chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose_number=4 date=20/Apr/2022; COVID 19 Treatment; dose_number=4 date=20/Apr/2022; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 28Mar2021 as dose 2, single (Lot number: ER8733), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "Sleep Apnea" (unspecified if ongoing), notes: Other medical history: Sleep Apnea. The patient's concomitant medications were not reported. No Known allergies. No Other medication in 2weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05May2022, outcome "unknown", COVID-19 (medically significant) with onset 05May2022, outcome "recovering" and all described as "dose_number=4 date=20/Apr/2022; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Negative, notes: Tested negative with PCR on 04May2022; (unspecified date) Positive; (06May2022) Positive, notes: Testing positive with antigen tests May 6, 7 & 8th so far..; (07May2022) Positive, notes: Testing positive with antigen tests May 6, 7 & 8th so far..; (08May2022) Positive, notes: Testing positive with antigen tests May 6, 7 & 8th so far... Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 15th June 2016). On 7th October 2015, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced shoulder pain. On an unknown date, the patient experienced neuritis and bursitis. On an unknown date, the outcome of the shoulder pain, neuritis and bursitis were unknown. It was unknown if the reporter considered the shoulder pain, neuritis and bursitis to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was reported by a nurse to a pharmacist. There were 5 employees who received FLUARIX QUADRIVALENT, and experienced increasing pain at the shoulder, one week later after vaccination. Among the 5 employees 2 patients were female and the genders of the other 3 patients were unknown. One of the patients was treated at the emergency room. Other patients were seen by their primary care physician and diagnosed with possible bursitis or neuritis. The patients were underwent Nuclear magnetic resonance, but it was unknown that, who amongst 5 patients underwent had the test and what are the outcomes. It was reported that, according to one physician the cause of the events was maladministration, but the nature of maladministration was not certain. The reporter stated that, she provided all the information she had available.
Eats half of what he used to eat on the plate; Mouth gets very dry at night; Fever; Metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Eats half of what he used to eat on the plate), DYSGEUSIA (Metallic taste in mouth), DRY MOUTH (Mouth gets very dry at night) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 09-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth) and PYREXIA (Fever). On an unknown date, the patient experienced DECREASED APPETITE (Eats half of what he used to eat on the plate) and DRY MOUTH (Mouth gets very dry at night). At the time of the report, DECREASED APPETITE (Eats half of what he used to eat on the plate), DRY MOUTH (Mouth gets very dry at night) and PYREXIA (Fever) outcome was unknown and DYSGEUSIA (Metallic taste in mouth) had not resolved.            No concomitant medications were reported. No treatments were reported.   This case was linked to MOD-2021-032335 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information provided:New events added and events outcome updated; Sender's Comments:  MOD-2021-032335:Same reporter/Different patient
Patient describes swelling and redness in the left arm. Also, very sore to move around. Started in the evening of 08/04/22. Improved after ibuprofen given on 08/05/22 and ice. Still sore after a couple hours on ibuprofen.
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age without any pertinent medical history or drug reactions/allergies. On 13-JUN-2013 the patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot #J00043, expired date: 10-APR-2014). There was no concomitant therapy. It was reported that the patient experienced developed redness, soreness and bruising around injection site on an unspecified date. The patient treated with BENADRYL. There was no diagnostics studies performed. The outcome of all the events was reported as recovering/resolving. The patient sought medical attention by coming to pharmacy. Additional information has been requested.
Syncope. Did not fully pass out, but felt a wave of tightness, followed by paleness (tech said color drained), followed by lightheadedness.
Shingrix given 7/8/2020. Fluarix given 9/21/2020. Shingrix given 10/28/2020. Eye infections 9/28/20, 10/7/20, 10/23/20 Back pain, joint pain Hip pain 11/2/20 Toe pain 11/10/20 Pt is seeing multiple doctors about sudden onset of pains and infections. Doctors think it may be related to Shingrix vaccinations and told pt to call Pharmacist to report.
SEVERE NOSE BLEED LASTING 10 MINUTES APPROXIMATELY 1 HOUR AFTER SECOND DOSE OF MODERNA VACCINE. I DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NOT A RECURRENCE OF BLEEDING AFTER IT STOPPED.
chills; muscle aches; slight nausea; bad head ache esp in my right temple n towards the front on that side; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2020 09:00, the patient received the 2nd dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced chills, muscle pain, nausea and headache. On an unknown date, the outcome of the chills and headache were unknown and the outcome of the muscle pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the chills, muscle pain, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the 2nd Shingrix shot at 9 am. Later that day the patient had muscle aches and chills.  Eighteen hours after receiving vaccination, the patient woke up at 3 with a bad head ache especially in the right temple n towards the front on that side . The patient had slight nausea and still had the muscle aches.
I got the injection shots at 9:50 am.  One shot in each arm but I cant remember exactly which shot was given in which arm but about 25 minutes to a half hour after the injections I got severe pain in my lower back and the pain is so severe and excruciating.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/12/21Lot#EL3248 2nd dose 02/03/21,lot#EN5318 Diagnosed covid positive:08/13/21 Symptom onset:08/12/21 Exposure:Home Symptoms:Cough, fatigue, head ache,sore throat, nausea, congestion.
