chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    No relevant concomitant medications were reported.  It was also reported that there was potentially a second lot number that was expired on 28 Feb 2023 and was administered to patients on 3 Mar 2023, but HCP did not had any details on that event at that time. The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Note: Second shot was administered on December 15th,  2020, approximately 10 weeks after first shot.  About a week after first shot on September 28, 2020, I had an acute onset of tinnitus. I've never had persistent ringing in my ears before. Symptoms waxed and waned in the following weeks, largely subsiding by the time of the second shot. About five days after second shot, symptoms started ticking up again. Noticed that symptoms can be worse after eating. Might be some stomach/inner ear nerve correlation, since there is some gut pain/inflammation after shots for a few days?   Went to doctor about 10 days after first onset. No inner ear infection. I told her that it was hardly noticeable that day and that melatonin the night before might have helped. Recommended I continue taking melatonin and follow up if symptoms persist. Have not been back to doctor since symptoms were slowly disappearing.  It's been about a week since second shot. Will see if symptoms subside in next few weeks as with first shot. Will visit primary physician or ENT specialist if symptoms persist. I filed similar report with GlaxoSmithKline on this day, December 21, 2020.  I've never had any issues or similar symptoms with other vaccine shots, i.e. yearly flu shots.
Sedation diaphoresis Per ER report, effects were most likely not due to his vaccine, other causes.
Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown that patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023).    No concomitant medication details was reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not have any details on this event at this time. The second potential lot was confirmed to not be used.   No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Initial report was received on 29 May 2012 from an electronic lay press article. A 19-year-old female had received an injection of MENINGOCOCCAL VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time developed meningococcal meningitis. The patient was taken to the hospital on 25 May 2012 and died on 26 May 2012. No further information was available at the time of the report. The patient's outcome was fatal. Documents held by sender: None.
Approx 2 hrs p/DTP/OPV, had abdominal pain, emesis then fainted & was then unresponsive for 30 secs w/circumoral pallor, recovered quickly;
Severe Tics resembling Tourettes.  He 10-30 tics per minute.  He did not have these symptoms at all before the vaccine.
woke up sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (woke up sweating) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (woke up sweating). At the time of the report, HYPERHIDROSIS (woke up sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
02/03/2021: face blotches and chapped skin began and continue 02/05/2021: 12:30 PM nausea; starting 5PM and throughout entire night: intense pain in both thighs, intensified menstrual cramps that brought me to tears, extreme cold, head pressure, little sleep 02/06/2021: All day and throughout night: bad headache, achy, fatigue, chills, intensified menstrual cramps (ex: active labor pains), thigh pain (myalgia), unable to sleep due to body cramping 02/07/2021: All day: dizzy, cold extremities, weakness, thigh pain 02/08/2021: All day: fatigue 02/09/2021: All day: fatigue, eyes burn, waves of heat like a fever, headache 02/10/2021: All day: fatigue, eyes burn, headache
TONGUE AND LIPS STARTED TINGLING AND GOING NUMB, FELT LIKE TONGUE WAS GETTING THICK AND THROAT WAS CLOSING.   STATED THAT IT HAPPENED ALMOST IMMEDIATELY AFTER VACCINE.   GAVE BENADRYL 50MG IM  LEFT DELTOID AT 9:19 AM.
Per internal reported event: Received the following information from patient via email to Dr.: "Yesterday morning at about 7:20am, I received my first dose of the Moderna COVID vaccine at Hospital. I waited 15 minutes in the lobby, felt fine, and left.  While I was still driving, about 7:45am, I noticed that it had become difficult to swallow.  My throat felt swollen.   I decided to stay close to the hospital, and ended up driving to Pharmacy and taking 50 mg benedryl and 400 mg ibuprofen at 8:00am.  I called my primary care provider and left a message, and decided to go to work (started at 9am). I took another 50 mg of benedryl at noon.  My provider called me early in the afternoon, and was unable to give me advice.  He recommended contacting Hospital (vaccine clinic).  I experienced chills in the afternoon, and after I left work at 3pm, I took another 400 mg of ibuprofen, a hot shower, and slept for 3 hours.  I felt much better after the nap.  I reported all of this to the CDC yesterday afternoon through their "check-in" feature."
