chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Follow-up information was received from the health care professional on 28 December 2009. Based upon this new information, it was determined that the case meets serious criteria, and has been upgraded. The following narrative contains information for the initial report received on 03 December 2009 and the follow-up report received on 28 December 2009. A 39-year-old female patient received a left deltoid intramuscular injection of FLUZONE SV 2009-2010 (lot number U3351AA) on 03 December 2009. Approximately 15 minutes post-vaccination, she developed pain in the arm, especially the shoulder joint, and hives with generalized itching. She was given BENADRYL 25mg at the time of the reaction, and continued taking it at 25mg twice daily x 2 days. On 04 December 2009 she required a doctor visit, and at that time was started on a MEDROL dose pack. Allergies included TEQUIN and erythromycin, and concomitant medications included NEURONTIN, CYMBALTA, vitamin C, and PRILOSEC. She was not ill at the time vaccination. The patient was considered to be fully recovered on 10 December 2009. This case has the same reporter as case number 2009-05303. Documents held by sender: None.
Mom states large, red, swelling around vaccine injection site. Instructed to give Benadryl, Motrin and use warm compress.
This spontaneous report was received from a licensed practical nurse and refers to 14 patients of unknown age and gender. The patients' concurrent conditions or medical history were not reported. On unspecified dates since 11-JAN-2016, improperly stored doses of M-M-R II) (lot # M017347 with expiry date of 06-APR-2018; or lot # reported as M032157 with expiry date on 07-JAN-2018; dose and route of administration were not reported) were administered to the patients. The vaccine was stored over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 6 minutes. There was previous temperature excursion of over 46 degrees Fahrenheit but under 77 degree Fahrenheit for 1 hour and 30 minutes. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007841: US-009507513-1701USA007856: US-009507513-1701USA007855:
he got the fever; This is a spontaneous report from a non-contactable consumer or other non hcp (parent). A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on 16May2021 23:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in May2021, He got the fever. reporter asked, what can I do, do I need take him to emergency, Can I give Tylenol or something. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
FEELING FOGGY; JOINT ACHES; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 123 pounds, and height was 65 inches. The patient's concurrent conditions included immunoglobulin type a deficiency, endometriosis, ibs, dust allergy, cat allergy, grass allergy, fragrance allergy, alcoholic, non smoker, gluten allergy, dairy allergy, and soy sensitivity, and other pre-existing medical conditions included allergic to dust, grass, cats, certain medical adhesives, fragrance. patient had no drug abuse illicit allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 18:30 for prophylactic vaccination. Concomitant medications included folic acid, loratadine, magnesium, montelukast sodium, senna alexandrina, vitamin c, and vitamin d.  On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 13-MAR-2021, the subject experienced feeling foggy. On 13-MAR-2021, the subject experienced joint aches. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced fatigue. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling foggy on 16-MAR-2021, joint aches, and fatigue on 15-MAR-2021, and fever on 14-MAR-2021. This report was non-serious.  Additional information was received from patient on 19-Mar-2021. The following information was updated and incorporated into case narrative. Patient's demographics added (height, weight), patient's concurrent conditions (immunoglobulin type a deficiency, endometriosis, ibs, dust allergy, cat allergy, grass allergy, fragrance allergy, alcoholic, non smoker, gluten allergy, dairy allergy, and soy sensitivity),  Concomitant medications were added from additional information which included folic acid, loratadine, magnesium, montelukast sodium, senna alexandrina, vitamin c, and vitamin d.
Severe pain to entire upper left arm. Pain was almost unbearable. Severe facial sinus pain, as if my face would explode. Lightheaded. Took 1 extra strength Tylenol and slept all day. Left arm is still hurting and there is swelling at injection site.
I was covered in hives on my entire body from mid-thigh up until my ears/chin starting the next morning. I attempted to take a bath to resolve the issue but it started burning/itching so I went to  Care. They wanted to give me steroids but I was concerned about building immunity with the vaccine so they treated me with a topical steroid cream. After a couple of days, the hives went away, and I also took Benadryl to alleviate my symptoms.
Injection site soreness (including lymph nodes under that arm), low grade fever, chills, headache, nausea, body/joint aches as well increased tinnitus symptoms/volume (both ears).  All symptoms EXCEPT the increased tinnitus symptoms were gone by noon the next day, Saturday, March 27th.  As of today, the tinnitus continues to be almost unbearable it has increased in volume so much.
Red rash on her chest and arms; Had a tightness and lump in her throat; Had a tightness and lump in her throat; Cheeks were flushed; This is a spontaneous report from a contactable nurse and contactable physician. This nurse reported similar events for 3 patients. This is the 2nd of 3 reports.   A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced red rash on chest and arms, tightness and lump in throat and cheeks were flushed. The patient outcome of the  events was unknown.    The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516277 different patient, same drug and same event.
