chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Nov2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastroparesis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Bi-Polar" (unspecified if ongoing); "peripheral neuropathy" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "chronic migraines" (unspecified if ongoing); "extremely lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Geodon, reaction(s): "Drug allergy: Geodon"; Abilify, reaction(s): "Drug allergy: Abilify". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Feb2023 to 24Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Chills; Headache; Fever; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), PYREXIA (Fever) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 29-year-old female patient (gravida 5, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 immunisation.    The patient's past medical history included COVID-19 on 25-Mar-2020, Miscarriage and Elective abortion (one past pregnancy, 1 abortion). Concurrent medical conditions included Multigravida. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 06-Apr-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 20-Feb-2021 and the estimated date of delivery was 27-Nov-2021. On 06-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), PYREXIA (Fever) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) beginning at sixth week of the pregnancy.  On 06-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 08-Apr-2021, CHILLS (Chills) had resolved. On 09-Apr-2021, PYREXIA (Fever) had resolved. On 13-Apr-2021, HEADACHE (Headache) had resolved.            No treatment medication was reported. EDD was given as Nov-2021.
Approximately 24 hours after shot he ran a fever of 103, then 104 and 2.5 days later it went up to 106.4 (105.4 axillary).
Patient received expired MMR vaccine during well child clinic visit. No adverse reactions experienced. Provider and parent was notified.
I was getting weak, low energy levels and abdominal pain, Dr. referred to Rheumatologist and Lupus was diagnosed. Dr. ordered biopsy of the kidney showed increase in protein levels in my urine. Went to hospital via ambulance due to extreme pain in my abdomen, blood pressure 247/70. I also have noticed blue purple blotches on my arm. I now have to stay out of the sun due to Lupus.
Headache for 45 days consisting of pressure across forehead, nausea and photophobia, with continued intermittent headache to date. Chest pain with feeling of racing heart rate and pressure in center of chest that is worse at night while laying down. Fatigue that is abnormal and severe.
30MAR98 pt devel @ least 33 chickenpox by next morning the amount doubled, also pink eye;pt seen by nurse & MD;
I developed cipro toxicity in 2017 due to a dose of cipro combined with steroids. Symptoms include neuropathy, tendon damage, vision and hearing issues, muscle aches and burning sensations throughout the body. These symptoms flare. I have been pain free for four months before getting the Pfizer vaccine. All of my symptoms came back 2 hours after the shot.
prolonged high pitched crying & screaming > 2 hrs; 2 hrs p/inject sl swelling in inject area (LMT); tx none @ time of react administered peds DT in place of DTP @ 4 month well baby
Dizziness; Pain/redness at the site of the injection in left arm; Pain/redness at the site of the injection in left arm; Cramps in both feet; Mild shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSPNOEA (Mild shortness of breath), VACCINATION SITE PAIN (Pain/redness at the site of the injection in left arm), VACCINATION SITE ERYTHEMA (Pain/redness at the site of the injection in left arm) and MUSCLE SPASMS (Cramps in both feet) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tinnitus.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Mild shortness of breath). On 09-Mar-2021, the patient experienced DIZZINESS (Dizziness), VACCINATION SITE PAIN (Pain/redness at the site of the injection in left arm) and VACCINATION SITE ERYTHEMA (Pain/redness at the site of the injection in left arm). 09-Mar-2021, the patient experienced MUSCLE SPASMS (Cramps in both feet). At the time of the report, DIZZINESS (Dizziness), DYSPNOEA (Mild shortness of breath), VACCINATION SITE PAIN (Pain/redness at the site of the injection in left arm), VACCINATION SITE ERYTHEMA (Pain/redness at the site of the injection in left arm) and MUSCLE SPASMS (Cramps in both feet) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  treatment for the events included Bananas and Magnesium supplements for muscle cramps in  feet.
on 1/11/21, developed swollen lymph node on right clavicle area- pea sized  tender to touch, sore with head movement to the left.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 12May2021 as dose 2, single (Lot number: EW0150) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Wheat" (unspecified if ongoing); "Known allergies: milk" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Patient did not receive any other medications in 2 weeks. Patient received Paxlovid (anti-viral) from 15Sep2022 to unknown date for treatment of COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective, covid-19 and the suspect drug BNT162B2.
swelling, warmth, tenderness to left upper arm from deltoid to elbow starting evening of day vaccine given. Seen in office 2 days later. Advised cool compressed & benadryl
ITCHY, SORE, TENDERNESS, SWOLLEN, HOT TO THE TOUCH, RED. TYLENOL AND MOTRIN WERE TAKEN.
