chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Magnesium was low on blood test; She gets a magnifying glass to refer to her medical notes; States she weighs a lot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Lot number: FL9262) at the age of 76 years as dose 1, single and administration date 26Mar2021 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. Relevant medical history included: "blood cancer" (unspecified if ongoing), notes: she has a history of a blood cancer.; "Essential thrombocythemia", start date: Oct2020 (ongoing); "Depression" (unspecified if ongoing); "High cholesterol" (ongoing); "Type II diabetes" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Heart murmurs", start date: 2012 (unspecified if ongoing); "herniated disc of neck", start date: 2016 (unspecified if ongoing); "herniated disc of back", start date: 1974 (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Peripheral neuropathy", start date: 2010 (unspecified if ongoing); "Mediastinal adenopathy" (unspecified if ongoing); "knees hurt" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE taken for depression (ongoing); ROSUVASTATIN taken for blood cholesterol increased (ongoing); ASPIRIN (E.C.) (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing); CALCIUM PLUS VITAMIN D (ongoing); MAGNESIUM (ongoing); HYDROXYUREA, start date: Oct2020 (ongoing). Past drug history included: Hydroxyurea, start date: Oct2020, for Essential thrombocythemia, notes: 500 mg twice a day and then once a day, alternating. The following information was reported: BLOOD MAGNESIUM DECREASED (non-serious), outcome "unknown", described as "Magnesium was low on blood test"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "She gets a magnifying glass to refer to her medical notes"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "States she weighs a lot". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
having bad headaches and body aches cannot fully urinate and always feel like he needs to urinate
After receiving my first dose of the moderna vaccine I felt my heart begin to flutter for several minutes.  I lost feeling on the left side of my face and my tongue became numb. The symptoms remained for well over five hours until I took two Benadryl.  Then the symptoms subsided.  I have had a terrible reaction to the drug Compazine in the past which resulted in loss of motor control in my face.  While I never lost control of my motor functioning after receiving the vaccine, the loss of feeling in my face was similar to my past reaction to Compazine.
Lightheaded/dizziness; Feeling warm; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Feeling quite unwell; Strong flu symptoms; Felt very hot/cold; Intense aching; Muscle soreness all over; Inflamed lymph nodes (esp in neck); Some nausea; Internal temp (taken under tongue) was also very low, about 95 degrees; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 20Jan2021 (14:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included naproxen sodium (ALEVE) and cannabidiol (CBD OIL). On 20Jan2021 (14:45), after the vaccination, the patient became lightheaded/dizziness; had started feeling warm; and had uncomfortable tingling sensations that started in the fingers and moved up to the arms. On 20Jan2021, about an hour or two after the vaccination, the patient had begun feeling quite unwell; had strong flu symptoms; was feeling very hot/cold; had intense aching; muscle soreness all over; inflamed lymph nodes (especially in the neck); some nausea; and internal temperature (taken under the tongue) was very low at about 95 degrees. The patient had received treatment for the reported events; blood pressure was taken; and he was given water. The adverse events had required doctor or other healthcare professional office/clinic visit. The outcome of the events, 'lightheaded/dizziness', 'feeling warm', 'uncomfortable tingling sensations that started in the fingers and moved up to the arms', 'feeling quite unwell', 'strong flu symptoms', 'feeling very hot/cold', 'intense aching', 'muscle soreness all over', 'inflamed lymph nodes (especially in the neck)', 'nausea' and 'internal temperature (taken under the tongue) was very low at about 95 degrees', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
The lymph nodes in my left armpit swelled and severely hurt.; The lymph nodes in my left armpit swelled and severely hurt.; My entire arm from my neck to my wrist swelled as well.; My entire arm from my neck to my wrist swelled as well.; The left side of my left breast is also swollen.; My arm is still very swollen and painful.; My entire arm from my neck to my wrist swelled as well.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 26Apr2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetic (type 1 diabetes mellitus), anxiety, depression and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), ubidecarenone (COQ), insulin human injection / isophane (HUMULIN N), insulin lispro (HUMALOG) and venlafaxine (MANUFACTURER UNKNOWN); all for an unknown indication from unknown date and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 08:00, the patient's lymph nodes in left armpit swelled and severely hurt. Over the course of 2 days, the patient's entire arm from neck to wrist swelled as well. The left side of the left breast was also swollen. Over 5 days after the vaccine, the patient's arm was still very swollen and painful. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph nodes in left armpit swelled and severely hurt, entire arm from neck to wrist swelled as well, left side of the left breast was swollen breast is swollen, arm was very swollen and painful were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
patient was with age related weakness (her daughter brought her in with aid of a walker) and a reported mild dizziness  before administering vaccine. 10 minutes after administering vaccine, she felt more dizzy and couldn't keep sitting posture in chair and urinated while sitting in the chair and leaning on her daughter. Called 911 for an ambulance.  Laid her flat on the floor and observed for her breathing. Her breathing looked normal and she was responsive to verbal  conversation.  No CPR was administered as the patient is able to breath on her own and responsive to verbal conversation. During conversation she just reported severely dizzy.  EMS personnel arrived in about 10 minutes and took her to to the hospital
Body itching; Vagina was itchy; knot in her throat; Back was welting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body itching), VULVOVAGINAL PRURITUS (Vagina was itchy), SENSATION OF FOREIGN BODY (knot in her throat) and URTICARIA (Back was welting) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced PRURITUS (Body itching), VULVOVAGINAL PRURITUS (Vagina was itchy), SENSATION OF FOREIGN BODY (knot in her throat) and URTICARIA (Back was welting). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency and MICONAZOLE NITRATE (MONISTAT) at an unspecified dose and frequency. On 29-Dec-2020, PRURITUS (Body itching) and SENSATION OF FOREIGN BODY (knot in her throat) had resolved. On 10-Jan-2021, VULVOVAGINAL PRURITUS (Vagina was itchy) and URTICARIA (Back was welting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Physician recommended not to take second dose.   This case was linked to MOD-2021-023215, MOD-2021-023215 (Patient Link).
