chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was given a dose of a Moderna booster shot that was drawn from a recently expired vial. The manufacturer was contacted regarding this event. We are not aware of any adverse outcomes.
On 04/24/21 I did a telehealth visit because I thought I had a UTI and got antibiotics for it. On 04/26/21 in the early am, I woke up with a fever, and I had another telehealth visit which ultimately lead to me being diagnosed with Shingles. I went to the immediate care center later that same day (diagnosed with shingles) and, again on the 27th, where they wanted a urine sample but I was unable to provide one. I was sent to the ER where they gave me a catheter (diagnosed with neurogenic bladder). I was unable to urinate without a catheter for the next few weeks and after about 3 weeks total, it resolved.
Nausea beginning after shot and continuing over 24 hours afterward; Chills; Fatigue and brain fog; Repeated panic attacks and emotional distress
Tongue swelling a bit. Postules formed. Bumps all over tongue. No fever or other symptoms
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 15-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax; soreness in deltoid after injection; had bursitis type pain and limited ROM; improving slowly
Received 2nd dose of Moderna CoVid19 Booster shot on left arm on April 24, 2022 at 12:55pm.  Sore pain on poke area started to be felt together with back muscle pain, joint area and lower legs areas by about 8:00pm of April2 24, 2022.  Took 1-cap Acetaminophen at bedtime 10:30pm.  The next day, April 25, 2022 more severe pain was felt on the same areas restricting usual daily home activities.  Took 1-cap of Acetaminophen at 11:00am.  Towards the evening, pain still existed, took another 1-cap Acetaminophen at 6pm.  Reddish spots were starting to appear along neckline, armpits, groin, legs and poke areas.  Upon wakeup of April 26, 2022, noticed more red spots on skin and muscle pains gone except with poke area, took 1-cap Benadryl Antihistamine. at bedtime.  Upon Wakeup on Apri27, 2022, more red spots appear on skin below arms, legs (upper and lower), took 1-cap Benadryl for allergy.  As of this writing reddish spots become more prominent on areas mentioned.
Severe headaches, photosensitivity, severe joint & muscle aches, dizziness, very low BP necessitating holding of BP meds for several days despite adequate hydration, chills, body rash, palpitations and cardiac rhythm gallops, balance disturbances and requiring assistance to negotiate stairs, nausea. pain did not respond to ibuprofen at all.
Patient felt nauseous, sweaty and fainted with severe stiffness. Patient stopped breathing during this event. Patient woke up with confusion and had fatigue for the rest of the day followed by a fever.
pt recv vax & exp swollen lump on the arm;lump appeared around the site of the inj & was described to be a size of an egg;it was swollen & pt c/o painful when touched;
I felt like I had the flu; My head was pounding; Neck hurt; Face and ears hurt; Face and ears hurt; Joints were terrible; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Mar2021 09:45 (at the age of 72-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included diabetes. The patient had known allergies to penicillin, SUDAFED (pseudoephedrine hydrochloride), aspartame, caffeine, FLEXERIL (cyclobenzaprine hydrochloride), bentyl, morphine, minocin, diprivan, belladonna, coated paracetamol (TYLENOL), zantac, progesterone, apples, lactose intolerant, chocolate, mayonnaise, water. Concomitant medications included cetirizine hydrochloride (ZYRTEC); glimepiride; ergocalciferol (VIT D), all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient felt like she had the flu, her head was pounding and had neck hurt, face and ears hurt, reported that joints were terrible, and was dizzy as soon as the burning needle went in and lasted for about 4 hours on 02Mar2021 09:45. The patient reported that the serum was in her arm and didn't move for a long time (as reported). The patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Arm pain; Neck pain; Back pain; Shoulder pain; Headache; Nausea; Vomiting; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), NECK PAIN (Neck pain), BACK PAIN (Back pain), ARTHRALGIA (Shoulder pain) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-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 (Arm pain), NECK PAIN (Neck pain), BACK PAIN (Back pain), ARTHRALGIA (Shoulder pain), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm pain), NECK PAIN (Neck pain), BACK PAIN (Back pain), ARTHRALGIA (Shoulder pain), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Per EMS/Hospital report patient had difficulty breathing and cardiac arrest with prolonged CPR (greater than 45 mins in the ER) who was resuscitated.  Family subsequently arrived including son and daughter and all family members were in the ER room are in agreement that patient would not want further aggressive cares given her extremely poor prognosis in light of chronic debilitation with numerous medical issues and now a very long period of CPR.   Hospital Course After updating family they stated patient would not want further aggressive cares given her grim prognosis and chronic severe and debilitating medical issues.  She continued to have myoclonic jerking.  She was extubated to comfort cares in the ER and did not pass immediately therefore brought to a room.  She received comfort cares and passed away at 0450 with family present.
