chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse practitioner to a sales representative and described the occurrence of fever in a 4-moth-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On 05 July 2005 the subject received the 2nd dose of Pediarix. On 05 July 2005, less than one day after vaccination with Pediarix, the subject experienced a "high fever." "At midnight" on 06 July 2005, the subject developed a rash "all over her body." On 11 July 2005. the subject experienced wheezing. The subject was treated with diphenhydramine hydrochloride (Benadryl). At the time of initial reporting , 13 July 2005, the fever and rash had resolved on or before 13 July 2005 and the wheezing was ongoing. The vaccination course with Pediarix was discontinued. The nurse practitioner considered the events were possibly related to vaccination with Pediarix.
PATIENT WAS GIVEN 1ST DOSE MODERNA VACCINE AT AGE 17. NO ADVERSE EFFECTS NOTED.
Symptoms began following an upper respiratory infection in September with abnormal sensation in her toes that then extended to the soles of her feet.  She describes it as walking on marbles or flip flops with bumps in the soles,, as well as hypersensitivity. Symptoms significantly worsened following a flu vaccination on 10/14/23. Presented to PCP on 10/20/2023 with lower extremity numbness and tingling, and SOB.
Employee came in for Moderna Booster  1st dose was given on 9/2/21   2nd dose given 9/30/21  booster given on 11/19/21.  When error was recognized, observed employee for 40 minutes. No reports of illness and none were observed.
Pain at site of injection.  At 10 days post (today), level of pain is still increasing.  Muscle and nerve pain.  Treated with rest, heat, topical Rx cream (analgesic/anti-inflammatory/steroidal).
Left leg swollen @ injection site with mild pain induration measured @ 4 X 4, mom was told to apply cool compress to site.  Admin. BENADRYL 1 tsp. with Alt. LORATIDINE.
Red, warm to the touch, welt surrounding injection site began to spread down left arm. Right side of face became red, warm. Mildly feverish, mildly achy, mild nausea.   After approximately 2 hours, symptoms resolved without medication.  Redness around injection site resumed previous size.
Information was received from a lawyer regarding a case in litigation. It is alleged in litigation that a male patient with chronic hepatitis C was vaccinated with dose of VAQTA on 12-DEC-2008, 14-JAN-2009 and 17-FEB-2009. On DEC-2011 the patient experienced oral pain and soreness. The patient reported removal of a small fibrotic oral lesion on 17-MAY-2012. He also experienced low white blood cells and nightly ache of knees and ankles. Additional information has been requested.
Amnesia; Muscular weakness; Headache; This case was received via VAERS (Reference number: 1247184) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of AMNESIA (Amnesia), MUSCULAR WEAKNESS (Muscular weakness) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020b21a) for COVID-19 vaccination.     The patient's past medical history included Lumbar puncture (Spinal tap for CSF fluid.). Concurrent medical conditions included Hypertension, Depression and Guillain Barre syndrome. Concomitant products included CITALOPRAM HYDROCHLORIDE (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]) for COVID-19 vaccination, ATENOLOL and HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced AMNESIA (Amnesia) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Muscular weakness) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, AMNESIA (Amnesia), MUSCULAR WEAKNESS (Muscular weakness) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Magnetic resonance imaging: normal (normal) MRI was normal. On 02-Apr-2021, Viral test: inconclusive (Inconclusive) result given recovered/resolved.. On 02-Apr-2021, X-ray: normal (normal) x-ray result showed no tumors..     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.   Treatment medication include high dose steroids and on 02-APR-2021 immunoglobulin therapy.  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.
