chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy (Penicillin-rash). Concomitant products included LEVOTHYROXINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved.  This case was linked to MOD-2021-373454 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received contains significant information. Patient's race, height and weight, Medical history, Concomitant and treatment medications were added. Events date and outcome were updated.
RED , SWALLEN INJECTION SITE, PT HAD FEVER THAT FLUCTUATES, BUT HAS GOTTEN DOWN BY MOTRIN,
24 hrs after vaccine got low grade fever, chills anad myalgias, called off work
Child had induration and redness warmth on left arm where injection was given then rash and induration spread throughout whole body face to feet with induration and warmth to touch.
legs began weeping; swelling of her legs got worse; bad fatigue; terrible headache; vasculitis of both legs; legs became swollen; This spontaneous case was reported by a consumer and describes the occurrence of VASCULITIS (vasculitis of both legs), PERIPHERAL SWELLING (legs became swollen), PAIN IN EXTREMITY (legs began weeping), CONDITION AGGRAVATED (swelling of her legs got worse) and FATIGUE (bad fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VASCULITIS (vasculitis of both legs), PERIPHERAL SWELLING (legs became swollen), FATIGUE (bad fatigue) and HEADACHE (terrible headache). On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (legs began weeping) and CONDITION AGGRAVATED (swelling of her legs got worse). At the time of the report, VASCULITIS (vasculitis of both legs), PERIPHERAL SWELLING (legs became swollen), PAIN IN EXTREMITY (legs began weeping), CONDITION AGGRAVATED (swelling of her legs got worse), FATIGUE (bad fatigue) and HEADACHE (terrible headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Biopsy bone marrow: other (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included: Heart medication. Treatment information was not provided
since 2mo rotavirus, diarrhea (water green stool) once day or every other day for 2 months now, nonbloody
pt devel t102 on 18APR95- 19APR 430AM; t103.4 R, crying all day, @ times the cry was high pitched on 20APR; t104.2; mom noticed pts hands were twitching & staring into space;
Severe aches in joints, especially injected arm. Began severe headache, nausea, vomiting.  Body was quivering, jaw quivering bad pretty bad. Did not go to emergency room, but one step away from it. Still have pain in elbow of injected arm (right).
three weeks after the vax he had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-SEP-2022 Reporters comment: This case was reported by patient's friend via interactive digital media. The patient's doctor told the patient that at his age he should get that vaccine so he would not get shingles. Three weeks after the Shingles vaccine he had shingles. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Patient first reported feeling a tingly/"prickly" feeling down his left arm and left shoulder, we advised patient to stay an extra 30 minutes for closer monitoring. About 15 minutes later his left knuckle began to swell with some redness, patient reported no difficulty breathing and no itching of the throat. Pharmacist decided to give Diphenhydramine 50mg IM after patient consented. The swelling and redness began to subside within 10 minutes. Patient received a ride home from family due to drowsiness from the Diphenhydramine
Tubersol 1 ml in his left deltoid today IM; Tubersol 1 ml in his left deltoid today IM; individual that injected the pediatric patient meant to give the patient a Tetanus vaccine; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 years old male patient who received TUBERCULIN TEST [TUBERSOL] instead of TETANUS TOXOID and reported that Tubersol 1 ml in his left deltoid today IM and individual that injected the pediatric patient meant to give the patient a Tetanus vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); and HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]).  On 12-Jul-2019, the patient started taking TUBERSOL (TUBERCULIN TEST) 1 mL (lot - C5569AA, 08-Apr-2021) for Tuberculin test.  It was a case of actual medication error due to vaccine overdose, inappropriate route of vaccination and wrong vaccine administered.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
phantom nerve sensation; a feeling like something was crawling on my skin (leg); sensations began occurring occasionally a couple of weeks after fully vaccinated but but stopped occurring several weeks after fully vaccinated.
No adverse events thus far. Patient received Component 1 (MenCYW) of the vaccine but did not receive Component 2 (MenA)
1st dose 2019, 2nd 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose was received in 2019).  On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 2019, 2nd 2023). The outcome of the drug dose administration interval too long was unknown.  Additional Information: GSK Receipt Date: 31-MAR-2023 The patient got the second dose of Shingrix this year (2023).  The healthcare professional had asked if these 2 doses were valid or if the patient had to restart the vaccine series.  The reporter did not shared information regarding the two Shingrix doses (Lot number, expiry date, date of administration). The reporter had consented to follow up. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Bruising/varicose veins came on 2-3 days after receiving SHINGRIX. No fevers or rashes. Painful- started out 5/10 now only 3/10 per Dr.. Patient reported that he had massaged the area. Treatment Plan: Observe.
