chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost vision in one eye; had eye pain and was diagnosed with optic neuritis; burning, tingling in both legs; burning, tingling in both legs; general muscle weakness; This is a spontaneous report received from a contactable pharmacist. A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in 2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. HCP calling regarding a patient, who reached out to the Pharmacist inquiring about treatment recommendations and any information regarding her diagnosis, that received her 2nd Pfizer Vaccine dose 2 weeks ago and started with reactions after 2 days. The patient reported burning, tingling in both legs and general muscle weakness. She also had eye pain and she was diagnosed with optic neuritis and had lost vision in one eye as a result. Reporter was asking if there have been any reports of this. The outcome of the events was unknown. HCP was asking if any "post market research" has shown any reports of "multi system inflammatory syndrome as seen in children post Covid 19 illness." HCP also inquiring about Guillain-Barre syndrome reports in post EUA reports.; Sender's Comments: Based on the information provided, and on plausible temporal association,  the Company  assessed that a reasonable possibility could not be completely excluded that the reported events optic neuritis and lost vision were related to the  PFIZER-BIONTECH COVID-19 VACCINE.
Chicken pox; This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's comment: Pharmacist reported that the patient developed chicken pox after receiving the Shingrix vaccination. The reporter consented to follow-up.
8x8 cm red area on rt anterior thigh, t100.2 R; Seen p/ 4 hrs; no more pertussis;
Hypotension/Unconsciousness approx 4min after injection, possibly due to anxiety or fear of needles. Slumped out of chair in waiting area resulting in minor trauma to face/mouth.
Patient was given the pfizer vaccine without the diluent being mixed in the vaccine. Patient waited in office for 30 min with no reactions or symptoms. CDC was called and was told that no patient harm was done. Patient notified.
Within 15-minutes of vaccination, the patient reported dizziness. Patient rated the dizziness as 4/10. EMS evaluated patient on-site. Patient has a history of cardiac stent placement and EKG displayed PVC's <6 min. The patient was hypertensive (164/81). Patient denied chest pain or difficulty breathing. EMS believed the patient had a psychosomatic response secondary to their anxiety. Patient's condition improved and refused further evaluation, treatment, or transport to hospital.
Body aches and headache the morning following vaccination. Headache continued next day, but lesser. Relieved by Ibuprofen both days.
Dose administered after exposure to room temperature >24 hours; Dose administered after exposure to room temperature >24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours). On 14-Oct-2021, PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes, reaching a maximum of 10 degrees Celsius.   This case was linked to MOD-2021-374037 (Patient Link).
In error: Administered 0.1 ml Td ID instead of PPD. Left forearm no erythema no pain or itch. 10 mm area of induration noted. 4 days past injection area remained 10 mm no symptoms.
Rash around the injection site area; Signs of being in pain and fussy; Signs of being in pain and fussy; This case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 2-month-old male patient who received Hib (Hiberix) (batch number FY4E9, expiry date unknown) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 23339G, expiry date unknown) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Hiberix .5 ml, the 1st dose of Pediarix .5 ml, Pediarix Pre-Filled Syringe Device, the 1st dose of Rotarix lyophilized formulation (oral) 1 ml, Rotarix Oral Applicator Device and PREVNAR. On 14th June 2022, 1 days after receiving Hiberix, Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device and not applicable after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced injection site rash, pain and irritability. On an unknown date, the outcome of the injection site rash, pain and irritability were unknown.   It was unknown if the reporter considered the injection site rash, pain and irritability to be related to Hiberix, Pediarix and Pediarix Pre-Filled Syringe Device. It was unknown if the reporter considered the pain and irritability to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 16-JUN-2022 Reporter's Comments: The patient's parent brought patient in for a rash around the injection site area. The patient also displayed signs of being in pain and fussy.  The reporter wanted to know if these side effects had happened in past.  The reporter reached out to report adverse events to see if the vaccines could have been of cause.  On 14th June 2022, 1 day after receiving Prevnar, patient experienced injection site rash, pain and irritability. It was unknown if the reporter considered the injection site rash, pain and irritability to be related to PREVNAR.
Information has been received from a physician concerning a female with n allergies who on 028-JUL-2007 was vaccinated with a 0.5 ml third dose of Gardasil. There was no concomitant medication. On 05-JUL-2007 the patient developed a bump around her hands and was swollen over the neck area. A "blood test was performed" results not reported. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There were no adverse events involved with the first and second doses of Gardasil. Additional information has been requested.