There was no adverse event. The adult dose of FLUZONE vaccine was given to a newborn child on the day of birth, inadvertently, instead of the Hepatitis B vaccine. We are reporting that  there have been no adverse reactions to the child 24 hours later. The hepatitis B vaccine was given to the child as well, when the mistake was realized.
Tinnitus.  Earnings ringing. It hasn?t stopped.  I got my second shot after going to ear doctor to confirm no hearing loss.  Second shot was yesterday (delayed because of concern about the ringing) and the ringing is more pronounced following the second shot.
Sick; felt like having a fever, no actual fever.; more than 36 days from first vaccination; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), FEELING ABNORMAL (felt like having a fever, no actual fever.), PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) and NAUSEA (Nauseous) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis. Concomitant products included METOPROLOL SUCCINATE for an unknown indication.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), FEELING ABNORMAL (felt like having a fever, no actual fever.), PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) and NAUSEA (Nauseous). At the time of the report, ILLNESS (Sick), FEELING ABNORMAL (felt like having a fever, no actual fever.) and NAUSEA (Nauseous) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states she has BVC (no acronym provided) metoprolol succinate ER given for BVC. it was reported that patient was unable to get the second dose due to family issue.     Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Followup information received wherein new event was updated.
Pain and stiffness in the left side of the neck for several days. Later I developed pain and stiffness in the left shoulder, getting worse and lasting still today.  I reported this to my Primary Care Provider. He examined me on 8-30-2019, made a diagnosis of Tenosynovitis of left shoulder and prescribed me Ibuprofen 325 mg tablets and Tizanidine 4 mg tablets.
issues sleeping at night; can't breathe; something with her sinus; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (issues sleeping at night), DYSPNOEA (can't breathe) and SINUSITIS (something with her sinus) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 003B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (issues sleeping at night), DYSPNOEA (can't breathe) and SINUSITIS (something with her sinus). At the time of the report, INSOMNIA (issues sleeping at night), DYSPNOEA (can't breathe) and SINUSITIS (something with her sinus) outcome was unknown.            Treatment information was reported that patient had taken cold medicine for adverse event on unknown date through unknown route of administration. It was reported that the patient would go to see her doctor next week. No Concomitant medications were reported.
11 soft tissues nodules in the left breast (Malignancy was not excluded); 2 heaptic nodules in liver; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (11 soft tissues nodules in the left breast (Malignancy was not excluded)) and HEPATIC MASS (2 heaptic nodules in liver) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL, CARVEDILOL, FENTANYL and MORPHINE for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced BREAST MASS (11 soft tissues nodules in the left breast (Malignancy was not excluded)) and HEPATIC MASS (2 heaptic nodules in liver). At the time of the report, BREAST MASS (11 soft tissues nodules in the left breast (Malignancy was not excluded)) and HEPATIC MASS (2 heaptic nodules in liver) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Angiogram: 11 nodules in breast and 2 hepatic nodules (abnormal) 11 soft tissues nodules in the left breast. Malignancy was not excluded and 2 hepatic nodules in liver,  CTA of the chest, abdomen, and pelvis..         Concomitant medicines included vacfotan No treatment information were reported  Action taken with the drug in response to events was not applicable.
DAY ONE -fatigue  -physiological anxiety that lasted a couple of hours - feeling like I had way too many shots of espresso -palpitations a couple of times -swelling, tenderness to palpate, and sharp intermittent pain in upper knuckle of  right pointer finger joint (this has never previously occurred, so assuming it's related to the vaccine; there was no injury or strain that preceded it) DAY TWO -worse fatigue , headache, and constipation  -mild body aches (could also be fibromyalgia) -severe depression as the day went on, including crying spells, thoughts of suicide, negative obsessive thoughts (I do have a history of depression but wasn't depressed at the time of the vaccination, and these depressive symptoms were extreme for me) -feeling generally "out of it," not right in my head, emotional and exhausted
Patient was not given the complete dose of Pentacel which caused the dose to be invalid.  The patient was only given the Pentacel Solution of the vaccine.  Therefore per the Provider to make the dose valid patient was given then a dose of HIB LT Lot:UJ584AA to valid the correct dose.  Patient also received Prevnar RT Lot:EN8811 which the patient was due for at the time of the visit.
Patient received flu vaccine (Fluarix quad) on 11/5. Came in to pharmacy on 11/7 reporting lump under skin and redness on arm at a site lower and more inside than the injection site. Patient states it has been getting better. Counseled to call doctor and to use a warm compress and massage the area with the lump.
Expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment medication information was reported.  It was reported that no excursion occurred. The Moderna vials were taken out of the freezer, thawed and administered as instructed. No delays occurred in administration of Moderna vaccine. On 12 Nov 2021 all vaccines were administered within 2 hrs.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received includes updated Second reporter Information.
pt recvd vax;v,fainting, pain at 1:30pm; seen by MD;felt pt probably fainted from hypotension; c/o stiffness about the back, shoulder, neck & Lt arm;
This spontaneous report has been received from a registered nurse referring to an unspecified patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 13-MAR-2018, the patient was vaccinated with VAQTA lot number reported as M039209 with expiration date of 11-MAR-2018, (strength, dose and anatomical location were not provided) for prophylaxis (expired product administered). No adverse events were reported. Follow up information has been received from the nurse on 29-MAR-2018. The patient's birth weight was updated, and the patient had no brothers and sisters. On 13-MAR-2018, the patient was vaccinated with the second dose of VAQTA intramuscularly. Error was noted after the administration. The patient's parent was contacted several times beginning on 15-MAR-2018 with messages left, and finally spoke with the patient's mom on 29-MAR-2018. All vaccine boxes had expiration date written visibly on front, nurses checked expiration date before administration, vaccine expirations being checked weekly and documented.
Pt reported severe itching of skin. No difficulty with respiration or swallowing. No hives developed. Vital signs stable. Pt reported mild dizziness. Sxs improved with BENADRYL 150 mg.
Patient spouse called & said on day 2 (possible evening of day 1) patient experience n/v and dizziness.  Discussed Shingrix side effects and other possible causes including influenza, heart issues, etc.
Donor stated that she had dizziness and was lightheaded while she was at work the day following her recieving the vaccine. She also stated that she waited an about an hour after after getting the vasccine before she started working out. She stated that she is on a low calorie intake diet and dizziness/headaches/lightheadedness have been common for her. Denies nausea/vomiting.
Within 5 mins of receiving flu shot, patient experienced nausea and dizziness.  Symptoms lasted a few minutes & Patient was able to walk out.
No additional adverse events reported; A 15 year ald female received PROQUAD yesterday; This spontaneous report was received from a registered nurse and refers to a 15 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.      On 30-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # U009261, expiration date: 19-SEP-2022) 1 dose in the left deltoid for prophylaxis (product administered to patient of inappropriate age). No additional adverse events reported.
Headache; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored Program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 22Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache on 23Feb2021. The outcome of the event was unknown. The patient was querying if he could take Advil for the event or not and if it would interfere with the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient described dizziness, vision disturbance, shortness of breath and severe fatigue. Onset of symptoms about 3 hrs after vaccination. Pt. stated severe anxiety R/T shots/needles @ time of vaccination. Pt. referred to physician, unknown if treated.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue and general body pain. On an unknown date, the outcome of the influenza-like symptoms, fatigue and general body pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fatigue and general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient states that after receiving the 1st dose of the SHINGRIX vaccine, she experienced flu-like symptoms that included body aches and fatigue. The patient stated that the symptoms started approximately 48 hours after receiving the injections. The patient stated that the symptoms lasted for a few days then resolved. This case has been linked with case US2018126866 same patient for 2nd dose.
Case number PHEH2014US019134 is an initial spontaneous report from a nurse received on 19 SEP 2014. This report refers to a 58-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. On 18 SEP 2014, he was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (overdose).
Patient received both vaccines in right arm separated by an inch apart on Friday 8/21/20. Patient returned to pharmacy on Sunday 8/23/20 with complaints of being unable to move arm, very sore, and warm to the touch. She had three small welts that were pink and raised and irritated that were not at the site of injection but around it. She explained that she did not have the same effect with the first dose of Shingrix but she did not have any other vaccine at the same time as that one. This was her first Pneumonia vaccine however.
Pt developed 2 brief seizures and a low-grade fever. Both self resolved. Seizures occurred about 20 hours, post vax.
new onset Bigeminy, treated and corrected at emergency department by intravenous administration of magnesium
Redness and swelling at injection site 3" X 4" starting in the evening of immunizations. No fever or pain. Seen in office on 02/11/2020. Improved by 02/13/2020.
PATIENT RECIEVED MENACTRA VACCINE AND TDAP BOOSTRIX ON OCTOBER 12TH 2021, PATIENT RECIEVED MENACTRA VACCINE AND TDAP BOOSTRIX AGAIN TODAY ( JUNE 9TH 2022 ). PATIENT IS STABLE AT THIS TIME. INSTRUCTED PATIENT TO REPORT TO ER OR PCM IF ANY CONCERNS.
Patient complained of breathing difficulties 4 hrs. after receiving Flu vaccine. Pt said she also had a fever and received breathing treatment in emergency room. Patient filled two scripts (FLONASE and PROAIR). Dr unsure if breathing problems due to flu vaccine.
All over body / muscle aches - unable to sleep well due to extreme discomfort. Pain started around 8pm and intensified through the night. Started to abate early afternoon next day. Did take extra strength Tylenol 4 times between 8pm 2/8/21 and 2pm 2/9/21. As of today, 2/10/21, still have joint pain in right  hand knuckles and mid back / right shoulder blade and at injection site.