chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bacterial skin infection in his leg; it was swollen below the knee to ankle and a "solid sheet of red."; it was swollen below the knee to ankle and a "solid sheet of red."; feeling bad; Initial information received on 12-Nov-2019 regarding an unsolicited valid serious case received from a pharmacist.  This case involves a 59 years old male patient who experienced bacterial skin infection (bacterial infection) in his leg and feeling bad (Feeling abnormal) while he received FLUZONE (QUADRIVALENT INFLUENZA VACCINE).  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  Ongoing medical condition: bad diabetic (Diabetes mellitus).  On 01-Nov-2019, the patient received a 0.5 ml dose of suspect received FLUZONE (QUADRIVALENT INFLUENZA VACCINE) lot UJ223AA (Expiry date 30-Jun-2020) via intramuscular route in the left deltoid.  On 02-Nov-2019, the patient developed a serious feeling bad (feeling abnormal) 1 day following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.  On 05-Nov-2019, the patient developed a serious bacterial skin infection in his leg (bacterial infection), swollen below the knee (Peripheral swelling) and solid sheet of red (erythema) 4 days following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.  Final diagnosis was bacterial skin infection, feeling bad, Extensive swelling of vaccinated limb and Redness of legs.  An antibiotic as corrective treatment was received.  On an unknown date, the event outcome is reported as recovered for all the events.; Sender's Comments: This case involves a 59 years old male patient who presented with bacterial skin infection while he received FLUZONE. The time to onset is compatible with the role of the vaccine. However, patient's medical history, medical condition at time of vaccination and lab test ruling out predisposing etiologies were not reported. Based upon the reported information and considering the infectious nature of the event, the role of the vaccine cannot be assessed.
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received FLUARIX QUADRIVALENT (batch number 5J9E9, expiry date 20th May 2015). In 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to FLUARIX QUADRIVALENT.
3/3/21 at 8pm I had a 101.2 fever I didn't take any medication for it and it lasted all night and throughout the next day I was tired and slept a lot on Friday the 5th when I woke up I woke up without a fever but I started having back pain and on Saturday I was unable to move it was very painful and had trouble walking. I got pregnant 2 weeks after my second dose.
Patient inadvertently received four doses; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a infant patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included hepatitis B (received a dose of hepatitis B (unknown brand) at birth) and Engerix B (received 3 doses on an unknown date).   On 29th April 2022, the patient received the 4th dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 29th April 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-APR-2022 Reporter's comments: Nurse practitioner reported that a patient inadvertently received four doses of Engerix-B due to a transmission error with the patient's vaccination record. On the day of reporting, the patient received 4th dose of Engerix B. The patient was reportedly not experiencing any adverse reactions at the time of the call. Additional information was not known during the call due to the caller being out of the office. The consent to follow-up was given. Additional Supportive Information: The patient received 4th dose Engerix B which led to extra dose administered.
Pt started having difficulty breathing about 5/10 minutes after Anthrax shot # 2 was given. The corpsman laid pt down in the shock position. We then monitored pt. We then noticed a red rash with small bumps around his chest. Pt's breathing became more labored so we gave the pt a 25 mg injection of Benadryl. Pt was ok after that.
Day 1 Diarrhea, Fatigue, Dizziness  Day 2 3 4 5 Add Nausea, Headache, Fever to me but not thermometer, Sweating,  Body Achs, no appetite. mild cough first time, worse 2nd injection.
2 year old patient received boostrix on 6-July-2022 instead of infanrix; 2 year old patient received boostrix; 2 year old patient received boostrix on 6-July-2022 instead of infanrix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 2-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 6th July 2022, the patient received Boostrix. On 6th July 2022, unknown after receiving Boostrix, the patient experienced underdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the underdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comments:  The nurse reported that the patient received Boostrix on 6th July 2022 instead of infanrix. The reporter consented to follow up Additional Supportive Information: The patient received Boostrix instead of Infanrix, which ed to underdose, inappropriate age at vaccine administration, wrong vaccine administered. This case has been linked to the case US2022089285 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022089285:Same reporter
Information has been received from a 75 year old female with "allergic reactions to barbiturates and anything for pain", and no pertinent medical history, who in "October 2006", was vaccinated with a dose of 0.5ml PNEUMOVAX 23. Concomitant therapy included AFLURIA (manufacturer unknown) in the opposite arm. The patient stated that "that evening my arm became red and painful and swollen. Iced it and took TYLENOL and it was back to normal by the end of the following day. "She said that she had gotten other pneumococcal vaccines prior to this one, but she did not know if they were PNEUMOVAX 23 or not. There were no labs or diagnostic tests performed. The patient sought unspecified medication. The patient recovered at the end of the following day. Caller also stated that she has "a problem with my pancreas and will need surgery" but she does not feel that this was related to PNEUMOVAX 23. No further information is available. This is an amended report. Influenza vaccine was updated to second suspect and trade name AFLURIA. Trade name AFLURIA had been removed from narrative.
