chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 2nd dose of COVID-19 Moderna vaccine. Monitored patient for 10 minutes and she reported feeling faint and dizzy. She had not eaten since breakfast. Patient slid out of chair. RN helped ease to floor; observed gasping. The patient became unconscious. RN called 911, initiated CPR and administered EpiPen. Patient responded to CPR and EpiPen. She began aspirating. She was turned to her side and began coughing. Her pulse was irregular. The patient continued to be monitored and vitals obtained: RR 22, pulse 102, SPO2 97, BP 190/56. An ambulance arrived; patient was alert and oriented.
A non-serious spontaneous report of inadvertent administration of FLUMIST to a person greater than 49 years of age was received from a health professional concerning a 52-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 19-Oct-2011. FLUMIST was inadvertently administered to a 52-year-old female. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pt given Hep A 1st dose and Tdap on 4/11/06, and on 4/12/06 pt woke up feeling chilled with a fever of 102.  Denies any other symptoms. Had fever off and on all day, used antipyretic to reduce fever, was back to normal by 7pm on 4/12/06.
1. Extreme fatigue, requiring two 2 hour naps.  2. Approximately 12 hours after vaccine, lost sense of muscle mobility. All muscles were weak and flaccid. This sensation remained for about one hour, then muscular ability resumed.
Administered on 10/11/21 with 30mins dizzy, lightheaded, with 4 hrs horrible jaw pain on same side as injection lasting approximately 2 wks, unadle to properly chew food on left side, also left sided facial and neck pain lasting 2 wks.
I was vaccinated with 1 primary dose of J&J Covid vaccine on 4/8/2021, 1st primary dose of Pfizer Covid vaccine on 6/28/2021, and 2nd primary dose of Pfizer Covid vaccine on 7/19/2021. No noticeable issues with my body in 2021.  Slight tremor in my hand in early 2022 which I saw Dr.  on 3/25/2022 by virtual visit. Also experienced dizziness, face easily overheating/feeling flushed/red, resting heart rate at 100 bpm with onset in March 2022 as well. My weight as this time was 135 lb when I had been 145 lb in January 2022. I also mentioned I had what I believed to be hyperhidrosis or oversweating from my palms, armpits, and feet since I was 10, possibly even earlier. These were originally explained as due to a lack of sleep and stopping exercise and eating enough to maintain muscle weight.   I saw Dr.  for an annual physical on 6/17/2022. The dizziness and the tremor in my hand was gone by then. My weight was now 125 lb. We did blood tests for my thyroid along with other tests, and a few days later discovered that I had hyperthyroidism.
Arm very sore; A lot of soreness in the lymph nodes on her neck; The lymph node near front of neck slightly swollen; Vertigo; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 14:00 (Lot number: ER8727) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: breast cancer 4 years ago. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Mar2021 18:00, outcome "recovering", described as "Arm very sore"; LYMPH NODE PAIN (non-serious) with onset 30Mar2021 18:00, outcome "recovering", described as "A lot of soreness in the lymph nodes on her neck"; LYMPHADENOPATHY (non-serious) with onset 30Mar2021 18:00, outcome "recovering", described as "The lymph node near front of neck slightly swollen"; VERTIGO (non-serious) with onset 30Mar2021 18:00, outcome "recovering", described as "Vertigo"; DIZZINESS (non-serious) with onset 30Mar2021 18:00, outcome "recovering", described as "Dizziness".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not have allergy to medication, food, or other products.  No follow-up attempts are possible. No further information is expected.
No adverse effects were reported.  I am reporting a dosing error.  I gave pt. 20mcg Engerix dose instead of 10mcg Engerix dose for his age of 19.  I spoke to manufacturer, manufacturer said to continue dosing schedule according to age.
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 49-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 49-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
sore arm; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and PYREXIA (fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Apr-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) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) outcome was unknown.