Information has been received from a 23 year old male who in January 2011, was vaccinated with GARDASIL and received his second dose in March 2011, the patient had symptoms of muscle aches starting January 2011 sometime after the first dose of GARDASIL. Prior to receiving his second dose of GARDASIL, blood was drawn and tested for Lymes disease. It came back positive. The patient was being treated with doxycycline (manufacturer unknown) 100mg twice daily for 21 days. There were no other adverse events reported. The patient had discussed with physician. At the time of the report, the patient's status was not recovered. The follow up information has been received from the consumer who had performed Lymes test positive/Elisa test positive; Western IGG antibody positive (Band 41 and Band 34); IGM positive (Band 41 and Band 34) on unspecified day. At the time of the report, the patient's status was unknown. Additional information has been requested.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown demographics. The patients' current condition, historical condition, historical drug, drug allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (strength, dose, unit, route and frequency not reported) (Lot#: N021171, Expiration Date: 11/01/2018) and PROQUAD (strength, dose, unit, route and frequency not reported) (Lot#: N024563, Expiration Date: 06-MAR-2019), (Lot#: N025718, Expiration Date: 17-MAR-2019) (Lot#: N023965, Expiration Date: 28-FEB-2019) and VARIVAX (strength, dose, unit, route and frequency not reported) (Lot#: N020015, Expiration Date: 17-JUL-2019), (Lot#: N020014, Expiration Date: 17-JUL-2019), (Lot#: N024566, Expiration Date: 07-SEP-2019) as prophylaxis which. No adverse effects reported. STERILE DILUENT used for reconstitution of all products was properly stored. Temperature & Timeframe was reported as 6 Fahrenheit to 14 Fahrenheit for 4 hours and 15 minutes and 15 Fahrenheit to 46 Fahrenheit for 1 hour 45 minutes. It was reported there was a previous temperature excursion. No product quality compliant (PQC) was reported.
8/2/21: The is a 70 year old female that came to the emergency room on 8/2/2021 complaining of coughing and shortness of breath.  She has had signs of an upper respiratory infection sore throat then followed by a non productive cough for the last week. Her oxygen level was 90% u[on arrival and 3 Liters of O2 was stated.  8/7/21: completed remdesivir, on baricitinib; on heated-high flow 90% 60L supplemental O2 8/16/21: She was discharged home with 4L oxygen and home healthcare.  Note: patient previously vaccinated with J&J COVID-19 vaccine on 3/22/2021  Lot Number 1805029.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-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 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID-19 treatment with Paxlovid from 26Jul2022 till 31Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested as part of f/u surveillance from known exposure- asymptomatic- tested positive on binax rapid antigen 9/9/2022 Patient has had primary series plus 2 boosters, all Moderna- due for bivalent booster
Patient said arm started hurting and she felt really bad and had fever on 1/23/2019. Patient called me the morning of 1/24/2019. Patient said her right arm hurt badly down to her elbow and also had a rash that ran down to her elbow which she noticed the morning of 1/24/2019. On the evening of 1/24/2019 she said her arm was really red and hot and she was feeling bad. On 1/25/2019 she said about 1/2 of the rash was gone after she said she applied alcohol on the rash. She was feeling better.
7PM cold chills (severe) inject site is hard up into arm pit area & is painful;
Pt. complains of soreness, redness and "hives-like" bumps around injection site, (L) arm, since yesterday (9/27/11). Pt. received injection on 9/26/11. Pt. advised to contact primary care provider.
Client states that it started off just a little red, but now is an area about the size of the palm of her hand, it is hot to the touch and has a hard welted area in center. Client states it is very painful to touch. Advised client to apply cold compress to the area and if symptoms worsen to follow up with physician for evaluation.
Slight pain around the injection site. 2nd dose resulted into mild fever for 1 day. Body ache for 2 days, headache for 2 days.
