chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: VETERAN REPORTS STARTING 12 HOURS AFTER VACCINE FEVER, JOINT PAINS, MUSCLE AND BODY ACHES, FATIGUE AND TIREDNESS. LASTER ABOUT 24 HOURS APAP AND NAPROXEN HELPED
Severe swelling and redness at arm at site below injection. No treatment was started. Patient was advised to be seen by a doctor with urgent care.
Congestion-treatment was Albuterol Sulfate and Prednisone-congestion returned.
Hospitalization: 12/7/2022 - 12/15/2022 (8 days) Presentation to the ED: generalized weakness, and hyperglycemia  COVID + date: 12/15/2022 Treatment: NONE, PATIENT WAS ASYMPOMATIC AND TESTED POSITIVE ON A TRANSFER SCREEN.  Discharge to: SNF.    RESIDENT.  MODERNA 003C21A 5/15/2021 MODERNA 053E21A 8/20/2021
PATIENT REPORTED TO PHARMACY THAT HE EXPERIENCED RASH ALL OVER THE BODY AND DOCTOR TOLD PATIENT TO TAKE OTC LORATADINE TO CONTROL THE SYMPTOMS. THE RASH WAS GONE AFTER TAKING LORATADINE ON SUNDAY.
Information has been received from a health care professional concerning an 11 year old male pt who on 05/01/2001 was vaccinated with a second 10 mcg dose of hep b vaccine recombinant. There was no concomitant medication. On 05/03/2001 two days after vaccination, the pt presented to the clinic complaining of headache, pain at the injection site, chest pain and his right hand and arm were swollen. Subsequently, the pt recovered. Additional info has been requested.
child developed a rash to trunk on friday afternoon as stated by mother. On Saturday it spread to face, trunk and extremities and she was irritable.No breathing problems reported or noted by parent, just the rash. Monday she was taken to her pediatrician where she was prescribed medication and an ontiment. Thursday she was seen at the clinic where a mild. old, rough rash was noted to trunk only. No redness with rash was noted.Parent stated that child was not irritable ,no fever noted, and behavior by child was normal to parent. Child was sound asleep when she came to the clinic.
This spontaneous report was received from a pharmacist via company representative referring to a male patient of unknown age who on an unknown date, was vaccinated with a dose of ZOSTAVAX (lot # not reported). The pharmacist was reporting a patient, who was administered ZOSTAVAX on an unspecified date, was diagnosed with shingles. The shingles rash affected the arm opposite to the arm that received the vaccination. The outcome of shingles was unknown. The patient sought medical attention. Additional information is not expected.
Three days post injection (right upper arm) the area around the injection site became swollen, irritated and painful and measured approximately 2 inches in diameter. On the fourth day the skin surface broke open and clear fluid began weeping from the injection site. This continued for two more days and the affected area had to be bandaged to contain the fluid and prevent further irritation. The site eventually scabbed over, ceased weeping and healed over after another 5 days. There is no residual scarring or skin damage.
NAUSEA STARTED 24 HOURS AFTER THE SECOND VACCINATION AND AFTER 10 DAYS THE NAUSEA WORSENED TO A CHRONIC CONDITION WHEREBY THE PATIENT WAS UNABLE TO EAT FOR 36 HOURS AT WHICH TIME THE PATIENT ATTENDED AN URGENT CARE FACILITY ON 3/15/2021. THE PATIENT WAS DIAGNOSED WITH CHRONIC NAUSEA AND PRESCRIBED ONDANSETRON ODT FOR THE NAUSEA.  THE PATIENT HAS TAKEN ONE 4MG DOSE AND IS PROCEEDING TO TAKE FOOD AGAIN AS ADVISED BY THE MEDICAL PRACTITIONER. THE LONG TERM EFFECTS ARE NOT KNOWN AT THE TIME OF FILING THIS REPORT.
Small bumps et injection site, warm to touch, raised. Symptoms started 1 wk after injection.
Breakthrough case admission after 3 vaccines Moderna 3/1/21 lot# 023M20A;  Moderna 3/29/21 lot# 010A21A;  Moderna 12/16/21 lot# 030H21B
Itchy lump on injection site then then travelled to a 1.5 inch diameter around the injection site, exactly one week after the shot. Continues to itch  a day after it started.
I experienced the normal moderate soreness after both injections as well as the expected mild flu like symptoms for about a day after the second injection.  The primary reason i am reporting an adverse effect is that I am still experiencing mild soreness in the shoulder muscle into which the vaccine was injected.  Occasionally, this soreness seems to be present in the other muscles of my upper arm as well.  This mild soreness has persisted and been very consistent ever since the initial moderate soreness from the first injection subsided about 2 months ago.  I have not experienced this type of lingering soreness following any previous vaccination.
