chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting 2 days after the first vaccine (April 16, 2021, 3:30 PM) Dizziness started and continued for a week after the vaccine had taken place; Abdomen pain in the upper right quadrant also occurred; Abdomen pain in the upper right quadrant also occurred as well as nausea; Was sent for an Ultrasound and blood work. Both came back negative for anything except a gas bubble in abdomen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 15:30 (Lot number: EW0162) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TRI LINYAH taken for contraception. The following information was reported: DIZZINESS (non-serious) with onset 18Apr2021, outcome "recovered" (24Apr2021), described as "Starting 2 days after the first vaccine (April 16, 2021, 3:30 PM) Dizziness started and continued for a week after the vaccine had taken place"; ABDOMINAL PAIN UPPER (non-serious) with onset Apr2021, outcome "recovered" (24Apr2021), described as "Abdomen pain in the upper right quadrant also occurred"; NAUSEA (non-serious) with onset Apr2021, outcome "recovered" (24Apr2021), described as "Abdomen pain in the upper right quadrant also occurred as well as nausea"; FLATULENCE (non-serious) with onset Apr2021, outcome "recovered" (24Apr2021), described as "Was sent for an Ultrasound and blood work. Both came back negative for anything except a gas bubble in abdomen". The events "starting 2 days after the first vaccine (april 16, 2021, 3:30 pm) dizziness started and continued for a week after the vaccine had taken place", "abdomen pain in the upper right quadrant also occurred", "abdomen pain in the upper right quadrant also occurred as well as nausea" and "was sent for an ultrasound and blood work. both came back negative for anything except a gas bubble in abdomen" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, abdominal pain upper, nausea, flatulence.  Additional Information: Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness which started and continued for a week, abdomen pain in the upper right quadrant as well as nausea and negative for anything except a gas bubble in the abdomen in the abdomen was resolved on 24Apr2021.  No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) for prophylaxis. On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, couple of days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm and couple days after receiving the vaccine, the patient experienced pain in his left arm. The pain affected the patient's entire left arm, which was constant and never went away. The reported lot number (G41M2) for SHINGRIX did not exist and was updated to G47M2, according to sales database.
Tdap/adacel was indivertibly given to a child of 2 years old. No adverse reactions. Follow up made two days and seven days after administered. Parents reported no side effects.
I went there to get my booster shot as I received my second shot on 4/5/2021 and am obese, so once the CDC opened up the eligibility, I immediately scheduled my booster once the 6 months hit. Once I spoke to the pharmacist and told him I was there to get the booster, he asked why my reasoning was, I said obesity, and he said obesity is not a valid reason. He said that I had to be a first responder or in crowded public settings in order to get the vaccine and he pointed to some document from 9/27/2021. I said that I knew that was wrong and he was insistent that I was not receiving the booster, so I left.
Loss of feeling in left arm and forearm, then numbness X 1 hour. Ache in arm spread to left side of body, 1 1/2" redness at injection site with a lump. Cough, malaise, sweats, headache, nausea and cramps. The 2nd day, had intense anger/emotional response X 1 day.
Pt received HPV vaccine then attempted to leave clinic after 10 mins and had syncopal episode, pale low blood pressure - was back to normal in 15 min.
Pt developed shingles on face (below (R) eye) 1 mo after varicella vaccine. Treated with acyclovir, but then developed periorbital cellulitis; rx'd with TMP - SMZ & KEFLEX, topical erythromycin. Also required ophtho consult - cornea uninvolved.
Pt developed shortness of breath. Fount to have PE. Physician feels PE could be result of vaccines since pt has no known risk factors or cause for this incident. Pt started on Xarelto since other meds contraindicated due to pt allergies.
After administration of flu vaccine, MA left out of the room to check a hemoglobin and mom report that patient became immediately dizzy and fell to the table.  When I went in to see patient, she was pale, flushed, and clammy, and having shallow breathing.  Oxygen quickly placed on patient and color came back slowly, oxygen saturation 100% but patient continued to feel dizzy and tired.  911 called and patient transported to ER for further evaluation.
7 weeks late on getting the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (7 weeks late on getting the second dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (7 weeks late on getting the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (7 weeks late on getting the second dose) had resolved. Not Provided          No concomitant medications were reported.     No treatment medications were reported.
Client reported to the health clinic to report that her left arm still hurt 2 weeks following the vaccine. She claimed that it was the vaccine.  Unable to fully extend her arm upward. due to pain  of 6-7/10.  Had been taking  tylenol and ibuprofen for pain. No swelling, redness or hardened tissue at the time of examination on 11/1/19. Limited ability to raise arm above her head before her complaints of pain. Refused warm compress. - plan to follow up with that at home. Followed up with her physician and subsequently reported 'tendonitis'.
syncope, mother witnessed event, after event, patient lied down for approximately 15 minutes, feet elevated, cool papertowel on forehead, ate some candy, patient recovered.  monitored blood pressure throughout.
