chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA182241, 2018SA182252, 2018SA182253, 2018SA182254, 2018SA182255. This case involves patient (age and gender not reported), who received a vaccine, which on 01-Jun-2018 reached to 52.8 degree F for 43 minutes and on 04-Jun-2018 product reached 48.2 degree F for more than 30 minutes, before he/she received a dose of vaccine IPOL lot N1K931M via intramuscular route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not reported if the patient had any adverse event or not. 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. Documents held by sender: none.
Arm was burning immediately after injection  several hours later pain in lft arm pain left upper chest around to lft back shoulder blade, very nauseated interrupted sleep very fatigued . No treatment waiting on Dr to call me.
No adverse event; First dose of ROTATEQ vaccine was administered on 20-MAR-2021 to a 4 month old.; This spontaneous report was received from a nurse, via company representative, referring to a 4-month-old patient of unknown gender.  The reporter did not provide information on the patient's historical drugs, historical conditions, current conditions, and concomitant medications.  On 20-MAR-2021, the patient received the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (route, lot number, and expiration date were not reported) (product administered to patient of inappropriate age). No further adverse events were reported.
Redness, swelling of left arm. 48 hrs. after receiving Imm's. 0 temp.
Rash, itching, pain and redness below site of vaccination.  Pt. was seen in Urgent Care and diagnosed with delayed reaction to COVID vaccine.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On an unknown date (in 2013), the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route and lot # were not provided). No other co-suspects were reported. Pharmacist reported that the patient might have experienced titers on the threshold of not responding to RECOMBIVAX HB after completing series within the last six months. Patient's outcome was unknown. Additional information has been requested.
Starting approximately one week post vaccination, I began to experience pronounced breast swelling and tenderness in both breasts. These symptoms are still present today (two weeks post vaccination).
Referred to as Covid Arm.  Bright red around injection area , warm to the touch, skin very hard.  Lasted 7 days.
NO ADVERSE REACTION ASSOCIATED WITH THE ERROR; PATIENT SAW MEDICINE GO DOWN HER ARM TO ELBOW/MEDICINE CAME OUT OF HER ARM; PATIENT DID NOT RECEIVE THE FULL AMOUNT (PARTIAL DOSE); This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 350 pounds, and height was 182.88 centimeters. The patient's concurrent conditions included latex allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient was not pregnant at the time of report and and had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced subject saw medicine go down her arm to elbow/medicine came out of her arm. On 17-MAR-2021, the subject experienced subject did not receive the full amount (partial dose). On an unspecified date, the subject experienced no adverse reaction associated with the error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient did not receive the full amount (partial dose), no adverse reaction associated with the error and patient saw medicine go down her arm to elbow/medicine came out of her arm was not reported. This report was non-serious.; Sender's Comments: V1: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
the day p/vax pt was not feeling well & was very fatigue;pt later devel all over joint pain;no fever;
9:00 Pt c/o abnormal feeling to throat, However, pt couldn't describe feeling clearly. Denies throat itchiness/pain, tightness or tingling; VS: BP 188/80, HR 76, RR 16, Temp 97.7, SpO2 100% RA, Drank 1 cup water  9:06 Drank 8 oz water with swallowing difficulty, Pt verbalized "I am nervous because I'm afraid of needles" 9:15 BP repeat 172/89, HR 70, RR 16, SpO2 100% RA 9:18 Pt left RUH symptom free
20-30mins p/vax localized burning feeling, warm to touch-shooting pain @ site like a beesting when touched or rubbed-shooting pain started again;took 2 aleve tablets-applied ice to arm @ 5PM; still warm & shooting pain-less severe but const
Reaction to varicella vaccine in the past; Information has been received from Pfizer (manufacturer control number 202100918869) on 21-JUL-2021.  This spontaneous report was received from a consumer, referring to her daughter, a 14-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, caller stated she was just talking to a different representative and was sent to talk to us. Her 14-year-old daughter had a reaction to varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) in the past at age 1. Her daughter was scheduled to get her first Pfizer Covid vaccine on friday. Caller stated that she was concerned about the varicella virus vaccine live (oka/merck) (VARIVAX) reaction. She said her pediatrician was not administering the Pfizer vaccine and could not give her any information. Caller researched it on her own and found 5 common ingredients in varicella virus vaccine live (oka/merck) (VARIVAX) and Covid vaccine that she could identify. Caller wanted to know there was a real concern linked to varicella virus vaccine live (oka/merck) (VARIVAX) and the Covid vaccine. She was concerned about her daughter's adverse reaction to the prior vaccine. She did know the common ingredients. She said she knew if her daughter had a reaction to the first vaccine, it would not be recommended for her to get the second one. Caller wanted her daughter to get the Pfizer vaccine, but she was concerned that she should not (vaccination complication).  The outcome of vaccination complication was not reported. The causal relationship between the event and the suspect therapy was related.
