chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 4 vaccines Moderna 1/28/21 Lot# 007M20A;  Moderna 2/27/21 Lot# 03120A;  Moderna 11/15/21 Lot# 034F21A;  Pfizer  10/5/22 Lot# GJ5342
Patient passed away; patient had blood clots in his brain/ Legs/ Lungs/ Arms; Severe hypotension; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Patient passed away), THROMBOSIS (patient had blood clots in his brain/ Legs/ Lungs/ Arms) and HYPOTENSION (Severe hypotension) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Patient passed away) (seriousness criterion death), THROMBOSIS (patient had blood clots in his brain/ Legs/ Lungs/ Arms) (seriousness criterion death) and HYPOTENSION (Severe hypotension) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: This case concerns the death of a patient of unknown age and gender after administration of mrna-1273 ()LOT  UNKNOWN). Very limited information regarding this event/s has been provided at this time. Further information has been requested. Critical details such as the mRNA-1273 date of administration, onset of any signs an d symptoms, and date of death is lacking.; Sender's Comments: This case concerns the death of a patient of unknown age and gender after administration of mrna-1273 ()LOT UNKNOWN) .  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  Critical details such as the mRNA-1273 date of administration, onset of any signs an d symptoms, and date of death is lacking.; Reported Cause(s) of Death: Unknown cause of death
headache, joint pain, body aches, loss of energy, heart palpitations, loss of appetite
Information has been received from a Nurse Practitioner concerning an 18 year old female who on 11 Dec 2006 was vaccinated with the first dose of Gardasil (yeast) (Lot # 653736/0868F). Concomitant therapy included hormonal contraceptives (unspecified). Within 48 hours post vaccination, on approximately 13 Dec 2006 the patient experienced a severe headache. The patient sought unspecified medical attention. The headache was treated with Tylenol and resolved "in one day". Additional information has been requested.
Presented with right leg numbness on 4/8/22- underwent CTA which showed occlusive thrombus of right posterior tibial and peroneal artery- underwent embolectomy, despite attempts to salvage leg, ultimately underwent right below-knee amputation 5/3/22
Sweaty immediately after shot. No big deal. Now about 10 days after shot, still very fatigued and head foggy. The main issue is back pain. Spine pain. The top half of my spine has discomfort at its best and mild/modern pain the rest of the time. It's constant. At times my spine feels cold and tingly. Then my entire core gets cold and tingly. I've never had back pain or injured my back. This pain is directly related to the vaccine and my experience seems to be outside the norm of side effects subsiding after a couple days.
This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown ages and genders. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ lot number M004508 expiration date 29-JUN-2017. Dose, the patient's frequency, anatomical location and route of administration were not provided. Temperature: 32.9 Fahrenheit degrees, time:5 hours. Digital data logger was involved, no previous exposures and no product quality complain involved. No other suspect medications or concomitant therapies were reported. No adverse effects were reported. This is one of four reports received from the same reported. (1607USA008403-1607USA009533-1607USA009534). Additional information has been requested.
Child received a 2nd dose of FluMist, and should have only received 1 dose, due to age. Child was 10 years old at the time of the adverse event. Per mother no signs or symptoms noted after adverse event. Adverse event was reported.
Received vaccine at 4:19pm and felt ill at 10:00 pm that eve. Reports fever, chills, achy  bones, Headache, lethargy/fatigue. Sudden onset of sxs. Took Advil and slept. Able to attend college in am but remained fatigued and achy. No fever in am.
Almost 24 hours after my first vaccine, I woke up from a nap and my left armpit was swollen and sore. Within a few hours, I had throbbing pain into the left side of my breast. I assumed it was from my lymph nodes reacting, but I didn't know if this is normal or expected. Also, I hadn't heard anything about swelling, tenderness in the armpit or breast discomfort. I took tylenol and ibuprofen and the breast throbbing went away before I went to sleep that night. The swelling and tenderness in my left armpit lasted for 4 days.
