chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient began experiencing anterior right deltoid pain 2 hours after receiving the flu vaccine. The pain continued in the following days with certain movements and she had symptom improvement with NSAID use. She was diagnosed with post-injection bursitis two weeks post-injection and prescribed methylprednisolone along with modified activity with some improvement. An MRI 2 months post-injection showed bursitis and partial rotator cuff wear and tear. Physical therapy was recommended.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA298622, 2018SA298603, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298695 and 2018SA298701 (same reporter). This case involves a patient of an unknown demographics who received 5 ml dose of vaccine FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 via intramuscular route and site of administration arm NOS on an unknown date which was stored incorrectly. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose (patients was injected 5 ml with this previously frozen FLUZONE HD) and incorrect product storage (temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time). It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
Pt developed Pertussis disease. Onset of symptoms, 8/5/00. Pt was admitted  on 6/5/00, 6/27/00 X 1 day, 6/29/00 X 10 days for po intake decrease, loose and watery stools and dehydration. On 8/4/00, pt started having a mild cough. On 8/9/00, pt had severe cough and whoop with post-tussive vomiting. On 8/15/00, pt started on erythromycin X 14 days for treatment of Pertussis.
Injection site erythema/induration 4 cm; pruritus. Treated with anti-inflammatories; ice pack; topical and oral BENADRYL.
pt recv vax 9OCT98 & arm was already red & bruised;pt was seen by RN on 12OCT98;site was red & extremely tender to touch;red area was approx 3in in diameter, center of red area bruised approx size of vax area was warm to touch;seen by MD
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (recommendation to defer second vaccine dose up to 42 days), WEIGHT DECREASED (lost 20 pounds), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea) and VOMITING (throwing up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Irritable bowel syndrome (previously diagnosed with IBS and Crohn's disease.) and Crohn's disease (previously diagnosed with IBS and Crohn's disease.) Concomitant products included FUROSEMIDE, METOPROLOL, LISINOPRIL, CLOPIDOGREL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced WEIGHT DECREASED (lost 20 pounds), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), VOMITING (throwing up) and FATIGUE (felt tired of this symptoms). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (recommendation to defer second vaccine dose up to 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (recommendation to defer second vaccine dose up to 42 days), WEIGHT DECREASED (lost 20 pounds), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), VOMITING (throwing up) and FATIGUE (felt tired of this symptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information provided. Most recent FOLLOW-UP information incorporated above includes:On 28-May-2021: No specific follow-up information recorded.
Upon receipt of vaccine: pain/redness/swelling at injection site and headache (expected and resolved by 12/31/2020); then on 1/7/2021, redness returned with swelling consistent with hives, accompanied by intense, prolonged itching at the injection site. Swelling and redness persists.
pt was seen on 24NOV92 for 6 mo exam; ear infection was noted; since the pt was afebrile; pt had brief generalized seizure; taken by ambulance to ER where exam was nl x/OM; 1DEC92 a 2nd brief generalized sz occurred;
05/25/2021 @ 3:15 pm, Patient was given a Kin rix IM in his right arm, then a Pro quad vaccine in his left arm, subcutaneous.  Tolerated both vaccines well, and had not complaints at that time.  I informed mom that he may have a topical reaction where the pro quad was given, since given subcutaneous, where it may be red, swollen and warm to touch.  05/26/21 Spoke with mom the following day about another matter and she mentioned that his arm was a little swollen and hard, but no complaints.  05/27/21 Mom called stating that  last night around 5:00pm  his arm started looking blistered and hard feeling, so she  took him to ER.  One at ER the blister started oozing, they wrapped it up and prescribed Cephalexin and Hydroxyzine.  Dr. prescribed Bactroban ointment to use too.  Mom states that the morning on the 27th, his arm started to look a lot better.
Pt. developed "tiny little red bumps starting Sat. eve to L ear and has now spread to her entire body but she does not seem bothered by it".
Erythema with streaking to axilla. Tx Motrin Augmentin T po Bid x 3 days.
