chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported today (the date of dose 2 in her Pfizer series) that she has experienced non-stop tinnitus since the date that she received her Flu and Covid-19 vaccines on November 26th. Recommended that she contacts her PCP to potentially set up a hearing test/exam/referral.
Itchy red rash from neck down to groin.; red rash/hives from neck down to groin.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm on 22Mar2021 at 15:30 (at the age of 36-year-old) as single dose for COVID-19 immunisation. Medical history was not reported. The patient experienced allergy to sulfa drugs. The concomitant medication included probiotics (MANUFACTURER UNKNOWN) and collagen (MANUFACTURER UNKNOWN) for unknown indication. Prior to 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 4 weeks prior to the COVID-19 vaccine. On 26Mar2021 at 08:00, the patient experienced itchy red rash and hives from neck down to groin. The patient had received antihistamine as the treatment for reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events Itchy red rash from neck down to groin and red rash/hives from neck down to groin were recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt had tonic-clonic sz which lasted about 2min;also had a fever of 101 @ the time of the sz;pt has a hx of sz;seen 2 2wk p/event and is recovered;
Client reports that for 1st dose  she experienced a few seconds of dizziness. Client reports it resolves on its own.  Client was approved to get second dose with a 30 minute observation.  Client did not have a reaction to second dose within the 30 minute observation period.
Acute swelling of left leg. Erythema, swelling began within hours of injection only at site of DTaP.  2 days after injection left continues with significant swelling and erythema.
Vaccine administered past published expiration date. Contacted Moderna, received this communication:The vaccine administered on November 10, 2021 and November 15, 2021 from lot number 046C21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration, therefore there is no need for revaccination.
Vasovagal syncope; This spontaneous report was received from a pediatrician and refers to an 11-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, administered at the office, (strength, expiry date, route of administration, and anatomical site of vaccination were not provided) for prophylaxis.  On an unknown date [reported as within 15 minutes after the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)], the patient experienced vasovagal syncope. At the time of reporting, the outcome of the event vasovagal syncope was unknown.  The causal relationship between vasovagal syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review, the event of vasovagal syncope was determined to be medically significant.
shingles kept getting worse and she is now having a huge flare up with sores all over the left side of her body; welts feel like they are burning alive all over body; cannot move; pain; nausea; fever; shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), BURNING SENSATION (welts feel like they are burning alive all over body), MOVEMENT DISORDER (cannot move), PAIN (pain) and NAUSEA (nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HERPES ZOSTER (shingles) with CONDITION AGGRAVATED (shingles kept getting worse and she is now having a huge flare up with sores all over the left side of her body), PAIN (pain), NAUSEA (nausea) and PYREXIA (fever). On 23-Feb-2021, the patient experienced BURNING SENSATION (welts feel like they are burning alive all over body) and MOVEMENT DISORDER (cannot move). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles), BURNING SENSATION (welts feel like they are burning alive all over body), MOVEMENT DISORDER (cannot move), PAIN (pain), NAUSEA (nausea) and PYREXIA (fever) had not resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Contact information has been updated.
1.5 hours after MMR immunization, became dyspeneic with wheezing breathings. Red, raised, bumpy hive-like rash at injection site that spread to left shoulder and left upper back. outer area reddened and hurting. Complained of headache. To ER 1.5 hours later for Rx. Given inhaler and Benadryl at discharge.
itchiness; Reaction; Received first dose in 25Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), HYPERSENSITIVITY (Reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose in 25Feb2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose in 25Feb2021). On an unknown date, the patient experienced PRURITUS (itchiness) and HYPERSENSITIVITY (Reaction). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose in 25Feb2021) had resolved. At the time of the report, PRURITUS (itchiness) and HYPERSENSITIVITY (Reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received captured no new information.
