chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received shot in right deltoid on October 16, 2023. She came back to the pharmacy on October 19, 2023 to report an adverse reaction and this was the first time she made contact with the pharmacy after the shot. Her forearm and a bit of the area above the elbow on the upper arm was red and inflamed and, she said, hot to the touch. The area around the injection site appeared normal. Patient also received a flu shot in the other arm and there was no reaction in that arm. Patient said she had been self-treating with Tylenol. When I asked if she took Benadryl, she stated she hadn't. I told her to seek immediate help with her primary care provider or at an urgent care/emergency room as soon as possible.
9-16-10 - vaccine administered. 9-17 - tired. 9-18 - throat hoarse. 9-19-10 - hives, itching, hoarseness. 9/20/10 Pred 25 mg bid PC x 4 days ZANTAC OTC BENADRYL OTC.
Fever 101.8 ax on 20JUN91; Pt irritable & not sleeping; Swelling noted by mom on lt neck 20JUN91; Dx cervical adenitis; Rx Ceclor;
The evening after the client received his first dose of Pfizer, he reported chest pain and fluttering in his chest while playing basketball. This event lasted approximately 5 seconds and resolved without intervention. The client is being followed by his pediatrician. Per his parent, these events have happened before, but this was the most severe.
Administration error-seemed like most of the vaccine came out where the needle and syringe attach; most of the vaccine came out where the needle and syringe attach; A spontaneous report  was received from a healthcare professional concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced administration error- seemed like most of the vaccine came out where the needle and syringe attach. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unspecified date, it was reported by the health care professional that it did not seem like the patient received any of the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event of was administration error- seemed like most of the vaccine came out where the needle and syringe attach was considered recovered/resolved on an unknown date; Reporter's Comments: This case concerns a subject, who experienced a non-serious unexpected events of Vaccine underdose and Syringe Connection Issue. The events occurred at the time of first dose of the study medication administration. The events are more related to administration error rather than related to or caused by company medication. Based on the current available information, the events are assessed as unlikely related to mRNA-1273.
Woke up with nausea, heartburn and pressure in my chest... over four days nothing I would do gave me relief, not antacids, bland diet, nothing. Ended up in ER thinking I was having a heart attack. All test were negative... EKG, X-ray of chest, Blood work normal. I was diagnosed with Gastritus. My registered dietician daughter-in-law placed me on a special diet but nothing changed so I went to see the doctor.
Pt recvd vax & did not seroconvert p/3rd dose; pt exp sinusitis between 1st & 2nd dose;
43 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (43 days since the first dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (43 days since the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (43 days since the first dose) 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 by the reporter.
Information has been received from a pharmacist concerning a female patient who on approximately 23-MAR-2012 ("2 months ago") was vaccinated SQ with a single dose of ZOSTAVAX (Merck) (lot # not reported) at the pharmacy. On approximately 23-MAR-2012 ("2 months ago") the patient developed redness and swelling at the site of injection. The patient had difficulty raising the affected arm which caused her to miss 2 days of work as a hospital nurse. The patient contacted her unspecified physician and was prescribed an unspecified medication. Subsequently, the patient fully recovered from the events on an unspecified date. Having difficulty raising the affected arm was considered to be disabling by the reporter. No further information is available.
heaviness in chest, difficulty breathing, tiredness. Feels like I have a respiratory virus, but chest xray was clear.
Pt started feeling queasy and lightheaded after vaccine when walking through the store. person with her said she caught her as she lost consciousness.
Previously received Pfizer vaccines for primary series and first booster dose in 2020 and 2021. Patient presented to the ED on 9/19 with 3 days of episodic abdominal pain, worse on 9/19, centered around RUQ. Associated nausea and vomiting. Patient admitted for observation and symptom control. No acute surgical intervention at this time.
17Apr15-chills, body aches, h/a, hives on trunk, site is hot to touch, swollen/painful lymphnodes.
Within minutes body was extremely hot, throat felt weird and lips went numb. This shot was administered by my employer (it's an annual requirement to stay employed). They gave me Benadryl and symptoms improved. Within 20-minutes symptoms returned stronger and included shortness of breath. EPI was administered. Symptoms remained and my heart rate increased. I was then transported via ambulance to the hospital for additional treatment (fluids, Benadryl, prednisone, Pepcid). Discharged with Benadryl and Pepcid for 5 days (still in progress).
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) 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.   Concomitant medication information was not reported. Treatment information as not reported.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, between January-February 2014, the patient was vaccinated with one dose of PNEUMOVAX 23 lot # H012650 expiration date 27-FEB-2014 (dose and route were not reported) that had been stored in January 2014 (starting 16-JAN-2014) at 30 F minimum for a total of 112 hours. No adverse effect reported. This is one of several reports from the same source. 1403USA000542, 1403USA001589, 1403USA001588, 1403USA001587. Additional information has been requested.