Body aches, headache, chills, nausea. Started 11 hrs after injection
I started to get very achy knee joints.; The achy joints progressed to my hands and ankles and feet.; swollen; had difficulty walking and clenching and grasping with my hands; This is a spontaneous report from a contactable consumer. A 63-year-old male consumer received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8730, Expiration date: unknown) via an unspecified rout in right arm on 03Apr2021 at 07:30 am (at the age of 63-year-old) as dose 2, single for COVID-19 immunisation. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6203, Expiration date: unknown) via an unspecified rout in left arm on 13Mar2021 at 08:30 am (at the age of 63-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Non-Hodgkins Lymphoma. Patient had no known allergies. Concomitant medications were not reported. The patient reported that on 06Apr2021 "3 days following the second Covid 19 vaccine he started to get very achy knee joints. The achy joints progressed to his hands and ankles and feet. The symptoms progressed further and his hands, feet, and ankle became very swollen, very painful and he was unable to wear my regular shoes, and had difficulty walking and clenching and grasping with his hands. My joints are very painful". It was reported that the patient had other medications in two weeks, had not covid prior vaccination, not covid tested post vaccination. Treatment was given with Prednisone since symptoms occurred. Patient underwent laboratory test included Nasal Swab on May2021 resulted Negative. Outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
pt exp fever 104.6 R;difficult to wake;call to MD & was recommended pt be put in bath & APAP started 30" p/vax;sz (jerking, staring, glossy eyes);02 was began as 02 level was 82;bad cold;pharyngitis & bilat OM;feb sz
Pt recvd 3 doses of vax & p/3rd dose pt's liver function tests were elevated;
Pain and severe swelling from injection site down to knee. Couldn't walk. Cellulitis/severe infection. 1/29/09-DC summary received for DOS 12/3-12/5/08-DC DX Right thigh cellulitis. Presented with right thigh swelling, redness and pain.
Day after injection: fever 101.6, chills, sweats, aches, pain at injection site, headache BP very low 87/45 at night, dehydrated 2nd day after: fever 100.6, same symptoms but lesser degree, BP114/79 3rd day after: fever 99.6, symptoms lessening but still chills and sweat. Moderna was the manufacturer What was most alarming was the low BP/ By the way, I had Covid in late March early April and still have antibodies.
Pt develp fever occurred about 2 hrs p/receiving vax; highest temp recorded 102.6 ax; Fever lasted approx 18-20 hrs; 26JUN91 broke out w/rash;
Pt exp a shoulder ache following vax w/Hep B; No further details were provided;
COVID 19 Treatment; COVID 19 Treatment; 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), on 15Feb2021 as dose 1, single (Lot number: En6201), on 09Mar2021 as dose 2, single (Lot number: En6206), on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A) and on 18Apr2022 as dose 4 (booster), single (Lot number: Fm9992) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
THE SAME DAY OF MY SECOND VACCINE AND ONE DAY LATER I EXPERIENCED A KIND OF JUMPS ON MY LEFT CHEK, MY NOSE FLOW MORE THAN NORMAL AND A LITTLE BLOOD CAME OUT OF MY NOSE
Initial report was received from a lay press report on 07 November 2011. Verbatim from report: "Ordinary flu vaccine has always worked out for a 77-year-old was perplexed on a recent Monday when her clinic gave her high-dose version without asking first. Confusion turned to anger that night as she lay in bed at her home. Her muscles ached, her head pounded and her stomach churned. "I've had the flu shot before and never had a problem", she said. "Why was this different?" She was back to full strength the following Friday. But she wonders if she would have taken the high-dose version if her clinic had offered her a choice. The outcome was not reported. Documents held by sender: none.
temperature excursion and reported VARIVAX that had undergone temperature excursion was administered to a patient; No additional AE reported; This spontaneous report was received from medical assistant and refers to an approximately 18-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-NOV-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) valid lot #U029496, expiration date: 21-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided). That vaccine experienced a temperature excursion (Product storage error). It was reported that there was a previous temperature excursion, which was -10 degrees Celsius (C) up to 8 C (-7.2C) for 7 hours 54 minutes and 0 seconds, and the current excursion was -10 C up to 8 C (0.1C) for 444 hours 0 minutes and 0 seconds (also reported as 442). No further information was provided. No additional adverse event was reported (No adverse event).
It started under my left breast with a numbness, a rash started in the same spot on Sunday and I went to urgent care where I  was diagnosed with Shingles, over the next few weeks it wrapped around my left side to my back it was burning and itchy feeling that lasted a bout a week but two weeks tor get resolved.
