chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning 5 patients who were vaccinated with PNEUMOVAX 23. Subsequently the patient experienced redness, soreness and warmth to the touch in a 3-4 inch area around the injection site after immunization with PNEUMOVAX 23. It was reported that 2 of these cases happened recently, and 3 of them happened about 6 months ago. The patients sought unspecified medical attention. No other information was available at this time. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Pt had severe fatigue, fever, stomach aches, dizziness. She missed 20 days of school in 2007/2008 during her 3 series of shots. In March 2008, she was diagnosed with Juvenile Rheumatoid Arthritis, which can be set off by a live virus. She had symptoms through all 3 shots until March of 2008.  8/15/08 Reviewed PCP medical records of 9/1994-5/2008. FINAL DX: polyarticular juvenile inflammatory arthritis. Records reveal patient experienced usual state of good health on 7/23/2007.  Next office note is for 3/6/08 for bilateral hand pain she had for 4-5 mo.  Had been seeing podiatrist for ankle pain that patient experienced for several months.  Exam at that time revealed diffuse fusiform swelling symetrically of both hands esp in PIP joints of fingers.  Referred to rheumatologist & consultant records included.  Symptoms at that time included pain & stiffness in multiple joints incl hands, wrists & ankles w/stiffness esp bad in mornings.  Started on methotrexate.  Referred for second opinion which is also included.  Missed 20 days of school due to current symptoms.  Agreed w/diagnosis.  Increased meds & referred to PT/OT.  Returned to initial rheumatologist for continued f/u.  Minimal improvement & started Humira & serial labs.
One hour after receiving the first dose of the COVID 19 vaccine, the employee experienced the following symptoms:  migraine, nausea, vomiting, skin felt prickly, lightheaded and dizzy, diarrhea.  This lasted from 4/23/21 through 4/26/21.  Symptoms except headache resolved by 4/28/21.  Employee notes she stopped breastfeeding the day of her vaccine, so she thinks this may have contributed to the headache.  Employee is consulting her primary care provider about these symptoms and if she should  receive dose 2 of the COVID 19 vaccine.
Localized pain/swelling @ injection site; chills, body and muscles aches, fever of 103.5 orally at highest 02/03/2012 @ 1am.  Warm pack applied intially, then cold pack applies x 2 days (on 02/03 - 02/04/2012).
Localized swelling, soreness, fever, malaise. TX: TYLENOL, rest, fluids, f/u appt as needed.
Shingrix 3rd dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 34L52, expiry date 6th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 10th October 2019) and Shingrix (received 2nd dose of Shingrix on 23rd December 2019).   On 5th July 2022, the patient received the 3rd dose of Shingrix. On 5th July 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The pharmacist called to inquire that, any report of adverse effects.  The reporter wanted to know how to proceed. The reporter confirmed that the patient was administered the third dose of Shingrix in their facility.  No additional details were provided.  The reporter consented to follow up. Additional Supportive Information: The patient inadvertently received third dose of Shingrix, which led to extra dose administered.
rash on arms; This case was reported by a consumer via call center representative and described the occurrence of rash in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. The patient was treated with prednisolone. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced rash on her arms.  The patient saw her physician and was treated with a prednisone taper and that the rash was improving but has not resolved yet. Consented to follow up.
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (COVID arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (COVID arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Itching, at an unspecified dose and frequency. On 20-Feb-2021, TYPE IV HYPERSENSITIVITY REACTION (COVID arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included high blood pressure medications.
