chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea/loose/soft bowel movements) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Colectomy since an unknown date.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced DIARRHOEA (diarrhea/loose/soft bowel movements). At the time of the report, DIARRHOEA (diarrhea/loose/soft bowel movements) had not resolved.            Treatment for the events includes pedialyte, bismuth subsalicylate
swelling at injection site around 4 inches; redness at injection site of about 4 inches; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient had swelling and redness at the injection site of the old shingles shot.  The redness and swelling was around 4 inches. The patient asked did that mean I will with this one?
Given Hep A vaccine and 2nd Dose of Chicken Pox vaccine on same clinic visit.  High fever at 101F, small skin colored bumps covering much of her back, nausea and vomiting.
3 hours after vaccination client noted a raised, itchy rash located at injection site approx. 1.5"- 2" in size. Can still see injection puncture.  3 days after vaccination, client states that she has also had red, dry, itchy, patches all over her body since her vaccine as well. Especially on legs and abdomen. States that she does have  a history of eczema. Called PCP office and was ordered an eczema cream to try, has not started the cream yet nor seen PCP at present.
Day after 2nd vaccine had aching in all joints, chills with low fever, headache lasting 24-48 hours.  Hip pain continues worsening with walking and standing over time.  Hips started to ache after first vaccine but didn't realize it was attributed to vaccine.  Started taking fish oil and Glucosamine tabs for joints.  Hip pain after 2nd vaccine increased and continues today.  Went to Internal Medicine clinic to be seen on 1/25/2021.  Xrays, UA, ANA, CBC and CMP were done.  Xrays show mild degenerative changes to hips bilaterally.  ANA elevated at 2.1.  Everything else within normal limits.  Physician then added RA, C- Reactive Protein and Sedrate, all coming back WNL. Will be making appointment with Rheumatoidologist.
pt taken to ER on 10SEP92, low grade temp, constant crying & drowsiness admitted for 3 days; reported by hosp to clinic; pt had complete loss of muscle control & could not stand alone;
I had a bad sore throat and headache. I took a home COVID-19 Test that came back positive. I called my Primary Care Physician who prescribed the Paxlovid and a Z-Pak that I have finished. I am feeling better but low on energy, a little sinus trouble.
The adverse event that occurred one day after immunization with SHINGRIX included idiopathic erythema and non-itchy red rash on areas of the upper arm, neck, shoulder, and back. After 3 days, post-immunization, the patient's injection site itself was self-limiting where pain and erythema resolved although a rash appeared on areas other than the injection site which included the back, neck, upper arm, and shoulder area. Patient reports that this type of rash occurs with some other immunizations in the past with his medical history. Symptoms of the rash were self-limiting and will seek out medical provider if rash continues or worsens. Based on patient's feedback, he did not feel as though emergency care was required for alleviation of symptoms.
PFIZER MONOVALLENT WAS GIVEN WRONGLY INSTEAD OF BIVALENT
No adverse event noted.  Patient received pediatric monovalent Moderna in error.  Should have received adult bivalent booster dose.  Moderna manufacturer box is marked booster.
SEVERE (pain level 10) neck pain radiating into shoulder back groin and  right arm. Continuing flare up of pain.
Low grade fever (onset 3-4 hr after vaccination with 48 hr duration, treated with Tylenol and Advil); Headache (onset 3-4 hr after vaccination with 48+ hr duration, treated with hydration and Tylenol and Advil), Chills (onset 12 hr after vaccination with 48 hr duration, treated with sleep and Tylenol and Advil); Swelling, pain and heat at injection site (onset unknown but noticed around 12 hr, no treatment, duration 48+ hr), soreness/pain at left armpit and groin (onset around 12hr, treated with Tylenol and Advil, duration 48+ hr)
Redness & swelling to injection site, reported by step mom, no pain, no itching.
I had the shot when it first. Amen out. I now need it again,because I got them Aug 26 of last yr./ suspected vaccination failure; I had the shot when it first. Amen out. I now need it again,because I got them Aug 26 of last yr./ suspected vaccination failure; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2020, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient said he/she needed the vaccine again, because patient got Shingles on 26th August 2020.  No vacation or nothing along with the epidemic of covid.  The patient was stuck in the house ,like a house plant. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case has been linked with US2021AMR104380 and US2021AMR104377, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104377:same reporter (1st folks case) US-GLAXOSMITHKLINE-US2021AMR104380:same repoter (2nd folks case)
Muscle pain (back. arms. legs), skin pain/sensitivity, headache, fatigue, malaise, swollen lymph nodes (all moderate to severe, unable to work)
Swollen - red flu shot site, nauseous, dizziness, hives, hoarseness voice, itchy throat, paleness, weak, elevated blood pressure and fast heartbeat.
