chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with longstanding ITP on nplate (romiplostin) with dramatic decline in platelets after 2nd vaccine to 0 (has been 0 since 04/2021.  Have retried steroids, promacta, IVIG, and rituximab.  Repeat bone marrow biopsy and pathology negative for primary process.  Strongly suspect
getting brown; felt like a hot sunburn almost like a hand size; itchy; started getting hot, red bumps on left arm where she got vaccine; pain, like sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain, like sore), RASH ERYTHEMATOUS (started getting hot, red bumps on left arm where she got vaccine), SUNBURN (felt like a hot sunburn almost like a hand size), TANNING (getting brown) and VACCINATION SITE PRURITUS (itchy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN (pain, like sore). On 24-Jan-2021, the patient experienced RASH ERYTHEMATOUS (started getting hot, red bumps on left arm where she got vaccine) and VACCINATION SITE PRURITUS (itchy). On 25-Jan-2021, the patient experienced SUNBURN (felt like a hot sunburn almost like a hand size). On 27-Jan-2021, the patient experienced TANNING (getting brown). At the time of the report, PAIN (pain, like sore), RASH ERYTHEMATOUS (started getting hot, red bumps on left arm where she got vaccine), SUNBURN (felt like a hot sunburn almost like a hand size), TANNING (getting brown) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
After being vaccinated in the morning, the student presented to the nurse's office a little after noon with c/o tearing and blurred vision in her right eye.  She had clear drainage from her right eye and a visual acuity of 20/40 in her right eye and 20/30 in her left eye.  On 12/14, the student presented to the school nurse with partial right sided facial paralysis.  Mom was notified and stated that she had noticed some "droopiness" over the weekend.  Mom picked her up and took her to the hospital where she was admitted with a prelimary dx of Bells Palsy.  She was treated with IV steroids and antibiotics.  The student was discharged from the hospital on 12/16 and has not returned to school at this time.
horrible rash on both armpits; This is a spontaneous report received from a contactable consumer (reporting on herself). A 72-years-old female patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiry date not reported), via intramuscular route of administration in right arm on 06Feb2021 16:00 as a single dose for COVID-19 immunization. Medical history included ongoing autoimmune thyroiditis (Hashimoto's disease) diagnosed 30 years ago. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for autoimmune thyroiditis (Hashimoto's disease) (75mg once a day). It was reported that patient was calling about the Pfizer covid vaccine. She went Saturday (06Feb2021) at 16:00 for her first dose of the shot. Within 3 hours she developed a horrible rash on both of her armpits, still has the rash. She was afraid to get the second dose. Advised to contact hcp. She was in the hospital waiting to get a lung scan, it was outpatient. For treatment she declines any, She was going to her primary doctor at 13:45 today. She was told to schedule her own second appointment which she thought was weird since most people get the second appointment with the first dose. Advised to contact facility. No history of previous immunization with the Pfizer vaccine or any other additional vaccine (within 4 weeks) that was administered on the same date as the Pfizer suspect.  Information on lot/batch number has been requested.
Information has been received from a physician referring to a now 13 year old male patient. The first dose was vaccinated with RECOMBIVAX HB (dose, lot number not provided) to the patient at birth; and schedule was maintained as per the prescribing information of 0, 1, 6 months. On an unknown date the patient developed colitis. The antibody titer was drawn in 2014 and it was no number value but the result showed non-reactive to Hepatitis B. In March 2015, client was vaccinated with one booster dose of Hepatitis B and antibody titer drawn in May 2015 showed result of 8.76; still not at the level it should be (failed to seroconvert). Physician states when the booster dose was administered in March 2015 client was on Infliximab therapy. The outcome and reporter's causality of colitis was not provided. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a 82 year old female patient with allergy to penicillin. On 22-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, lot number L031273, expiration date 19-NOV-2016, (dose and anatomical location were not reported). The patient's concomitant therapies included valsartan. On an unknown date in 2016, the patient experienced "injection site rash." No treatment was given and no laboratory diagnostics were performed for the event. At the time of reporting, the outcome of the injection site rash was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
swelling; Area appeared filled with fluid; This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 1st dose of Shingrix. In December 2019, 36 hrs after receiving Shingrix, the patient experienced eye swelling and edema. On an unknown date, the outcome of the eye swelling and edema were recovering/resolving.   It was unknown if the reporter considered the eye swelling and edema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient had swelling under both eyes and area appeared filled with fluid. The patient observed when woke up at 4 am on tuesday morning, but thought that it started in the night before. Till the time of reporting, the eye swelling and edema were recovering but not completely resolved. The reporter consented to follow up.
Information has been received from a healthcare worker concerning a female patient who on 07-OCT-2010, was vaccinated with a dose of GARDASIL (lot# not reported). It was reported that the patient fainted after receiving GARDASIL. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. No further information is available.