Headache, dizziness, nausea, extreme fatigue, foggy head, and cognitive dysfunction the day after the vaccine
PT BEGAN TO EXPERIENCE A BLISTERS THE NEXT DAY. BLISTERS/RASH ON ABDOMEN, LEGS AND OTHER PLACES ON BODY. PT THINKS THE BLISTERS ARE SHINGLES BROUGHT ON BY THE COVID VACCINE
Pt states she went to ER at 9pm after receiving vaccine at 1000 earlier in the day. Pt had increasing swelling, redness and pain in LUE. Per pt, she developed compartment syndrome and had a LUE fasciotomy.
Approximately 3 days after influenza vaccine patient developed fine red raised rash on bicep of arm in which flu vaccine was administered. Size of rash approximately 2 inch diameter. Administration site is sore but no redness or rash identified there. Pt reports rash feels deep in skin. Pt doctor contacted and instructed to go to Doctor, however, pt called and stated rash appears to be dissipating. Did not seek further medical attention. Unclear if at all related to vaccine.
Information has been received from a consumer concerning his wife who "1 year ago" in approximately May 2007, was vaccinated with ZOSTAVAX. The patient experienced shingles "1 week ago" on approximately 20-MAY-2008. There was no product quality complaint. No further information is available.
pt stated having  3 days of high fever, weak and winded even after talking on the phone, and head aches for 10+ days. Pt reports feeling her heart rate elevated at rest confirmed by her fitbit saying heart rate in 120's. After not feeling well she had a virtual doctor appointment, they said it was just from the vaccine with no other treatment/testing done. She tested negative for COVID-19 on 3-19 after still not feeling well.  on 3/26 patient still "winded" (fatigued, not SOB per pt) but is slowly feeling better, about 90% back to normal.
Case received on 24.Oct.2011 from a pharmacist and forwarded by Crucell. The case was processed together with follow-up information received on 25- and 26.Oct.2011. This case concerns the reporter, a 52-year-old female patient who, on 21.Oct.2011, received the first dose of VIVOTIF (batch number 3002105). The patient had received Japanese encephalitis vaccine on 18.Oct.2011 and had concomitant medication with ARMOUR THYROID. It was also reported that the patient had taken VIVOTIF twice in the past without problems. On 21.Oct.2011 at 7:30, the patient took the first dose of VIVOTIF with an extra glass of water. At 8:00 ie less than one hour after VIVOTIF intake, she took her ARMOUR THYROID medication. At 8:30-9:00, the patient had breakfast with cereals and almond milk. At 11:30, while she was at work, the patient began to feel hot and took off her lab coat. Over the next hour she became very hungry. At 12:30, the patient began to feel ill and needed to sit down; she then became hot and felt like she was going to pass out. The paramedics came, administered unspecified IV treatment and took the patient to an ER, where she was stabilised. She was found with dropped blood pressure and shock. At the time of this report, the outcome was unknown. The case was considered non-serious.
3:20 pm Patient waited longer than was required in Observation as he noted a gradual onset of itching over his entire body.  He became concerned when his throat was itching and followed up with the NP in Observation. Immediate evaluation by EMS and NP.  VS Normal.   3:Benadryl 25 mg po at 3:30.  Still itching at 4:00 pm and given additional 25 mg PO of Benadryl.  Itching subsided by 1715.  Discharged at 17:23 with no additional symptoms noted. Airway remained patent. No increase in secretions or difficulty swallowing.
Large, red, swollen approx 6" wide x 4" long (oval) around the injection site. Very sore to the touch.  Very hard knot around injection site.
59 yo BF presented to clinic 3/24/09 with c/o pins and needles and tingling in right arm x ~ 3.5 weeks. Onset was weeks following 02/09/2009 vaccination with Hepatitis B vaccine and influenza IM injections in the right arm. MD will continue to monitor. Unclear association at this time. Pt will return to clinic for f/u in ~1 month.
