chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately following injection, site started to bleed (on blood thinner). Site started swelling (quarter size in about 1 minute). Patient stated she felt a tingling feeling throughout body and was a little dizzy. I offered her some water. She moved to a chair with arms while calling her pcp. She did not feel safe to drive and wanted 911 to be called. She left the pharmacy in an ambulance. 3 to 4 hours later she called back to update us, she had increase in blood pressure (211 over something she could not remember). Patient was given IV fluids and monitored until bp went down. She was released and told not to take the second dose.
Woke up around 3 am with a mild headache, soreness, and mild fever. Went back to sleep and woke up again around 7 am.  Had mild fever and soreness throughout the day, but all symptoms subsided by the end of the day. Slight soreness at the vaccination site persisted for an additional day before subsiding.
Patient complained of severe HA approximately 1.5 hours after vaccine administration. She presented to ER with self-report of BP of 198/130, "dry heaves", HA that was "real hard and strong." She also reported to have "little bit" of light sensitivity and was "really dizzy." She was treated in ER for "migraine." At the ER she received "compazine" for nausea.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with doses of improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, strength dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Radiating heat from chest to stomach.  Extreme swelling of feet and legs.  Skin broken open and peeling.  Feet go from hot to cold.  Blood work done 3 times at physicians office and once at the ER.  Recommended Podiatrist.  She recommended to see a Nuerologist.  Referral was done and was scheduled for December 2.  Now we are told she doesn't have an appointment there.  A different referral was given to another Nuerologist but she can't be seen until December 14.   Meanwhile no Dr at the ER nor  at  her primary care office will give any reason why she is having continued problems.  They did say the blood work showed Liver inflamation but basically gave no reason why.  ER said low in Potassium.  Extremely painful to walk.  She was given hormone therapy and muscle relaxor.  Also Gabapatenin.  Nothing given to help with pain.
This spontaneous report as received from a pharmacist refers to a female nurse of unknown age. Patients concurrent condition and medical history were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot number and expiry date unspecified) (dose, route unspecified). No concomitant therapy was reported. On an unknown date, the patient experienced could not lift her arm for a week (disability). The outcome of event was unknown. The reporter considered the event to be related to PNEUMOVAX23. This case is linked to several reports via same reporter link. Additional information has been requested.
3 inch area where shot was administered is swollen, red, area is painful and itches.  Have on and off had a fever and yesterday, dizzy and no sense of balance.
Rash Narrative: employee states: the next morning she had a rash over her chest, neck, and inner portion of both upper and lower arms which responded to triamcinolone
PT STATED HE HAD A MILD FEVER AND SOMEMILD FLU IKE SYMPTOMS THE FIRST 24 HIURS AND PAIN AT  IJECTION SITE THE WAS FINE, BUT AWOKE TODAY (THREE DAYS LATER) AND WAS ITCHY ALL OVER HIS BIDY AND WAS STARTING TO GET RASH.  HE STATED HE HAS NOT TRIED ANY NEW FOODS, DETERGENTS, CLOTHES, SKIN PRODUCTS OR BEEN OUTSIDE IN ALLERGENS.  PT BOUGHT BENADRYL AND CORTISONE CREAM AND WAS ADVISED TO SEE MD ESPECIALLY IF GOT ANY WORSE.
Secondary amenorrhea; Damage to cervix, uterus, and fallopian tubes; Primary ovarian insufficiency (POI)/Premature ovarian failure (POF); Nausea; Head and body aches
CHEST INFECTION; This spontaneous report received from a patient via a company representative (media inbox) concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included HIV positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) frequency 1 total, dose was not reported, administered on 05-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 13-APR-2021 (8 days after vaccination), the patient had been fighting a chest infection, meaning coughing up thick yellow phlegm. He was recovering and had no fever, no headache. "He had not been sick, even with a cold for two years. This was an anomaly." Patient travelled for a living literally all international 3 weeks a month. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest infection.. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-COVID-19 VACCINE AD26.COV2.S-Chest infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Numbness in arm - then hand then elevated BP EMT phoned & pt taken to hospital for observation.