Upper respiratory infection: fatigue,  scratchy throat, intermittent cough, runny nose. Symptoms lasted about 10 days
This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th December 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 8th December 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the Pediarix vaccine was partially administered to the patient because the vaccine leaked out the syringe because the syringe was cracked, which led to incomplete dose administered. The reporter was inquiring whether the vaccine should be administered again and if so, when since patient did not receive the entire recommended dose. The syringe was cracked before administering the vaccine, but not noticed until it was actually administered. As per report, it was something the vaccine administrator did that caused the syringe to crack. No product quality complaint raised. The reporter did not provide any additional details. The reporter consented to follow-up.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 26th March 2018, for tolerance refer, US2018GSK181073). On 24th September 2018, the patient received the 2nd dose of Shingrix. On 24th September 2018, less than a day after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The patient received the Shingrix on the right arm. The patient stated that, he sat down and pharmacist stood when he received the shot. The patient experienced pain and soreness at the injection site which lasted for 4 days, although it was 50 percent better in the last 24 hours.
Information has been received from a licensed practical nurse concerning a 12 year old female who on 15-JUN-2007 was vaccinated SC in the right deltoid with a first dose of Zostavax (Oka/Merck) (lot # 656607/0163U) instead of the second dose of Varivax (MSD) that she was scheduled to receive.  This was reported to be human error and not product confusion.  Unspecified medical attention was sought.  The patient's mother stated that the patient had no reaction.  There was no product quality complaint involved.  Additional information is not expected.  The patient's siblings had similar experiences with vaccination (WAES # 0707USA01865 and 0707USA01867).
Patient suffered from SOB 4 days after receiving injection, was diagnosed on 4/14/21 with bilateral PE's. Admitted to hospital.
Day 1 Started with throat itching  followed by cough  with in 20 mins post vaccine later in evening left lung pain with SOB Day  2 Shortness of breath , left lung pain, cough Day 3  - Day 4 PVCs  Taking Zyrtec and Pepcid for 4 days , Evaluated by EMTs onsite , did allergy treatment and evaluated by PCP
Severely ill infant with onset of vomiting on 9/29/2012 with fever x 2 days. Abdomen dilated, pale skin, capillary refill greater than 3 seconds. Fire Rescue called to scene taken to Medical Center and then transferred to Pediatric Intensive Care Unit at another Medical center. Underwent laparotomy. Found to have purulent peritonitis with no identifiable intestinal leak, no intussusception. Peritoneal fluid culture was M.R.S.A (Patient is slowly improving in PEDIATRIC INTENSIVE CARE as of today 10/04/2012). Family members at home have history of M.R.S.A infections.
Husband alleges that the patient sustained an inflamed left arm, high fever, and was diagnosed with cellulitis. These caused her to spend two nights in the hospital.
87-year-old female with hx diverticulitis (2020), functional quadriplegia, hypertension, rheumatoid arthritis, hypothyroidism.  She presented to the ED with c/o nausea and hypoxia 89% at home following diagnosis of COVID-19 approximately 1 week ago and confirmed on ED visit on 10/17/2021.  Endorses shortness of breath, nonproductive cough, fever, chills, myalgias.  Denies chest pain, palpitations, lightheaded/dizzy, headaches.  ED work up significant for tachypnea 31, hypoxia 90% on RA, elevated trop 26 (was 22 on 10/17/2021).  Normal lactic acid 1.6.  CXR reveals bilateral opacities concerning for early infiltrates, however, final radiology read is pending at the time of admission.       Tested positive on 10/15/2021
Patient received initial covid vaccine (Pfizer) on 10/5/2022.  MD ordered Pfizer monovalent vaccine for 2nd dose but bivalent booster dose administered.  Pt is pregnant, EGA=32 weeks, 3 days
Initial information received on 13-Feb-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a two years old female patient who received an expired fourth dose of ACT-HIB (lot UI738AA and Exp. Date 15-Nov-2017) via unknown route in the right thigh on 30-Nov-2017. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR, MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACC.) for Immunisation. It was an actual medication error case due to expired vaccine used. No adverse event reported. 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. Follow-up report received from an-other healthcare professional on 14-Feb-2019. No additional information was received. List of documents held by sender: none.
