chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with Health Authority concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  Chief, Medical Staff and the Commander were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Healthcare Resolution Specialist and Health Authority, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
mom reported lump size pea devel in RAT approx 3 days p/vax & lasted approx 1wk-no other problems & lump now gone;
No additional AEs; Caller reported patient received a dose of PROQUAD that was reconstituted with Mencyw-135 Liquid Conjugate component  (Diluent for MENVEO) instead of the Merck Diluent.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with Mencyw-135 Liquid Conjugate component (Diluent for MENVEO) (lot number AMXA764A with an expiration date of 20-SEP-2024) instead of the Merck Diluent (product preparation error). Then, the patient was vaccinated with the reconstitution of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose 0.5 milliliter administered intramuscularly for prophylaxis (vaccination scheme frequency and anatomical location were not provided; valid lot number W007744 with an expiration date of 04-SEP-2023, therapy type: rHA). No additional adverse events were reported.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Ex-smoker.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Patient started having irregular heart beat and chest pains on 04/03/2021 and was admitted to the Hospital on 04/04/2021 at 0200.
1/15/21 vaccine 10:00am 5:00 pm hives itching, chills, diarrhea, chest tightness "took Childs allergy medicine - had no Benadryl in house" 1/20/21 still has hives and itching
"Patient with history of 2 COVID vaccines who admitted with COVID detected PCR.  Provider d/c note:  "" was admitted with sx's of confusion and fever with  hx of recurrent UTI-ureterolithiasis x 5 in the last few months. Additionally she was covid + without respiratory sx. She was placed on empiric abx based on prior urine cultures. Urine and BC were no growth after 72 hrs urology was consulted and infectious ds was contacted case discussed abx were stopped. She did have an abnormal CT scan not felt to be consistent with acute cystis-pyelonephritis clinically. She improved daily was afebrile after day 1 and is discharged home off of abx no covid tx in the absence of hypoxia, pneumonia. She will follow up as scheduled with urology.
Within 15 minutes of receiving the vaccine, patient began complaining of rapid heart rate. RN came over to monitor, and found HR @130 BPM. Rapid response/medical emergency was called. Refused further medical treatment. Stayed 5-10 mins longer than the 15 minutes recommended observation period, and felt better before leaving.
Got symptoms only after the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got symptoms only after the second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got symptoms only after the second dose). At the time of the report, VACCINATION COMPLICATION (Got symptoms only after the second dose) outcome was unknown.            No relevant concomitant medications were reported.  Treatment medications not reported.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17 Jun 2021 included no new information.
sore throat, cough, and headache; sore throat, cough, and headache; sore throat, cough, and headache; This is a spontaneous report from a contactable nurse.  A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration on 24Dec2020 as single dose for COVID-19 immunization.  There was no medical history and no concomitant medications.  The patient experienced sore throat, cough, and headache on an unspecified date. No treatment was given for the events. The outcome of sore throat, cough, and headache was not recovered.
Breakthrough case admission after 5 vaccines Pfizer 5/11/21 Lot# Ew0176;  Pfizer 6/1/21 lot# Ew0191;  Pfizer 10/1/21 lot# FC3184;  Moderna 5/19/22 lot# 049L21A;  Pfizer 9/27/22 lot# A57163B
This spontaneous report was received from a medical assistant and refers to an 18 year old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 18-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Mild headache, moderate chills, moderate body aches all over, injection sight sore with mild swelling
9:10...Patient noted to be very pale, was assisted to the mat.   BP 110-60, HR 62 9:20...BP 106/62, HR 70 9:35...BP 104/60, HR 62 9:40...Left ambulating with mom.
Sore/bruised and raised injection site. Sore arm started immediately and is still sore 3 days later. Did not notice raised injection site until 10/31/21. No other side effects for booster dose.
fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LUPI21-04373.  A 7 year-old patient received bnt162b2 (BNT162B2), administration date 24Dec2021 (Batch/Lot number: unknown) at the age of 7 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered", described as "chills". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever to 104.8 (axil) x 24 hrs following vaccine. Temp normal by ~ 36 hrs.
