chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of passed out in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter had reported this adverse event on behalf of another unknown patient. The reporter stated that while he was visiting his doctor's office, he was informed that, the patient received the SHINGRIX vaccine in the doctor's office and the patient passed out very soon after receiving the vaccine. The patient passed out at the doctor's office. The reporter did not have any additional information regarding the patient or the event. Please note that this was the reporter's healthcare professional information and this was the office that mentioned the patient in this case.
The patient caught Covid-19 on July 1, 2023; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The patient caught Covid-19 on July 1, 2023) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Batch- 013M20A) on 20-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, Batch-008B21A) on 26-Mar-2021, Moderna COVID-19 Vaccine (Dose-3, lot number 066F21A) on 19-Nov-2021, Moderna COVID-19 Vaccine (Dose- 4 and lot number 084J21A) on 14-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 31-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (The patient caught Covid-19 on July 1, 2023). At the time of the report, COVID-19 (The patient caught Covid-19 on July 1, 2023) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. It was reported that patient did not reported any side effects. Patient did not remembered which arm she received the all her Moderna Covid-19 vaccines. Treatment details was not reported by the reporter.
Unlike the first shot (which was just light swelling and arm soreness), I had a bad reaction to the second shot. I was fine with no symptoms/reaction other than swelling and soreness at the injection site until a few hours after I got the shot. Extreme nausea is my main symptom and I am still feeling it the next day. Today (the day after the shot) I am also feeling dizzy, light-headed, fatigued, and generally unwell. I have been drinking plenty of fluids but that only helps temporarily. Ingesting protein at dinner helped temporarily but otherwise it was a struggle to eat and I felt like I might vomit so I just laid down and that helped a bit. I use medical marijuana and vape nicotine and both did not help my nausea and nicotine made it worse so I lessened my usage. I would recommend people sleep and drink water, for sure. But would appreciate being given an anti nausea med recommendation that can help; might be good to include that in vaccine literature.
After first vaccine blurry vision started within 36 hours. After second vaccine started blurry vision, dizziness, fatigue,
Around 1 week following 2nd Pfizer covid shot, developed a numb/tingling sensation in top of tongue. Gradually progressed over the course of 10days. Numbness and tingling tip of tongue to right lateral side of tongue. By day 7 of 10 right side of cheek radiating up to side of right ear was tingling. No motor deficits occurred only sensory. By day 10 symptoms resolved. I took ibuprofen 200mgx2 three times a day on day 8-10.
experienced profound fatigue, headache, and muscle and joint pain ? mostly across my upper torso, shoulder to shoulder and from neck to mid-chest. This continued for over 48 hours, making activity impossible
He received Moderna vaccine #2 on 7/9/21 @ 5:30 pm at Pharmacy. Pt states he woke-up on 7/10/21  around 7am and reports he started having, fever, soreness, and extreme fatigue. Symptoms continued into next day, and he started with chest pain /discomfort. Pt reported to hospital on 7/13/21 for further evaluation and treatment. Pt was seen in ER, had elevated Troponin of 17, negative D-Dimer, and abnormal lab results. Chest x-ray was normal, EKG and ECHO performed. Pt started on re. treatment of Colchicine 0.6mg, po, BID, Ibprofen 800mg, po,  Q8hrs, and Pantoprazole 40mg, po, daily.  Pt scheduled to f/u with Dr. on 7/28/21
Chills and shaking overnight(3/4/21 -3/5-21); lack of appetite and nausea the next day (3/5/21); tiredness (3/5/21
pt recvd vax & exp pins & needles sensation in both hands & feet p/2nd dose; sx peripheral neuropathy; pt was not treated; sx persist
Facal numbness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Facal numbness) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Facal numbness). At the time of the report, HYPOAESTHESIA (Facal numbness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information provided.
Double vision; Chills; Low graded fever (99.8); A spontaneous report  was received from a consumer, concerning a 75-year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced double vision, chills and low graded fever (99.8).   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 30 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number 012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31JAN2021, after the vaccine administration, the patient developed chills and low-grade fever of 99.8, hence he was given with acetaminophen to alleviate these symptoms. On 01 FEB 2021, the patient started experiencing double vision, hence, on 05 FEB 2021, the patient went to their eye doctor who instructed the patient to go to the emergency room (ER). The ER doctor admitted the patient to the hospital to run some tests and labs.  The patient was tested for stroke, tumor, and bell palsy and all these tests were negative. The hospital conducted several CT and MRI and they were all negative. The neurologists did not know what was going on with the patient. Hence, he was discharged from the hospital on 07 FEB 2021. The patient was still having symptoms. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of the events double vision, chills and low graded fever (99.8) were considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Pt w/shortness of breath, fever, chills and productive cough for 1-2 weeks prior to arrival and found to be hypoxemic and confirmed COVID-19 pneumonia. Tx w/abx, steroids, O2, remdesivir, Vit C; dc'd to LTAC d/t persistent need for high O2 levels.
