chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temp started about 2PM day of inject; t100-102 for 24 hrs; remained 99.2-99.8 since; Red hard area size of fifty cents piece; bruised area almost to knee; Called MD who did not want to see pt as he doesn't immun & doesn't know much about;
Narrative:  A 73yo male with PMH of Hearing Loss, Solitary Nodule of Lung, Cerebrovascular Accident, Hypertension, Hyperlipidemia, PTSD, Neurocognitive Disorder and Depressive disorder. On September 21, 2021 the patient was reported with a historical  ADR of influenza vaccine induced anaphylaxis by ED Physician Assistant. It was updated from initial NKA in the ED, upon patient's admission to unit. The ADR report did not include which influenza vaccine, manufacturer's name, Lot #, who administered it, where and when it was administered, Unable to fine Flu immunization record.
redness ands swelling in arm 2-3 days after vaccine. 2x2 cm "knot" still present at vaccine site
called mom to check on patient told mom she wasn't feeling good but when mom spoke to her she was not responding her, mom got on interstate. Mom stated that she involuntary motions, mouth and eyes open, arms straight in front of her, pale like all color drained. Mom stated it took at least 3-5 min to get back to normal to where she was responding to her. patient told her that she couldn't move and couldn't breathe but could hear mom-she told mom she was frozen.   Mom took to hospital and vitals were good when she got there, she was moving and talking back to normal self  Mom stated it was approximate 20-25 min from time it was given in office that the event happened.
Allergic to moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic to moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection 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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic to moderna vaccine). At the time of the report, ALLERGY TO VACCINE (Allergic to moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No information regarding corrective treatment was reported by the patient.
pt recvd vax; uncontrollable high crying more than 3 hrs; fever of 104; mottled skin discoloration "rash" 24 hrs; trembling; jerking; to PMD 15 sep94; tx w/ meds;
UrticariaPruiritus Narrative: dizziness, achy, redness,warm
Fever (103 F)-started Friday 4/18/08; Rash (diffuse, but more concentrated around ears and forehead at hairline)-started Sunday 4/20/08 Oral lesions Runny nose *ODH recommends to report event to VAERS
Numerous papules on trunk, back of neck and upper legs. No pustules or umbilication. Does not itch.
At 2 mo vaccines-2 days after administration parents called that baby having irregular breathing. Told to go to ER. Resolved. Parents didn't go to ER. After 4 mo vaccines again with episodes of abl breathing and seizure activity. EA for video EEG. Baby admitted, parents refused VEEG after episode period in 10 hours.
sore arm were I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm were I got the shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm were I got the shot). At the time of the report, VACCINATION SITE PAIN (sore arm were I got the shot) had resolved.            Patient did not take any regular medications. It was reported that, the reporter was on his 60s, may be the year and the month was march but the date was missing. The caller mention that after the 1st and 2nd shot of the Moderna COVID-19 vaccine he had a "sore arm were I got the shot" for a few days Treatment information was not provided.   This case was linked to MOD-2021-400033, MOD-2021-400044 (Patient Link).
A few days after 1st vaccine, I experienced tinnitus in both ears, with right ear being more severe. I have never had tinnitus before, or had any ear problems prior to the vaccine. The symptoms have not improved, and I still continue to have tinnitus to this day.
This spontaneous report was received from an administrator referring to unspecified patients of unknown ages and genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ orally (strength, dose number, lot number and expiration date were not provided) or prophylaxis. The vaccines experienced temperature excursions. Furthermore, no product quality complaint was involved. It was reported that the vaccine ROTATEQ was supported. Also the reporter was not sure if the vaccine was administered or not. This is one of several reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1612USA008791: US-009507513-1612USA003396.
Coughing up blood, chest congestion,  cannot lift my right arm. Night sweats.
Fever and arm redness and swelling 1 d after injxn. Resolved in 24 hrs. No treatment except TYLENOL.
No adverse effects; on 7/22/2019 a patient was administered improperly stored RECOMBINAX HB; This spontaneous report ws received from a registered nurse refering to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 22-JUL-2019,the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R001529 and expiration date 07-NOV-2020 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse event was reported. The temperature excursion was reported as above 47 degrees Fahrenheit / 9 degrees centigrades (mainly 9.9 degrees centigrades) during a time frame of 1 hour and 50 minutes. No previous temperature excursion was reported. No digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA004312: US-009507513-1908USA001033:
Patient complained that she got Shingle Rash appear on her back at west line the next day after she received vaccination. She complained that it is painful. She has not received any treatment. She said she attempted to call dr but they are busy. She did discontinue her valtrex while she received shingles vaccine. She did said it is getting little better.
