chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This is a spontaneous report from a contactable physician. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The physician was giving Pfizer vaccines as part of his medical group to patients and employees. One patient came in today (29Mar2021) for her second dose and the day after she got her first shot, she got shingles on an unspecified date. The physician considered the event serious as other medically important condition. It was improving but has not gone away completely. The patient did not receive the second dose today, states they rescheduled her appointment for tomorrow 30Mar2021. The physician wanted to know if this is something that has been reported, could it be connected to the vaccine and if so, what is the guidance about second doses. The patient was recovering from the event.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "Shingles" cannot be completely excluded based on temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Tinnitus, ringing in right ear approximately two weeks after receiving the second dose of Pfizer vaccine
Considerable pain for 2-3 days; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history included hypochondriasis from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date and had "no trouble." On an unspecified date, the patient experienced considerable pain for 2-3 days (non-serious).  The clinical course was reported as follows: The reporter stated he had a family member (sister) who received the second vaccination in a different state. The patient had no trouble with the first dose of the COVID-19 vaccine and had considerable pain for 2-3 days with the second dose. The reporter stated there was nothing serious or to be concerned about. The reporter stated that the patient had been a hypochondriac. The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Seen in outpatient clinic 11/3/14 AM with decreased appetite, increased fussiness, emesis, abdominal distension, reddish-black stools worsening over 2 days.  On physical exam, distended abdomen with a diaper with currant jelly stool. KUB confirmed intussusception. Sent to ED. Treated initially with air enema, not resolved so had surgery to reduce and partial colocetomy.
A few weeks after my first dose I begin to express my heart racing at random times. When this happens I become very sweaty and feel like I might faint. This has never happened to me prior to the vaccine
The pt experienced lethargy, high fever, asthma, and eczema flared up for 4-5 days after received the 1st dose of Hepatitis A.
Within 2 minutes of receiving this HPV vaccine, my son had these symptoms: ringing in both of his ears, blurry vision, and not able to see, he said that everything went dark and he was not able to see anything at all for several minutes, even though his eyes were open the whole time and he was looking at me, he said that his body felt weird and that he was unbalanced and he might fall down, even though he was sitting down on the exam table in the exam room. He said that everything was spinning around, that his head really hurt, and that he needed to lay down. I alerted the nurse that gave him the vaccine, then I had my son, lay down on the exam table. Patients pediatrician, Dr., came into the room and asked patient how he felt and what was going on. His pediatrician said that sometimes adolescents have syncope or fainting after vaccines and that this certain  HPV vaccine can cause syncope and/or fainting after the vaccination. I stayed with my son, in the exam room with him lying down on the exam table and his pediatrician periodically checked on him and came into the exam room for the next 20 minutes and she monitored his reactions to the vaccine. After 20 minutes, she had patient sit up on the exam table and sit upright for 10 minutes. She then came back to the exam room after 10 minutes and she asked patient how he felt and he said that he felt better. She then allowed patient to stand up and try to walk around the exam room while she was there with us, to make sure that he was able to walk around okay and that he didn't fall. After 5 minutes, she said that she felt that he was okay enough to go home. She told him to take it easy for the next few hours and she told me to keep an eye on him for the next few hours. She said if he had any symptoms return or if he had any other symptoms or problems to call her office and they would see him right away, I monitored my son, the rest of that day on 01/18/21 and he seemed to be feeling okay and he did not seem to experience any other side effects from the vaccine.
Sore arm; This is a spontaneous report received from a contactable consumer (herself). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 2Feb2021 16:00 to Left arm at single dose for COVID-19 immunization. Medical history included Depression, High Cholesterol, Asthma and High b/p. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) at 88ug and metformin at 500 mg twice a day. It was reported as on 02Feb2021 patient experienced with Sore arm day after injection. Seriousness was reported as non-serious and patient did not receive any treatment for the event.  No follow-up attempts are possible. No further information was provided.
I received the second dose of the series of shots and felt immediate muscle cramping that went from the point of injection up the right side of my neck and head. To this day, the right side of my head is sore and tender to the touch. The next day I had a rash on my chest about five inches by five inches. My face broke out with pimple like lesions that lasted for three weeks. Some of my co-workers complained that I had bad body odor despite that fact that, I shower twice a day and use deodorant. I had a temporary case of depression and lack of motivation.
