chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 16 year old patient. On 09-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
This report states that on 03/11/2002 a 69 year old male pt received a Fluzone SV '01-'02 vaccination administered on 10/29/2001 in his left arm. Nine to ten weeks later the pt developed pain in his left arm-had surger in Feb 2002 for pinched nerve. The pt was seen by a physician and was given a diagnosis of Parsonage-turner Syndrome. From follow up received at manufacturer on 5/10/02 additional pt history and lab results.
Patient was given Pfizer Vaccine on 5/16/21 at 11:00-11:10am.  I read through the patient medical history through the handheld and noticed there was "yes" on seizure history.  I ask the mother what happened and she told me it was from the first incident with the Pfizer vaccine.  At the time of the first incident the mother stated that patient fainted and convulsed upon regaining consciousness.  Patient has had no history of seizures prior to then or had any big injuries that could trigger it.  Patient's mother states physicians think it's triggered by anxiety and not a true seizure, so MRI or tests was not needed.  Doctor recommended patient to come back if it happens again.  With the information provided I used professional judgement and was on high alert with the patient.               After administrating the vaccine to the patient, I monitored patient's vitals carefully. Patient was stable and I walked with him to his seat near the wall and left him with his family.  About a few minutes later the mother told me to come to her aid.  Patient had a 1 time continuous seizure for about 30 seconds-1minute.  After regaining consciousness the patient said he did not remember getting the vaccine. Patient's mother was very concerned and under control and did not overreact to the situation.  Also, I promptly relayed to (pharmacist) to call 911 and he called a member of management.  While pharmacist was on the phone with 911 the patient regained consciousness.  I monitored patient's vitals while I waited for a member of store management.  Store management took a little bit longer to respond (5-10 minutes) but arrived to document the whole incident.               About 30 minutes after the incident patient's vitals were stable and the ambulance was not needed and the family took him to the hospital to get monitored. Patient rode the electric wheelchair was escorted out by store management to the car.
Lost consciousness; palms began to itch, then soles of feet; This is a spontaneous report from a consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (lot number was EL8982 and expiration date was unknown) via an unspecified route of administration at left arm 18Jan2021 14:30 at single dose for COVID-19 immunisation, amoxicillin via an unspecified route of administration from 18Jan2021 at 14:50 at 4 DF for dental apt, procaine hydrochloride (NOVOCAIN) via an unspecified route of administration from 18Jan2021 at unknown dosing regimen for an unspecified indication. Medical history included 3 joint replacements and known allergies to raw celery, clover honey and ragweed. Concomitant medication included atorvastatin calcium (ATORVASTIN), brimonidine tartrate, timolol maleate (COMBIGAN), levothyroxine, tolterodine.  There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. The patient had no reaction in first 15 minutes. Within 20 minutes of shot, patient took 4 amoxicillin for dental apt (as reported), then received procaine hydrochloride (Novocain). 45 min after shot, her palms began to itch, then soles of feet. Then she total loss of sight on 18Jan2021 at 15:30. Patient lost consciousness at emergency room check-in. Patient visited emergency room/department or urgent care. Patient received epinephrine injection as treatment. She also had CT scan of head and chest in Jan2021. She did not have COVID tested post vaccination. The outcome of events was recovered in 2021. The action taken in response to the events for amoxicillin and procaine hydrochloride was unknown.
pt vax hepta B. pt ex n/v 30 min aft vax.  sx remitted spont.   no addit. vax.
Ended up getting influenza b; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient).  This case involves a patient (unknown demographics) who ended up getting influenza b (influenza), after received INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing medical history asthma.  It was unknown if the patient had any other medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious influenza b (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory test results included: On an unknown date: Influenza virus test, Result: getting influenza B.  The patient went to emergency room (ER) and got breathing treatments and 3 different medications and a shot but it did not help his asthma. The patient will still get the vaccine every year for 65 and older.   It was unknown if the patient experienced any additional symptoms/events.   The details of medication and reason for taking the medicine was not provided.   It was unknown if there were any other lab data/results available.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
A few hours after getting vaccinated my arm was very sore and had some swelling around injection site. I woke up the next morning with a headache and felt achey all over. By early afternoon I was extremely tired, face was flushed, chills, some hot flashes, and still very achy. I spent the afternoon sleeping then slept all night. Woke up this morning feeling MUCH better, but a little light headed still.
Approximately 5 minutes after vaccine was given she noticed a rash start to develop on her right arm around the injection site.  Rash then spread across chest.  No itching, no pain.  No hives. She said her heart was racing when she first noticed rash but attributed this to anxiety.  Checked pulse and O2 Saturation about 10 minutes after symptoms began.  Pulse 88, O2 sat 98.  She was offered benadryl but declined.
