chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POTENTIAL DVT; LEG SWELLING; INTERMITTENT LEG PAIN/ PAIN ABOUT 3 AND HALF INCHES DISTAL TO THE KNEE ON THE LATERAL PART OF THE LEFT CALF/ PAIN TOWARDS BACKSIDE; This spontaneous report received from a patient concerned a 51 year old female of unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, non smoker, Hashimotos disease, and high blood pressure, the patient was on medication for high blood pressure and Hashimoto's and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) on left arm, dose was not reported, frequency one total administered on 04-SEP-2021 at 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-SEP-2021, the patient experienced leg swelling and intermittent leg pain/pain about 3 and half inches distal to the knee on the lateral part of the left calf, and sometimes pain just towards the backside, and potential DVT. The patient who is HCP, also shared that the pain is a bit worse if she presses down on the spot. She noted that it was started in morning of 05-SEP-2021 about 11 o clock. She was keeping the leg elevated at the heart but did not confirm if she had any plan to contact her PCP as she was concerned of potential DVT. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent leg pain/ pain about 3 and half inches distal to the knee on the lateral part of the left calf/ pain towards backside, and the outcome of leg swelling and potential dvt was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210908758-COVID-19 VACCINE AD26.COV2.S- Potential DVT. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Patient arm with redness and swelling from shoulder to elbow left side. Afebrile. Patient to go to ER if swelling/ redness, increase or because febrile or painful to the touch.
Syncope x 3 occasions before emergency services arrived. First was ~6 minutes post vaccination, patient felt lightheaded, passed out, slumped over in his chair in the waiting room before eventually falling to the floor. No head trauma in the fall. RPh responded to the patient, once he came to he was able to state his name, where he was, etc. Pharmacist took blood pressure of patient. He felt well enough to sit up in chair and was consuming water. He admitted to not eating much that day. About 3-4 minutes later, patient passed out again in chair next to RPh, she stabilized him again until he came to (<1 minute). Emergency services were called. He denied any history of seizure disorder or metabolic conditions. After emergency services arrived, pt passed out again while talking with EMT, to which they moved him onto stretcher and escorted him out to the ambulance for transport to the hospital.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PYREXIA (A little bit of fever) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (Redness). On an unknown date, the patient experienced PYREXIA (A little bit of fever) and CHILLS (Chills). At the time of the report, ERYTHEMA (Redness), PYREXIA (A little bit of fever) and CHILLS (Chills) outcome was unknown. No Concomitant medications were reported. The patient took Tylenol as treatment medication. This case was linked to MOD-2021-038916 (Patient Link).
N&V, diarrhea, Pale, Lethargic, Weak, (Per mother) lasting 2 Days.
I first started having symptoms on Tuesday July 12. I had chills, fever, and severe cough. The next morning I still had the chills and a low fever. However when I coughed, the pain was not there which led me to believe they had improved. I took to at home COVID 19 test on Wednesday July 13th and they were positive. I called my doctor and had a teleconference where I described my symptoms. She prescribed Paxlovid. I got the medication that evening and took the first dose. My symptoms began to improve the next day after the 2nd dose. took the medication over the course of 5 days taking my last dose on Monday July 18. I retested myself for COVID-19 and was negative both times.
My tongue swelled slightly and the right side of it became numb.  This lasted for 30 minutes.  If it had gotten worse I would have gone to a hospital but it went away.   Also, starting around 8 PM on Thursday and lasting until Saturday evening, my hips and lower back were extremely stiff and achy.
Information was received from a 78 year old female patient with anxiety, asthma, high blood pressure, benign thyroid nodules and no known drug allergies. The patient reported that 3 to 4 years ago, she was vaccinated with ZOSTAVAX 0.65 ml, once, (lot number not provided) subcutaneously for prevention of shingles. Concomitant therapies included gabapentin and montelukast sodium (manufacturers unknown). In the middle of September 2015, the patient developed shingles, located on the right side of her buttocks and they itch. She had an office visit with her physician and was treated with valacyclovir and BACTRIM. The outcome of her shingles was reported as not recovered. No further information was provided. The relatedness of the shingles to ZOSTAVAX was not provided. Additional information has been requested.
got a positive test on 31Dec2020. Her 2nd dose is due on Wed and she is currently symptomatic.; got a positive test on 31Dec2020. Her 2nd dose is due on Wed and she is currently symptomatic.; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Dec2020, the patient got a positive test. Her 2nd dose was due on wed and she was currently symptomatic. Patent would to know if she should get second dose on her scheduled date even though she still was feeling unwell. The outcome of the events was unknown.  Information about batch/lot number has been requested.