This spontaneous report as received from a nurse refers to a 23 months 13 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Little itching on the injection arm; Little swelling on the injection arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Little swelling on the injection arm) and VACCINATION SITE PRURITUS (Little itching on the injection arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE SWELLING (Little swelling on the injection arm) and VACCINATION SITE PRURITUS (Little itching on the injection arm). At the time of the report, VACCINATION SITE SWELLING (Little swelling on the injection arm) and VACCINATION SITE PRURITUS (Little itching on the injection arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-315671 (Patient Link).
Pt had syncopal episode /p MMR shot. Subsequently had amnesia & disorientation.  Could not remember place or time initially. 20 hrs /p the shot, the period of amnesia was from the injection until nightfall approx. 4-6 hrs.
Patient experienced arm pain the day after her vaccination. Two days later she had redness on her arm around the injection site. She said it was warm to the touch and hurt. Patient said the next day the redness got bigger and was still warm to the touch. It was around 5 inches in length. Patient went to doctor and they stated it was an infection and patient was prescribed antibiotics.
Vaccine 1427pm. Pruritic hives at (R) elbow 1/2-1/1/4" long x approx 1/2" wide. BENADRYL 50 mg given po at 1440. Pruritic hives continued to arise on (R) upper arm and forearm and later. Pt reported a slight headache.
Headache everyday for over 2 weeks now, has not gone away.  Arm is still sore
Patient initially tolerated her immunizations well. Patient passed out a couple minutes after administration. She fell from her chair to the floor and woke up in a few seconds. She woke up feeling dizzy. This nurse was in the room at the time of event. Doctor was called into room  immediately. Patient was evaluated by Dr., P.A. and RN. Dr. evaluated her head due to falling and she was without injury. Patient was given apple juice, blood pressure was taken and was 92/58. Patient generally tolerated apple juice well but still felt a little nauseated. She was brought to a table to lie down. Later, she felt well enough to walk out of the office on her own in roughly 45 minutes. By that time her color was normal and her blood pressure was 110/68.
within 15 min of injection, my throat got itchy and tight. difficult to swallow. I got dizzy and my face and chest felt like sunburn. The EMT on duty took my vitals with extremely high BP. he had another EMT confirm. They transferred me via ambulance to hospital ER for anaphalaxis. I was given benedryl on the way in  iv.  At the hospital, dr gave steroid and epinepherine in iv port. this helped me swallow and my vitals stabilized and i was released hours later with scrips for prednisone, pepsid and benedryl. Follow up with my primary care dr.
While patient receiving boosters and assessment questions being done, noted that first immunization done 73 days after COVID antibody infusion.
High fevers, possible febrile seizure, flu-like symptoms, swollen erythematous right arm at the site of both vaccines.
Initial reaction to second dose was typical inflammation response - fever, chills, extreme fatigue and aches for 36 hours. Initial reaction also included severe joint pain. The joint pain has persisted to current date. The pain is most intense in joints that had previous pain from arthritis, surgery, burst disk or injury (in order, fingers, neck, neck, knee and hip.) In each case the pain after the vaccination is several degrees more intense than I experienced in the year previous to the vaccination.
Extreme lower back pain; Fever of 102 Degrees; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Extreme lower back pain), PYREXIA (Fever of 102 Degrees) and FATIGUE (Tiredness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and LOSARTAN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever of 102 Degrees) and FATIGUE (Tiredness). On an unknown date, the patient experienced BACK PAIN (Extreme lower back pain). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Extreme lower back pain) had not resolved and PYREXIA (Fever of 102 Degrees) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 102 (High) 102 F.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Other treatment information included heating pad.
I went for a mammogram screening I brought up that I had found lump on both breasts. I had noticed that the right side was bigger than the left side. On February 23, 2023, I had an ultrasound of my breast done. The results for both the mammogram and the ultrasound were negative for anything unusual, just extra breast tissue.
No adverse effect; the patient was administered a dose of improperly stored ROTATEQ; This spontaneous has been received from a medical assistant, concerning an approximately 7 week patient of unknown gender and ethnicity.    The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 07-MAR-2019, the patient received a first dose of improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R002700 and expiration date 24-AUG-2019), taken orally as prophylaxis. On 15-MAY-2019, the patient received the second dose of vaccine.   In addition, the vaccine was exposed to temperature: 1.2C for timeframe 30 minutes with previous excursion: -2.13C for 3 hours. The excursion call was made by a data logger. No adverse effects reported.  This is the second of the three patients.; Sender's Comments:  US-009507513-1905USA011943: US-009507513-1905USA012681: