chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Oct2021 11:30 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 02Oct2021. Past drug history included: Yes for Allergies, notes: known allergies: Yes. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Leg Left), administration date: Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: SNEEZING (non-serious) with onset 10Oct2021, outcome "not recovered", described as "Strong sneezing"; COUGH (non-serious) with onset 10Oct2021, outcome "not recovered", described as "coughing"; HYPERSENSITIVITY (non-serious) with onset 10Oct2021, outcome "not recovered", described as "suspect an allergic reaction to an ingredient in the 3rd shot". Therapeutic measures were not taken as a result of sneezing. Additional information: Prior to vaccination the patient not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to the Emergency Room via EMS with lip, palette, and  throat swelling and tingling, itching, and hives.  The patient was treated with epinephrine x 2 doses and diphenhydramine.  The patient began having symptoms soon after receiving the Johnson and Johnson COVID 19 vaccine.
Systemic: Patient reports Canker sores-Medium, Additional Details: Patient called pharmacy on  01/06/2022 12:38pm reporting she experienced canker sores after vaccine
Tingling of lips; Tingling of tongue; Numb like feeling in tongue; Sensitive lips; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736), via an unspecified route of administration in the left arm on 04May2021 at 10:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included endometriosis, penicillin allergy, shellfish allergy and food allergy (ginger). Concomitant medication included cimetidine (TAGAMET) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the left arm on 16Apr2021 at 13:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient previously taken erythromycin (MANUFACTURER UNKNOWN), FLAGYL and clindamycin (MANUFACTURER UNKNOWN); all for unspecified indications on unknown dates. 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 04May2021 at 10:30, the patient experienced tingling of lips and tongue, then numb like feeling in tongue followed but sensitive lips which began 30 minutes after vaccination. The clinical outcome of the events tingling of lips and tongue, numb like feeling in tongue and sensitive lips were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
About 10 minutes after vaccination, patient felt lightheaded, nausea and appeared to be pale. She was nervous and felt scare at the time of vaccination. We found out patient didn't eat and wasn't hydrated. We provided water, orange juice and father approved for us to call paramedics. Paramedics didn't take her away. We were informed that patient had low blood pressure but did not go to the hospital. I followed up with patient and she said she was okay and she had food to eat. I informed patient to try to reach out to the family physician for follow up and discussion about the vaccine.
ocular shingles; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional information was provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient received the first dose of Shingrix and 1-2 weeks after receiving the vaccine, the patient had a recurrence of ocular shingles.
A little soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little soreness in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (A little soreness in her arm). At the time of the report, PAIN IN EXTREMITY (A little soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided. No concomitant medication provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18 May 2021 included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 3rd April 2019, the patient received the 1st dose of SHINGRIX. On 6th April 2019, 3 days after receiving SHINGRIX, the patient experienced axillary pain and injection site pain. On 7th April 2019, the patient experienced fatigue, shortness of breath and knee pain. On an unknown date, the outcome of the axillary pain, injection site pain, fatigue, shortness of breath and knee pain were not reported. The reporter considered the axillary pain, injection site pain, fatigue, shortness of breath and knee pain to be related to SHINGRIX. Additional details were provided as follows: On 3rd April 2019, Wednesday, the patient received 1st dose of SHINGRIX in her left arm, bicep. SHINGRIX batch and lot number was not available. On 6th April 2019, the patient started to develop lot of pain and tenderness underneath the arm and had difficulty applying deodorant. The patient also experienced pain at the injection site. On 7th April 2019, Sunday, the patient ran a half marathon and at three-fourths of the race, she started to experience fatigue, shortness of breath, and hip and knee pain and had to walk at the end of the marathon. The patient stated that, she had trained for the race and used to exercise a lot and was not expecting these side effects, hence attributed all the side effects to the SHINGRIX vaccine. The reporter consented to follow up.
Pfizer-BioNTech COVID-19 Vaccine EUA Mild diabetic reaction (light-headed, dizziness) to the sucrose, lasting the same afternoon, through the night, and all the next day.
ACUTE NON ST ELEVATION MI 3/7/2022 SADDLE PULMONARY EMBOLISM SADDLE PULMONARY EMBOLISM 2/22/2022 SADDLE PULMONARY EMBOLISM ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/25/2022 SADDLE PULMONARY EMBOLISM
Scattered skin rashes and itchy patches: Back of right thigh, inside of right elbow, upper face, back of left shoulder
I was 10 weeks pregnant at the time of my second dose,  with an estimated date of delivery of 8/12/2021. I developed fevers, chills, and myalgias for the whole day after I received the second dose of the COVID vaccine (1/14). My max measured temp was 100.4F - my OB advised me to take Tylenol around the clock to ensure I didn't have higher fevers. I did not record any above 100.4F.