Information has been received from a physician concerning a health care provider's 20 year old son who was vaccinated with the second dose of GARDASIL on unspecified date.  In July 2008, the patient experienced headache after receiving the second dose of GARDASIL.  On unspecified date, he recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Pain at injection > 30  days , Dull pain radiating down left arm, Pain radiating to left side of neck, elevated temp, headache, fatigue/tiredness,  muscular pain, left deltoid, pain
Patient called clinic stating she has noticed slight tingling and slight swelling in legs since receiving her COVID-19 vaccine. She also states something "feels different" on the L side of her face. She overall doesn't feel "normal."   She is going to follow-up today with her PCP.
Rash around her right foot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash around her right foot) in an 83-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash around her right foot). At the time of the report, RASH (Rash around her right foot) had not resolved.            No concomitant medications provided. It was reported that when patient received second Covid-19 shot, she got a rash around her right foot which started about two weeks after second shot. She mentioned the rash was ongoing and she was scheduled to follow up with her physician this coming week.  No treatment information provided.   This case was linked to MOD-2021-052736 (Patient Link).   Reporter did not allow further contact
Cardiac event with ST elevation on EKG, and elevated troponin. Pt has no cardiac history.
Per ER evaluation dated 8/18/04: S: Anthrax vaccine dose 6 yesterday..."this one has swollen worse than any others with rash that has continued to spread". Patient complaining of right shoulder pain and redness after receipt of 6th anthrax vaccine yesterday. No SOB, no N/V/D, no chest pain. O: Afebrile. Right deltoid with mild erythema (approx size of fist), mild edema, no vesicles, mild warmth. A/P: Vaccine side effect. Tx with hot compress, Ibuprofen 800 mg 3x/day, and follow up as needed. Jan 2019 note: Patient has had ongoing chronic health concerns which he relates to receipt of anthrax vaccine.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: El9264), on 09Mar2021 as dose 2, single (Lot number: En6206), in left arm and on 17Oct2021 as dose 3 (booster), single (Lot number: Fh8020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Urothelial cancer immunotherapy treatment." (unspecified if ongoing), notes: Urothelial cancer immunotherapy treatment.; "Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LEVOTHYROXINE; NEBIVOLOL; OLMESARTAN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Tested positive again for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: patient took Paxlovid for 5 days. Felt good day 6 to day 10. Day 11 woke with stuffy nose and sinus congestion. felt achy. Tired. No fever. Tested positive again for COVID. Known allergies: Codeine and sulfa.
The patient sated that she has been tired, the left arm is swollen and has a red rash and arm is wrinkled
Next day body pain and joint pain;  3rd day joint pain more localized to my injured knee; but severe; that night insomnia with nerve pain in legs and feeling insect bites over my body (no insects)
The vial was initially stored in refrigerator on 13Mar2023 and administered on 19-Apr-2023.; No adverse event; Administered expired Moderna Vaccine to the patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to the patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 19-Apr-2023.) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2023, 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 19-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to the patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 19-Apr-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to the patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 19-Apr-2023.) 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 (Administered expired Moderna Vaccine to the patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 19-Apr-2023.).    No concomitant medications were reported. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date. The vial size was 2.5 ml.  The vial did not undergo any temperature excursions. No treatment medications were reported.  This case contains information for the 6th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:
the ball reappeared, bigger,harder,ball hurts on pressing,small ball of liquid as if the vaccine were there; ball reappeared, this time it is bigger and harder; if pressed it the ball hurts; discomfort in her arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (the ball reappeared, bigger,harder,ball hurts on pressing,small ball of liquid as if the vaccine were there), INDURATION (ball reappeared, this time it is bigger and harder), PAIN (if pressed it the ball hurts) and LIMB DISCOMFORT (discomfort in her arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004621A and E31B21A) for COVID-19 vaccination.     No medical history information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced SWELLING (the ball reappeared, bigger,harder,ball hurts on pressing,small ball of liquid as if the vaccine were there), INDURATION (ball reappeared, this time it is bigger and harder), PAIN (if pressed it the ball hurts) and LIMB DISCOMFORT (discomfort in her arm). At the time of the report, SWELLING (the ball reappeared, bigger,harder,ball hurts on pressing,small ball of liquid as if the vaccine were there), INDURATION (ball reappeared, this time it is bigger and harder), PAIN (if pressed it the ball hurts) and LIMB DISCOMFORT (discomfort in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was reported to take birth control pills. Upon internal review on 04-Aug-2021, age was corrected to 25 years.   This case was linked to MOD-2021-114521 (Patient Link).
