chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 01/19/2021 and 02/16/2021. Lot numbers, clinic, and injection sites were not entered into the immunization system. The individual tested positive for COVID-19 several times: tests were positive on 01/12/2022 (x2), 01/20/2022, 01/25/2022, 01/26/2022, and 01/31/2022. They presented to emergency department on 01/19/2022 with primary complaints of anemia symptoms, diarrhea, and dehydration. The individual was admitted to 01/19/2022. They were found to have Cryptosporidum antigen in stool sample. They were also found to have esophargitis, Hypernatremia, pulmonary infiltrates, and encephalopathy.  The individual was put on palliative care on 02/04/2022 and died on 02/05/2022.  The individual was immunosuppressed due to medication, having received a heart transplant about 20 years ago. The individual was not boosted, having received only 2 doses of COVID-19 vaccines.
Patient states injection site became hot, red, swollen area with bruising 3-inches long.
Patient was placed in observation area post Pfizer COVID vac administration. After Approximately 10 minutes, patient Passed out and was found on the floor with wound on (L) side of forehead with bleeding noted. Large knot noted above (L) eyebrow. BP 116/60  Awake, responsive, diaphoretic, bounding pulse, pale. Patient was assisted to stretcher with O2 at 2L NC and ED team transported to  ER. Given fluids in ER.
pt recv vax &  became pregnant (LMP 12DEC95);estimated delivery date is 18SEP96;12JAN96 lab eval revealed a negative varicella antibody titer;@ time of report, pt @ 27wk gestation no other adverse exp,no pregnancy complications;nl delivery;
Shot administered in Left deltoid Terrible shoulder, elbow, back & arm pains Headaches Nerve pains Took notes as symptoms varied and increased/decreased with attempts to treat
Vision Problems; Information has been received from a lawyer regarding a case in litigation and refers to a currently 67 or 68-years-old patient (pt.) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-SEP-2016, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as subsequently), the pt. was treated by health care providers (HCP) for vision problems (visual impairment). The pt. claimed damages as a result of injuries to itself. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Muscle aches and joint pain over 7 days now. I also had some bloating with the injection for a few days after. Symptoms started 30 minutes post injection. I started with headache and fatigue, along with the muscle and joint aches; the joint aches have persisted.
1. One week after the 1st shot, skin rash on the back of my neck. Lasted about a couple of weeks.  2. On the same day of the 2nd shot, more than 30 tiny subcutaneous bleeding points on my left eye lid. Recovered the next morning.  3. Two days after the 2nd shot, monthly period came, 6 days earlier than it should be, with interval from the last month of 22 days (usual interval of 28 days). And it took about 2 weeks to almost finish (last month it was 5 days to finish). 4. Generally feel tired and weaker ever after the 2nd shot. Not recovered as of today.
Patient started having chest pain and SOB 2 days after shot with severe swelling of (R) arm.  10/27/08 MR received for DOS 10/10-16/2008 with D/C DX: Acute Respiratory Failure. Severe Hypokalemia. Congestive Failure. COPD. Morbid Obesity. HTN. Sleep Apnea. Severe Degenerative Arthritis.  Pt presented after recent hospital d/c for sepsis, with c/o allergic rxn to Pneumovax received upon d/c. Pt developed SOB, wheezing, fever and redness and swelling of the arm. Noted to be hypokalemic on admission with bilateral wheeze and rhonchi. Tx with abx, steroids, and K+ with improved fever and SOB.
she may have had an allergic reaction the shot; Greater than 35 days between Moderna Covid-19 vaccinations; Covid Arm; And it is itchy progressively moving down her arm; she noticed a welt on her at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (she may have had an allergic reaction the shot), TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations), VACCINATION SITE PRURITUS (And it is itchy progressively moving down her arm) and VACCINATION SITE URTICARIA (she noticed a welt on her at the site of injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (And it is itchy progressively moving down her arm) and VACCINATION SITE URTICARIA (she noticed a welt on her at the site of injection). On 29-Mar-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid Arm). On an unknown date, the patient experienced ALLERGY TO VACCINE (she may have had an allergic reaction the shot) and INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations). At the time of the report, ALLERGY TO VACCINE (she may have had an allergic reaction the shot), TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), VACCINATION SITE PRURITUS (And it is itchy progressively moving down her arm) and VACCINATION SITE URTICARIA (she noticed a welt on her at the site of injection) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided.  Treatment details included Cortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up information received contains added event - Delayed type hypersensitivity and Intentional deviation from dosage regimen added.