Hives all over legs on 2/27/2022, went away for 4 hours, developed again all over body and lasted until 3/1/2022.  Went away for a day and came back on 3/2/2022 into 3/3/2022. Went away for 2 days and developed the hives again on 3/6/2022.
diarrhea; vomiting; Had shot at 9am, by 3pm had a 99.9 fever; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205) via an unspecified route of administration on 27Feb2021 at 08:00 (at the age of 51-years-old) in left arm as a single dose for covid-19 immunization. Medical history included rosacea from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. The patient had no known allergies. Concomitant medications received in two weeks included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); mometasone furoate (NASONEX); bupropion hydrochloride (WELLBUTRIN) and doxycycline (DOXY [DOXYCYCLINE]) low dose time, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever of 99.9 on 27Feb2021 at 15:00. She woke up at 4 am with diarrhoea then vomiting on 28Feb2021. Till 3 pm she had vomited ever two hours since 4 am. The patient took Tylenol for fever and received no treatment for other events. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 20May2020. The outcome of all the events was recovering.   No follow-up attempts are possible. No further information is expected.
I had muscle aches at night, I woke up the next day with bronchitis symptoms a sore throat, sinus drainage, and a runny nose including sneezing, and coughing up mucous. It became worse throughout the day. On 01/04/2023 my COVID-19 test was negative and by 01/05/2023 I had a positive test. I went to urgent care on 01/05/2023 and my COVID-19 test their was positive there as well, PAXLOVID was prescribed and I reported in VSAFE the same day.
This spontaneous report was received from a medical assistant and refers to multiple unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of VAQTA lot number M022924, expiration date 24-JAN-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided) were administered to a multiple unspecified number of patients for prophylaxis. The vaccine was exposed to a temperature of 67 Fahrenheit degrees for 16 hours. There was no previous temperature excursion, and the call was not because of a "data logger. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same soured. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004337: US-009507513-1706USA004338: US-009507513-1706USA004336: US-009507513-1706USA004335:
slept more; more tired than normal; The caller mentioned she was breastfeeding at the time; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept more), FATIGUE (more tired than normal) and EXPOSURE VIA BREAST MILK (The caller mentioned she was breastfeeding at the time) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 16-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Transmammary) 1 dosage form. On 16-Dec-2021, the patient experienced EXPOSURE VIA BREAST MILK (The caller mentioned she was breastfeeding at the time). On 17-Dec-2021, the patient experienced SOMNOLENCE (slept more) and FATIGUE (more tired than normal). At the time of the report, SOMNOLENCE (slept more), FATIGUE (more tired than normal) and EXPOSURE VIA BREAST MILK (The caller mentioned she was breastfeeding at the time) outcome was unknown.      No concomitant and treatment medications were reported.  Parent stated that the child has not currently received any COVID-19 vaccinations at this point in time.  Parent stated that she received the Pfizer booster dose on 27-May-2022 and her child experienced side effects after the Pfizer dose also.   This case was linked to MOD-2022-592947 (Parent-Child Link).   See case MOD-2022-592947 for details regarding the child case.
Right arm dermititis for 3 weeks, no swelling, itiching, burning. After5 weeks #13 toohache for 8 weeks with eventual root canal redo from 3 years ago. 8 weeks later, root canal to #11.
I had a 103 degree temperature for 9 hours, was hallucinating, chills, headache and I could not feel my fingers. They were numb. Hands pain.
Patient was given the Pfizer Pediatric vaccine at the adult dose 0.3 ml. Patient then informed of wrong vaccine and dose. Was given 0.3 ml of Pfizer adult vaccine with no dilution.
