chrisvoncsefalvay/vaers-outcomes huggingface dataset:
There was a man I knew that didn't take his 2nd dose of the Moderna Covid-19 vaccine who died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (There was a man I knew that didn't take his 2nd dose of the Moderna Covid-19 vaccine who died) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 22-Nov-2021 The patient died on 22-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported  Company Comment: This is a fatal case that concerns a male patient of an unknown age, with no relevant medical history reported, who experienced the unexpected fatal event of DEATH. He died on 22-Nov-2021, after an unknown time interval after the dose of the mRNA-1273. The cause of death was not reported. The rechallenge was not applicable as no additional dose is going to be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-395669.; Sender's Comments: This is a fatal case that concerns a male patient of an unknown age, with no relevant medical history reported, who experienced the unexpected fatal event of DEATH. He died on 22-Nov-2021, after an unknown time interval after the dose of the mRNA-1273. The cause of death was not reported. The rechallenge was not applicable as no additional dose is going to be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Patient described swelling of her arm and pain to the upper part of her arm, stomach upset and nausea, chills throughout the night, and continued redness and swelling to the left arm.
About 12-14 hours after my second dose of the Pfizer Covid-19 vaccine, I had symptoms consistent with passing out. I was in bed trying to get warm from the intense chills I was feeling. My eyes felt like they rolled up to the back of my head, I felt a sinking feeling, and I snapped out of it with a warm feeling all over and my chills were gone.
This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 18-year-old female patient who received BEXSERO. Concomitant products included BEXSERO. On 24th June 2016, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site urticaria. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site urticaria were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site urticaria to be related to BEXSERO. Additional information was provided as follows: On 26th May 2016, the patient received 1st dose of BEXSERO with no reaction. No other vaccines were administered during this office visit. The 2nd dose of BEXSERO was administered on left deltoid. After administration, a red wheal was noted at the injection site which was 4 inches in diameter and slightly raised (extensive swelling of vaccination limb). No further information was reported regarding the event.
death approx 17-19hr p/vax;autopsy report list SIDS as COD;
ADVERSE EVENT NOS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious. This case, from the same reporter is linked to 20211254439.
Pt has hx of epilepsy but did not inform staff of this. Pt received vaccine. Approximately 12 minutes in to 15 minute observation period, pt expressed she began to feel an aura. RN tended to pt. Pt was safely lowered to the ground where she was placed on her right side. Pt was alert but not responding to RN questions, thus EMS was called as a precautionary. Seizure activity described as full body movements began and lasted approximately 30-40 seconds. EMS arrived post seizure. Post seizure, pt alert and answering questions appropriately. Declined going to hospital via EMS. RN placed call to pt boyfriend who came and picked up pt from the West Allis health department.
Asthma diagnosed 02Dec2021; Ventricular premature depolarization diagnosed 10Nov2021; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8734) at the age of 63 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing) and "Enlarged prostate" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6207; Anatomical site: left arm; Route of administration: unspecified), administration date: 12Mar2021, when the patient was 63 years old, for COVID-19 immunisation.  The following information was reported: ASTHMA (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Asthma diagnosed 02Dec2021"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Ventricular premature depolarization diagnosed 10Nov2021". The events "Asthma diagnosed 02Dec2021" and "Ventricular premature depolarization diagnosed 10Nov2021" were evaluated at the physician office visit. Therapeutic measures were taken as a result of asthma and ventricular extrasystoles.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment included Albuterol inhaler.
Patient reported a loss of smell from her 1st dose of Moderna COVID19 vaccine that lasted profoundly for the first 5 days after her first dose on 5/24/21 at her 2nd dose appointment on 6/21/21. She also stated that her sense of smell hasn't returned to normal completely. She said she had a negative COVID test prior to her first dose because she had a surgical procedure and didn't have any other symptoms to indicate she had a COVID infection.
Palpable lymph nodes both sides in neck, behind the collar bone and behind both ears. With mild fever of 99.3 degrees Fahrenheit.
The patient brought by her parent came to the health center for a nurse visit appointment for the COVID vaccine. An administration error and deviation occurred, the clinical staff associate administered the incorrect COVID vaccine for her age. She was given a first dose of the Moderna COVID vaccine and scheduled for a second dose appointment. Patient arrived at health center on 9/20 for her 2nd dose of Moderna and was unable to receive. The incident was forwarded to management. Nurse manage was able to gather the necessary information from parent. The mother denied her daughter having any adverse or abnormal signs and symptoms from receiving the Modera COVID vaccine, she stated "she actually did really well,
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulpha" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication was received in 2 weeks. Covid rebound symptoms 4 days after completing treatment AND testing negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore arm and shoulder-4 days. Sore throat-8days. Extreme fatigue. Sleepiness-approx. 30 days. Intermittent nausea-approx. 6 weeks. Dizziness-caused fall and visit to ER.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In March 2017, reported as on 15-MAR-2017 and 16-MAR-2017, the patients were vaccinated with improperly stored GARDASIL 9 lot # M009378, expiry date 23-APR-2018, lot # M031557, expiry date 07-APR-2019 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects noted. Administered doses of vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 10 hours. Data logger was involved. Previous temperature excursion reported was between 32 to 35 degrees Fahrenheit for 18 hours. This is one of several cases received from the same reporter. Additional information is not expected, as there was no consent given for further contact.; Sender's Comments: US-009507513-1703USA008776: US-009507513-1704USA000918: US-009507513-1704USA000916:
L arm allergic reaction with cellulitis 10/6/02. Emycin 333 tid x 10d. Prednisone 10mg 2 x day until gone x 7 days.