Pt. fainted about 1 minute after receiving vaccines. -Patient fell from exam table on to the floor hit head and face, eyes rolled back and looked like he was having a seizure, rolled him to a side until he recovered 5 min later, he stated he felt ok. We did an EKG, was sent to cardio, and sent to do a CT of the Brain. I gave patient his vaccines (3) that were ordered, asked the patient if he was ok afterwards he said yes. I stepped out of the room and was walking away when I heard a noise of chairs bumping against the wall and the child's mom asking for help. I ran back to the room and saw the child on the floor having what looked like a minor seizure. I held him and turned him on to his left side and just told the mom not to worry while called doctor, the child then gained consciousness and his color came back, we gave him water and doctor took over the consultation. (Pt's mom states he fell on his face). I ran back to the room when I saw the child was having what looked like a seizure, I layed him on his left side and told one of the other MA's to call doctor. I calmed the mom down and explained it happens with certain patients but he would be ok. We brought him water and leaned him against the wall, then doctor came in and took over the office visit.  Patient was ordered and X-ray and a CT scan of the Brain to make sure he is ok. Also and EKG was done and he was referred to Pediatric cardiology to rule out anything else that could have caused him fainting.
LEFT SIDED FACIAL SWELLING, TONGUE SWELLING, SLURRED SPEECH, DYSPHAGIA, ARM AND FEET TINGLING, HEADACHE, NAUSEA.  SYMPTOMS STARTED THE EVENING THAT THE VACCINES WERE ADMINISTERED AND CONTINUED TO PROGRESS THROUGH THE NIGHT AND INTO THE NEXT MORNING.  8/3/09 Spoke with parent who stated pcp felt it was an allergic reaction.  No hospital or ER visits.  Fully recovered with minor scarring at injection site.  Case closed.
At 9:10 AM, after receiving flu vaccine, patient stated that "itching at the site" almost immediately. Shortly thereafter, patient complained of 'itching around nose and mouth' and subsequent "itchy throat and tongue". 9:25 am administered 0.3mm Epinephrine  1:1000 at site of flu vaccine injection SC. (* times approximate)
Sore arm; Seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizures since an unknown date. Concurrent medical conditions included Epilepsy. Concomitant products included CARBAMAZEPINE (TEGRETOL) and PHENYTOIN (DILANTIN [PHENYTOIN]) for an unknown indication.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, SEIZURE (Seizures) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had 1 seizure on 07-Sep-2021, 5 seizures on 10-Sep-2021 and another seizure on 18-Sep-2021. Patient had no other adverse event or pre-existing condition. No allergy was reported. Patient had not visited primary care yet regarding this event.  No treatment information was provided.  Company Comment: This case concerns a 61-year-old, female patient with previous relevant medical history of seizures, epilepsy and use of concomitant medication, who experienced the unexpected event of seizure. The event occurred 1 days after the first dose of mRNA-1273. The rechallenge was unknown since no information about the outcome of the events was disclosed. The medical history of seizures, epilepsy and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 61-year-old, female patient with previous relevant medical history of seizures, epilepsy and use of concomitant medication, who experienced the unexpected event of seizure. The event occurred 1 days after the first dose of mRNA-1273. The rechallenge was unknown since no information about the outcome of the events was disclosed. The medical history of seizures, epilepsy and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Subsequently the pt experienced a macular rash around waist. The reporting MD noted, rash has no papules or vesicles. It does not appear to be a typical chicken pox rash.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX. On 7th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site itching, injection site inflammation and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching, injection site inflammation and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site itching, injection site inflammation and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced injection site burning. The health care professional stated that the pharmacy had already reported the adverse event. The call center representative did not collect patient initials or vaccine lot number or expiry date. It was reported that the pharmacy had already reported this case, however, the duplicate case could not be found.
fever-forhead highest at 100.4, productive cough, headache, wheezing, loss of taste, loss of smell, diarrhea, sinus congestion, nasal congestion, chest congestion, chest tightness, chest pain-with coughing,  starting 11/6/21
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a medical center as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, he was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt recvd pneumococcal vax & w/in 24 hrs following vax pt's arm became severely swollen, erythematous & hot to touch; also c/o myalgias & a t100; w/in 1 wk sx subsided;
After receiving Covid-19 product Moderna RX team and RPh were under the impression that this product was to be used for booster doses. After due diligence and checking VARS it was found to be that this patient may have received 0.25ml of that product (rather than the recommended 0.5ml dose for boosters).  I will then contact the patients physician to see if they would like us to repeat the dose.
Near syncope-dizzy, lightheaded, diaphoretic,  blurred vision, decreased responsiveness. Evaluated by EMS-BP 100 palp, BS 110, decreased responsiveness.  2:36 pm-transported by rescue squad.
