chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a 18-year-old female patient. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in 2012 (when the patient was 12 years old), she was vaccinated with first dose of GARDASIL injection (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 12-OCT-2018, the patient wanted to know if she could complete the series with GARDASIL 9. No adverse symptoms were reported.
Within 48 of dose 3 I noticed I had a rash on my trunk.  It was red, messy, angry rash.  It was blotchy, hot and inflamed.  It was not itchy, but it was burning.  It was also under my breasts and in the creases on my legs.  In the areas that it was not angry, it was a misty rash.  The rash progressively got worse but as of today, January 16, 2023, I have no rash.  The rash is gone but the itching has continued.  I have been taking Benadryl to help.  I had tele health visit my doctor on January 13, 2023.
My arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm hurt) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (Lymph nodes taken out of her right arm). Concurrent medical conditions included Cancer.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (My arm hurt). On 18-Mar-2021, PAIN IN EXTREMITY (My arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not receive any treatment
severe and debilitating shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 27-SEP-2013 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster)(for prophylaxis). Within approximately four to five months of receiving zoster vaccine live(ZOSTAVAX) (in 2014), the patient experienced severe and debilitating shingles requiring extensive medical treatment. These injuries continue today and were caused by zoster vaccine live(ZOSTAVAX).  As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  As a direct and proximate result of Defendants' conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Defendants made conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public.
Swollen at the injection site, Injection site inflammation , site  warm, severe head aches on 9/14. I took her to doctor on that date. Shortly after she started to have red dots all over her. He has now been diagnosed with Henoch-Schonlein Purpa. I tried to report this around the time that this first happened and Dr.'s office refused to give me the information on the vaccine until recently when i called again. My daughter is still suffering with the HSP.
UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from unspecified side effects. This report was non-serious.
reported to be cold one day; had a very low grade fever (97.6 Fahrenheit); some headaches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included pancreatic condition which happens every 6 months. The patient's concomitant medications were not reported. The patient reported to be cold one day, had a very low grade fever (97.6 Fahrenheit) and had some headaches on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Whelp is about 4 in long. Stood up about 1/2 inch. Couldn't lift a grape by the time he got home. Pain was a 20 on the  scale of 1-10. Can only pick up maybe a coffee cup now.  Limited range of movement. If standing the pain is not bad, but when he sits the pain gets worse. Fell asleep standing up and broke the wall sheet rock with his fall. Laying down he has to pick a position to try and get comfortable, with the arm hanging off the bed. Night time is the worse. When the sun is going down he can feel the pain coming on and them stand up for comfort. If he holds his arm up above his neck it doesn't hurt as bad.   He was given a shot when he went back to the doctor.  Rec'd Flu and Tetanus shot on the same day.
arm soreness; headache; chills; dose was given on the 34th day after the vial was thawed; dose was given on the 34th day after the vial was thawed; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given on the 34th day after the vial was thawed), PRODUCT STORAGE ERROR (dose was given on the 34th day after the vial was thawed), MYALGIA (arm soreness), HEADACHE (headache) and CHILLS (chills) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given on the 34th day after the vial was thawed) and PRODUCT STORAGE ERROR (dose was given on the 34th day after the vial was thawed). On an unknown date, the patient experienced MYALGIA (arm soreness), HEADACHE (headache) and CHILLS (chills). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (dose was given on the 34th day after the vial was thawed) and PRODUCT STORAGE ERROR (dose was given on the 34th day after the vial was thawed) had resolved. At the time of the report, MYALGIA (arm soreness), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. First dose was given 28 days prior.   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Non-significant follow up- Contact details added
Moderna COVID-19 Vaccine EUA Extreme fatigue Muscle Weakness Weakness in limbs Disorientation Memory loss Inability  to stand or walk Delusion Depression Loss of Appetite
Narrative: 94 yo male patient with the following medical issues: dementia-progressing urge incont. gait disturb. CAD w/ isch cardiomyopathy-stable/compensated htn-reasonable died on 6/1/2021. Last facility chart note on 3/29/2021. Pt received care and meds from non-facility providers. Pt did receive covid vaccines from hospital on 1/15/21 & 2/12/21. This death is likely related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Headache, cold, hot, nausea, swelling at vaccination site, red and itchy at vaccination site too, fatigue Was sick for 17 days. Dr. prescribed steroids and nausea medication.
Nurse attempted to give vaccine with the mom holding the patient.  Patient moved and the needle slipped out.  No vaccine was given.  RN changed the needle and safely administered full dose on the other arm with mom holding the patient securely.
