash is got worse; it's under my breast, it's on my stomach, it's on my shoulders, under my armpit"; NERVOUSNESS (non-serious), outcome "unknown", described as "nervous"; ILLNESS (non-serious), outcome "unknown", described as "sick"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". Additional information: She said that she got her booster last Thursday (as reported) and what happen was there was a lump on her upper arm and doubt there was the big rash. Reporter stated that the lump in the red circle was not with the injection site but she noticed that day, she thought it looked like she got like kind of the rash or something. The rash got worse, it's under her breast, on her stomach, shoulders, under her armpit. She wanted to know what on put on it because she doesn't want it there. Stated that she the booster. The reporter stated that she could call her doctor the mass general on Monday and see what they would say because that's where she got the vaccine and it's only up to street though (as reported), stated "once if she wanted to ordered me some I can get it". Further stated that she doesn't known if she should just try some BENADRYL or something. Stated that she just got nervous when she saw it because she had just got over and was sick the week before with her COPD and then she got this (as reported). Stated that she did not know what was wrong. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
evening (8PM) of 10JUN pt was noticed having convuls & taken to EER; mom had given APAP & cool bath because felt warm but did not take temp;
Approximately 12 minutes after the injection my lips began to tingle and feel like they were swelling. My mouth, jaw, and teeth began to tingle and became numb. I was in the 30-minute wait period. After 30 minutes I reported the side effect to personnel at the checkout station who said that was not a side effect he had on the list.  I took a Claritin 10 mg tab approximately 1 hour later with no resolve of numbness. I took a 10 ml dose of Benadryl at approximately 9 pm and again at 1 am.  I continue to have a slight tingling sensation on my face as of now.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2011, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician, for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Body aches and sore; swollen lymph node in armpit of injection site arm.; sore, swollen lymph node in armpit of injection site arm.; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0153) via an unspecified route of administration on an unknown date(at the age of 36-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. 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 were not reported. On 18Apr2021, the patient experienced body aches and sore, swollen lymph node in armpit of injection site arm. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches and sore, swollen lymph node in armpit of injection site arm was recovering at time of this report.   No follow-up attempts are possible. No further information is expected.
She denies any further AE; temperature excursion/patient has received the supported vaccine prior to temperature excursion evaluation; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-DEC-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter, lot # T021828, expiration date 25-JUN-2022 (route of administration was not provided) for prophylaxis. The administered vaccine experienced temperature excursion of -6.7 degrees Celsius, for a time frame of 22 hours. There was no previous temperature excursion reported. There was no adverse event reported. The digital data logger was involved.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013452: US-009507513-2012USA013037:
Cellulitis, KEFLEX 500 mg PO /3 TIMES A DAY for 10 days.
hungry; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EN6202) at the age of 44 years as dose 1, single and administered in arm left, administration date 14Apr2021 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Eosinophilic asthma" (ongoing), notes: Verbatim: Eosinophilic asthma, diagnosed for most of her life; "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia, diagnosed 10 years ago; "Hypothyroidism" (ongoing), notes: Verbatim: Hypothyroidism; "Overactive bladder" (ongoing), notes: Verbatim: Overactive bladder, diagnosed about 5 years ago. Concomitant medication(s) included: DUPIXENT taken for asthma (ongoing); TIZANIDINE HYDROCHLORIDE taken for asthma (ongoing); CELEBREX taken for fibromyalgia (ongoing); LEVOTHYROXINE taken for hypothyroidism (ongoing); MYRBETRIQ taken for hypertonic bladder (ongoing); RISPERDAL taken for bipolar disorder (ongoing); SEROQUEL taken for bipolar disorder (ongoing); LAMICTAL taken for bipolar disorder (ongoing); ATIVAN taken for bipolar disorder (ongoing); SINGULAIR taken for asthma (ongoing); ZONEGRAN taken for asthma (ongoing); TEGRETOL taken for bipolar disorder (ongoing); MELATONIN taken for sleep disorder; B12-VITAMIIN; DULERA; SPIRIVA RESPIMAT. The following information was reported: HUNGER (non-serious), outcome "recovered", described as "hungry"; FATIGUE (non-serious), outcome "recovered", described as "tired".  Additional information: Patient clarified that the first two shots she was absolutely fine, states the only symptoms she had was she was hungry, tired and wanted to rest a couple of days, nothing serious. Patient stated she was trying to wean down to a lower dose. Stated she takes two asthma inhalers regularly. Patient did not had any other vaccine within four weeks prior to first administration of covid-19 vaccination. Patients family medical history relevant to adverse event was provided. There was no any relevant Tests.  No follow-up attempts are possible. No further information is expected.