SCALP HAIR BECAME DRY, THIN, AND BRITTLE; SCALP HAIR BECAME DRY, THIN, AND BRITTLE; DIFFUSE SHEDDING OF SCALP HAIR; HEART PALPITATIONS; HOT FLASHES; INSOMNIA; FATIGUE AND WEAKNESS; FATIGUE AND WEAKNESS; CHEST PAIN; DIFFICULTY TAKING A DEEP BREATH; MOOD SWINGS; DIFFICULTY CONCENTRATING AND MEMORY LAPSES; DIFFICULTY CONCENTRATING AND MEMORY LAPSES; ACHING AND STIFFNESS IN KNEES, THIGHS, HIPS, AND LOWER BACK; ACHING AND STIFFNESS IN KNEES, THIGHS, HIPS, AND LOWER BACK; HAIR LOSS ON FOREARMS, EDGE OF EYEBROWS, AND LOWER LEGS/ DIFFUSE SHEDDING OF SCALP HAIR; HEAT INTOLERANCE; ELEVATED THYROID PEROXIDASE ANTIBODIES; GOITER / THYROIDITIS; GOITER / THYROIDITIS; NECK TENDERNESS IN THE AREA AROUND ADAM'S APPLE; This is a spontaneous report from a contactable consumer or other health care professional. A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), (Lot Number: EWO173, Expiry date not reported) via unspecified route of administration administered in left arm on 01May2021 at 15:30 (at age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine within four weeks. Patient received other medications in two weeks include dietary supplements. Patient previously took beta lactam antibiotics, azithromycin, ibuprofen, and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO150, Expiry date not reported) via unspecified route of administration, administered in left arm on 10Apr2021 at 15:30 (at age of 46-years-old) as single dose for COVID-19 Immunisation. On unspecified date in May2021 (after vaccination) patient experienced scalp hair became dry, thin and brittle, diffuse shedding of scalp hair, heart palpitations, hot flashes, insomnia, fatigue ,weakness, chest pain, difficulty taking a deep breath, mood swings, difficulty concentrating and memory lapses, aching and stiffness in knees, thighs, hips, and lower back, hair loss on forearms, edge of eyebrows, and lower legs, heat intolerance, elevated thyroid peroxidase antibodies, goiter / thyroiditis, neck tenderness in the area around adams apple. Patient did not receive treatment for the events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The Patient underwent lab test and procedures include PCR test was negative on 29Jun2021; Anti-thyroid antibody test result was elevated thyroid peroxidase antibodies on unspecified date in May 2021. The Outcome of the events was not recovered.   Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected.   Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Wheezing, shortness of breath, felt like someone was sitting on my chest. Was given a burst of 40mg of Prednisone for 3 days and Nebulizer treatments 4 x a day. The Prednisone and nebulizer treatments helped.
One week post vaccine I experienced Guillan Barre? symptoms. Both legs were weak, my heartbeat was off rhythm, I began shivering uncontrollably and I wasn?t cold. The symptoms lasted off and on for about four days.
Cheek swelling, redness. Benedryl po 25mg x1. Outcome almost back to baseline. No sob.
Vaccine 5:30 pm 2/27, sensitive skin  10:30 am 2/28 - 1:30 pm 3/1, sore joints in hands and feet 3/1 and 3/2, sore armpit 3/1 to current (3/3), pain decreasing, sore and pink patch at and below injection area 3/1 to current.
Patient complained almost immediately of dizziness and metallic taste. Symptoms continued and pt was monitored for 40 minutes. Given water, vitals were taken including fingerstick. HR: 94 BP: 140/90 SPO2: 98%, on room air, fingerstick: 118. All vitals were normals, EMS was called
Severe puritis, redness swelling, pain, Continued to spread over 24 hours with hives developing and puritiis spreading to entire upper arm Physician visited day after injection.  Benadryl injection given with triamcinolone cream provided.  Redness and rash continued to spread.
