chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Concurrent or medical history were not reported. On 06-JAN-2015, the patient was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Secondary suspects and concomitant therapies were not reported. Pharmacist reported that since the receipt of the vaccine, the patient had and at the time of report, complains of pain around the injection site, particularly when waking up in the morning. Additional information has been requested.
I26.99 ACUTE PULMONARY EMBOLISM 3/15/2022 I82.409 ACUTE DVT, UNSPECIFIED VEIN 5/11/2022 I82.412 ACUTE DVT OF LEFT FEMORAL VEIN 5/20/2022 J96.10 CHRONIC RESPIRATORY FAILURE 1/10/2022 J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/3/2022 I26.99 ACUTE PULMONARY EMBOLISM 3/15/2022 I82.409 ACUTE DVT, UNSPECIFIED VEIN 5/11/2022 I82.412 ACUTE DVT OF LEFT FEMORAL VEIN 5/20/2022 J96.10 CHRONIC RESPIRATORY FAILURE 1/10/2022 J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/3/2022 I26.99 ACUTE PULMONARY EMBOLISM 3/15/2022 I82.409 ACUTE DVT, UNSPECIFIED VEIN 5/11/2022 I82.412 ACUTE DVT OF LEFT FEMORAL VEIN 5/20/2022 J96.10 CHRONIC RESPIRATORY FAILURE 1/10/2022 J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/3/2022
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with doses of improperly stored GARDASIL (dose and frequency not reported). No adverse experiences reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Sedation, Palpitations, inj site soreness, weakness, palpitations, sleepiness; mild SOB  Narrative:  inj site soreness; day 2-5 weakness, palpitations, mild SOB, sleepiness; Day 8 dizziness, mild SOB, palpitations on exertion
The patient had soreness in the arm that became severe within a day or so. She had a swollen arm that was hot. She also got flu like symptoms with a fever (up to 103 per patient) and headache. This lasted until the following Monday and lasted almost a week. On the following Monday she started to feel better and was getting better by the time she came in on 12-20. The patient still reported some redness at the site.
Pt was evaluated in the ED 2 days prior and was negative for COVID, but returned due to increasing shortness of breath and was found to be COVID positive with clinical pneumonia and acute hypoxic respiratory failure.
Red, swollen, itchy, hot to the touch area around injection site pt was placed on ZITHROMAX.
After receiving the vaccination on 11/01/2001 the patient experienced redness, pain and swelling in the left upper arm. Then 2 or 3 days later the patient developed welts on her chest. When the patient returned to the Dr on 11/05/2001 she was diagnosed with shingles.
Developed uncontrollable muscle twitching and spasms after 1st dose, after 2nd dose twitching and spasms got worse.  Seen my PCP and she put me on tizanidine for spasms.  Helps mostly at night when trying to sleep.
5 days after receiving vaccine. My stomach began to hurt, constipation began(which I've never had). Pain everytime eating. Pain got so bad went to the hospital. Continued treatment plans (fiber, restorolax buscopan) been told IBS IBS.. months later after continuing pain was diagnosed with celiac and on going health issues. Virtigo unable to walk and est drastic weight loss. Depression
a two months old female patient was given Ipol and Kinrix (Dtap and polio) on 12-Aug-2019; infant was vaccinated in arm; Initial information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a two months old female patient who was given a 0.5ml dose of IPV (VERO) [IPOL] lot number not reported via intramuscular route in the right arm and KINRIX (Dtap and polio) on 12-aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was an actual medication error due to extra dose administered and Vaccine administered at inappropriate site.  Adverse event was not 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.  Information on the batch number was requested.  List of documents held by sender: none.
Glaucoma diagnosis; Had the COVID arm; Arm was hot; Arm was itchy; Injection site was hard; Had a like a little rash; Arm was red; Arm was swollen; A spontaneous report was received from a consumer (patient), concerning herself, a 71 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced glaucoma diagnosis (glaucoma), had the COVID arm (vaccination site reaction), arm was hot (vaccination site warmth), arm was itchy (vaccination site pruritus), injection site was hard (vaccination site induration), had a like a little rash (rash), arm was red (vaccination site erythema), and arm was swollen (vaccination site swelling).  The patient's medical history was not provided. No concomitant product use was reported.  On 22 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 042L20A), intramuscularly in the arm for the prophylaxis of COVID-19 infection.   On 29-Jan-2021, seven days after the vaccine was administered, the patient experienced COVID arm, arm was itchy, red, swollen, hot and the injection site was hard, had a like a little rash. The rash went down to their elbow and up to top of the patient's shoulder. The symptoms calmed down in three days. On an unspecified date, the patient was diagnosed with glaucoma after getting the first dose of vaccine. The patient was due for the second dose vaccine on 01 Mar 2021. The patient was scheduled to have glaucoma surgery on 08 Mar 2021. Treatment medications included to take diphenhydramine and put ice and hydrocortisone cream on it.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of the event, glaucoma diagnosis was considered as unknown, and that of events had the COVID arm, arm was hot, arm was itchy, injection site was hard, had a like a little rash, arm was red, and arm was swollen were considered as recovered/resolved on 01 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Had muscle cramps in both legs & unsteady walking/gait, tongue felt thick and affected her speech.