side effects with Lot# 041L204; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects with Lot# 041L204) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L204) 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 an unknown date, the patient experienced VACCINATION COMPLICATION (side effects with Lot# 041L204). At the time of the report, VACCINATION COMPLICATION (side effects with Lot# 041L204) 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 concomitant medication was reported.  It was reported that the patients had side effects with Lot# 041L204.  Treatment medication was not provided by the reporter.
After getting the bivalent COVID booster on Monday morning (9/19/22), I experienced the usual side effects, including fatigue and chills.  At breakfast the next day, I fainted.  This was preceded by sweating, dizziness, and nausea.  I was unconscious for perhaps 10-15 minutes.  Afterwards, I recovered fine, rested, and had no other fainting episodes.  I had fatigue and a mild headache throughout Tuesday (9/20/22).  By Wednesday (9/21/22), I was feeling fine.
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office staff manager). This case is linked to case 2018SA331474, same reporter. This case involves a 6 years old male patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 09-Nov-2018, the patient received a 0.25 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259NA, expiry date 30-Mar-2019 via unknown route in the left deltoid. It was an actual medication error due to vaccine underdose. It was reported that patient who should have received 0.5 ml only received 0.25 ml of vaccine FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, swelling arm and intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a quick question about how the SHINGRIX vaccine was given. The patient received her 1st dose of SHINGRIX as a subcutaneous, which led to wrong route of vaccination. The patient even asked to be sure if it was to be given this way. Turned out, it was supposed to be given intramuscularly. The patient had a rather bad reaction to the SHINGRIX vaccine, her arm was red and swollen and very sore for 1 week. The patient's actual question was how would this affect the vaccine's effectiveness. The patient got the 2nd dose of SHINGRIX intramuscularly on the date of reporting. The patient wanted to know whether she need another 3rd dose or should she be okay.
bodyache.  PT receive J/J vaccine yesterday approx 0930 reports onset of bodyaches, chills, HA and nausea since last night. denies feeling ill prior to vaccination.   28 yo F, no known chronic medical conditions, got the COVAX (J&J) at 0930 yesterday; at about 1900 she started to experience severe fatigue, chills, frontal HA, body aches, and nausea. No fever, neck pain, vomiting, diarrhea, urinary urgency/frequency, hematuria. No CP, cough, SOB, abd pain. Felt well prior to receiving the vaccine.
Patient age is less than approved age of vaccine. She reported a very sore arm on 1/29/21 but no other side effects
Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the right arm on 19Dec2020 at 10:15 AM in a hospital at a single dose for COVID-19 immunization. Medical history included asthma and GERD. The patient was not pregnant at the time of vaccination and had no known allergies. The patient had no other vaccine in four weeks, had no COVID-19 diagnosis prior to vaccination, and was not tested for COVID-19 post vaccination. Concomitant medication included omeprazole (PRILOSEC). On 27Dec2020 at 18:00, the patient experienced a recurrence of redness, swelling, and pain at injection site measuring 5.5 cm x 5.6 cm occurring on day 9 post injection. Site reaction was identical to the initial reaction occurring on days 2 and 3 of Dec2020, which resolved by day 4. The patient received no treatment for the events. Outcome of the events was not recovered/not resolved.  Information about the lot/batch has been requested.
Patient's arm became numb upon administration. Pharmacist who administered the immunization had her sit in the waiting are for 10-15 minutes. The patient then left stating she was ok. She went to the ER the next day due to her arm going numb again. Patient was prescribed a steroid at the ER.