This case was reported by a physician and described the occurrence of transient amnesia in a male subject aged between 70 and 79 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included forgetfulness. The subject did not have a history of amnesia. The subject had received previous flu shots with no adverse events to previous flu shots. The reporter did not know what flu vaccines the subject received previously. On 6 September 2013 the subject received a dose of FLULAVAL (1 injection, unknown route, left arm). On 6 September 2013, less than one day after vaccination with FLULAVAL, the subject experienced transient amnesia and possible transient ischemic attack. Per the physician, the subject "was fine after the vaccination and left office." Per the physician, the subject reported "transient amnesia that lasted 8 to 12 hours" and the subject reported that he "can't remember what happened in the 8 to 12 hour timeframe of amnesia." At the time of reporting, the subject was "aware." The physician "was unsure if this was due to FLULAVAL, as it may also be 'possible TIA (possible transient ischemic attack).'" This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were resolved.
I tested positive for COVID-19 3 months later. I had chest and nasal congestion, headache, chills, body aches, pain, and fatigue. I had these symptoms for 4 days. My chest and nasal congestion comes and goes. I called my doctor the day I tested positive. The doctor did not prescribe me PAXLOVID because it conflicted with my ELIQUIS.
Patient received vaccine on 6/19/06 and presented to clinic on 6/21/06 with swollen right arm where DtaP was administered. Patient was prescribed Atarax, Tylenol and cold compress.
after receiving Shingrix + flu shot, patient went home and napped. Had stroke like symptoms when awoke from nap (could not move arm or leg, could not talk). Husband called EMS, by the time paramedics arrived, she was back to normal.  2 hours later, patient experienced same symptoms and was brought to the ER. Then had these symptoms on and off every hour.  Was placed in intensive care and diagnosed with stenosis/stroke.
all-over body aches; chills; nausea; fatigue; general malaise; injection site is achy; This is a spontaneous report received from a contactable patient. A 59-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202, via an unspecified route of administration in the left arm on 18Mar2021 at 13:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient medical history included arthritis, fibromyalgia, kidney disease, high blood pressure and mild asthma. The patient previously received ampicillin and vancomycin and experienced allergy. Concomitant medications included blood pressure and depression medications (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Mar2021 at 02:30, the patient experienced all-over body aches, chills, nausea, fatigue, general malaise and vaccination site pain. The patient was treated with pain medications (unspecified) and resting. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of all-over body aches, chills, nausea, fatigue, general malaise and vaccination site pain was not recovered.   No follow-up attempts are needed. No further information is expected.
A report has been received from a Health Professional concerning a 53 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT was started on an unknown date. Nurse reported that she inadvertently administered FLUMIST QUADRIVALENT to a 53 year old male at the community health center on 13-Sep-2013. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by company physician.
She got her vaccine, she felt fine until that evening she started feeling bad, had 3rd booster, but during the night she was practically delirious  When she woke up in the morning her temp was climbing 103.4, got it down with Tylenol, really bad headache.  The worst problem was her heart, has a normal resting heart rate of 50, and it was going from 50-90, shooting up and plummeting.  This went on all day.  Went on all Monday, got some sleep Monday night.  Woke up Tuesday, still had the headache.  Her temp got down to normal during the day and finally felt better.  By Wednesday she was OK.     She called her PCP, cardiologist and her dermatologist.  Her dermatologist told her not to take anything she didn't need to take.  Her PCP told her to take Tylenol.  Her Cardiologist told her to take it easy for the next two days, just lie around.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 10-JUL-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 24 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient seen at a vaccination clinic and given first dose Pfizer EN6204 in LA on 3/12/2021. Subsequently returned for second dose and was given the Moderna vaccine to complete her series.