This study case was received from the investigator in a trial on 16 July 2013. A 32-year-old male subject with a past medical history of elevated cholesterol and headaches was found to have encephalitis following immunization procedures 11 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 08 April 2010. Troponin I, ECG, echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
pt recv vax 12FEB96 & on 28NOV96 pt exp typical progressive lesions of chickenpox w/a rash all over body;
Case was vaccinated for Covid in AUgust 2021, then was hospitalized for Covid in January 2022. Hospitalized at:  Hospital  COVID Assessment & Plan Fully vaccinated against covid. Patient was tachypneic and reported shortness of breath at time of admission, thought to be compensatory for DKA. However, he does have e/o covid pna on CXR. Precludes use of monoclonal abs. He is not hypoxic and does not qualify for steroids or remdesivir. Sore throat now resolved. Started on abx briefly but wbc nml and pct normal so stopped rocephin yesterday.
Multiple large puss filled pimples on upper body area; Skin rashes; This spontaneous case was reported by a consumer and describes the occurrence of ACNE PUSTULAR (Multiple large puss filled pimples on upper body area) and RASH (Skin rashes) 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 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACNE PUSTULAR (Multiple large puss filled pimples on upper body area) and RASH (Skin rashes). At the time of the report, ACNE PUSTULAR (Multiple large puss filled pimples on upper body area) and RASH (Skin rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were provided by the reporter.  No Treatment medications were reported.
Patient came to clinic today for other reasons; however, reported having a poking sensation 15 minutes post-vaccination to left chest wall. Afterward, she developed daily headaches, brain fog and severe fatigue, which remain ongoing today.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. It was reported that on an unknown date, an unspecified number of patients might have been vaccinated with a dose of GARDASIL (lot number, expiry date, dose, route unspecified) which was exposed to 1 degree Celsius for up to 14 hours (reported as 1 degree Celsius for up to 14 hours was a supported excursion for GARDASIL. No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
Within 1-2 hours after receiving the 1st dosage of Pfizer vaccine my child had a runny nose. It has now been 24hrs and he still has a non-stop runny nose and fever.
This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9267, Expiry date: not reported) via an unspecified route of administration on 19Feb2021 (at the age of 88 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9263, Expiry date: not reported) via an unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization. Calling about the COVID vaccine. Was fortunate to get the first shot after much anguish and with time, and was scheduled for the second shot, she understood it was recommended be given three weeks after the first shot, her appointment was for 4 weeks after. Calling to find out, would it be just as effective as the recommended three weeks. On an unspecified date in 2021, Shortly often receiving the second dose of the Covid vaccine the patient developed a rash. Her dermatologist thought it might be Shingles. The rash had little blisters and itched. Lab test showed it wasn't Shingles. They identified it as a dermatitis. She had not had negative reaction to other vaccines. The rash had gone away. The patient underwent lab tests and procedures which included laboratory test: Lab test showed it wasn't Shingles. They identified it as a dermatitis in 2021, weight: 132 lbs. in 2021. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Pt. states that after receiving the 1st dose of Shingrix 09/17/2021, started experiencing symptoms that evening of extreme chills, fatigue, dizziness, upset stomach, bloating, and weakness. Lasting 3 days time, No noted Primary visit. Still continuing to experience upset stomach and bloating.
The Pneumococcal vaccine was placed with the Flu vaccine by the other pharmacist. When I came on duty the tech ask me to do a Flu shot. I grabbed the open vial out of the same place as always and it was the wrong vaccine. I later gave correct vaccine later the same day.
Chest pressure, trouble breathing pulse ox at 95%  vomiting diarrhea nauseous chills
Fever; Nausea; This is a spontaneous report from a non-contactable reporter (other healthcare professional).  A 38-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 38 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot Number: Unknown, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Respiratory decompensation approximately 8-12 hours after administration of first dose of ROTATEQ.; The patient aspirated on the ROTATEQ; Inappropriate age at vaccine administration; This spontaneous report was received from a pharmacist and refers to a 3-month-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter (Inappropriate age at vaccine administration) (lot number 1947634 has been verified to be a valid lot number, expiration date reported and validated as 05-MAY-2024), administered orally for prophylaxis.  He was given the vaccine; however, the patient was intubated, and it was believed that the patient aspirated on rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (aspiration) on that day. Then, on that same date (reported as 8-12 hour after vaccination), the patient experienced respiratory decompensation (respiratory failure). The patient was already hospitalized when the events occurred. At the reporting time, the outcome of the events was unknown.   The causal relationship between the events and the suspect vaccine was not provided.
NOSE BLEEDS; PAIN; FATIGUE; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (NOSE BLEEDS), PAIN (PAIN), PYREXIA (FEVER) and FATIGUE (FATIGUE) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (FEVER). On an unknown date, the patient experienced EPISTAXIS (NOSE BLEEDS), PAIN (PAIN) and FATIGUE (FATIGUE). At the time of the report, EPISTAXIS (NOSE BLEEDS), PAIN (PAIN), PYREXIA (FEVER) and FATIGUE (FATIGUE) outcome was unknown.            Concomitant medications were not reported.  Action taken with Humira (Adalimumab) was reported as discontinued. The reporter's causality for the events of fatigue, nose bleeds and pain was not provided for Humira (Adalimumab).  The reporter's causality for the event of fever with Humira (Adalimumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment medications were not reported.