This spontaneous report was received from a nurse prescriber (also reported as nurse practitioner) concerning a multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with a dose improperly stored of VARIVAX (dose and route were not reported) lot # M005972 with expiration date 02-FEB-2016, which was stored at 8.6 Fahrenheit Degrees for 1 minute, 6.5 for 1 minute and 47 Fahrenheit Degrees for 1 hour and 40 minutes. The temperature excursion was detected with a data logger. There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
upon returning to work, pt phone office to report feeling of nausea, dizziness & inc heart rate;was kept on line & transferred to PAC to advise
cramping Narrative:  He reports having developed diffuse pruritus, rash, and abdominal/bilateral LE cramping after the first vaccination in this series. -Itching started the next day, experienced from the waist down. The following day, his  entire body was affected. This was worst for the next 2-3 days and lasted for 5 in  total. He took benadryl, which helped somewhat with the itchiness, but also caused drowsiness ("It knocked me out."). He tried to apply a topical steroid, but the area was too diffuse and there was only temporary relief over the applied  areas. -Rash described as diffuse, erythematous, warm to touch and patchy. No  swelling, urticaria, hives, sloughing. This started the night after vaccination and  affected the lower half of his body only. Similar to the pruritus - the rash was the  worst for the following 2-3 days and lasted for about 5 days in total. - Abdominal/bilateral LE cramping: worse than baseline cramping, states onset was  24-48 hours post vaccination and lasted for 2 days. He took his routine pain medication and achieved some relief.
Ringing in ears upon waking up the morning after adminstration, tinnitus.  Patient was treated with Benadryl and Antivert
neurosurgeon who received the Pfizer COVID-19 vaccine died immediately after administration; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number unknown, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient neurosurgeon who received the Pfizer COVID-19 vaccine died immediately after administration on an unspecified date. The patient died on an unspecified date. The cause of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about the lot/batch number could not be obtained. No further information is expected.; Reported Cause(s) of Death: neurosurgeon who received the Pfizer COVID 19 vaccine and died immediately after administration
S/s - headache, fever (101.0 at highest), lethargy shortness of breath, chest pain/heaviness lasting 2.5 days. No treatment given (advised to go to ER, but didn't comply).
Cold feeling in left calf; Pain in vein of left calf; Swelling on right side of face, especially eye.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold feeling in left calf), PAIN IN EXTREMITY (Pain in vein of left calf) and SWELLING FACE (Swelling on right side of face, especially eye.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced SWELLING FACE (Swelling on right side of face, especially eye.). On 09-Apr-2021, the patient experienced FEELING COLD (Cold feeling in left calf) and PAIN IN EXTREMITY (Pain in vein of left calf). At the time of the report, FEELING COLD (Cold feeling in left calf), PAIN IN EXTREMITY (Pain in vein of left calf) and SWELLING FACE (Swelling on right side of face, especially eye.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
When she got the shot she had some soreness but it went away quickly. A few days later her shoulder started to "act up". She had tendonitis in the past. A week later she had a muscle spasm in the other arm that was extremely painful. She almost went to the ER but then went away after 2 hours. The arm she had the shot in she has had lots of pain. She had very limited range of motion, unable to put on her shirt or deodorant. She went to an orthopedic physician group about the second week in October and the physician assistant thought she had torn a bicep tendon. It hurts in the front of the shoulder and when she moves her arm forward. She started physical therapy on 10/19/09. The pain keeps her up at night.
Two weeks following her first Pfizer injection, patient developed hypertension (up to 158/92, her normal bp is 110s/70s), chest pressure and new-onset arrhythmias found on ECG and Holter monitor to be PVCs.  The symptoms are improving now 1.5 months after symptom onset, but haven't resolved.
had a procedure done and had anesthetics and IV; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (had a procedure done and had anesthetics and IV) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Anesthesia on 09-Sep-2021 and IV flush on 09-Sep-2021.   On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SURGERY (had a procedure done and had anesthetics and IV). The patient was treated with PREDNISONE at a dose of 50 mg. At the time of the report, SURGERY (had a procedure done and had anesthetics and IV) outcome was unknown.            No concomitant medications were reported.
Received HPV and Td 6/21/13 - Rash started 6/22/13. Hives - red, blotchy, itchy and spreading.