Day after injection she had itching of hands, (R) ear, waist, eyes and arm pits. Next day swelling of lips and mouth with redness and swelling of the inj site. Tx: BENADRYL IM 50mg, SOLUMEDROL 125 mg IM, RX: Prednisone taper 10 mg.
No other adverse events reported.; A patient received a pediatric dose of VAQTA today that was expired.; This spontaneous report was received from physician referring to a patient of unknown age and gender.  The patient's current conditions, pertinent medical history, past drug reactions or allergies and concomitant medications were not reported. On 07-JUN-2022, the patient received an expired pediatric dose of hepatitis A vaccine inactivated (VAQTA) (strength, exact dose, vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot number T023913 has been verified to be a valid lot number for syringe formulation with and expiration date reported and established as 31-MAR-2022), administered for prophylaxis (expired product administered). It was reported that the dose was properly stored up through time of administration.  No other adverse events reported (no adverse event).
lump at site of injection (increased in size), severe/persistent nausea, headaches, body aches, low grade fever, fatigue, loss of appetite
Atrial fibrillation, ischemic stroke right internal capsule, ER, tpa, recovered much of neurologic deficit
Blanching pink papular rash on torso only.  Started on 2/8/04.
Delayed (8 day delay) allergic reaction. Swollen, inflamed  ears -- both upper portions of external ear (helix, anti-helix, triangular fossa). Isolated clustering of small bumps and blistering on hands and feet and systemic bumps and blisters on torso, arms, and legs. Receiving hydroxyzine HCL, topical cream for itching. Day 8 after vaccine itching at vaccine site, hands and feet and inflamed ears. Each day after the itching symptoms are easing, although the blistering began day 10 after vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8732), in left arm and on 17Nov2021 as dose 3 (booster), single (Lot number: 33026BD) at the age of 65 years, in left arm for covid-19 immunization; carvedilol (CARVEDILOL), (Batch/Lot number: unknown) at 6.25 mg 2x/day for hypertension; losartan (LOSARTAN), (Batch/Lot number: unknown) at 50 mg 1x/day for hypertension and also reported as other medications/products within 2 weeks. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "High Cholesterol" (unspecified if ongoing); "Stent RCA", start date: Sep2011, stop date: Sep2011, notes: Stent RCA. Concomitant medication(s) included: ASPIRIN. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.   Clinical course was reported as, The stopped all medicine for HTN (hypertension), Cholesterol and aspirin day 1 and proceeded on Paxlovid treatment as scheduled with no variation in dosage or application. On day 3 started HTN (hypertension) medicine only (Carvedilol 6.25mg BID and Losartan 50mg once daily), headaches started within a couple of hours and persisted until I took 1300 mg Acetaminophen. Day 4, same results/same treatment. The patient had headaches, so, he thought this was odd. There was no change in routine, and he was well hydrated. Slight diarrhea but not severe. The nasal and mouth taste is awful but the treatment worked. The patient started to feel better on Day 3 and improved measurably over the remaining 2 days of treatment.  No follow-up attempts are possible. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine  I experienced shat I would describe as very heavy menstrual bleeding the day of receiving my second dose (6/12/2021). The bleeding was comparable to the amount typically experienced a few days after giving birth. It lasted for about a day and a half. A week later, a small amount of bleeding occurred but only lasted for about six hours.
Left arm red and swollen. Given MOTRIN and warm compresses. Mother also gave BENADRYL. Fever 103 - Given office appt - Mother canceled took to hosp.
Child had PREVNAR (Rt) thigh 6/1/11; came in 6/3/11, at injection site edema and increase temp. to skin per Dr.
Soreness in arm; fever; chills; runny nose; cough; COVID-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Covid-19"; SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "COVID-19"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in arm"; PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered", described as "chills"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; COUGH (non-serious), outcome "unknown", described as "cough".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The recovery is so painful; appendicitis; This is a follow up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for self. This consumer reported in response to Non-HCP letter sent. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Rx261443606215) via an unspecified route of administration on 04May2021 as dose 2, single for COVID-19 immunisation (at the age of 54 Years). Medical history included appendectomy from 20May2021 to an unknown date. Concomitant medications were not reported. Historical vaccine includes bnt162b2 (First Dose Lot/Batch number: Rx259586906215) on 06Apr2021 for COVID-19 immunisation. On 20May2021, patient experienced appendicitis. The recovery is so painful. The patient reported, I sincerely hope there is no connection like I have been reading and hearing about. Patient was admitted to hospital due to the event. Treatment was received. Patient reported that I had never been to the hospital for medical issues. I had 2 friends call me to let me know of same experience of appendectomy within 2 weeks of 2nd vaccine. The clinical outcome of the events appendicitis was recovered and the event the recovery is so painful was recovering.  Information about lot/batch number cannot be obtained.