There was a lot of soreness at the site of the shot for a  couple of days, but it was not unexpected. The next evening, as the shot spread through my system, hives appeared on my trunk from chin to groin. It was hot and tender at first, then got itchy as it faded. There was no difficulty breathing or I would have gone to the ER. Treated with OTC CLARITIN and BENADRYL after calling Dr.'s office on April 16. It took about a week to totally clear my system.
(L) deltoid pain, sweating, malaise, chills, flushing and high fever for 3 weeks. Headaches, vomiting, nausea, arthralgia, myalgia. Rash lower extremities. Tinnitus. Abnormal liver lupus like symptoms, vasculitis like symptoms. Test, enlarged spleen. Fevers 101-103 every night for 3 wks.
Immunization was given after of 12-8-22. Moderna manufacturer was notified and case # MI-00003113 was assigned. The Lot of AS7166B was tested and found per Moderna the vaccine DID have the necessary activity to protect against the SARS-CoV-2 virus at the time of administration. Patient and patient's PCP notified.
Approximately 10 days after smallpox, patient woke with several open lesions on face. He had dental extraction on day 9 of vaccine and took narcotic for pain. He likely self-inoculated. He had scab formation at day 5 f/u. Sites covered on face until scab falls off.
stroke; blood clots; This case was reported by a consumer and described the occurrence of stroke in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant) and clot blood (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke and clot blood were unknown.   It was unknown if the reporter considered the stroke and clot blood to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and patient experienced stroke and blood clots. The reporter was talked about covid vaccine and its similar reactions except the stroke and blood clots with shingles vaccine.
Soreness/at injection site; Overwhelming fatigue/Tiredness; Headache; pain a lot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis, and chronic fatigue, both from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. Patient had the first Pfizer vaccine (unspecified vaccine) on 23Jan2021 and since then had expected some soreness which patient had at the injection site on an unspecified date in 2021. And they even on that might be tiredness. Well patient already have chronic fatigue so patient know about tiredness. Patient did remember the headache (2021) were also which already have with chronic fatigue which patient have. Now chronic fatigue likes very tired but normal not act tired as with this vaccine. This morning patient tried to get in card to go to the grocery store to get some groceries and have to comeback that how tired and fatigue that was. Now patient just wondered "the fatigue it was a very "pain a lot" (not clarified) byproduct of this vaccine. It must be (incomplete sentence)." The "things" (not clarified) patient was concerned was, patient heard on the news that the second vaccine would be rougher or have more side effects than the first and that's the reason patient called and the second vaccine which patient was due to have on February 13th would have more side effects than this first one. With the first one expected this overwhelming fatigue. It has been relatively now. Headache, soreness on the injection site but patient thought the tiredness would go away but it has not. Now patient questioned if the second vaccine will that be Pfizer also. The patient had not recovered from the event fatigue. The outcome of the other events was unknown.   Information on lot/batch number has been requested
Pt ran over 101 degree fever.  She had chills, aches, nausea, arm extremely sore.  Lasted about 24 hours.
Vaccines given 7/26. 7/30 pt awoke with severe headache and vomiting. Went unconscious. Found to have had a cerebellar aneurysm. Pt died 7/31.
This is a spontaneous report from a contactable male (husband). Caller and his wife of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced soreness in the skin and reported that the soreness was experienced in 6 years' time. The patient wanted to know if she can take Tylenol or Ibuprofen for the soreness of skin. The outcome of event was unknown. Information on the lot/batch number has been requested.
This spontaneous report as received from a healthcare worker refers to a 10 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 29-SEP-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
1510 - patient c/o tongue tingling and numbness. Also feels like back of throat has something stuck on it. Taken via w/c to private observation. Gave patient water. States she has difficulty swallowing it.  O2 99%; HR 110; RR 16: BP 124/95. EMT on site in attendance. Per assessment with pen light, throat is not swollen or red. Patient states she feels like it is much lower and points to tracheal area. Lungs auscultated, BBS CTA, no wheezing, no stridor. Offered patient 25 mg Benadryl. Pt. declined. States she drove herself and that it will make her too drowsy.  1525 HR 101; O2 99%, BP 123/106; recommended ambulance for further eval/transport.. Patient refused. States she will call her husband to come and drive her home. States that the tongue is feeling swollen now.  1530 - Benadryl 25 mg given IM Lt. Deltoid per EMT. 1531 - BP 160/100; HR 104; O2 98%  1535 - Dr. present 1537, Thickness in throat decreasing as per stated by patient. Lungs assessed per Dr. , Lungs CTA, no wheezing, no stridor. Per assessment Dr. , throat clear without swelling noted. Advised per Dr.  to avoid second dose and to take additional benadryl PO once home. Waiting for husband to arrive.  1555 - B P 116/96; HR 96; O2 99% 1559 - Husband arrived. Patient states she feels fine and ambulated with husband to personal vehicle. Gait steady. States she will f/u with physician
arthritis; could barely walk; developed terrible joint pain in my shoulders and knees; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 26Jan2021 at 13:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the left arm on 05Jan2021 at 13:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 31Jan2021 at 15:00, the patient developed terrible joint pain in shoulders and knees to the point where she could barely walk and was diagnosed with arthritis which she never had before. The events lasted roughly four weeks and had subsided almost completely then but it was still not back to normal. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events joint pain in shoulders and knees to the point where she could barely walk and arthritis which included steroid treatment. On an unknown date, the patient underwent X-ray and the result was arthritis. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events joint pain in shoulders and knees to the point where she could barely walk and arthritis was resolved with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Body aches, headache, fever, chills beginning  @ 2 am 1/21/2021. RLQ pain beginning @ 7:00 pm 2/4/2021. Appendicitis--diagnosed 2/5/2021 @ approximately 12 pm.