Report 20010070641 described dizziness in a male vaccinee of unspecified age who received hepatitis B vaccine recombinant (Engerix-B). The vaccinee is a physician. The vaccinee's allergies are unspecified. He had "some reflux" and took Prilosec. In December 2000, the vaccinee received his 1st dose of Engerix-B without adverse event. In January 2001, the vaccinee received his 2nd dose of Engerix-B. Approx. two months later, he experienced dizziness, nausea, numbness and tingling in his legs and hands. He was seen by a neurologist. Nerve conduction studies were within normal limits. As of 03/016/2001, the outcome of the events was ongoing.
Approx eight days later, a sudden rash appeared at vaccine site and was extremely itchy and uncomfortable, lasting for several days.   Also I?d like to note that the day after receiving the vaccine, I had extreme headaches, cramps and vomiting, needing to call a doctor for help.
Fussiness, clamminess, HR 132, RR 20-30; adm to hosp for dehydration due to poor PO intake;
Vaccine failure, flu shot on 11/08/2005.  patient tested flu A positive on 01/23/2006.
Tingling down right arm, vitals within limits, 134/78, P-68,R-18, O2 97%, client refused EMS transport.  client is waiting in her cr till she feels 100% and then she will go on her way home.  Pt. reassessed multiple times to use EMT for transport, but pt. refused stating "I feel fine, I want to go home.
Patient is a 37 y/o officer who contacted the Vaccine Healthcare Centers network after experiencing adverse events following receipt of the H1N1 vaccine on the morning of 14 Jan 2010. She was well at the time of vaccine receipt; she took no chronic medications except intermittent NSAIDS for musculoskeletal pain and oral contraceptives. On 16 Jan '10 (2 days post vaccine receipt) she became lightheaded and dizzy in the shower. She "greyed out" and slumped to the floor. She was evaluated in the ER and EKG and labs were all normal. While in the ER, it was noted that her heart rate increased by over 30 beats per minutes upon standing, with no decrease in blood pressure. This was the day, according to the patient, "that my life changed forever". NOTE: She states in late childhood/adolescence she had sporadic instances where she became lightheaded and dizzy but never passed out. These episodes lasted only 1-2 seconds soon after standing up and quickly resolved. They did not affect her activities and she was able to exercise, run, and dance without symptoms. A tilt test in 2010 diagnosed POTS after she had a 30 point increase in HR when going from supine to upright. She since then has developed orthostatic hypotension. Patient continues with multiple debilitating symptoms affecting many body systems for the past 2 years. In spite of numerous diagnostics and specialty consultations she currently is receiving no effective treatment due to the lack of resources and provider expertise for recognizing, diagnosing and treating this condition. With intervention, she is currently pending a referral at one facility and testing at another facility.
Immediately after injection pt became red in face, started coughing, trying to vomit, lips turned blue, wheezing. Oxygen sat 89-91%. Pt. given Epi, breathing tx with XOPENEX and another inj.of Epi. Pt states improved, but was transferred via EMS to local hospital.