A consumer report has been received. The report concerns a 39 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 22-Oct-2012. The patient experienced ARMPIT SWOLLEN, BREAST SWOLLEN and RUNNY NOSE which started on 22-Oct-2012. The outcome of the event of ARMPIT SWOLLEN, BREAST SWOLLEN and RUNNY NOSE is unknown. The report was considered to be non-serious.
I developed shingles (red, itchy, linear, vesicles  following Dermatome L4/L5.  Within 24 hours I was started on Valcyclovir. The versicles no longer. itch, are not painful and are improving.  I have had chickenpox but have not been vaccinated for shingles.
Chronic spontaneous urticaria (CSU) developed 11 or 12 days after getting the booster and it still has not gone away. I went to a clinic, where they thought it was scabies but it did not improve with treatment. I then went to my dermatologist, Dr who also couldn?t pin point what caused it. She prescribed me 20 mg Zyrtec daily to help with the constant itching. I finally realized what the cause was when I began talking with others online who had the same condition and their doctors were attributing it to the moderns booster.  Symptoms are intense itchyness and hives constantly throughout the day and night. I?ve never had hives before, and have never had an allergic reaction to anything.
major asthma attack; temp of 102; This is a spontaneous report from a consumer (patient parent) reported for son. A 12-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Ew0177, on 14May2021 16:00 at single dose in left arm (at the age of 12-year-old) for COVID-19 immunization. Medical history included asthma. The patient had no Known allergies. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medication was not reported. The patient had seen his pulmonologist the day before and had a really good check up for his asthma. He had his shot on 14May2021. On 16May2021 he had temp of 102. On early hours of 17May2021 he had major asthma attack. Reporter was very well educated in how to help with an asthma attack. So didnt need to seek medical attention. But it took several nebulizer treatments, couple days a prednisone to get him back to his base line. His temperature lasted a total for 4 days and missed 5 days of school. Reporter did call his pulmonologist for directions on what to do. The outcome of major asthma attack was resolved in 2021. The outcome of temp of 102 was resolved on 20May2021.
Information has been received from a healthcare worker concerning an unspecified number of patients, who on unknown dates were vaccinated with improperly stored GARDASIL (doses, routes and lot # not reported). No adverse events were reported. Additional information has been requested.
This spontaneous report as received from a physician assistant, via a company representative, referring to a 14 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated in the left deltoid with the second dose of GARDASIL 9, intramuscularly, for prophylaxis (strength, lot number and expiration date were not reported). On an unspecified date, a few days after vaccination, the patient developed swelling at injection site and supraclavicular lymphadenopathy. No treatment was provided and no laboratory tests were carried out. The reporter informed that the patient was being monitored for any further symptoms. The outcome of injection site swelling and lymphadenopathy was unknown. Causality assessment was not provided.
Patient presented for second dose without an appointment during a 30 minute period that our computer tracking system was down.  Due to system being down, patient received 2nd dose today only 12 days after receiving the first dose.  The patient thought they were instructed to return 10 days after the 1st dose, but this was misunderstood.  They were only able to get through as we had no way to look up their previous appointment during that brief time period.  I spoke with patient, and she was feeling fine as of several hours after the 2nd dose.
Two or three days after receiving my first shot of the Moderna vaccine, I began having severe tinnitus (ringing in ears). I have had minor tinnitus for the past five years as a result of attending a very loud concert, however, that normally didn't disrupt me. The tinnitus since my vaccine has been so severe that it sometimes keeps me from falling  asleep or wakens me. After a few weeks, the tinnitus was less severe, but it has not returned to its normal levels. I've read of many other people who have the same symptom, so I'm hesitant about getting another vaccine dose. I'll get guidance from my ENT.
This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a patient who received BOOSTRIX (batch number 3YM7S, expiry date unknown) for prophylaxis. On an unknown date, the patient received BOOSTRIX. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The nurse reporting that, the patient had a reaction to BOOSTRIX vaccination and they were doing a VAERS report.
Very severe diahrrea  on the day of the vaccination starting about 6:00 PM lasting for about 14 hours
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to about 6 patients of unknown age (gender unknown). On an unknown date about 6 patient was vaccinated with VARIVAX, subcutaneous (strength, dose, frequency unknown) which was improperly exposed to 10F for 3 days and to 5-9.6F for 360 hours. No known adverse effects. Additional information has been requested.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-FEB-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 368, 88, 320, and 80 hours, with the lowest recorded temperature of 33, 30, 29, and 34 degrees Fahrenheit (0.55, -1.11, -1.66, and 1.11 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. Medical history and drug allergy were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot# and expire date were not reported). Concomitant drug was not reported. No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm at injection site; This is a spontaneous report from a contactable healthcare professional reported for himself. A 41-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685, expiry date: unknown), intramuscular on the left arm on 22Dec2020 01:30 at a single dose for COVID-19 immunization. There was no medical history. The patient's concomitant medications were not reported.  The patient experienced sore arm at injection site on 22Dec2020 02:00. Outcome of the event was not recovered. No treatment was given. Patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The event was considered non-serious.
