chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Based on the additional information received on 23-MAY-2017, the report previously considered as non-valid became valid (identifiable patient was reported). Initial unsolicited report received from a nurse on 01-MAY-2017. This was an invalid case as no patient identifiers were reported. This case involves a dose of DIPHTHERIA/TETANUS ADSORBED TOXOIDS THIOMERSAL FREE ADULT (TDAP) (batch number, expiry date, route and site of administration were not reported) was administered on an unspecified date. Medical history and concomitant medications were not reported. On an unknown date, following the vaccination, unspecified adverse event occurred (it was reported as "caller said she has some questions about an AE with TDap vaccine"). Lab data and corrective treatment were not reported. The event outcome was not reported. Follow-up information received from a nurse in the United States on 23-MAY-2017. This case involves a 60-year-old patient (unknown gender) who received a 0.5 ml intramuscular dose of TDAP vaccine batch number: U5604BA, on 26-APR-2017 at 3 pm. The patient illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Adverse event following prior vaccination was also reported as none. On 26-APR-2017, few hours following the vaccination, the patient experienced shoulder sore that night. On 27-APR-2017, one day following the vaccination, the patient's arm below injection site inflamed, swollen and painful. On 29-APR-2017, three days following the vaccination, the patient experienced inflamed to inner arm, increased swelling. It was reported that the patient required emergency room/doctor visit. The patient did not have any lab data. On 28-APR-2017, the patient called doctor's office and was told to use ice, TYLENOL or MOTRIN. The patient also received steroids and cephalexin. On an unspecified date, the patient recovered from the events (reported as 'on 17-MAY-2017 followed up to patient, arm slightly pink, pain and swelling resolved'). List of documents held by sender: none.
Arm sore at injection site. Can't raise arm without pain. Can't sleep on left side (side of injection).
thought pt was choking & quit breathing went to clinic temp was 99-couldn't find anything wrong-went to clinic was 102 they called it febrile seizure went back for EEG, showed nothing; rash
Rapid temperature fluctuation starting day of dose 2, severe convulsions starting 2 weeks later, sporadic loss of motor control
Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 16-JUL-2013 by a physician, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-MAR-2016, patient was treated by physician for a painful rash that was diagnosed as severe shingles. Although shingles is an incurable viral condition, patient has been prescribed VALTREX to manage her symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored Oral, ROTATEQ (Lot #, dose and route were not reported). No symptoms were reported. This is one of the several reports from same reporter. Additional information has been requested.
Diarrhea, Extreme tiredness, body aches, fever, nausea, loss of appetite, I felt extremely weak. Symptoms lasted only 24hrs
Moderna vaccine was given to a 16 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was given to a 16 year old patient) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No specified medical history has been reported.     On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was given to a 16 year old patient). On 23-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was given to a 16 year old patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received contained no new information On 23-Jul-2021: Non-Significant follow up appended
pounding headache with second dose; shaky, chills, super hot on and off with second dose; shaky, chills, super hot on and off with second dose; shaky, chills, super hot on and off with second dose; woke up and look like she had taken a shower/huge sweat; feeling sick; cold hot; nausea with second dose; fever of 100.4; achy and whole body hurt with second dose; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 17Mar2021 16:30 at the age of 36-year-old as dose 2, single for covid-19 immunisation. The patient's medical history was none and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 16Fe2021 at the age of 36-year-old as dose 1, single for covid-19 immunisation. On 18Mar2021 patient felt fine, not even a sore arm and no spot until 12 hours later she woke up, was shaky, had chills, was super hot on and off, and had a fever of 100.4. States over the weekend she was still nauseous and a really bad headache. States she was nauseous for a couple of days, Thursday and Friday. States she checked her temperature but does not know how high it was when she was sleeping. Patient states between 4 and 4:30 am 18Mar2021 she was achy and whole body hurt. States she tried to get ready for work, it happened on and off, shaky, cold hot and ended around 1 pm on 19Mar2021. On 19Mar2021 evening she had a pounding headache and woke up Saturday 20Mar2021 fine from that. On 20Mar2021 she woke up broken in a huge sweat and look like she had taken a shower, she was drenched must have broken a fever and fever was on and off, chills on and off and she ended up laying down and had 4 blankets and was still shaking. Patient had to take off from work because of it.  Nausea would come and go, on and off that whole weekend. On18Mar2021 patient take Tylenol after she was feeling sick. States later she took Excedrin migraine when she had a pounding headache but does not remember if she took it. States it is typically what she would take if she has a headache. Patient did not visit emergency room or physician office in response to the event. The outcome of the events cold hot, achy and whole body hurt, huge sweat, feeling sick, shaky/chills/ super-hot  was recovered on 19Mar2021, Event fever, pounding headache was recovered on 20Mar2021, events nausea was recovered on 22Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