Shingles belt; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   On 15th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix, a couple days after that experienced shingles belt for a couple weeks.  The patient completely recovered from the  shingles belt. The reporter consented to follow up.
Had varicella vaccine 5/3/04: developed red raised papular rash chest 5/12/04: vesicular: face, scalp, and mild on arms and legs. Mild, itchy and no fever, mildly irritable.
Bad muscle aches in upper left arm, limited use of left arm due to muscle pain, red spot at injection site that has gotten larger over the past 3 days, red spot is warm to the touch, fatigue, diarrhea, malaise, stomach cramps
Patient relayed to daughter that he was cold and was having chills.  He stated he was going to take a shower.  He passed away sometime after this and was found 2 days later per his daughter.  Date of death was listed as 9/17/2020 on death certificate.
Patient received seasonal and H1N1 injections in RD on 11/23/09 according to provider orders. Given by trained staff. Protocols followed. Patient c/o redness and pain in arm at F/U apt on 2/4/2010. Still has hypopigmentation upon assessment 2/4/2010.
Pt. c/o pain to Lt arm x 2 mos. Thought it was the vaccine, came into clinic today for visit with doctor with c/o burning pain to entire arm. Pain/burning to Lt arm x 2 months, got the SHINGRIX vaccine at last visit in August.
After waiting my 15 min, and left the facility about 10 min later my left side of face tingled. Then about 1 hour after getting the shot I had a horrible leg crap in left leg to the point it was hard to walk.  Went to ER and ruled out blood clot and I also developed sores in my mouth. That night I started feeling warm sensation down both arms and tingling in both hands and this had been going on each day throughout the day where I have a warm sensation down my arms and through my upper chest and is not going away, today 3/14/21 I went to urgent care again as now left side has swelling in my lymph nodes in my chest and I still have the tingling in my face and my head does not feel right. Urgent care did a neurological base test and I seem fine in that department but told me to report the warming sensation as it?s not my skin but I feel it inside.
Patient received a 2nd dose of Novavax.  She had previously received Janssen COVID vaccine on 4/9/21, Moderna Covid booster on 11/26/21 and a first dose of Novavax on 4/48/23.  There have been no adverse events reported by the patient.  Patient's doctor was notified and he confirmed that he recommended to patient she receive Novavax vaccines.
Client states that after her 1st dose Pfizer COVID vaccine (LOT: EW0179, Expiration 08/31/2021) received 05/06/2021 she developed a bilateral inner arm and belly rash during her 15 minute observation period. She reported she did not alert the EMTs at the time but left the site and went home to take a 25mg Benadryl. She stated the symptoms resolved approximately 1.5 hours after taking the Benadryl and did not return She denied any other symptoms such as chest pain, shortness of breath, facial swelling, tongue, mouth, throat swelling or tingling. She reported positive for an anaphylactic reaction to strawberries, but otherwise denied allergies to any other medications/foods/environment. She denied any other significant medical history or medication use.
This spontaneous report as received from a pharmacist refers to a 18 years old female patient who in sometime in May 2012 was vaccinated with her first dose of GARDASIL 0.5 ml, injection, intramuscularly on left arm (lot number not provided) and the second dose of GARDASIL (dose, route and lot number was not provided) was administered on 09-JAN-2013. No adverse effect reported. Additional information has been requested.
Teeth ache, muscle ache, pain at injection site, chills, 100.2 F temperature
8* days after injection, pain, swelling, itching, redness and hot spot at injection site.
6/7 35y.o. G3P2002 at 39w0d by s presents to Triage with c/o contractions. 6/7 SVD of baby girl
pt recvd vax & w/in 2hrs p/vax pt exp welts & a rash;pt was treated w/DPH;
Shingles; Rash on thigh and butt; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2022, the patient received the 1st dose of Shingrix. In August 2022, 4 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The reporter was the patient. The patient received dose of Shingrix and stated that 4 days after vaccination patient developed a rash on her left thigh and butt which was confirmed as shingles by her doctor. The reporter consent to follow up.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
All over body rash; This case was reported by a physician via sales rep and described the occurrence of generalized rash in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had all over body rash. The reporter consented to follow up.
