chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headaches; Body Aches; Excessive Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6205), via an unspecified route of administration in the left arm on 09Mar2021 at 11:50 and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8732), via an unspecified route of administration in the left arm on 31Mar2021 at 00:15 as a single dose for COVID-19 immunisation. Medical history included osteo-arthritis and high blood pressure. The patient had a history of allergy to nickel. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) 12.5 milligrams and losartan (MANUFACTURER UNKNOWN) 50 milligrams. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 at 14:00,  after the first dose of vaccine, the patient experienced headaches, body aches and excessive fatigue daily. After the second dose of vaccination these symptoms persist with increased body aches. Therapeutic measures were taken as a result of events which included treatment with consultation, ibuprophen, exercise for neck, left shoulder/arm. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events headaches, body aches and fatigue were not resolved.   No follow-up attempts are needed. No further information is expected.
I experienced severe pain in arm and shoulder that worsened over 3 days leaving my arm unusable....and blistering of my skin or bubbles or welts around shoulder area.... Received shot on Thursday... symptoms began getting better on Sunday and Monday
Employee became unresponsive, with vagal event, approximately 5-10 seizure like activity. Woke up after 1 minute.
allergic reaction; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a 70-year-old female patient (reporter's wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reaction. The patient was being monitored in the hospital. Corrective treatments taken as a result of the event included antihistamine. The outcome of the event was unknown.  The information on the batch number has been requested.
I had fatigue, fever, and malaise. The most marked symptom was fatigue. I did not take Paxlovid. I took over the counter medications to treat my symptoms. It took about 10 days to recover. I went to the center and they did a swab for both flu and COVID-19.
Discharge Provider:  MD Primary Care Provider at Discharge: MD    Admission Date: 2/15/2023 Discharge Date: 2/17/2023   a 58 y.o. female with past medical history of interstitial lung disease/pulmonary fibrosis from COVID 19 infection back in 2021 currently on 2 L nasal cannula with activity, DM type II, hypertension, hypothyroidism, obstructive sleep apnea, coronary artery disease, recently diagnosed ductal cell carcinoma in situ of left breast.   She presented to the emergency department on 2/15/23 with fever, chills, headache and shortness of breath, nausea and vomiting. She was not able to eat or drink anything today, she started feeling more short of breath so she presented to the emergency department for evaluation. In the emergency department she was noted to be afebrile, with T max of 38.7 rectally, patient was saturating well on room air, labs were significant for sodium of 132, serum creatinine of 1.11 and blood glucose level of 335, complete blood count was unremarkable, lactic acid was 1.8.  Chest x-ray shows subsegmental atelectasis in the right lower lung without focal infiltrate.  Viral PCR came back positive for COVID-19 infection, patient desaturated to 87% with ambulation without oxygen.  She received Tylenol and albuterol and 1 L normal saline bolus, fever resolved. She was admitted for observation.  She clinically improved, Pox was 99% on RA at rest. Nausea and vomiting resolved, and she tolerated well DM liberal diet. Hyponatremia and AKI resolved, creat. on admission was 1.2, at discharge 1.09.  DM II well controlled with current meds.  She was discharged home on 2/17/2023 Should follow up with PCP as needed and with her onco/ rad onco as scheduled before.  She should stay in respiratory isolation until 2/25/23.
3 hours after injection, soreness and pain on the arm, light headedness, dizzy, tired and headache, night of vaccine-- > day 1 after vaccine-- > headache , soreness on the arm, chills, sweats, body is hot, heart pressure day 2 after vaccination (AM) chest (feels like costcochondritis)
28FEB92 tc from MD pt having low grade fever, flu-like aches & only sm amt soreness of inject site of arm;
Severe Muscle pain all over (back, neck, leggs, arms hands, feet) 2-3 days  Headache - 4-5 days Shivering - 1 day Completely bedfast 2 days
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 12-OCT-2012 01:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA: Three days after second dose of Moderna COVID-19 vaccination patient reported headache, erythema at injection site, swelling, voice changes, coughing, and myalgias. Patient advised on OTC/home remedies and to return to clinic if symptoms worsen or fever or streaking from injection site develop.
pt recv vax 20SEP96 & w/in 35min pt exp a stomachache, several coughs, & watery eyes;pt exp wheezing & eyes were swollen shut;pt was treated w/epi & nebulizer & taken to ER:pt tx w/DPH & pred & released from the emergency p/short stay;
Information has been received from a registered nurse concerning a 10 month old male patient who on 23-Jul-2009 was vaccinated with the first dose of ROTATEQ (Lot # 663215/0571Y). No adverse symptoms noted. The patient sought medical attention. Follow-up information was received from the registered nurse concerning the 10 months male patient with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions who was vaccinated with ROTATEQ. No concomitant therapies were included. No adverse events were reported. No further information is requested.
This is an initial spontaneous report from a contactable reporter (Non Health Care). A child (age, gender and race unknown) started to receive PREVNAR 13 and an unspecified liquid multivitamin (for pediatric), both since an unknown date, at an unknown dose and frequency, for an unknown indication. The relevant medical history and relevant concomitant medications were unknown. It was reported that the consumer might had experienced drug interaction between PREVNAR 13 and unspecified liquid multivitamin on an unknown date. She further mentioned she came to know about the interaction when she observed a pop up in the electronic medical records suggesting it. The relevant laboratory test was unknown. The last actions taken with both the therapies were unknown, at the time of report. Therapeutic measures taken in response to the event, if any, were unknown. Clinical outcome of the event was unknown, at the time of the report.
back surgery for internal infusion; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (back surgery for internal infusion) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BACK DISORDER (back surgery for internal infusion) (seriousness criterion medically significant). At the time of the report, BACK DISORDER (back surgery for internal infusion) outcome was unknown.            No concomitant medications were reported. Patient was having back surgery for internal infusion. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of internal infusion was Not reported for cosuspect rinvoq. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns adult female patient of unspecified age with concurrent medical condition of HIDRADENITIS that was treated with UPADACITINIB (RINVOQ), who experienced the unexpected, serious (medically significant) of Back disorder (back surgery for internal infusion) that occurred on an unknown date in context to a dose of mRNA-1273 vaccine. The clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Hidradenitis treated with UPADACITINIB (RINVOQ) co-suspect remains a risk factor for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns adult female patient of unspecified age with concurrent medical condition of HIDRADENITIS that was treated with UPADACITINIB (RINVOQ), who experienced the unexpected, serious (medically significant) of Back disorder (back surgery for internal infusion) that occurred on an unknown date in context to a dose of mRNA-1273 vaccine. The clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Hidradenitis treated with UPADACITINIB (RINVOQ) co-suspect remains a risk factor for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date. Date vaccine stored in Standard Freezer on 01-Apr-2022. No treatment medications were reported.
At first, throat and lungs were a bit tight for most of a day or two.  Other issues started - burning up and down spine, painful nerve tingling all over - comes and goes.  Still going on, but not as much nerve tingling, a month later. Burning in spine still on and off.  Peripheral neuropathy.  Some numbness in spine, lower spine and leg muscles.
Pt has had vomiting, loose stools and increased fussiness with torticollis since 2 mo vaccines.
Narrative:  The patient received three doses of Pfizer COVID 19 in Jan/Feb/Sep 2021. The patient presented to the ED with hypoxemia and hypotension on 9 Jun 2022. The patient was admitted with covid 19 pneumonia, Acute kidney injury, and respiratory depression. The patient was treated with steroids, inhalers, antibiotics, and remdesivir. The patient was discharged on oxygen on 18 June 2022. Reported per EUA.
ADMITTED FOR ARF WITH HYPOXIA AND COVID + .. CXR NEG .. WAS STARTED ON ABX FOR POTENTIAL SUPERIMPOSED CAP
Chills; weak; hung-over feeling; pain and swollen lymph node under left arm (injection arm); pain and swollen lymph node under left arm (injection arm); This is a spontaneous report from a contact consumer (patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1283), via an unspecified route of administration on Jan2021 08:00 AM at single dose for covid-19 immunization. Vaccine location was left arm. Patient received the first dose on Dec2020 10:00 AM (lot number EK5730) at left arm for covid-19 immunization. The facility type vaccine was hospital. Known allergies included Penicillin. Concomitant medication included omeprazole. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Chills, weak, hung-over feeling the evening after second dose. Second day, pain and swollen lymph node under left arm (injection arm). The events onset date was reported as 13Jan2021 02:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was not recovered.
5 minutes after receiving PNEUMOVAX and FLUVIRIN, pt. complained of hotness all over & tingling on her tongue. EMS were dispatched. BP & pulse  were WNL for pt's medical history. Pt. refused ER visit & asked to go home 45 minutes after vaccine.
Tingling and numbness in ulnar distribution hand  involving the  Left 4th, 5th fingers starting 2 weeks after the vaccine,  Symptoms have been persistent for 6 days. No associated weakness or pain. No associated neck pain or shoulder swelling, no axillary adenopathy.