Per patient's girlfriend, patient momentarily passed out within a few minutes of getting the vaccine. Upon approaching him, he appeared pale. The girlfriend called 911 and they had an ambulance check him out and was fine upon their readings
Patient is on medication to block menstruation due to PMDD. Period started the next day after the shot and has not stopped  as of 10/7/21.  Doctor prescribed taking two of the birth control pills for 5 days but this has not helped.
The patient was here for a COVID booster. He received a flu shot on 9/21/2022 and was given a second one on 10/31/2022 in error.  He was scheduled on our flu/COVID clinic and the MA did not see in his EMR that he had received a flu shot already.
Vaccine administered beyond best use date. Best use date listed as 12/22. No reported adverse affects from the patient.
930am after vaccines administered, patient began screaming and wouldn't stop screaming unconsolable 1545pm - left thigh red and tender to touch, ? fever, not sure had Tylenol at 900 and 1400 patient responded well to Benadryl.
constructed, scratchy throat; constructed, scratchy throat; This is a spontaneous report from a contactable consumer or other non-health care professional. A 63 year age old male patient received bnt162b2 (Pfizer BIONTECH covid-19 vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 26Mar2021 13:30 (Lot Number: ER8727) as dose 2, single for covid-19 immunisation. Medical history included , from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took BNT162B2, Dose 1, Lot number: EN6206, for covid-19 immunisation on 05Mar2021, 12:30 PM. The patient experienced constructed, scratchy throat, constructed, scratchy throat on 27Mar2021. It was sometimes worse (splitting). My husband 63; (same date/batch) and I both have had a constructed, scratchy Throat since taking the shot. Really should warn people. It is now over 30 days. No COVID prior vaccination and no COVID tested post vaccination. Non allergic. The outcome of events was not recovered.   No follow-up attempt are possible. No further information is expected.
Patient reported having normal immunization site tenderness. Two immunizations administered into patients right arm approximately 1 and 1/2 inches apart on 10/5/16. Patient reported rash started in the evening on 10/6/16 directly over injection sites. Woke up 10/7/16 with a more prominent rash over injection site.
Patient brought into Covid Observation Area after reporting Left facial/jaw weakness and numbness, 15 minutes after receiving Pfizer Booster. Noted Left eye and Left facial droop. Daughter states patient has history of TIA 2004, with residual Left sided weakness. No deficits noted to Left arm, left leg, strong grips to both hands, positive push pull to both feet. Patient alert and oriented x 4, speech clear. Denies any chest pain or shortness of breath.  10:40am: VS: Temp 96.9, BP 130/71, HR 59. RR 18, 100%.  10:45: Patient reports improving numbness to left side of face, but reports left arm feeling numb. Noted strong grips bilaterally.  Blood pressure cuff removed from left arm and placed on right arm.  VS: BP 152/70, HR 57, RR18, 02 sats 100% RA.  10:46am- Call placed to on call ED physician, Dr. Informed of patient symptoms above. Per Dr, have patient evaluated in ER via family transport or 911. Daughter states she is able to drive patient to ED for further evaluation. Explained importance of early intervention due to patient history and symptoms she is experiencing.  10:50am: VS: BP 159/66, HR 57, RR 20, 02 sats 100% RA.  10:51am- Patient discharged. Family to transport patient to ED via  via private vehicle for further evaluation.
Patient became diaphoretic, had hot flashes and hypotensive. She was placed in a trendelburg position until her BP improved and she felt better.
Pt reported a h/o faintness with needles and blood.  Immediately following vaccination, pt felt lightheaded.  There was a brief loss of consciousness. EMS was available at the site and was immediately on hand to help.  Pt had pallor, BP 68/40, P 60.  Was assisted to lie down.  After 45 minutes patient was recovered and left independently.  BP  128/68 and P 72.  No injury.
Elevated temperature of 100.1 F, arm soreness, pain/sensitivity in the lower teeth
Awoke at 7:30am with increased injection site soreness in upper L arm and a headache with fatigue, symptoms resolved after I took a single dose of naproxen sodium 220 mg at 2pm and currently feel no side effects
pt recvd vax & exp swelling, stiffness, & aching in both ankles & left wrist & hand; the following day pt exp aching & swelling in right wrist;
This case was reported by a healthcare professional (nurse and also subject) and described the occurrence of needle stick injury in a 43-year-old female subject who was administering KINRIX (GlaxoSmithKline). On 25 March 2013 at 14:35 the subject administered a dose of KINRIX (unknown details) and experienced inadvertent exposure to vaccine. On 25 March 2013, immediately after vaccination with KINRIX, the subject experienced needle stick injury to the "top left hand". The subject (also nurse) stated that "after administering the vaccine", the plunger "fell right off" and the subject (nurse) "got pricked." This case is also associated with a product quality complaint. The healthcare professional considered the events were clinically significant (or requiring intervention). The nurse stated that "now I have to get bloodwork done to make sure I have not been infected by anything." At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with KINRIX.
