chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up on the morning of April 10 with nausea and chills. Had a headache since the night before, but I sometimes get headaches due to neck pain so I cannot fully attribute the headache as an effect of the vaccine. Vomited three times within two hours and experienced diarrhea at the same time. Fell back asleep for four hours and felt little nausea and no chills afterwards. Took ibuprofen for headache 24 hours after time of vaccine. Felt back to normal the next morning.
The night of my shot I experienced extreme burning in my whole body, as well as pain and tingling. This lasted for 2 days.
On 1/10/11 within seconds after administering vaccines child broke out in urticarial rash on trunk and chest. Right ear became erythematous and protruding. The child did not have difficulty breathing or drooling. BENADRYL Elixir given. Due to rapid onset child referred to ER. Child followed up on 1/31/11; child stable, was sent home after ER visit on 1/10/11. Child improved after BENADRYL.
Dizziness that turned into vertigo andvomiting; Dizziness; Dizziness that turned into vertigo; This is a spontaneous report from a contactable consumer, the patient. A 65-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 25Feb2021 at 16:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilia myalgia syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC); all for an unknown indication on an unknown dates and unknown if ongoing. On 26Feb2021, the patient experienced dizziness that turned into vertigo and vomiting. She also reported that the two episodes lasted about 20 minutes each. The vertigo was so bad that she could not see or function. If she had been driving she could have crashed. The events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, dizziness and vertigo were resolved on an unknown date in Feb2021 after the duration of 20 minutes.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 22MAY95 & LMP 8MAY95; 10JUN95 through 15JUN95 devel a upper resp infect which was treated w/APAP & sudafed
administration of expired fourth daptacel dose at just under 23 months of age, rather than 15-20 months of age with no reported adverse event; administration of expired fourth daptacel dose at just under 23 months of age, rather than 15-20 months of age with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 months old female patient who was administered expired fourth dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] at just under 23 months of age, rather than 15-20 months of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine (HIB); PCV15 and tozinameran (Pfizer Biontech COVID-19 vaccine) all for Prophylactic vaccination.  On 28-Jun-2023, the patient received a dose 0f 0.5 ml (dose 4) once of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: C5893AA; expiry date: 21-Jun-2023) via intramuscular route in right thigh for Prophylactic vaccination (Immunisation).  On 28-Jun-2023 the patient was administered expired fourth dose of Daptacel at just under 23 months of age, rather than 15-20 months of age with no reported adverse event (expired product administered) (product administered to patient of inappropriate age) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jun2022 at 12:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Other medical history: Anxiety and depression; "depression" (unspecified if ongoing), notes: Other medical history: Anxiety and depression; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin and ibuprofen. There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: ibuprofen", notes: Known allergies: Penicillin and ibuprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There was no other medication in 2weeks.Anti viral details product for COVID 19 Treatment included Paxlovid Treatment start date: 15Jul2022 and Treatment stop date: 21Jul2022.Known allergies include penicillin and ibuprofen and Other medical history included Anxiety and depression.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, Fever, Sweating for 36 hrs.  Pain at injection site.  Severe headache.  Unable to eat for 24 hours and vomiting roughly 16 hours after the vaccine.  I had this same reaction to the Moderna booster when I got it before.  Almost 48 hours later I still feel fatigue and feverish but much better.  However it is intense and I was bedridden for the better part of 36 hours.
Shingrix vaccine was administered subcutaneous / given SC instead of IM; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2021, the patient received Shingrix (subcutaneous). On 17th May 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix subcutaneously instead intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021105195:same reporter (deleted case)
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  with expired vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.).    No concomitant medications were reported.  It was reported that the patient was administered dose after 30 day use by date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial underwent temperature excursion. 9 days past expiry date the patient received the vaccine.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2022: Follow up received wherein patient demographics, event added and narrative updated.
Patient received a second dose of the Pfizer Covid tris booster, and was supposed to get the newer Pfizer Covid Bivalent. Patient had no adverse reaction, no symptoms, no issues at all. The clinical pharmacist was consulted, and there was no harm or safety concerns to patient.
