chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial non-serious case, was received on 19-Sep-2017, from other health professional concerning a 54-year-old, adult, female patient. The patient had no medical history and had not taken any concomitant medications. On 19-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number: 195214, expiry date: 30-Apr-2018, PTC number: 1024623). It was reported that, during vaccine administration while pushing the plunger, the entire Luer-Lok came off completely with the needle (25 gauge) was in the patient arm and partial dose was administered. It was reported that, no adverse event occurred following the vaccination. It was stated that, the product was stored in an original packaging in the refrigerator in a good condition. No signs of leakage nor the hub was cracked. No treatment medication was taken. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195214 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017/2018 FLUCELVAX commercial season for syringes for Luer-Lok separation during administration. The most likely root cause can be attributed to improper handling by the user. The outcome was not reported. The reporter assessed the event as non-serious. Follow-up report received on 20-Sep-2017: PTC (pharmaceutical technical complaint) report was updated. PTC number 1024623 was added. Amended narrative accordingly. Significant case correction received on 11-Oct-2017: Added new event as syringe issue. The narrative was amended accordingly. Follow-up report received on 04-Nov-2017: Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195214 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017/2018 FLUCELVAX commercial season for syringes for Luer-lok separation during administration. The most likely root cause can be attributed to improper handling by the user. Expiry date was updated as 30-Apr-2018. Amended narrative accordingly.
Numbness in arm after vaccine after waiting the 15 minutes. Patient went to MD to get it checked out
Redness, mild swelling, induration, some pain and pruritus around shot site, worsened some on day 2 of reaction.  Area affected limited to 15-16 cm area on right arm at injection site.
approx 7days p/vax pt became listless & refused all po intake; p/12 hrs, devel bilious emesis. barium enema revealed an irreducible ileocolic intussusception. this was reduced during surgery 5/27
Diagnosed with pulmonary embolisms on March 3, 2023.  Woke up at 4:30am with severe chest pain and shortness of breath.  Pain subsided after an hour and I was able to drive to my  primary care doctor's office and was instructed to go the ER.  I was uncomfortable but was able to drive to the ER and arrived around 10am.
Sore arm after each shot (5/18/21 and 6/8/21); Extremely stiff painful back/ back ache/stiffness/ immobility of back following 2nd dose on 6/8/21 that lasted a few days.
Information has been received from a nurse practitioner concerning a female vaccinated intramuscularly with 3 dose of 0.5 ml GARDASIL. After each dose the patient developed pain from her shoulder to her neck. The patent was seen by a physician in the office. The pain lasted 4 days each time. The outcome is recovered for the first two events of pain and unknown for the last. additional information has been requested.
Information has been received from a licensed practical nurse concerning a 13 year old female with no health history or allergies who on 02-JUL-1997 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck) (lot# and site of administration not reported). On 21-AUG-2009, the patient developed a few raised red spots and on 22-AUG-2009 she was seen in the office with more than 100 raised red spots, afebrile. On 24-AUG-2009 the  nurse reported that the patient had chickenpox now. The patient was treated with calamine lotion and oatmeal baths. No laboratory diagnostics studies were performed. At the time of this report, the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
PFizer vaccine administered after being stored at regular freezer temps longer than recommended. Dose determined invalid, client contacted and recommended repeat dose.
Starting at 04:00 PM on the day of the shot. 07/30/2021, I had moderately severe back and neck pain. It was quite severe. I have back pain and neck pain that I manage, but this was quite severe, I would give it a 7.5 on a scale of 1-10. The next day, 07/31/20201 I had the moderate arm pain and the back and neck pain was continuing out on the same pain level. 2 day after,08/01/2021,  the side effects were coming on even more, on top of the neck and back pain, I had fatigue, nausea, and lightheadedness. On Tues, 08/03/2021- the dizziness started and I had a strange sensation in my face.  I called the doctor's office on 08/03/2021- Advised me to take Methyl prednls0L0NE.  The next day, 08/04/2021, no back pain and I had energy. I had taken 6 tablets the 1st day, Tuesday.  On 08/05/2021, no back pain and I had energy, but in the evening I had dizziness.  On 08/06/2021, dizziness increased still no back pain, I called the doctor's office  she advised me to increase fluids, start checking BP.  My BP is better because it was quite high 154/84 , now 09/07/2021 it's 118/58. and  I still continue to have dizziness. Just moving my head, I feel dizziness.
symptoms: runny nose, drainage, coughing started 12/09/22.  worsened on 12/10.  Did rapid Covid test 12/11/22 @ 8:00AM.  Positive.  Called Dr's office after-hours nurse line.  Reported symptoms and + Covid test.  Because of mild symptoms, directed to isolate, mask, avoid contact, maintain social distancing.  Treat symptoms (sudafed, mucinex) and call back in 24 hrs.  Symptoms improved and was removed from quarantine 12/14.