Cytomegalovirus infection; This is a literature report.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant" (unspecified if ongoing), notes: Time since transplant-14 mo; "HIV nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression; Mycophenolate for Immunosuppression, notes: 250 mg BID; Prednisone for Immunosuppression, notes: 10 mg. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE), for COVID-19 immunisation.  The following information was reported: CYTOMEGALOVIRUS INFECTION (medically significant), 15 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Lymphocyte count: 1.02, notes: Admission; Polymerase chain reaction: 1285 IU/ml, notes: CMV highest; SARS-CoV-2 antibody test: Negative; White blood cell count: 3, notes: Admission. Therapeutic measures were taken as a result of cytomegalovirus infection.; Sender's Comments: Based on available limited information and the drug temporal relationship, the causality between the events  Cytomegalovirus infection, and the suspect drug "BNT162B2" cannot be completely excluded. Case will be reviewed further on receipt of FU information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient;
A report was received from a consumer on 12/18/03 concerning a 3 year old female vaccinee who inadvertently received 0.5ml of Fluvirin in the thigh on 12/10/03. On 12/10/03, the vaccinee inadvertently received 0.5ml of Fluvirin in the thigh. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Child given flu vaccine 10-9-09.  Developed fever for following 2 days.  Then on 10-13-09 developed urticaria.
Individual had received/completed Moderna series 1 and 2 on 4/20/2021. When asked for volunteers for the Pfizer vaccination the individual stepped forward stating he would like to receive the Pfizer dose. Individual also completed Screening & Administration form indicating that he had not received a vaccine in the last 14-days.
Patient with episode arms and legs shaking, unable to suck on pacifier and difficulty holding head upright patient crying throughout episode; episode lasted about 10-15 minutes. Patient seen in ER and diagnosed with infantile spasms.
itching, redness spot about 3 inches long by 2 inches wide at injection point.
Headache, dizziness and upset stomach.  Won?t know outcome until later today or tomorrow. Took two Tylenol Extra Strength and a Zyrtec.
Erythema 1 1/3"x1 1/3" and raised.
On 3/15/00, the pt received his third injection of Lymerix. Two hours later, the pt experienced uncontrollable trembling and his body ached. He called the ER and was told he was having an allergic reaction.  The pt was treated with Benadryl. The most recent information received on 3/16/00 reports the outcome of the events as resolved.
25NOV91 to ER following sz; for 1-1 1/2 wk prior to sz, pt exp foregetfulness, slow mentation, bedwetting, hallucinations, dec grades from A's to F's; EEG 25NOV91 1 abn spike; 12JAN92 cont abn spikes; CT scan 12JAN92 cerebral atrophy;
Blood clot in lungs and low oxygen levels. Had to stay in hospital for 10 days.
2d p/vax pt devel erythema on thigh where DTP administered; seen @ hosp dx'd w/cellulitis; tx'd w/Keflex improved well
Beginning on 12/19, both hands were extremely itchy and spread to back throughout the day. Spread to face and scalp as well. Evening of 12/19, hives started all over body. Patient went to urgent care the following day on 12/20 to have hives examined, placed on tapered dose prednisone and Claritin. Following day, patient had wheezing and while on tapered dose of prednisone required going to hospital due to lack of improvement. Another course of prednisone was given and was told to stop Clairitin and start Allegra and Pepcid. After both courses of Prednisone, hives and itchiness of palms of hands and feet are still coming and going
Patient was inadvertently given Dtap vaccine, not indicated for patient's age group. According to immunization guidelines the dose of Dtap the patient received is counted as a valid dose, but the patient should have been given Tdap vaccine.
My arm was sore for a day or so after the second shot. Then it felt fine. On day seven I woke up to a very sore arm again. As bad or worse than the initial soreness
Six months after the vaccine I woke up at  3AM with a rightsided headache and severe vomiting.  The headache lasted for over two weeks.  I went to Urgent care after 6 days of the headache & heartbeat sound in my left ear, who sent me to the ER for a CT.  Sept 24, 2021.
About 2 days after receiving the Shingrix IMZ pt noticed red itchy areas. When she scratched those areas the red spots spread. She now has approximately 20 itchy red spots and some are raised red areas. They are on her wrists, arms, left shoulder, inner thighs, right leg (behind the knee), left leg (front of the ankle). Has not taken any medication to sooth the itching until today took 1 tablet of Zyrtec.