10/18/10 Given shot & then cried, calmed down, got dressed & began to leave office & then c/o severe abdominal pain. By the time got outside office doubled over in pain (<5 min). Went car, buckled in refused snack & kept screaming. Came back in & vomited in office. During vomiting episode got very weak & unresponsive. Afterwards he improved & was back to baseline. Total (<10-15 min) observed in office. Pt alert oriented no more abd pain & says he feels ok, but looks tired now playful with toys. (A) Shot rxn - prob secondary to being upset, but unclear if directly to shots.
Patient came to pharmacy on 6/16/21 to report the allergy reaction she developed the next day after receiving her fist Moderna dose. Patient does not have a regular physician and went to ER with allergy rash all over her body. She received a shot (medication name is unknown), prescription for Medrol and Hydroxyzine. She also purchased Zyrtec OTC and has been taking all 3 medications but so far she has no relief. Patient reported that she also had to drop out of school.
Heard a rumor that they have received expired vaccines; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Heard a rumor that they have received expired vaccines) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Heard a rumor that they have received expired vaccines). On 29-Jan-2021, EXPIRED PRODUCT ADMINISTERED (Heard a rumor that they have received expired vaccines) had resolved.            No concomitant medications were reported.   No corrective treatment was provided.   This case was linked to MOD-2021-035882, MOD-2021-035855, MOD-2021-035873 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No new information was received.; Sender's Comments: This report refers to a case of expired product used in a 73 year old female with no associated AEs. MOD-2021-035882:Patient's First Dose MOD-2021-035855:Husband's First Dose MOD-2021-035873:Husband's Second Dose
pt stated she woke up on 3/17/2021 and her left hand was numb.  Today 4/7/2021 her hand is still numb.  The numbness is extending to her the lateral side of legs and toes are tingling.  her left side of her face is numb and she has some numbness in her chest.  It is like she is having electrical shocks that comes and goes.  the right hand has some numbness that comes and goes.  In the evening the pain is more intense.  she is very upset and feels like there is nothing anyone can do to help make her feel back to normal.  Pt spoke with doctor and has been ordered blood work which she will have done on 4/9/21.
On 11-SEP-2019, the patient was administered the second dose of MMR II after first dose of MMR II was administered on 20-AUG-2019; No adverse effect; On 11-SEP-2019, the patient was administered the second dose of MMR II after first dose of MMR II was administered on 20-AUG-2019; This spontaneous report has been received from nurse referring to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. The patient's current condition, pertinent medical history, drug reactions/allergies were not reported. On 20-AUG-2019, the patient was administered with first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot number, expiry date, frequency, route of administration were not reported) for prophylaxis. On 11-SEP-2019, the patient was administered with second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot number R030806, expiry date 24-OCT-2020, therapy type rHA (dose, strength, frequency, route of administration were not reported) for prophylaxis (inappropriate schedule of product administration) (circumstance or information capable of leading to medication error). No adverse effects were reported. There was no product quality complaint present.
Gout in my left toe; This is a spontaneous report from a contactable patient. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Right arm on 06Jan2021 06:30 PM as a single dose for COVID-19 immunization, lot number: EJI685. Patient had no known allergies and had COVID prior vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jan2021 07:00 AM patient experienced gout in his left toe, event resulted in emergency room/department or urgent care. Treatment received included colchicine (COLCRYS). Patient had not been tested for COVID-19 post vaccination. At the time of the report patient was recovering from the event.
This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may have had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Additional information has been requested.
Fever, chills/shivering, sweats, dizziness and nausea.
One week after injection: chills, shivering, diarrhea, fatigue for three days; developed bleeding gums for several days; developed petechiae on upper and lower legs that lasted for several weeks
INTESTINAL COMPLICATIONS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced intestinal complications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of intestinal complications was not reported. This report was non-serious.