26 days after my first Moderna vaccination I developed Shingles. I talked to my sisters family and she also developed Shingles after a COVID vaccination.
My very strong baby, became weak. less alert, refused to nurse, wailed for three days straight, hardly slept, suffered from joint pain, was inconsolible, needed chiropractic adjustments as her body went out of alignment following the shots, didn't run a fever, but acted sick and lethargic.  Called the Dr's office and they told me to take the baby to the ER.  The ER dr and nurse said I didn't know how much she was eating or not eating because I was breast feeding.  The ER dr said that her reaction was normal to the shots and that she should feel better in a day or so.  It took her two months to start nursing regularly and on the left side.
At 09:30, complained of hands and face swelling; 02 at 4L via NC, 911 called, Epi given with no improvement; 2nd Epi given; complained of tongue swelling and was given 50mg Benadryl IM; increased difficulty breathing; 3rd Epi given and transported to hospital via ambulance.
nerve issues; Found it terrible; got the shingles vaccine age 36; This case was reported by a consumer and described the occurrence of nervous system disorder in a 36-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nervous system disorder, feels awful and inappropriate age at vaccine administration. On an unknown date, the outcome of the nervous system disorder, feels awful and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the nervous system disorder and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient got the shingles vaccine age 36, which led to inappropriate age at vaccine administration. The patient found it terrible and had some nerve issues too.
Documents reviewed. Vaccine administered, patient tolerated well. Patient reported feeling hot ~5 min  after vaccine administration. She reported intermittent throat tingling and L arm itching ~15  min after vaccine administration. BP 122/70, HR 102, O2 98%. Consulted with MD. Patient  transferred to ED for further observation.
A few days after the first vaccine, her left arm was itchy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (A few days after the first vaccine, her left arm was itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029KC0A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Heart disease, unspecified and Asthma.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (A few days after the first vaccine, her left arm was itchy). At the time of the report, VACCINATION SITE PRURITUS (A few days after the first vaccine, her left arm was itchy) outcome was unknown.        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 medications provided. No treatment information is provided.   This case was linked to MOD-2021-083149 (Patient Link).
Initial report received from a consumer on 18 November 2013. A 09-year-old female patient whose medical history and concomitant medications were not reported received FLUZONE (batch number; UH899AD, expiration date: 30 June 2014) in left deltoid on 05 November 2013 (route of addministration unknown). The patient had swelling of approximately 15x22cm and her left arm was measured to be about 1.5 cm larger than her other arm. Pediatrician observed this reaction to the Flu vaccine and indicated that it was red and there was observable swelling but the patient had no observable pain response, no respiratory or fever responses. Pediatrician indicated that a second child within the same family was administered the vaccine from the same lot with neither response nor complaints. Lab investigation and corrective treatments were not reported. The patient's reaction was resolved within 36 hours of the consultation. Documents held by sender: none.
One week after 2nd injection, began vomiting after eating. Stomach pain/upset, diarrhea, excessive burping.  Unable to eat.  CT normal.  H Pylori tested positive.  Treated with 2 antibiotics.  Still having symptoms a month later.  Surgeon diagnosed gastroparesis, prescribed Reglan for 10 days to see if it helps.  Just started that treatment today.
Pt's Mother reported the child cried the rest of the day and carried a fever of 103-104 x 24 hours. No local reaction.
From initial information received on 01/21/04 from a physician, regarding an adverse event occurring in the USA, it was reported that a 34 year old female patient received a Fluzone SV '200-'2004 USP vaccination, lot number not reported, administered intramuscularly on 12/10/03 at 10:00 AM. 12 hours post vaccination the patient developed a maculo-papular rash over her body lasting 12 days. The rash resolved after treatment with Medrol. The patient reportedly did recover from this event. From information received on 05/18/04 from a physician, it was reported that the information has been reviewed and no additional information is available. No further information is anticipated, this case is considered closed.
