chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was 1st punctured on 18-Jul-2022 at 9:30am and administered on 19-Jul-2022 at 10:28am.; Administered with vaccine from a vial punctured for more than 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for more than 24 hours) and PRODUCT STORAGE ERROR (Vial was 1st punctured on 18-Jul-2022 at 9:30am and administered on 19-Jul-2022 at 10:28am.) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2022 at 10:28 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022 at 10:28 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for more than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was 1st punctured on 18-Jul-2022 at 9:30am and administered on 19-Jul-2022 at 10:28am.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for more than 24 hours) and PRODUCT STORAGE ERROR (Vial was 1st punctured on 18-Jul-2022 at 9:30am and administered on 19-Jul-2022 at 10:28am.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Date and time vial was first punctured 18-Jul-2022 at 9:30am. Nurse in a regional health center reported that they administered a pediatric dose of the Moderna Covid-19 which had been punctured for more that 24 hours (vial was 1st punctured on 18Jul2022 at 9:30am) to a 9-month old patient on 19Jul2022 at 10:28am. Dose administered greater than 12/24 hours post puncture. It was reported that number of vials/doses was 1 dose. Post puncture vial was stored in refrigerator. Vial did not undergone any temperature excursions.
Injection site noted small knot, red raised bumps in circle around injection site size of half dollar, vomited once, diarrhea since 11AM on 03/02/2006.
aches; chills/shivering; generally not feeling well.; don't fall asleep; I have been feeling tired and like funny like a you have a cold or something/fatigue; I have been feeling tired and like funny like a you have a cold or something/cold; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 23Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable consumers (including the patient). A 70-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number and expiration date were not provided), via an unspecified route of administration on 20Dec2020 at single dose for immunization. Medical history included hot flashes. There were no concomitant medications. The patient stated that she just got the shot yesterday (20Dec2020) at the hospital she just went. Today (21Dec2020), she was feeling like a kind of funny and further described she had been feeling tired and like funny like she had a cold or something. She had a shot in the arm. It was further reported that she received the vaccine on Sunday (20Dec2020) at the hospital she works at; reported side effects of aches, chills, and generally not feeling well. She also stated tiredness and fatigue, she didn't fall asleep even if she did a night shift. For 2 days, she felt achy, chills were bad, she was cold, and was shivering, then they went away. The patient had hot flashes before, but it wasn't like that. She was having cold. Then it would go away, took a while. She had them (feeling tired, feeling cold, generally not feeling well, didn't fall asleep) since Monday (21Dec2020), then yesterday (22Dec2020), she felt the chills, aches and fatigue. The patient wanted to know how long to expect the side effects to last. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Brachial plexus neuritis - Arm burning. Pain, Lim ROM, spasms (x 2+ months). ROM exercise. Starting PT now. Oral prednisone.
p/recv vax pt exp soreness; warmth; swelling & induration at the inj site; addl information requested;
pt recvd vax & 12MAR94; no prev rxns; pt returned on 14MR93 w/ h/o urticarial rash, erythema, swellin @ hands/feet consistent w/sz sickness;
LEFT ARM PAIN WITHIN HR. 4-5 HRS AFTER VACC, HAD SEVERE HA FOR 4 DAYS UNRELIEVED BY ADVIL AND HIGH TEMP(NOT TAKEN)WITH PROFUSE DIAPHORESIS FOR 36 HRS.
Vaccine was given 1 week early. First dose was given on 7/20/21 and second dose was given on 8/3/21
Information has been received from a registered nurse concerning a patient who, 45 days ago, on approximately 21-FEB-2007, was vaccinated with varicella virus vaccine live (Oka/Merck). The patient subsequently developed a rash of greater than 50 lesions. At the time of reporting the patient had not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia.   Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.
Pt had negative reactions to previous vaccines, but the reaction to the MMR was immediate and severe. He experienced chronic (daily) vomiting, diarrhea, and gastrointestinal distress. The gastrointestinal problems continue and are unresolved other than vomiting.