No additional adverse effects reported; When the Medical Assistant drew back on the syringe there was blood in the syringe so the needle was removed from the Patient's arm; This spontaneous report has been received from a medical assistant via a company representative, concerning a 36-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication were not reported.      On 14-JAN-2020, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number 1637642 has been verified to be a valid lot number, expiration date reported and validated as 28-MAY-2022) 1 dosage form on her left deltoid as prophylaxis (concentration, dose number, frequency of vaccination scheme, and route of administration were not reported).    On the same day, when a medical assistant drew back on the syringe containing the f HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), there was blood in the syringe (wrong technique in product usage process) therefore, the needle was removed from the patient's arm and it was set aside. On the same day, a new vial of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was drawn up and the patient was vaccinated in her right deltoid.   No additional effects were reported.
Numbness in right forearm.  Evaluated by EMS.  1:30 pm numbness resolving without treatment and discharged home.
Within 2 hours arm was very very sore.  Progressed through the night to the point of extreme pain to move arm.  Couldn't reach into cupboards, no range of motion without extreme pain, no strength in arm to lift anything, run sweeper etc. I have tried hot and cold compresses, lidacaine patch, thera-worx, lots of tylenol, some advil.  I have a TENS unit and started using that 5 days ago.  Has helped some.  Been 5 weeks with this pain. I am a side sleeper so that was definately out when I did get to rest.
swelling at the bottom of the foot, Swelling was more like she was standing on a golf ball.; lips were swollen; her inner mouth as well(swelling); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling at the bottom of the foot, Swelling was more like she was standing on a golf ball.), LIP SWELLING (lips were swollen) and MOUTH SWELLING (her inner mouth as well(swelling)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Swelling of tongue. Concurrent medical conditions included Fruit allergy (Allergic to kiwi), Allergy to nuts (hazelnut) and Allergy to sting (bee stings).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling at the bottom of the foot, Swelling was more like she was standing on a golf ball.), LIP SWELLING (lips were swollen) and MOUTH SWELLING (her inner mouth as well(swelling)). At the time of the report, PERIPHERAL SWELLING (swelling at the bottom of the foot, Swelling was more like she was standing on a golf ball.), LIP SWELLING (lips were swollen) and MOUTH SWELLING (her inner mouth as well(swelling)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were reported i.e., Liver support pills and collagen powder drink. No treatment information was reported.   This case was linked to MOD-2021-317669 (Patient Link).
Early heartbeats beginning on 3/20/23 - on 3/24/23  went to ER , Blood Pressure 200, and admitted , discharged 3/25/23.  New Rx - 12.5 mg Metoprolol daily
Guest's mother reported to observation staff that son had low blood sugar per alert from wearable blood sugar monitor and requested a glucometer to check.  Internal EMT responded and checked guest BG, initial reading was 38. Guest talking and drinking juice box at time of EMT arrival. EMT gave guest glucose gel and rechecked after 15 minutes - BG increased to 62. Guest reported feeling better and was walked to car with mother by EMT. Guest reported not having eaten lunch and that they would get a meal as soon as they left the site.
Approximately 15 minutes after injection, I began to experience chest tightness and labored breathing  similar to the early onset of an asthma attack. The rescue inhaler helped reduce the effects but did not fully eliminate them. The Symbicort Inhaler also helped with breathing but not chest tightness. Although not severe, effects continued to linger 10 hours after injection.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JAN-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 18-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Mother brought pt in for PPD read with complaints of redness, swelling and fever at site of left deltoid. Pt has full ROM without complaint of joint stiffness. Pt evaluated by RN. Doctor appt sch  for 5/18/07.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 55-year-old male patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX. On 17th October 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and influenza-like symptoms. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and influenza-like symptoms were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: On Tuesday, the patient received SHINGRIX on left deltoid. The day after vaccination with SHINGRIX, the patient experienced flu-like symptoms, injection site redness and swelling (extensive swelling of vaccinated limb). The area affected had been expanding to cover a 3 by 6 inch area. These symptoms had almost completely resolved. It was beginning to resolve.
Information has been received from a licensed practical nurse concerning a 9 year old female patient who on 24-MAR-2008 was vaccinated SQ with a fourth dose of 0.5 of VARIVAX (Merck) (lot # 659351/1775U) at 10:26 AM. Subsequently, on 26-MAR-2008 the patient developed vesicles and also a red, warm, swollen injection site from the vaccination. Medical attention was sought, the family spoke to the nurse. It was unspecified if lab studies were performed. The patient was treated with BENADRYL. At the time of the report the patient was recovering. There was no product quality complaint involved. This is one of several reports from the same source. Follow up information has been received from the pediatrician's office. The onset date of the adverse events were reported as 25-MAR-2008 at 11:40 AM. The reporter provided the following information: itching, pain, swelling and warmth at injection site. The initial area of reaction measured 8 cm X 8 cm and was reduced to 4.25 cm of erythema and mild induration on "24-MAR-2008". There were no vesicles. There were no illnesses at time of vaccination and there were no lab tests performed. The adverse events were recovered on 30-MAR-2008. There was no mention of outcome of pruritis. No further information is available.
