chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered her first SHINGRIX dose in the pharmacy on 5/3/18. She came into the pharmacy again on 5/19/18 and reported that she experienced an injection site reaction from the vaccine. She stated that on day 2 or 3 after getting the vaccine her arm got quite sore and there was a red, swollen area around the injection site. She said that the area was warm and it got itchy as well. She went to see her primary doctor a week or two after getting the vaccine to have the area looked at. The physician told her not to receive the second dose of SHINGRIX. Patient told me that her arm stayed itchy and sore for a couple weeks, but it has since resolved.
Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It is complained and alleged that the patient was inoculated with ZOSTAVAX vaccine on or about 26-AUG-2014 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-APR-2016, the patient was treated at a medical facility for an ongoing painful rash which was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other  damages. Additional information has been requested.
Urticaria (L) arm and face (L) eye (R) eye - 15 days later arrived c/o increased rash from 6-15-16 - 6-30-16.
Patient received a transplant and now qualifies as an immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (Patient received a transplant and now qualifies as an immunocompromised patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (Patient received a transplant and now qualifies as an immunocompromised patient) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Patient received a transplant and now qualifies as an immunocompromised patient) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The patient received the two primary and the booster doses of the Moderna Covid 19 vaccine. However after receiving them, the patient received a transplant and now qualified as an immunocompromised patient.  Treatment information was not provided by the reporter. Company comment: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced serious (medically significant) unexpected event of immunodeficiency, which occurred on an unknown date after administration of the booster dose of mRNA-1273 vaccine. It was reported that after receiving the 3 doses of Moderna vaccine, the patient received a transplant and now qualifies as an immunocompromised patient. No further information regarding previous medical history of organ failure, other medical history or clinical course of the event were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced serious (medically significant) unexpected event of immunodeficiency, which occurred on an unknown date after administration of the booster dose of mRNA-1273 vaccine. It was reported that after receiving the 3 doses of Moderna vaccine, the patient received a transplant and now qualifies as an immunocompromised patient. No further information regarding previous medical history of organ failure, other medical history or clinical course of the event were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
After the second dose about 48 hours after, I developed a dry cough which has been lingering for over three weeks. It?s turned into a more productive cough as time went on. No other symptoms. Went to the doctor and they tested for covid (negative), pneumonia (negative), so they diagnosed me with bronchitis.
Got Dtap #4 3PM, pain all night, fever 103. This morning jerking motion until fine, cry.
Arm pain (normal arm soreness) within first 24 hours. Swollen lymph nodes, especially in the arm pits and neck. I am a fitness trainer and RDN, no weight issue, and very high muscle composition, lungs are in excellent health.   Around mid afternoon next day, several hours after teaching an exercise class, I developed a fever and flu like symptoms. That Saturday night, I developed extreme nausea, along with sleep in and out the entire night due to nausea and fever.   This continued until Monday afternoon, over 2 days later. Then the symptoms disappeared in the blink of an eye, indicated it was definitely vaccination related.
Fever ranging from 101.9-104.2 for two days following second vaccine. Severe body aches, dizziness, headache started about 8 hours after shot was administered and lasted into day 3. Swollen lymph nodes close to injection site appeared on day 3. Exhaustion still ongoing on day 4 (today).  Alternated max allowable dose of tylenol and ibuprofen, layering every 2-3 hours to attempt to control fever, cold compress used.
I started feeling extremely fatigued and had really bad headaches and heart palpitations. I also felt extremely nauseous with dry heaving. I waited until July 16th or 17th to see a doctor. I explained my symptoms to the doctor, and he gave me something for nausea and a shot for my headache. He said he was not going to test me for COVID because he thought it would be a false positive. The medication didn't help any of my symptoms. I was tired of taking the Tylenol and ibuprofen because it wasn't helping at all either. The nausea has gotten better, but the extreme fatigue, heart palpitations, and headaches are still here.
hot flashes, headache, tiredness, sweating, injection site reaction (redness, warm )
A few of days after the shot I had gotten a rash on my back. After about a month and a half went to doctors and was put on prednisone. The medicine had almost gone away and now is back stronger. My back was very sore almost 3 months later with rash worse. Just took my last dosage and the rash is very sore and very red. I also have felt tired and ache.
No side effects or symptoms; HCP called to report that expired VARIVAX was administered to a Patient. VARIVAX expired on 13AUG2023, and it was given to a patient 15AUG2023, confirmed no side effects or symptoms reported. Confirmed no previous temperature excursion and read suppo; This spontaneous report was received from a medical assistant and refers to a 20 year old female patient. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant medications included diluent (manufacturer unknown).  On 15-AUG-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL once (lot # U025204, expiration date: 13-AUG-2023) (route of administration, anatomical location not provided) as prophylaxis. It was confirmed that no side effects or symptoms were reported.
