chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache / presented in the front and base of skull by neck; General Aches; General Discomfort; Fever; Increased Heart Rate; Increased Blood Glucose; Arm Pain at Injection Site; leaving work for the rest of the day; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 15 hrs after receiving Shingrix, the patient experienced headache, general body pain, general discomfort, fever, heart rate increased, blood glucose increased, pain in arm and inability to work. On an unknown date, the outcome of the headache, general body pain, general discomfort, fever, heart rate increased, blood glucose increased, pain in arm and inability to work were recovered/resolved.   It was unknown if the reporter considered the headache, general body pain, general discomfort, fever, heart rate increased, blood glucose increased, pain in arm and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm around 6 pm at pharmacy approximately 2-3 months ago from the date of reporting. Less than a day, after vaccination with dose of shingrix, the patient experienced general body pain, general discomfort, heart rate increased, blood glucose increased, pain in arm. The patient reported that, 15 hours (at 9 am) after vaccination experienced headache, 18 hours (around noon) after vaccination experineced inability to work and 20 hours(by 2 pm) after vaccination experienced fever. The patient reported that, in the next morning experienced headache at 9 am, and around noon headache intensified to the point of leaving work for the rest of the day. The headache described as worst, that the patient ever had and that it presented in the front and base of skull by neck. The patient reported that, after getting home, the patient had fever of 100 to 101 degree. The patient stated that, heart rate was in mid 120s and blood glucose spiked to the 300s. On the next day of vaccination at 6 pm, the patient feeling better other than arm pain ferom injection. The patient reported that, the arm pain was lasted for about a week.      Lab Comments: on an unknown date, lab test were performed
Rabies immune globulin 300 units/1 mL given intramuscularly when the order was for Rabies Vaccine 1 mL given intramuscularly
Two Covid vaccines performed on my left arm while pregnant. While breastfeeding large blood clots have been coming out of my left breast. I went to get my booster this week  and switched to my right arm and within two days larger and more frequent flood clots have started coming from the right breast. Mammogram and ultrasound have ruled out breast cancer and papilloma.
4/12/21 Ear ringing, vertigo, headache, plugged ears approximately 8 hours after vaccine along with 102 temp. 5/10/21 Ear pain until seeing a quick  care and had right ear infection. Placed on antibiotics and ear drops. Continued tickling on right ear with ear ringing  June 28th told Gynecologist and she recommended a follow up to see a family Dr  July 10th urgent care with severe ticketing in right ear keeping me awake and ringing. Wax removed.  Oct. 15th chiropractic appointment for adjust to help with ear ringing  October 25th. Audiologist appointment for ear ring. Referral to an ENT. No appointments available  for 5 months
Alot of soreness and swelling at the shot site; Alot of soreness and swelling at the shot site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient just had the first one and experienced a lot of soreness and swelling at the shot site. Additional supportive information: Follow-up would not possible as no contact details were available.
Suffered all the mild symptoms during the day following jab The syptoms started to deveop leading to violent shivering and coldness that lasted approx. an hour Developed into fever and increasing pain across shoulders, armes neck and head. Increasing headache severity By evening of the 2nd experiencing chest pains, slight difficulty breathing, raging and increased pulse, this lasted for approx. an hour efore receeding and falling asleep. Awoke later with mild effects described above I have referred to online descriptions of adverse effects of Moderna and the description of Myocarditis fits  Very unpleasant
tired; I can't see all that well; can't move that well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "I can't see all that well"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "can't move that well".  Additional information: Patient had to stop taking Xeljanz due to taking the vaccine. Patient was taking Xeljanz 5 MG.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6/28/99 to MD, had conjunctivitis-progressed to a corneal infect on lt eye then resolved; 7/27/99 dx pneumonia; 8/7/99 dx w/possible immuno deficiency; 9/15/99 dx common variable immunodeficiency;
Syringe malfunctioned and leaking during administration; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced syringe malfunctioned and leaking during administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, a health care provider administered the mRNA-1273 vaccine to a patient.  During the administration, the syringe malfunctioned and leaked during administration.  The health care provider was uncertain if the patient received the full dose of the vaccine or how much of the vaccine was spilled. The patient had no observable symptoms and did not receive any treatment for the event.  Action taken with mRNA-1273 in response to the event was not reported.   The event, syringe malfunctioned and leaking during administration, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, syringe malfunctioned and leaking during administration, to study drug.; Reporter's Comments: This case concerns a  patient of unreported age and sex. The patient's medical history is not provided. The patient experienced an unexpected event of syringe malfunctioned and leaking during administration. The event occurred on 22 Dec 2020  during administration of the first dose of the study medication. The sponsor assessed the event as unrelated to the mRNA-1273 vaccine.
Headache, Myalgia, Arthralgia & NauseaVomiting  Narrative: dose 1-day 2-3- pain/ soreness at inj site dose 2-day  1-2-pain/ soreness at inj site; day 1-2-ha; nausea; chills; fatigue; bodyache.   Other Relevant History:
Several hours after the injection, my arm had a swollen, itchy, red circle of 2 1/2 inches in diameter around the site. It spread to 4 inches on my upper arm with a fever of 100 degrees. I took TYLENOL for 5 days and used ice. It is slowly disappearing.