Vaccine administration error, related to temperature excursion, associated with an adverse event. The clinic explained prior to thawing and administration of the vaccine, it was stored in frozen temperatures for longer than recommended by the manufacturer.
Symptoms started 11.29.20. Felt lathargic, had stomach issues. Then on 12.01.20, had red large spot, size of orange in area where vaccine was given. Then rash on left hand was itching appeared, then rash with little bumps appeared on hand and arm. Symptoms are all on left hand and left arm. Still redness, with little bumps filled with puss like fluids.
37 hrs after receiving PEDIARIX infant was apneic requiring PPV - increase in periodic breathing and desaturations.
Pt presented to ER approximately 36 hours after imms with c/o ants/bugs crawling on his legs and quadricep tightening and excessive irritability. He was admitted. Events decreased. About 4 days after presentation. Symptoms resolved.
Covid; Rash on back and trunk; Itching on back and trunk; Covid cough; This case was reported by a consumer and described the occurrence of covid-19 in a 81-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th January 2023, the patient received Shingles vaccine. On 28th January 2023, 1 days after receiving Shingles vaccine, the patient experienced covid-19, rash, pruritus and cough. The patient was treated with codeine + promethazine (Promethazine-Codeine) and nirmatrelvir + ritonavir (Paxlovid). On an unknown date, the outcome of the covid-19 was not recovered/not resolved and the outcome of the rash and pruritus were recovered/resolved and the outcome of the cough was unknown.   It was unknown if the reporter considered the covid-19, rash, pruritus and cough to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-FEB-2023 Reporter's comments: This report was submitted and was submitted by public reporting reference via the online direct entry reporting system. The reporter reported that his wife and he took the new Shingles vaccine and from 28th January 2023 to the date for by January 29th both had covid, plus had rash and itching on back and trunk. The patient received other products paxlovid and promethazine-codeine syrup. The itching and rash were gone at the time of reporting and was just left with Covid.  The reporter had consented to follow-up. Additional supportive information: This case was linked with US2023AMR018937 which was reported by same reporter. Note: The cough was coded as event based on drug indication as after vaccination patient had covid cough for which received treatment.  Onset date for Covid kept as 28th January 2023 as reported from 28th but by 29th both had means we are not sure who experienced 1st.; Sender's Comments:  US-GSK-US2023AMR018937:Same reporter
Pt returned to Clinic on 3/11/13 for fever, face rash, swelling of face, body rash. Pt given immunizations on 3/1/13 and doctor suspects reaction to MMR vaccine. Fever x 4 days.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 23-APR-2012, patient received improperly stored VARIVAX dose 2, from lot # 669842/0931AA expiry date: 13-JUN-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient developed left arm pain and left leg pain that self resolved following administration of Johnson and Johnson vaccination.  It was determined by the vaccination Clinic provider, who administered the vaccination, that the patient did not qualify for the Johnson and Johnson vaccination, after this was administered.  I then evaluated the patient in the urgent care department later that afternoon.
Sore throat, chills, aches, cough - all 4 days following flu vaccine. Went to urgent care on the 6th day after symptoms began and tested positive for covid-19.
Pt reported experiencing chest heaviness, pain into backard neck approximately 1 after vaccination. Pt reported mild swelling in face and lower lip. Pt also reports dizziness and weakness upon reporting to ER at 4:00pm on 3-2-21. Pt reports she had a cardiac workup at ER and released after observation
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Post-concussion syndrome" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing); "peanuts" (unspecified if ongoing); "coconut, peaches" (unspecified if ongoing). Concomitant medication(s) and other medication in 2 weeks included: ALLEGRA. Past drug history included: Compazine, reaction(s): "Known Allergies:Compazine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 09Apr2022 to 14Apr2022. On 19Apr2022, the patient had a rebound infection on day 12 after feeling well for two days, five days after her last dose of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Got shot and still got shingles/suspected vaccination failure; Still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell; Fatigue; Severe headache; Joint pain; Muscle pain/Extreme body pain; Woke up this morning to an extremely fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Woke up this morning to an extremely fast heartbeat), GAIT DISTURBANCE (Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell), FATIGUE (Fatigue), HEADACHE (Severe headache) and ARTHRALGIA (Joint pain) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065J21A-B, 034F21A, 006H21A and 03H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation (Patient was taking Warfarin for atrial fibrillation.). Concomitant products included WARFARIN for Atrial fibrillation, PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Woke up this morning to an extremely fast heartbeat). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell), FATIGUE (Fatigue), HEADACHE (Severe headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain/Extreme body pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fatigue and Headache, at a dose of Two tylenol. At the time of the report, TACHYCARDIA (Woke up this morning to an extremely fast heartbeat), GAIT DISTURBANCE (Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell), FATIGUE (Fatigue), HEADACHE (Severe headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain/Extreme body pain) was resolving.            Patient woke up with extremely fast heartbeat on 22-Apr-2022.   This case was linked to MOD-2022-547021 (Patient Link).