IPOL were exposed to a temperature excursion/low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes/ accidentally left the refrigerator door open too long/Product used:Used, with no reported adverse event; Initial information was received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 years old female patient who received poliomyelitis vaccine (inactivated) (ipv) (vero) [Ipol] which were exposed to a temperature excursion/low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes/ accidentally left the refrigerator door open too long with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant medications included hepatitis B vaccine for Prophylactic vaccination.  On 08-Jun-2023, the patient received a dose of suspect poliomyelitis vaccine (inactivated) (ipv) (vero) Suspension for injection at dose of 0.5 ml (lot number: V1A021M, expiration date: 27-Feb-2024) via intramuscular route in unknown administration site for Immunization (Immunisation) which were exposed to a temperature excursion/low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes/ accidentally left the refrigerator door open too long with no reported adverse event (poor quality product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event ipol were exposed to a temperature excursion/low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes/ accidentally left the refrigerator door open too long/product used:used, with no reported adverse event.  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 the guidelines. 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.
Flushing of face, mild headache, blotchy skin on truck (front and back), upset stomach  Gave Benadryl 50mg at 11:15am  Symptoms not progressing
swollen tongue/sore throat started that evening, got worse over next 3 days.  sore throat went away on day 3, swollen tongue continued  for several days.  was not severe enough to seek medical treatment but it was painful to eat. COVID test negative
Moderna Spikevax 12+ (Covid) 23-24 PFS This was the 6th Moderna vaccine I have received and the first one to leave a reaction.  After removing the band-aide on my left upper arms there was a 2" long & wide, red circle rash, which was itching constantly.  Because my arm was still slightly sore I cold only gently scratch it.  I tried rubbing alcohol to stop the itch.   Of all the Moderna  shots I have had, this was the first time to have any sort of reaction other than the sore arm and tiredness the next day.  Today is 5 days after, rash & itch are still present.  It does seem to be fading a bit.  I felt it was important to report this change.
Caller confirmed he contracted COVID-19; Caller confirmed he contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), COVID-19 (medically significant), outcome "unknown" and all described as "Caller confirmed he contracted COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he contracted COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient reported that he was fully-vaccinated with the 2 Pfizer-BioNTech COVID-19 vaccines and 2 Pfizer boosters (did not specify monovalent/bivalent). The patient confirmed he contracted COVID-19 and was prescribed Paxlovid. He said he took the first dose and reported he "don't feel so good". He got the first dose yesterday and asked if there will be problems if he stops taking the Paxlovid?. "Do not stop taking PAXLOVID without talking to your healthcare provider, even if you feel better."   Follow-up attempts are completed. No further information is expected.
Pt. presented with  a large encircled area of right arm, just below the typical injection site for deltoid IM injections. The area was red, mildly swollen, slightly warm per pt.,  and itchy. She stated it begun recently, a few days after injection. She thinks it started Mon 07-23, the day after vaccine administration. She was instructed to report to doctor's office, and was told we would report the adverse event as well.
Patient was at a clinic appointment and very well Thurs, Oct 24,2019. Her LFTs were normal for her baseline at lab draw. A few hours after her flu shot, she started vomiting. It went on for 2 days until she became lethargic and appeared jaundiced. On Saturday, Oct 26, 2019 I took her to ED where she presented with cholangitis and elevated lfts. She now has a biliary drain inserted. It should be noted that last year, she had a similar, although less severe response and was hospitalized with severe vomiting and elevated LFTs after her flu shot.
Immediate swelling of eyes, redness/swelling of cheeks. Treated with Benadryl 20 mg PO, prednisone 30 mg PO. By 11:20, decrease in redness/swelling.
Patient called today (7/7/15) to report that following the shot she experience: "cloudy urine, abdominal bloating, nightmares and trouble sleeping" she did not seek medical attention immediately but has been experiencing these symptoms have been fleeting since then.