HYPOTENSION CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 11/17/2022,  12/30/2022,  1/18/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
SEVERE weakness in legs and arms. SOB, headache, neck weakness, twitching, jerking, uncoordinated, dizzy, hardly able to walk, mind fog, chest pain.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a six-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
No adverse event; expired vaccine was dosed to 4 individuals; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In July 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that expired vaccine was dosed to 4 individuals on 10-Jul-2023, 14-Jul-2023 and 17-Jul-2023. The  vial size was unknown. The vial was initially stored in the refrigerator on 10-Jul-2023. The vial did not undergo any temperature excursions. NDC number was reported as 80777028299. No treatment medication was reported.  This case contains information about patient 3 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733819 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733819:Master case (Patient 1)
arm was also sore for a bit; headache; muscle pain; joint pain; chills; nausea; ran a fever for about 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was also sore for a bit), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Diabetes, COPD, Asthma and Hypertension. Concomitant products included WARFARIN SODIUM (COUMADIN) for Clot blood.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was also sore for a bit), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (ran a fever for about 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was also sore for a bit), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (ran a fever for about 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Had fever shortly after the vaccination, swollen lymphnodes, and hot red raised injection sight. I have had itchy throat for 8 days and hives for the last 3 days.
Patient was found to have NSVT on recent pacemaker check.  This occurred 4 days after receiving her 2nd Pfizer COVID-19 vaccination.  Patient states it was a 'blip' on her device.  She had no further other symptoms noted.  Patient is unsure if is related to the vaccine or if this was something else related to cardiac history.  Her primary care provider did ask that she report this.
Mild fatigue and muscle ache lasting 2 days; Mild fatigue and muscle ache lasting 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Apr2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Intramuscularly in upper right arm at 11:30 as dose 1, single), administration date: 04Mar2021, when the patient was 75 years old, for COVID-19 immunisation, reaction(s): "tested positive for Covid-19". The following information was reported: FATIGUE (non-serious), MYALGIA (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "Mild fatigue and muscle ache lasting 2 days".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient started having multiple CHF exacerbations 10 days post vaccine after having been mostly stable for a while. He was repeatedly readmitted for exacerbations and ultimately was deemed not a candidate for advanced cardiac therapies due to some life choices. He ultimately succumbed to his illness on 09/10/2021
I've been having really painful menstrual cramps and heavier than normal flow and spotting.
Minutes after I received the injection -- I felt a shiver/chill throughout my entire body.  These shivers/chills are still happening daily -- about 5 times/day.  I also have had very sore leg muscles and knee pain since the vaccine.  I've had some soreness in my knees before but this is very different.  It is preventing me from walks etc.
Patient reported significant pain during administration of Prevnar 13 vaccine.  Similar complaints from other patients have been received recently at this clinic.
A non-serious spontaneous report of "administration of expired product" was received from a registered nurse concerning a five-year-old female subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The product expired on 19-Jan-2010. On 27-Jan-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy), ERYTHEMA (red) and URTICARIA (hives) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (itchy), ERYTHEMA (red) and URTICARIA (hives). The patient was treated with ISOPROPANOL (RUBBING ALCOHOL) for Itching, at an unspecified dose and frequency and CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy) was resolving and ERYTHEMA (red) and URTICARIA (hives) had not resolved. Not Provided      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.   No concomitant medication was provided.
Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 16-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3755AA received on 17 May 2011, lot number C3755AA received on 26 July 2011 and lot number C3796AA received on 25 October 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 25 May 2012, approximately seven months after the last dose. On 25 May 2012, the subject developed a cough and paroxysmal cough on 30 May 2012 without a whoop. Laboratory testing included positive PCR on 01 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 08 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Found down at work. Head CT revealed R basal ganglia hemorrhage with extension into R lateral ventrical. Started on IV cardene. No surgery indicated.
10/20/14 PM chills, body aches-continued into 10/21/14. 10/21/14 AM vomiting-coffee ground emesis x1-called PCP-ZOFRAN. (Vomited 3-4 x total) Dizzy. 10/22/14, 10/23/14 Weakness, general body aches persisted, Gatorade for dehydration-persisted. 10/30/14 Saw PCP-lab work ordered EKG WNL.
(L) headache, scalp itching, burning beginning 2 days after being given vaccine on 8/7/08. Effects slowly resolved and became intermittent only with periods of stress for 3-4 weeks. No sx's after 9/10/08.
patient developed chest pain and shortness of breath 2 days after receiving 2nf covid vaccine. he presented to urgent care/followed by ED transfer for ST elevation on EKG and elevated troponin (0.72 ng/ml)
Covid Arm reaction 5 days after the second Moderna dose -- an angry dark red blotch 6 in by 4 inches that persisted for 4 days before fading in color.  It was warm to the touch and itched.
pt recv vax 7APR97 & 8APR97 had swelling & tenderness @ site;9APR97 felt disorientated, just felt odd noted light sensitivity (photophobia) 10APR97;11APR97 malaise, eyes hurt;12APR97 h/a, muscle ache, vertigo, t101;rash face & abd;