Patient c/o of a reaction post MMR vaccination that was administered on 10/9/2020.  Reports an itchy/tingling rash at the injection site that started on 10/13.  States that the rash began to spread over her generalized body over the following days.  Denies drainage.  Denies pain.  Denies shortness of breath, chest pain, wheezing, or a fever.  Has not taken any OTC medication for the symptom relief.  States that no other household members have similar symptoms.  Denies the use of any new body products.    Reports a normal appetite and activity.  No other complaints at this time.
INCREASED CHEST PAIN; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included congestive heart disease, penicillin allergy, and sulfas allergy. The patient experienced drug allergy when treated with oxycodone hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced increased chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased chest pain. This report was non-serious.; Sender's Comments: V0:As per standard protocol, MAC comment is not required for non-serious cases
whole arm swelling in injection arm about 45 minutes after injection also felt sick to her stomach. treated with ice packs for a couple hours and swelling resolved.
Muscle aches all over, extreme in shoulders, hips and back. Headache and low grade fever. Nausea. Exhaustion and skin tender to touch. Arm with injection site still quite sore (painful to even raise the arm) muscle aches and tired 48 hrs after vaccine. Much improved after 36 hours.
Blister rash present on knees, elbows & buttocks. Bx of elbow lesion -> herpetiformis dermatitis. Treatment with DAPSONE 25mg twice daily - revised to 50mg twice daily. Nov. 6th '08 visit to G.I. MD. Suspect celiac dx - prescribe gluten free diet. 11/24/08 pt. admit at ER with reaction to DAPSONE - discharged 11/26/08. d/c DAPSONE. 12/19/08 endoscopy - result Bx positive for celiac sprue. Continue with gluten free diet per MD. Follow up bloodwork March 17th 2009 weakly positive transaminases <20 from original Bx strongly positive >100 11/6/08. Continue now on gluten free diet. ZOSTAVAX was given 2/15/08 with onset of symptoms of rash ~9/29/08. No evidence of celiac dx or herpetiformis dermatitis before administration of vaccine - query whether vaccine produced auto-immune reaction?.  8/7/09 Hospital records received DOS inpatient 11/25/08 to 11/26/08 and GI consult 3/27/09. Assessment: Celiac disease, herpetiform dermatitis. Methemoglobinimia secondary to dapsone. Patient taking dapsone for dermatitis herpetiformis began noticing increased fatigue, blurry vision, paresthesias, shooting pains in neck, shoulders, back, arms and legs. She presents as extremely anxious, with 1 day of neck pain, posterior and mid-scapular pain, short of breath, chest pain, nausea, bilateral lower extremity cramping pain. Hypertensive, tachycardic, weak, hypokalemia. Loose stool. Lightheadedness. Anemia. Arthralgias.
next night big, red, hot, flat, nonitchy rash on right forearm; migraine aura of paresthesias.; red, hot, and itchy on my right ankle area; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 18:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included migraine with prolonged aura, Hashimoto's disease, OSA (obstructive sleep apnea), airborne allergies, and obesity. The patient had known allergies to latex, pollens, mold, dust mites, and cats. Concomitant medications included thyroid (ARMOUR THYROID), verapamil (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), and EFFEXOR XR; all taken for an unknown indication and received within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 18:00, the patient had a migraine aura of paresthesia, immediately on vaccination, and developed first rash in the night, on the right ankle area, which was red, hot and itchy. On 25Mar2021, the next night, the patient experienced second rash on the right forearm, which was big, red, hot, flat, and non-itchy. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events migraine aura of paresthesia, first rash in the night, on the right ankle area, which was red, hot, and itchy and a second rash on the right forearm which was big, red, hot, flat, and non-itchy were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
18 month old given Adacel Adolescent/Adult dose.  Nurse verified med with 2nd nurse, but both missed wrong med and did not scan med prior to giving.  Error discovered upon scanning med after dose given. Mother contacted and returned to clinic with child approx 30 min after dose.  Help Desk contacted, verified Adacel dose counts as valid dose as it was dose as it was dose 4 in series, with no need to re-vaccinate. Informed mother of error and information received from Help Desk that dose is valid. Instructed mother may give Tylenol or Ibuprofen for discounted or fever.  Left clinic at 10:15, 1 hr after dose was given, child playful and content with no unusual sign or symptoms.
Patient was given vaccines on 10/3/13 in the afternoon, approx 1:30pm. By 8:00pm that evening, mom called to report extensive redness, swelling and pain. He was taken to urgent care on 10/6/13 and dx with cellulitis.
Pt felt dizzy, confused, "like she was drunk" immediately after vaccination. 911 was called and arrived shortly thereafter. Emergency personnel took vitals and questioned patient, determined no allergic reaction was taking place. Did not give any treatment. Pt refused going to hospital for observation.
next day after vaccine around noon patient started having stomach cramps and diarrhea that lasted 6 days. Very watery.