PATIENT CALLED ON 1/30/13, 2:21PM STATING THAT SHE COULD NOT SLEEP BECAUSE OF HER ARM HAVING TOO MUCH PAIN. WHERE SHE WAS ADMINISTED THE PNEUMONIA VACCINE, YESTERDAY. PATIENT STATED THAT THE PAIN RAN DOWN TO HER FINGER TIPS; IT WAS INFLAMED, HARD, PAINFUL, AND NOT RED. PATIENT WANTED TO KNOW IF THIS WAS NORMAL AND WHAT SHE COULD TAKE. TWO HOURS LATER PATIENT'S DAUGTHER CALLED STATING THAT SHE WAS AT PATIENT'S HOME AND PATIENT CANNOT MOVE HER ARM AND WAS DEFINITELY UNCOMFORTABLE. THE FOLLOWING DAY I CALLED THE PATIENT AFTER THE NURSE PRACTITIONER TOLD ME TO FOLLOW UP WITH HER. PATIENT STATED SHE WAS BETTER AND HAD A LITTLE BIT OF PAIN. AND THE NIGHT OF THE SHOT SHE FELT NUMBNESS AND WAS SCHEDULE THAT SAME DAY TO COME IN TO SEE THE DOCTOR.  WHEN PATIENT CAME IN AND SAW THE MEDICAL DOCTOR THE LEFT ARM WAS SWOLLEN AND IN PAIN-WAS RESOLVING. WAS TENDER AND STARTED TO SWELL UP WITHIN HOURS OF THE PNEUMONIA SHOT PATIENT SELF TREATED WITH TYLENOL. AT THE TIME THAT PT WAS ADMINISTERED THE PNEUMONIA SHOT WE WERE NOT AWARE THAT SHE HAD RECEIVE THE PNEUMONIA SHOT A YEAR AGO (2/2012). AFTER PATIENT LEFT FROM HER PHYSICAL EXAM WE GOT HER IMMUNIZATION RECORDS FROM HER PREVIEWS DOCTOR THAT SHE HAD GOTTEN THE SHOT. DOCTOR'S EXAMS: "LEFT DELTOID INJECTION SITE IS ONLY SLIGHTLY ERYTHEMATOUS <1/2 cm. THERE IS SOME MOTTLED ERYTHEMA LOWER IN THE ARM 7-17 CM ABOVE OLECRANON AND AROUND 1/3 THE CIRCUMFERENCE OF THE ARM- NOT INDURATED. THE LEFT ARM SWELLING 12CM PROXIMAL TO OLECRANON = 40CM CIRCUMFERENCE. THE RIGHT ARM 12 CM PROXIMAL TO OLECRANON = 38 CM MINIMAL IF ANY TENDERNESS. AND NORMAL FOR NEUROLOGY VASCULAR FUNCTION. DOCTOR'S DIAGNOSIS: 995.29 ADVERSE REACTION TO PNEUMONIA (RESOLVING PPV REACTION, DOUBT INFECTION).
Information has been received from a physician concerning a patient who was vaccinated with a first dose of rotavirus vaccine. On 06-NOV-2006, eleven weeks after the first dose, the patient came into the office for the second dose. The physician decided not to administer the second dose. No product quality complaint was involved.  No other information was provided. Additional information has been requested.
H/o pain, redness, induration with in 24 hours. Pt examined 72 hours later ecchymosis 2cm x 10 cm area reticulated erythema.
Intermittent fever lasting 11 days. Rash, which disappeared and re-appeared on 08/14/2016.
Information has been received from a RN concerning an adult male pt (WAES0404USA02435) and his spouse (WAES0405USA00427) who on 12Apr04 were vaccinated with a dose of varicella virus vaccine live. In Apr 2004, soon after vaccination, both the husband and wife developed a chickenpox rash. Their child who was 6 years old was not vaccinated, but was reported to have developed a rash within the last day or so, on approx 27Apr04. The treatment was diphenhydramine HC1 (Benadryl). Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
7x7cm area of erythema right arm where DPT given warm and red-not infected.
Right eye blepharospasm and right hand myoclonus intermittently (a few seconds, once or twice a day), cold intolerance
Red, raised rash on upper arm of injection 1 week after vaccine. Very itchy and hot to the touch.