No adverse event; Administered expired vaccine to 12 year old on 03/14/2023Vaccine expired 03/12/2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 12 year old on 03/14/2023Vaccine expired 03/12/2023) and NO ADVERSE EVENT (No adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 12 year old on 03/14/2023Vaccine expired 03/12/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 12 year old on 03/14/2023Vaccine expired 03/12/2023) and NO ADVERSE EVENT (No adverse event) outcome 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 (Administered expired vaccine to 12 year old on 03/14/2023Vaccine expired 03/12/2023).    No concomitant medications were reported.  The event expired vaccine used was coded conservatively as there was mention of two conflicting dates for the vaccine expiration. Administered expired vaccine to 12-year-old on 14-Mar-2023 Vaccine expired 12-Mar-2023 vaccines were pulled from freezer 10-Mar-2023 Nurse who pulled vaccines noted they were set for expiration 30 days from that date which is 09-Apr-2023.  No treatment medications were reported.
Fever 100.4 body aches and sore throat lasting over 2 days now a constant headache and fuzziness
Received vaccine 10/27/06 on 11/08 c/o severe muscle aches and bone pain generalized. Experienced pain when touching face. Difficulty to move, felt bad for approx 30 hours took no meds. Pain gradually diminished on 11/10/06 developed hives on arm and torso, takes Benadryl and hives gone on 11/11/06, cannot identify anything new or used that would cause hives.
Approx 30 mins after leaving health dept lips started swelling. Took shower. Lips continued to swell, then throat started hurting. Called health dept approx 4:25pm. Advised to go to ER. Left about 4:30pm to go to hospital. 7/10/06-ED and DC summary received from facility. DC DX: Allergic Reaction. ED report:PE revealed mild edema to upper lip, oropharynx clear, HR 114 tachycardia without murmur. Respirations 24. Afebrile.  RX with IM Decadron and Benadryl, oral Tagamet and prednisone. No further complaints, swelling resolved. DC home on Prednisone for 3 days.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 30 months old male patient who was inadvertently vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6301MA) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration and accidental overdose. It was unknown if any adverse event occurred or not following the administration of vaccination. 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. Documents held by sender: none.
Arm swollen, hot, sore to the touch. Progressively worsened over the next 6 days.  Fever, chills, tremors present.  Re-visited the Dr. on 9/28.  Prescribed antibiotics and steroids to lessen the swelling and fight infection diagnosed as cellulitis by a PA.  In speaking to the Dr. the following day, he felt, sight unseen, that the reaction was to the Diphtheria portion of the immunization.  When reporting tremors getting more severe, they took me off of antiobiotics (sulfa) and steroids and prescribed another antibiotic.
This spontaneous case, initially received from a pharmacist on 06-Nov-2018, concerns a 67-year-old, elderly female patient. The patient's current condition included nerve pain (since an unspecified date). The patient's concomitant medications included ASA and meloxicam. On 06-Nov-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported]. On the same day, within few minutes of vaccination, the patient experienced bulging up and raised area at the injection site. The patient was monitored and consulted her primary care physician (PCP). It was reported that, the patient was not hospitalized. On an unspecified date in 2018, within few days of vaccination, the patient had recovered from the event. The reporter assessed this case as serious (medically significant). Follow-up report received on 15-Nov-2018: Added patient's current condition nerve pain in patient tab. The outcome of the event injection site swelling was changed from not reported to recovered (within few days of vaccination). It was not sure about the indication of the concomitant medication meloxicam. The narrative was amended accordingly.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In February 2019, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: Exact date of vaccination was not provided. The healthcare professional could not provide batch number and expiration date.