chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AE or PQC reported; administration of expired VARlVAX to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.  On 04-JAN-2022, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml (lot #S032357, expiration date: 14-OCT-2021) (strength and route of administration were not provided) for prophylaxis (expired product administered). There was no additional adverse event (AE) or product quality complaint (PQC) reported (no adverse event).
Severe light headedness, severe nausea, all muscles are rigid, tense, sore
I had Robotic Inguinal laporoscopic surgery for two hernias; tenderness @ injection site lasting 48 hrs.; This case was reported by a consumer and described the occurrence of injection site tenderness in a 82-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included enlarged prostate.   On 25th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site tenderness and hernia. On an unknown date, the outcome of the injection site tenderness was recovered/resolved and the outcome of the hernia was unknown.   It was unknown if the reporter considered the injection site tenderness and hernia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 81 or 82 years. The patient experienced tenderness at injection site lasting 48 hrs. The patient was in good health.  The patient took medication for enlarged prostate daily. Two months prior to the reporting, the patient had Robotic Inguinal laparoscopic surgery for two hernias. First surgery ever. The patient when should I take the second dose
I had 2 reactions, one was swelling which started almost immediately and was like a hard knot in my arm and of course there was pain. 2 days after the shot I started getting a rash and it got bigger and bigger, so maybe 4-5" in diameter. It was itching. I took some Benadryl for it. It lasted about a week. I called a Dermatologist, sent pictures. Both reactions lasted about a week. I just got my 3rd dose last Saturday 9/25/2021 and I'm getting the same rash like the one after my 2nd dose.
Given 3 doses of vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for an unknown indication.   Previously administered products included Shingrix (received 2 dose of shingrix on an unknown date').   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a person was given 3 doses of shingles vaccine, which led to extra dose administered. The reporter asked if it was something to be panicked or should remain calm. The follow-up would not be possible as no contact details were available.
Erythema, inflammation & urticarial like eruption around site. Rash to (L) deltoid.
Woke up with extreme weakness and fatigue.  Numbness began Thurs 10/1. Hospitalized.  Symptoms worsened until Wed 10/7.  Symptoms were presumptive Guillain-Barre Syndrome. Although treating physician did not confirm diagnosis because she did not manifest all classic symptoms and spinal fluid did not reach diagnostic levels. She was treated based on symptoms including 5 treatments of high-dose immunoglobulin therapy.  11/2/09 Hospital records and discharge summary received service dates 10/5/09 to 10/11/09. Assessment: Guillain-Barre syndrome. Hypertension possibly secondary to Guillain-Barre syndrome. Possible Addison's disease.  Post vaccination injections of corticosteroids to shoulder and foot for degenerative arthritis/tendonitis. Augmentin for presumed sinus infection. Patient presents with general weakness and fatigue for one week. Body aches, tingling skin. Numbness around knees. Paresthesias, which seemed to be ascending with possible paralysis of larger muscles. Shortness of breath. Decreased sensation ankles and toes. Wide-based gait.  Tx w/IVIG, improved & d/c to home.   ICD-9 Codes: 357.0 Acute infective polyneuritis, 401.9 Essential hypertension, 280.9 Iron deficiency anemia, V12.51 Personal history of venous thrombosis and embolism, V58.66 Long-term (current) use of aspirin.
Approx. 5 minutes after receiving the MMR vaccine at his 18 mo visit, he developed hives around the injection site. I notified the nurse and she consulted with the pediatrician who said to give Benadryl. The nurse gave the Benadryl and made notes of the reaction in his chart.
Pt presented to clinic with R arm swollen, hot to touch, c/o pain at injection site.
One day and 11 hours after receiving shot itching on right arm, tender to touch 2x3 inch pink rash. Cortisone cream, Tylenol and Benadryl
cluster headaches' intensity is through the roof/cluster migraines have kicked up in frequency; felt off a few days after the vaccine; bowel movements are different.; digestive system has felt off; he hasn't felt up to par in the last 2 weeks/he doesn't feel like himself; This spontaneous case was reported by a consumer and describes the occurrence of CLUSTER HEADACHE (cluster headaches' intensity is through the roof/cluster migraines have kicked up in frequency), VACCINATION COMPLICATION (felt off a few days after the vaccine), BOWEL MOVEMENT IRREGULARITY (bowel movements are different.), FEELING ABNORMAL (he hasn't felt up to par in the last 2 weeks/he doesn't feel like himself) and DYSPEPSIA (digestive system has felt off) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included Diverticulosis. Concurrent medical conditions included Headaches cluster and Liver cirrhosis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (he hasn't felt up to par in the last 2 weeks/he doesn't feel like himself). On an unknown date, the patient experienced CLUSTER HEADACHE (cluster headaches' intensity is through the roof/cluster migraines have kicked up in frequency), VACCINATION COMPLICATION (felt off a few days after the vaccine), BOWEL MOVEMENT IRREGULARITY (bowel movements are different.) and DYSPEPSIA (digestive system has felt off). At the time of the report, CLUSTER HEADACHE (cluster headaches' intensity is through the roof/cluster migraines have kicked up in frequency), VACCINATION COMPLICATION (felt off a few days after the vaccine), BOWEL MOVEMENT IRREGULARITY (bowel movements are different.), FEELING ABNORMAL (he hasn't felt up to par in the last 2 weeks/he doesn't feel like himself) and DYSPEPSIA (digestive system has felt off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he was due for his second dose of Covid-19 vaccination 20-APR-2021. Patient also reports having a history of cluster migraines that had been regressing in frequency. Those cluster migraines had kicked up in frequency in the last two weeks. He also reported increased intensity of the cluster headaches. To treat the cluster migraines the patient had to hyperventilate with oxygen when they start. He had to do it 4 times yesterday.