Brain stroke.... Oral medicine, plasma, physical therapy.... Outcome to be known, to early to call.... At this moment I lost completely my balance.
Immediately after injection, metallic taste in mouth, headache, backache, dizziness, nausea. The next day, significant neck/back/shoulder pain.
No adverse event; Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. 054A22A) for COVID-19 prophylaxis.     Patient had no known allergies. It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19.     On 08-Apr-2023 at 2:33 PM, the patient received third dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) .5 dosage form. On 08-Apr-2023 at 2:33 PM,  after starting mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine).    Concomitant medication not reported.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vial did not undergo any temperature excursions.  Vial size given as 10 dose vial.  Vial was initially stored in the refrigerator on 07 Apr 2023 and Date of administration of vaccine on 08 Apr 2023.  Treatment medication not reported.  This case was for patient 1 out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-738752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2023: Significant follow up received contains reporter details, medical history, patient details and product details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738752:Patient 2
Not feeling the greatest; Cheeks were red and flush; Dizzy; Bedridden for last 12 hours; Fever of 102 degrees fahrenheit; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling the greatest), FLUSHING (Cheeks were red and flush), DIZZINESS (Dizzy), BEDRIDDEN (Bedridden for last 12 hours) and PYREXIA (Fever of 102 degrees fahrenheit) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vaccination (Patient has never had reaction with any shot except for the shingles shot.). Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), METOPROLOL TARTRATE, LOSARTAN POTASSIUM, ROSUVASTATIN CALCIUM, CALCIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced MALAISE (Not feeling the greatest), FLUSHING (Cheeks were red and flush), DIZZINESS (Dizzy), BEDRIDDEN (Bedridden for last 12 hours), PYREXIA (Fever of 102 degrees fahrenheit), CHILLS (Chills) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, MALAISE (Not feeling the greatest), FLUSHING (Cheeks were red and flush), DIZZINESS (Dizzy), BEDRIDDEN (Bedridden for last 12 hours), PYREXIA (Fever of 102 degrees fahrenheit), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever or Chills  Cough  Muscle or body aches  Headache  Congestion or running nose
C/o pain and burning down arm and towards scapular and clavicular area. Saw MD on 11/11. Prescribed a course of prednisone and PRN FLEXERIL. Will be followed up by MD in December.
Muscle pain and redness over injection site, which has. Diphenhydramine 25 mg TID.
Stiffness and extreme fussiness the day of the shot. The next day had a fever and lethargy.
Patient said she got a high fever and had a small seizure at work and they called an ambulance and her blood pressure 150/100.  The recommended that she go to the ER but she did not.  She came to the Pharmacy the next day and said she felt better.
Patient received Pneumococcal 23 when he was supposed to receive  the HPV vaccine.
Patient said that she had regular pain and soreness for a day or two after vaccination, that went away after a few days.  About a week after, she said she started to experience a pain and soreness radiating down her arm that intensified when she raises her arm.  This was reported via the phone.  She says there does not have any visual redness or irritation.  Will follow up with her doctor if it does not improve
about thirty seconds after the vaccination her daughter started to "pass out"; had a headache later that night and went to bed early; This spontaneous report was received from a patient's mother via a company representative and refers to a 13-year-old female patient. The patient did not have any pertinent medical history, concomitant therapies, drug reactions or allergies. On an unknown date in April 2019 (reported as about five months ago), the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) to prevent Human Papillomavirus (HPV). About thirty seconds after the vaccination, the patient started to pass out, she was caught by a nurse and, according to the reporter, she was "okay". On that same day (reporter as later that night), the patient experienced a headache and she went to bed early. On an unknown date in April 2019 (reported as the next day), the patient recovered from the event (reported as "she woke up and she was fine"). The patient did not sought medical attention and had no lab diagnostics or studies performed. She did not receive any treatment for the events.  The causality assessment was not provided.  Upon internal review, the event of "started to pass out" was determined to be medically significant.
Patient became diaphoretic, decreased level of consciousness, decreased blood pressure. Patient reported that he did not feel well. within approximately 15 minutes of vaccine administration. Health department staff responded, ems was called. Patient was not given any medications onsite and later refused EMS transport. Situation resolved within a span of 30 minutes.
Had a seizure while driving following the the shot. I was behind the of my car when the accident occurred. My car caught on fire and was a total loss.
The pt lost speech and social skills (eye contact) and began exhibiting strange behaviors, shortly after his MMR vaccine in 2/99.