22APR98 pt recv vax & by evening lt deltoid red & hot & swollen applied ice by mom;next morning hard @ inj site & very red;cont w/ice;next day hives on arm;
PATIENT STATES THAT PAIN BEGAN ON 9/25 AFTER HITTING HER THUMB.  SHE HAD PAIN IN HER RIGHT THUMB, INDEX, AND MIDDLE FINGERS. SHE ATTRIBUTED IT TO THE BUMP.  THE NEXT DAY ON 9/26 HER ENTIRE RIGHT HAND WAS PAINFUL, HER KNUCKLES WERE SWOLLEN.  ON 10/4, BOTH HER KNEES WERE SWOLLEN AND SHE WAS UNABLE TO SQUEEZE HER HANDS CLOSED. ON OCTOBER 8, SHE REPORTED IMPROVEMENT AND THERE WAS MINIMAL SWELLING.  OCTOBER 13, PATIENT STILL REPORTED TROUBLE WITH HER HANDS. sHE REPORTED PAIN MOSTLY WHEN SHE TRIES TO REST AND SHE IS NOT SLEEPING WELL. sHE FEELS THE SWELLING INCREASES WHEN SHE LIES DOWN. SHE HAS SEEN HER FMD. ON OCTOBER 16, SHE IS STILL HAVING PAIN IN BOTH HANDS AND NOT SLEEPING WELL.  HER GRIP IS GREATER IN THE RIGHT THAN THE LEFT. HER HANDS WERE NOT OBIOUSLY SWOLLEN.  ON OCTOBER 23, THE PAIN CONTINUES TO WAKE HER UP AND NOT SLEEPING WELL.
fever for 24 hours; chills for 24 hours; experiencing weight gain about 5 Lbs. a month and has gained 30Lbs. in total.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for 24 hours), CHILLS (chills for 24 hours) and WEIGHT INCREASED (experiencing weight gain about 5 Lbs. a month and has gained 30Lbs. in total.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024A20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-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 PYREXIA (fever for 24 hours), CHILLS (chills for 24 hours) and WEIGHT INCREASED (experiencing weight gain about 5 Lbs. a month and has gained 30Lbs. in total.). At the time of the report, PYREXIA (fever for 24 hours), CHILLS (chills for 24 hours) and WEIGHT INCREASED (experiencing weight gain about 5 Lbs. a month and has gained 30Lbs. in total.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant drug details were reported. No treatment details were reported.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on 14-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml) (lot # 656049/0187U). Concomitant therapy included Adderall tablets. On approximately 15-MAR-2007, the patient experienced headache and abdominal pain. Unspecified medical attention was sought, At the time of this report, the outcome of the events was unknown. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Immediately after the vaccine was administered, the patient felt dizzy and three hours later, the patient experienced abdominal pain. The patient also experienced headache. The dizziness subsided after 30 minutes, and subsequently, the patient recovered from the abdominal pain. Additional information has been requested.
72 hrs after shot severe pain in lower abdomen and groin area right at bikini line left side worse.
Rash and its spreading, warm to the touch and its going on; Headache; Muscle pain; Tired for couple of days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash and its spreading, warm to the touch and its going on), HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Tired for couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Tired for couple of days). On 17-Mar-2021, the patient experienced RASH (Rash and its spreading, warm to the touch and its going on). On 16-Mar-2021, HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Tired for couple of days) had resolved. At the time of the report, RASH (Rash and its spreading, warm to the touch and its going on) had not resolved.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-064623 (Patient Link).
Patient was seen in ED for RLE burn from exhaust on 5/25/13.  Tetanus vaccine was given.  Redness noted to the injection site after vaccination. Patient was discharged home.  The redness worsened at home and the patient returned to ED on 5/27/13.  Patient was seen and discharged home on Keflex and Motrin.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 56-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 08-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Fever; aches; chills; arm pain shoulder to wrist; general lethargy feeling of unwell; general lethargy feeling of unwell; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 11:15 (Batch/Lot Number: EL9263) as DOSE 1 SINGLE for covid-19 immunizations (Age at vaccination 53 years). Facility type vaccine: Health Clinic. The patient past Medical history included PVCs (Premature ventricular contractions) from an unknown date and unknown if ongoing and  covid-19 from an unknown date and unknown if ongoing if covid prior vaccination: Yes. Concomitant medication(s) included zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL XL SANDOZ) taken for an unspecified indication, start and stop date were not reported; fish oil (OMEGA 3 [FISH OIL]) taken for an unspecified indication, start and stop date were not reported.  The patient previously took morphine and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 10Mar202116:00, the patient experienced fever, aches, chills, arm pain shoulder to wrist and general lethargy feeling of unwell. The event outcome was not recovered.  No follow-up attempts are possible. No further information is expected.