Swelling and erythema (L) thigh noted this AM. Immunizations given 4/16/18. Pt also had blank stare x 45 min at school. During that time he was not interacting with anyone until Dad arrived - At which time he "snapped out of it" and is now ok. Dad made question of actions related to pt wanting his helicopter which he referred to when father arrived (as stated per father). No family Hx of seizures. To follow up with Dr. (Peds Neurology) 4/19/18.
Expired dose of Havrix was administered to a female patient.; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 15th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 15-FEB-2023  Reporter's Comments: The reporter consented to follow up via email  Additional Supportive Information: On the day of reporting, the patient received an expired dose of Havrix vaccine, which had led to expired vaccine used.
Information has been received from a pharmacist via a company representative referring to a "couple" of unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with VARIVAX (strength, dose, frequency and route were unknown). The patient's concomitant medication was not reported. On an unknown date the patient developed shingles an unspecified time after receiving an unspecified dose of VARIVAX. Action taken and outcome were unknown. The causality between the events and VARIVAX was not reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 19Apr2021 as dose 2, single (Lot number: ER8731) at the age of 29 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Nov2021 as dose number unknown (booster), single (Lot number: 67F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rapid test; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information:Known allergies: No.
FAINTED POST IMMUNIZATION; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 26 year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included needle phobia, alcohol use (Social - 1-2 drinks per week; very light drinker) and non-smoker. The product was stored in appropriate temperature conditions (it was stored properly from receipt to administration). The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) administered on 07-MAY-2021 to left arm as prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 07-MAY-2021, the patient fainted post immunization. On the same day, she was feeling exhausted and had headache. On 08-MAY-2021, she experienced low grade fever and lethargy. Till 10-MAY-2021, she was feeling exhausted and had headaches. On 13-MAY-2021, she identified lack of smell while cleaning house (cleaning products). On the same day, she had positive rapid home test for COVID 19 and she tested negative at health care professional (HCP). On 14-MAY-2021, she was tested positive polymerase chain reaction (PCR) for Covid 19 (headache, exhausted, low grade fever, lack of smell and lethargy). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted post immunization on 07-MAY-2021, and was recovering from confirmed covid-19 infection. This report was associated with product quality complaint: 90000179636 This report was serious (Other Medically Important Condition).  The narrative states the patient received the vaccine on 07-May-2021 and had a positive Covid-19 test on 14-May-2021 with 7 days elapsed between vaccine and test. There was not sufficient time elapsed for the patient to achieve immunity therefore this report was not considered a lack of effect. The suspected product quality complaint has been confirmed to be voided there was no PQC identified within the reported complaint. Voided based on the PQC evaluation/investigation performed".; Sender's Comments: V0:20210530216-covid-19 vaccine ad26.cov2.s-Fainted post immunisation. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Case number PHEH2014US012540 is an initial spontaneous report received from a nurse on 19 Jun 2014. This report refers to a 10 year old female child. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12098, expiry date: 03 Jul 2015) intramuscularly at a dose of 0.5 ml of 10 Jun 2014. On 11 Jun 2014, she developed swelling and redness at vaccination site which was about the size of a baseball. The outcome, causality and seriousness were not reported.
25JUL97 mom reported illness in both children following 1st hep b pt leg was locked up, red, swollen & n/v, dehydration;event reported today because mom is considering completing series ER MD apparently told mom illness was d/t a bad lot
Sharp pain, occasional weakness, upper left arm & shoulder. This pain started within hours of the injection. Continued and went to Corporate health for evaluation and treatment. Started a Medrol Dose Pack and NSAID on 11/2/2011. Finished Medrol Dose Pack on 11/8/2011 and pain returned 11/9/2011.