Patient complained of rash on abdomen @ 15 of the on Sunday 10/3/05. Came to office 10/21/05, rash on abdomen, back, axillary area, upper thigh and face.
Vax received morning of 11/4. Expected tenderness on 11/6 and 11/8. On 11/9 awoke with severe tenderness, swelling, and edema to right deltoid extending into R shoulder and neck. Headache also, temperature of 99.2. Seen in ER. Swelling decreased throughout the day. Fever, tenderness and headache on 11/9 evening. Only mild tenderness son 11/10 morning with no fever or edema. Treatment: Heat, Tylenol, Motrin, Benadryl cream.
On 2/3/2023, I experienced a really runny nose. I thought it was an allergy symptom at first. On 2/4/2023, I took a home COVID-19 test and got a positive result. I felt okay on 2/4/2023 during the day, but I began to feel worse that evening. I called in sick to work. On 2/5/2023, I had a fever that was at 102 at its highest point, but it hovered around 100 for most of the day. I began taking MUCINEX and NYQUIL. The fever would break when I took the medicine, but it would return whenever the medicine wore off. I slept for most of that day. On 2/6/2023, I continued to have a fever of around 100 for most of the day. Again, it would subside when I took the medicine and return when the medicine wore off. I had ringing in my ears that was so severe that I felt dizzy. I also had a headache and nasal congestion. On 2/7/2023, the symptoms from the prior two days continued, but I lost my senses of taste and smell. On 2/8/2023, I still had a fever in the morning and a lack of taste and smell, but my energy level was a lot better. On 2/9/2023, I was finally fever-free without the use of medicine. I also started to get more energy back. On 2/10/2023, I had even more energy and no fever. I had some wheezing, though. On 2/9/2023 and 2/10/2023, I continued to use MUCINEX, but I stopped using NYQUIL. On 2/11/2023 and 2/12/2023, I continued to get more energy and would use an albuterol inhaler whenever I would get shortness of breath. I also continued to use MUCINEX. At the time of this writing, I have not fully recovered my sense of smell, but I've recovered more of my sense of taste. On 2/12/2023, 2/15/2023, and 2/18/2023, I took home antigen tests and got negative results on all of them.
CoughWheeze some mild congestion, scratchy throat post nasal drip Narrative: 12/29 Tested positive COVID
Patient had a Moderna Bivalent COVID vaccine on 9/22/2022.  He was given another dose today (1/31/2023) by mistake.  When I spoke with him today at 3:35pm he denied any problems.  I will plan to f/u with him tomorrow afternoon.
suspected vaccination failure; shingles located on the top of his head; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 29th October 2019, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 72 or 73 years. The patient received the 1st and 2nd dose of Shingrix in 2018.  Couple of days before the date of reporting, the patient was diagnosed with shingles  and his doctor gave him cream.  The shingles were located on the top of his head. No additional details were available. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation were unknown.
Mild rash noted around bilateral thighs where vaccines were given 2 days prior (1/11/2016). No redness noted. BENADRYL 1.25 ml PO administered (1/13/16).
No additional AE reported; Patient who was previously administered VAQTA via VAQTA Pediatric/Adolescent Formulation on 09/24/2022; 03/15/2023, beforeCorresponding Patient was administered Corresponding Patient's 2nd VAQTA Dose via Intended VAQTA Adult Formulation; This spontaneous report was received from a medical assistant and refers to an 18-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-SEP-2022, the patient vas vaccinated with first dose of hepatitis a vaccine, inactivated (VAQTA) (via VAQTA pediatric/adolescent formulation) while the patient was 18 and 1/2 years old(product administered to patient of inappropriate age). On 15-MAR-2023, the patient left the reporter's facilitybefore being administered patient's second dose of hepatitis a vaccine, inactivated (VAQTA) via intended VAQTA adult formulation adverse event regarding previous dose was spotted. The patient was never administered second dose of hepatitis a vaccine, inactivated (VAQTA) (via intended VAQTA adult formulation prior to or at the time of the report). Caller was unable to further clarify these statement's at the of the report. No additional adverse event was reported and no further information was provided.
About 3 hours after injection (8/6/21), started having shortness of breath  and tightness in chest. For about 48 hours it was pretty regular every few hours. Felt like I couldn't take a deep breath. Asthma? Histamine reaction? Got fatigued easily and couldn't exercise at all without getting out of breath. It took a week for it to go away. Still not doing regular exercise. Taking it slow. Had hip pain(8 /7/21). At 1:00 am on 8/8/21 I was woken up by left arm pain. Not a injection site, but above and below elbow(including elbow) Took an hour or two to find a comfortable position to go to sleep.  Had a few red spots on legs appear in the first week.  I don't feel as well as I did before the shot. (Breathing, lung capacity)
small fiber neuropathy; neurological condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "small fiber neuropathy"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "neurological condition". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Severe