chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It's about the size area of an orange puffed out; Not real hot but kind of hot; it is red; Having a little itching just around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Not real hot but kind of hot), INJECTION SITE MASS (It's about the size area of an orange puffed out), VACCINATION SITE PRURITUS (Having a little itching just around the site) and VACCINATION SITE ERYTHEMA (it is red) 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 No adverse event.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Having a little itching just around the site). On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Not real hot but kind of hot) and VACCINATION SITE ERYTHEMA (it is red). On an unknown date, the patient experienced INJECTION SITE MASS (It's about the size area of an orange puffed out). At the time of the report, VACCINATION SITE WARMTH (Not real hot but kind of hot), INJECTION SITE MASS (It's about the size area of an orange puffed out), VACCINATION SITE PRURITUS (Having a little itching just around the site) and VACCINATION SITE ERYTHEMA (it is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case concerns a female of unknown age with NS unexpected events of vaccination site mass, vaccination site warmth and NS expected events of vaccination site erythema, vaccination site pruritus.  Event onset 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a female of unknown age with NS unexpected events of vaccination site mass, vaccination site warmth and NS expected events of vaccination site erythema, vaccination site pruritus.  Event onset 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
After receiving the vaccination, the patient stated she wasn't feeling well. She had a history of fainting after giving blood. She asked for juice or gatorade so I went to grab her a drink. When I came back, she had passed out and was convulsing. After a few seconds she came to and was briefly disoriented. She quickly realized what happened and said the same thing happened before. She felt fine other than rubbing her head but didn't report any pain. I sat with her for about 45 minutes total. She denied an ambulance/further care, and her boyfriend came to get her. When she was leaving, she said she felt completely normal and had no concerns.
administered a dose of Boostrix on 06Sep2023 via intravenous route instead of intramuscular.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 06-SEP-2023, the patient received Boostrix (intravenous). On 06-SEP-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered a dose of Boostrix on 06Sep2023 via intravenous route instead of intramuscular.).  The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-Sept-2023 Pharmacist reported a nurse administered a dose of Boostrix via intravenous route instead of intramuscular.  At the time of reporting, the reporter did not had the dose lot number / expiration date, and did not had any patient information. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The patient received a dose of  Boostrix intravenously, which led to intramuscular formulation administered by other route.
screamed for 24hrs p/vax & had a fever of 101 for 24hrs
Fever at bed time on day of shot 99 F and the next night 98.9 F; Arm sore at the site of shot; Headache; Tiredness; This is a spontaneous report from a non-contactable (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES).  A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 14:00 (lot number: EN6205; expiry date: unknown) at the age of 50-years-old, as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included omeprazole; vitamin D NOS, cyanocobalamin (VIT B12), and calcium taken for unspecified indications, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with Covid-19 prior vaccination. On 12Mar2021, at 21:00, the patient experienced arm sore at the site of shot, headache, tiredness, fever at bed time on day of shot 99 Fahrenheit (F) and the next night (13Mar2021) 98.9 F. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for Covid-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
The COVID-19 vaccine administered through vaccine administrator, Health clinic, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
Redness, Swelling and Pain at and around Injection Site.  Muscle and Joint Pain from Head to Toe. Temperature of 102.1 F.  Upset Stomach with Dry Heaves.
This spontaneous report was received from a male patient in his "60's", who is also a physician, via a field representative. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date when the patient was in his "50's", he was vaccinated with ZOSTAVAX (Lot #, expiration date, strength, dose and anatomical location of administration were not provided), administered through injection, in combination with a sterile diluent (manufacturer unknown) (lot #, expiration date, strength and dose were not provided) for the prevention of shingles. Then a couple years later (date unspecified), the patient developed shingles. It was unknown if the patient received treatment for the event. It was stated that the patient did not seek medical attention. No further adverse event (AE) information was reported. At the reporting time, the patient had recovered from the shingles. The causal relationship between the event and the vaccine was not provided. Additional information is not expected as there was no consent to contact the reporter.
feel like crap; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th June 2022, the patient received the 2nd dose of Shingles vaccine. On 25th June 2022, 1 days after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's Comments:  This case was reported by a consumer via interactive digital media. The patient received second shot a day before reporting and he/she felt like crap on the day of reporting. The reporter reported he/she does have side effect, but worth it if he/ she did not get shingles.