OTC meds for fever and cold/mucus; OTC meds for fever and cold/mucus; Fever/ OTC meds for fever; Vomited; Chills; Headache; Dizziness; Nauseous; Tired; Stuffy nose still; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 18:30 (Lot number: FK127) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: OTC allergy pills cetirizine. Concomitant medication(s) included: FLU taken for immunisation, administration date 18Nov2021; CETIRIZINE taken for hypersensitivity; BENADRYL. The following information was reported: NASOPHARYNGITIS (non-serious), SECRETION DISCHARGE (non-serious) all with onset 24Nov2021 04:00, outcome "recovered with sequelae" and all described as "OTC meds for fever and cold/mucus"; PYREXIA (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Fever/ OTC meds for fever"; VOMITING (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Vomited"; CHILLS (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Chills"; HEADACHE (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Headache"; DIZZINESS (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Dizziness"; NAUSEA (non-serious) with onset 24Nov2021 04:00, outcome "recovered" (Nov2021), described as "Nauseous"; FATIGUE (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Tired"; NASAL CONGESTION (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Stuffy nose still". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nasopharyngitis, secretion discharge, pyrexia. Additional comment: Patient was not reported Covid prior to vaccination and has not been tasted for Covid post vaccination. Other medical history and allergies were reported as none.
This spontaneous report was received from a physician referring to a 12 year old male patient. The patient had no medical history, drug reactions/allergies or concomitant medications to be reported. On 10-JUL-2017, the patient was vaccinated with the second dose of GARDASIL 9 in the right arm for prophylaxis; the route of administration was unknown (lot # N003703, expiration date: 29-OCT-2019). On 10-JUL-2017 (reported as "since injection"), the patient experienced a "lump" at the injection site (vaccination site mass). On 26-DEC-2017, the patient was seen in the office and the physician ordered an ultrasound of the injection site for the same date (results were not available at the time of the report). The patient reported no pain or other symptoms and no treatment was given for the event. At the time of the report, the outcome of vaccination site mass was not recovered. The causality assessment between the GARDASIL 9 and the aforementioned event was not reported.
Patient became nauseated at 11pm 1/20/21 and fever of 101, passed out in bathroom dry heaving and woke up at 4am, Heartrate 182, short of breath, continuous vomiting, called EMS, was given zofran on route to ER, upon arrival to ER heartrate reduced to 130's, patient reports being given toradol and IV Fluids, and was released. Patient reports fever range of 101-103.
kidney stones; kidney function problems; pain; This spontaneous report was received from a a nurse practitioner and refers to a 12 year old female patient. The patient's concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported), to protect against hpv related cancers and diseases.  On an unknown date, the patient experienced kidney stones, kidney function problems, pain and missed a year of school. The patient was hospitalized on an unknown date at the clinic. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided by the reporter (however reporter mentioned that unspecified person at the clinic said "problems were due to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)").   All events were considered to be disabling due to the patient missed a year of school. Upon internal review, the events of kidney stones and kidney function problems were considered to be medically significant.
Approximately 1 pm developed high fever (not measured) and severe chills. At 2:30 took 2 adult ibuprofen. At 4 pm chills decreased. 1-2:30 preferred darkness, eye pains, migraine headache which lasted until 10 pm. Residual fatigue for next 48 hrs. like the flu.
Genital herpes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number : unknown), via an unspecified route of administration on an unspecified date as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included food allergies with white sugar and white flour. The patient's concomitant medications were not reported. On an unknown date, the patient experienced genital herpes. She stated that, she experienced genital herpes and she had some food allergies with white sugar, white flour and was asking if there was a concern in receiving the second shot on the 17Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
pt recvd vax 20DEC94 & devel fever 1st day & tender redness of rt upper arm distal to inject site over next 2d; tx w/cold compresss, APAP, DPH; eval clinic 22DEC94 sx resolved x 2d arm-nl by 24DEC94;
shingles after 1st dose; first dose of shingrix in 30th Dec 2019 and 2nd dose on Sep 3 2022; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number LG2XJ, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2022, the patient received the 2nd dose of Shingrix. On 30th December 2019, the patient received the 1st dose of Shingrix. On 3rd September 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Oct-2022 Reporter's comment: The pharmacist reported that the patient developed shingles after 1st dose of Shingrix and received late second dose. The vaccine administration facility was the same as primary reporter. The consent to follow-up was granted. Additional Supportive Information: The patient received 2nd dose longer than the recommended interval, which led to lengthening of the vaccine schedule.
