chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breakthrough infection; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (breakthrough infection). At the time of the report, BREAKTHROUGH COVID-19 (breakthrough infection) outcome was unknown. Not Provided          Patient was not a clinical trial participant.  No concomitant medications were reported.  It was reported that patient had a breakthrough infection after having Moderna booster vaccine.  No treatment information was reported.  Company comment: This spontaneous case concerns a patient of unspecified age and gender with no medical history reported, who experienced the unexpected serious (medically significant) AESI event of Breakthrough COVID-19 that occurred unknown days after receiving the third dose (booster ) of mRNA-1273.222 vaccination in COVID-19 vaccination series. The details of previous 2 vaccines and date of current administration were not provided. No further details on risk factors, medical history, clinical course, additional vaccination details, concomitant medications and treatment details were provided. The outcome of the report was unknown at the time of report. Ongoing COVID-19 pandemic could be a confounder for the event Breakthrough COVID-19. The benefit-risk relationship of mRNA-1273.222  Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender with no medical history reported, who experienced the unexpected serious (medically significant) AESI event of Breakthrough COVID-19 that occurred unknown days after receiving the third dose (booster ) of mRNA-1273.222 vaccination in COVID-19 vaccination series. The details of previous 2 vaccines and date of current administration were not provided. No further details on risk factors, medical history, clinical course, additional vaccination details, concomitant medications and treatment details were provided. The outcome of the report was unknown at the time of report. Ongoing COVID-19 pandemic could be a confounder for the event Breakthrough COVID-19. The benefit-risk relationship of mRNA-1273.222  Vaccine is not affected by this report.
Fever, muscle aches, headache, coughing, dyspnea, fatigue, and paresthesias.
TROUBLE SLEEPING; NUMB PINKY AND RING FINGER; TINGLING IN THE LEFT PINKY/RING FINGER; JOINT PAIN; LOW GRADE FEVER; NAUSEA; MUSCLE ACHES; HEADACHE; LEFT ARM PAIN; LEFT SHOULDER PAIN; This spontaneous report received from a patient concerned a 49 year old female. 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, intramuscular, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left shoulder pain. On 10-APR-2021, the subject experienced left arm pain. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced low grade fever. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.5 degrees. On 15-MAY-2021, the subject experienced numb pinky and ring finger. On 15-MAY-2021, the subject experienced tingling in the left pinky/ring finger. On an unspecified date, the subject experienced trouble sleeping. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, nausea, and muscle aches on 17-APR-2021, low grade fever on 12-APR-2021, and headache on 13-APR-2021, had not recovered from left arm pain, left shoulder pain, numb pinky and ring finger, and trouble sleeping, and the outcome of tingling in the left pinky/ring finger was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Pink to violaceous nonscaly papules coalescing into plaques on the thighs,  inguinal folds, abdomen and posterior axillary regions-further characterized with histologic features consistent with granuloma annulare in an   interstitial pattern (medication reaction can also induce this pattern).    Rash has persisted--treatment is continuing.
Injection given 11/3/03 approx. 5:20pm. Explained to pt's father possible reaction-local. Told him to use ice and Tylenol or Motrin. Vis sheet given. Local reaction noted 48 hrs later 11/5/03.
Headache, nausea, dizziness, temperature 99 degrees.  Symptoms began today, call if worse.
Pt received Moderna COVID19 vaccine on 28 Dec 2020. Pt developed red area on left arm that became progressively larger. Patient reports no shortness of breath or difficulty breathing after vaccination. Pt went to ER to be evaluated and returned to clinic after visit. Red area measured 68cm and warm to touch.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 16-OCT-2018 the patient was vaccinated with an expired dose of ROTATEQ vial (dose and frequency were not reported) (lot # N005080, expiry date: 03-OCT-2018) orally for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Lymph nodes swelling and pain around the armpit (only left side). It subsided after 3 days. Did not seek medical treatment.
Fever, chills, headache, nausea, increased heart rate, body stiffness
Patient describes feeling extremely nauseous and fell unconscious and hit her body on a table when she passed out.
heart beating is much more pronounced and at times accelerated.  occasional chest pressure.  slight shortness of breath.
Received 3rd Dose of Moderna (0.5 ml) when patient was not truly immunocompromised. Patient assured vaccinator prior to vaccine administration that he was immunocompromised. Wife of patient was also at site to receive 3rd dose of Moderna vaccine; after an educational discussion with the vaccinator, wife informed us they were not immunocompromised and thought they were eligible for their third dose due to their age and her heart condition. Patient educated on immunocompromised criteria for the 3rd dose of Moderna , vaccine administration error, and reviewed side effects of Moderna. Patient verbalized understanding. Informed that it would be reported and to call us if he had questions or concerns.