horrible migraines; I feel like the intensity of the migraines has gotten worse as well as the duration that they last; This is a spontaneous report from contactable other HCP reporting for himself.   A 35-year-old male patient received bnt162b2 (BNT162B2), at the age of 35 years dose 1 via an unspecified route of administration on 09Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 30Jan2021 15:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Vaccination Facility Type Hospital. Medical history included gastric bypass in 2014, diabetes mellitus and covid-19. There were no concomitant medications. The patient previously took Z-pak and experienced drug hypersensitivity. The patient experienced horrible migraines on 09Jan2021 15:30 with outcome of recovered and "I feel like the intensity of the migraines has gotten worse as well as the duration that they last" on 09Jan2021 15:30 with outcome of unknown. No treatment received. Description as reported: "I had horrible migraines after both of my vaccination shots within 6 to 8 hours after the shots were administered. Both of which lasted easily over about 24 hours. Since I got my shots I have not increased in the number of migraines but I feel like the intensity of the migraines has gotten worse as well as the duration that they last". The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event migraine and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
high blood pressure, chest pain, shortness of air - intermittent after getting the dose. Patient experienced this 2x on different occasions, the first time was 3/7/21-3/8/21 and again 3/20/21-3/22/21. EKG, stress test, and ECHO were completed after second concerning episode and no urgent cardiac issues were found. Follow-up with PCP scheduled 4/7/21.
Moderately sore arm, improved after 4 days Moderate headache, improved after 4 days, recurred several times over 4 weeks Intermittent Nausea
pt recv vax w/o problems;10min post vax pt walked up hall & collapsed to floor;cont breathing & responded immed but was nauseated & began to vomit;vitals were stable;pupils were equal & t100;airway clear;no congestion;responded to questions
Neuropathy peripheral; Hypoaesthesia; Paraesthesia; Injection site warmth; Injection site pruritus; Injection site erythema; This case was received via VAERS (Reference number: 1283744) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy peripheral) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Hypertension (mild). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), IRBESARTAN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy peripheral) (seriousness criterion medically significant), HYPOAESTHESIA (Hypoaesthesia), PARAESTHESIA (Paraesthesia), INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (Injection site pruritus) and INJECTION SITE ERYTHEMA (Injection site erythema). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy peripheral), HYPOAESTHESIA (Hypoaesthesia), PARAESTHESIA (Paraesthesia), INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (Injection site pruritus) and INJECTION SITE ERYTHEMA (Injection site erythema) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Approximately 12 hours post dose patient experienced tingling sensation in legs during sleep. Days 2 to 8 post dose, experienced tingling in feet and slight numbness in feet and lower legs. Slight numbness was noticed in fingertips on days 7 and 8. Diagnosis was peripheral neuropathy due to reaction to 1st Moderna Covid-19 shot. On day 7 post dose developed an itchy red spot at injection site approximately 1 inch diameter. By day 8 reaction, at injection site progressed to intense response: large affected area of 4 inches by 3 inches, redness, itchy, area hot to the touch due to reaction to the 1st Moderna Covid-19 shot. Physician recommends no 2nd Moderna COVID-19 shot, or any other COVID vaccine.  No treatment medication details were reported.  Company Comment: 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: 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.
Seizures began 6/21/2021; no history of seizures; no family history of seizures.  Doctors unable to find any other cause of adult onset atonic seizures.
did not receive the second dose on time because the patient started chemotherapy.; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th March 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix on time because the patient started chemotherapy.  The patient wanted to have the 2nd dose on the day of reporting.
COVID VACCINE CLINIC- Administered dose to pt  with previous reaction to vaccine in general. Pt was laying down for administration. Pt stated he was feeling nauseated and felt as if he was going to pass out immediately after administering the dose, pt started sweating and looking pale. We provided water and juice for pt. Rapid Response team came and assessed pt, took vitals and determined pt was ok. Pt discharged and walked out without assistance accompanied by parent.