Patient presented to the emergency department complaining of generalized rash and itching. Patient was treated with benadryl and released home after her symptoms resolved.
4/1/2012 Fever, blister formation, followed by crusting and erythema over a 20 mm sized induration TB injection site, RFA, 4 days after injection. 4/2/12: PPD test injected 12:20 pm 4/4/12: TB test read positive 20mm.
FEVER BEGAN ON 10/19/16 AROUND 5PM AND LASTED THROUGH THE NEXT DAY.  PATIENT ALSO HAS FELT SORE AND ACHY SINCE DAY OF IMMUNIZATION.  ON 10/27/16 SHE WOKE UP WITH A LARGE RASH AROUND INJECTION SITE.
Received vaccinations at 3:30 PM. Around 8 PM started experiencing shooting pain from shoulder to elbow. Also had trouble sleeping and immobility in right arm. Dr. prescribed LORTAB. Patients thinks it's PNEUMOVAX.
48 hours after 2nd dose of Pfizer covid vaccine, woke up with numb arms, hands cramped backwards, severe abdominal pain with 1 small loose stool and dry heaving eith unrelenting nausea. Seen in urgent care for nausea medicine and IV fluids. Immediately upon arriving home, began to have bloody BMs. No stool present, only dark red clots and fresh red blood. No pain, no history of hemorrhoids. Continued to poop blood throughout 7 hour wait in emergency room.  Sent home, stopped pooping blood 24 hours after initial onset. Moderate stomach cramping and nausea persisted for 6 additional days and had to take prescription medications for both. Weakness, loss of appetite and inability to work lasted approximately 7  days. General fatigue has increased since injection. Both urgent care provider and ER doctor believe this is result of ?stomach virus?
Patient received the Moderna booster 4 months instead of 6 months after the 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 22-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  No treatment medications provided by the reporter.
This RPh is unsure if this was already reported-- it was noted there was a Flu vaccine given 10/2/2020, then Shingrix 10/9/2020.  Went to ER for leg weakness, difficulty walking 10/18/20. Lumbar puncture, dx Guillain Barre, treated with IVIG x5 days. Improved, not quite to baseline but was expected to improve further.   Discharge for rehab 10/29/20.
Intense ringing of left ear only. This came on abruptly about 34 hours after the injection. It lasted consistently (24/7) for 6 days. At day 7, it is intermittent and not as loud/intense. I saw Dr. on Aug. 3rd - 2 days after the ringing started. She advised likely an effect from the vaccine given the time and never experienced this before. She wrote a Rx for 5mg Lexapro to aid me with anxiety ringing is causing. She ordered a hearing test for me that day, which resulted in no injury or changes (normal) and I followed up with ENT, ARNP who just chatted with me about tinnitus and ways to relieve it. Today, Aug. 11th, the ringing is still present, but continues to diminish.
Information has been received from a nurse concerning a 2 month old female who on 30 Oct 2006 was vaccinated PO with the first 2.0mL dose of Rotateq (human bovine) (lot #655296/0979F). Concomitant vaccinations administered on that same day included a dose of Pediarix, a dose of HIBTiter and a dose of Prevnar. The nurse reported that on 31 Oct 2006 the patient developed green, strong odor diarrhea which "smelled liked rotavirus" and a fever between 101 and 102.6F. The patient was noted to have gone to the Emergency Room (ER) twice but was not hospitalized. On 04 Nov 2006, the patient's diarrhea and fever resolved. Additional information has been requested.