Serum sickness like reaction with whole body hives and joint pain. Seen in ER. Treated with oral prednisone and then seen by immunologist on outpatient basis. Confirmed not an allergic reaction but hyper immune response. OCD symptoms and autoimmune encephalitis  (PANS) diagnosed after seeing psychiatrist, neurologist, rheumatologist, immunologist, therapists.
pt reports whole body aches since vaccine and as of 10/12/21 feeling of pins and needle, tingling on the tongue. Pt also reports loss of appetite.
WITNESSED BY MATERNAL GRANDMOTHER WHILE PLAYING OUTSIDE SUDDENLY STARING WITHOUT RESPONSE, LIMP, PALE AND SWEATING FOR 3-7 MINUTES TIRED FOR HOURS AFTERWARDS
Nausea, vomiting, diarrhea, headaches. Member says symptoms appeared early this morning around 0730.
Rash that covered his whole body; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that covered his whole body) and PAIN IN EXTREMITY (Sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Bladder infection (Diarrhea and rash on butt as a reaction to antibiotic.). Concurrent medical conditions included Cancer. Concomitant products included AMOXICILLIN for Bladder infection, LEUPRORELIN ACETATE (LUPRON) and PREDNISONE for Cancer.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced RASH (Rash that covered his whole body). At the time of the report, RASH (Rash that covered his whole body) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A itchy rash to trunk of body to legs/ Rash and itchiness to the trunk of body, legs and arms.; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (A itchy rash to trunk of body to legs/ Rash and itchiness to the trunk of body, legs and arms.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Colitis microscopic, Depression, Pain, Inflammation and Sleep difficult. Concomitant products included BUDESONIDE for Colitis microscopic, CELECOXIB (CELEXA [CELECOXIB]) for Depression, MAGNESIUM for Inflammation, LORATADINE (LORTAB [LORATADINE]) for Pain, ZOLPIDEM TARTRATE (AMBIEN) for Sleep difficult.   On 02-Mar-2021 at 3:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021 at 3:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021 at 3:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (A itchy rash to trunk of body to legs/ Rash and itchiness to the trunk of body, legs and arms.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash pruritic, at an unspecified dose and frequency and HYDROCORTISONE for Rash pruritic, at an unspecified dose and frequency. On 07-Apr-2021 at 8:00 AM, RASH PRURITIC (A itchy rash to trunk of body to legs/ Rash and itchiness to the trunk of body, legs and arms.) had resolved.            Action taken with mRNA-1273 in response to the  event s were Not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Outcome of the event, second dose information, medical history, treatment medication and concomitant medications were updated.
p/vax pt exp rash on lt upper arm, hurts to touch, looks like insect stings lasted 7-10 days;hearing in both ears reduced fading in & out, happens @ least once daily x 30-40 seconds;
Sore throat, mild bronchial congestion, mild muscle aches, soreness in left arm; Sore throat, mild bronchial congestion, mild muscle aches, soreness in left arm; Sore throat, mild bronchial congestion, mild muscle aches, soreness in left arm; Sore throat, mild bronchial congestion, mild muscle aches, soreness in left arm; This is a spontaneous report from a  contactable nurse (reported for herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on left arm on 21Dec2020 08:45 at a single dose for immunization. Medical history included rosacea, primary hypertension, Hashimoto's Thyroiditis  and penicillin allergy. The patient's concomitant medications were not reported. The patient experienced sore throat, mild bronchial congestion, mild muscle aches, and soreness in left arm; all on 22Dec2020 at 06:30. The patient did not receive treatment for the events. Outcome of the events was recovering.
A report has been received from a Health Professional concerning a 19 year old, Female subject, who had been receiving FLUMSIT quadrivalent (intranasal). FLUMIST quadrivalent started on 15-Dec-2014. Patient received expired FLUMIST quadrivalent on 15-Dec-2014, FLUMIST quadrivalent was discontinued on 15-Dec-2014. The outcome of the event of expired FLUMIST quadrivalent administered is unknown. The report was considered to be non-serious.
Patient presented to clinic with red warm area on upper arm of 8 cm. Patient stated that the area was "hard" yesterday, but today just redness and warm to touch. She does state that it is painful over the reddened area. Patient advised by MD to watch for further reaction and report to clinic tomorrow if reaction is worsening.