Vigorous reaction due to inappropriate dosing (15 jabs for immunologically naive patient), resulting in satellite lesions forming.  Initiated antibiotic for bacterial prophylaxis and NSAID for analgesia.
main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; has kept her up nights three nights; vision was double; fatigue; Arm soreness; This is a spontaneous report from a contactable consumer (patient).  A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Mar2021 (at the age of 42-years-old; not pregnant), at 10:00 AM (Lot Number: ER2613) as a single dose in the left arm for COVID-19 immunisation.  Medical history included eosinophilic oesophagitis and known allergies: sulfa drugs both from an unknown date and unknown if ongoing. Concomitant medications included finasteride (PROPECIA), lorazepam (ATIVAN) and fluticasone propionate (FLOVENT (reported as FLOVENT 200)); all taken from an unspecified date for an unspecified indication. On 18Mar2021 at 5:00 PM, the patient reported that the main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise and has kept her up nights three nights since vaccine. After the dose, the patient's vision was double, but she thought it was just because of fatigue. Patient also reported that arm soreness was going away. No treatment was received by the patient for the reported adverse events. Post vaccination COVID test: polymerase chain reaction (PCR) COVID test/ nasal swab was conducted on 18Mar2021 and the result was negative. The outcome of the event "arm soreness" was recovering and not recovered for all other events.  No follow up attempts are needed. No further information is expected.
PATIENT WAS 14 YEARS OLD AND RECEIVED COMIRNITY 10MCG/0.2ML DOSE. NO ADVERSE OUTCOMES HAVE BEEN DOCUMENTED
pt recvd vax 12FEB93 & exp Bell's Palsy-like sx (numbness & swelling on 1 side of face); pt was seen by MD;
Sudden onset severe depressive episode (no history of depression) starting 2 days after receiving the vaccine (3/12/21) which have been ongoing since then. Starting 3 days ago began having paranoid delusions (3/28/21-today). Frequently crying with no life stressors. Severe insomnia (a few hours of sleep in the past 5 days). Cataract surgery on 3/30/21, started experiencing feelings of hopelessness. Symptoms have been accompanied by poor appetite, intermittent dizziness over the past 2 weeks. PCP believes they may be related to vaccine.
Information has been received from a physician concerning a 30 year old male patient with a history of hepatitis C who on 3/16/04 was vaccinated with a dose of varicella virus vaccine live (lot # 646533/0830N). On 4/1/04, the patient appeared with break through chicken pox. Unspecified medical attention was sought. On 4/5/04, the reporter stated the patient has several health issues and is currently hospitalized. The reporter noted the patient was not hospitalized because of chicken pox, nor hepatitis C. A product quality complaint was not involved. Additional information has been requested. Follow Up: On 07apr2004, the patient recovered from chickenpox. Subsequently, the patient was discharged. A product quality complaint was not involved. Additional information is not available.
Seemed to reactivate my polymyalgia rheumatica autoimmune; Seemed to reactivate my polymyalgia rheumatica autoimmune; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3180), via an unspecified route of administration, administered in right arm on 30Jul2021 18:30 (at 65 years old) as dose 1, single for COVID-19 immunization. Medical history included polymyalgia rheumatica, and allergies to fluorquinolone family of antibiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. The patient previously took erythromycin, sulfamethoxazole, and levofloxacin and experienced drug allergy. On 31Jul2021, the patient reported muscle pain and reported that the vaccine seemed to reactivate her polymyalgia rheumatica autoimmune. There were no treatments received for the events. The outcome of the events was not recovered.   Follow-up attempts are completed, No further information is expected.
Left thigh is 15x15 area of redness, swelling, itching and painful.
12/11/2009 Admitted to the hospital with meningococcal bacteremia and pneumonia.
pt given anthrax vaccine 02 Jun 08 left deltoid SQ.  pt started experiencing an swelling and an outbreak of lesions on his lower face and neck on 05 Jun 08.  pt went to ER 08Jun08.  pt was Rx benadryl, cleocin, and bacitracin.  Pt was seen at Clinic 09 Jun 08.  Dr. referred pt to Allergy clinic.
CHILD BECAME DIZZY THEN FAINTED WITH LIKE A SEIZURE. DEVELOPED A HEADACHE AND RASH THAT DAY. WAS DIZZY ON AND OFF SEVERAL DAYS AFTER INJECTION.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis. The patient had no known allergies. The patient was not ever diagnosed or tested with COVID. No medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination for each condition. The patient had not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone temperature excursion from the day they received the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vial undergo temperature excursions). No concomitant medications was reported. The temperature excursion from the day they received the vaccine on the 24Jun2022 until 24Aug2022, because their freezer was not acceptable according to the local authority, they do not know a what temperature the vials were because they did not have DDT. They had administer 4 doses out of a 100 doses. The vial was stored at frozen storage at the time of the excursion. It was unknown, if the vial reached maximum or minimum temperatures. The vial was not moved from freezer to refrigerator. Not found any visual inspection any vaccine state change. 96 doses of vials or doses were impacted. No adverse event cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). No treatment drug details was reported.