Pt was seen 3 days post vax by a physician with 6.5 X 9 " area of redness, induration over left thigh with central 1" X .5" blister. Pt was treated with antibiotics.
parents had declined the flu shot and it was administered into the patients Left Deltoid  Mom was  called and informed
approximately 2 days after vaccine administration, site became tender, red, hot, and achy. Symptoms increase over the next several days and spread from site (left deltois area) to inner aspect of upper arm in several similar lesions. Patient presented to Emergency Department on day 5 and was given benadryl.
Got lightheaded,nauseated and pale after standing after vaccination.  Remained alert and oriented after falling.  Her father caught her before she hit the floor. Vomited a small amount after sitting up.  Remained a&O x4.   b/p 110/62 pso2 99% heart rate 70.  Monitored then released with her father@1320.  Informed to seek medical attention for any further problems.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Patient developed rash, itching, dryness, and soreness on skin surrounding eyes 3 to 5 days after booster administration. Denies starting new diet/medication/skin products and any visual changes/disturbances. She has been taking OTC Claritin every day since symptom onset, which seems to help, but is concerned if symptoms will resolve on its own. Patient was advised to try OTC Benadryl and topical hydrocortisone for the next 2-3 days and to seek medical attention if symptoms are still not better.
Still nauseous but not vomiting anymore; Vomiting the entire day; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vomiting the entire day and was nauseous.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number 011L20A) for prophylaxis of COVID-19 infection.    On 30 Dec 2020, the day after administration, the patient was vomiting the entire day and was not able to go to work.  On 31 Dec 2020, the patient stated that she was still nauseous, but was not vomiting anymore. No treatment information was provided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of event, vomiting the entire day, was resolved on 30 Dec 2020.  The outcome of the event, nauseous, was unknown.; Reporter'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. Further information has been requested
Cough; Headache; This non-serious case was reported by a other health professional and described the occurrence of cough in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: Cough) and headache (Verbatim: Headache). The outcome of the cough and headache were not reported.   It was unknown if the reporter considered the cough and headache to be related to Arexvy.     It was unknown if the company considered the cough and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-MAY-2023 The reporter reported that the patient experienced cough and headache after receiving Arexvy vaccine. The patient had been self-medicated. The reporter reported that the patient was tested negative for covid. The patient had been struggling to reach the clinic. The reporter gave the patient the clinic's number and told that they would escalate further. The reporter did consent to follow up.
Flu like symptoms with fever and chills off and on for 24 hrs. Aches and joint pain and stiffness. Headache as well.
Expired Havrix administered; This case was reported by a nurse via other manufacturer and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 16th February 2023) for prophylaxis.   On 28th February 2023, the patient received Havrix. On 28th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 28-Feb-2023 Reporter comment: The nurse called to report that an expired dose of Havrix was given to a patient on the day of reporting.  The vaccine expired on16 February 2023. There was no additional adverse events and no product quality complaints. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Pfizer on 4/2 and 4/23 and 8/18. Positive on 9/13
Case number PHEH2015US019474, is an initial spontaneous report from a medical assistant received on 29 Sep 2015. This report refers to a 61-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1516201) intramuscularly at a dose of 0.5 ml on 17 Sep 2015. On the same day immediately after vaccination, the patient experienced redness and swelling in the deltoid muscle. Further the patient developed itching down the arms. Final outcome of the events was unknown. Seriousness and causality was not reported.
On 1/22, I noticed a painful red itchy bump on my left foot.  Another bump appeared on my right index finger the day after, and then another bump appeared today 1/28 under my right arm.  They are getting larger, more painful and swollen, itchier, and seem to be filled with white pus.  The one on my left foot has burst.
1.75 inch x 1.25 inch erythematous papular patch warm with slight itch x 6 weeks.
Report adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Report adverse event) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (Report adverse event). At the time of the report, VACCINATION COMPLICATION (Report adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Developed chills roughly 12 hrs post 2nd vaccine. Developed fever and body aches. Fever was down Wed morning but spike Wed afternoon.
Information has been received from a Nurse Practitioner (also reported as Nurse prescriber) concerning to a multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with unspecified doses of VARIVAX or with unspecified doses of M-M-R II (strength, dose, route of administration, frequency, lot number and expiration date were not provided). No concomitant medications were reported. On unknown dates, after receiving the unspecified number of doses of VARIVAX or M-M-R II, the patients had negative titers (antibody test negative). The outcome of the antibody test negative was unknown. The relatedness between the event and therapy with VARIVAX and M-M-R II were not reported. This is one of two reports received from the same reporter. Additional information has been requested.
1 dose powder only; 1 dose powder only; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa418a, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo 5 mg. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had taken Menveo 1 dose powder only which led to the inappropriate reconstitution technique and inappropriate dose of vaccine administered. The reporter did not agreed to follow up.
Dose 1: Patient got the shot at 3:00 PM, at 6:00 PM their tongue started to swell, left sided facial drooping, numbness, and tingling. Patient took Motrin at 7:30 PM. All S/S continued until 12:00 the following day.  Dose 2: Patient got the shot at 10:30 AM in the gluteus maximus. A baseball size swollen knot appeared the next day and stayed for 1 week post vaccination.
