chrisvoncsefalvay/vaers-outcomes huggingface dataset:
head rush immediately after injection; extremely sore arm; This is a spontaneous report from a contactable consumer. This 65-year-old  female consumer (patient) reported that:  A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 10:00 as SINGLE DOSE for covid-19 immunisation. Medical history included, covid-19 covid prior vaccination: Yes. Concomitant medications included amlodipine taken for an unspecified indication, metformin hydrochloride taken for an unspecified indication, the patient previously took flagyl metronidazole and experienced drug hypersensitivity, ciprofloxacin, and experienced drug hypersensitivity.  The patient experienced head rush immediately after injection, extremely sore arm and the events were assessed as Non serious by health authority and outcome of the events recovering   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
the tissue feels really weird/uncomfortable; Tissue at the injection site feels hard; Injection site itchy; rash at the injection site the size of a base ball; injection site the size of a base ball and the tissue feels really weird its red,; Injection site burns; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (the tissue feels really weird/uncomfortable), VACCINATION SITE INDURATION (Tissue at the injection site feels hard), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (rash at the injection site the size of a base ball) and VACCINATION SITE ERYTHEMA (injection site the size of a base ball and the tissue feels really weird its red,) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (the tissue feels really weird/uncomfortable), VACCINATION SITE INDURATION (Tissue at the injection site feels hard), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (rash at the injection site the size of a base ball), VACCINATION SITE ERYTHEMA (injection site the size of a base ball and the tissue feels really weird its red,), VACCINATION SITE PAIN (Injection site burns) and VACCINATION SITE SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOMFORT (the tissue feels really weird/uncomfortable), VACCINATION SITE INDURATION (Tissue at the injection site feels hard), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (rash at the injection site the size of a base ball), VACCINATION SITE ERYTHEMA (injection site the size of a base ball and the tissue feels really weird its red,), VACCINATION SITE PAIN (Injection site burns) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
10-12-09 Upper and lower extremity weakness. 10-13-09 Muscle weakness and pain.
This case was reported by a physician via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received ROTARIX. On 4th April 2016, the patient received the 2nd dose of ROTARIX (oral). On 4th April 2016, less than a day after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details provided were as follows: After vaccination the patient spitted out the dose. The reporter did not have the lot number and the expiration date. No other adverse event was reported.
Red, swelling about size of palm of hand below injection site, itching, being treated with Keflex 500MG capsule 4 times a day for 7 days
8 days after vaccine right arm hot to the touch, painful, large red patch around injection site, red patch is increasing in size. Today 1/17/21 now arm is bruised and swollen
Extreme pain of upper extremity, erythema 8x4 cm in size and edema extending approx 4 cm outward from arm. Treatment: ibuprofen, ice, elevation, cephalexin
Pt was given Proquad at age 12 yr. 6 mons of age - with no adverse event.
Left supraclaviular adenopathy/lymphadenitis with cellulitis. Tmax 100.1, fatigue No treatment given except for anithistimines and acetominophen.  Still resolving
High fevers of up to 102 degrees, intense headaches, difficulty breathing, fatigue, malaise, body aches, dizzy, weak, unable to get out of bed
No adverse event; HCP gave an expired Moderna bivalent vaccine today 02-Jun-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP gave an expired Moderna bivalent vaccine today 02-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 02-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP gave an expired Moderna bivalent vaccine today 02-Jun-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP gave an expired Moderna bivalent vaccine today 02-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 gave an expired Moderna bivalent vaccine today 02-Jun-2023).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to MOD-2023-727539 (Patient Link).
Intense pain, hot from injection site, down entire arm immediately after given.  Continued pain after two days into two weeks, shooting pains , crawling at injection site,and throbbing, even at elbow and wrist.  Arm was also very weak, and still gets tired and throbs .  Has been 4 weeks this week-end . Reported to nurse who tod me to see my Dr. which I did this week.  No redness at injection site, just soreness, know something was off, according to side effects.   Very tired feeling, still, and had some flushed color the first week in my face and like heat flashes for two weeks.    Hope to get the normal feeling back in my arm.  Not sure ?   Maybe a nerve was nicked?  But was not like a Bee Sting like tech described it would feel like that day.  Had a ruff start.
