chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got a very light case/got after my injection was extremely mild, less than half a dozen outbreaks; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a severe case of shingles) and covid-19. Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the 1st dose of Shingle shot and got a very light case of shingles and it was extremely mild, less than half a dozen outbreaks. The patient had first called his/her doctor's office and informed, but they knew nothing about the correlation between the two. The patient had autoimmune conditions and fully believe that contributed to his/her rare side effects.  The follow-up would not possible as no contact details were available. For tolerance to 2nd dose, refer case US2021AMR176035.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176035:Same reporter
Weds 4/7 I got very ill, and went to the ER that night. I had my appendix removed at 9 am the morning of 4/8.
Shingrix was not reconstituted properly; Shingrix was not reconstituted properly; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number G9455), (batch number 7373X), (batch number 3FE44), (batch number 5T495), (batch number HL9AJ), (batch number 22M3K), (batch number L4459), (batch number MY2Y2) and (batch number C9Z43) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix was not reconstituted properly) and inappropriate dose of vaccine administered (Verbatim: Shingrix was not reconstituted properly). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-Jun-2023 The registered nurse stated that she believed that Shingrix was not reconstituted properly and only the adjuvant portion was administered to a patients as she had one lyophilized vial left but not an adjuvant. The reporter thought that the occurrence was with one patient but cannot be certain as they had just started investigating and did not had any patient identifiers at the moment. The reporter asked that if the lot number on the box matches the lyophilized component. The reporter provided the following lot numbers but stated that she cannot narrow down which one was administered as some of the lots pull up as Shingrix and some do not. It was explained that the box and lyophilized component have the same lot number. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received only received the adjuvant portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Exhaustion; Extreme insomnia; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 12:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome, post-traumatic stress disorder and IgA deficient. Patient had allergies to cephalosporin (MANUFACTURER UNKNOWN) class of antibiotics. Concomitant medications included vilazodone hydrochloride (VIIBRYD), topiramate (TOPAMAX), cetirizine hydrochloride (ZYRTEC), vitamin D6 (MANUFACTURER UNKNOWN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate and dexamfetamine sulfate (ADDERALL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccine within four weeks prior to the vaccination. On 29Mar2021 at 22:00, the patient experienced exhaustion. And on an unknown date in Mar2021, the patient experienced extreme insomnia. It was reported as day 1- the patient experienced exhaustion and days following-extreme insomnia. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measure was taken as a result of the events. The clinical outcome of the events exhaustion and extreme insomnia was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Bells Palsy right side of face, sx. almost gone on 2/23/2021
It was like having Covid 2.0 over the next 30 hrs; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (It was like having Covid 2.0 over the next 30 hrs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (I got Covid between Christmas and New Yr. last yr. and lost my sense of smell and taste.) in December 2020.    On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced SUSPECTED COVID-19 (It was like having Covid 2.0 over the next 30 hrs). At the time of the report, SUSPECTED COVID-19 (It was like having Covid 2.0 over the next 30 hrs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient received their 1st dose of Moderna Covid-19 vaccine and was like having Covid 2.0 over the next 30 hours.   The patient also reported that they got Covid between Christmas and New Yr. last yr. and lost their sense of smell and taste. Reportedly, over the last 10 months their taste had been coming back pretty well.  No treatment information was provided.  Company comment: This case concerns a male patient of an unknown age, with past medical history of COVID-19 infection last year, and after first dose of mRNA-1273 the patient experienced non serious unexpected AESI of Suspected COVID-19. The patient reported "like having COVID-19" during 30 hours after first dose of mRNA-1273. No further information provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-460259 (Patient Link). Sender's Comments: This case concerns a male patient of an unknown age, with past medical history of COVID-19 infection last year, and after first dose of mRNA-1273 the patient experienced non serious unexpected AESI of Suspected COVID-19. The patient reported "like having COVID-19" during 30 hours after first dose of mRNA-1273. No further information provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
aches and pain for 2 days and chills. Also felt very tired for 2 days  Took Tylenol  for the pain and the pain was gone immediately.
Patient experienced 102F after vaccination; palm tenderness; he could not grip or open anything; white bumps only on the back of hands and top of his lips; white bumps only on the back of hands and top of his lips; was exposed to HPV through unprotected sex and was then given GARDASIL 9 vaccine; This spontaneous report was received from a nurse practitioner via a company representative referring to a 33-year-old male patient. The patient's medical history, drug reactions/allergies and concomitant therapies were not reported.   On an unspecified date in March 2023 (reported as 2-3 weeks ago), the patient was exposed to human papillomavirus (HPV) through unprotected sex; then, on an unknown date in 2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose intramuscularly (strength, lot #, and expiration date were not provided) (Product use in unapproved indication).   On an unknown date in 2023, the patient experienced 102 degrees Fahrenheit after vaccination (Body temperature abnormal), within 48-72 hours later the patient experienced palm tenderness (Tenderness) to the point that "he could not grip or open anything" (Musculoskeletal disorder). Patient also developed white bumps only on the back of hands (Limb mass) and top of his lips (Lip disorder). It was not reported whether the patient had sought medical attention or received any treatments. The outcome of the events was unknown.   The causal relationship between the events of body temperature abnormal, tenderness, musculoskeletal disorder, limb mass and lip disorder and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Two hours post vax, the pt experienced flu-like symptoms, joint pain, malaise, shakiness, chills, and a fever of 101. Tylenol was given and Lymerix was discontinued.