Information has been received from a health professional concerning a 7 year old female who on 1/7/05 was vaccinated with a dose of varicella virus vaccine live. On 9/22/05, the patient's brother developed chicken pox (WAES0510USA04952). On 10/7/05, the patient developed chicken pox breakthrough. Additional information has been requested.
Tested positive for Covid; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L204) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive Positive.     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 relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-024399 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: The reporter was sent follow-up request but asked us to contact another person for more details. Safety is working on this request.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On 02/02/23 I had symptoms of coughing, tired, dry mouth and had I taken Home COVID-19 Test on the next 02/03/2023. I was sent by my doctor to the urgent care. I was retested a positive. I was prescribed Paxlovid.  I felt better by day three of four. I still have dry throat from time to time with scratchiness
Welt appeared later same day. Pt self medicated w/50 mg Benadryl; applied ice tx. No further reaction.
not had a sense of smell or taste; not had a sense of smell or taste; Headache are off and on; little tired; she cannot think; hoping it is her sinuses; When she gets up and moves around and when up and moving with the mask on, she is lightheaded; nose is stopped up; with her mask on she can hardly breathe; busts out in a sweat; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the left arm on 18Jan2021 07:40 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took cortisone in her both knees and left shoulder from 15Jan2021 for inflammation and could not walk and was making her feel bad. On Friday (22Jan2021), she started having headaches and was a little tired. Everyday, she would take her temperature and she never had a fever. The last couple of days on 24Jan2021, she has not had a sense of smell or taste. She works and sees patients. She cannot think. Headaches are off and on and ongoing. She was hoping it is her sinuses. When she gets up and moves around and when up and moving with the mask on, she is lightheaded and gets tired. When she lays down, she is ok. Her nose is stopped up and she has not gotten up to eat anything today. The patient told it is strange, she hasn't run a fever but if she gets up and moves around with her mask on, she can hardly breathe, she busts out in a sweat, and it gives her a headache and she don't have a taste bud. Therapeutic measures were taken as a result of headache and included treatment with naproxen sodium (ALEVE). Outcome of the intermittent headache, tiredness, loss of smell was not recovered while of the remaining events was unknown.
Pt c/o pain in left arm after receiving her first dose of anthrax.  The pain started one day after receiving the dose and lasted for 3 days.
Information has been received from a licensed practical nurse concerning a 76 year old female with no known allergies, asthma, diabetes, hypothyroidism and hyperlipidemia who on 04-JAN-2007 was vaccinated in the left arm with a 0.65 ml dose of Zostavax (lot#654604/1406F). Concomitant therapy included SYNTHROID, ZOLOFT, alendronate sodium, LIPITOR, PROVENTIL, XANAX, AMBIEN, diclofenac Na, ADVAIR, aspirin, calcium (unspecified), vitamin D (unspecified), DECONEX. The next day, on 05-JAN-2007, the patient called the office complaining of slight redness and itchiness at the injection site. By the next morning, on 06-JAN-2007, the injection was more irritated, dry, and red. Unspecified medical attention was sought and no treatment was required. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date. A product quality was not involved. Additional information has been requested.
Daughters report that mother, pt., was sleepy with a possible fever the day after the 1st Moderna COVID-19 vaccine  which was administered on 5/5/2021.  On 6/2/2021 she received the 2nd Moderna dose.  The following morning, 6/3/2021, at 7am she was awaken by her daughter and had a fever of 101 degrees F, began vomiting shortly after and whole body was shaking.  Ambulance was called and transported her to Hospital ER where she was admitted.  Several tests were performed.  Diagnosed with a UTI, treated and released on 6/7/2021 to Rehab center for therapy for 3-6 weeks.