I had the vaccine on Wednesday. On Saturday,  I woke with up my equilibrium being off ( kinda like when you're on a ship ) and pretty intense back and joint pain.  By Saturday  night, my equilibrium  was a little better but I still had back pain. I went to see the doctor and was advised to take Advil.  By Sunday, my equilibrium was better and there was a reduction in back pain. Each day  the back pain has gotten better.
Information has been received from a physician concerning a 16 year old female student with a penicillin allergy who on 06-APR-2007 at 3:00 pm, was vaccinated IM in the right deltoid with her first dose of Gardasil, lot #654272/0319U. At 7:00 p.m. the patient experienced sudden chills down with vertigo lasting less than 5 seconds. No further information is available.
Fever, unconsolable, rash, vomiting, diarrhea X 3 days.
Pt reported full body "itching" shortly after receiving her influenza vaccine.  Denies rash or hives.  No other symptoms.
RN wrote a progress note that the mother called and left a message to the HD that her son had a fever of 103 degrees the day after the vaccination administration on 04/15/14, an that she was alternating Tylenol and ibuprofen, and that the fever was down to 100.7 in the Morning of 04/16/14 and the pt. vomited that morning as well. RN left voicemail for mother explain side effects of vaccinations and when to call/ encouraging mother to notify family physician. 06/09/14 - This RN saw mother at immunization appt. in clinic site. Mother stated, "He got better after he vomited on 04/16/14 and I never took him to the doctor, I did get the message from the nurse, the nurse said he would get better, and he did." "He did have some jerking in his sleep though." This RN explained to the mother that the jerking could possibly have indicated a seizure, and explained and showed the mother the most recent print out of the CDC Recommendations to Contraindications and Precautions to Common Vaccinations, and explained that the mother would have to take the child to be evaluated by her family physician as to the appropriateness of future DTaP doses due to the possibility of the child experiences a possible seizure within three days of receiving a DTaP dose. The mother agreed to this and stated that she would take her child to be evaluated, "I go to the Family Practice," she said.
Patient possibly inadvertently received 1cc of Moderna Covid vaccine instead of 0.5cc. Patient was notified. State of MD was notifed.
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-MAY-2016, the female patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 08-MAR-2017, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: shingles. The patient claims damages including: injury to themselves, loss of consortium, and economic losses.The outcome of the shingles is unknown. Additional information has been requested.
64 year old female with a history of Non-ischemic cardiomyopathy with defibrillator in place.  She received the Moderna Vaccine at clinic on 2/26 and on 3/26 (Lot# 014M20A and 031A21A  respectively). She had not received any device therapy for at least one year and had not been hospitalized in over one year.  She presented to  ED on 3/27 after her defibrillator fired. She was transferred to hospital and evaluated by EP there who felt that ventricular fibrillation prompting defibrillator therapy was triggered by COVID vaccine.  After discharge on 3/31, she had another VF episode. On 4/2 admitted awaiting EP consultation. 4/5/21 DISCHARGE SUMMARY STATES: #Recurrent defibrillator therapy in setting of Recurrent VF :   AICD interrogation showed underlying rhythm to be Vfib.  Possible adverse event associate with vaccine reported to VAERS. Interrogation at emergency department on 3/27 revealed 14 beats of polymorphic V. tach, possible lead misplacement.  S per hospital showed lead appropriately positioned.  Repeat echocardiogram done at hospital demonstrated an EF of 45 to 49%, device was reinterrogated there.  She was seen by EP at that time with recommendations to continue home beta-blocker and follow-up.  Upon return to emergency department, cardiology was reconsulted and communicated with EP with recommendation for stopping metoprolol and starting Nadolol 40mg BID and Mexiletine 150 BID.  She did not have any further ventricular tachycardia for over 48 hours after this change and was felt safe for discharge home on these two medications.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  It was unknown if the vial was initially stored in the refrigerator The vial did not undergo any temperature excursions   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non significant information.
In March my husband started having left hand tremors.   He is still having them.  I noticed he was shaking and he said he's had it since he had his 2nd shot.