Pt reportedly doing well until about 2 nights ago- started feeling some chills, attributed it to worsening winter temps outside. Following morning had a sore throat, some nasal congestion, questionable cough (denied to me, admitted to ED MD). Symptoms seemed to improve after he had a "fruity drink" his wife gave to him. He has since been more fatigued, most notably today, when he was unable to get off the toilet.    Wife states that pt is wheelchair bound at baseline, does not walk. Able to help with transfers out of bed and into the wheelchair (uses a bedside pole). Has been able to do this for the last few days, although wife has noticed it seem to be more difficult than usual. Was able to do this this morning, when she got pt up to go to the bathroom. Pt able to sit on the toilet, use the bathroom, however was too weak to get up. Home Health Nurse happened to stop by shortly thereafter and talked to pt and wife about going to the ED. 911 called. EMS arrived, pt noted to have BG to 44. Temp 100. Pt given orange juice and brought to ED.    ED eval notable for hypertensive pt, otherwise vitally normal with glucose to 28. Given D50. Otherwise had an unremarkable lab workup, renal function decreased but about at baseline. Infectious w/u notable for CXR with patchy opacities R>L, concerning for COVID PNA. UA pending.  Pt with limited admission to symptoms, reluctantly stated he had a sore throat for a day, denied cough (did admit this to ED MD), some nasal congestion. Denies difficulty breathing. No chest pain. No diarrhea.  1/11/2022 PROGRESS NOTE HEMATOLOGY ONCOLOGY We are following this 85 year old male currently hospitalized with covid 19, and found to have right basilic vein thrombosis with edema.    We recommend lovenox 1.5mg/kg daily x 2 weeks and then transition back to coumadin or any other DOAC covered through his insurance.    No further hematology/oncology recommendations at this time. 1/12/2022 patient is seen and examined today.  He is awake, oriented, not in distress.  Responds commands appropriately.  No issues or complaints noted overnight.  Hemodynamics remained stable.  No fevers noted.  O2 sats are normal on room air.  1/14/2022 Discussed with him about overall condition, he keeps repeating me but cannot answer more questions.  Also video swallow evaluation was done which does show that he is aspirating things.  Speech therapy recommended complete n.p.o.  Discussed with his wife in regards to his condition, further treatment plans including feeding tube versus hospice care.  She could not decide at this time.  She would like to talk to patient as well as her brother to discuss more about this.  1/15/2022 He is awake, minimal confusion noted.  Responds commands appropriately.  Saturating well on room air.  He was changed to hospice/comfort care as of 1/14/2022.  No other issues or complaints noted overnight. 1/17/2022 pt new to me today - NAEO - awake in am, asks for sips of cold water - provided at bedside - no report of pain to me (did get pain meds just before)
9:10 am Patient started to complain of feeling like her throat was getting thicker. Started to feel flushed, sweating, hoarse, and coughing some. 9:15 Epi-pen injector administered. Ambulance called, Patient never lost consciousness. She was alert and talking the whole time. Sent to E/R by ambulance.
eyes swollen, neck swollen, hands appeared puffy; back & chest had a rash lasted 5 days; no difficulty breathing or swallowing;
second dose Of Shingrix was given only 5 days after te first one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number DJ455, expiry date 26-JAN-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (SHINGRIX).   On 10-FEB-2023, the patient received the 2nd dose of Shingrix. On 10-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: second dose Of Shingrix was given only 5 days after te first one). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 18-MAY-2023 The reporter reported that the 2nd dose of Shingrix was given only 5 days after the first one and wished to know how to proceed. The information about the vaccine, patient and event were provided.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
A 21 year old college student was given MMR vaccine on 6/6/23 on Left upper arm at Health Clinic. On 6/12/23 patient reports redness to vaccine. Patient came to Health Clinic on 6/13/23 and was evaluated by NP for possible allergic reaction. NP and supervising MD evaluated the possible vaccine reaction on LUA, isolated erythema and dryness to L upper arm in the shape of band aid applied to site. No SOB or diffuse rash or hives noted.  Student with previous allergy to adhesive. No referral to ED required. Student advised to treat lesion with OTC hydrocortisone cream and emollients to improve skin dryness.