2 days after immunizations had diarrhea all day. Next day fever. 4 days after immunizations had seizure. Taken to local hospital. Diagnosed with otitis media. Put on antibiotic. Details sketchy. Mom is Russian and doesn't speak English well. She was out of town when this occurred and relatives caring for child provided few details.
Intussusception. Vaccine give 7/22/09, 8/3/09 - decreased p.o intake, vomiting, temp 99.8. 8/5/09 - persistent vomiting, no stool --> to Emergency Room where bloody stool occurred. Air contrast enema relived an intussusception.  10/02/09 Received hospital medical records for 8/5/09-8/6/20009. FINAL DX: Intussusception, enema reduced Records reveal patient experienced vomiting x 2 days, mucous dark red stool, fever, drawing up legs, no urine output x 1 day, irritability, lethargic.  Surgical consult done.  Admitted for observation s/p enema reduction of IS.   ICD9 codes: 5600.
Contracted Shingles, itchy, painful rash which after 7days sa local doctor in another country while on holida who examine site of rash and confirmed was shingles. Given lotion and pills. Medication:- Pills - Zostex                                    Novaminsulfon                      Lotion - Anaesthesulf
I became lactose intolerant.   now I can?t consume milk or baked goods with milk.
Fever, chills, shaking, listlessness, exhaustion, sleeplessness, body aches, skin sensitivity, headache, light nausea/lack of appetite, pain in arm at injection site and down arm and hand/inability to lift arm.
Fever of 102F 12 days post vaccination. Unsure duration, because it is only 12 hours since the fever started but it is still present. Ranges from 100.8-102
Information has been received from a registered nurse concerning a 30 year old female patient who on 26-JUN-2007, was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot# 654977/0888F).  Subsequently, the patient described a severe local injection site reaction described as redness through the shoulder into the arm, pain and induration.  Unspecified medical attention was sought.  It was reported that the reactions subsided in several days.  TYLENOL was ordered for pain.  On an unspecified date, the patient fully recovered.  No product quality complaint was involved.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  This is one of three reports from the same source.  Additional information has been requested.
Four hours later after received vaccination he complaints of tingling sensation in both cheeck with associated edema and redness. Treated with Solumedrol 125 mg IV and Benadryl 50 mg IV. Patient improved and was discharge with instruction .
pain in the arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) and PYREXIA (fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (pain in the arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Scheduled for second dose on 12Oct2021.  Concomitant medication use was unknown Treatment information was unknown
I had swollen lymph nodes. Then, I got a bad sinus infection and vertigo that has been ongoing for a couple of months now. I have issue with right ear with drainage. I went to my doctor about this. They did a CT scan, normal result. They also did a hearing test, normal results. They are sending me for further testing.
Pierced vial more than 20 times to administer booster doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Pierced vial more than 20 times to administer booster doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Pierced vial more than 20 times to administer booster doses). At the time of the report, PRODUCT ADMINISTRATION ERROR (Pierced vial more than 20 times to administer booster doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.   No treatment information provided
I woke up early morning throat had no saliva, no sore throat. I dint had a temperature and got up  to get some water. The next day I woke up the same way went to work. While at work had to tilt my head to swallow my water.  On Saturday I woke up same symptoms drove myself to ER. Since my first dose I have to wake up at every night to drink water. This has never happened before Dose 1.
I have a history of PVC's. I have not had them since 2019 they have picked up since receiving the vaccine. On the morning of the 8th my heart was pumping super hard. It felt like it was skipping a beat and I had to catch my breath. I would experience these beats up to  few within a 10 minute timeframe. I also experienced a constant headache.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm, as dose number unknown, single (Batch/Lot number: unknown), in left arm and as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Undifferentiated Spondyloarthritis." (ongoing), notes: A monthly injection of Cosentyx was taken 18Jul2022. Concomitant medication(s) included: COSENTYX taken for undifferentiated spondyloarthritis, start date: 18Jul2022. Past drug history included: Knonwn allergies: morphine, reaction(s): "Knonwn allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included that the patient started paxlovid for the treatment of COVID-19 on 18Jul2022 and Treatment stopped on 22Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a healthcare worker refers to a 76 year old male patient. Medical history was not reported. On 29-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 (lot number: H018989, expiration date: 12-MAR-2014, dose number, dose, units, route of administration, anatomical location was not reported). The reporter stated that she inadvertently administered expired PNEUMOVAX 23 to a pateint on 29-MAY-2014. No adverse effects were reported. Additional information has been requested.
Pt experienced muscle aches, headache, GI upset and itching with no observed rash.