Received a 3rd booster instead of a Shingles vaccine; This spontaneous case was reported by an other caregiver and describes the occurrence of EXTRA DOSE ADMINISTERED (Received a 3rd booster instead of a Shingles vaccine) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced EXTRA DOSE ADMINISTERED (Received a 3rd booster instead of a Shingles vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Received a 3rd booster instead of a Shingles vaccine) outcome was unknown.            Reporter asked if it's safe that patient received that close another 3rd booster dose or not. It was reported that patient does not have any side effects. No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Received first dose of Covid 19 vaccine.  Pt instructed to wait in observation for 15 minutes.  Pt waved nurse over, stated that he has a condition where he passes out and "feels it coming on" nurse and Paramedic notified.  Pt moved to floor feet elevated vitals per paramedic stable. Observed for extended time, vitals remain stable, pt at baseline, felt comfortable leaving alone.
mild facial redness; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 9-month-old female patient received BNT162b2 (BNT162B2), on 21Oct2022 as dose 1 (maroon cap), single (Batch/Lot number: unknown) at the age of 9 months for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset 21Oct2022, outcome "recovered", described as "mild facial redness". Additional information: The reporter stated that a patient received their 1st dose of the vaccine and then within 1 hour developed mild facial redness. The facial redness resolved on its own; it was very mild. The patient's parents still want her to receive dose number 2. Caller was asking if it is safe to give her the 2nd dose. Patient received the first dose on 21Oct2022. The caller wanted to know if it would be safe for a 9-month-old patient to receive the second dose of the Pfizer-BioNTech Covid 19 Vaccine (maroon cap). The patient developed a mild facial redness after receiving the 1st dose on 21Oct2022 and the patient was 9 months and 18 days old when she received the first dose.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the event and the suspect drug BNT162B2 cannot be excluded
Reports of soreness in the whole arm but mostly from elbow to the wrist, slightly itchy, looks like sunburn but not hives. Advised to use cold compress, TYLENOL & BENADRYL.
vaginal bleeding heavy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation, administered at Pharmacy or Drug Store.  Relevant medical history included: "I have not had my period in more than 2 years." (unspecified if ongoing), notes: I have not had my period in more than 2 years. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications within 2 weeks of vaccination. Past drug history included: Codeine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: Sep2021, when the patient was 54 years old, for Covid-19 Immunization, reaction(s): "Swelling of breast lymph nodes". The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset Sep2021, outcome "recovered" (2021), described as "vaginal bleeding heavy". The event "vaginal bleeding heavy" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of postmenopausal haemorrhage. The clinical course of events was as follows: Swelling of breast lymph nodes after first shot - left breast so much had to reschedule a breast exam. After second shot a week after she experienced vaginal bleeding heavy at times up to 10 days.  She had not had her period in more than 2 years. Since the vaccination, the patient has not been tested for COVID-19. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report was received from a pharmacy intern regarding 6 patients of unknown demographics. There was no information about concurrent condition and historical medication. On one of the following dates 14-MAY-2016, 01-JUN-2016, 08-JUN-2016, 09-JUN-2016, 22-JUN-2016 and 05-JUL-2016 the patients were vaccinated with improperly stored ZOSTAVAX 19400 PFU lot # L044530/ expiration date-09-FEB-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received shot 3 PM. Experienced chills and fever of 101 F at 6 PM. Took Tylenol and slept. In AM, no more fever, but aches continued throughout next day.
Red, swollen, warm, non-tender area around injection site.  Went to employee health and she was told to report symptoms to the hotline. Symptoms resolved on own after several days without treatment.
Woke up with a red rash size of a quarter, 2" below injection site. Was hot to the touch. It increased in size to about 3" Round. It had a hard white lump in the middle. I went back to pharmacy. Pharmacist looked at it and said she never saw this before. She called Glaxo who said a rash at inj site is normal. They sent me some reaction paperwork. The rash and lump were gone on Saturday night. I also had a lot of fatigue.
9 days after the first vaccine, my ears started ringing so loudly.  About a week later, it calmed down and I did get the second vaccine.  9 days after that, my ears started ringing again, this time the volume much higher.  It has been 3 weeks today and it is still ringing so loudly. It is interrupting sleep, causing anxiety and making day to day activities difficult.  It is ringing all the time and is unrelenting.
blood clot on his lower left leg; pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 67 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization; Bnt162b2 (dose 2), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 01Mar2022, outcome "unknown", described as "blood clot on his lower left leg"; PAIN (non-serious) with onset 01Mar2022, outcome "unknown", described as "pain". The events "blood clot on his lower left leg" and "pain" were evaluated at the emergency room visit. Clinical course: The patient had gotten a blood clot on his lower left leg which was diagnosed on 01Mar2022. He went to the emergency room due to the pain. He wanted to ask if the booster dose can cause blood or if there's evidence. He also mentioned that he was turning 68 soon.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Swelling, low-grade fever, induration, hot to touch, red and itching.