No additional AE info; Nurse calling for  TE evaluation of refrigerated products mentions vaccines were administered to 4 patients.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-APR-2022, the subject was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (valid lot #U032681, expiration date: 26-OCT-2023) (strength, dose, route of administration and anatomical location were not provided) as prophylaxis. A temperature evaluation of refrigerated products  was made and showed that for 4 hours 2 minutes 0 seconds, the temperature vaccine was 58.5 Fahrenheit (F) (Product storage error). No previous temperature excursion occurred. There was no adverse event reported.  This is one of for reports received from the same reporter (captured in MARRS#2205USA000274, MARRS#2205USA000454 and MARRS#2205USA000252). ; Sender's Comments:  US-009507513-2205USA000454: US-009507513-2205USA000274: US-009507513-2205USA000252:
Right Hand eye lid began drooping on 20Jun2022 adversely affecting my eyesight.  Consulted my primary doctor at earliest opportunity on 24Jun2022.   My primary Doctor referred me to an ophthalmologist which I visited on 12Jul2022.  I am now awaiting my appointment to the eyelid surgical ophthalmologist which the earliest I could get was 29Sep2022.
This  82 year old female received the Moderna Covid shot on 2/17/21    and went to the ED on 2/25/21     and was admitted  on 2/25/21 with the following diagnoses listed below. Thrombocytopenia, unspecified
Within 7 minutes she started feeling a very warm sensation in her neck moving upwards which slowed down her breathing. She checked her pulse and it was low. She experienced blurry vision and extreme fatigue for 3 days.
I was bedridden for three days following the day I received the 1st dose. Ten days after receiving the vaccine, I got COVID arm. My doctor prescribed me antihistamines and it made me feel worse. I ended up taking Benadryl and it made me feel much better. The Benadryl helped it to not itch so bad. It lasted for four days. Ever since I received each vaccine, my arms, from wrist to elbow, itch badly on a daily basis. I have also noticed that after receiving the vaccine, I feel fatigued a lot more than I ever did. I usually hit the ground running with energy.
It has been 5 months since first vaccine; Stomach cramping; Burning stomach; really tired and down; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramping), DYSPEPSIA (Burning stomach), PRODUCT DOSE OMISSION ISSUE (It has been 5 months since first vaccine) and FATIGUE (really tired and down) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021 at 1:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021 at 2:00 AM, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramping). 11-Mar-2021 at 2:00 AM, the patient experienced DYSPEPSIA (Burning stomach). In March 2021, the patient experienced FATIGUE (really tired and down). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been 5 months since first vaccine). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramping) and DYSPEPSIA (Burning stomach) had not resolved and PRODUCT DOSE OMISSION ISSUE (It has been 5 months since first vaccine) and FATIGUE (really tired and down) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included some unspecified herbs.  Symptoms continued through 11 Mar 2021 and 12 Mar 2021. Symptoms lessened on 13 Mar 2021 and returned on 14 Mar 2021 continuing until 16 Mar 2021. recent antibody test shows that they are lower  Treatment information provided included famotidine which did not relieve symptoms   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up appended (Adverse event updated)
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 female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient received Paxlovid from 04Oct022 to 08Oct2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE; Patients that were administered products after they were involved in a temperature excursion / Temp excursion freeze was unplugged merck OK to use; This spontaneous report was received from a register nurse referring to a 4-year-old male patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 13-NOV-2022, freezer became unplugged from unit (Cord came unplugged from unit); and the vaccines were moved to the pharmacy freezer.   On 14-NOV-2022, 2 doses were given, the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot number W026315 and expiration date of 18-FEB-2024, subcutaneously on the right leg and the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot number W018837 expiration date of 14-JUN-2024, subcutaneously on the left leg both for prophylaxis. The medication error occurred in storage in clinical practice. No additional adverse events were reported.  The vaccine was exposed to a temperature excursion of 30.6°F with a time frame of 2 hours. There was no previous temperature excursion. It was unknown whether the vaccine was used according to the instruction leaflet.  A call was placed to the manufacturer and to state who advice vaccines could be given.
Case number PHEH2012US018882 is an initial spontaneous report received from a physician on 05 Sep 2012. This report refers to a male patient whose medical history, past drugs, current conditions and concomitant medications were not repotted. It was reported that he received a dose of MenA lyophilized conjugate vaccine component of MENVEO (batch number: A10033, expiry date: Sep 2012) reconstituted with MENACTRA on 04 Sep 2012. No adverse reaction was reported.
Woke up from nap with swelling right upper lip. Swelling spread to right side of face within an hour. Mother gave BENADRYL and took child to be evaluated. He was given oral prednisone and swelling significantly decreased in an hour and was gone by evening.