4/8/21 pt had brain fog like he was in a haze and felt strange being very relaxed like he had taken a tranquillizer  he felt better next day.  pt seemed to be fine at this point. 4/22/21 pt seemed to be fine and went to the store where he went shopping.  He put shopping bags in car.  He was found in his car after and hour and 20 minutes by a couple of bystanders unresponsive.  911 was called and he transported to ER.  He was intubated but patient died. Unknown is any test were performed.
Three patients with no current illnesses, had received a left deltoid, intra-muscular injection of FLUZONE SV '2006-2007 USP, lot number U2193AA, on 16 October 2006 at 16:00 pm. The next day, they experienced a metallic taste in their mouths. Past medical history and use of other medications were not provided for any the the patients. Diagnostics and treatments received were not reported. The recovery status of patients is unknown. Follow-up information received on 06 March 2007. One (I) female patient, 41 years of age was identified. She did not have any illness at the time of vaccination and was not on any medications. She did not have any other vaccinations within 4 weeks of receiving Fluzone.
Severe headache/migraine, fever, joint pain, dizziness, trouble concentrating/thinking straight, nausea
11-13-02 left arm about elbow red, swollen, warm to touch. Temp 98.3 Dr. gave Keflex 500mg qid for 10 days ordered for cellulitis. Recovered from adverse affects
Pfizer COVID-19 Vaccine EUA: Myopericarditis Patient reported receiving 2nd Pfizer COVID vaccine on 7/16/21. On 7/17/21 patient started experiencing chest pain and presented to the Medical Center on 7/19/2021. Patient was then transferred to another hospital.
Two days post vax, the pt developed explosive diarrhea, 2 episodes of vomiting, crankiness and colic. The pt was seen by a physician and subsequently recovered.
Patient began screaming in an unusual and high-pitched manner shortly after getting home after receiving her 2 month immunizations. Patient then stopped breathing, turned pale and difficulty catching her breath with some blueness around her lips. Patient felt hot but not feverish and her eyes did roll back at times but no seizure.
Pfizer 8/6/21, 8/27/21. Poisitve on 1/28/22
Evening of vaccine: immediate soreness at injection site, dissipating after stretching/massaging Day after vaccine, AM: fatigue; muscle aches; slight persistent headache; restless leg; occasional shooting chest pains in right side of chest, under the arm, or in middle of chest, or other varying areas Day after vaccine, early PM: continuing fatigue; continuing muscle aches; continuing headache; significantly diminished chest pains; mild chills 2 days after vaccine, AM: continuing mild soreness at injection site 2 days after vaccine, PM: diminishing mild soreness at injection site
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 36 year old male vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
Developed one hive in the evening, same day as vaccine given. Developed a few more hives by morning. Had hives to abdomen and back by the end of that evening. Given Children's Zyrtec and applied topical hydrocortisone 1%. Rash was gone by the following day. Never had difficulty breathing, swelling, drooling, or difficulty swallowing.
red rash on my stomach and back / internal and external rash; shingles. It was affecting the nerve endings in my back and abdomen; Wednesday night I woke several times in severe pain.; internal and external rash were in fact shingles; lower back pain / pain in my back was like a knife stabbed me and kept pushing up; sharp abdominal pain on my right side; This case was reported by a consumer and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, 2 days after receiving Shingrix, the patient experienced shingles, low back pain and abdominal pain. On 4th November 2020, the patient experienced poor sleep. On 5th November 2020, the patient experienced red rash and nerve injury. On an unknown date, the outcome of the shingles, low back pain, abdominal pain, poor sleep, red rash and nerve injury were unknown.   It was unknown if the reporter considered the shingles, low back pain, abdominal pain, poor sleep, red rash and nerve injury to be related to Shingrix.  Additional details were received as follows: The patient started experiencing lower back pain and started experiencing sharp abdominal pain on right side.  The pain level increased until Wednesday night and woke several times in severe pain.  Thursday  woke with a red rash on stomach and back.  The pain in back was like a knife stabbed and kept pushing up. The patient went to ER where a cat scan was done that showed that my internal organs were good, ruled out kidney stones, appendicitis, liver or pancreas issues, and gallbladder problems.  The diagnosis was the internal and external rash were in fact shingles. It was affecting the nerve endings in my back and abdomen.
