chrisvoncsefalvay/vaers-outcomes huggingface dataset:
November 22, 2022, I had a mild sore throat and tight almost like an allergic reaction but not quite. The following days I started to get a chesty cough and began to have a slight wheezing. November 28th, I went to urgent care. I had a COVID-19 test and it was negative. I was diagnosed with walking pneumonia. I was prescribed Z-PAK. I was told to take hot showers and hydrate. By Friday most symptoms have subsided, but I continue to have the deep, chesty, cough but not as often.
For the  week following receiving the 2nd Moderna vaccine (2/19/21)  I experienced a rapid heart rate, shakes, significantly elevated blood pressure (~190/100 and my average BP is ~116/74). My periods starting in March 2021 have been completed irregular, severely heavy with clotting and lasting much longer than they usually do (average 9-10 days). My periods prior to  getting the Covid vaccine were ALWAYS 28 day cycles since I started getting a period at age 12. I am NOT in birth control pills and have had a tubal ligation.  I am also experiencing severe fatigue still since the 2nd vaccine.
right leg lymphedema; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Lot: EL9264), administration date: 17Feb2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot: EN6205), administration date: 17Mar2021, when the patient was 73-year-old, for COVID-19 immunization. The following information was reported: LYMPHOEDEMA (non-serious) with onset Mar2022, outcome "recovering", described as "right leg lymphedema". Therapeutic measures were taken as a result of lymphoedema. Additional information: patient does not see NDC/EXP on the vaccine card, the booster information was handwritten on the bottom which he got that at (specialty pharmacy name) (name withheld), there are also two unknown codes A53 and L2. Treatment for the lymphedema has been massage treatment and using a compression stocking, thigh high, on his right leg lymphedema. The lymphedema has gotten better. He has worn the compression stocking on his right leg continuously since the stockings were received in April, he has been using it daily.
This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on 11Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced an allergy after the 1st dose. The outcome of event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Redness from chest up, hives, dyspnea, cough. Took Benadryl and used inhaler.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. In August 2017 the patient was vaccinated with an expired dose of ZOSTAVAX lot # M020921, expiration date 18-JUL-2017, for prophylaxis. No adverse effects reported.
Had vaccination, but had shingles/ suspected vaccination failure; had shingles, are bad bed fellow; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient had shingles, took the vaccination but had shingles again. The patient stated that, shingles were a bad bed fellow. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
The child developed a fever and irritability post vax. Continued taking a bottle however. The child improved on 5/4/01 and mother thought symptoms resolved. Child placed down for a nap at 10:00PM on 5/4/01. 2 hours later the child was discovered apneic with vomitus. Autopsy states cause of death as probable suffocation. Child taken to hospital in full cardiac arrest.
No adverse reaction was noted.  Pt. received Moderna booster on 1/11/22 -pt. didn't make us aware, didn't have card available, and it wasn't  in his chart under Immunizations . We gave a second Moderna booster today (2/7/22).  Pt. was in the office for an office visit . Denies any complaints at present. Dr. was made aware. No new orders was made.
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. On 19-MAR-2013 the patient was vaccinated with an expired dose of 0.65 milliliters (ml) ZOSTAVAX (lot # 0364AE, expiration date 16-MAR-2013) subcutaneously. No adverse effects reported. Additional information has been requested.
PREVNAR 13 and FLUZONE HIGH DOSE given on 10/20/16. Pt reported for FLUZONE, red, rash, itchiness that went away. For PREVNAR 13 reported knot in arm that took a couple of weeks to resolve.
noticed two bumps over the left side side of the neck near the injection arm; tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF FOREIGN BODY (noticed two bumps over the left side side of the neck near the injection arm) and TENDERNESS (tender to touch) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure. Concomitant products included LISINOPRIL and AMLODIPINE for Hypertension, ASPIRIN [ACETYLSALICYLIC ACID] and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced SENSATION OF FOREIGN BODY (noticed two bumps over the left side side of the neck near the injection arm) and TENDERNESS (tender to touch). At the time of the report, SENSATION OF FOREIGN BODY (noticed two bumps over the left side side of the neck near the injection arm) and TENDERNESS (tender to touch) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs are Iron pills, Calcium supplement.   This case was linked to MOD-2021-078184 (Patient Link).
Lots of crying and discomfort after the injections. He also had a fever and was restless for days. For months after he was unable to sleep for more than 30min-1hr at a time. Then he never started talking. Would cry if strangers looked at or talked to him. Still not sleeping better than a newborn at 1 year. Now he is almost 3. He can't even speak. He can't say no, mommy, daddy, help, up, stop, or even hi. He can't eat meat without gagging, he screams as loud as he can 1000's of times a day and spits on us to the point where I want to hide from him. With ear plugs in. He still wakes up multiple times a night. The list goes on.