received only adjuvant portion of Shingrix without reconstitution; received only adjuvant portion of Shingrix without reconstitution; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 7532P, expiry date 18-AUG-2024) for prophylaxis.   On 05-OCT-2023, the patient received Shingrix. On 05-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only adjuvant portion of Shingrix without reconstitution) and inappropriate dose of vaccine administered (Verbatim: received only adjuvant portion of Shingrix without reconstitution).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The pharmacy manager requested data on the administration of adjuvant portion of Shingrix without reconstitution. They had 4 patients (unknown) to received Shingrix between Oct 5, 2023 and Oct 6, 2023 and one of the patients did not receive a full dose because there was an extra lyophilized vial. The pharmacy manager requested additional data if they revaccinate all 4 of the patients, was there any harm in giving 3 doses of Shingrix vaccine. The patients were unknown to the pharmacy manager at time of call to medical information. No patient was re-administered a dose of Shingrix at the time of the call, per the call, the pharmacy manager was going to wait 2 months prior to have each patient return for another Shingrix vaccine. Patients were potentially going to receive 3 total doses by the end of the Shingrix series. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Lasting pain initially at injection sight spreading with occasional pain shots down the arm. Pain has been on going since injection
Sensation of tongue swelling during observation-about 15 minutes after vaccine, Medical Emergency team called and arrived less than 10 minutes after call, they assessed and brought pt to ED. Pt's vitals were recorded & stable and information sheet given to ED team. Copy scanned into pt's chart.
she could feel the vaccine going through the muscle/ felt this on the left side of her back; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SENSORY DISTURBANCE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "she could feel the vaccine going through the muscle/ felt this on the left side of her back".  Additional information: The patient's age was reported as 75 (unit: unspecified). The event started 6 hours after receiving the first dose 3 weeks prior and it lasted one minute.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received fro a physician concerning a 75 year old female who on 21-AUG-2007 was vaccinated with a dose of 0.65 ml ZOSTAVAX vaccine (Oka/Merck). On 03-JUN-2008 the patient experienced shingles rash. The patient was seen by the physician. Additional information has been requested.
Symptoms began approximately 14 days after vaccines were administered. We first noticed a small vesicle on her right outer thigh approx 12 days after vaccination. Two days later she developed a fever 102.5, anorexia, and fatigue. Other vesicular lesions developed on her left thigh (1) and her lower torso. We have been managing her symptoms at home.
Temperature of 103 for two days; severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Oct2021 at 03:15 PM, at 72-year-old, as single dose (Lot Number: FF8839) for covid-19 immunisation. The patient was not pregnant at the time of vaccine. Known allergies was penicillin. Other medical history was none. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 at 01:00 pm, as single dose (Lot number: EL9266) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Mar2021 at 04:00 pm, as single dose (Lot number: EN6206) for covid-19 immunisation. The patient was 71-year-old at first and second dose. No other vaccine in four weeks. There were other medications in two weeks (as reported). Prior vaccination the patient had not got covid and the patient had not been tested covid post vaccination. The patient stated she had temperature of 103 for two days and severe diarrhea on 03Oct2021 at 07:00 AM. The patient got no treatment for events fever and diarrhea. The outcome of events temperature of 103 and severe diarrhea was recovering.  Follow-up attempts are completed. No further information is expected.
sore arm; The patient got the flu and pneumococcal 13-valent conjugate vaccines at the same appointment; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 30Sep2020 at single dose for immunization; and influenza vaccine (FLU), via an unspecified route of administration on 30Sep2020 at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient got the flu and pneumococcal 13-valent conjugate vaccines at the same appointment. The patient had a very sore arm for 48 hours. While it was sore, the patient was able to fully use it. The shots were administered on 30Sep. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Mild reaction on my arm; A spontaneous report was received from a consumer concerning a 80-year-old, male patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who had experienced mild reaction on arm.  The patient's medical history, is not provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 15 Jan 2021. Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Experienced mild reaction on arm.   No relevant lab data is reported by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of event, mild reaction on arm was unknown.   The reporter did not provide an assessment for the events,mild reaction on arm.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Pt tested positive for COVID on admission for non COVID related issues.  Asymptomatic for COVID
Subjective left facial muscle weakness/numbness two days after vaccine. Treated with prednisone, valacyclovir for presumed Bell's Palsy.
At the time the Moderna covid-19 vaccine was given the patient was 17 years of age.
HCP reports possibility of three doses of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional details were provided as follows: The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The healthcare professional reported possibility of three doses of Shingrix for the patient, which led to extra dose administered. No further information was reported. Note: This case was conservatively kept valid with event extra dose administered as it was not clear if the patient had received extra dose or not.