Symptoms, especially nasal congestion returned 4 days after stopping Paxlovid; Symptoms, especially nasal congestion returned 4 days after stopping Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 11May2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 12Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: allergies; "epilepsy" (unspecified if ongoing); "hormonal joint condition" (unspecified if ongoing), notes: hormonal joint condition. Concomitant medication(s) included: VENTOLIN [SALBUTAMOL SULFATE]; MONTELUKAST; DUPIXENT. Past drug history included: Dilantin, reaction(s): "Known allergies: Dilantin", notes: known allergies Dilantin, keppra; Keppra, reaction(s): "Known allergies: keppra", notes: known allergies Dilantin, keppra. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Symptoms, especially nasal congestion returned 4 days after stopping Paxlovid". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional information: Symptoms, especially nasal congestion returned 4 days after stopping Paxlovid. Anti-viral details: product-COVID 19 Treatment, brand-Paxlovid, Treatment start date-06May2022, Treatment stop date-11May2022, Indication: Treatment of COVID-19. Ae treatment: Steroid inhaler, acupuncture, nasal rinse etc  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received vaccine, and no reactions.   Nine days after the vaccine slowly had drooping on the right side of his face, numbness on the right side of his face, mainly around the mouth, a little on the eye, hard to close the right eye.  General soreness around his mouth when he tries to eat or talk a lot.  Limited movement of his face do to swelling, difficulty closing his eye, and headache.   Went to the ER on 3/7/21 and admitted him as they believed he had a blood clot, diagnosed him with Bell's palsy on Monday 3/8/21.  Was given corticosteroids for 9 days Prednisone 60 mg.  The symptoms are slowly improving but still has the Bell's palsy.
Headache; Numbness in the face; Migraine after he had 1st Pfizer dose/migraine was returning; Migraine after he had 1st Pfizer dose/migraine was returning; This is a spontaneous report from a contactable nurse (patient's parent). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0177), via an unspecified route of administration on 10Jun2021 (at the age of 19 years old) as dose 1, single for COVID-19 immunization. Medical history included migraine (but he was fine for like the last 2 years), diabetes, and food and drug allergy (not further specified). Concomitant medications were not reported. The reporter stated that the patient got his migraine on an unspecified date in Jun2021 after he had 1st COVID vaccine on 10Jun2021, the next day, 11Jun2021, he started having headache and continued on to the point that they ended up scheduling the Doctor's appointment. He was having anywhere from 2-7 migraines a day and they had the Doctor appointment and the Doctor started treatment on him. His migraine was so bad that he had numbness in his face and required an emergency room (ER) visit for that. The reporter thought that the Pfizer vaccine may have somehow contributed to the side-effects his migraine was returning. It was reported that the headache became different instead, he used to have migraine like once in a while, they go away and they were treatable, now they are coming in clusters and Tylenol, Ibuprofen even the prescribed medication the Doctor had given him which was Topamac was not helping and reached to severe enough level that he was actually having numbness in his face. The reporter said that after getting that Pfizer vaccine, the patient started getting severe migraines every day. They were bringing him to a point of tears. Nothing he had experienced before was like this. The outcome of the event "migraine was returning" was not recovered, and for other events was unknown.
Fever, cough, hard time swallowing fluids, feet hurt, sore throat, and cough
Information regarding Prevnar was received from an investigator regarding a 2 month old male participant in a study who experienced SIDS. The participant received the first dose on 5/29/01. The participant also received the first dose of Infanrix, the first dose of Engerix B and the first dose of IPOL on 5/29/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 5/29/01. Dose regimen was 1 dose 1 time per day. Concomitant therapy included Infanrix, Engerix B, and IPOL. On 5/31/01, 2 days post vaccination, the patient expired as a result of SIDS per the county coroner's office. The investigator considered the relationship between sudden infant death syndrome and Prevnar to be remote. The medical monitor considered the event to be not related to the study product. This report of a serious, labeled event is being submitted in an expedited time frame as requested by the FDA. No additional information reported on autopsy report rec'd 03/02/2005. Autopsy Report received which states COD is SIDS.
Vials not stored properly may have been administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vials not stored properly may have been administered) 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 an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials not stored properly may have been administered). At the time of the report, PRODUCT STORAGE ERROR (Vials not stored properly may have been administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was unknown by the reporter.  On an unknown date, vaccines being stored had 17 temperature readings that were over 28F. 50 doses of this vaccine were given to patients after the temperature excursion. No other information was provided regarding the 50 patients.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received and reporter information and event information updated.