Swelling at the injection site/ the area was 4 inches long and 6 inches in width around her arm; Redness at the injection site; vaccine was given lower in arm than should have been; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2022, the patient received the 2nd dose of Shingrix. On 6th June 2022, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and vaccine administered at inappropriate site. The patient was treated with cefalexin (Cephalexin). On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-Jun-2022 and 13-JUN-2022. Reporter's Comments: The patient self-reported this case. The patient received her second dose of Shingrix in arm and that evening after vaccination she noticed some swelling and redness at the injection site. Over the following days the patient noted the swelling had grown and the patient stated at the time of the reporting the area was 4 inches long and 6 inches in width around her arm and red. The symptoms had not yet resolved, the arm was still red and swollen. The patient's doctor has prescribed Cephalexin in which reporting day was her 3rd day of treatment. The patient also stated that her physician suggested that the vaccine was given lower in her arm than should had been. The reporter did not consent to follow-up. Additional Supportive Information: The vaccine was given lower in arm than should had been, which led to vaccine administered at inappropriate site.
Moderate swelling of (L) arm from above the elbow to shoulder with mild erythema. Pt reported mild pruritus. Ibuprofen 300MG Q6-PO PRN, BENADRYL 25MG twice daily PRN and Ice
4/8/21 at 5pm started flulike symptoms.  Had a restless sleep from 10pm-12:45am when I woke up in AFib, lasted until about 4:30am. I'd been being treated for Afib for 3 months, episodes were getting less frequent. This was the worst one I've ever had, almost went to the ER in the middle of the night, BP got as high as 141/129.  Question 21 - I did not have a face to face visit with my doctor, instead I sent messages to my doctor with ECG & BP readings that I took throughout the night, asked if I should continue with the current medication change they had recommended before the Covid shot, and they replied back via message.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm and dizziness. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the dizziness was not recovered/not resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. The reporter considered the dizziness to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. Less than a week after vaccination, the patient experienced dizziness. Till the time of reporting, the patient was still experiencing dizziness two weeks after vaccination with SHINGRIX. The patient had denied permission to contact their physician.
No adverse event; HCP states that they administered shot to patient after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered shot to patient after their expiration date) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered shot to patient after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered shot to patient after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered shot to patient after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 3 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:master case
I HAD NO ADVERSE REATIONS.  When I received the vaccine the needle and syringe were not tightened enough to were the vaccine leaked out to the syringe down to my elbow.  I don't believe that I got the full first dose of the Moderna Vaccine. I also have a video which shows what had happened. I was wondering if I need to have another dose given or wait until 1/20/21 for the second Moderna dose?
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received anti-viral treatment with Paxlovid from 11Dec2022 to 15Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had sore arm; stomach ache; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 for COVID-19 immunization. Medical history included IBS (Irritable bowel syndrome). Concomitant medications were not reported. It was reported that informed that had the second covid-19 vaccine and had sore arm and stomachache. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
mom says pt stared straight ahead x 1 wk; had  prolonged crying x 1 wk; no fever; seen by MD; MD requests no more pertussis; no lasting effects; no further testing done;
Fatigue, headache, sharp pin like pain in/around my heart, heart feels constricted, left eye had a blurry effect, itchy and swollen where injection was given,
Moderna Booster Dose (0.25ml) inadvertently given to 9 year old.
Muscle pain the following day- took 1000 mg of Tylenol twice, a red circle appeared around injection site on third day the size of a nickel, on 05/04 the circle grew to a half dollar size and is itchy. Took a Benadryl and applied hydrocortisone cream as needed. On 05/06 the circle grew larger (we outlined it in pen to monitor) and there's more of a dark red ring on the outside and less red in the center. It continues to itch and is tender to the touch.