Blood pressure dipped to 85/56; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6206) via an unspecified route of administration in left arm on 17Mar2021 at 13:15 (at the age of 60-year-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021 at 19:30 (approximately 6 hours later), the patient blood pressure dipped to 85/5. No therapeutic measures were taken as a result of the event. 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 clinical outcome of event hypotension was resolved on an unknown date.   No follow-up attempts are needed. No further information is expected.
Received 1st dose of Moderna COVID on 01/11/21 in left arm.  Five days post vaccination (01/16/21), developed pain/tenderness above left clavicle- left supraclavicular lymph node was swollen (approx size of a walnut); got larger over next few days and very tender/painful.  Saw primary care physician who ordered mammogram and ultrasound of area (details below).  Lymph node(s) remained enlarged for 3-4 weeks (was still palpable (about pea sized) at time of second COVID vaccination).  Enlargement attributed to vaccination.   Second dose of Moderna COVID vaccination was administered in right arm- no lymph node swelling occurred post second dose.
Case number PHEH2014US014755, is an initial spontaneous report received from a nurse on 21 Jul 2014 and with a follow up information received from the nurse on 26 Aug 2014. This report refers to a 16 years old female patient. Her medical history and concomitant medications were not reported. Nurse reported that the patient inadvertently received only the Men CYW-135 liquid component of MENVEO (batch number: M11081) intramuscular on 16 Jul 2014 at 1.45 PM, without being reconstituted with Men A component. No adverse event was reported. No further information was provided. Follow up information received from the nurse on 26 Aug 2014: Updated patient identifiers (date of birth, age, gender, height and weight), batch number of MENVEO, date and time of vaccination.
Client phoned nurse on 4/4/00 and complained of an unusual loss of appetite, intense headache, dizziness, disorientation and muscle aches developing from injection site radiating to all over body. Injection site was red, hot and edematous to axilla per client. Complained of fine, red rash on trunk, only. Resolved on 4/2/2000.
Red welps /bumps on inner thigh of left leg. They didn't hurt and started to go away as time went on.
A dose of expired TYPHIM VI was administered to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (MI) (Reference number- 00849879) and transmitted to Sanofi on 09-Nov-2021.  This case involves a 73 year old male patient who was received an expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Prophylactic vaccination.  On 06-Nov-2021, the patient received a 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A871M, expiry: 11-Oct-2021, formulation: Solution) via intramuscular route in the right deltoid for Prophylactic vaccination.  It was reported "Pharmacist reported that a dose of expired TYPHIM VI was administered to a patient. The caller would like information on the use of expired products and what steps need to be taken."  No other 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 holder's compliance with the requirements set out in the 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.
No adverse effect reported; patient was inadvertently administered ROT A TEQ and PEDV AXHIB, on 10/23/2019, that was improperly stored; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.     On 23-OCT-2019, the patient was inadvertently vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R033251, expiration date 29-JUN-2020 (exact dose, frequency and route of administration were not reported) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R027321, expiration date reported as 29-JUL-2021, but upon internal validation established as 09-JUL-2021 (exact dose, frequency and route of administration were not reported) for prophylaxis. The administered doses of vaccines experienced the temperature excursion of 30.07 degrees Fahrenheit for 35 minutes. The previous temperature excursion of 77 degrees Fahrenheit for 30 minutes was reported. The data logger was involved. No adverse effect reported.
Pt's mother called next morning and stated pt had stiff neck and difficulty turning head. Mother observing and treating with NSAID and TYLENOL. At 14:30 spoke with pt, feeling much better with little stiffness. At 16:00 only minor stiffness, mostly recovered. Told to contact MD if not getting better or getting worse, faxed MD.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 03:00 PM as dose 1, single (Batch/Lot number: unknown), in right arm, in Apr2021 03:00 AM as dose 2, single (Batch/Lot number: unknown), in right arm, in Nov2021 12:00 PM as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and in May2022 02:00 PM as dose 4 (booster), single (Batch/Lot number: unknown), in left leg for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthiritus" (unspecified if ongoing) and none known allergies. Concomitant medication(s) included: HUMIRA, start date: Dec2021. The following information was reported: DRUG INEFFECTIVE (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: (unspecified date) Unknown results, notes: indication=Treatment of COVID-19; (Jul2022) Negative, notes: tested negative for 4 days; (Jul2022) Positive, notes: then positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea, severe myalgias, arthralgias; unable to get out of bed due to weakness; edema of extremities
Left arm - pain unbearable at time of injections. 2 months later, still experiencing pain and unable to move arm.
the patient complains of a sore arm after getting their vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "the patient complains of a sore arm after getting their vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.