No adverse event; 1st dose on 12Feb2021 and 2nd dose on 24Mar2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 12Feb2021 and 2nd dose on 24Mar2021) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 028L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot (about 20 years ago.). Past adverse reactions to the above products included Autoimmune disorder with flu shot.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 12Feb2021 and 2nd dose on 24Mar2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 12Feb2021 and 2nd dose on 24Mar2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 12Feb2021 and 2nd dose on 24Mar2021).    Patient has not had COVID No concomitant medication was provided by reporter. No treatment medication was provided by reporter. It was reported that patient has a funny immune system and got an autoimmune disorder from the flu shot about 20 years ago   This case was linked to MOD-2022-636503 (Patient Link).
Muscle ache at injection site within 2 hours. Approximately 8 hours later, chills. Then at 6am fever, dizziness, fainted, ringing in ears, low blood pressure. Lasted for 3 more hours. Pedialyte, oyster crackers, 400mg Advil and rest helped aid recovery.
More than 36 days since first dose, no second dose received at this time; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days since first dose, no second dose received at this time) 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 15-Jul-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days since first dose, no second dose received at this time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days since first dose, no second dose received at this time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter.  Treatment information was not provided by reporter.   Reporter did not allow further contact
Given MMR and VARIVAX in (R) thigh 3/30/11. A month or so later, pigment started going away in (R) thigh, leg and top of foot! It has not come back still!!
Passed out has become very confused and paranoid, unstable with walking, restless had to be Hospitalized
PATIENT RECEIVED HER 1ST MODERNA SHOT AT 1:15PM  AT OUR PHARMACY.  IT WAS GIVEN BY NURSE.  AT 1:30P.M. PATIENT STARTED C/O ITCHING ON BILATERAL ARMS AND SLIGHT RASH ON BOTH LOWER PORTIONS OF HER ARMS.  I ASSESSED FOR ANAPHYLAXIS SYMPTOMS, THE PATIENT HAD NONE.  SHE HAD NO OTHER ADVERSE SYMPTOMS.  I ADMINISTERED 50MG OF DIPHENHYDRAMINE IM TO LEFT ARM.  THE PATIENT WAS ACCOMPANIED BY HER MOTHER.  I REACCESSED PATIENT 15 MINUTES LATER AND SHE FELT A LITTLE BETTER.  THE PATIENT LEFT AROUND 20 MINUTES AFTER THE INJECTION WITH NO FURTHER COMPLAINTS.  SHE HAS AN EPI PEN AT HOME, HAS USED ONE BEFORE AND COUNSELED HER IF AT ANYTIME SHE  WERE TO HAVE S/S/S  OF ANAPHYLAXIS TO USE HER PEN AND CALL 911.  I CALLED THE PATIENT ABOUT 20 MINUTES AFTER THEY LEFT TO CHECK ON HER, SHE SAID SHE WAS SLEEPY BUT SHE WAS OK.
THE CLIENT WAS GIVEN A PEDIATRIC COVID-19 PFIZER VACCINE INSTEAD OF THE ADULT DOSE.
This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a male patient of unspecified age. It was reported that, whenever the flu vaccine was withdrawn, the vaccine leaked out from the rubber stopper. As the secured lock was popped off the vial the rubber stopper was dented in and off a little. It was reported that, when the nurses removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication leaked. On 03-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from a leaked vial. There were only 5 doses left out of the 10 doses in the vial. It was reported that sample vials were available in which they had one opened vial and 46 left. The package was not damaged, but the rubber stopper was damaged. From the withdrawal of first vaccine, the leakage was observed. The needle used was 25-gauge needle and the syringe were 3 ml syringe. The user had added air to the vial from the syringe. At the time of this report, no adverse event was reported. This case is linked to case 201805390 (same reporter). This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034101. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A follow-up revealed the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be User-Improper Handling. The reporter assessed the case as non-serious. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252334 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.
my lips and mouth were tingling then started tingling in my chest; my lips and mouth were tingling then started tingling in my chest; started having some tightness in my chest; dizziness / lightheadedness; blood pressure went up; Headache; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 23Mar2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported. The patient stated about minutes after vaccine shot on 23Mar2021, my lips and mouth were tingling then started tingling in my chest and started having some tightness in my chest, my blood pressure (BP) went up. The patient also had lightheadedness, headache, and dizziness along with the high BP with tightness in my chest on 23Mar2021. On Friday (26Mar2021) my BP in the ER (emergency room) was 182/102 and 168/112. The physician in the ER said this was a reaction to the second COVID shot received. The outcome of the events lips and mouth were tingling, tingling in my chest, tightness in my chest, blood pressure went up, headache, and dizziness was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Approx 15 minutes after receiving injection of Hep B, presented to school nurse c/o dizziness, throat "stuffy", was given Benadryl by school nurse. Rescue squad called, but was not transported, was OK by the time the mother arrived at school. Taken to PMD, was told that they were not sure if was reaction to Hep B.