This spontaneous report was received from a health professional refers to unspecified number of patient of unknown demographics. These unspecified patients were administered an unspecified number of doses of improperly stored ROTATEQ (lot # and expiry date unspecified) on an unspecified date since 02-FEB-2015. No adverse effects were reported. Outcome of the event was unknown. The reporter considered the event to be related to ROTATEQ. This is one of several reports from the same reporter (MARRS # 1503USA006661). Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020). On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, fever, chills and malaise. On an unknown date, the outcome of the injection site erythema, fever, chills and malaise were recovering/resolving. The reporter considered the injection site erythema, fever, chills and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: At 13:15, the patient received SHINGRIX on right deltoid. The healthcare professional was unsure of symptoms onset day, but believed it was within 24 hours of administration.
Erythema multiforme (rash) prior-seen in office 8/1/02 and 8/6/02.
Shivering, hot and cold, body aches, body sweats, low fever 99.5 max., weakness/tired from 6am until approx. 4am the next day when I went to sleep.
Fever, chills, body aches, headache, vomiting all within of 4 hours of getting the vaccine. Taken Tylenol, zofran,  and dicyclomine
One day after the vaccine, I had chills, muscle aches, headache, and neck pain on the left side. Two days after the shot, my chills went away, and neck pain increased. The neck pain has persisted since then and only worsened. I have a hard time fully opening my jaw to eat.
About half an hour after I got vaccinated, all of a sudden my mouth and throat got a very weird sensation. They were very dry with a strange metallic taste. I drank plenty of water but the feeling stayed for a couple hours. Next morning I thought it was all gone, but the same feeling came back with a lesser intensity. It gradually faded away. My shoulder got really sore for about two-three days. It was hard to lift my arm above my head. This morning I woke up with swollen lymph nodes in the armpit on the side where I got the injection.
Arm is sore to the touch; His arm is sore to the touch and it is a little red at the site, and it itches. He states he can feel a knot there; His arm is sore to the touch and it is a little red at the site, and it itches.; A little red at the site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore to the touch), VACCINATION SITE INDURATION (His arm is sore to the touch and it is a little red at the site, and it itches. He states he can feel a knot there), VACCINATION SITE PRURITUS (His arm is sore to the touch and it is a little red at the site, and it itches.) and VACCINATION SITE ERYTHEMA (A little red at the site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AMLODIPINE, FINASTERIDE, FUROSEMIDE, UMECLIDINIUM BROMIDE (INCRUSE ELLIPTA), LISINOPRIL, METFORMIN, PHENTERMINE, PREDNISOLONE, FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]), LOVASTATIN and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore to the touch), VACCINATION SITE INDURATION (His arm is sore to the touch and it is a little red at the site, and it itches. He states he can feel a knot there), VACCINATION SITE PRURITUS (His arm is sore to the touch and it is a little red at the site, and it itches.) and VACCINATION SITE ERYTHEMA (A little red at the site). At the time of the report, PAIN IN EXTREMITY (Arm is sore to the touch), VACCINATION SITE INDURATION (His arm is sore to the touch and it is a little red at the site, and it itches. He states he can feel a knot there), VACCINATION SITE PRURITUS (His arm is sore to the touch and it is a little red at the site, and it itches.) and VACCINATION SITE ERYTHEMA (A little red at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported
DEVELOPED HIVES ON BUTTOCK, UPPER THIGHS, AND WRISTS. COMPLAINING OF ITCHING. SEEN BY MD - NO OTHER EXPLANATION FOR REACTION EXCEPT FOR THE VACCINE.