Left arm swelling 2" above elbow no central skin breakdown-warm to the touch-some erythema.
About 5 hours after my shot my left arm began hurting way worse than after a flu shot. I have barely slept Sat, Sunday, Monday or Tuesday night because of the intense pain. I couldn't raise my are at all until yesterday I could slowly raise from my elbow to my hand. Today, 3-10 I can finally raise the upper part of my arm very slowly with some pain. It still hurts constantly but is getting better than it had been. I just can't sleep because of the pain. I have taken muscle relaxers, tylenol and ibuprofen but nothing helps.
muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, 5 days after receiving Bexsero, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after vaccination with Bexsero, stiil had considerable muscle pain.
Quadracel vaccine that was expired by one day was given to a consumer, no adverse event; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old patient (gender not reported) who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5248AA and Exp. Date 21-Aug-2019 )via intramuscular route in the left deltoid on 21-Aug-2019.  The patient's medical history not reported and concomitant medications included MMRVAXPRO vaccine for imunisation.  It was an actual medication error case due to expired vaccine used. It was reported that Quadracel vaccine was expired by one day was given to patient.  It was not reported whether the patient experienced any adverse event post 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.  List of documents held by sender: none.
A lot of neuropathic pain; Shingles; This is a spontaneous report from a contactable Nurse (patient). A 75-years-old female patient received BNT162B2 (PFIZER-BIOECH COVID-19 VACCINE, solution for Injection, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 02Feb2021 as second dose, single dose for covid-19 immunization (at the age of 75-year-old). Patient previously received first dose of BNT162B2 (Lot number: ELO142) Anatomical Location: left upper arm on 12Jan2021. The patient medical history and concomitant medications were not reported. She is a very healthy person. It was reported that on 09May2021 the shingles started after the second dose. patient believes it seems to be a latent effect. The shingles show up a couple months later. Also reported A lot of neuropathic pain. Patient reported that she is calling about the Vaccine and is suspicious of the side effects with regard to Shingles. She is trying to follow it as she is a health care worker as well and find out how many people have gotten shingles after receiving the vaccine. she has shingles and has received the shingles vaccine. She is curious to know how many other people have had this happen after the vaccine. She is just relating if her shingles are related to the Pfizer COVID vaccine. She has been kind of trying to google it as she has been feeling suspicious. She has had shingles for about 5 weeks. She said after talking with multiple people she knows they have been noting the increase of shingles cases as well this year, seems it may hit the immune system in a way that brings these things back up more easily, even though they had received the shingles vaccine. She sent a picture to the hospice doctor she works with to show him her shingles. she also adds shingles aggravating. She has seen it, that is has been related to someone having had an active COVID case, that has shown shingles, She doesn't believe she has had an active case of COVID, but she guesses it could always have been subclinical, but there is relevance between people with active COVID and getting shingles after getting the COVID shot. Patient visited physician office for events. ER visit: no. the outcome for the event shingles was reported as not resolved and for A lot of neuropathic pain outcome was unknown.   Information on Lot/Batch number was available. Additional information has been requested ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021685057 Same reporter/ AE, different drug/ patient
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006537:
I scratched my leg and it would not clot. I am not on a blood thinner so I thought this was strange.; facial paralysis; This is a spontaneous report received from a contactable consumer (patient). The consumer reported for himself that the 71-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 01Mar2021 09:30 AM at single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Family medical history relevant to ae(s) was none. Concomitant medication(s) included ongoing amlodipine 5 mg taken for an unspecified indication from an unspecified start date and ongoing; ongoing simvastatin 20 mg taken for an unspecified indication from an unspecified start date and ongoing; ongoing ascorbic acid/betacarotene/ biotin/ calcium/ chloride/ chromium/ copper/ folic acid/ iodine/ lycopene/ magnesium/ manganese/ molybdenum/ nickel/ nicotinic acid/ pantothenic acid/ phosphorus/ potassium/ pyridoxine hydrochloride/ riboflavin/ selenium/ silicon/ thiamine/ vanadium/ vitamin b12 nos/ vitamin d nos/ vitamin e nos/ vitamin k nos/ xantofyl/ zinc  taken for an unspecified indication from an unspecified start date and ongoing and Hypertension drug. The patient experienced facial paralysis 45 minutes after the administration on 01Mar2021 10:15AM with outcome of recovered , "i scratched my leg and it would not clot. i am not on a blood thinner so i thought this was strange." on 02Mar2021 with outcome of recovered on 02Mar2021.  The report was assessed as srious and seriousness criteria of the events was medically significant. Facility where the most recent COVID-19 vaccine was administered was School or Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none.  The clinical course was reported as follows: On the drive home from receiving the vaccine, I experienced facial paralysis that lasted about an hour. The next day, I scratched my leg and it would not clot. I am not on a blood thinner so I thought this was strange.   Information on the lot/batch number has been requested.