This spontaneous report was received from a medical assistant refers to three unspecified patients of unknown age and gender. Three unspecified patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, three unspecified patients were vaccinated with improperly stored (at a maximum 49.1 F for total 66 hours and 37 minutes) ROTATEQ vial, lot # L033694 (16-JUN-2017) (dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/ allergies were unknown. On an unspecified date in June 2017, the patient was vaccinated with improperly stored doses of PROQUAD (Lot # M007960, expiration date 15-AUG-2017 or Lot # M049122, expiration date 13-JUN-2018) dose, route were unknown for prophylaxis (the nurse reported that since 02-JUN-2017 this patient and 5 more received the improperly stored doses of vaccine). The lot # and expiration date for the properly stored sterile Water diluent used to reconstitute the doses of PROQUAD was not provided. No adverse effects were reported. The temperature excursion was from 6°F to 14°F for 1 hour, no previous temperature excursion was reported, the call was because a data logger. No product quality complaint was involved. This is one of 6 cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006743: US-009507513-1706USA010999: US-009507513-1706USA011001: US-009507513-1706USA011002: US-009507513-1706USA011003.
As I was walking home after the shot I got blurry vision. And then about 3 pm I noticed my veins in my left hand were getting really big and shrinking  and the veins were pulsating. I now have a migraine and my left leg is tingling and I am having to talk out of the right side of my mouth.
Sudden development of eye floater; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 23Mar2021 at 10:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient medical history included allergies. The patient had known allergies. Concomitant medications included levocetirizine dihydrochloride (XYZAL) for allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 02Mar2021 at 11:30 as a single dose for COVID-19 immunisation. On 27Mar2021 at 12:00, the patient experienced sudden development of eye floater. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event eye floaters was recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix had fever and cannot even get out of bed.
Patient reports had feelings of feeling high as if she had received Stadol 1.5 hours after flu vaccine. Lasted 24 hours; went to ER at time feeling started. MD thought it could be reaction with other meds.
Initial report received on 14 November 2009 from an investigator. A 66 year old female subject developed BELL'S palsy on 7 November 2009 i.e. 33 days after receiving an intramuscular injection of FLUZONE SV 2009-2010 on 5 October 2009 in left arm (UD12321). The subject had medical history of left bundle branch block, mitral valve prolapse, migraine, hypothyroidism, hypercholesterolemia, gastroesophageal reflux disease, irritable bowel syndrome, arthritis, cataracts. The subject was on concomitant medications NORVASC, VYTORIN, PRILOSEC, LOTRONEX, SYNTHROID, CELEBREX. On 7 November 2009, the subject developed facial weakness and was diagnosed with BELL'S palsy. No treatment prescribed by her neurologist. Magnetic resonance imaging (MRI) of her brain was negative (per subject). She will follow up with ophthalmologist for additional care. Corrective treatment details were not provided. The events of BELL'S palsy and facial weakness were ongoing at the time of this report. According to the investigator, the event was related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. List of the documents held by sender: None.
Tinnitus gotten worse after receiving COVID19 vaccines; dizzy; vertigo; brain fog like when people get COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus gotten worse after receiving COVID19 vaccines), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (brain fog like when people get COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus gotten worse after receiving COVID19 vaccines), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (brain fog like when people get COVID-19). At the time of the report, TINNITUS (Tinnitus gotten worse after receiving COVID19 vaccines), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (brain fog like when people get COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the tinnitus,  in 25% of the patients who already had the condition, had gotten worse and this was accompanied by a cluster of symptoms like vertigo, dizziness and brain fog. No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021 contains no new information.
his regular COVID test came back positive; his regular COVID test came back positive; This is a spontaneous report from a contactable nurse (reporting for himself) from a Pfizer-sponsored program. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 23Dec2020, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 23Dec2020, the patient received the COVID vaccine. On 28Dec2020, he had a negative rapid COVID test, and then on 01Jan2021 his regular COVID test came back positive. The patient would like to see if he should still get the second dose of the vaccine. Outcome of the events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event SARS-CoV-2 test positive based on the known safety profile. However given the short duration of 9 days since the vaccine first dose, it is unlikely patient would have fully developed immunity.
Developed ITP, initial symptoms included Petechia, bruising, and mucosal bleeding (mouth blood blisters).