This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection, lot # N009775, expiration date 20-SEP-2018, for prophylaxis (strength, dose, route and anatomical location not reported), which was inappropriately stored. The reporter stated that the vaccine had been under temperatures from -14 °C to -10 °C for 360 hours, without a previous temperature excursion. The sterile diluent (MERCK STERILE DILUENT) used for reconstitution of the dose of PROQUAD was properly stored. No adverse effects reported. This call was made because of a digital data logger. This is one of several reports coming from the same source.; Sender's Comments: US-009507513-1712USA014470: US-009507513-1712USA014472: US-009507513-1712USA014469: US-009507513-1712USA014468: US-009507513-1712USA014471:
10/15/2004 Patient received DT vaccine, 10/15/2004 PM confusion/delerious overnight.  No documented fever.  Developed fever on 10/17/2004.  10/19/ evaluated for dizziness.  Noted viral pharyngitis (strep test negative 10/19/).
Myalgia Fatigue, Half of left arm felt numb for more than an hour.
Slight fever 10/15, temperature 104 on 10/16, with eyes roll back, seemed unresponsive.  Head jerked to side (this is a new trich of his).  No arm or leg movement noted.  Did not turn cyanotic this may have been a febrile seizure.  Given 48 hours of oral antibiotic (Amoxicillin, eefrizil).
6 days after vaccine, I noticed a red small circle at the injection site. I pressed on it slightly and noticed it hurt to the touch. The next day I woke up with a red rash at the injection site. It hurts to the touch still.
Heart fluttering that became more and more frequent for further durations of time, Holter monitor that was prescribed determined that I was having atrial fibrillation and atrial flutter. Next step was to go to a cardiologist, was given the options of medication or an ablation onto the heart. I decided to go with the ablation and will be going on with this procedure on Tuesday 12/21/2021. Doctor did explain that this procedure may not work, being about 90% affective.
Pt recvd vax on 3JUN92 & on 8JUN92 pt devel sudden onset of flu-like sx, including diarrhea w/black stools, feverish feeling, & aching in joints;
Body aches; woke up with a fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and PYREXIA (woke up with a fever) 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 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (woke up with a fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in October 2021 for Fever, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches) outcome was unknown and PYREXIA (woke up with a fever) was resolving.            NO Concomitant drug reported.   This case was linked to MOD-2021-370234 (Patient Link).
Patient was mistakenly given MMRV and Varicella at the same time.  Mother reported elevated temp and redness at the site of the MMRV.  There aren't any adverse affects at this time, but we were told to complete this report anyway.
severe prolonged crying w/irritability w/in 24hr of vax >4hr of crying;fever to 101 for 24hr;
Diagnosed with Shingles; Rash; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included ongoing valacyclovir. In Mar2021, the patient had rash; and was diagnosed with shingles. The outcome of the events was unknown.  Information about batch/lot number has been requested.
MISSED THE THIRD DOSE; VOMITED THE SECOND DOSE OF VIVOTIF; This spontaneous case report was received from a caregiver (PVX2019-505) on 25-Feb-2019. The report describes a female consumer who "vomited the second dose of Vivotif" and "missed the third dose". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   It was reported that the consumer took the first two doses of Vivotif on 20-Feb-2019 and 22-Feb-2019, respectively. On 23-Feb-2019, she vomited and saw the pill in her vomit. She did not vomit afterwards. She did not take any more doses afterwards and planning to take vaccine shots.  The caregiver also stated that her daughter was not ill. She did not believe that vomiting was due to the Vivotif as the consumer also vomited a week before she started Vivotif.  The action taken with Vivotif with respect to the event "vomited the second dose of Vivotif" was dosage discontinued while with respect to the event "missed the third dose" was not applicable.  The clinical outcome of the event "vomited the second dose of Vivotif" was resolved while with respect to the event "missed the third dose" was unknown.  Company's Comment: In this case, it was reported that the consumer "vomited the second dose of Vivotif" and "missed the third dose". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took unrefrigerated doses" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer "vomited the second dose of Vivotif" and "missed the third dose". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took unrefrigerated doses" was considered as not applicable.