L arm sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (L arm sore for a couple of days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (L arm sore for a couple of days). At the time of the report, PAIN IN EXTREMITY (L arm sore for a couple of days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.   This case was linked to MODERNATX, INC.-MOD-2021-078282 (E2B Linked Report). This case was linked to MOD-2021-078282 (Patient Link).; Sender's Comments:  MODERNATX, INC.-MOD-2021-078282:cross linked to Dose 2
Nurse giving injection, patient and mom were present when apparent seizure took place. I was called stat to room where pt was sitting in a chair. Apparently patient was sitting on exam table when the HPV (2nd inj) was given and she began her seizure activity. She is amnestic of event.
Raised, swollen area around injection site, roughly 1.5 inches in diameter. Firm to the touch and itchy. Symptoms began 4/9/2021, 1 week after vaccine dose #1.
High fever 101.6 , Headache, nausea vomiting, Short of breath on exertion with a drop in saturation to mid 80's.  High BP with exertion.  High heart rate with exertion in the 140-150 range.
There was a syringe malfunction. When giving the vaccination, I had the needle in the patient's arm, and went to inject the drug and the vaccine sprayed all out of the side of the syringe, therefore no drug getting into his muscle. His entire arm was wet and the patient and caregiver experienced this happen, as well. We gave the patient another dose after speaking to our vaccine specialist at Pharmacy as well as the patient and patient's caregiver.
Student reported that same day she received Tdap vaccine she developed numbness and tingling; pain in the left arm from deltoid radiating down to left hand. By the next am she stated she could not feel her (L) hand.
ABCESS IN RIGHT HIP, SEPTIC, HEART, LUNGS PNEUMONIA
Fever 24 hours, whole body muscle aches 24 hours, tired 24 hours, chest pain, lump in right armpit 5 inches in diameter
pain in shoulder; pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in shoulder) and MYALGIA (pain all over body) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No reported medical history.     On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2020, the patient experienced MYALGIA (pain all over body). On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (pain in shoulder). On 01-Jan-2021, VACCINATION SITE PAIN (pain in shoulder) was resolving and MYALGIA (pain all over body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
redness & swelling, non painful-from lt deltoid area of inject spreading to lt elbow vax given on 8JUN94; inc swelling & redness 10JUN94; pt seen in clinic on 10JUN94;
Information has been received from the authors of the literature article, concerning to a 2-year-old healthy immunocompetent girl with a 4-day history of a moderately painful, pruritic rash on the left leg, accompanied by intermittent fevers 4 days before presentation. She attended daycare but had no history of contact exposure. Past history was notable for eczema and cradle cap after birth. She had received a single dose of VARIVAX at 12 months of age. Physical examination revealed coalescing papulovesicles along the left lower leg, most prominent along the left shin and calf in an L4 dermatomal distribution, with occasional lesions on the left posterior thigh and one on the left buttock. Varicella zoster PCR was positive for vaccine-strain varicella zoster virus (VZV). The child was started on a 7-day course of acyclovir 30 mg/kg three times a day, with complete resolution of the rash 10 days after the office visit. This report is linked to MARRS 1710USA005866, from the same literature article. Sender's Comments: US-009507513-1710USA005866.