This is a spontaneous report from a contactable consumer, a Pfizer employee/clinician who reported for her nephew. A 6-month-old male patient received a single dose of PREVNAR; rotavirus vaccine; DTaP; IPV; Hib vaccine; and hepatitis B vaccine, all were given via an unspecified route of administration on 24Oct2014 between 10:00 AM and 2:00 PM, and administered in a doctor's office. It was unknown if the vaccines were purchased from public fund, private fund or military fund. The dose and lot numbers of the vaccines were unknown. The reporter stated that the vaccines were probably administered on the leg, but did not know for sure. No information was available about other vaccines given four weeks prior to the event. Medical history included ongoing acid reflux disease since birth taking baby ZANTAC, and was started with a cold before he got the vaccines from an unknown date. Concomitant medications included ZANTAC. It was reported that the patient was being weaned from ranitidine hydrochloride; however the patient did receive ranitidine hydrochloride on the night of 24Oct2014. The patient previously received the rotavirus vaccine on an unknown date and experienced a fever. The reporter was not sure if the patient was given PREVNAR last time (when he had shots) or not. The patient experienced throwing up on 24Oct2014 at night at an unknown time. The patient was not hospitalized and the reporter did not think the patient visited the doctor due to the event. It was unknown if the patient went for any blood work due to the event. The clinical outcome for the event of throwing up was recovered on an unknown date in Oct2014. It was reported that it was unknown if the patient received PREVNAR 7 or PREVNAR 13. It was reported that the mother of the patient thought that it was the rotavirus vaccine that caused the vomiting. Also, the mother of the patient thought that the patient was coming down with a cold before the patient got the vaccines, which might have contributed to the event. The reporter was not sure about the causality of the event, if the event happened due to these vaccines. Follow-up (29Nov2014): Follow-up attempts completed. No further information expected.
Information was received from a registered nurse, who reported that on multiple unspecified dates, multiple unspecified patients were administered improperly stored VARIVAX (lot # M035687, expiration date 10-AUG-2018) (dosage and route of administration not provided). No adverse effects reported. No additional information provided. Temperature/Time frame: > 14°F but < 46°F for 3 hours.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA012015: US-009507513-1702USA012014: Original Case : 1702USA009271 US-009507513-1702USA012016:
Discharge Provider:   Primary Care Physician at Discharge:  Admission Date: 12/22/2022  Discharge Date: 12/29/2022 COVID positive date: 12/22/2022 DKA, type 1, not at goal [E10.10] AKI (acute kidney injury) [N17.9]   HOSPITAL COURSE: Pt. is a 10-year-old female presenting with severe DKA from new onset T1DM, possibly triggered by COVID-19 infection. She was obtunded when she presented to the outside hospital and was improved, but somnolent, upon arrival to our ICU on 12/22. She did receive mannitol x1 for concern of cerebral edema. Insulin was started at 0.1 units/kg/hr and her fluids were adjusted based on her potassium, chloride, bicarb, and glucose. Over the first day the patient received 150ml/hr of D10.45NS without K and subsequently had marked improvement of her neurologic status. She complained only of abdominal pain. Endocrinology visited in the patient and her family for discussion of her new diagnosis and next steps.    On 12/24 she had worsening AKI for which nephrology was consulted and evaluated the patient. CK slightly elevated. Renal U/S showed borderline enlarged kidneys and reactive right urothelial thickening. Urinalysis showed bacteria, 26 WBC, and blood, and was sent for culture. Urine culture 12/24 with pan-sensitive E. Coli. Asymptomatic. Indwelling cath from early AM 12/24 - AM 12/25. Oliguric from AKI. Transitioned from Ceftriaxone to Keflex 12/26 for a total of 7 days of antibiotics. Potassium was added back into her fluids given her degree of hypokalemia. The patient was transitioned to SubQ insulin and given a general diet. Her fluids are kept on due to her degree of dehydration, and RFP were obtained q8h overnight into 12/25.    