Approximately 1 week post Tdap injection, presented with half-dollar size knot right deltoid area. 5-8-08 knot same size right deltoid area is now red, hot to tough and painful to touch.
8 days, post vax, developed red, itchy, indurated lesion (0.3cm) with 3 papules/vesicles at injection site. 1 day later, further red, itchy papules on trunk and extremities.
Onset @ 1:00 am 01/17/21: Nausea, Dizziness, Tremors, Chills, Headache, and weakness
Redness, warm, swelling and then just pain. Went to ER-given BENADRYL-resolved.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Patient was very clammy and hot-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild
Narrative: COVID infections following completion of COVID vaccine series 05/28/21 COVID vaccine dose #1 (J&J) 07/21/21 Pt presents to screening denying symptoms; reports close exposure to COVID positive person (wife); COVID NEGATIVE 07/23/21 Pt presents to screening asymptomatic but states that family member tested positive; COVID negative 07/28/21 Pt presents to screening reporting cough and headache for 2 days and exposure to COVID positive wife; COVID POSITIVE 07/30/21 Pt reports improved symptoms of chills, cough, fatigue, fever, muscle pain, runny nose, SOB, sore throat and headache; continued loss of taste/smell
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hyper- cholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 05Aug2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL9265, Anatomical location: Arm Left), administration date: 28Jan2021, when the patient was 64-year-old, for COVID-19 immunisation, reaction(s): "If you were talking about adverse events of the Pfizer vaccine for go series. There were none other than pain add the injection site"; BNT162b2 (DOSE 2, SINGLE, Lot number: EL9266, Anatomical location: Arm Left), administration date: 25Feb2021, when the patient was 64-year-old, for COVID-19 immunisation, reaction(s): "If you were talking about adverse events of the Pfizer vaccine for go series. There were none other than pain add the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "If you were talking about adverse events of the Pfizer vaccine for go series. There were none other than pain add the injection site". Additional information: Patient received BNT162b2, on 25Jun2022 as dose 4 (booster), single (Lot number: FP7135) in left arm.
Nausea and headache appeared immediately. Began vomiting + diarrhea within 2 hours of injection time. After being unable to keep food/fluids down over 24 hours, was instructed to go to ER.
SHAKING, AS IF COLD. STARTED ON 10/27/2023. PATIENT WAS ASSESSED FOR CELLULITIS/INFECTION BUT DID NOT PRESENT WITH ANYTHING EXCEPT CHILLS/SHAKING. RECOMMENDED PATIENT BE SEEN BY PRIMARY CARE UNLESS CONDITION WORSENS AT WHICH POINT THE PATIENT SHOULD SEEK MORE URGENT CARE.
Lip swelling and hives to arms and back.  IV Benadryl, Solumedrol, and Pepcid administered.
Vertigo, moderate fever, aches, headache, fatigue.  All symptoms went away within 36 hours except vertigo. Vertigo lasted for several more days requiring adjustment to activity and then ultimately Epley procedures to get rid of vertigo.
I've had shortness of breath for the last 3 weeks since I've gotten the vaccine. The day after I've had severe leg pains and sometimes that pain comes but not all the time.
some peculiar side effects which are not normal; talking to voices in my head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (some peculiar side effects which are not normal) and SOLILOQUY (talking to voices in my head) 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 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (some peculiar side effects which are not normal) and SOLILOQUY (talking to voices in my head). At the time of the report, FEELING ABNORMAL (some peculiar side effects which are not normal) and SOLILOQUY (talking to voices in my head) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. The patient heard voices of people that had personal vendetta against him. The patient had never experienced anything like this before receiving the vaccine.