Information has been received from a physician concerning a 12 month old patient who on 05-NOV-2010 was vaccinated with 1/2 dose of ZOSTAVAX (Merck) injection instead of VARIVAX (Merck) accidentally by a student nurse on the left arm. The patient was not experiencing any known symptoms. Follow up information has been received from the physician. The physician stated that the child had not experienced any problems since ZOSTAVAX (Merck) (lot# 665521/1226Y) was administered. The physician stated that he felt the mix up was due to the labels being too small and the names of the vaccines were too easy to confuse with one another. No additional information is expected.
fever 103, shaking for 30 mins, no tonic clonic activity; teeth grinding;
A patient received an expired dose of Quadracel, no AE; Initial information received on 22-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4 years old male patient who received an expired 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot: C5497AA, expiry date: 17-Jul-2020) once via an intramuscular route in the right leg for prophylactic vaccination on 22-Jul-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) which were given on 22-Jul-2020 for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Potential Moderna vaccine administration error; potential Moderna administered in error to a 12 year old female. Vaccination card states Moderna, but nurse is unsure if patient actually received Moderna or wrote down Moderna in error. Patient experienced mild arm soreness, but no other symptoms. Mother was upset when notified. Advised to notify if any new symptoms occurred and to recognize any symptoms requiring emergent care. Ramifications are being handled internally.
Within 24 hours I experienced left shoulder pain. (Rotator cuff). Several visits to primary care, x-rays, MRI, medication for pain, physical therapy and scheduled for treatment with surgeon orthopedic.
No events in the office. Pt had syncope episode at home about 18 hours after the immunization.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Woke up the day after with pain in my right arm, became very tired, muscle aches, headaches, chills and low grade fever.
Injection site was red and swollen and sore by 7 PM the night of injection. 6 AM the next morning Friday the fifth, severe bodyaches, headache, fatigue, fever up to 101.8°. Saturday morning,6th, I?ll symptoms resolved except, left arm pit/axillary swollen (tennis ball size) and painful to touch. Likely swollen lymph nodes. No imaging done to confirm.
Immediate deltoid muscle spasm and soreness.  16hrs- chills no fever 24hrs- extreme r shoulder pain only if touching skin - moving only felt like bad muscle soreness. But touching skin was externally bad strange nerve type lightning pain. No pain if still and not touching.  Nerve pain lasted about 6 hours. Also had headache off and on  Back to normal around 36 hours
Symptoms started on 8/10/2021 with chills, runny nose, fatigue.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 [reported as "shortly after" receiving ZOSTAVAX], the patient developed headaches, painful rashes on both her legs and waist, along with a reduction in her eyesight. Thereafter, the patient presented to her primary care group and was diagnosed with shingles. As a direct and proximate result of these malfunctions, 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. The outcome of the events is unknown.  Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of injection site pain in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 23 December 2010 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, unknown arm). On 26 December 2010, 3 days after vaccination with BOOSTRIX, the subject spoke of injection site pain in the shoulder where the injection was given. It was noted that the pain may have started prior to 26 December 2010. The subject visit her physician in regards to the pain. At the time of reporting, the pain was unresolved and the subject was receiving ibuprofen for relief. In the reporting nurse's opinion, the subject needed something stronger for her pain. They were speculating if the pain was due to neuritis related to tetanus immunization. The subject was treated with ibuprofen. At the time of reporting the events were unresolved.
mild rash-very limp-over a weeks time legs became like two stiff sticks; pt just started to crawl @ 10months/not on knees;
Covid Vaccine expired per 10 week rule (refrigerator storage) on 6/16/2022 at the end of the day. Staff administered expired vaccine. Information relayed to patient's mother. Waited 15 minutes after administration. Patient not having adverse reaction at the time of leaving clinic.
Left sided numbness/ weakness/ muscle twitching/ presyncope/ lower extremity weakness/ ADEM.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was a 59 yo female with secondary progressive MS. She was found dead in her home on 4/12/21 with no definitive cause of death reported to the agency. On 4/6/21 she was reached about receiving her second COVID-19 dose but could not come in due to her being "sick" with an undetermined illness. Her other comorbidities were primarily related to symptoms of MS including dysphagia, bladder dysfunction, and constipation. She also required a scooter for any walking.
8:57 am Patient had complaints of increased heart rate. 9:00 Vitals pulse 84, R 20, BP 140/78. Patient was give water to drink. 9:30 am Observed for additional 15 minutes, patient feeling better upon leaving.