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 190/100, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to normal level within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 for 12 hours before returning to my normal rate of 60.
Due to extreme weakness unable to rise up in bed, unable to stand or walk for about 2 hours. After that able to stand and walk with assistance.
Developed 4 inch red band around arm under injection site.  Extremely itchy.  Took topical and oral Benedryl  (Note:  Patient was extremely nauseated and tired with sore arm for 24 hours after vaccination, but got better then on day three, rash appeared.)
Red raised solid area approx 30x40 cm, not hot left arm where Varicella was listed as given at that site.
side effects from the moderna covid vaccine, second shot was worse; several joint pains and swelling; several joint pains and swelling; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (side effects from the moderna covid vaccine, second shot was worse), JOINT SWELLING (several joint pains and swelling) and ARTHRALGIA (several joint pains and swelling) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 003c21a) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient experienced IMMUNISATION REACTION (side effects from the moderna covid vaccine, second shot was worse), JOINT SWELLING (several joint pains and swelling) and ARTHRALGIA (several joint pains and swelling). At the time of the report, IMMUNISATION REACTION (side effects from the moderna covid vaccine, second shot was worse) outcome was unknown and JOINT SWELLING (several joint pains and swelling) and ARTHRALGIA (several joint pains and swelling) had not resolved.      No Concomitant medications were provided.  It was reported that on unknown date Humira every other week was not working, and physician switched to every 10 days with event reported as Lack of drug effect and outcome as unknown Patient also had several joint pains and swelling with Adalimumab Solution for Injection, Single Dose Pen. The reporter's causality for the event(s) of Humira every other week was not working, and physician switched to every 10 days, several joint pains and swelling unknown onset, side effects from the moderna covid vaccine, second shot was worse with Adalimumab Solution for Injection was Not Provided.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  No treatment medications were provided.
Patient received vaccine affected by the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion). On 11-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion) 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 considered PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion) to be not related.    No concomitant medications were reported.  No adverse events have occurred.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Patient demographics were updated. Date and batch/lot number of vaccine were added.
Patient had no adverse event of side effect. Patient received wrong dose 0.2mL pediatric dose instead of 0.3mL of Pfizer vaccine. Event reported by nurse immediately once given and noticed error and submitted an incident report. Notified Lead nurse and Supervisor. Patient parent was notified.
Arm is hot, running fever in it, red, itchy; Arm is hot, running fever in it, red, itchy/ It is reddish in the area got the vaccine and down below where the the needle was stuck; Arm is hot, running fever in it, red, itchy; Nurse did not give the vaccine in the muscle, it was given in back of her arm; This is a spontaneous report from a contactable consumer (patient reported for herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6205 and expiration date: Jun2021) via intramuscularly, in left arm on 05Mar2021 at 09:04 AM (at the age of 62-year-old) as dose 2 0.3 ml, single for COVID-19 immunization. The patient had no medical history and concomitant medication. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318 and expiration date: 31May2021) via an unspecified route of administration, in left arm on 12Feb2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient had not received additional vaccines on same date of the Pfizer suspect. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no AEs following prior vaccinations. The patient went on Friday 05Mar2021 to take her second vaccine. However, the nurse did not give the vaccine in the muscle. It was given in the back of her arm. Now, on 06Mar2021, her arm was hot, running a fever in it, red, and itchy. She did not remember what time she noticed her arm was hot, running fever in it, red, and itchy. Patient confirmed all events still ongoing, but better. It did not itch as much. It was still warm, but better. That area was reddish. It was reddish in the area got the vaccine and down below where the needle was stuck. Patient indicated she was calling because she wanted to report these events. She never got these before. She did not see where she got the actual vaccine, where she was stuck because she turned her head because she did not want to see the stick. She just noticed later that the Band-Aid was on the back of her arm instead of on top where the muscle part is in the deltoid. The AEs did not require a visit to the Emergency Room or Physician's Office. The patient had no relevant tests. The outcome of the events arm was hot, running fever in it, red, and itchy was recovering.  No follow-up attempts are possible; No further information is expected.
I haven?t had the chills like that in forever! It came in waves. You just lie there, hot, and ache all over, then this wave of chills hits for maybe 5 seconds then dissipates. The 2 mins later, it happens again! And this goes on for  an hour or more! I had to pee but was worried I?d be too cold to stand still. So I waited until I could not wait anymore. OMG! Trying to stand up! It?s as if my joints no longer worked! And when I did stand up I was dizzy as hell! The next day, utter exhaustion. I am so weak, it takes effort to move. Even breathing took work! I didn?t sleep all night as every position I lay in was uncomfortable and had twinges of chills. The amount of energy it takes to physically get up and walk to the bathroom is dumbfounding! This morning I am achy, hot and cold, exhausted, and just had a bout of dry heaves. I?m hoping to be able to get some sleep today.