Vaccine administered 10.9.14. On 11-3-14 patient presented to pharmaciy and stated he had 5 red spots on left arm between elbow and wrist.
Fever, Chills, Body aches. Worst symptoms resolved in a few days. Still feeling fatigue a week after vaccination. Have moments of light nausea.
I got sick with a bad (non-COVID) viral infection 1 week after my J&J booster shot. I was sick for an entire month. Chest cold, coughing, congestion.
postherpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to an elderly patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 06-DEC-2012 (at approximately 77 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and postherpetic neuralgia. The outcome of the events was unknown.
Daughter took 2nd dose yesterday and got very sick and skin was hot to the touch; Daughter took 2nd dose yesterday and got very sick and skin was hot to the touch; At 1am the daughter called and was having trouble breathing; Today her rash is gone but now the skin feels raw; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for her daughter (patient) of an unspecified age that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date in 2021 (reported as yesterday) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization a few weeks ago after which the patient developed an intermittent, fine, itchy rash and still had it as of last weekend. The reporter stated that the patient took 2nd dose yesterday and got very sick and skin was hot to the touch. At 1am, the patient called and was having trouble breathing. Today the rash was gone but now the skin feels raw. The patient would like to talk about the side effects with someone. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated, she was aware of a female patient that had the Shingrix and experienced headache. At the time of this report, limited information was provided. This is 1 of the 3 cases reported by same reporter.
I felt just a little something when they gave the injection.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (I felt just a little something when they gave the injection.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I felt just a little something when they gave the injection.). At the time of the report, IMMUNISATION REACTION (I felt just a little something when they gave the injection.) outcome was unknown.            The concomitant and treatment medication was not reported. On 01-Jan of an unknown year, the patient felt a little something after injection was administered.   Out of 4 shots, fourth shot was the 1st one after which the patient had no pain. The patient di dnot know what else he was given for which he had no pain, unable to read the writing of the reporter and LOT no was not known.
Vaccine was given on July 31 2006. She began having numbness and tingling in her feet and hands on or around August 13th or 14th, which persisted and slightly worsened until she was seen in our office on August 21st.  Her neurological examination was normal, she had an elevated sedimation rate (39), mild protienuria, otherwize normal labs. MRI of her lumbosacral spine showed a (possibly old, chronic) subarachnoid cyst.  She was referred to a neurologist and was seen on August 25th and was found to have weakened severely and was admitted to PICU for suspected Guillian-Barre syndrome which was confirmed by lumbar puncture.  She was treated with IVIG with rapid improvement and has gone home.  She is slowly improving and has residual weakness.  Medical records including neurology received/reviewed. Final diagnosis is GBS. Was treated with IVIG as indicated on VAERS form. Per records pt has residual weakness. 12/19/06-progress notes received for and DC Summary DC DX: GBS.
Patient did not have a reaction to the vaccine but did become positive.  Test positive on  08/30/2021
Two days after the injection I began to have deep pain in my left side axilliary lymph nodes. It felt like a stabbing pain in the front part of my underarm. Over a week the pain has continued at the same level and gradually continued to spread through my underarm area.  Today (with 10 days of reaction) I continue to have pain. Sometimes if feels like stinging.
rt deltoid swollen & tender for 4 days & ultrasound showed edema cons w/myositis but no abscess; infect disease consult w/MD suggested treat w/dicloxacillin to be safe but allergic rx likely;
Client reported difficulty breathing after the injection and then intermittently up to one month before booster dose on 2/26/22.
injection site started to really itch, there was no pain, it was swollen, and is continuing to grow; vents Verbatim term injection site started to really itch, there was no pain, it was swollen, and is continuing to grow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site started to really itch, there was no pain, it was swollen, and is continuing to grow.) and VACCINATION SITE SWELLING (vents Verbatim term injection site started to really itch, there was no pain, it was swollen, and is continuing to grow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (injection site started to really itch, there was no pain, it was swollen, and is continuing to grow.) and VACCINATION SITE SWELLING (vents Verbatim term injection site started to really itch, there was no pain, it was swollen, and is continuing to grow). At the time of the report, VACCINATION SITE PRURITUS (injection site started to really itch, there was no pain, it was swollen, and is continuing to grow.) and VACCINATION SITE SWELLING (vents Verbatim term injection site started to really itch, there was no pain, it was swollen, and is continuing to grow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.