Approximately two weeks post vax pt experienced a rash with over 50 lesions. Physician noted fairly certain varicella like rash and not wild type in nature. Pt was afebrile. Follow up data states unspecified medical attention was sought. The patient's brother had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
He got COVID a month after getting the shot; He got COVID a month after getting the shot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GJ3277) for COVID-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He got COVID a month after getting the shot". Clinical course: The patient reported that he had a total of 5 of the Pfizer vaccines. He would like to know if the shot that he had was the bivalent. He mentioned he got COVID a month after getting the shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Localized inflammation/questionable infection 4 x 6 cm developed 24 hrs s/p intradermal vaccination, worsening after 24 hrs.
About 30-45 minutes I began to feel tingling in my tongue and throat. A few hours later my face became numb - it was a circle around my face. The next day (3/7) the right side of my face was numb and showing symptoms of what doctors later decided was Bells Palsy. on 3/7 I had fatigue and general feeling bad like I had the flu. On Monday 3/8, I was feeling worse and I called the advice nurse who advised I go to the  Emergency room due to right face partial paralysis, numbness, and face drooping. They diagnosed Bells Palsy and prescribed Valtrex and prednosone. From 3/9-12 the right side of my face was numb, droopy and I had ear pain and a lot of fatigue. By Saturday 3/13 I was feeling better and have gradually gotten better through today 3/26. I still have numbness in my right cheek. and occasional tingling in my lips. My doctor has advised me to go ahead and get the second dose of vaccine tomorrow 3/27. Also, during the week of 3/7 - 3/12 I had some dizziness and a general foggy feeling in my head.
On, March 11, 2021 the morning after my Dad received his second Moderna COVID vaccine, he was so sick he couldn't get out of bed. Body aches, chills, muscle aches and fatigue. My brothers had to help him out of bed and to the restroom. He didn't eat for several day and when he drank liquids we had to hold his head up he was so weak. That continued for about a week. The second week he progressed to sitting up in a wheel chair. He was eating small amounts and walking slowly with assistance. On March 30, 2021 he had a massive stroke. He was rushed to the hospital where he received a Thrombectomy to remove the blood clot. He now has AFIB and will be on blood thiner for the rest of his life.
Fever really bad; Chills; arm site is sore; Tired; A spontaneous report was received from a 61 year old female healthcare facility staff member who received Moderna (mRNA-1273) and developed fever, sore arm site, feeling tired, shivery.and  chills  The patient's medical history, included history of COVID-19 infection in May 2020. No relevant concomitant medications were reported.   On 29 Dec 2020,  the patient received her first of two planned doses of mRNA-1273 (Lot # 026L20A) in the left arm for prophylaxis of COVID-19 infection.   Patient developed fever 101.8-102°F, , sore arm site, feeling tired, chills and shivery after receiving vaccine.    Treatment for the event included alternating paracetamol and ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, fever, chills, sore arm site, feeling tired and shivery, were unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 (dose and route of administration were not provided) for prophylaxis. No adverse event was reported. Temperature/Time frame: 32F and 36F for 30 minutes, 32F and 36F for 30 minutes, 32F and 36F for 30 minutes (3 identical excursions only identified). A data logger was involved. No adverse effects were reported. Additional information has been requested.
Approximately two hours after receiving the Monkeypox vaccine in my left abdomen, I began to feel a very strange sensation in my left eye; swelling, irritation, I have the color of red color in its entirety, the eye is with a very small appearance, with difficulty to see, my vision of my left eye is blurred, and I have an apparent bag of retained liquid in my eyelid; in the same way my eye is tearing.
Very sore arm, vomiting, nausea and fever (101 deg) in a 9-hour period (between 3:30 am and 12:30 pm 4/12) - vomited 7 times. Patient visited urgent care (health center Dr.) 1 pm 4/12
Pt exp an unspecified rxn following vax w/Hep B vax;
spontaneous report as received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies were not reported. On 17-OCT-2018 (also reported as on 27-AUG-2018, discrepant information), the patient was vaccinated with an expired dose of VARIVAX lot # M041079, expiration date; 06-OCT-2018, subcutaneously, as prophylaxis (Strength and dose were not reported). Concomitant therapies included MERCK STERILE DILUENT lot # R006343, expiration date: 01-DEC-2020.
The next morning, the patient noticed swelling, redness, and a welt at the site of injection. Reported itchiness and warmth at site.