Palpitations with HR of 120 within 5 minutes after receiving the vaccine. Wheeled to the ER for further evaluation. Dizziness and high BP.  Was given Benadryl, Pepcid and Solu-Medrol and a liter of NS. Discharged after 2 hours with Benadryl and Prednisone prescribed for home meds.
Suspected heart inflammation; high heart rate; chest pain; palpation; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183) via an unspecified route of administration in Arm Right on 11Jun2021 12:45(at the age of 37 years old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication the patient received within 2 weeks of vaccination included metoprolol tartrate (METOPROLOL TARTRATE) taken for an unspecified indication. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no: EW0183) via unspecified route of administration on 24May2021 as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination the patient was diagnosed with COVID-19. The patient experienced suspected heart inflammation, high heart rate, chest pain, and palpation on 12Jun2021 10:00. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was colchicine. Since the vaccination the patient has not tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events not recovered.  Follow-up attempts are completed. No further information is expected.
A day after the vaccine, I experienced hot flashes, dizziness, low grade fever (99.4) and headache. Also on the second day, continued to experience headache.
Information has been received from a physician concerning an 18 year old female who on 14-AUG-2008 was vaccinated with a second dose of GARDASIL (lot #660393/0067X) in the left arm. "The patient developed a rash at the injection site shortly after receiving the vaccine. The rash was itchy and swollen and continued to spread into fungal infection. The rash was described as a papular erythemic rash". The patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Right after vaccine I had a headache. Dry throat, I had to continue clearing my throat. My throat was burning.
Expired Havrix administered/gave an expired Hep A vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 6th February 2023) for prophylaxis.   On 24th February 2023, the patient received Havrix. On 24th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comments: The nurse (licensed vocational nurse) just gave an expired Hepatitis A vaccine (Havrix). The health care professional (HCP) had no details about patient. The reporter gave consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Severe diarrhea x1 week, vomiting. Seen at ER. Tx - to keep hydrated, to give PEDIALYTE.
Pharmacist provided Janssen vaccine to this 16 year old patient, when the minimum age requirement is 18. No reported adverse event by patient.
Seen in hospital emergency room on 7/25/10 for a itchy rash on posterior arms and back with no constitutional symptoms. Skin exam described as consistent with chicken pox. Pruritic crops of vesiculopustular lesions on erythematous base in various stages of healing c/w classic Varicella eruption per doctor's note.
Noticed red rash in front of left ear 5 days post vaccination in left arm.  Rash is not itchy.; This is a spontaneous report from a contactable consumer.   A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 23Mar2021 (at the age of 68-years-old) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced red rash in front of left ear 5 days post vaccination in left arm. Rash is not itchy.  The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The pt experienced a localized reaction that 12 cm area of redness, swelling, induration, tenderness and dark skin color.
N/A Patient's mother reported no adverse events.on  8/8/22 via telephone call.
Patient is 11 years and 9 months old and was administered a dose of Pfizer BioNTech vaccines corresponding to 12 years of age.
Describe the method of shaking and for how long: Rubbed back in forth between my hands; noticed that there are some floaties in prefilled syringes; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on [27Feb2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter (Other HCP) from product quality group, Program ID: (004756).  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GD8455, Expiration Date: Apr2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG TECHNIQUE IN DEVICE USAGE PROCESS (non-serious), described as "Describe the method of shaking and for how long: Rubbed back in forth between my hands"; LIQUID PRODUCT PHYSICAL ISSUE (non-serious), described as "noticed that there are some floaties in prefilled syringes".  Additional information: They have a box of Prevnar 20 and noticed that there are some floaties in prefilled syringes. There was one Prevnar 20 given to a patient from that box, and it was confirmed that the one given did not have floaties. There is one syringe that is cloudy and one syringe that the particles can be seen in, these have not been administered to a patient. The floaties as they have kind of formed on the side of the prefilled syringe and looks like a little white cloud as it has been sitting there. White circles floated before shaking. After shaking, particles approximately 2mm didn't dissolve, they just floated. They were mild but visible. Method of shaking was described as rubbed back in forth between hands. Color did not change after shaking. The product was stored in refrigerator near the middle of the shelf in the box.  Follow up (22Feb2023): This is a spontaneous follow-up report from a product quality group. Updated information include: The event liquid product physical issue was added. Device reportability assessment updated.
Received Trumenba vaccine in R arm and complained of shooting pain radiating down the arm to her fingers, about 1 hr after she got the shot. Then she started complaining of nausea and dizziness which lasted until the next morning. Pt was unable to move her arm due to the pain, which resulted in the mom calling the office. All symptoms had subsided about 36 hours later.
nausea; diarrhea; night sweats; This is a spontaneous report from a Pfizer-sponsored program received from a contactable other healthcare professional and a consumer. A 51-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Apr2021 (at 51-years-old) at unknown, single for COVID-19 immunisation and tofacitinib citrate (XELJANZ XR tablet 11 mg) on 16Feb2021 at 11 mg. Medical history and concomitant medications were not reported. The patient experienced nausea, diarrhea, night sweats and 8 missed doses of tofacitinib citrate when he had his COVID vaccine, in Apr2021. The action taken with tofacitinib citrate was temporarily withdrawn on 19Apr2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
High fever over 102, numerous large, deep blisters on soles of feet with one filling with blood, lethargic, crankiness, refusal to eat. Fever lasted for three days (07/27/2011-07/30/2001). Blisters still present but healing as of 08/11/2011.