On the night of 6/29/21, developed hives in random places on abdomen, back, legs, backs of arms. Applied calamine lotion and hives were gone in the morning.
pT WAS GIVEN VACCINE. sHE STAYED IN THE PHARMACY AREA 15 MINUTES. SHE WENT SHOPPING AND CAME BACK ABOUT 20-25 MUNITES LATES STATING SHE HAD A PAIN IN HER LEFT JAW RADIATING UP TO THE LEFT TEMPLE(EYE). i ASKED HER ALL THE WUESTIONS,. SHE DID NOT HAVE SWELLING OF FACE MOUTH OR TONGUE NO DIFFICULTY BREATHING. SHE DID NOT WANT BENADRYL. I GAVE HER ACETAMINOPHEN 500MG. SHE STAYED IN BOOTH FOR 15 MINUTES WITH TECHNICIAN WATCHING HER.I CHECKED OFTEN AND WAS=FEELING BETTER EACH TIME. WHILE IN THE BOOTH SHE SHARED ALL THIS INFORMATION WITH TECHNICIAN ABOUT UNFILLED CAVITIES IN HER MOUTH AND IT COULD HAVE BEEN FORM THAT. AFTER SHE LEFT ANOTHER TECHNICIAN MENITONED THAT SHE WAS VERY NEEDY ON HER FIRST VISIT. BOTH TECHNICIANS ON DUTY FELT SHE WAS MAKING IT UP FOR ATTENTION
Felt itchy all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Felt itchy all over) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Heart disorder. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (Felt itchy all over). At the time of the report, PRURITUS (Felt itchy all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included cholesterol medication, blood thinners and heart medicine.  Treatment information included unspecified lotion and rubbing alcohol.   This case was linked to MOD-2021-018473 (Patient Link).
Patient received vaccines in consultation room. Upon walking out of the vaccination room the patient fainted to the ground. She came to (became responsive) within a minute or so. Did not stop breathing.  Upon asking her if she was okay she said she was nauseous. Paramedics were called to check the patient out. No other treatment was given from rite aid staff except for something to settle her stomach- water and crackers. Patient was able to leave the store within 15-30 minutes unassisted. No issues as we could tell. Called patient next day to see how she was doing. Mom of the patient said she was doing fine was just tired.
I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies penicillin" (unspecified if ongoing). Concomitant medication(s) included: LATANAPROST, start date: Mar2014, stop date: May2022. Vaccination history included: Covid-19 vaccine (Primary immunization completed.), for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 29Apr2022, outcome "not recovered" and all described as "I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive; (04May2022) Negative, notes: I completed the full course of treatment and tested negative; (08May2022) Positive, notes: I tested positive for Covid again but do not have any symptoms yet,. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Other medication in 2 weeks was Yes. Anti viral details:product=COVID 19 Treatment, brand=Paxlovid, treatment start date was 29Apr2022,treatment stop date was 04May2022,indication was treatment of COVID-19.I tested positive for Covid on the morning of 29Apr2022 and started Paxlovid that evening. my symptoms of fever, scratchy throat, and fatigue lasted until 01May2022. I completed the full course of treatment and tested negative for Covid on 04May2022. On 08May2022 I tested positive for Covid again but do not have any symptoms yet. Adverse event start date was 08May2022. Adverse event start time was 06:00 PM . If patient recovered was not recovered. If treatment ae was no  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient claims soreness on injection site. Patient says soreness still persists up to today's date.
Provided second dose of Pfizer vaccine too early. Dose # 1 given 8/18/21 and this second dose was given on day 13.
pt became weak & faint like sx followed by nausea & vomiting; EMT services were @ clinic site applied 02 PRN;
General edema, erythema at site, 3 X size of lt thigh. Pt unable to bear weight, firmness, heat (induration) intermittently X 3 days per moms report
COVID-19 symptoms; Body Ache; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID-19 symptoms), MYALGIA (Body Ache) and HEADACHE (Headache) 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 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID-19 symptoms), MYALGIA (Body Ache) and HEADACHE (Headache). At the time of the report, SUSPECTED COVID-19 (COVID-19 symptoms), MYALGIA (Body Ache) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
ARM EXTREMELY SORE, REDNESS AT INJECTION SITE THAN HAS SPREAD DOWN THE ARM OVER THE WEEKEND. PT TOOK 400MG IBUPROFEN IMMEDIEATELY AND 2 650MG APAP.
Swelling, redness, and heat at the injection site - 4 days.  Headache within first hour that lasted about 6 hours. Slight nausea that dissipated overnight.  Stiff neck for 2 days that appeared overnight.  Sore muscles and joints the following day lasting 2 days.   Tiredness.    Took Ibuprofen and rested at home.