chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Residences who received Moderna vaccine contracted COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Residences who received Moderna vaccine contracted COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Residences who received Moderna vaccine contracted COVID-19). At the time of the report, COVID-19 (Residences who received Moderna vaccine contracted COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details were not provided. This is spontaneous case concerning patients with unknown medical history, who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred after an unknown dose number of mRNA 1273. Reporter states that a group of nursing home facility residents were diagnosed with COVID 19 after being vaccinated. This case has no identifiers or valid patient for all standards, and so, invalid.   The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is spontaneous case concerning patients with unknown medical history, who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred after an unknown dose number of mRNA 1273. Reporter states that a group of nursing home facility residents were diagnosed with COVID 19 after being vaccinated. This case has no identifiers or valid patient for all standards, and so, invalid.   The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medication was provided. 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of august to middle of October 2022. No treatment medication was reported.   This case involved information about the patient 20.   This case was linked to US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662859, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662863, US-MODERNATX, INC.-MOD-2022-662865, US-MODERNATX, INC.-MOD-2022-662869, US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662873, US-MODERNATX, INC.-MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662876, US-MODERNATX, INC.-MOD-2022-662879, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-662958, US-MODERNATX, INC.-MOD-2022-662995, US-MODERNATX, INC.-MOD-2022-663011, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-663014 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662849:Patient 1 US-MODERNATX, INC.-MOD-2022-662859:Patient 2 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-662863:Patient 5 US-MODERNATX, INC.-MOD-2022-662865:Patient 6 US-MODERNATX, INC.-MOD-2022-662869:Patient 8 US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662873:Patient 10 US-MODERNATX, INC.-MOD-2022-662875:Patient 11 US-MODERNATX, INC.-MOD-2022-662876:Patient 12 US-MODERNATX, INC.-MOD-2022-662879:Patient 13 US-MODERNATX, INC.-MOD-2022-662881:Patient 14 US-MODERNATX, INC.-MOD-2022-662958:Patient 15 US-MODERNATX, INC.-MOD-2022-662995:Patient 16 US-MODERNATX, INC.-MOD-2022-663011:Patient 18 US-MODERNATX, INC.-MOD-2022-663014:Patient 19 US-MODERNATX, INC.-MOD-2022-663014:
I experienced a very large 2-3 inch wide red knot around the injection site about ten days after the vaccine. It was raised, puffy, red and itchy. It was more stingy than painful. I was told to go in to see the Doctor/nurse at the workplace clinic who wanted to look at it. They gave me a steroid injection and instructed me to get the second dose in the opposite arm. After about 3 days, the redness/swelling went away.
sudden sharp pain on left side, severe body pain especially in neck and shoulders, hot/cold flashes, migraine, headache, severe fatigue, blurry vision, skin sensitivity to touch, body aches, back pain so bad couldn't stand straight, jaw pain. currently on day 5 of symptoms. called doctor they advise to just watch symptoms
Pt awoke on 10/19/04 with fever, chills nausea and headache. Treated with Advil and Bedrest.
Information has been received from a registered nurse concerning a 5 year old female with no illnesses at the time of vaccination, who on 04-FEB-2004 was vaccinated with VARIVAX (Oka/Merck). The patient received the second dose of VARIVAX at 1:41 p.m. (Oka/Merck) (661444/0529X) on 11-AUG-2008, and two days later, on 13-AUG-2008, developed a fever and rash on her face, torso, arms and buttocks. There were no vesicles or pustules. The patient was instructed to treat with calamine lotion. Subsequently the patient recovered. Medical attention was sought at the physician office. No further information is available.
Nasal Flu Vaccine was given the full dose in one nostril (0.2ml) instead of 0.1ml given in each nostril.
Pt did not respond p/3 doses, 2 of ? Recombivax & 1 of Engerix-B; 4th & 5th doses were given using Engerix-B & still tested neg;
This spontaneous report as received from a physician refers to a 13 year old female patient. Who unknown dates in 2012 (reported as two years ago) was vaccinated with dose 1 and 2 of GARDASIL (lot number, expiration date and route were not provided) and on 29-JUL-2014 the patient received the third dose of GARDASIL. Additional information has been requested.
She started running a fever and vommiting up everything we fed her. She started screaming and crying, arching her back and thrashing her head from side to side. Nothing we did could calm her down. We gave her tylenol, tried bathing her, putting her in her swing, patting her and bouncing but nothing would calm her down. When we arrived at the Drs office on 9/27/16 the dr did an exam and a CBC. Her WBC was really high, and we were told she had an "infection". Dr sent us home with Hyosyne oral drops and new formula. The drops seemed to help a little at first, but then she started screaming and crying again.