9 hours after receipt of second dose of moderna  shot I started to experience an abrupt onset of severe headache, joint and body aches, I felt very hot but could not find a thermometer, but then had extreme chills and had trouble getting warm, dizziness, nausea, vomiting,, lots of fatigue and weakness. These symptoms were relentless for 48 hours and then I was very tired, weak and felt shakey inside, as if my blood sugar was too low( it was checked and was not low) for about 10 days. I am still tired but all other symptoms have resolved. It was a very intense, scary set of symptoms.
Patient was administered a second dose of Pneumovax 23 despite receiving an initial dose one year prior
My sleep was disturbed was a while; This is a spontaneous report from a contactable Other Healthcare professional (patient).  A 36-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration, administered in Arm Left on 02Jun2021 (at the age of 36 years old) as dose 1, single for covid-19 immunisation. Medical history included HT (hypertension) from an unknown date and unknown if ongoing , hyperthyroidism from an unknown date and unknown if ongoing. Patient had no Known allergies. Concomitant medications included losartan potassium 100mg taken for an unspecified indication, start and stop date were not reported; levothyroxine 75mcg taken for an unspecified indication, start and stop date were not reported.  The patient experienced my sleep was disturbed was a while in Jun2021.It was reported that he had his first shot on 02Jun2021. With that he did not get many symptoms except his sleep was disturbed was a while. 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. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for adverse events. The outcome of event was recovered on an unknown date in Jun2021.   Follow-up attempts are completed. No further information is expected.
Employee complained of  heart palpitation, chest discomfort/tightness, headache, neck pain, felt hot, and face flushed-symptoms started within 30 minutes of administration of 3rd Hepatitis B vaccine.
Woke up January 18 with small rash and itching at injection site.  By 1pm, I noticed a rash on my neck and chest.  By 6 pm it was very itchy and spread over my back.  It is reddened and extremely itchy.  This morning, January 19, it continues to be extremely itchy and has spread down to my thighs.  I took Benadryl 50 mg at midnight and it didn?t seem to help.
Heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Heart palpitations".  Additional information: The reporter stated that her niece was also experienced heart palpations after the two doses of the Pfizer covid vaccines, she was a lot younger than her mom.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101294229 same reporter/product/event, different patient
sickness for 48 hours; my system is totally aired out; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from Pfizer RxPathways. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced sickness for 48 hours, my system is totally aired out. Verbatim and Event Description: Phone call received from the patient regarding Pfizer-BioNTech COVID-19 Vaccine. During the call, the patient stated After first dose my system is totally aired out, miserable, sickness for 48 hours after first dose. Date the event description was reported: 23MAR2021. Outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up (06Apr2021): Follow-up attempts are completed. No further information is expected.
HAVE NEVER BEEN IN SO MUCH PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced have never been in so much pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of have never been in so much pain was not reported. This report was non-serious.
I received the vaccine around 4 PM on Friday 3/30/2018 and woke up Sunday morning (4/1/2018) feeling very ill. By Sunday night I developed a fever of 103.9, weakness, severe pharyngitis into the ear, body aches and chills. Monday I went to see my PCP because I was concerned it was strep, but the rapid test was negative. Monday afternoon I developed nasal congestion and rhinitis, nausea, and diarrhea in addition to continued fever, weakness, body aches and chills. I was unable to eat, or drink and only urinated twice Monday and twice Tuesday. By Weds I was started to feel a little better, but was still weak. I am continuing to slowly recover and returned to work for half a day on Thurs and Fri (today). I am still feeling a little unsteady and weak, and my throat is still slightly sore but is tolerable. I am now concerned about receiving the 2nd and 3rd doses of the vaccine.
Feeling pain in chest around heart; Kind of spasm; Very unconformable; Very rapid heart beat; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Feeling pain in chest around heart), MUSCLE SPASMS (Kind of spasm), DISCOMFORT (Very unconformable), PALPITATIONS (Very rapid heart beat) and DYSPNOEA (Shortness of breath) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Allergy.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Feeling pain in chest around heart), MUSCLE SPASMS (Kind of spasm), DISCOMFORT (Very unconformable), PALPITATIONS (Very rapid heart beat) and DYSPNOEA (Shortness of breath). At the time of the report, CHEST PAIN (Feeling pain in chest around heart), MUSCLE SPASMS (Kind of spasm), DISCOMFORT (Very unconformable), PALPITATIONS (Very rapid heart beat) and DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took Tylenol to reduce pain. Patient use to carry Epi pen along.