Fatigue; low fever; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TESTOSTERONE. Vaccination history included: Comirnaty (Dose Number: 2, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Comirnaty (Dose Number: 1, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Fatigue"; PYREXIA (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "low fever"; PAIN (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "body aches". Therapeutic measures were not taken as a result of fatigue, pyrexia, pain.  Additional information: No other vaccine in fourweeks. No covid prior vaccination and no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
per pt's dad, about 1 minute after vaccination, client stated she was not feeling well.  She was then observed unconscious for about 60 seconds.
15 year old had first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old had first shot) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old had first shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old had first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
c/o h/a after received vaccine b/p 139/ 81, HR 101, 02 sat 99 monitored vss when left clinic, ee to f/u with her PCP
Have had migraines for over 1 month now since getting the flu vaccine.  Have had over 15 migraines since the vaccine (37 days ago).  Although I have experienced cluster migraines in the past (typically 3 or 4 times a year), I have never had this many migraines in a cluster.  It has averaged about 1 every two days since the vaccine.  I have not experience this level of migraines before.  Since the migraines started the day of the vaccine, I am attributing the number and duration of continuing migraines to the vaccine.
Report 20010268181 describes a 28 year old female who did not respond to the hep B vaccine (Engerix-B) immunization series. Medical history, concurrent conditions, and concurrent medications were not specified. On 11/14/2000, 12/19/2000, and 05/08/2001, the vaccinee received her first, second and third IM injections of Engerix-B, respectively. A titer (NOS) drawn for this vaccinee on 11/02/2001, approx. six months after the third injection of Engerix-B, was "negative."
Mom states that the evening of the day vax admin infant became extremely irritable; Over the following 2 days (Mon eve - Wed eve) pt cried w/unusual high pitched cry, very difficult to console, didn't nap, slept poorly; poss fever;
Elevated blood pressure and headache.  2 mos Blood pressure still elevated and now on bp medicine
9 days following IM injection pt noticed swelling of his supraclavicular lymph node on the same side as the injection.
Patient come in to our office to get the first dose of COVID-19 vaccine on  01/15/21 . Allergies reviewed first , all documented properly . Patient reported that he wake up  on  the same vaccine  date at 11:55 pm with pruritus in the trunk and back , he turn on the light and looking for a mirror to see what happen . He saw multiples hives in the trunk , back , inguinal area , internal area of the thigh , also he felt  and saw swelling in the lips and trouble to swallow , denied difficulty to breath or chest pain .Patient immediately take 2 tablets of Cetirizine 10 mg  orally  and went to sleep, next day  he felt better ....continued
Arm was sore; Headache; Nausea; Tiredness; Muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm, headache, nausea, tiredness and muscle pain. On an unknown date, the outcome of the pain in arm, headache, nausea, tiredness and muscle pain were unknown.   It was unknown if the reporter considered the pain in arm, headache, nausea, tiredness and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received first dose of Shingrix and immediately after vaccination his/her arm was sore but two days later the patient had a headache, nausea, tiredness and muscle aches. The reporter asked how soon do the side effects appear after the first dose of Shingrix and asked could it be from the shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
This case was reported by a healthcare professional (nurse) and described the occurrence of cleft lip and palate in a foetus subject of unspecified gender who was exposed to FLULAVAL (GlaxoSmithKline), Cephalexin, and Amoxicillin in utero when the mother received treatment for urinary tract infection during pregnancy. On 14 October 2013, the 19-year-old mother started amoxicillin orally at an unknown total daily dose and received a dose of FLULAVAL. On 21 October 2013, the mother started cephalexin orally at a total daily dose of 1000mg. The mother's last menstrual period was 10 August 2013 and estimated date of delivery was reported as 23 May 2014. Per the nurse, the fetus was exposed to amoxicillin and FLULAVAL at 9 weeks and 2 days gestation and exposed to cephalexin at 9 weeks 3 days gestation. The exposures were during the first trimester. Examination of results revealed no evidence of defect from prenatal testing at the time of reporting on 11 November 2013. Results of an obstetrics ("OB") ultrasound examination on "30 January 2014 showed right cleft lip and palate." On 30 January 2014, 101 days after exposure to cephalexin and 108 days after vaccination with FLULAVAL and exposure to amoxicillin, the fetus experienced cleft lip and palate. At the time of reporting, the outcome of the event was unknown. The reporting nurse did not document whether she considered the event related to the mother's treatment with amoxicillin, FLULAVAL or cephalexin. The healthcare professional considered the events were a congenital anomaly. GlaxoSmithKline considered the event to be medically serious.
After getting both vaccines my legs started to ache and my joints became painful. I got both boosters and after each this leg pain got worse. After my second booster (4-21-22) my legs hurt so much for four days that I could barely walk.  From the first booster on, my ankles were painful when I would get up and first start to walk. The painful legs made sleeping difficult.  I finally went to my primary care physician on May 26, 2022 because I was worried that I had Lyme disease or some form of arthritis.  Now, the further away I am from the booster the better I feel.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Systemic: patient cannot lift arm above shoulder-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient visited a doctor and received a steroid pack, but still no better
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient was talking to RN after vaccine administered when he was observed slumping in his chair with head down. He did not respond to verbal/ touch cues. Pulse thready. This lasted less than 30 seconds. RN called pharmacist. Patient became diaphoretic with beads of sweat on face & arms after regaining consciousness. Disorientation resolved quickly and he could recollect previous conversation. BP 91/34 and this resolved with 2 bottles of water. Patient stable after 15mins, remained for 30.