This spontaneous report as received from a physician via field representative refers to a male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with GARDASIL injection (dosing details, strength, lot#, and expiry were not reported) intramuscularly. Fifteen minutes post vaccination, the patient fainted as he was about to leave the physician's office. The patient sought medical attention as he was in the doctor's office. The outcome of syncope was unknown. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. This is two of two reports received from the same reporter. Additional information has been requested.
unable to get second dose n timeframe because of unrelated knee surgery and rehab for the surgery; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (unable to get second dose n timeframe because of unrelated knee surgery and rehab for the surgery) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (unable to get second dose n timeframe because of unrelated knee surgery and rehab for the surgery). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (unable to get second dose n timeframe because of unrelated knee surgery and rehab for the surgery) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient had an unrelated knee surgery, and then rehab for it was keeping her from getting the second dose.  No relevant concomitant medications reported.  No treatment information was provided.
This case is one of a cluster of three patients who experienced adverse events following administration of ADACEL (lot number U4090BA and sanofi pasteur Ltd. lot number C3961) and FLUZONE, lot number UH463AA. The events for the other patients were captured in case 2011-10184 and 2011-10242. Initial report was received on 14 October 2011 from a healthcare provider. A 45-year-old male patient (date of birth not reported) had received on 29 September 2011 an intramuscular injection of FLUZONE and ADACEL. On 10 October 2011, the patient experienced decreased range of motion and pain down his arm. The patient was prescribed ice, heat, ibuprofen and TYLENOL. The patient was evaluated by the reporter and not the physician. No further informational was available at the time of the report. The patient's outcome was reported as resolving. Documents held by sender: none.
the patient's husband came in the next day asking what to do because  had red hives all over her body. I told her to take benadryl every 4-6 hours and see her primary doc if continued.
administered during active case of shingles/another facility was unaware of the patient status; This case was reported by a pharmacist via call center representative and described the occurrence of drug administration error in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (shingles flare up) and pain.   On 21st March 2022, the patient received the 1st dose of Shingrix. On 21st March 2022, unknown after receiving Shingrix, the patient experienced drug administration error. On an unknown date, the outcome of the drug administration error was unknown.   Additional Information: GSK Receipt Date: 22-MAR-2022 Reporter's Comment: The patient was administered dose of shingrix during an active case of shingles flare up. The patient was admitted to ER (Emergency room) on 19th March 2022 for active flare up shingles and was given treatment for pain. The patient was on day 8 to 9 of active flare up of shingles.  The another facility was unaware of the patient status and administered to patient a dose of Shingrix on 21st March 2022, which led to drug administration error. The reporter consented to follow-up.
Joint/muscle pain, T 102, headache, nausea, chills Tylenol x1 each day Afebrile after 24 hours then febrile again 2nd day in evening. Tylenol again x1.
I experienced severe itching; itching all over in the mouth and had sharp pain and had a fever of 100.5.
26 year old male, presented for pfizer COVID-19 vaccine today, no history of anaphylactic reaction. Approx 15 minutes post vaccine, patient reported he felt his throat was warm, felt like it was "tightening" and was having difficulty swallowing and felt short of breath. Given an epi-pen, 50 mg IM benadryl. Initially refused ED transfer via EMS.
Pt nauseous then passed out - unresponsive for 3-5 minutes - was sweating and dizziness when she awoke - after about 20-30 min felt better - still nausea and headache.
JYNNEOS vaccination error no wheal. revaccinated 0.5 SQ
Discharge summary "Patient had  recently suffered a NSTEMI.  He had two stents placed there 1st diagonal and in LAD. He had been doing well and compliant with aspirin  and plavix  when he  was  awoken with  sscp- squeezing. He was admitted and found at cath to have another blockage for  which a third stent was  placed in ostial diagonal branch. Pain resolved completely. He was stable overnight.  He was  stable for discharge to  home  on  3/31/23."
Significant lymphadenopathy in right axilla/clavicular region days 1-3 post injection.  Later devloped sudden onset symptomatic dermatographism/ hives developing under areas of clothing, touch, pressure or heat (full body). Started 11 days after receiving Moderna booster.  Worst days 1-5 after onset, improving after day 7  but still present in a mild form 12 days after onset (currently). Two other colleagues who work in the same unit had the same symptoms in a similar time frame after receiving booster.  Treatment included quadruple dose of 2nd gen Anti-H1 (cetirizine) QD per lit review, 50 mg Benadryl  QHS, and prn hydrocortisone cream and Benadryl cream.
15 minutes after vaccine was given patient stated that she was feeling dizzy, faint and nausea.  Patient was given some water.  Vital signs were taken and within normal limits.  Patient denied shortness of breath, swelling of throat or face, chest pain or pain any where.  After observing for 15 minutes patient felt better and denied any concerns.  She was encouraged to go to the local ER if any other symptoms arose after going home and she verbalized an understanding.  Patient left with spouse.