HAD SOME INFLAMMATION IN HER BIG TOE AND HANDS; 1ST VACCINE CAUSED MILD FLU LIKE SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (HAD SOME INFLAMMATION IN HER BIG TOE AND HANDS) and INFLUENZA LIKE ILLNESS (1ST VACCINE CAUSED MILD FLU LIKE SYMPTOMS) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLAMMATION (HAD SOME INFLAMMATION IN HER BIG TOE AND HANDS) and INFLUENZA LIKE ILLNESS (1ST VACCINE CAUSED MILD FLU LIKE SYMPTOMS). At the time of the report, INFLAMMATION (HAD SOME INFLAMMATION IN HER BIG TOE AND HANDS) had not resolved and INFLUENZA LIKE ILLNESS (1ST VACCINE CAUSED MILD FLU LIKE SYMPTOMS) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of INFLAMMATION and INFLUENZA LIKE ILLNESS with Humira was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-634801 (Patient Link).
Initial consumer report received on 04 Jan 2010: This patient was vaccinated with S-OIV FLUVIRIN (batch no. 102134P1) on 18 Dec 2009. The patient vomited and presented with cold like symptoms on 25 Dec 2009. The events resolved on Dec09. Outcome of the events was reported as condition unchanged.
Baby developed fever, lethargy, pallor the evening and morning following vaccines. Had elevated WBC and CRP. Sepsis workup performed cultures all negative. On Rocephin for 7 days. Hospitalized 11/7-11/10. I was the attending for his hospital stay. Per acknowledgement: No further information available, please contact private physician.  Nurse follow up on 06/16/04 states: "clinical sepsis, WBC increased." Nurse follow up on 06/16/04 states: "no new information."
10/28/04 rec'd c/o from patient of joint pain that began 3 days after vaccination and has persisted x 1 week.  Responds to Ibuprofen- c/o severe ankle and neck, knee pain.  Afebrile, no rash or edema.  No resp. or C-I sx. (hx-MS)
Chills, fever and head ache from 12/6/19 AM to Sun. 12/8/19
Headache started a few hours after shot. Dizziness and fatigue followed the following day, along with slight headache. Nasal congestion started on 12/30/2016. 12/31 Nasal and eye pain on right side of face. Fluid drained from right eye and pain worsened in Nasal passage. Sneezing and congestion in right Nasal passage. 1/1/2017 eye and Nasal pain on right side continued to get worse, burning, itching, headache, and irritability. Dizziness comes and goes. 1/2/2017, woke up with swollen eye and discharge that seemed to be conjunctivitis and nose raw and sore (still right side only). Blister developing on top right lip. Still fatigued and facial pain on right side of face. Chills all over body that started on 1/1/2017.
Acute idiopathic thrombocytopenic purpura;   Iron deficiency anemia due to chronic blood loss
Two days after receiving FLUMIST patient developed red rash on all four extremities. Rash was painful and itchy which caused concern and patient was taken to ER.
after 3rd booster today, shortly after developed throat tightness and hoarseness. had to take antihistamine. This also occurred after the second dose I had shortly after getting the vaccine and I took antihistamine. Since it happened again on the third dose, I am inclined to report as if further vaccines are required, I may not be able to get one if developing signs of reaction that could lead to anaphylaxis or worse symptoms. May need to pre medicate if necessary in the future. No other history of reactions to other immunizations
No adverse reaction, simply received Flu vaccine instead of Tdap, as patient had requested to receive flu vaccine at a later date.  No symptoms or complaints.  reporting due to administration error.
Information was received from a pharmacist via a company representative. The pharmacist reported that there are "12 confirmed cases of mumps" and "19 cases pending" on unspecified dates (patient demographics not provided). The pharmacist reported that "some of the 12 cases" have had two doses of M-M-R II (dates of vaccination, lot numbers, dosages and routes of administration not provided). The outcome of mumps is unknown. There was limited knowledge of the "mumps outbreak," therefore no further information was obtained. Additional information has been requested.
She developed left arm swelling itching, pain and redness on 1/16/21.  Took benadryl and the swelling, itching tenderness improved, bu redness has increased.
Patient received a 0.5 mL Moderna dose substituted for Dose 3 Pfizer booster dose as a mix and match. Patient was observed for recommended time without voiced concerns. Patient did not experience an adverse event. Patient family attempted to be contacted by telephone with voice message to return phone call. Patient family voiced no concerns.
Pfizer COVID-19 Vaccine EUA  Patient was in medical monitoring and started to wave nurse down. Stated she was feeling light headed. Got her in a wheel chair was hot sweaty and looking like she was going to faint. Got her jacket off and cooled down never fainted. Patient stated she ate lunch. Vitals. BP 116/68, pulse 88 bpm, pulse ox 97%, RR 16 brpm. Patient monitored and then discharged to home.