Patient received the 1st vaccine of Moderna  around 11:10am. Within a couple of minutes of receiving her injection she signed she felt dizzy, and lethargic. Pt was taken to the observation area where she continued to feel the same after taking sips of water. Pt then stated she felt hot as well. Pts checks were visibly flushed. Pt was given an ice pack to put on her back over her clothes. Pt then started to sign their lips felt tingly and throat felt thick and weird. It was around 11:30am patient given 50 MG of Diphenhydramine  and was administered oxygen at 2L. Oxygen increased to 3L patient unresponsive to 2L. O2 Sat 100% and Pulse 104. Second set of vital signs were 110/78, O2 100%, pulse 85 at 11:45 a.m. Patient was transfer to floor as she was unresponsive.  Pt wouldn't respond to painful stimuli for 2-3 mins. EMS was then called. During this time pts O2 continued to stay at 100% with pulse at 85-87.Oxygen increased to 6L. After 2-3 mins of trying to have pt gain consciousness, pt  started to react to sternum rubs. By this time EMS services arrived around 11:50-11:55am.Once paramedics arrived pt was assed and deemed pt was stable but wanted to take her in for a full workup to be on the safe side. Pt was then transferred to Community Regional Medical Center.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-years-old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.    On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of herpes zoster was unknown.     Additional information has been requested.
We re-administered second doses due to those patients not receiving first vaccine / seemed to be leaking hubs; medication leaked out / ran down the patient's arm; seemed to be leaking hubs; seemed to be leaking hubs; This case was reported by a nurse and described the occurrence of exposure via skin contact in a patient who received FluLaval Tetra 2020-2021 season (batch number 2J3TT, expiry date unknown). This case was associated with a product complaint.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, the patient experienced exposure via skin contact, accidental underdose, syringe leak and pharmaceutical product complaint. On an unknown date, the outcome of the exposure via skin contact, accidental underdose, syringe leak and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that, Flulaval prefilled syringes needle was inserted into unknown arm of patient, the user pushed on the plunger and all of the medication leaked out of the hub/luer lok and ran down the patient's arm, which led to exposure via skin contact, accidental underdose and syringe leak. Another dose was administered to the patient successfully. The prefilled syringes were pre-assembled immediately prior to administration, needles used for all suspect products were 25-gauge, 1 inch. The reporter had returned the one prefilled syringe from lot 2J3TT and syringes had the needles still attached, no known damage to the blister/carton, no damage noted to the syringe barrels. The consent to follow-up was granted. This case had been linked with US2020AMR208088, reported by the same reporter.   Follow up information was received from QA department on 30th November 2020: Conclusions of the QA statement were received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.  A customer reported a complaint which falls within the following product technical complaint category: PRTC syringe/needle connectivity issue based on the defect description. An investigation has been conducted, including review of the reported defect trends, the returned sample, the retained samples and our production records, which has demonstrated that the subject batch was produced in compliance with the applicable procedures and met all required specifications. Additionally, no deviation which could be related to the reported complaint has been identified and all of applicable verifications confirmed the conformity of the batch to specifications. Given the outcome of its investigation, GSK Biologicals considers the complaint that is the object of this report as unsubstantiated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR208088: same reporter
1day after shot:Fever,chills, body ache.  2 days after shot: Symptoms from day before gone but noticed a Tennis ball sized lump under left arm/pit area.  One week and one day after shot: slight swelling under left arm/pit area.
Swollen. Painful at injection site. Very red and hot. 2 days later still red, painful and hot. Also now itching.
Callers mom received first dose and was diagnosed with shingles a few days later.; This is a spontaneous report from a contactable consumer reporting for Mother via medical information team. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter asked whether her mother can get the second dose of the vaccine. After receiving first dose of vaccine, patient was diagnosed with shingles a few days later. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.