16 hrs after injection of Tdap developed redness and swelling; seen in office 8/17/07 with erythema 17x17 cm; induration 11x12 cm; itchy; Benadryl and ice applied. No further sx or tx.
Left cheek hot and red and swollen.    I had cheek filler (Volumna) approximately 1 year ago in both cheeks.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 04Apr2021 as dose 2, single (Lot number: ER8734) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Aug2022, stop date: 27Dec2022; ALENDRONATE SODIUM, start date: 01Sep2022, stop date: 27Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: after 5-day Paxlovid, still tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid (Lot number: GF4083) 22Dec2022 to 26Dec2022 as COVID-19 Treatment. The patient had no known allergies.
Numbness and tingling in right leg about 4 days after 2nd vaccination, moved to  right foot. Then moved to left foot but didn't affect left leg..  Feet are cold now, legs are okay now, just the feet. Hands, lips, & tongue, & face feel numb and tingly too.  Spoke with Dr on phone.  Client stated he took Tylenol for a couple of days after vaccination. Stated injection site is black & blue. Client still dealing with numbness & tingling. Waiting  to speak with Dr again. Phone call to office.
Started with a red patch on injection arm midway between elbow and shoulder July 8, 2021. The red patch continued to grown until it was 6 inches long and 3 inches wide as of July 12, 2021. Started with a headache July 8, 2021 and continued until July 12, 2021, with severe ringing in my ears.  I also have  a lymph node behind left ear that is swollen. I?ve been tired as well since July 8th. I did take Benadryl hoping it would help with the red patch as well as medication for the headache, but it never helped. Things got progressively worse.I called the CDC and they advised seeking medical attention which I did today, July 12, 2021. When I arrived at the doctor my blood pressure was 130/100, no fever, pulse ox was 99. My doctor felt it was a reaction from the vaccine and began a course of treatment to relieve the symptoms.
Date: 4/1/2022 staff member came in, 0940 for a booster shot their third vaccine. They completed the pre-vaccination worksheet. I verbally went over the pre-vaccination paperwork with them. They reported no adverse reactions to previous injections of Moderna. I administered Moderna vaccine at 0945, a booster dose, of 0.25 ml in left deltoid.     Vial lot #  033K21-2A  and expiration date 04/09/2022.  The employee did not have their vaccine card.  I completed a new card, using their previous vaccination information from the program for them.  At 0945 I administered 0.25 ML of Moderna booster dose and monitored them for 15 minutes. The employee showed no signs or symptoms of adverse reactions to this vaccination. The employee was alert and verbally responsive. Registered Nurse, on duty,  assessed employee post injection and found no signs or symptoms of anaphylaxis or negative side effects. At 1000 the employee walked out of clinic without showing any signs of difficulty.  After checking the employee's vaccination dates against the memo providing instructions for vaccinations I saw that I administered the vaccine 2 months too soon. The correct date of the third dose of Moderna should have been given on 6/28/2022. I alerted the Registered Nurse on duty to what happened and was directed to alert the Nurse Consultant III.
First Moderna vaccine given 2/15/22. Employee requested a second vaccine through employee health. Per local mandate, employees must have two vaccines by 2/28. Person administering the vaccine did not verify the timing between vaccines. Patient did not understand that she still needed to wait 28 days between doses.
Information has been received from a consumer concerning her 6 year old son with no medical history and drug allergies who was vaccinated with the first dose of MMR II one year ago. There was no concomitant medication. Subsequently the patient developed autism after receiving his first and only dose of MMR II. The patient showed emotional and behavioral problems. He did not like hear loud noises. The patient was seen by a physician for medical attention. He was recovering. No further information was available. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested.
Swelling of palate approx. 5 minutes post COVID Vaccine Dose #1.  VS normal and stable.  Received diphenhydramine 50mg PO with symptom resolution within 20 minutes.  Observed for 40 minutes and D/C'd in stable condition with no sxs present.
Restlessness  Migraine Body aches Hot flashes  Chills Fatigue