5 1/2 X 12 cm redness warm @ sight of injection; no tender
Buzzy ear/Buzzy nose/Buzzy lips/Buzzy tongue; felt shaky; felt thickness in her tongue; Trouble swallowing/throat felt weird as her swallowing was not as smooth with slight stopping; blood pressure was at 190/85; throat felt weird; This case was reported by a consumer via call center representative and described the occurrence of ear buzzing in a 69-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number M774A, expiry date 30th June 2020) for prophylaxis.   On 22nd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 22nd October 2019, immediately after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced ear buzzing, tremor, tongue thick, swallowing difficult, blood pressure high and pharynx strange sensation of. The patient was treated with prednisone and salbutamol (Albuterol Nebulizer). On an unknown date, the outcome of the ear buzzing, tremor, tongue thick, swallowing difficult, blood pressure high and pharynx strange sensation of were recovered/resolved.   It was unknown if the reporter considered the ear buzzing, tremor, tongue thick, swallowing difficult, blood pressure high and pharynx strange sensation of to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient stated that she was at her gynecologist office for a regular visit.  The patient received Fluarix Quadrivalent 2019-2020 season and within a minute after getting the vaccine she experienced buzzing in her ears, nose, mouth, lips, and tongue. She also felt shaky, and felt thickness in her tongue and her throat felt weird as her swallowing was not as smooth with slight stopping and at down and drank some water. The feeling started to intensify, she was taken down to the urgent care downstairs right away after. Upon checking her blood pressure was at 190/85 at the urgent care.  The patient was given IV prednisone and albuterol nebulizer treatment at the urgent care. Within half an hour her system calmed down and everything resolved. The patient was given prednisone to take orally for 5 days and next day she went to her general practitioner and was told that she needs to finish the 5 days oral course of prednisone so there was no rebound.  The patient also followed up with her allergist and was recommended to not get the Flu vaccine until she goes through baseline blood test and was scheduled for serum triptase baseline blood test next week. The reporter consented to follow up. No other details were provided. The reporter did not have the doctor's name.
Headache, Arthralgia, Fever, NauseaVomiting, chills, Narrative:  Other Relevant History:
This spontaneous case was initially received on 05-Nov-2015. The case report was received from a consumer and concerns a patient with unknown age and gender. The patient received AFLURIA on an unknown date, Batch no: U55406, Route of administration: Intramuscular, Dose: less than 0.5 ml. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient experienced Received less than 0.5 mL dose / Less than 0.5 mL once. Reporter's assessment: Non serious.
Client became unresponsive, started shaking and became rigid; this lasted approx. 30 seconds. Then he became lightheaded, and started vomiting. We had the client lie down on a chair and elevated his legs. He was still dizzy and lightheaded. Later in the day he c/o headaches.
2DEC94 t104 ER told to give APAP; 5DEC94 seen by MD who had throat culture done & gave ATB Cefzil; 6DEC94 mom noticed rash over lower body 230PM & called MD told to stop ATB x 24hrs; 1FEB95 ER said had measles from vax;
No additional AEs; expired lot of PNEUMOVAX 23 / lot expired on 1/8/23 and vaccine was administered on 1/20/23; This spontaneous report was received from a Medical Assistant and refers to a 75 year old male patient. Information regarding the patient's concurrent conditions, pertinent medial history and concomitant medications was not provided.     On 20-JAN-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), (Lot # U018309, expiration date 08-JAN-2023), dosage 0.5 ml once, route of administration and anatomical location were not reported for prophylaxis.  No additional adverse events, no product quality complaint (PQC) were reported.
Strange head pain leading to lightheadedness, feeling like I may pass out. It lasted only a couple minutes but then subsided and I felt fine. Head pain went away and I did not feel lightheaded anymore. This happened 3 times throughout Saturday first around 8:30 am, then in the afternoon around 1 pm and one more time in the evening around 8 pm. Slept fine all night and then felt fine Sunday morning 4/18 until it happened around 11:00 am. Once again I did not pass out even though thought I might and and it subsided again after a couple minutes.
Case number PHEH2012US012262 is a combined initial spontaneous report received from a physician on 14 Jun 2012 with a follow up information received on 20 Jun 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that on 18 Nov 2011, he was vaccinated intramuscularly on to unspecified site with MENVEO (batch number: A10029) that was reconstituted and stored in the refrigerator for three to five days. No adverse event was reported following the medication error.