Sore; A spontaneous report was received from a consumer concerning, a male patient who received Moderna's COVID-19 vaccine and experienced being sore.  The patient's medical history included Chronic lymphocytic leukemia (CLL). Concomitant medication used by the patient within two weeks prior to the event included intravenous immune globulin (IVIG).     On 28-Dec-2020, the patient received their first of two planned doses of mRNA-1273, intramuscularly in the left arm for prophylaxis of COVID-19 infection. Following his first vaccine dose, patient stated no symptoms, just sore. Treatment information was not provided. There was no change planned to the dosing schedule of mRNA-1273 in response to the event, sore.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, sore was not reported.   The reporter assessed the event sore as related to study drug.; Reporter's Comments: This case concerns a male patient of unknown age, who experienced a non-serious unexpected event of Pain after receiving the first dose of mRNA-1273, lot # unknown. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
no adverse event; inadvertently administered one dose of the monovalent vaccine on 12Feb2023 which expired on 06Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered one dose of the monovalent vaccine on 12Feb2023 which expired on 06Feb2023) and NO ADVERSE EVENT (no adverse event) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered one dose of the monovalent vaccine on 12Feb2023 which expired on 06Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered one dose of the monovalent vaccine on 12Feb2023 which expired on 06Feb2023) and NO ADVERSE EVENT (no 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 considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered one dose of the monovalent vaccine on 12Feb2023 which expired on 06Feb2023).    No concomitant medications were reported. No treatment medications were reported.
Case number PHEH2013US023969 is an initial spontaneous report received from a medical assistant on 12 Nov 2013. This report refers to a 2-years-old female patient. Her medical history and concomitant medications were not reported. She was inadvertently vaccinated with an intramuscular dose of FLUVIRIN (batch number: 1308101) on 12 Nov 2013. No adverse event was reported following the maladministration.
1 of 3 pts who recvd DTP/HIB/OPV & exp an acute severe inject site rxn @ the DTP site; rxn included erythema, swelling, hot to the touch & pain; also had irritability; resolved w/in 24 hrs; tx w/APAP/cold compresses; pt vaxed from same vial
Moderna on 3/3 and 3/31. Positive on 8/21 admitted on 8/29 to current
Fluzone High Dose was administered to a 60 year old male with no ae; Fluzone High Dose was administered to a 60 year old male with no ae; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 60 years old male patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot no: US293AA, expiry date: 15-Jun-2020) via intramuscular route in right deltoid on 06-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Product administered to patient of inappropriate age and overdose. It was reported that fluzone high dose which was administered to a 60 year old male with no ae.   At the time of reporting, the patient had no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Patient was seen at clinic on 12-16-15 for vaccines. Tdap and HPV administered to left arm, and MENVEO to right arm. Patient follow up w/us on 12-18-15 due to possible allergic reaction to vaccines. Warm compresses were apply to affected area by parent. Patient to follow on 12-21-15.
I developed an itchy rash on my upper arm near my injection a few days after the second vaccine shot. It has lasted for two weeks and appears to be subsiding now. I have developed a noticeable tinnitus in my ears since the second vaccine shot which is still very prominent.
PATIENT CAME IN WITH COMPLAINTS OF ITCHING AROUND THE NECK AND UPPER CHEST AREA.  SHE HAD SMALL BUMPS RESEMBELING HIVES AND SCRATCH MARKS AS IF SHE'D BEEN SCRATCHING.
No adverse event; HBP calling to report adverse event regarding a 13 month old patient who was inadvertently administered PROQUAD and VARIVAX at the same time.  HBP stated that the doses were administered today, 9/25/2023, due to an administration error.  Both doses o; This spontaneous report was received from an other refers to a 13-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 25-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), lot number X012148, expiration date 28-OCT-2024, 0.5 milliliter (route of administration not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) lot number X010531, expiration date 11-APR-2025, 0.5 milliliter (route of administration not reported) (extra dose administered). No adverse event was reported.  "Lot number X012148 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD).
Covid Vax 1  - 3/26/2021.  Lot ER8732 Covid  Vax 2 - 4/16/2021. Lot EW0169 Booster -  12/15/2021. Lot  33130BA  1 month after my booster, I started hearing my pulse in my right ear. This began on January 12, 2022 and HAS NOT STOPPED