Missed the third dose of the Vivotif on day 5; A spontaneous report was received from a caregiver on 16AUG2022. It described a male patient of unknown age who "missed the third dose of the Vivotif on day 5" (PT: Product dose omission issue). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization. It was reported that the patient took the first dose of Vivotif on 12AUG2022. He missed the third dose of the Vivotif on day 5 as he forgot to take the drug this morning (at the time of the report) on empty stomach, he ate something. Now, two doses are left. Reportedly, the patient neither had any concurrent disease nor taking any medication. The patient had not undergone any kind of surgery in the past. The outcome of the reported event was not applicable.  Additionally, it was reported that the patient had no difficulty while having the vaccine.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer missed the third dose of Vivotif on day 5 (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer missed the third dose of Vivotif on day 5 (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.
continued to grow together; rash on my arm after taking the moderna; Red bumps; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my arm after taking the moderna), Red bumps and continued to grow together in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No medical history is provided, concomitant drugs are provided.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced RASH (rash on my arm after taking the moderna) and Red bumps. On an unknown date, the patient experienced continued to grow together. At the time of the report, RASH (rash on my arm after taking the moderna) was resolving and Red bumps and continued to grow together outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: updated concomitant meds, added additional 3 events updated events start date
On 09-17-16 child was seen in ED for febrile seizure at home. On 9-16-16 had fever of 102F, temp in ED on 9-17-16 was 100.4F.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 40 months old male patient who was administered a 0.25 ml first dose of FLUZONE QUADRIVALENT, lot number: UT6259MA, expiry date: 30-Jun-2019, via intramuscular route in the right thigh on 07-Nov-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error due to vaccine underdose. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
VERY SWOLLEN GLANDS UNDER CHIN (SIZE OF HALF TENNIS BALL); This spontaneous report received from a parent concerned a 20 year old male. 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, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced very swollen glands under chin (size of half tennis ball). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very swollen glands under chin (size of half tennis ball). This report was non-serious.
Hard of hearing; My left arm where the shot was is sore; It is hurting so bad; This is a spontaneous report from a contactable consumer (patient). An unknown age and gender patient received BNT162B2 (Covid Vaccine) on 17Jan2021 09: 00 AM at single dose on left arm for covid-19 immunization. Medical history and concomitant drug were not reported. Consumer stated, 'I just wanted to call and see what to do, I got my Vaccine shot (Covid vaccine) at 9 AM this morning on 17Jan2021 and then all of a sudden my left arm where the shot was is sore. I want to know what to put on it ice or heat. I don't want to put on the wrong thing and make it worse. It is hurting so bad.' Consumer stated 'I am hard of hearing. I am a retired sales man.' Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Bruising and sore arm; Bruising and sore arm; Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy), VACCINATION SITE BRUISING (Bruising and sore arm) and VACCINATION SITE PAIN (Bruising and sore arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Moderate, irregular consumption) on 27-Sep-2020 and Smoker (6 years ago). Concomitant products included PARACETAMOL (TYLENOL) for Headache, 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 Pregnancy.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Aug-2020 and the estimated date of delivery was 05-Jun-2021. On 26-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On 27-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Bruising and sore arm) and VACCINATION SITE PAIN (Bruising and sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 26-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruising and sore arm) and VACCINATION SITE PAIN (Bruising and sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2020, Pregnancy test: positive (Positive) Positive. On 06-Jan-2021, Ultrasound scan: positive (Positive) 3rd - The fetus was 1 week behind size compared to actual date..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided. On 04-november-2020 genetic testing with normal outcome.  Company Comment: This is a case of product exposure during pregnancy with AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: ADR form received. The reported events were updated. Added patient demographics. Added Medical history details. Updated concomitant medications. The patient reported she only experienced bruise and sore arm. No contusion was experienced.; Sender's Comments: This is a case of product exposure during pregnancy with AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. 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.
4/28/2021 6 pm:  arm at injection site started hurting mildly. By 9 pm most of my arm hurt. By 11 pm the pain ran from the top of my neck (on the left side only) all the way down to my wrist. My wrist ached like what those with arthritis pain would describe as severe joint pain. Hurt to move it. I found if I elevated it, even just slightly the pain would lessen to the point where it was manageable.   4/28/2021 9 pm: more fatigued than normal, became ebbing exhausted by morning of 4/29 and did not improve until evening of 5/2. By 5/3 I felt normal everyday energy level, but then on 5/4 I was utterly exhausted again, and felt lightheaded and had chest pain for several hours. After napping on 5/4 and sleeping as much as possible on 5/5 I felt better again and have continued to feel well since 5/5.  4/28/2021 11 pm: chills & hot flashes (with fever spiking to low 100 degree range, which last until about 1 pm 4/29/2021 and began occurring less frequently at about 10 am 4/29.  4/28/2021 11 pm: though exhausted by this point, I did not feel tired. I had insomnia and slept a total of about 2 hours all night.   4/29/2021 8 am nausea and dizziness and headache (only on the left side of had)  when I woke up. I ate a small amount of toast and felt like throwing up, but did not actually throw up. Went back to bed and slept for a couple hours. Upon waking still dizzy and nauseated with nausea and dizziness symptoms dissipating at about 9 pm and gone by the morning of 4/30.
Rash and itching started on February 5th on her left arm down to her elbow.  She also had some shortness of breath for a day or two.  Patient no longer has shortness of breath.  She still has the rash and itching.