probably have still got influenza; Started not feeling good today; temp it was normal , 2 hrs later it was 100.00; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who probably have still got influenza, started not feeling good today and temp it was normal, 2 hrs later it was 100.00 after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient probably have still got influenza (influenza), not feeling good today (malaise) and temp it was normal, 2 hrs later it was 100.00 (body temperature increased) (unknown latency) following the administration of influenza vaccine.  Relevant laboratory test results included: Body temperature - On an unknown date: [100]  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (probably have still got influenza, Started not feeling good today, temp it was normal, 2 hrs later it was 100.00).  At time of reporting, the outcome was Unknown for the events.
Severe (R) shoulder pain stiffness loss of range of motion. Decrease quality of life. Can't do normal routine. Pain mile to severe all times.
CHILLS; SWEATS; MILD FEVER; HOT/COLD; ACHES/ BODY ACHES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced mild fever. On 12-MAR-2021, the subject experienced hot/cold. On 12-MAR-2021, the subject experienced aches/ body aches. On an unspecified date, the subject experienced chills, and sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sweats, mild fever, hot/cold and aches/ body aches was not reported. This report was non-serious.
Case number PHEH2014US004368 is an initial spontaneous report from a consumer received on 27 Feb 2014. This report refers to 31-year-old female patient. She had no existing condition before the vaccination. Concomitant medications were not reported. She was vaccinated with one single dose of FLUVIRIN (batch number: 13392P) intramuscular on 28 Oct 2013. On the same day, she went for a swim and every time she lifted her arm she experienced a sharp pain where she had received the injection. She never had pain in her left arm. It does not hurt to touch but to this day, she experienced the same level of pain whenever she lifts her arm. The reporter assessed the events as serious (significant disability). Outcome of the events was reported as condition unchanged. Causality of the events was not reported.
Information has been received from a Doctor of Pharmacy concerning a 25 year old female patient with unknown relevant medical history and past drug history, who on an unknown date started VARIVAX (Merck), unknown dose and frequency, for unknown indication. On 24-MAR-2010, the patient was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included unspecified oral contraceptives. On 26-MAR-2010 the patient developed a cold sore on her lip. It was unknown if there was any relevant laboratory data. It was reported that as of 26-MAR-2010, it was unknown if the patient continued on VARIVAX (Merck), and the cold sore on her lip had not abated. Additional information has been requested.
p/vax inj site red, swollen, sore rt deltoid;MD observed;
Expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) for prophylaxis.   On 17th November 2022, the patient received Shingrix. On 17th November 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's comment: The pharmacist reported that the patient was administered with a dose of Shingrix on 17th November 2022 which had expiry date of 15th November 2022. Additional; supportive information: The reporter consented to follow up.
Information has been received from a consumer concerning her 13 week old daughter with no pertinent medical history and no known drug reactions/allergies who on 13-APR-2010 was vaccinated orally with her first dose ROTATEQ (dose not reported, lot number 665252/0021Z). There was no concomitant medication. It was reported the patient developed diarrhea on 15-APR-2010 and since then, she has had 7 greenish stools per day and had not gained weight. No lab studies were performed. The physician was contacted by phone and an evaluation was scheduled. At the time of the report, the patient had not recovered from the events. Follow up information was received from a physician via medical records concerning a 12 month old female with no pertinent medical history reported and no illness at the time of vaccination who on 13-APR-2010 at 15:30, was vaccinated orally with a first dose of ROTATEQ (lot number 665252/0021Z). Other vaccines given within 28 days included PENTACEL (first dose, IM into right thigh, lot number C3564AA). It was reported that on 14-APR-2010, the patient had an increased frequency of stools, up to ten stools per day. The patient was feeling uncomfortable, fussy, gassy and irritable for at least a week. Colitis was diagnosed. Laboratory test performed included stool culture (with normal flora isolated after 24 and 48 hours, no OVA and parasites seen and 1 WBC) and stool occult blood (2+ positive). The patient recovered on 01-JUN-2010. Upon internal review stool occult blood (2+ positive) was determined to be an other important medical event. Additional information is not expected. All available medical records will be provided upon request.
warmth at injection site; hardness at injection site; swollen at injection site; soreness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PAIN (soreness in injection site) and VACCINATION SITE SWELLING (swollen at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in injection site). On 17-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site) and VACCINATION SITE SWELLING (swollen at injection site). On 13-Feb-2021, VACCINATION SITE PAIN (soreness in injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site) and VACCINATION SITE SWELLING (swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.