Patient was given the immunization in the afternoon on 3/28/19. On Friday, 3/29/19 the patient reported all over body aches, trouble breathing, and the injection site was red and warm and measured 15X13cm. Sunday 3/31/19 the patient was feeling better.
Erythema & swelling of injection site and diffuse skin erythema & nausea & vomiting.
a 35 years old female patient received an expired dose of Flublok Quadrivalent/No AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case is linked to case 2019SA316754, 2019SA316777 and 2019SA316778 (same reporter).  This case involves a 35 years old female patient who vaccinated with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Nov-2019, the patient received a 0.5 ml an expired dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1824, expiry date: 30-Jun-2019) via intramuscular route in the left deltoid.  It was an actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician concerning an 18 year old white female who on 1/15/99, was vaccinated with 1 dose of Hep-B vaccine recombinant. In January, 1999, several days, post vax, the pt experienced left upper extremity weakness and right upper eyelid droop. The pt sought unspecified medical treatment. The physician noted "EOM's intact, no facial paralysis, normal fundi, and no other cranial nerve deficits." The pt has recovered from upper extremity weakness "after 2 days" and eyelid droop "7 weeks after the injection." No further information is available.
Husband has vitamin D deficiency and stage 4 kidney failure; Husband has vitamin D deficiency and stage 4 kidney failure; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer reported for her husband that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 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 history and concomitant medications were not reported. The patient had vitamin D deficiency and stage 4 kidney failure on an unspecified date. It was clarified that husband had first covid vaccine shot than found out about his conditions. The outcome of the event was unknown.   Information on lot/batch number is requested.
After receiving the Men B Vaccine client began exhibiting jerky movements. She was swaying forward and almost fell into the wall and forward. The nurse caught her and placed her on a bed. The client was pale, skin was moist and clammy and BP was 90/60. After compress were applied and water was give the BP was reassessed and was 100/68. The client felt better and had dizziness or light headiness.
Burning sensation in arm, tingling in fingers of left arm within the first hours. Then large red welt appeared on the arm. The welt has increased in size every day since and remains bright red, hot to touch, and 2.5 inches across.  Ice packs, warm compresses, and ibuprofen or Tylenol does not seem to help.
From faxed correspondence received at manufacturer on 08/09/2002, it was reported that a 55-year-old male received his 4th dose of Imovax Rabies vaccine on 07/24/2002. The pt experienced low-grade fever and tingling sensation all over his body the day of vaccination. No other symptoms were reported. The first 3 doses were uneventful. The reporter refused to provide pt info at this time except for pt initials and DOB.
Hepatitis B & measles, mumps, rubella vaccine given.  Following MMR, she lost consciousness for approx 10 seconds.  Assisted to lounge.  4:10p B/P 140/94 P. 68.  4:20p B/P 124/80 P. 68 L 120/90 S.  4:35p 128/88 P. 68 L 138/88 P. 68 S.
Shortness of breath  Chest pain, unspecified type  CT Angiogram chest EKG Aspirin 81mg Iopamidol Morphine  Ondansetron  AT THIS TIME IT IS NOT ADVISABLE TO GET THE SECOND COVID VACCINE UNTIL YOU GET A CARDIAC WORK UP
Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a patient of unknown demographics who received half the dose of PENTACEL (Suspension for injection). The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received half dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported. It was a case of actual medication error due to vaccine underdose. It was unknown if adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
RED FACE; SWOLLEN FACE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 102 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 22-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced red face. On 22-MAR-2021, the subject experienced swollen face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red face, and swollen face on 22-MAR-2021. This report was non-serious.
COVID BREAK  My Husband had it first and we separated after he got a positive test May 14. The 18th of May I woke up wit a sore throat and tested positive on the 18th. I called my PCP they had me add to my chart the test result. I talked to a pharmacist two had a long conversation and I picked Paxlovid. The medication was very helpful. The first  vaccines I received were Pfizer and then I switched to Moderna
Patient presented for virtual care visit today with complaints of possible vaccine reaction:   received covid Pfizer booster on Friday. Now with complaints of slight "numbness and tingling" on lert left chest wall started yesterday  -received the shot on the left upper arm. NO localized reaction noted.  -endorses muscle tenderness on the left chest wall, able to reproduce the pain when palpated. States it feels slightly "numb", denies any actual pain, shortness of breath or chest pain. States it feels "like taking a lidocaine patch off".  -has been taking tylenol and doing warm compresses, but symptoms have persisted. Denies any worsening symptoms  -denies any visual changes, no loss of motion or decreased ROM. Pain occasionally radiating to left breast.