Tiredness; Nausea; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2018, the patient received the 1st dose of Shingrix. On 2nd July 2018, 1 days after receiving Shingrix, the patient experienced tiredness, nausea and dizziness. On an unknown date, the outcome of the tiredness, nausea and dizziness were recovered/resolved.   It was unknown if the reporter considered the tiredness, nausea and dizziness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient experienced tiredness, nausea and dizziness after each vaccination and the symptoms lasted for a day. The outcome reported for all AES in the structured field of XML is "recovered/resolved with sequel" instead of "recovered/resolved" (outcome uploaded). For tolerance of 2nd dose of Shingrix, refer case US2019AMR186591.
two days of recurrent sudden, severe, crushing  right sided chest pain lasting 10 min to 3 hrs that occurred 2 days after second dose of covid vaccine. pain radiation to back presented to ED, found to have elevated troponin and d-dimer. also endorsed emesis and diaphoresis. Denies sob. discharged two days after hospitalization.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years 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 was not reported. Concomitant medication(s) included: TRUVADA, start date: Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Negative; (01Aug2022) Negative; (05Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient received other medication in two weeks. Paxlovid (anti-viral) treatment started on 24Jul2022 and stopped on 29Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
"I had arm and armpit soreness that evening and still am experiencing some today along with lymph node swelling on the same side where the shot was administered. The night of the 9th I experienced dizziness, chills, and nausea. I woke up with a 102 fever on Sunday which continued into Monday morning. I also had a headache all day Sunday the 10th and was very fatigued."
Vaccination at 12:00 pm on 2/25/21 12:10 pm: Severe muscle spasms throughout body, hyperventilation and bright red skin tone across arms and face 911 was called. EpiPen was administered after receiving consent from patient. Patient immediately started to feel better. Emergency response arrived 12:15pm and completed assessment. Patient did not need to be transported to hospital
Itching all over the body that lasted since the day of the first dose until today. She still has it.
Single raised .5 cm lesion with dark center to proximal dorsal phalanx of right 3rd digit 9 days after receiving smallpox vaccination and 7 days after injuring hand (breaking skin) while working on his car.
Mother came in to get the booster dose. Nurse checked  the consent form possibly in a rush and missed that it was a booster.
I received the dose at 5:35am on 3/6/21 went home slept most of the day woke up and felt tired, 8:00pm on 3/6/21 I left for work drove a few miles up the road and fainted and crashed my vehicle.
cough, fever, malaise, chest xray on 1May92 showed bilat infiltrate rt >lt, TX w/ amoxicillin 500 mg. No prior hx of pnenmonia.
I PASSED OUT ON DAY 2  WHILE OUTSIDE AND REQUIRED STITCHES. WHILE AT A MEDICAL FACILITY GETTING X-RAYS, I PASSED OUT A SECOND TIME AND WAS RUSHED TO THE EMERGENCY ROOM.
Around 10PM in the evening on 10/04/2011, I begun to have hives on the back of both my arms. This cleared up by morning, however, when I woke up 7AM on 10/05/2011, I had hives on my abdomen. They disappeared by 10AM on 10/05/2011. I have also had a headache since the shot.
This spontaneous report was received from a pharmacist (patient's daughter) via a company representative regarding a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated two separate doses of ZOSTAVAX within a four month period (dose, route of administration, lot # and expiration date were not reported). On an unknown date (after the second injection of ZOSTAVAX), the patient experience a localized site reaction. The duration of the localized site reaction was not provided. On an unknown date, the patient recovered from localized site reaction (duration of the event was not provided). The relatedness between the event and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
On 12/18/2021 I had the expected reaction, low grade fever, chills, body aches, fatigue. I did not take any pain reliever or fever reducer. On 12/19/2021 in the evening I began having a chest tightness feeling along with pain between my shoulder blades. I used a heating pad on my back all day. The pain was minor so I was not concerned. On 12.20.21 I woke up at 1am with far worse chest pain and should blade pain along with a bloody nose. I waited about 30 minutes and the pain just felt bad so I drove myself to the er.
After about 10 mins patient  was limp sweaty and eyes rolled back, after few minutes she fully came back stated she was fine
pt recv vax; w/in 5 mins,devel induration, burning sensation & pain at the inject site;dizziness,n, abd cramping & pallor; pt also weak & hot prior to v; recovered;
no energy at all; He also experienced a sore arm; developed severe fatigue afterward, no energy, could not work or get out of bed or do anything; developed severe fatigue afterward, no energy, could not work or get out of bed or do anything; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982; Expiration Date: May2021) via an unspecified route of administration, administered in arm left on 11Feb2021 (at the age 57-year-old) at dose 1, single for covid-19 immunisation. He took the first Pfizer COVID shot this last Thursday. Medical history included ongoing high blood pressure (Diagnosed for 25-30 years). Concomitant medication included losartan potassium (LOSARTAN AGP) 100mg taken for high blood pressure from an unspecified start date and ongoing (he has been on it for 3 years). On an unspecified date in 2021 the patient experienced developed severe fatigue afterward, no energy, could not work or get out of bed or do anything, on 12Feb2021 no energy at all, he also experienced a sore arm. Reporter, male, aged 57 received first dose last Thursday and developed severe fatigue afterward, no energy, could not work or get out of bed or do anything. He also experienced a sore arm. Symptoms have resolved today. Then, he experienced a side effect from that following day up until today. He had no energy at all. He couldn't do anything or even work. He wants to know is this a normal side effect. Will he experience the same thing with the second dose. His left arm was sore that Friday. He didn't want to be where he was. He didn't feel good. Then, Saturday, Sunday, Monday and today he has been at home the whole time. He hasn't left at all. He is wondering when he goes back on the 04Mar2021 for the second one will it be worse or the same as the first one. He wasn't going to take the vaccine, but then decided to. Outcome of the events developed severe fatigue afterward, no energy, could not work or get out of bed or do anything was unknown, no energy at all was resolving and he also experienced a sore arm was resolved on 13Feb2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
After administration of COVID vaccine - pfizer, patient noted that he didn't feel that it went into the deltoid, that the injection site had been too low.  Questioned if he should be administered another dose. No symptoms.  consulted with other clinic staff, ID oversite and will follow-up to determine if patient develops appropriate response to vaccine or if will require additional vaccination
Patient's Mom reports that patient c/o slight numb feeling at injection site (where received Td vaccine), left arm. Observed area no redness, slightly puffy, hard area sight. Patient was nauseated with vomiting early am (Emesis less than half cup) but okay at this time.No further vomiting. Advised that possible side effects to left arm is what she described. If condition does not improve or worsen will seek medical attention.