This spontaneous report was received from a Licensed Practical Nurse, referring to a 5-year-old patient of unknown gender. There was no information reported regarding the patient's medical history, concurrent conditions or concomitant medication. On 17-DEC-2018, the patient was administered an improperly stored dose of PROQUAD (strength, route and dose not provided) lot # R017628 and expiration date 18-DEC-2019, for prophylaxis. The dose was reconstituted with a properly stored sterile water diluent (MERCK) (lot # and expiration date not provided). No adverse effects reported. It was reported that the storage temperature of the vaccines was 6 to 14 Fahrenheit degrees and the time frame was 18 minutes. There was no previous temperature excursion and the call was because of a "data logger". This case is one of two from the same reporter (Information captured in MARRS # 1812USA011856). Sender's Comments: US-009507513-1812USA011856.
Patient lost consciousness following administration of vaccine. Happened within 5 minutes of receiving. He regained consciousness roughly 30 seconds to 1 minute later, but complained of fatigue and continued to have vision difficulties/ weakness. Patient was very pale and skin was hot to the touch, noticeable perspiration. EMS was called and patient was taken to local emergency department.
10/13/03 Seen for rash, 8 lesions, some crusted, some pustules, some papules, characteristic of chicken pox. Received vaccine 7/98. Follow up on 12/16/03: "Pt developed fever for 3 days prior to visit on 10/13/03.  Fever lasted 24 hours then developed a rash 2 days later characterized by papular vesicles and purpules. I do not know how many MD's have taken care of her before seen in my office the immunization events does not include Lot # or Manufacturer name it was given in 1998.  She was fine and sent home 10/01.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EN6207), on 22Apr2021 as dose 2, single (Lot number: EW1071) and on 17Oct2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Depression" (unspecified if ongoing), notes: General depression/anxiety; "Anxiety" (unspecified if ongoing), notes: General depression/anxiety; "ADHD" (unspecified if ongoing), notes: ADHD. Concomitant medication(s) included: PROZAC, start date: Aug2014; ADDERALL, start date: May2016.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: Tested positive for Covid on Saturday 8Oct2022; (16Oct2022) Negative, notes: Tested negative for Covid on Sunday 16Oct; (21Oct2022) Positive, notes: Tested strongly positive for Covid Friday 21Oct; (24Oct2022) Negative, notes: Tested negative by Monday 24Oct. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: It was reported that Patient took Other medication in 2weeks. Patient received Paxlovid for treatment of covid-19, Treatment start date was 08Oct2022,Treatment stop date was 13Oct2022.
Patient developed fever 103 at 800 am 10/25/08. Vomited 10/25/08 and  10/26/08 and once 10/28/08. Fever also present up to 103 on 10/26/08. Patient was given 0.5ml dose instead of 0.25ml.
This spontaneous report was received from a medical assistant and refers to a 6 month old patient. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot number, expiration date, dose, strength and route of administration were not reported). On an unknown date, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot number, expiration date, dose, strength and route of administration were not reported). On an unknown date, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot number, expiration date, dose, strength and route of administration were not reported). On an unknown date, the patient was vaccinated with the fourth dose of RECOMBIVAX HB (lot number, expiration date, dose, strength and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
No adverse event; 1st dose was administered 24-Jun-2021 and 2nd dose was administered 16-Jul-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 24-Jun-2021 and 2nd dose was administered 16-Jul-2021) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 24-Jun-2021 and 2nd dose was administered 16-Jul-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 24-Jun-2021 and 2nd dose was administered 16-Jul-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 24-Jun-2021 and 2nd dose was administered 16-Jul-2021).    No concomitant medication was reported.  No treatment information was reported.      This case was linked to MOD-2023-730156 (Patient Link).
OCCASIONAL PAIN IN ARM AND SHOULDER DURING THE DAY, BUT EXTREME PAIN IN SHOULDER RADIATING DOWN THE ARM INTO MY HAND UPON RECLINING EVERY NIGHT. I DID NOT SEEK TREATMENT BECAUSE I WITNESSED MY MOTHER, WHO RECEIVED THE SAME SHOT ON THE SAME DAY, AT THE SAME DOCTORS OFFICE BE TOLD OUR SAME SYMPTOMS WERE NOT RELATED TO THE SHOT. SHE ALSO FILED A REPORT TODAY.