58 years old patient was administered Menveo 2 vial; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 58-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 26-SEP-2023, the patient received Menveo. On 26-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 58 years old patient was administered Menveo 2 vial).The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2023 The reporter stated that 58 year old patient was administered Menveo 2 vial the day before reporting as she was traveling to a high endemic area, which led to inappropriate age at vaccine administration. No lot/expiration date was available. The reporter consented to follow up.
L ARM PAIN, SEVERE BODY ACHES, JOINT PAIN, HEADACHES, FEVER AND FLU LIKE SYMPTOMS. BODYACHES, ARM PAIN, FEVER,  SHORTNESS OF BREATH, NAUSEA, VOMITING CHEST PAIN
Information has been received from a licensed visiting nurse concerning a 17 year old white female who on 13-SEP-2007 at 16:00 (previously reported as 14-SEP-2007) was inadvertently vaccinated with the second SC dose of varicella virus vaccine live (Oka/Merck) (lot# 657105/1000U) in the right arm 6 days after first dose (lot# 657105/1000U) on 07-SEP-2007 (previously reported as 8 days after dose). No adverse symptoms were reported. It was noted that the patient was scheduled to receive a dose of Gardasil (MSD). No medical attention was sought. There was no product quality complaint. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 27-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # 672676/0069AE, expiry: 03-APR-2013) subcutaneously which had expired. The pharmacist did not know the day of the month on which the ZOSTAVAX expired. No adverse effects reported. Additional information has been requested.
No additional adverse effect reported; PNEUMOVAX23 underwent temperature excursions was administered; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On 20-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T020639, for prophylaxis (strength, dose and route were not provided). The administered vaccine underwent temperature excursions (Product storage error). The storage temperature of the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was reported as below 36 degree Fahrenheit (34.0 degree Fahrenheit) for a time frame of 12 hours 57 minutes. There was no previous temperature excursion. No additional adverse effect reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2109USA007275:
Information has been received from a licensed practical nurse (L.P.N.) concerning a 24 month old premature born male (2 month early) with asthma who was vaccinated subcutaneously with a first 0.5 ml dose of VARIVAX "at one year old" (in approximately November 2007). On 05-DEC-2008 the patient received a second dose of VARIVAX. On the same day, he also received a dose of "flu shot" (manufacturer unknown). On 06-DEC-2008 the patient developed fever as high as 103 degrees F, wheezing and shortness of breath. He was seen at an urgent care center and was given antibiotics and "mini-neb" treatments. It was reported that no lab diagnostics studies were performed. The patient was seen in a physician's office since the events had not improved "over the weekend". At the time of the report, 08-DEC-2008, the patient had not recovered. Follow-up information received on 02-FEB-2009 from the L.P.N. indicated that the patient was a premature baby born at 31 weeks gestation. On 05-DEC-2008, at 15:30, the patient was vaccinated in the right thigh with a second dose of VARIVAX (Lot #661008/1317X). It was reported that illness at the time of vaccination included reactive airway disease (RAD) and seasonal allergies. In the afternoon of 06-DEC-2008, the patient developed RAD, fever of 103 and vomited once. Respiratory Syncytial Virus (RSV) test was negative. Chest x-ray showed no active disease. The patient was treated with AUGMENTIN, albuterol (via nebulizer), PEDIAPRED and TYLENOL. It was reported that the patient recovered. His last visit was on 12-DEC-2008. The reporter considered the patient's events to be other important medical events. Additional information has been requested.
Case number PHEH2014US024343, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow up information received from the nurse on 26 Jan 2015. This report refers to a 67-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 14511P. expiry date: Mar 2015) intramuscularly in right deltoid at a dose of 0.5 ml on 04 Nov 2014. The nurse reported that FLUVIRIN prefilled syringe stored at 49 F for 1 hours and 15 minutes was administered to the patient. No adverse event reported following this medication error. No adverse events occurred due to vaccination. Follow up information received from the nurse on 26 Jan 2015: Updated site of vaccination and reporter comment in narrative only.
Patient received full dose (0.5mL) Moderna Third Dose. Patient should have received Moderna Booster Dose (half-dose, 0.25mL).