Local reaction to left thigh - red, raised wheal with papules 3 cm. Also, scattered pink papular eruptions on face, trunk & pubis.
On 2/10/21 I had pain  and mild itching at the injection site. 2/11 I noticed red raised pinpoint lesions with itching and burning at the injection site. By that evening it turned into more diffuse erythema and pinpoint lesions that looked like hived, again itchy. The next morning 2/12 the rash was worse with multiple pin point lesions, red erythematous patches, with itching and burning to the injection  as well as involving my right hand, forearms,  and  feet. By the time I saw the MD it was involving my chest.. I was seen by a MD 2/12/21 and dx with folliculits.  Up to this point I was using hydrocortisone cream to soothe the itching and ice packs. Since seeing the MD on 2/12  I  started cetrizine,predinsone and Kenalog cream.
The patient is asymptomatic but tested positive with a PCR test on 3/24/21.
Dizziness, Headache, Myalgia & Fever Narrative:  Body aches Chills Fever Dizziness Head pressure
Information has been received from a physician concerning a female who was vaccinated with all three doses of GARDASIL (lot#'s not reported) at a different office. The physician is treating the patient because she is experiencing headaches that she did not have before the vaccination series. The patient's outcome was not reported. Additional information has been requested.
Headache, Myalgia, Diarrhea, NauseaVomiting, N/A Narrative: 1030hours received dose. 1130hours developed HA not alleviated with OTC Acetaminophen. 1200hours upset stomach, not alleviated with "jell-o" and clear soda, developed nausea. Had 4-5 bouts of BMs from time of dose to 1300hours.
Swollen eyelid until today 12/14/2015. Rapid shallow breathing (first 3 days after vaccinate), behavior changes: isolation, irritation, sadness, apathy. Legs weakness (walking difficulties). Until now 12/14/2015.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had acute illnesses and chronic and long standing health conditions.     On 02-Apr-2022 at 4:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 4:41 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This vaccine was administered up until its Mfg Exp date of 04-Apr-2022.  Vaccine administration time was reported as 16:41:45. The patient received the second booster dose.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Same local reaction; A little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Same local reaction) and VACCINATION SITE PAIN (A little sore arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A, 039K20A and 058E21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included CELECOXIB (CELEBREX), CORTISONE, BIMATOPROST (LUMIGAN) and GABAPENTIN for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE REACTION (Same local reaction) and VACCINATION SITE PAIN (A little sore arm). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhea, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Same local reaction) and VACCINATION SITE PAIN (A little sore arm) outcome was unknown.            It was reported that concomitant medication gabapentin was discontinued after third dose due to nausea.  Concomitant medications also included thyroid medication 75 mg once a day.   This case was linked to MOD-2021-354510, MOD-2021-354559, MOD-2021-354510.
Developed slight shortness of breath, dry cough and runny nose.  Symptoms are mild.
Red, raised, warm area on posterior right arm, measuring 4mm x 2mm, placed on ORAPRED 2 tea daily for 3 days and instructed BENADRYL cream.
Resident had seizure activity on 12/17/22 with several seizures during the day.  at 4 pm  he had a seizure that wouldn't stop and was given Ativan IM and seizure stopped.  At 1700 he had another seizure and Ativan was given IM but seizure continued.  EMS was called and they started an IV, intubated him and gave meds and took him to the hospital .  He has had a seizure 2 days after getting his 1st Pfizer COVID vaccine on 3/25 LOT # fm0698  and was sent to the ED and came back the same day.  His 2nd COVID vaccine was given  on 6/29/22 lot# FP7135 and didn't have a seizure until 7/28/22.  He was sent to the ED and came back within 24 hours. He was given Flu vaccine afluria lot # as3615b on 11/4 and had a seizure on 11/7/22.  He was not sent out the the ED at that time.  He does have a history of breakthrough  seizures but it seems that every time he has gotten a vaccine, he had a seizure.  Our MD wanted me to report this.
This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) as a single dose via an unspecified route of administration in left arm on 22Mar2021, at 14:45 PM (at the age of 52 years) for COVID-19 immunisation. The patient had no known medical history.  It was reported that there are no allergies to medications, food or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. Concomitant medication was not reported. The patient had not tested positive for COVID-19 since having the vaccine. On 23Mar2021 at 10:00, the patient reported that she had fever, nausea without vomiting, headache and body ache. The patient did not received any treatment for the reported events. The clinical outcome of the event fever, nausea without vomiting, headache and body ache was not resolved at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.