Injection site pain 2 days duration; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain 2 days duration) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ATENOLOL and VITAMINS NOS for an unknown indication.    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 VACCINATION SITE PAIN (Injection site pain 2 days duration). At the time of the report, VACCINATION SITE PAIN (Injection site pain 2 days duration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
86-year-old spanish speaking female brought into the ED with concerns of slurred speech and confusion that was noted at 3 PM on 4/8.  Patient's last known well was at 10 AM on 4/8.  GCS on arrival 15.  NIH SS 2 recorded at 18: 12 (for mild right-sided facial droop and mild dysarthria).   In the EMS blood glucose was 122, no meds were given.  Patient is not on any anticoagulation.  Patient's blood pressure was elevated at 233/78.  Patient denying any headaches, nausea, vomiting.  Per the family no focal neurologic deficits noted except for dysarthria which was improved during the ED visit.   Neurology contacted in the ED for stroke code.  Patient outside of TPA window.  CT head was negative.  CT head negative for acute intracranial infarction.  Chest x-ray negative for any acute cardiopulmonary findings.  Patient was started on nicardipine drip in the ED with the blood pressure reduced to 145/70, then turned off.  CBC showed mild leukocytosis (14.8) likely reactive.  CMP unremarkable.  PT/INR was also obtained.   After discussion with neurology given the CT head and CTA head and neck, CTP negative are reassuring for low concern of stroke. ASA 325 once was given. However neurology does recommend an admission for further evaluation with an MRI for notably rule out stroke.  After discussion with family and the physicians the patient refused admission.   Upon reexamination no further worsening of her initial symptoms, blood pressure controlled.  Patient was discharged in a stable condition.  She was discharged AMA.  Patient was thoroughly explained the risks and benefits of leaving AMA.  Patient said she understood and was advised to come back if the symptoms worsen.  Patient was discharged with aspirin, Plavix and atorvastatin.  Recommended to follow-up with the PCP tomorrow soon as possible.  Also advised to return to the ED if any of the symptoms return.
At bedtime, both arms ached, slept poorly, got up several times during the night. In the morning, woke with a headache, lightheaded, dizzy, knew I would not be able to drive safely. By afternoon, felt somewhat better.
This is a spontaneous report from a contactable pharmacist. A patient of an unspecified age and ethnicity received a dose of PREVNAR 13, on unknown date at single dose for immunization. Relevant medical history and concomitant medication were not reported. On unknown date the patient experienced redness, warmness, soreness, and itchiness at the injection site after administration of vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Pfizer / BioNTech - Dose Number: 3 ... Moderna - Dose Number: 4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 at 12:00 as dose 1, single (Lot number: EJ1685), in right arm, on 04Jan2022 at 12:00 as dose 2, single (Lot number: EJ1686), in right arm and on 21Aug2022 at 12:00 as dose 3 (booster), single (Lot number: FC3181) at the age of 73 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2022 at 12:00 as dose 4 (booster), single (Lot number: 0451249), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "bronchiectasis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered", described as "Pfizer / BioNTech - Dose Number: 3 ... Moderna - Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (31Oct2022) Negative; (02Nov2022) Positive, notes: Started having rebound symptoms 02Nov and positive test again. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment was PAXLOVID. No known allergies.
pt recv vax 23FEB96 & 5MAR96 pt devel chicken pox w/approx 2 dozen lesions;the older brother devel chicken pox that same day (WAES96031272);
On 2.23.21 at approximately 1 PM, Vaccine lead, , RN, was notified by temp nurse, , RN did an incorrect vaccine was administered on  Upon review of vaccine card, RN discovered that client, received a first dose Moderna Vaccine at Site and was given a second dose of Pfizer vaccine. Client denies any adverse reactions and was observed post vaccine for 30 minutes.
The following morning I found what look like a bruise (a dark purple mark) on the left side of lower lip, about a 1/2 inch long. It was not sore and faded away a day later.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season).  On 7th September 2018, the patient received the 1st dose of SHINGRIX. On 7th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on the left arm. On the same day, the patient also received an unspecified flu shot on the opposite arm (right arm) but there were no events associated with the flu shot. Later in the day after vaccination with SHINGRIX, the patient experienced redness, pain and arm soreness at the injection site. The redness on the left arm was described as about 3 inches in circumference. The contact details of the physician was provided. The reporter had given consent for follow up.
Metallic blood taste in mouth 2.5 hours from getting 2nd shot Lost some taste; Lost some taste; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old female non pregnant patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3248), via an unspecified route of administration in right arm on 23Mar2021 at 09:45 (at the age of 42 years) as a single dose for COVID-19 immunisation. Medical history of the patient includes nose bleeds. Concomitant medications include Ibuprofen (MANUFACTURER UNKNOWN), vitamin c (MANUFACTURER UNKNOWN) and vitamin d (MANUFACTURER UNKNOWN) for unknown indication taken within 2 weeks of medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3248), via an unspecified route of administration in right arm on 02Mar2021 at 10:00 (at the age of 42 years old) as a single dose for COVID-19 immunisation. 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 and since the vaccination, the patient was not tested for COVID-19. On 23Mar2021 at 12:00 PM the patient experienced metallic blood taste in mouth 2.5 hours from getting second shot and lost some taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic effects were taken as a result of the events. The clinical outcome of the events metallic blood taste in mouth and lost taste was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
When they administered the booster, they gave me a full dose not the half dose required for booster vaccine. At about 06:00PM I started not feeling well. I felt woozy, tired and was not able to think clearly. When I woke up in the morning I passed out. I was taken to the hospital in an ambulance. At the hospital they did a CT Scan of my lungs, CBC, Echocardiogram, Chest CT and they did not find anything wrong. They weren't sure if it was because I was dehydrated when I was vaccinated. I was diagnosed with Syncope and possible dehydration. I was discharged the next day.
Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 11-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). The total cumulative excursion time was 24 hours with the highest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt soreness to arm of injection fever >102. Counsel to place cold compress to area and take TYLENOL for fever. Pt also spoke with doctor.
Missed the second appointment; 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 PRODUCT DOSE OMISSION ISSUE (Missed the second appointment) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second appointment) 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.   No concomitant products were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Followup received on 14-JUL-2021  contains no new significant information. updated primary reporter details On 14-Jul-2021: Follow up received included on 14-JUL-2021 contains no new significant information
Approx 24 Hrs after injections started swelling, warm to touch, red, diameter 6 1/2" x 6" swelling. No fever.
RN gave wrong dose. Patient was notified. Patient has not had any adverse effects thus far. He will be monitored for the next few weeks, & was given a phone # to call if he experiences any problems.
Heart palpitations, chest and throat tightness, dull and sharp chest pain, Migraine headache, dizziness, feel like passing out, difficulty concentrating, hand and feet numbness and tingling, muscle cramping, extreme fatigue, naseous, difficulty breathing; feels like suffocating even though taking breaths (not getting oxygen), accelerated resting pulse and blood pressure (100+), sleep apnea, shaking (hands, legs, etc) loss of 25lbs since 02Apr10. Majority of symptoms come and go in waves; chest tightness and headache are constant.
Rash on torso and all extremities appeared within 24 hours of flu vaccination. Seen by her own physician.
?Covid arm? - pain, itching and redness at the injection site  8 days after first covid vaccine dose
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, abdominal tenderness, lip/tonge/chin numbness, loss of appetite, earache, orbital tenderness, lack of sleep. Narrative:
This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-FEB-2016, the patient was inadvertently vaccinated with VAQTA 25/0.5 (units not reported), intramuscularly (dose, lot # and expiration date were not reported). There were no adverse effects reported. Additional information has been requested.
This is a spontaneous report from a contactable consumer and subsequently from a contactable nurse on behalf of physician. A 18-year-old female patient received TRUMENBA (Lot # M13066, Expiration Date 30Sep2016) intramuscular 0.5 ml single dose in the left arm on 06Jan2016 15:30. Medical history and concomitant medications were not reported. The patient complained of weak on 07Jan2016 with outcome of recovered, terrible headache on Jan2016 with outcome of recovering, fatigue on 07Jan2016 with outcome of recovered, joint pain in knees on 07Jan2016 with outcome of recovered, really sore in vaccine area on 07Jan2016 with outcome of recovered, a little nausea on 06Jan2016 with outcome of recovered, pain on 06Jan2016 with outcome of recovered. Clinical course was reported as follows: The patient received TRUMENBA on 06Jan2016 and during the night she woke up with a little nausea and some pain. By the time she woke up on 07Jan2016 morning and the nausea was gone, but the pain had worsened, she had a terrible headache, was weak, had fatigue, joint pain in her knees and was really sore where the vaccine had been administered. The adverse events did not require an emergency room or doctor visit. She took ADVIL on 07Jan2016 night and her mom was a pediatrician who monitored her. The nurse was provided with the information regarding the adverse events by the patient. The nurse considered there was a reasonable possibility that the event is related to suspect product. The nurse was willing to be contacted again by Pfizer on the reported adverse events. Follow up (17Feb2016): New information reported from a contactable nurse on behalf of physician included: suspect dosage; indication detail; reported informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Client's father stated that child started out with a rash on the arm where she got the shot, raised area about the size of a quarter and it itiched.  Father reported that client had not taken any Benadryl or medication for the rash.  No temp reported.
Initial sore arm, then vomiting and diarrhea, then pain intestional  tract like diverticulitis from past.  Saw doctor on 1-25-21; prescribed ciprofloxacin HCI with blood work done, Blood work showed infection
COVID 19 bivalent vaccine given as a 2nd dose. No adverse event to report.
Within 5 minutes of getting the vaccine patient stated he was starting to feel like he had after the first vaccine. Patient was laid supine. Feet elevated, water provided. Patient was pale and mildly diaphoretic.  HR was 40 by O2 monitor. O2 applied at 2 L for comfort. MD notified and evaluated patient. MD recommended ER evaluation/observation. 911 was called and the patient was transferred to the ER by EMS personnel. The patient was monitored continuously prior to transfer.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, malaise and headache. On an unknown date, the outcome of the injection site pain, malaise and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, malaise and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported via Medical Science Liaison (MSL). The age at vaccination was not reported. The reporting physician was the patient. In 2018, the events were resolved.
Administration Error was reported to management, the provider and the manufacturer and instructions were given by the provider and manufacturer. Menquadfi was given in place of Hib in error. The mother was contacted and was informed of the mistake. She was scheduled to come back and recieve the Hib vaccine and was advised that the meningococcal series will need to be began as usually because due to the age of the patient he will not be fully protected by the Medquadfi.