Approx. 4-5 days post 2nd dose of Pfizer vaccine, HCW developed SOB,  bilateral ear pain, rapid pulse rate, elevated blood pressure that progressively worsened.  HCW sought treatment at an Urgent Care and was referred for further evaluation.  HCW was subsequently hospitalized for 26  hours and was diagnosed with Myocarditis and Atrial Fibrillation (A Fib).  HCW reports brief incident of AFib post Surgery in 2019.  HCW has been on PO meds for A fib and will have cardioversion on July 29,2021.
This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and unknown gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored MMR II (lot # L011528 and expiration date 03-APR-2017; lot # L012482 and expiration date 10-APR-2017 and lot # L024265 and expiration date 01-JUL-2017) (dosing details unspecified) (also reported nurse was unsure of which vaccine was administered). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 4 hours and 19 minutes. Previous temperature excursion: No. Data logger: Yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Student came to the clinic on 12-18-12 and stated that 2 days later her arm began to feel warm and pink and painful to touch. On 12-18-12 her arm (left) is still pink from armpit to just above elbow, outer aspect, small area 2 inches x 1.5 inches below site more pink & tender to touch.
Vulnerable; This is a spontaneous report from a contactable consumer (patient's daughter) or other non hcp. A 73-years-old male patient (Reporter's father) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 2021 as DOSE 2, SINGLE for covid-19 immunisation (It is about 6 months now after his second Pfizer Covid vaccination). Medical history included diabetes mellitus and heart attack (the patient has diabetes and had suffered a heart attack prior to his Covid vaccination). The patient's concomitant medications were not reported. The patient received dose 1 of bnt162b2 on an unknown date for covid-19 immunisation. The patient experienced vulnerable on an unknown date in 2021. The reporter want to enroll the patient in the Covid booster trial. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Severe fever, muscle aches, itchy eyes Fever 101.2 at 6 AM, took 500 mg Tylenol
Arm continued to hurt, thought it was just from injection but as days passed pain went up to my shoulder and within a week I couldn't raise my arm without causing severe pain.
I received an email this morning regarding a concern from a flu vaccine last October 2017. This is the first complaint received to pharmacy. She stated that she received a flu vaccine Oct 26, 2017 as well as her husband and child. She states that her arm has been hurting over the past several months and has been seeing a physician. She states he does not know what is wrong with her and suggests she see a specialist. She is a traveling individual here from another country and has 6 months of travelers insurance that ends in June and is concerned what to do medically when she needs to be seen from a doctor in the future. She states her arm continues to hurt and that she cannot get further insurance unless she has a preexisting condition from prior injury.
Muscle & bone ache throughout body, lack of energy, lack of appetite, headache, flush - increasing during the day and into the next day with fever on and off.  Treated with extra strength Tylenol every 4 hours.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information on pertinent medical history and concurrent condition was not provided. On an unknown date in 2014, the patient was vaccinated with first dose of VAQTA (dose, route, strength, lot # and expiry date not reported) for prophylaxis. On an unknown date in 2016, the patient received second dose of VAQTA. On 27-JUL-2017, the patient was vaccinated with third dose of VAQTA (lot #: N005796 and expiry date: 26-MAY-2018). The nurse stated that the third dose of VAQTA was an event related to a documentation error and was not related to product confusion. No adverse effects were reported. Outcome not provided. Additional information is not expected.
The morning following the vaccination, the patient stated the injection site itched and a welt developed under the skin. By Monday April 11, 2016, the patient stated the welt was already beginning to disappear and itching had stopped.
In late December I found two lumps on the back of my neck. I called my primary care physician who ordered an ultrasound of the lumps. I had this done on March13, 2023. the results came back inconclusive. I will be having a biopsy of the lumps on March 23, 2023.
Patient with J+J COVID vaccination who admitted to hospital with positive COVID test.  Provider discharge note below:  "Hospital Course: Obese diabetic smoker and alcohol abuser sent from alcohol rehab for hypoxemia and dyspnea; ER evaluation documented COVID PCR positive despite vaccination and booster.  ER evaluation confirmed hypoxia and imaging noted RUL lobar infiltrate suggestive of bacterial pneumonia rather than COVID pneumonia.  Patient admitted and treated for COPD exacerbation and CAP as well as possible COVID pneumonitis; patient had difficult to control blood sugars on Decadron.  Rapidly improved, weaning to room air and tolerating diet and activity.  Given his vaccinated status and his steroid induced hyperglycemia, he was not continued on his Decadron at discharge.  Patient given oral antibiotic and increased nebs and counseled on the importance of smoking cessation and alcohol abstinence to prevent further life threatening consequences of these.  He was monitored for alcohol withdrawal and treated occasionally with Ativan under the CIWA protocol.  He was reminded as to the need to wear his CPAP nightly and advised to pursue weight loss also.  He was discharged on an increased dose of metformin, but it is expected that he will probably not gain enough glycemia control on this and will need to cross over to Lantus and prandial insulin.  He was informed of the likely outcome."