Patient received the Moderna COVID-19 vaccine before pregnancy; vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Patient received the Moderna COVID-19 vaccine before pregnancy) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-Mar-2021 and the estimated date of delivery was 06-Jan-2022. On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Patient received the Moderna COVID-19 vaccine before pregnancy) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (Patient received the Moderna COVID-19 vaccine before pregnancy) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not have any adverse events to the prior doses of the Moderna COVID-19 vaccine.  The second and third dose of the vaccine was administered at 3 and 32 weeks of gestation respectively  No concomitant medication information was provided by the reporter.  This spontaneous report concerns a 34 year old female subject with no relevant medical history who was administered mRNA-1273 vaccine before and during pregnancy. The subject was administered the first, second and the third doses of the mRNA-1273 vaccine. The first dose of vaccine was administered 10 days before the last menustrual period. The second and third dose of the vaccine was administered at 3 and 32 weeks of gestation respectively. As per the report, the mother did not experience any adverse event after any of the vaccine doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous report concerns a 34 year old female subject with no relevant medical history who was administered mRNA-1273 vaccine before and during pregnancy. The subject was administered the first, second and the third doses of the mRNA-1273 vaccine. The first dose of vaccine was administered 10 days before the last menustrual period. The second and third dose of the vaccine was administered at 3 and 32 weeks of gestation respectively. As per the report, the mother did not experience any adverse event after any of the vaccine doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Moderna vaccine use for COVID-19 under Emergency Use Authorization (EUA): Severe swelling of lymph nodes on the side where shot was given. Pain radiating to arm pit and breast. Lasted 5 + days.
The pediatrician gave our son a single dose of the DTaP vaccine on the morning of 12/26. (I am unsure if it was "DAPTACEL" or "INFANRIX" as our medical records do not indicate as such). On the afternoon of 12/26, our son developed a rash in the area where the vaccine was given. On the evening of 12/26, within 12 hours of receiving the vaccine, our son was vomiting all over his crib. That evening as well as the next day and week following the vaccine, our son had uncontrollable and nonstop crying.  The next day, on 12/27 as well as each day after that, our son started stumbling and falling down A LOT. I'd also like to note that in the months leading up to his vaccine, he was starting to say actual words and had a solid 5-6 words down in his vocabulary. Since the vaccine, he has never said those words again nor has he spoken any new words since. We are now in the beginning stages of working with a Speech Therapist and are also exploring working with an Autism Specialist because it has been suggested that our son's lack of development may be on the spectrum for Autism. I called the pediatrician on 12/27 to report the symptoms and they claimed there is no way it could have been the vaccine and that maybe he caught the flu since we had family visiting. However, nobody in the family was sick and we just knew it was the result of the vaccine but the pediatrician did not want to take responsibility for it. I'd also like to note that in 2017, our son received a single dose of the Polio vaccine in which he developed chronic eczema following the vaccine. I was able to treat it with various remedies over the course of several months following the vaccine, and we made sure not to vaccinate him again for another year. The next vaccine he received was the one above, DTaP, which resulted in different vaccine injury symptoms.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were recovered/resolved. It was unknown if the reporter considered the pain in arm and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. During the summer of 2018, the patient received SHINGRIX on an unknown arm. After receiving SHINGRIX, the patient experienced achiness (entire body) and a sore arm which only lasted 1 day. The reporter did not have any additional information regarding the event and did not feel comfortable providing patient initials or date of birth.
Received vaccine July 31, 2003. Fever after vaccine. Right arm swelled. turned blue. Next day pus, blue. Next day, red discoloration. Chest pain. SOB
Sudden sensorineural hearing loss with profound hearing loss in the right ear on 11/12/22. Pt was given a prednisone burst without recovery. Receiving series of intratympanic steroid injections currently. Poor prognosis for recovery
c/o feeling sluggish all weekend; coughing-phlegm 6DEC92 Pm took pirmatine; nausea PRN today;
Hives beginning at 4 pm on January 17 and progressed to severe itching and swelling. Benadryl and Famotidine taken.  Admitted to ED at 4 am on January 18, Prednisone given. Symptoms were improving and discharged at 7 am the same day. Hives and itching were worse and facial edema and rash noted on night of January 18. Treatments included Benadryl and Famotidine. Morning of January 19, 40 mg Prednisone and Benadryl every 4-6 hours. Morning of January 20, hives and rash and itching persists on stomach, legs, arms, and ears. 40 mg of Prednisone and Benadryl. (Present time - hives, rash, and itching still persists with less severity)
High fever developed within 24 hours of initial vaccine. Body aches, cough, shortness of breath, brain fog, short term memory loss, chronic and severe fatigue.