Post vax, pt began crying intensely. Mother took temperature and it was 104.5F (ax) and took baby to ER. She was given phanobneb X 3.
Dose #1 given  2/6/2021 Lot # N/A Pt hospitalized with Covid 19 6/28/2022-7/3/2022 Medical Center.
Symptoms are patient reported. Mother reports rash consistent with chickenpox comprised of 8 discrete lesions on the right upper trunk, neck and face. The rash occurred days after receiving vaccine and resolved completely by today.
This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. On or about 07-JUL-2015, the patient was inoculated (by an unspecified person) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-JUL-2015, he was treated by a physician (at an unspecified facility) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 26-SEP-2015, the patient sought subsequent treatment from a female registered nurse at a Medical Center for ongoing and worsening outbreaks of shingles. The male patient has been prescribed Acyclovir, triamcinolone cream and Neomycin-Bacitracin Polymyxin for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Swelling, redness, warmth at injection site 8 days after injection, began 01/07/21 and still currently present
Covid symptoms started right before Holiday and lasted 2-3 days, maybe a little longer. I was tired mostly and that was the main thing. I had antibodies on 12/29/21.
patient said that she was experiencing an extremely sore arm, redness and swelling at the injection site that has lasted 5 days
This spontaneous report as received from a consumer's wife refers to her 73 year old husband. The patient did not have any pertinent medical history or drug reactions/allergies. On an unknown date in January 2011 the patient was vaccinated with ZOSTAVAX 1 time vaccine subcutaneously (dose and lot # were unknown). Concomitant medication included Vinastride. On an unknown date in April 2011 the patient was diagnosed with the shingles after receiving ZOSTAVAX. She stated it was on his left side of his face, behind the ear. She also advised he was still experiencing pain in the nerve endings. He had seen his physician and had sought unspecified medical attention. The outcome of events was reported as not recovered/not resolved. No lab diagnosis studies performed. No treatment was given for adverse event, the doctor only diagnosed it. Additional information has been requested.
Contracted Covid 19 from a close family contact.  Took Paxlovid, prescribed by the nurse.  Medicine worked well enabling me to successfully recover from the virus at home.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with pinched nerve that caused nerve pain in her left arm. The patient had no allergies. On 28-AUG-2015, the patient was vaccinated with a single dose of ZOSTAVAX lot # L000448, expiry date 08-MAR-2016, subcutaneous in the left arm (dose was not reported). Concomitant therapies included EFFEXOR, PAXIL; LIPITOR and diclofenac. On an unknown date in 2015, the patient experienced a hard lump and muscle pain at the injection site, on her left arm. She also experienced trouble sleeping due to the muscle pain and had contacted her physician who recommended patient to use TYLENOL to help sleep. No laboratory tests were performed. At the time of the report, on 16-SEP-2015, the patient did nor recovered from the events. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Experienced an injection site reaction the day after receiving my vaccine. Woke up and had two painful red welts on my left arm. One at the injection site and the other about an inch away from the injection site. Both were extremely painful and hard bumps, hot to the touch, and itchy. Throughout the day, they slowly grew and merged together to form one large welt. The welt slowly went away, but I am still experiencing lingering side effects over a week later. I am still experiencing slight discomfort and itchiness and my arm is still red/purple in color where the welt was.
Redness, painful hard lump with Pneumovax. Fever of 101.8. Vomiting
Recieved first Vaccine on Wednesday 1/13/2021 and tested Positive for COVID 19 on Saturday 1/16/2021.  Only Symptoms are loss of taste and smell.
Pt complains of local site reaction. She also complains of numbness, heaviness and shooting sensation from the back of her neck to her fingers on the left side. She said symptoms started after receiving the vaccines and continued to get worse she was referred to a medical doctor.
Fever, chills, headache.   The headaches have gotten more frequent and severe with each Covid shot .