Over period of several days, site became red, inflamed, swollen, hot, blisters, painful. Eventual Size: 8" x 4".
Janssen COVID-19 Vaccine EUA  Beginning morning of 3/4/21. Nausea, extreme fatigue, body ache, severe headache, chills, fever, coughing.   Beginning morning of 3/5/21. Nausea, body ache, mild headache, coughing, chills, mild fatigue
(from notes at the time)- ~ immediate "awareness", but not "pain" Fri night (vax day) 5/7/21 -  restless, no/poor sleep Sat - tired Sat night  5/8/21- muffled hearing Monday AM 5/10/21 - ~dizzy, but not vertigo; stuffy ears - "pressure", muffled hearing Present - symptoms continue to this day
Same day as shot began having severe headaches that have not stopped  today is day 5 and still having painful headaches.  Neurologist recommended increase fluids and to wait it out.
This is a spontaneous report received from a patient reporting on himself a 75-year-old male who was administered a dose of PNEUMOVAX vaccine on 17-MAR-2017, for the prevention of pneumococcal disease administered by a pharmacist (lot # unknown). Medical history included the following: "blood sugar", "cholesterol", kidney stones, insomnia, and high blood pressure. On 18-MAR-2017, the patient's arm swelled. He stated that "it is twice the size of the other arm." The next day, 19-MAR-2017, he developed hardness and pain in three spots on the same arm. The patient has been taking ADVIL and BENADRYL which he said are not helping his symptoms. The patient reported he has an appointment with his doctor today, 20-MAR-2017. No further information was provided. Additional information has been requested.
pinkish reaction on arm at both injections; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (pinkish reaction on arm at both injections) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (pinkish reaction on arm at both injections). At the time of the report, INJECTION SITE ERYTHEMA (pinkish reaction on arm at both injections) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
ZOSTAVAX administered Monday 8/25/08 1:30pm.  Tuesday had a large welt, 2 1/2"x4 1/2" - red, hot, itchy - Sunday morning faded; today, Mon 9/1/08, have a bruise 1"x2 1/2".  Used 10% cortisone cream, morning + night to alleviate itching.
Within 5 minutes I lost hearing (right eye) felt as if full of water in my canal. One of my colleagues checked my ear for fluids on Thursday and prescribed me antibiotics by 1/26 it was gone. I exp nausea next day vomiting 6 times and also felt burning sensation in throat. I had no arm pain and no fatigue.
Patient started shaking with teeth chattering the evening of the shot. She also felt freezing and felt like she had a fever but did not take her temperature. Symptoms lasted until the next evening.
2 days p/vax pt exp flu-like sx & pain in both knees;the flu-like sx resolved w/symptomatic tx, but rt knee pain & lt knee burning persisted @ the date of this report;
Soon after completing the Pfizer vaccine, I began losing hair. I did not connect it to the COVID-19 vaccine. I resumed doing steroid injections into my scalp. Later that year I got my booster. Over the last two years my hair loss has accelerated, and for the first time since I was diagnosed with alopecia as an elementary schooler, steroid injections have failed. I now have about 60% hair loss.  I recently received the bivalent booster a few weeks after starting Olumiant, a medication for alopecia. It was only a few days after that booster that I first read about the link between the COVID vaccine and alopecia resurgence. It is the only thing that has been different for me in the last couple of years, and I now think it is directly related.  I am still on Olumiant, and it is early in the process - 1.5 months in. I'm still losing hair.
Case number PHEH2014US005392 is an initial spontaneous report received from a physician on 14 Mar 2014. This report refers to a 17-years-old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of two doses of MENVEO (batch number: not reported) on Jul 2007 and Dec 2012 respectively. It was reported that he was inadvertently vaccinated with third dose of MENVEO (batch number: M13051) intramuscularly on 11 Mar 2014. No adverse events were reported following the maladministration.
Fever of 101 and chills, inability to sleep during the night, aches, and small bouts of chills for the next 24 hours. Increased resting heart rate + 10 to 25 beats per min.
p/vax pt devel full blown case of chickenpox w/at least 20-40;pt exp irritability & a low grade fever;