This spontaneous report as received from a consumer refers to herself, a currently 56 years old female patient with HPV since approximately July 2011. On an unknown the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported) for treatment of HPV infection. Concomitant medication were not reported. After doing some research, the patient and her physician, decided to see if this vaccine would be of any help for the patient. Patient has been fighting HPV for the last year and 10 months (since approximately July 2011), also reported as "it had been 2 years she have it has been fighting this". Patient had had the warts cut off, burned off, and frozen off. With very little results,a and they were back within a few months. Patient was not sure that it was because GARDASIL, but patient stated that within two weeks after taking the first shot, noticed a large difference. Patient stated she will be taking the other 2 doses. The outcome of the patient at the moment of the report was not reported. The relationship between GARDASIL and the event was not reported. Additional information has been requested.
Dizzy, lips tingling. Rest, resolved spontaneously to discharge home. Pulse: 100 SPO2 98% BP 120/86
Approximately 18 hours of intermittent low grade fever, also suffered extreme fatigue and overall muscle soreness.  Took 2 Advil to help with fever and muscle soreness
Patient presented to the pharmacy 3 days after receiving the vaccine stating that his injection site was sore as it was previously but this time it was red and warm to the touch. His right arm from mid-deltoid to about 2 inches above his elbow was red on the exterior surface and the redness was starting to make its way to the interior surface of his arm. It looked like it could be possible cellulitis.
MMR vaccination 6/5/15 - Develop rash on feet and hands on 6/6. Seen in urgent care 6/8 - sent to Emergency dept - Admitted 3 days. IV fluids, BENADRYL.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 30-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Lupus; Had surgery for cancer; immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Lupus"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Had surgery for cancer"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised". Therapeutic measures were taken as a result of neoplasm malignant.  Clinical course details: The patient said that she has Lupus and has had surgery for cancer last year and was also on chemotherapy and radiation. She has had the Pfizer Covid shot four times and was asking if she could get the fifth shot of the vaccine. Sending precautionary AE - immunocompromised.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Very low BP, prickly feelings in extremities, lightheadedness, fainting, chills, shaking. This happened for 2 weeks. Felt good for 2 weeks then 5/14/2021 symptoms reappeared for 2 days then felt better the third day.
Our facility only has the capability to store COVID19 vaccines in the refrigerator. Patient was given a vaccine that was outside of the 10 week expiration window. The 10 week expiration date was 6/10/22, patient was given vaccine on 6/22/22. Patient has not reported any adverse events or symptoms to our facility at this time.
This spontaneous report as received from a registered nurse via company representative refers to a female patient of unknown age. It was reported that the nurse had seen an unspecified video on "You Tube" regarding unspecified patient who had suffered paralysis after receiving unspecified doses of GARDASIL at an unspecified time and date. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, route and dosage were not reported). On an unknown date the patient experienced paralysis. The outcome of paralysis was unknown. The event 'paralysis' considered to be significant disability. Upon internal review the event 'paralysis' was considered to be medically significant. Additional information has been requested.
Chills, Nausea, Headaches, Arm soreness. Side effects started about 13 hours after the shot and lasted until about 6:00pm the day after the shot.
Approx 6 hrs p/vax pt began shaking & turned blue; no resp distress, never LOC; fever 103.8 placed on ATB @ ER for pneumonia;
Itch around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PRURITUS (Itch around the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetic.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.    On 18-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itch around the injection site).   At the time of the report, INJECTION SITE PRURITUS (Itch around the injection site) outcome was unknown. Not Provided    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 treatment information was provided.
After receiving vaccines, patient walked about 15 feet when she suddenly felt nauseated and dizzy. She sat down and appeared pale. She was provided with water and a lollipop. After 2 minutes, she stated she felt better. She walked another 15 feet to the front office desk when she then collapsed into her mother's arms. She was carried to an exam room and laid on an exam table with her legs elevated She was alert and oriented. She was provided with more water. About 10 minutes later, it was noticed that the muscles in her arms were twitching. She stated her legs muscles were also twitching. Patient denied feeling cold, but was covered with a sweater anyways. After 20 minutes, she felt well enough to sit up and that her twitching was getting better. Denied nausea or dizziness. After 10 minutes of sitting, patient felt well enough to stand and stated that her twitching was mostly gone. She was able to walk around exam room without difficulty and felt well enough to leave.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced tiredness and muscle pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the tiredness and muscle pain were recovered/resolved. It was unknown if the reporter considered the tiredness and muscle pain to be related to SHINGRIX. Additional case details were reported as follows: The patient had some of the side effects from the shingles shot that he got on the day before reporting. The patient could not stay on phone as he was busy, but we would follow up at another time. No additional adverse event information was given.