The second time, it start bringing cold; you know like I was having a lot of sneezing; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 81-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 20Aug2021 (at the age of 81-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma, and prostate surgery where the patient described that "I had prostate surgery all this '28'/2012".  Patient previously took first dose of BNT162B2 (at the age of 81-year-old) (lot number: FA7485) on 30Jul2021 for covid-19 immunisation. The patient reported event described as "the second time, it start bringing cold" and "you know like I was having a lot of sneezing". Where the patient had cold and also experienced lot of sneezing back to back after the second dose of vaccination. But patient's voice was not clear at the time of reporting for the other information. The patient underwent lab tests and procedures which included urine analysis: unknown (And then I had urinalysis (further clarification unknown hence not checked in LAB)). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of all the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vaccine was given too high near the shoulder, almost on the shoulder bone instead of the deltoid. Felt shooting pain down the vaccinated arm in the middle of the night and shoulder ached more than normal.
I think I am having a local reaction to the vaccine. The site is red and is now itchy and indurated ( raised), It is similar to skin reaction when getting a PPD test.it got better after several days. I did see PCP who gave me steroids to  help decrease the inflammation.
Patient was given the 2nd Pfizer vaccine 7 days before the recommended time between the 1st and 2nd dose. Patient has been informed of the vaccine administration error.
Headache & Myalgia Narrative: after 1st dose: day 1 discomfort injection site; muscle ache; day 2 chills day 3 fatigue day 4 ha
Red swollen arm - started swelling at 9 PM 10/29. By AM 10/30 was red as well - patient is taking acetaminophen. Pain/inflammation is about same as of 10/30/15 at 1:07 PM.
will need to catch up with a second dose of VARIVAX; will need to catch up with a second dose of VARIVAX; no additional AE was reported; This spontaneous report was received from a nurse prescriber referring to an adult patient of "about 18 or 19 years of age". Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.  The patient's vaccination records showed that only one dose of varicella virus vaccine live (oka/merck)(VARIVAX)  was administered at 12 months of age for prophylaxis (dose, vaccination scheme frequency, route of administration, anatomical site of vaccination, lot # and expiration date were not reported). The reporter indicated that the patient would need to catch up with a second dose of varicella virus vaccine live (oka/merck) (VARIVAX). No additional adverse event reported.
Patient complained of feeling anxious prior to receiving vaccine.  She stated that she always gets nervous with vaccines.  Vaccine given at 1409.  Patient proceeded to observation area.  At 1415 patient complained of feeling hot and nervous; palms clammy.  Denied any shortness of breath or chest pain.  Vitals were taken:  BP 160/90, HR 130, O2 sat 99%.  Placed patient in reclined position.  Cooled patient and attempted to calm her.  Patient stated she was starting to feel better.  At 1445, vitals taken:  BP 130/80, HR 94, O2 sat 99%.  No respiratory distress noted.  Patient noticeably calmer and no longer clammy and shaking.
bumps, whelps, swelling of whelps, elbows & knees, fever;swelling of jaw, & ankles;went to ER 21FEB98 recv med for breathing because of swelling in jaws & throat;
Headache, Myalgia, Fever,  chills, Temp: 1/8-100 @ 4pm, 101.4 @ 6pm, 101.8@ 7pm, TOOK 2 TYLENOL, T-100.8 @ 8PM,. 1/9 @ 7 AM-100. TOOK  TYLENOL BY 1000 FEVER WAS GONE.  Narrative:
Information has been received from a 7 year old female who was vaccinated with a dose varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed a case of the chicken pox after receiving a dose of varicella virus vaccine live (Oka/Merck). The patient's status was not reported. There was no product quality complaint involved. No further information is available.
Swelling, redness and itching at the site of injection and muscle pain/soreness in the arm.
RN DID NOT CREAT A WHEAL THE FIRST ATTEMPT WHEN GIVING THE VACCINE, SO SHE WENT TO THE OTHER ARM AND CREATED A WHEAL ON THE SECOND ATTEMPT.
Within 30 sec. pt described itching at site, then tachycardia, then hives and weakness before leaving office treated with injectable steroids and antihistamine.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 09-OCT-2015 (reported as today), the patient was vaccinated with a second (extra) dose of ZOSTAVAX, vial (strength, dose, route of administration, lot # and expiration date were not provided). The patient received a first dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided) on an unknown date in October 2014 (reported as "1 year ago"). No adverse effects were reported. Additional information has been requested.
This case is linked to Case Number 2013-00133. Initial information was received on 02 January 2013 from a consumer, who is also the patient's husband. A female patient (age not reported) with no reported medical history received a dose of FLUZONE Intradermal (sanofi pasteur) on 22 September 2012 (lot number and site of administration not reported). An unknown amount of time following vaccination, the patient developed Type A Influenza and "it was confirmed by her doctor earlier this week". The patient did not develop an itchy red bump. The patient's outcome was not reported. Documents held by sender: none.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Shot at 8:30am. Fine all day noticed soreness in both arms and the checked temp with 100.0 fever