This spontaneous report was received from a licensed practical nurse refers to a female patient of unknown age. Medical history was not reported. The reporter informed that on 21-DEC-2011 the patient received her first dose of GARDASIL injection, lot number, strength, dosage, route and anatomical location were not reported. On 07-JAN-2012 the patient received the second dose of GARDASIL injection, lot number, strength, dosage, route were not reported and she was at that time (09-JUN-20140 in the office to receive her third dose. No adverse effect was reported. Additional information has been requested.
8.21.2018 I was doing shots on a child with coworker one today. We did a Meningo shot. Coworker one taught me how to mix the power Meningo with the specific meningo saline. The package has us mix an 'orange' topped powder vial with a 'gray' topped specific saline vial. I then realized that coworker two and I gave a Meningo shot before with an orange topped Meningo power and a vial of normal saline rather than the specific gray topped saline that goes with the Meningo powder. Coworker two was the individual who mixed the medications together, but I gave the Meningo injection. I started to worry if the immunization would work for the patient that coworker two and I took care of. I asked coworker one and coworker three because coworker two was not in the building. We looked on the CDC website. I found out that the Meningo powder CANNOT be mixed with normal saline and that it must be mixed with the specific saline that the manufacturer sends with the immunization powder. If I had known that Meningo vaccine had to be mixed with a specific diluent, I would have had coworker two draw up a new vaccine for the client. However, since coworker two has given these vaccines many times before, she should've known this information. Coworker one and I are looking into the next steps we need to take in order to report this immunization error. Patient has been notified via mail. The telephone we have for the client does not have a voicemail box set up and does not answer our phone calls. Incident report was filed. Patient notified via mail again on 10/29/2018.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 07-AUG-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degree C from 13-MAY-2014 to 07-AUG-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Live MMR and live VARICELLA both given in same thigh, also both given IM. 9/1 3:17pm RMA called home, left message to call back to see how pt is doing, any reactions? No return call as of 9/2 5pm. No adverse events reported.
pain at injection site; fever; shivering; lethargy; nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, fever, shivering, lethargy and nausea. On an unknown date, the outcome of the injection site pain, fever, shivering, lethargy and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, shivering, lethargy and nausea to be related to Shingrix.  Linked case(s) involving the same patient:US2022155554   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient had the same symptoms (fever, shivering, lethargy, pain at the injection site and nausea) but to a lesser degree.  The symptoms after her first dose had resolved. The reporter did not consent to follow-up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022155554, reported by same reporter.; Sender's Comments:  US-GSK-US2022155554:Same reporter
numbness in right foot, pain and numbness in right leg below the knee. Immediately had ultrasound of leg to confirm no blood clots. Then saw neurologist and orthopedic doctors. They suspect common neuropothy.  Started taking 30 days of 15mg Miloxacin and started PT.  MRIs of back and leg to be done 4/15.  Nerve function test to be done on May 20. No change after 4-5 days.
Pt has localzed rashed on right arm where vaccine was administered.  States it is painful and warm.
neck pain; pain in my left arm; headache; A spontaneous report was received from a Healthcare Professional concerning a 76 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, pain in my left arm, neck pain, and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the events pain in my left arm. On 3 Feb 2021, the patient experienced the events neck pain. On 30 Jan 2021, the patient experienced the events headache.  Action taken with mRNA-1273 in response to the events, pain in my left arm, neck pain, and headache was not reported.   On 30 Jan 2021 the outcome of events, headache was resolved. On an unknown date the outcome of events include, pain in my left arm, neck pain was not reported.; Reporter's Comments: This case concerns a 76-year old female patient who received the first dose of mRNA-1273 and experienced non-serious events pain in my left arm, neck pain, and headache. 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.
Mom called 4/29/10 to report a reddened raised area the size of a softball on right thigh. Patient c/o itching and hurting. Advised cold compress and BENADRYL and ibuprofen.
a 10 month old received a dose of Menquadfi with no reported adverse event; Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 months old patient of unknown gender who received a dose of vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Jan-2023, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE(Solution for injection) (unknown route, strength, lot number and expiry date) in unknown administration site for prophylactic vaccination(immunization).  On 06-Jan-2023 the 10 month old received a dose of menquadfi with no reported adverse event (product administered to patient of inappropriate age)(latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was reported " This morning a 10 month old received a dose of Menquadfi (meant for 2 year old). Can you have someone look into the ramifications of this administration error? We know sometimes that this has an effect on future vaccinations, so we want make sure there's a plan in case the parents calls."  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report from a contactable physician. A female patient of an unspecified age received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced gradually spreading diffuse pruritic rash over several days again starting about 24 hours post the vaccination, on an unspecified date. The outcome of the reported event was unknown at the time of this report. Follow-up (06MAY2015): Follow-up attempts completed. No further information expected.