NEUROPATHY 4/19/2023 ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI 4/21/2023 ACUTE NON ST ELEVATION MI NEUROPATHY 4/19/2023 ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI 4/21/2023 ACUTE NON ST ELEVATION MI
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 12Mar2021 as dose 1, single (Lot number: En6208), in right arm, on 02Apr2021 as dose 2, single (Lot number: Er8732), in right arm and on 04Nov2021 as dose 3 (booster), single (Lot number: Fg3527) at the age of 28 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: clindamycin, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid to treat vaccination failure, covid-19. Treatment start date: 22Jun2022, stop date: 26Jun2022.
"loopy" - counting backwards on a game board; using wrong words at time in sentences; sleep for one day
Developed intense chills that caused shaking around midnight after receiving vaccine. Took temperature and it was 100.1 F. Also felt nauseous and had a headache. Worst of the symptoms lasted for about 7 hours.
Pt. developed pallor, thready pulses, tachycardia about 10 mins. after injection. Resolved with treatment in 15 min.
6 straight hours of crying since injection not ill and afebrile, swollen left leg.
This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On 05-FEB-2016, the patients were administered improperly stored doses, by a time from of an hour and 30 minutes with a temperature of 57F, of VAQTA (Lot#, L034381, expiration date 21-DEC-2016; Lot# L030442, expiration date 19-DEC-2016; Lot# L014068, expiration date 02-NOV-2017). No adverse effect reported. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
Taste of vaccine in mouth; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (Taste of vaccine in mouth) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced TASTE DISORDER (Taste of vaccine in mouth). At the time of the report, TASTE DISORDER (Taste of vaccine in mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
Swelling and redness in left & right deltoid and mild fever. Went to ED, seen and released with Cephalexin.
Associate administering the vaccine accidently stuck her left pointer finger after administration of the vaccine when attempting to close the needle safety device. She drew blood.
Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation area when she started to experience a racing heart-rate and warmth. The patient was brought water, juice, and tried to relax. Patient was stable but after drinking juice started to feel swelling of the tongue and itching around the neck. Patient was given more water and a diphenhydramine capsule. Tongue swelling and itchiness decreased and the patient went home with her husband after improving. Total course of observed reaction was around 1 hour.
Spotting occurred hours after vaccination. Including blood clots. I am on week 1 of the pill period is not due for another 3 weeks. Menstrual cramping also present. Spotting has increased over the hours.
Morphea from just below inner elbow to vaccine insertion sight. Appeared about two weeks after the second dose. Went to the dermatologist today for unrelated reasons and showed her the morphea. She told me what it was. It can be caused by illnesses or vaccinations so wondering if the COVID-19 vaccination triggered it.
Flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms for one day following dose of vaccine. The reporter did not agree to follow up with GlaxoSmithKline.
Received vaccine at medical 4/13/2022 @ 845 am  At 4:50 pm on 4/13/2022 broke out with rash over over most of my body. Itchy and very warm to touch.  Took 50 mg of Benadryl. Continued Benadryl every 4 hours and rash just did get better. Drive to Hospital ER was seen in ER and diagnosed with Allergic reaction to COVID 19 Vaccine. Was prescribed Prednisone, ZyrTec and Pepcid. Was discharged and not admitted.
Patient admitted to hospital for nausea, vomiting, and diarrhea due to Covid.  She also had body aches, weakness, and sinus congestion.
Patient needed new card made to show her doctors.  I asked if she had any boosters or just the primary series to make the replacement card.  She said just the primary series cause after the 2nd dose she had vision problems less then 30 days out.  On 5/23/21 she woke up with grey vision in the middle of her eye on the right side.  She said her peripheral vision was okay but the middle was blurry to the point that she couldn't see the stop sign when driving later that morning.  She did say her mother had vision problems also and feels that the shot may have exacerbated any vision problems to happen.
BRUISING ON RING FINGER AND BOTH INNER THIGHS APPROXIMATELY 24 HOURS AFTER VACCINATION AND LASTING FOR 3-4 DAYS
Information has been received from a healthcare worker concerning a 12 or 13 year old female patient with no relative medical history, drug reactions or allergies who in January 2009, was vaccinated IM with her second dose of 0.5 ml GARDASIL (lot number, site and route not reported). The date of the first dose was not available. There was no concomitant medication. The patient became pale and dizzy after the second dose. On an unspecified date, the patient recovered from pale and dizzy. The patient had sought medical attention in physician's office. Follow-up information was received from a certified medical assistant who reported that he didn't know the patient's name or date of birth or the date that the patient received the first dose. On 22-JAN-2009 the patient was given the second dose of GARDASIL (lot number 661764/0650X). It was reported that no other vaccines were given to the patient that day. On 22-JAN-2009, after the patient was given the vaccine, she became pale and dizzy with no syncope. At this report time, the patient recovered. No further information was reported.