15min p/vax pt was waiting for bus & fainted;EMS was called by unk person;pt recovered well BP 112/68, pulse 68, 02 96%;pt brought into clinic for observation;BP 120/70, pulse 70;pt released to mom care, doing fine;
8 days after the vaccine was given , injection site became sore, swollen and red. There had been no problem when vaccine was given 8 days earlier other that a heavy feeling in arm for a few hours, but then all S/s disappeared.
Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 14-MAY-2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated at a care center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
I started having problems with my memory, I started noticing in may and progressively has gotten worse words slurring and not being able to put words together, tingling on my arms and legs. everything started going downhill after the vaccination. I had scans made in May and it came up I have MS . I am seen Neurology  and on  11/29/2021 I was told I have Lesion on my spinal from a CT scan. So since my last ST Scan in may I started taking Vitamin D. No one in my immediate family has MS.
After sinus surgery, low grade fever, shakes, chills, muscle pain, headache that did not fit with recovery time from sinus surgery. Dizziness... overreactive immune response. Rapid heart rate.  Headache severe, throbbing and not helped by Tylenol or Ibuprofen.   Infection from the surgery resolved after antibiotics but symptoms remained. Told I might have a "virus" and my immune system was over reacting. Vitamin B12 shot. Currently taking prednisone but still short of breath and fatigued.
This spontaneous report as received from a consumer refers to a 80 year old male patient with high blood pressure, high cholesterol and unspecified prostate issues. The patient did not have drug reactions/allergies. On 07-JAN-2014, the patient was vaccinated with ZOSTAVAX, intramuscular in the left arm (lot number, dose and frequency were not reported). Co-suspect therapy was not reported. Concomitant therapy was not reported. The patient reported that he was still having itching and numb like feelings at the injection site in the left arm after receiving ZOSTAVAX in January 2014. The patient did not feel this particular adverse experience on the same day as recieving the ZOSTAVAX vaccine; however, the "itching and numb like feelings at the injection site" started becoming worse gradually. No treatment was given to the patient. No lab diagnostic studies were performed to the patient. The patient spoke with the physician. The outcome of the events was reported as not recovered. Causality beteween the events and ZOSTAVAX was not reported. Additional information has been requested.
Symptoms: Experienced fever(100.9 degrees max), chills, sore throat, generally feeling bad - symptoms passed within 48 hours - experienced loss of taste about 7 days later for about 3 days Treatment: antibiotic - oral steroids - zinc - vitamin C - vitamin D3 Quarantine at home for 10 days
Information has been received from a medical assistant concerning an 18 year old female with no pertinent medical history or drug reactions or allergies who on 01-NOV-2006 was vaccinated with the first dose of GARDSIL vaccine (yeast) (lot no. 653978/0955F). On 11-JAN-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot no. 654389/0961F). On an unspecified date, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). On 30-JUL-2008 the patient was vaccinated intramuscularly with the fourth 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659962/1740U) and experienced a sore arm (which arm unspecified). There was no concomitant medication. It was not documented in the patient's record that a third dose was given however the mother of the patient insist she had received the third dose. At the time of this report, the patient was recovering from a sore arm. The patient sought unspecified medical attention in the office. Additional information has been requested.
Mother phoned and described patient's eczema worsening the evening after receiving a one month preservative free 0.25cc booster dose of influenza vaccine (1/10/2007).  Two episodes of diarrhea noted by mother today.  The child was diagnosed with an egg allergy (3 on 1-10 scale per mother) by allergist Dr. after receiving his initial vaccination.  The child had received the first dose without incident and had ingested eggs without adversity.  I made the referral to Dr. upon noting a diffuse patchy flaking erythematous rash on the otherwise well appearing child prior to receiving the first influenza dose of his lifetime.  The child's mother applied topical cortisone cream that evening per MD order.  Child's condition resolved to baseline by am.  Mother now states "He's doing just fine.  He is happy and playing."  Denies fever or worsening of rash.  Clear fluids and bland diet recommended with visit to MD for follow up if child's symptoms worsen or if the diarrhea remains unresolved for >24 hours.  Mother also instructed to keep child's urine clear and mucous membranes moist through oral hydration.  Mother verbalized understanding and was grateful for her son's care.
Ringing and muffling sound in ears, distorted hearing, dizziness, pain in ears, headache, some blurred vision, foggy