Extreme lower back pain starting early the evening of the shot. I was bedridden for Three days. The pain was too severe to sit or stand. As of today I still have discomfort in my lower back right side. Prior to the shot I had NO health issues.
fever, joint pain, body aches, headache, baseball size knot at injection site, redness of injection site, injection site hot to touch
I recently discovered that I received 2 separate vaccines for COVID-19. I did not discover this until I went to upload my vaccine status to my company's website and the first shot was Moderna (lot number 051C21A) and the second shot is Pzizer (lot number FA7485). I got my first shot at a pharmacy on June 23, 2021, and my second shot at a different pharmacy on July 21, 2021. I had to go to 2 separate pharmacies because the first one was closed when I went there to receive my second shot so I  had to go to the nearest pharmacy. Neither pharmacies noticed this mistake or informed me that they gave me 2 separate shots.  I am not a medical professional and I am not sure of the implications of this mistake or how it affects my personal health.
Patient presented for 2nd Pfizer vaccine at 1010 today. After administration of vaccine she was waiting 15 minutes in the waiting room and started to feel that her throat was swelling, heart racing, and felt "weird". The patient was brought back into the exam room to monitor. Vitals were  blood pressure 144/80mmHg,  pulse 71bpm,  O2 99. The patient was given water to drink and applied ice pack to back of neck. Retook vitals: blood pressure 134/78mmHg, pulse 78bpm, O2 99. Patient was observed until 1030, offered Benadryl 50mg IM per provider, patient declined, and went to waiting room to wait another 15 minutes. After a few minutes in the waiting room the patient decided to have the Benadryl 50 mg/mL IM injection, given at 1050. The patient then proceeded to have increasing chills, numbness on the left side of the face, and "felt weird". EMS was called per provider the provider to transport to the emergency department. While in the emergency department, the patient received famotidine 20mg IV push once, methylprednisolone 60mg IV push once, and sodium chloride 0.9% 500mL.
PATIENT GOT BOOSTER (0.25ML) DOSE OF SAME MANUFACTURER INSTEAD OF SECOND DOSE (0.5ML); 4 HOURS LATER PHARMACIST REALIZED ERROR ABOUT DOSE; CALLED PATIENT AND INFORMED HER; ADMINISTERED ANOTHER 0.25 ML DOSE ON THE SAME DAY TO MAKE TOTAL DOSE OF (0.5ML). TOTAL DOSE WAS ADMINISTERED ON THE SAME DAY BUT AT 4 HOURS INTERVAL. TALKED TO PATIENT FEW TIMES AFTER VACCINE ADMINISTRATION; PATIENT IS FINE. NO SIDE EFFECTS.
A pharmacist reported that an 18 month old female received an injection of Prevnar on 12/08/2001 and subsequently developed a 10 cm by 6 cm area of redness at the injection site. She required medical attention. No further info was available at the date of this report.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of eye puffiness in a 37-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 24 April 2013 at 09:10 the subject received 1st dose of ENGERIX B (1 ml, unknown details). On the morning of 25 April 2013, 1 day after vaccination with ENGERIX B, the subject experienced eye puffiness, eye pruritus, and watery eye. The nurse practitioner reported that the right eye was puffy, itchy and watery. On 26 April 2013, 2 days after vaccination with ENGERIX B, the subject experienced facial rash, pruritus of knees, swollen knee and hive on eye. The nurse practitioner reported that the subject had a "rash on right knee, itchy and swollen." The subject also experienced "a small amount of swelling in the left eye" and the lower eyelid "had a little hive." The subject was seen in the emergency room but was not kept overnight. The subject was treated with BENADRYL "after symptoms". At the time of reporting the outcome of the events were improved. The nurse practitioner stated that the subject "showed improvement by Monday [29 April 2013]". The vaccination course with ENGERIX B was discontinued. Per the nurse practitioner, the subject's doctor directed the subject "not to continue with the second and third doses" of ENGERIX B. The healthcare professional considered the events were probably related to vaccination with ENGERIX B. "Symptoms were probably related to the ENERGIX B as reported by the emergency room doctor."