On 12/25, IVF rate was decreased to avoid potentional fluid overload. RFP was rechecked and showed continued worsening kidney function. Pt was given lasix x2 due to decreased urine output.    On 12/26, morning RFP continued to show decreased kidney function. By this point patient had remained stable and DKA had nearly resolved. Given worsening kidney function patient was transferred out of the ICU to the Nephrology service for further management. Did have hypocalcemia and was started on calcium carbonate TID, and hypokalemia and this was repleted.   Creatinine continued to trend upward, 5.56 on 12/27. S/p aggressive fluid resuscitation, now euvolemic on exam. Oliguria, UOP 0.6 ml/kg/hr and hypertensive with systolics in the mid 120s and diastolics in the high 80s. Associated electrolyte abnormalities. Hemodialysis with renal biopsy considered, but creatinine did decrease to 4.91 on 12/29 with increased UOP to 2.5ml/kg/hr. Due to improvement patient was felt to be stable for discharge home with close monitoring of RFP and daily weights. Diabetes education was performed and parents were agreeable to the plan.
Red, hot, swollen rash the width of the arm and approximately half the width for the length. Took pictures to chronical Friday, Saturday and Sunday.  Used OTC benedryl cream and hydrocortisone cream at the suggestion of 3 pharmacists.  Responding, but still quite present on day 7 post vaccine. Beginning to see bruising where rash was extending around arm.
No adverse events occurs. This is vaccine given out of licensure. Pt received DTaP instead of Td due to age.
bad allergic reaction; itching and welts, like hives; itching and welts, like hives; didn't get any sleep last night; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302 and expiration date not provided), via an unspecified route of administration in the left arm on 18Jan2021 18:00 at  a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included other medications that she has never had a reaction to. The patient stated that she got her first dose of COVID vaccine on 18Jan2021 evening. On 19Jan2021, she had a bad allergic reaction, itching and welts, like hives or whatever that started on her arms that progressed to the rest of her body especially the buttocks, everywhere. She did not get any sleep on 19Jan2021 and was itching. She called the doctor's office to see if they could help her and they said they couldn't and told her she needed to contact the health department "or something." They aren't familiar with the vaccine and does not want to do anything that would put them in a legal situation. She stated she has an appointment on 08Feb for her next dose and she doesn't know if she can go through this again. She asked what can she do about this reaction. She started to get itching and "stuff" that was not bad until last night (unspecified date). She stated that it was like she had hives all over and itching out of control. She did not get any sleep and is still itching out of control. She wanted to know if she goes back to hospital if they will be able to do anything for her. It was her first shot and is scheduled for her second one on 08Feb2021. She was wondering will she have to go through all of this again. She had noticed hives on her arms on 19Jan2021 morning but mostly now are on her buttocks and thighs.  She stated that she had thought it was an allergic reaction to a fabric softener that she changed to. No treatment was given in response to the events. She has stated that she takes other medications that she has never had a reaction to. She does not think that they were related to this. The outcome of the events was not recovered.
patient received Tenivac instead of Adacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (MI) (Reference number- 00574999) and transmitted to Sanofi on 23-Apr-2021.  This case involves a 22-year-old female patient who received a 0.5 mL dose of  DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6669AA and expiry date: 15-May-2022) via an intramuscular route in the left deltoid for prophylactic vaccination on 23-Apr-2021 instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  This was a case of actual medication error case due to wrong vaccine administered (latency same day).  At the time of reporting, no adverse event was 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.