chills; I had a fever; lethargic; I woke up with a severe case of vertigo; This is a spontaneous report from a contactable other-healthcare professional (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 02Mar2021 (at the age of 69-years -old) as dose 2, single for COVID-19 immunisation. The facility in which the vaccination administered was other. The patient medical history included sinusitis, tinnitus, hypertension, hypothyroidism, anxiety, food allergy (Shellfish), drug hypersensitivity (sulfa), drug hypersensitivity (penicillin's). The patient concomitant medications within 2 weeks included thyroid (ARMOUR THYROID): buspirone (BUSPIRONE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); cholecalciferol, menaquinone (D3 +K2). The patient did not receive any other vaccines within 4 weeks of vaccination. The patient previously took first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269), via an unspecified route of administration, in the right arm on 09Feb2021 10:00 as dose 1, single for COVID-19 immunisation, cipro [ciprofloxacin hydrochloride monohydrate] and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested COVID-19. On an unspecified date in Mar2021, the patient experienced I woke up with a severe case of vertigo. On 02Mar2021 chills, I had a fever, lethargic. Therapeutic measures were taken as a result of I woke up with a severe case of vertigo, chills, I had a fever, lethargic and included treatment with stimulation with a machine on my head. Patient stated that 3 weeks later, I woke up with a severe case of vertigo. For 5 days I could not be alone, needed help toileting, walking, bathing and was in bed. I went to an ENT and diagnosed me. I have been treated weekly by him with treatments for my head. To date, one month later. I still have symptoms and will be treated again tomorrow. I never had vertigo and it is truly debilitating. The events result in physician office visit. The clinical outcome of the event I woke up with a severe case of vertigo was not recovered. The clinical outcome of the events chills, I had a fever, lethargic was recovered on an unspecified date of 2021.  No follow-up attempts are required. No further information is expected.
Malaise; lethargy; fever of 101.5; Anatomical Location: Leg Left; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 02Dec2021 15:30 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, start date: 20Oct2021, stop date: 20Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Leg Right, Vaccine Administration Time: 11:30 AM), administration date: 11Nov2021, when the patient was 6 years old, for COVID-19 Immunization, reaction(s): "Anatomical Location: Right leg". The following information was reported: MALAISE (non-serious) with onset 05Dec2021 18:00, outcome "recovering", described as "Malaise"; LETHARGY (non-serious) with onset 05Dec2021 18:00, outcome "recovering", described as "lethargy"; PYREXIA (non-serious) with onset 05Dec2021 18:00, outcome "recovering", described as "fever of 101.5"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 02Dec2021 15:30, outcome "unknown", described as "Anatomical Location: Leg Left". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, lethargy, pyrexia.  Additional Information: Serious was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received call from nurse at medical center that infant had died at ER around 4 PM the date of vaccination. The infant appeared well and healthy at the time of vaccination. 6/16/09 6/16/09 Autopsy report states COD as undetermined & manner of death as undetermined. Autopsy report also states pt given antipyretic & put down for nap after vaccination.  Found lying face down.  Examination revealed mild chronic inflammatory cell infiltration of lungs & no evidence of anaphylaxis.
This spontaneous report was received from a registered nurse refers to unspecified patients (also reported as female) of unknown demographics. On an unknown date the patients were vaccinated with doses of GARDASIL (lot#, expiration date and route not reported) after an interruption in the GARDASIL vaccination schedule. This is one of two reports from the same source. Additional information has been requested.
Arthralgia, myalgia, fatigue, Low grade temps, mild nausea, arm very heavy and sore, could not raise arm and shoulder.
Parosmia - smelling cigarettes/smoke all the time. Started a week after second dose and is still occurring
This spontaneous report as received from a physician refers to a 12 year old female patient with hypothyroidism and with no known allergies. The patient was not pregnant. on 30-APR-2013 the patient was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown). The patient experienced redness, warmth, swelling, and pain at the injection site after receiving GARDASIL. The patient sought unspecified medical attention, and was given "antibiotics" for treatment. At the time of this report the patient was not recovered. Additional information has been received.
given: Hib, pneumococcal,  dtap at 9;30am at 11:30am she developed swelling of lip, tongue, and eye area tx in the ER w epi, steroid. mom gave benadryl prior to arrival. pt watched in the ER and improved. unclear if anaphylaxis is related to vaccines. no other obvious inciting event.
About 12 hours after receiving my first dose, I broke out in a rash from head to toe. I was given a steroid shot and allergy pills to calm the rash. I waited the full 6 six weeks to get my second dose. About 12 hours after receiving my second dose, I had the same reaction. The reaction after the second dose was not as strong at first, but it gradually became as strong a reaction as the first.  I saw a total of five different doctors. I saw two different allergists. The second allergist I saw, performed allergy tests on me that pertain to the vaccine. It turns out that I am allergic to polyethylene glycol. I have never had this allergy, or wasn't aware of having it, prior to receiving my vaccines. The allergist kept thinking that I had a rash around the injection site, but I never had one there. It was just everywhere else.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 3:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 3:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 39.38 for dose administered on 28-Feb-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature of 27 degrees Fahrenheit on 09:00 AM and 26 degrees Fahrenheit on 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
tingling sensation in her arm; large inflamed area; itchy; red; arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PARAESTHESIA (tingling sensation in her arm), VACCINATION SITE INFLAMMATION (large inflamed area), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0128L20A) for COVID-19 vaccination.     no specified medical history was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, DICLOFENAC for Arthritis, ASCORBIC ACID (VITAMIIN C) for Combined immunity deficiency, MAGNESIUM for Cramps, OMEPRAZOLE for GERD, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Routine health maintenance.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 30-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (large inflamed area), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red). On 31-Jan-2021, the patient experienced PARAESTHESIA (tingling sensation in her arm). On 30-Jan-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, PARAESTHESIA (tingling sensation in her arm), VACCINATION SITE INFLAMMATION (large inflamed area), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient had Tylenol and little bit of ice as treatment measures.   Reporter did not allow further contact
This spontaneous report was received from a nurse referring to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 04-FEB-2019 the patient was administered with improperly stored ROTATEQ (product storage error). The current temperature excursion: 9 "C" for 63 hours. There was no previous temperature. No adverse effects were reported. Data logger was involved. (strength, dose, lot # and expiration date were not reported) orally for prophylaxis.
