chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 14-SEP-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # K010016, expiration date: 05-AUG-2015; dose not reported) subcutaneously (expired product administered). No known adverse effects were reported. Additional information has been requested.
Clinic hot and humid. Pt had no b-fast in morning. After shots administered (see #13 for order), pt passes out without warning - immediately 10 AM. Pale. Nursing care given. Pt responsive, color returns. Pt leaves clinic at 10:45, fully recovered. Hx irregular periods.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Extreme fatigue; Days without sleep; Flare up of gout and in a foot; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 13:30 (Lot number: EN6204) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 18Mar2021 17:00, outcome "recovered with sequelae" (2021), described as "Extreme fatigue"; INSOMNIA (non-serious) with onset 18Mar2021 17:00, outcome "recovered with sequelae" (2021), described as "Days without sleep"; GOUT (non-serious) with onset 18Mar2021 17:00, outcome "recovered with sequelae" (2021), described as "Flare up of gout and in a foot"; INFLUENZA LIKE ILLNESS (non-serious) with onset 18Mar2021 17:00, outcome "recovered with sequelae" (2021), described as "Flu like symptoms". Therapeutic measures were not taken as a result of fatigue, insomnia, gout, influenza like illness. Additional information: Patient with Covid-19 prior to vaccination was unknown. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Patient did not receive any other medications within 2 weeks of vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
swelling of her tongue.  She only has swelling to the left side of her tongue.  Redness and burning of her face and bilateral eye redness
severe ABD pain and chest pains that started 3-4 days after vaccine given, UA, CMP, CBC, US of ABD and CT ABD done, treated for mild UTI, s/sx did not improve,
sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up received on 31-may-2021 contains no new information.
30 MINS AFTER 1ST COVID SHOT HEART BEATING FAST TROUBLE BREATHING
exp pain in both breasts (severe) day following vax; 2nd day a welt formed on lt breast, then red's streaks & itching, next red rash; pain & itching cont as of 29DEC93;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received anti-viral Paxlovid COVID 19 Treatment which start date was 13Jul2022 and stop date was 17Jul2022.The patient was taking any other medications products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Sinus infection 5 days after completion of Paxlovid. adverse event start date was 22Jul2022. It was unknown if patient was recovered. No treatment received for AE  No follow-up attempts are possible, information about batch number cannot be obtained.
I was getting baggage from the car to the airport, and I was exhausted trying to get in there. I was having shortness of breath, achiness in my chest, and I was lightheaded. This did calm down after getting inside, but I had to stop and catch my breath a number of times getting into the airport which was unusual. This happened a second time when traveling and I had an appointment with my cardiologist shortly after, so I brought this up with him. He did a nuclear stress test, an EKG, and an ECG. These showed I had damage from a heart attack sometime in the recent past. I realized it may have happened in August when that could have occurred. I woke up and was cold and sweaty, I was having chest pain, I could not catch my breath and it felt like there was an elephant on my chest. Eventually it went away, and I never followed up on it because I did not realize what it was at the time. The cardiologist did do a Heart Cath and we saw that the artery was clear, there was no stents required and we manage it with medications. He was not really sure why the artery was clear but there was damage present, so we are not really sure what caused it. We did discuss that I had been positive for COVID-19 on the 30th of May which was a month after having the shot. It started with a scratchy throat, an intermittent cough, a fever, my body was achy, I was sluggish and tired. I tested positive and then was positive for about a week. My cardiologist said he thinks it could be because of being positive with COVID but at this point we are not sure what is causing the issues I am having. On the 22nd of February 2023 I was having shortness of breath, mental fogginess, and was just off. I checked my pulse ox, and it was low in the 84-88 range, and I did go to the ER, but they did not find anything during that visit.
PATIENT COMPLAINS OF BRIGHT RED RASH FROM SHOULDER TO ELBOW, FEVER OF 104 THAT HAS RESOLVED WITH TYLENOL, TENDERNESS OF THE ARM, ARM STIFFNESS THAT CAUSES DIFFICULTY WITH MOVEMENT.