swelling in his elbow; Swelling extended to patient forearm; This case was reported by a nurse via call center representative and described the occurrence of swollen joints in a 26-year-old male patient who received HAB (Twinrix) (batch number A955S, expiry date 22nd May 2022) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Twinrix. On 10th October 2020, 5 days after receiving Twinrix, the patient experienced swollen joints and swelling arm. On an unknown date, the outcome of the swollen joints was not recovered/not resolved and the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swollen joints and swelling arm to be related to Twinrix.  Additional details were reported as follows: On 10th October 2020, the patient experienced swelling in his elbow. Swelling in the patients AC (as reported) and back of elbow extended to the forearm. The patient had not consulted a physician, diagnosis was not available and outcome reported as ongoing.  The reporter consented to follow up.
AFTER ADMINISTRATION OF VACCINES PATIENT PASSED OUT. PATIENT WAS SUPPORTED BY NURSE WHEN SHE CAME TO SHE VOMITED x1. SHE WAS HELPED TO A COT AND COOL PACKS APPLIED TO BACK OF NECK. PATIENT WAS GIVEN JUICE AND MONITORED FOR 15 MINS. PATIENT LEFT WITH FAMILY.
6" x 4" induration, erythema, warmth on anterior left mid-thigh noted at return visit 6/24/11. Prescribed Cephalexin 250mg/5ml oral suspension, take 2 tsps every 12 hrs x 10 days.
That morning patient ran a very high temp of 103.7. After giving him a fever reducer his temp had spiked up again to 105. Patient had a seizure. He turned purple, was shaking and staring, and foaming at the mouth. He was rushed to the hospital by ambulance. The hospital checked his ears, ran a strep test, did an X-ray, took blood work, did a urine sample. The doctor told us everything came back fine. Patient continued to run a high fever up until Sunday. Then ran a low grade temp on Monday.  His temp was 104.4 Sunday morning at 4am. In his sleep he would wake up screaming and would act as if he wanted to roll or move but seemed as if he couldn't like his body just wouldn't move. He would not eat or drink anything. He was very lethargic at daycare on Monday Nov 2nd his teachers said he would sit and watch the other kids play. Mother did ask pediatrician Saturday Oct 31 at the follow up appt if his sickness could be related to the vaccines he received 10 days earlier. The doctor said it very well could be but she can't say and to keep an eye on him and that if he is still running a fever as of Tuesday Nov 3rd to bring him back in for more blood work.
Woke 06/21/2016 with pain at injection site (L) deltoid. Severe neck pain at the base of neck. Headache. No fever. Stiffness of neck decreased on 6/26/16.
Shortness of breath on the day of the shot. Then symptoms went away. About a week after she had chest pains for 1 day. On Sunday, June 13, she had chest pains and she couldn't eat or sleep. Symptoms continued for 2 days. Took her to the doctor who ordered blood tests, EKG and x-rays.
3/28/2021 at 6:00 a.m. patient reported chest pain to a family member. He arrived at her home at 6:15 and found her slumped to the right in her chair, unresponsive. Patient was taken to our facility via EMS. On arrival, patient could open her eyes but could not talk or move her extremities. She was treated with alteplase 100 mg and flown to a trauma center. She was released on 4/2 and is currently receiving rehabilitation services in our facility; she is expected to return home in 4-5 days.
Patient is experiencing ongoing symptoms eight days after the second dose of the vaccine. Symptoms include; -forgetfulness -dizziness -sharp headache as well as back of head and neck pain -nausea  -light headed -muscle Spasms -confusion -blurred vision  -difficulty understanding what people say at times. -loosing train of thought often  -at times dyslexia
Racing heart with heart palpitations. Started on second/third day after vaccination. Heart began racing throughout the day and pulse was high (over 115 pulses) while solitary and not moving. Lasted three days after throughout the day off and on and still having small heart issues in the morning.
Large, bee-sting like swelling and redness around injection site lasting more than a week.  Severe pain.