This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 09-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot # L002419, expiry date: 23-JUL-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe bilateral headache that woke up from sleep; Light and sound affected like a migraine; Also extreme fatigue and weakness (climbing stairs makes short of breath).; Also extreme fatigue and weakness (climbing stairs makes short of breath).; Also extreme fatigue and weakness (climbing stairs makes short of breath).; This is a spontaneous report from a contactable pharmacist (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number El 9262), via an unspecified route of administration from 20Jan2021 14:00 at left arm at single dose for covid-19 immunization. Patient received the first dose of vaccine on 31Dec2020 10:00 AM (lot number Ek5730) at left arm for covid-19 immunization, the first dose age was also 33 years old. Patient is not pregnant. The facility type vaccine was workplace clinic. Medical history included asthma, eczema. known allergies included Metronidazole, SSRIs. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications included bupropion, birth control, multivitamin, esomepaz. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe bilateral headache that woke up from sleep, treated with ibuprofen and Tylenol but still remained. Light and sound affected like a migraine. Also extreme fatigue and weakness (climbing stairs makes short of breath). The event onset date was reported as 21Jan2021 02: 00 AM. The treatment included ibuprofen and Tylenol. The outcome of events was reported as not recovered.
Shortly after the vaccines were given, a discussion followed regarding the next visit for follow-up. The client was noted to briefly lean over to her right side; the attendant asked her if something was wrong. I could hear a subtle noise, like air was escaping; then she sat back up. She seemed different; she did not move, her eyes seem to flutter, she didn't look towards me when spoken to  and she didn't speak, right away. There was noted hand tremors. The client was incontinent of urine. When the client became more responsive, she was slightly diaphoretic, began to talk and complained of being dizzy. She became emotional over what had happened. A cool wash cloth was placed on her neck and a juice box given.
P got pneumonia shot on 11/4/15. The arm got red, swelled, painful at injection site swelling was there until 11/9/15, Pt went to see MD about it.
Low grade fever (99.6-9) daily since injection, fatigue, malaise, weakness, paresthesia, chest pain. Symptoms ongoing, worse 3 weeks after initial dose, slowly resolving
Reports Itchy throat, difficulty breathing. Has a history of multiple allergies. Transferred to ED. Symptoms resolved.
I developed a headache that became increasingly worse over several weeks The headache did not respond to the usual interventions. Dr. ordered an MRI of my head which did ot show anything awry. Based on he symptoms she diagnosed Trigeminal neuralgia and prescribed carbamazepine.  The intensity of the headaches have lessened but still have headaches.
Fever 99.5-101.5, chills, body and joint pain, sore throat, chills, cough, chest congestion and pain, sore, red, irritated eyes.
Patient developed cellulitis after flu shot administration. Cleared up after 2 course of antibiotics.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right leg for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: Other medical history: Yes, Known allergies: Yes. The patient took concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient had known allergies. She received antiviral 5 day treatment for COVID-19, from 03May2022 to 08May2022. AE treatment: Many see doctors notes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On day 8 post vaccination, had head ache, intense fatigue, and an area around 4-5 inches surrounding injection site became intensely pruritic,swollen, warm to touch.  Symptoms still ongoing two day s later
Information has been received from a pharmacist referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated first and second doses of GARDASIL (dose, route not reported). The patient would be administered the third dose of GARDASIL 2 months late. The patient had not been administered this third dose of GARDASIL yet. No adverse effect reported. Additional information has been requested.
No additional AE; Caller reported AE on behalf of patient who was administered improperly stored VARIVAX. TE Filed (Case #02506183). No symptoms reported. Obtained consent to contact HCP. Additional AE Filed (Case #02506186). No additional AE/PQC.  Product Name: VARIV; This spontaneous report was received from a medical assistant and refers to a  patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 27.3/ 14 degree Farenheit up to 46 degree Farenheit for 1 hour 59 minutes with no previous excursion (Product storage error). No additional adverse event was reported.
While at work on 05-11-14 experienced flushed feeling confusion, lightheadedness, swollen lymph nodes (R) arm pain in armpit, diaphoresis. Stated took amoxicillin due to swollen lymph node rx from previous illness. Company nurse contacted on 05-13-14 when reaction was reported sent to doctor's office at this time.
pt recv vax 7OCT96 & that noc fever 103.8, listless;fever broke that AM;13 days later, cough, paroxysmal, whooping;
Janssen dose given at 11:38am.  At 11:45am Patient c/o feeling dizzy while sitting in the chair post vaccine (5 Min Jassen).  Patient fell backward onto the ground hitting his head and sustaining a posterior head laceration.  Vitals taken B/P 101/52 HR 58 RR 16 SPO2 100% RA.....  EKG completed and fluids N/S given.  Transferred out to ED
pt recv vax 22OCT96 & in the evening 22OCT96 pt was brought to office w/following s/sx: extreme irritability for greater than 3hr, redness, tenderness & swelling of lt thigh;swelling noted form mid thigh to below the knee;leg tender to move
Patient received their Pfizer COVID-19 booster shot and started having lower extremity pain 1 day later. Patient came to the hospital for evaluation by Dr.  Scans were positive for left lower extremity DVT.