This was NOT an "Adverse" event, but a completely unexpected positive neurological.  This may or may not be related to the second vaccination on 02Feb2021, however this positive event should be tracked.  My mother is 89 years old, and has significantly diminished cognitive abilities.  However 4 days following her second vaccination, 06Feb2021, she became very lucid, her cognitive abilities including memory, was like it was 10-12 years ago, including speed of thinking, responses to questions, she said it was as if she had awoken from having a stroke and recovered.  Her cognitive state does appear to have declined from 06Feb2021, but remains significantly better than prior to that date.  There is no explanation that I know of, no changes in medications, no changes in living conditions.  The question I have is if there was a shift in her immune state (I have extensive immunology background) due to the vaccination that temporarily effected her brain, I have no other explanation.  Again, for elderly people with senility, I believe this type of event should be noted and tracked.  Or is there a researcher who would be interested in this "positive" event that I can communicate with?
Fatigue, lightheadedness, dizziness, brain fog, decrease in appetite - all symptoms started at Item 5 and are currently continuing.
Doctor said it was arthritis from X-ray; a lot of pain in my back/soreness in my back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EN6201) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN. Vaccination history included: Bnt162b2 (First Dose, Lot No: EL9262, administration time=12:00 PM,, vaccine location=left arm), administration date: 23Jan2021, when the patient was 75 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19 and Since the vaccination not been tested for COVID-19. The following information was reported: ARTHRITIS (disability) with onset 16Mar2021 07:30, outcome "not recovered", described as "Doctor said it was arthritis from X-ray"; BACK PAIN (disability) with onset 16Mar2021 07:30, outcome "not recovered", described as "a lot of pain in my back/soreness in my back". The events "doctor said it was arthritis from x-ray" and "a lot of pain in my back/soreness in my back" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: (16Mar2021) arthritis, notes: Doctor said it was arthritis from X-ray. Therapeutic measures were taken as a result of arthritis, back pain which was PT. Chiropractor, Tylenol.   Clinical course: In March she woke up with a lot of pain in my back. she have never had back issues. Doctor said it was arthritis from X-ray. Have been through PT and a chiropractor and nothing gets rid of the soreness in my back. When she get up in the morning she have to hold on to the sink to wash her hands. After an hour she can move around but the pain and soreness never leave. she feel this is a result of the vaccine.   Follow-up attempts are completed. No further information is expected.
Could not move his arm; Swelled up; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of movement disorder in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced movement disorder (Verbatim: Could not move his arm) and swelling (Verbatim: Swelled up). The outcome of the movement disorder and swelling were not reported.   It was unknown if the reporter considered the movement disorder and swelling to be related to Shingles vaccine.     It was unknown if the company considered the movement disorder and swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that the patient received the Shingles vaccine and he could not move his arm and he swelled up. The reporter reported that it was very ugly. The case had been linked to the case US2023AMR103135 by same reporter for wife.; Sender's Comments:  US-GSK-US2023AMR103135:Original Case : US2023AMR101663/ Husband case
Swollen, red arm for 12 hours iced, ibuprofen and diphenhydramine.
Started with severe arm discomfort, ( not unexpected), progressed to muscle and backache,  by the next morning it was severe headache, muscle and joint pain, some nausea due to the headache.  Possible low temp but did not take it.  Literally everything hurt.  I am not wimpy and rarely get sick.  I took 3 Tylenol, ate a little and started moving.  By noon I was doing much better other than a very sore arm.
The day of the vaccine, reported several, HA, nausea and the smell of "dog poop". Able to maintain active, when sed count average was sent to ER with same AE. LP (neg), sx completely resolved.
Pain & redness at injection site. About 27 hours after injection baby experienced elevated temperature of 100.7 Fahrenheit and labored respirations of 75 respirations per minute. Gave one dose of Tylenol. Rechecked temperature after 30 minutes, decreased respiration rate to 65 labored respirations per minute, temperature of 100.4. Nurse line instructed to bring baby into ER. Temperature and respirations retuned to normal within 1 hour 45 minutes of 1 dose of Tylenol.
Almost 24 hours to the minute  my left cheek started swelling. Overnight my left eye became completely swollen.  It was approximately 20-30 percent open. I needed to go to urgent care and received a cortisone shot in my buttocks to get swelling to go down.
Three solid days of headaches, body aches, low grade fever.  Lymph node near injection site swelled to size of large grapefruit, and was red and warm to touch.
PATIENT STATES SCRATCHY AND ITCHY THROAT BUT NO THROAT SWELLING OR TROUBLE BREATHING. PATIENT OBSERVED FOR 15 ADDITIONAL MIN. PATIENT STATES FEELS FINE AFTER DRINKING WATER AND WA INSTRUCTED TO FOLLOW-UP WITH DR OR EMERGENCY DEPARTMENT IF HAD ANY FURTHER NEEDS AFTER DEPARTURE FROM VACCINE CLINIC.
Patient reported when she came back for her tuberculin skin test reading on 8/27/18 that her (R) upper arm where she received the varicella vaccine on 8/24/18 has redness, warmth; redness has increased somewhat.