1319 Tdap & Menactra given L deltoid. After 2-3 seconds, patient's eyes rolled up, she was incontinent of urine, arms & legs stiffened, and had a brief moment of decerebrate posturing. Mom denies history of seizures.  1320 Opened eyes and mumbled. B/P 120/60 Pulse 80 Respirations 20. Very lethargic. Aroused to answer questions appropriately.  1323 Able to hold up fingers on each hand appropriately. States very tired. Feet elevated. 1326 Called EMS and spoke with FNP with Dr's office.  1327 Pupils equal and reactive to light. Grips equal. B/P 90/60. Pulse 84. Respirations 20. Answers questions appropriately. Remains lethargic.   1335 B/P 90/60. Pulse 84. Respirations 20.  1337 EMS here. O2 sat 99% room air.  1342  Transported by EMS
On 4/23/01 the pt noticed a swollen area on right thigh the size of a nickel. No redness or drainage. Advised Mom to call private physician. The pt saw a physician on 5/9/01 and was placed on medication due to redness and swelling noted on both legs.
Fever- 100.5 degrees , Chills, Headache, Muscle aches,  Vomiting every 2 hours .  Couldn't hold anything down for 32 + hours.
One day after vaccination, a small, painful nodule developed on the left side of my nose just below the tear duct. About 12 hours later, it had grown to a large lump about 3.5 cm long and 1 cm wide, extending down and to the left of  my face. This was very painful. It led to significant swelling in the periorbital area. The swelling and pain continued through the next day. On the third day, I went to urgent care where I was diagnosed with cellulitis and put on 2 antibiotics (Augmentin and Clindamycin). The swelling and pain continued to get worse. On the 4th day, I went to ophthamology where I was referred to the emergency department. On the morning of the 5th day, I was finally seen in the ER. A CT scan and bloodwork were done. The CT scan showed no signs of an abscess and bloodwork was all normal. I was given doxycycline and stopped the clindamycin due to GI effects. I continued the Augmentin. On the 6th day, the swelling and pain were slightly less. I saw my PCP who referred me to infectious disease. I had a telehealth appointment on the 7th day with the ID specialist who encouraged me to submit a VAERS reports. Diagnosis is still listed as cellulitis. Today is the 8th day. The swelling and pain are significantly less pronounced, but the lump is still the same size and shape.
administered the fluzone QIV-PFS and while the needle was in the patient's skin the medication ran out onto the patients' arm with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 59 years old female patient who was administered the fluzone Qiv-Pfs and while the needle was in the patient's skin the medication ran out onto the patients' arm with no reported adverse event , it involved vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications and other vaccines were reported as none   On 12-Oct-2022, the patient received a  dose of 0.5 ml once (1x) of suspect INFLUENZA QUADRIVAL A-B VACCINE, with an unknown formulation and strength, (lot:  UT7716JA ; expiry date:  not reported)  via intramuscular route in the left deltoid for immunization.  It was reported that the caller stated that when she placed the needle on the end of the syringe, she heard a click sound prior to administration. The patient was administered the fluzone qiv-pfs and while the needle was in the patient's skin the medication ran out onto the patient's arm with no reported adverse event (accidental exposure to product) (onset date: 12-Oct-2022; latency : same day) . Large amount of vaccine was leaked  Action taken : not applicable.  Outcome: unknown   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 the 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.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 17-year-old female patient who received BEXSERO (batch number 156801A, expiry date 31st August 2017). Co-suspect products included FLUARIX QUADRIVALENT (batch number 5255R, expiry date 11th May 2017). Concomitant products included MENACTRA, TENIVAC and norgestimate and ethinyl estradiol. On 8th November 2016, the patient received the 1st dose of BEXSERO .5 ml and the 1st dose of FLUARIX QUADRIVALENT .5 ml. On 8th November 2016, an unknown time after receiving BEXSERO and FLUARIX QUADRIVALENT, the patient experienced vaccine administered at inappropriate site and labeled drug-drug interaction medication error. In November 2016, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were recovering/resolving and the outcome of the vaccine administered at inappropriate site and labeled drug-drug interaction medication error were unknown. The reporter considered the injection site swelling, injection site erythema and injection site warmth to be probably related to BEXSERO and FLUARIX QUADRIVALENT. Additional details were provided as follows: On 8th November 2016, at 9:15, the patient received BEXSERO and FLUARIX QUADRIVALENT in left deltoid, which led to vaccine administered at inappropriate site and labeled drug-drug interaction medication error. On the same day, the patient received MENACTRA (batch number U5415AA, expiry date 16th October 2017) and TENIVAC (batch number U5526AA, expiry date 15th December 2018) on right deltoid. Two days after multiple vaccines, the patient experienced swelling of the left arm below the injection site and it was injection site redness and warm to touch above the elbow. The patient required emergency room visit and then physician diagnosed a localized site reaction.