This spontaneous report was received from a licensed practical nurse referring to a 11 month old patient of unknown gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-JUL-2018, the patient was vaccinated with M-M-R II lot # reported as R002932 with expiration date 29-JUL-2018, per intramuscular route (incorrect route of drug administration) (dose, strength, dose, and anatomical location were not reported) for prophylaxis. No adverse effects were reported.
Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored MMR II (strength, dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt temp up to 104 R; Rash around inj site (PCV 7)
This spontaneous report was received from a consumer (patient's daughter in law) refers to a 91 year old female patient. The patient's pertinent medical history included legs swelling and hypertension. Drug reactions or allergies were not reported. On an unknown date in December 2015, the patient was vaccinated with ZOSTAVAX injection (dosage information, lot number and expiry date was not reported). Concomitant medications were not reported. On an unknown date in January 2016, the patient experienced bullous pemphigoid for an unspecified reason. The patient sought the medical attention by visiting a physician and no treatment was provided for the event. The outcome of event was reported as not recovered. Causality assessment was not provided. No product quality complaint was reported. Upon internal review, "Bullous pemphigoid" was determined to be medically significant. Additional information has been requested.
random bruise looking spots start to appear on my leg; finger joints start to feel pain and feeling the tight pressure on finger joints; knees and legs tend to get sleepy and numb feeling sometimes. One of the finger joints pain lasting for more than 2 weeks.
Information has been received from a Nurse Practitioner concerning an 11 year old female who on an unspecified date in May 2007, was vaccinated intramuscularly with 0.5ml of the first dose Gardasil (Lot # not provided). Post vaccination the patient passed out. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Patient presented with mid sternal chest pain and pressure and associated left arm/shoulder pain on 9/12/21 (2 days after receiving the second dose of the Pfizer COVID-19 vaccine). Troponin level was slightly elevated (0.13) on presentation but peaked at 10.38  6 hrs later. The patient was closely monitored without the need for intervention with medications. He was discharged home on 9/15/21 with resolution of his chest pain. Troponin level on discharge was 0.85.
FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE). At the time of the report, COVID-19 (FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.  On an unknown date, the patient experienced HAD COVID FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA1273)) was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of HAD COVID FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 31-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, few weeks after receiving the first dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 31-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, few weeks after receiving the first dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Numbness in right heel; pins and needles feeling extending to hands and feet; Itching; burning; Occasional pain following numbness in right heell; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in right heel), PARAESTHESIA (pins and needles feeling extending to hands and feet), PRURITUS (Itching), BURNING SENSATION (burning) and PAIN (Occasional pain following numbness in right heell) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and SIMVASTATIN for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced HYPOAESTHESIA (Numbness in right heel), PARAESTHESIA (pins and needles feeling extending to hands and feet), PRURITUS (Itching), BURNING SENSATION (burning) and PAIN (Occasional pain following numbness in right heell). At the time of the report, HYPOAESTHESIA (Numbness in right heel), PARAESTHESIA (pins and needles feeling extending to hands and feet), PRURITUS (Itching), BURNING SENSATION (burning) and PAIN (Occasional pain following numbness in right heell) outcome was unknown. Not Provided          Treatment medications were not reported, but it was reported that movement relieves symptoms. Action taken with the product mRNA-1273 was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-076261 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076261:
The next day after the vaccine my arm was red and really painful.  Each day the redness got larger and by friday it was near my elbow so I went to an Urgent Care.  I was given a prescription for an antibiotic because they states infection had set in it and I also took tylenol and antihistimines to help with the pain.
I ran a fever every day for over 3 weeks. It cycled, with the duration eventually becoming shorter, down to an hour or so at a time, but for the first 2 weeks, it was all afternoon and evening every day. I was also very fatigued. (I spoke to my doctor's office over the phone but they did not ask me to come in for an appointment.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Shingrix for prophylaxis. On 23rd May 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional information was reported as follows: The patient experienced pain in arm, where the patient commented that the second dose hurted a little more when injected as compared to the first dose. This case was linked to case US2018149465, reported by the same reporter for the same patient for the tolerence of 2nd dose.
A report was received from a health care professional on 12/6/03 concerning a 18 month old female vaccinee who inadvertently received Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee received Fluvirin. At the time of the report no adverse symptoms were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
chest pain, vitals taken and pt sent to ED; outcome(s) unknown at t his time