Fussiness and crying nonstop for over 3 hours-family called MD at 5:20 on 03/14/2014 to report nonstop crying and screaming uncontrollably since shots were administered.
Patient called to report a hive at the injection site that was about 1/2 dollar in size. Informed patient to take BENADRYL and apply hydrocortisone cream to hive. If symptoms worsen to call PCP and use back.
Periodically smells cigarette smoke.  Believes this started a few weeks after second vaccination.   Patient is a non-smoker and is not around any smokers.  He says he cannot correlate the cigarette smoke smell to any time of day or activities.    Patient has not had confirmed COVID or suspected symptoms that may have been COVID.  Patient does not have any neurological conditions.  Patient has not had any other past viral infections that may affect neurological system, other than chicken pox as a child.
A paramedic reported that her 75 year old father received an injection of Pnu-Imune 23 on 9/10/01. On 9/19/01, he developed shaking chills and a fever. On 9/24/01, he was hospitalized after his fever increased from 101F to 105.5F. He was discharged from the hospital on levofloxacin and as of 10/8/01, the fever persists.
It was reported that a 49 year old male pt received a TD Adult vaccination as well as an MMR II on 2/19/01. Reportedly, 2 days later, the pt reported tenderness in the left side of his chest, below the clavicle and slight redness and swelling at the injection site. The pt was seen in ER on 2/25/01 and admitted to the hospital with cellulitis. From telephone conversation on 3/2/01, it was reported that on 2/21/01, 2 days, post vax, the pt returned with redness, tenderness over entire left deltoid and a tender subclavicular node on the same side. The pt's condition worsened and he was hospitalized for 6 days after vaccine. The nurse believes the pt did well and has been discharged. The pt received IV Vancomycin; no surgery. Pt had no fever. F/U rec'd on 3/22/01, it was reported. The pt did not have redness, tenderness over entire L deltoid on 2/21/01. He complained that his L deltoid area and L arm was sore when he moved his arm. He had tenderness but no redness or swelling in the L side of his chest below the subclavicular area. The pt was examined on 2/21/01 and was told to continue to observe but at this time nothing was found to be out of the ordinary except his complaint of tenderness to chest. He was also instructed to return if he started having redness, increase tenderness or temperature. On 2/26/01, per phone call from administration that the pt had been admitted to the hospital 2/25/01 with cellulitis. As of 3/19/01 he is doing fine and working Also please note the MMR vaccine (was) rec'd in the R hip.
Narrative: An error occurred while administering the Modern Bivalent booster on 10/05/2022/. Patient was given .25mL instead of the full dose of 0.5mL vaccine. Patient was return to clinic for an addition.25mL dose on 10/06/2022
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8732), in right arm, on 30Apr2021 as dose 2, single (Lot number: EW0171), in right arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "DVT" (unspecified if ongoing); "PE" (unspecified if ongoing); "moderate high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ROBAXIN, start date: 27Jun2022; TYLENOL, start date: 01Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Anti-viral details, product COVID 19 treatment, Paxlovid, treatment start date 25Jun2022, treatment stop date (29Jun2022), lot number (GC0529), indication treatment of COVID-19, off (metallic) taste mild sore throat and runny nose symptoms resumed on Mon, 04Jul, If patient not recovered, if treatment ae: no, known allergies: none.
BLOOD CLOTS ALL THRU BODY TWICE; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots all thru body twice. It was reported as "I talked with a woman at a place that told me from her shot she got many blood clots all thru her body twice" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots all thru body twice was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20221146373- Blood clots all thru body twice. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Severe ringing in ears, extreme fatigue, joint swelling and metallic taste in mouth since shot 15 days ago. These issues are increasing not decreasing with time.
After one minute of immunization administer patient was speaking and understanding conversation  he fell from exam table. Older brother picked him up screaming his name. I was thinking patient was having a seizure I asked for him to lay back down. Dr. came into room I stepped out to call EMS. EMS arrived and took him to ER.
vaccine administered at facility. Approximately two hours later, patient reported feeling flushed, itching ears and throat. Patient stopped at clinic, where she was treated with an antihistamine. No acute distressed noted at the time. vital signs stable. Patient reported improving symptoms upon arrival.
Patient was found walking outside relative's house at 4:30 AM. She was found by police. Per mom, patient "seemed out of it" and "didn't want to answer." When asked later what she was doing, she said she was going to grandma/s house. No other symptoms.