a recurrence of cellulitis in her right arm; a recurrence of cellulitis in her right arm; headache; sore arm; Lymphoedema; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program, Pfizer First Connect. A 78-year-old female patient received the first (1st) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Jan2021 at a single dose as COVID vaccine. Medical history included cancer survivor and cellulitis in her right arm from being a cancer patient. Concomitant medication included quinine sulfate (LEXIQUIN). It was reported that after the 1st dose of the vaccine, the patient experienced a very bad headache and a sore arm on 2021 and didn't want to miss her 2nd dose. She wanted to know if it's still alright to get her 2nd dose and had some other questions. Her 1st dose of the Pfizer COVID vaccine was 2 weeks ago, afterwards on 2021, a recurrence of cellulitis in her right arm from being a cancer patient; she was put on Levaquin and her doctor told her she may absolutely not get her 2nd dose until at least 15 days after her Levaquin treatment. She's supposed to go for second shot this Saturday (also reported as Friday) but ended up coming down with lymphoedema on 2021. She also came down with cellulitis in her arm after receiving the first injection, which happens a lot to her. She's still on Levaquin and would be done in 3 days. She would like to know how many days she needed to wait to get the vaccine after stopping that. She would like to know how long she could wait in between doses and whether the effects of the 2nd dose of the COVID vaccine would be worse than the 1st. She would also like to know if she has to wait too long, what would happen. Would she need to start all over again? She also wanted to know about getting a new appointment. She spoke to the CDC yesterday and they told her 45 days, and she wanted to know if that was alright or not. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
No adverse events. Patient was suppossed to get the pfizer covid -19 (5-11 yr) bivalent vaccine and was given the pfizer covid -19 (5-11 yr) monovalent vaccine. Patient is doing fine.
That night she developed fever, chills, and sweats. The next evening she said her arm itches and she had a 4 1/2 by 2 3/4 bright red, hard and hot spot at flu injection site. The next morning it was over 5 1/2 inches by 3 1/2 inchs and even redder. She saw doctor the 1/19.
Injection site sore.  By weekend semi productive cough began and took Mucinex which helped.  On Monday 12/5, felt panicky; woke up in middle of night feeling cold and shivering uncontrollablly.  Also had a burning headache.  On Tuesday was in bed all day feeling sick.  At night shivering , shakes began again as well as headache.  On Wednesday was seen by chronic fatigue specialist who gave him a gammoglobulin, B-12 and vitamin intravenous drip.  Mentioned it was a neuropathy because had intense pain on feet.  Wednesday night slept much better but was either too hot or cold coughing to the point of chest pains.  Took Prednisone.  Yesterday felt better had sinus irritation, brown discharge when coughing.  Today felt roughness on mouth and discovered a fungal infection, began to take Diflucan and clotrimazole.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2weeks. No known allergies. Pretty healthy. Patient took the Paxlovid for 5 days from 08May2022 to 14May2022 and then on the 7the day felt fine. Initial symptoms were chills, sore throat, body aches and nasal drip. All cleared up by the 7th day and then on the 8th day began to get. Still had a sore throat and the post-nasal drip. Patient had just feeling sluggish. Patient did start taking Amoxicillin on the 10th day and three days into to it and still testing positive with nasal drip and sore throat. Patient believe that he had the recurring case of Covid or that the Paxlovid only masked the symptoms.
I routinely get my blood tested for other reasons. It was normal on my last test in September. On 11/23/22, my platelet count had plummeted, and I have since then been undergoing followup tests and treatment for ITP. Also, enlarged spleen.
little pain in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little pain in his left arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN and VITAMINS NOS for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (little pain in his left arm). At the time of the report, PAIN IN EXTREMITY (little pain in his left arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood thyroid stimulating hormone: high (High) high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Lab data: TPO Ab level were very high. Concomitant product: Thyroid medication.  Treatment information was not provided.   This case was linked to MOD-2021-054740, MOD-2021-054740 (Patient Link).
Started to develop worsening shortness of breath, back pain, pressure along with heart palpitations, and arm pain 3 weeks ago of 04/19/21.   On 04/19/21, she also started to develop worsening petechiae of the bilateral lower extremities, spreading up to her thigh.