Patient states the day after receiving dose two she is experiencing bilateral "shocks in both legs" from top of buttocks and down both legs anteriorly and posteriorly.  She reports pain when walking more than 100 feet.  Pain rates at 8/10 at worst and brings patient to tears.  She also reports low back pain at the same time.
Narrative:  Patient received Janssen vaccine on 03/18/2021, the patient reported right hip and buttocks pain that radiates to legs that stops at knees for one week post administration of vaccine. Patient reports taking Bayer Back and Body Aspirin (500mg). Patient also reports falling a few weeks ago and did have bruising.
30 mins post injection pt c/o "throat tightening and SOB". EMS attends. Eval and treatment by EMS. Pt transported for further eval.
I just had got a head cold. I had nasal and ear congestion with a sore throat. It was sinus congestion too. I had symptoms for about three weeks before seeing a doctor at urgent care. And another four days after seeing them. They prescribed antibiotics, I did start feeling better. I am 100 percent now.
I started to feel tired and had a headache. I also started to have diarrhea and leg cramps. I also had chills. All these symptoms were off and on. I also had cold sores that showed up here and there.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. On approximately 29-JUN-2015 (reported as "6 weeks ago"), the patient was vaccinated with first dose of GARDASIL 9 (intramuscularly, dose was not reported). The patient would receive the second dose on 08-AUG-2015. No adverse effects reported. Additional information has been requested.
Full body ache; Chills/ Shivers; Cold sweats; Headache; Mild nausea; Nasal congestion; Temperature over 103.5; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 14Apr2021 at 12:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and obesity (Obese: 282lbs, 6ft). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took cefalexin (CEPHALEXIN) and experienced drug allergy. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and tocopherol (VITAMIN E). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7534) via an unspecified route of administration in the left arm on 24Mar2021 at 12:15 as a single dose for COVID-19 immunisation. On 14Apr2021 at 20:00, the patient experienced full body ache, chills/ shivers, cold sweats, headache, mild nausea, nasal congestion and temperature over 103.5. The patient stated that he experienced shivers around 8 PM on the day of vaccination. He stated that he took some Ibuprofen, but he continued to have symptoms for over 40 hours. Therapeutic measures were taken as a result of full body ache, chills/ shivers, cold sweats, headache, mild nausea, nasal congestion and temperature over 103.5 and included treatment with Ibuprofen from an unspecified date in Apr2021 and unknown if ongoing. On 14Apr2021, the patient underwent body temperature and the result was 103.5 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the events full body ache, chills/ shivers, cold sweats, headache, mild nausea, nasal congestion and temperature over 103.5 were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information was provided. Patient age was 53 years 4 months. Beyond use date was reported as 17-Feb-2022. Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 days beyond use date. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up received: Patient information and vaccination details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Refused to stay the 15 minutes after second vaccination for Moderna. Patient was educated about the risk and side effects of the medication, and allergic reactions.
Booster COVID-19 vaccine dose given 5 months and 5 days after the second dose was administered in the primary series.
Pt recvd OPV/HIBTITER on 27OCT90, & became lethargic, irritable & had vomiting, felt warm for 3-4 days;
after 2nd vaccine got shingles/suspected vaccination failure; shingles after 2nd, shorter bought; shingles after 1st, not bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and shingles. On an unknown date, the outcome of the vaccination failure, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 01-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shingles. The patient got vaccine and then got shingles again which was not as bad. The reporter reported that then after 2nd vaccine got a shorter bought with shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Headache starting around 5-6 hours after injection and continuing through following day. Fever started around 8 hours after injection and reached 103.1 F. Nausea and vomiting in the middle of the night (around 12 hours after injection). Mild fever the following day.
Numbness in the cheeks, lips and the tongue; Numbness in the cheeks, lips and the tongue; Numbness in the cheeks, lips and the tongue; This is a spontaneous report from a contactable consumer (patient). This 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# SL3247), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history included ongoing thyroid. The patient's concomitant medications included thyroid (ARMOUR THYROID) for thyroid. Patient had a COVID 19 vaccine on 22Jan2021 and had couple of side effects with the numbness in the cheeks, lips and the tongue in Jan2021. No treatment received. Outcome of the events was unknown. No investigation assessment.
This spontaneous report as received from a medical assistant via a company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, "single 0.65 ml", "subcutaneous injection". Lot number were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that the patient who had received ZOSTAVAX, later developed Shingles (approximately in 2013), which caused patient to be in "a lot of pain." The patient visited the healthcare office with the Shingles "within the last 2 months". At the time of this report the outcome of shingles was unknown. The causality was not reported. Additional information has been requested.