Patient was found deceased at home on 2/20/2021, 8 days after receiving the 1st dose of COVID-19 vaccine.
After flu shot the next day pt c/o nausea, hives,itching "all over", Fever/chills. As of 10/31/07 c/o cough, body aches, hoarseness. Hives, itching resolved.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included CRESTOR, CYMBALTA, DIOVAN, Metformin, GLYBURIDE, INVOKANA, SYNTHROID and VICTOZA. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, pain and fever. On an unknown date, the outcome of the chills, pain and fever were recovered/resolved. The reporter considered the chills, pain and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient reported that she and her husband had the SHINGRIX. The patient's body temperature was recorded as 100 degree F. The patient had chills, fever, and achiness and lasted about 48 hour. This was 1 of 2 cases, reported by the same reporter.
Pt's mother phone 6/3/15 at 3pm. States site where MCV given at 2pm 6/2/15 is red, itchy and swollen. Asked about SOB, denies; no fever, no dizziness, slight sweating. Told to take daughter to physician if she doesn't improve. Also apply cold compress to affected area. It is noted pt weighs 411 lbs.
eyes began itching in the middle of the night and patient woke up with swollen face and eyes
pt had vax 2nd post partum day; pt devel macular rash, malaise, arthralgias 3-5 days later which lasted 8-10 days & resolved;
Menstrual cycle began 8 days early with unusual heaviness and cramping.  Menstrual cycle has been normal for years.
Following administration of #2 DTP, pt devel that evening an unusual high pitch cry & was unconsoleable all evening >3 hrs; sl elevated temp;
according to the case worker child was seen 4:30 21JAN99-child was happy, playful;no signs of child not feeling well;child was found by foster parents @ 12:45PM in crib not breathing;autopsy was performed-results are pending;
The next day i had a sore arm and had a headache. That headache started to grow and didn't not go away. It turned into a migraine, made me nausea and did no got away . I was charge nurse that night and I couldn't even open my eyes, I went down to the urgent care and they have Toradol shot and two Zofran.  I had a lingering headache for the next couple days, I also had fatigue but hard to say if it was the vaccine or me working nights.
Pt recvd vax & the next day exp tonic/clonic movements, dizziness, nausea cramping hands, loss of peripheral vision, abdo cramps, hyperventilating & h/a; reporter indicates that following extensive hx & lab work the dx was anxiety react;
Patient states on day of vaccination she took 400 mg of ibuprofen due to the pain in her left shoulder around the injection site. Patient then woke up the next day (03/13/2021) and noticed that all of her fingers were more swollen than normal. Throughout the day, the patient reports that her finger swelling resolved and did have some facial swelling.  4 days later on 03/17/2021 the patient developed 3 pustules on her left shoulder at the injection site and another on her right scapula. The following day (03/18/2021), the patient began to have swelling around her eyes and lips. She saw her PCP that same day and was prescribed prednisone, Zyrtec, and hydroxyzine; however, the patient continued to develop mild pustules throughout her body.  She presented to the ED on 3/19/2021 for evaluation. The patient was given 10 mg of dexamethasone and recommended to switch to benadryl.  After discharge from ED, patient reports that her rash has continued to worsen as it is spreading diffusely all throughout her body. Patient specifically states that her rash spread from her left arm into her chest, then to her back, groin, face, and lower extremities. On 03/21/2021, patient reports that her pustules advanced into target lesions around her face along with developing some lesions in her mouth, as well. Patient also notes that her skin "burns" whenever she itches it. Patient then went in to be evaluated by a dermatologist and was sent to the ED for admission to the hospital.     Patient currently hospitalized and undergoing work-up/treatment.  Current treatment includes oral anti-histamine, analgesics, topical steroid, and IV fluids.
COVID vaccine breakthrough case. Pfizer 3/6/21 EL9267 and 3/17/21 EN6202