Mother reports child broke out in rash after returning home, rash located on legs, shoulders and "a couple spots" on face. Denies any shortness of breath or other s/s of adverse effects. Advised to contact pediatrician and follow up prn.
At night, I was nauseous, I had, chills muscle aches, and developed a fever. In the morning, I had a 101 temp and then I took Tylenol. I also threw up chicken soup . I called my doctor after hours that Saturday but I spoke to a nurse. They told me to stay hydrated. I drank ginger ale and ate crackers. By Sunday morning, I started to feel better. By Monday, I felt 100% well.   Estimated date of delivery is November 6th, 2021. I was super tired the first trimester and the second trimester, I've been feeling great. I've been getting a lot of stuff done around the house. But it is hard to squat sometimes. I had a checkup May 24th and the doctor said that the baby was doing fine.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 19month old patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 20August 2003 the patient received the 4th dose of Infanrix. On 22August 2003, two days post immunization, the patient presented to the physician with an injection site reaction characterized by redness and a "large" area of swelling. The events resolved. The nurse considered the events were related to Infanrix lot DTPA610A2.
Headache, under the weather, "flu-like" symptoms. Resolved that night, felt normal next morning.
Day 1 after shot:  Soreness around the injection site - discomfort when raising arm, but now while exercising (ex: planks) Very sleepy throughout the day despite focusing on work projects - fell asleep on accident late afternoon the day after shot Day 2 after shot:  Soreness if fading and not as noticeable Still sleepier than usual (currently morning time)
No side effects reported; HCP calling to report AE for patient who received improperly stored PROQUAD on 02OCT2023. No side effects reported. No other medical information known. Operator of Device was a Healthcare Professional. HCP permission to contact obtained. See addition; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 02-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot #X018582 has been confirmed as valid, expiration date: 05-JAN-2025, Therapy Type rHA), administered for prophylaxis (strength, scheme frequency and route of administration were not provided). The vaccine underwent temperature excursion that same date, with a minimum temperature of -9.8 degree Celsius in a time frame of 12 minutes (Product storage error). No previous temperature excursion and additional side effects were reported.  This is one of 7 reports received from the same reporter.; Sender's Comments:  US-009507513-2310USA007901: US-009507513-2310USA007936: US-009507513-2310USA008300: US-009507513-2310USA008237: US-009507513-2310USA007907: US-009507513-2310USA007942:
Headache; body aches; didn't feel good; joint pain and muscle aches and fatigue; Lasted about 24 hours exactly. Then felt fine after that.  Pregnant: June 21, 2021; noneventful
Received ZOSTAVAX vaccine approx. 1pm 1/22/09 went to bed approx. 1030 pm that night-had bout of very fast,hard, heart palpitations lasting approx, 15 min. Resolved with no medical treatment. No residual problems. No HX of anxiety or heart palpitations.
Fever, chills, urinary pain.  "felt like when [he] had sepsis before".    this was his second dose and reports to reaction from first dose. Reports dizziness persists and his blood pressure was 80/60 at one point.  Back to 117/76 today.
Moderna Covid19 vaccine   Redness, swelling & itching at injection site approximately 28 hours after receiving vaccine lasting 24+ hours
The pt experienced a high fever and a sever headache within a few days following each shot. The headache was on and off from the 1st shot given. On 1/99 the pt was treated for end stage renal disease. Diagnosis also included severe hypertension.
The pt ran a fever of 99.5. She slept most of the day when she woke up from nap she had a fever of 102.5. Mom called the pediatrician they said to give her Motrin, Mother had Tylenol and the child was treated with that. At 2:30 that afternoon, the child began shaking and eyes were rolling and staring blankly. The parents called 911 and the transported her to the hospital