On January 21, 2021 at the Clinic, a PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the nurse inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The nurse then alerted the APRN, who escalated the situation to the manager. The manager then contacted Quality.  The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL. After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them.  Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of an abundance of caution.
Fever T-100.0, tongue swelling, rash, hand and feet swelling. Ibuprofen, Rocephin 500mg IM, Decadron 5mg IM. Sent home with instructions for Tylenol.
Patient complained of severe arm pain-she went to the doctor and was given fluid medication to help with accumulation of fluid at the back of the arm
she is having like muscular issues; she is feeling very weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: MUSCLE DISORDER (non-serious), outcome "unknown", described as "she is having like muscular issues"; ASTHENIA (non-serious), outcome "unknown", described as "she is feeling very weak".  Additional information: She said she took the Pfizer Booster Vaccine (Pfizer COVID-19 Vaccine). She said she was having like muscular issues that she was feeling very weak.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
papulovesicular rash-abd (8-10 spots) 1FEB 6FEB98;
Patient presented for immunization--clinic staff gave immunization without knowing patient was going to be getting immunization from Community Health. Community Health then gave patient immunization at which time it was noted she had already received the immunization 15 min prior. No reaction/adverse event noted at this time.
Constant eyelid twitching on right eye; Vision got blurry; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (Constant eyelid twitching on right eye) and VISION BLURRED (Vision got blurry) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Dec-2021, the patient experienced BLEPHAROSPASM (Constant eyelid twitching on right eye) and VISION BLURRED (Vision got blurry). At the time of the report, BLEPHAROSPASM (Constant eyelid twitching on right eye) and VISION BLURRED (Vision got blurry) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient isn't under any current regular or concomitant medication. Treatment information was unknown
Chills/sweats- started approximately 9pm hallucination (colorful dreams) after waking up at 1AM fatigue.
The patient came into the pharmacy on 11/11/19 3:40 pm and stated that she thinks that she had a reaction to her flu shot. The flu shot was administered on 10/19/19. The patient's son was with her today, and the son stated that he does not think that the symptoms/ reaction is due to the flu shot. I referred the patient to be seen by her provider, to assess the reaction that the pt. reports.  The patient reports a lump in her left arm near her elbow. She asked me to palpate the lump, which I could feel near the elbow. The area was not swollen, but there was a hard lump under the skin. The lump was not located near the area where immunizations are administered - the lump is much lower very near her elbow. The patient reported that she noticed this lump a few days ago. The patient reports no fever, no redness, no itching, no swelling. The patient said that the lump does not hurt, reports no pain from the lump.  The patient said her regular doctor, I encouraged her to make an appointment to have this lump evaluated, and I let the pt. know that I will call Dr. as well, and let them know what she is reporting. Called Dr.'s office and left message in nurse voice mail about this 11/11/19 4:02 pm. Asked the nurse to call us back.  Note: I am submitting this VAERS for documentation, since the patient thinks that this was caused by her flu shot.
SARS Cov 2 infection after first dose of Moderna vaccine; 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 SARS-COV-2 TEST POSITIVE (SARS Cov 2 infection after first dose of Moderna vaccine) 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 26-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (SARS Cov 2 infection after first dose of Moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (SARS Cov 2 infection after first dose of Moderna vaccine) 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.
Started body aches + sl swelling on Rt arm NO SOB, with wheezing, without swelling of upper face.
Fever, chills, pain in arm 10 hours after injection. Nausea and extreme fatigue with dizziness followed for 48 hours.
Injection site red, hot, swollen, sore, Temp 99.0 today 9/23/16.
Vaccines given at 6PM during evening clinic. Infant given tylenol. Parents report that at midnight infant was pale  and not breathing. 911 called and ambulance esponded. Infant gradually with stimulation returned to normal color but could not/ would not cry for 30 minutes. Decision was made not to transport child to eR. Child has been fine since with the exception of louder breathing. 4/28/06-Reviewed 5 page medical record-physician recommends not to give DTaP, no new medical information documented. No additional medical information to add to VAERS report.
face is itchy; This is a spontaneous report received from a  Sponsored Program  Support. A contactable female consumer (patient) reported for herself that:  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on 31Mar2021 as SINGLE DOSE, for covid-19 immunisation. Medical history included known allergies: environmental allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that no unaddressed medical questions referred or forwarded to Medical Information. The patient experienced her face is itchy on an unspecified date. Patient stated if she can take her allergy pills. No treatments were taken for events. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose of Moderna COVID-19 vaccine after receiving first dose on) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z3MZOA) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-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 (Did not receive second dose of Moderna COVID-19 vaccine after receiving first dose on). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose of Moderna COVID-19 vaccine after receiving first dose on) outcome was unknown. Not Provided. 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 medication reported No treatment information was provided. Upon in internal review on 04-Aug-2021, the age was corrected to 66 years
Rash on front of neck.  One straight horizontal line about an inch in size.  Slightly itchy and hot.  Took Advil.  By day 2 rash was much less noticeable and not bothering patient.
Patient came to pharmacy with red area surrounding injection location. Area was also slightly swollen, warm to the touch, but not painful to patient. Was going to contact her MD for possible antibiotic.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 0120M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced MYALGIA (Sore arm). On 16-Jan-2021, MYALGIA (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-058884 (Patient Link).
flu like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a patient who received Men B NVS (Bexsero) (batch number ABXA92AZ, expiry date 28th February 2022) for prophylaxis.   On 30th July 2020, the patient received Bexsero. On an unknown date, less than a day after receiving Bexsero, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Bexsero.  Additional information was received as follows: The patient experienced bodyaches, headache, and chills after a dose of Bexsero. Healthcare Professional refered to the patients events as "flu like symptoms". HCP noted the events began the same evening the vaccine was received. No outcome of events was reported.  HCP noted there were multiple patients reporting "flu like symptoms" following doses of Bexsero. HCP could not provide these patients demographics, lot numbers, or expiration dates. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158056:same reporter US-GLAXOSMITHKLINE-US2020158060:same reporter US-GLAXOSMITHKLINE-US2020158058:same reporter US-GLAXOSMITHKLINE-US2020158060:same reporter
Shots were given 5/27/03. That night, child developed runny nose, wheezing and pain in right leg. During the night on 5/28/03, child developed fever - at time of Dr visit on 5/29/03, temp is 99.9. Child is also very irritable and nurse reports "slight redness" of right leg. 6/4/03 - mother states that at Dr visit on 5/29/03, Dr found child to have ear infection.
Allergic reaction; This is a spontaneous case, initially received from pharmacist via Communications (reference number: SEQ19-03530) on 30-Sep-2019, concerning a male patient of an unknown age.   The patient's medical history and concomitant medications were not provided.  On the unknown date, the patient was administered unspecified Flu vaccine [Influenza vaccine, dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.  On the unknown date, after vaccination, the patient developed an allergic reaction.   At the time of initial reporting, the outcome for the event of allergic reaction was not reported.  The case was assessed as non-serious and reporter did not provide causality assessment.  No new information reported by pharmacist to Communications [reference number: SEQ19-04362] on 06-Nov-2019: Additional Communications number added. No changes in narrative.  Follow up received on 10-Oct-2019: Report type was changed from invalid to spontaneous as it was confirmed that the patient administered unspecified Flu vaccine instead of egg-based Flucelvax Quad. Narrative was updated accordingly.; Sender's Comments: Event of allergic reaction is considered as related to Flu vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild high blood pressure" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM, start date: 02May2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 09Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Dose 1 - No side effects Dose 2 - headache and low grade fever
Fever of 103, complaint of headache almost immediately, sore/dry throat, very irritable, soreness at sight, feet twitching, vomiting the next morning after shots, diarhea still going on-rash on day 3- The final vaccine was for chickenpox (but I was unclear if that is the same as smallpox)