chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient noticed that her tongue and mouth were tingling; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received first dose of BNT162B2 (Pfizer- BIONTECH COVID-19 Vaccine, solution for injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on 01Mar2021 (Monday), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Mar2021, Wednesday evening the patient noticed that her tongue and mouth were tingling. She denied any swelling in her mouth and tongue. She had not spoken with her HCP yet. She wants to know if this is a known side effect of the Pfizer COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
16 days (so far) of weakness; 10 days of fever of max 102.7F; 16 days of major rash; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 23Jul2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 21Jun2021 at 09:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 23Jul2021 at 18:00, the patient experienced 10 days of fever of max 102.7 degrees Fahrenheit; 16 days of weakness; and 16 days of major rash, now 50 percent of body. The adverse events did not result in doctor or other healthcare professional office/clinic visit/emergency visit. On 06Aug2021, the patient had an "ID Now COVID-19 test" (nasal swab) and the result was negative. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever, weakness, and major rash were recovering at the time of this report.
Increasingly sore shoulder continuing to get worse over the last 6 months. Can now barely lift arm above shoulder height.
Uncontrollable shaking; Thirsty; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Uncontrollable shaking), THIRST (Thirsty) and FATIGUE (Tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced TREMOR (Uncontrollable shaking), THIRST (Thirsty) and FATIGUE (Tired). On 03-Feb-2021, TREMOR (Uncontrollable shaking) had resolved. At the time of the report, THIRST (Thirsty) and FATIGUE (Tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included thyroid medication.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-027392 (E2B Linked Report). This case was linked to MOD-2021-023862 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027392:Crosslinked (MOD21-021326)
Pt developed eye pain within hours of 2nd vaccine and then was dx w iridocyclitis. is currently under care for possible Tubular interstitial nephritis uveitis
Patient complaint of feeling lightheaded, dizzy and heart racing. Vitals BP 130/88, O2 99%, P 85, T 98.1, R 18.  After 30 minutes of observation, patient expressed that she felt better and has a history of anxiety. VItals BP 126/80, O2 99%, P 68,  T 98.1, R 16. Patient was discharged from clinic.
Received vaccine two weeks expected period, got period 1 week late during this cycle where my cycle was consistent and regular months leading up to this
Febrile to 101.9 with a seizure lasting 10-15 minutes and post ictal around a few hours.  This occured approximately 24 hours after the vaccines were given.
I have been taking Humira for my Rheumatoid arthritis for 18 years.  For 18 years I was virtually symptom free for arthritis.  I have very severe arthritis, so this was pretty remarkable.  After taking the vaccine, Humira, and other medicines I?ve tried, are completely ineffective.  I am in terrible pain all day and all night.
h/a, aching eyes, aching forehead, dizziness starting w/in 1 1/2hr of vax;tx w/DPH & APAP;
Soon after Gardasil, pt developed fever, malaise, confusion.  Admitted to hospital and Dx'd with ADEM vs. cerebral vasculitis.  Has made nearly full recovery.  Question of Gardasil-induced vasculitis or immune-related acute CNS/systemic disorder.  3/3/09 MR received for DOS 9/25-29/2008 with D/C DX:  ACute intracranial process, possible immunization related vs vasculitis vs diffuse encephalomyelitis.  Recent Gardasil vaccination-uncertain relationship to this event.  Leukocytosis-most likely r/t steroids.  Mild hyponatremia during hospitalization.  Hyperglycemia 2' to steroid use.  Pt presented with c/o 1 1/2 wk hx fevers, weakness and altered mental status. Several ER visits prior to this admission.  Pt reports sore throat, tiredness, fatigue, H/A, increased HR and bilateral foot numbness. Pt tx with steroids and d/c for outpt f/u.
twice experienced hives on torso, neck, and face. never before have experienced hives. no new products, food, or other novel exposure prior to onset.
rash breakout on her neck, legs, hands, and arms; swelling in her legs, feet, and ankle. Itchiness; Itchiness; This is a spontaneous report from a contactable consumer reported for daughter-in-law (Patient) via Medical Information Team. A female patient of unknown age received first dose of BNT162B2 (Pfizer-BioNTech covid-19 vaccine, Lot number: Unknown), via an unspecified route of administration, on an unspecified date as an unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced severe reaction that had a rash breakout on her neck, legs, hands, and arms and had swelling in her legs, feet, and ankle, itchiness but no fever. Patient was due to go for the second dose this week. Reporter wanted to know if patient should get the second dose and further asked about what the percentage of protection after the second dose was and does she have some protection after just one dose. The outcome of events was recovered (after lasting for a day and half).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 19-MAR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558:
On 26-Sep-00, the vaccinee received her first right arm dose of Engerix-B. Sixteen days later, on 12-OCT-00, she experienced warmth, redness, and swelling at the injection site. As of 10-OCT-00, the outcome of the events is resolved.
no adverse event; expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 75-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    No concomitant medicine were reported. Age of the patient is 75 Year 1 Month. The patients received Moderna vaccine between 08 Apr 2022 and 15 Dec 2022. Completion date provided as 26-Jul-2022 ID 80777027399 No treatment medicine were reported.
Gave me Prevnar 20 the second time; Slight headache; Under my arm, the site where the injection was, pain like raising my arm, kind of my armpit there is pain in that area; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 17Oct2023 as dose 2, single (Lot number: GY1934), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 20 (Dose 1), administration date: 2022. The following information was reported: HEADACHE (non-serious) with onset Oct2023, outcome "unknown", described as "Slight headache"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "Under my arm, the site where the injection was, pain like raising my arm, kind of my armpit there is pain in that area"; EXTRA DOSE ADMINISTERED (non-serious) with onset 17Oct2023, outcome "unknown", described as "Gave me Prevnar 20 the second time".  Additional information: The patient stated that he was injected with Prevnar 20 and he thought he needed 2 shots in the series. He thought he was going to get something different but they gave him Prevnar 20 the second time yesterday and now he is experiencing slight headache but under his arm, the site where the injection was, pain like raising his arm, kind of his armpit there is pain in that area; under the armpit not near the site but on the same arm that this was injected. Patient does not know if he was supposed to take Prevnar 13. He went to the pharmacist and they told him that he should be getting 2 doses of Prevnar 20 because he was over 65 so his question was, is that accurate, should he be getting 2 doses of Prevnar 20, 1 year apart or should he have been given something different the second time.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.
Client presented 20 minutes after receiving vaccines to RN with hives noted on R eyebrow, below R ear, and on left wrist. No other adverse rxn. Mother states client has had hives before but is unsure of cause. This was the first time the client has received vaccines. Mother advised to watch client closely and give Benadryl ASAP. Hives gove by approx 4 p.m. later that day. Mother did not give Benadryl; instead Tylenol was given.
Developed red, blistering rash at injection site 1-2 days after injection, spread to trunk, other arm.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date recently, the patient was vaccinated with PNEUMOVAX23, 1 dose in the arm for an unknown indication. It was possible that the lot number was #J007786 Exp. 25-SEP-2015 because the pharmacist only had 1 other injection that was used from this box. The patient's relevant medical history, concomitant medications and past drug history were unknown. On an unknown date in the past week (approximately September 2013) the patient had edema at the injection site, the site swelled to the size of a silver dollar, some itching, and then the whole arm swelled like a balloon. It was unknown if there was any laboratory data. As of 29-SEP-2013 it was unknown if the patient would have another PNEUMOVAX23 injection and the outcome of the edema at the injection site, itching, and the whole arm being swollen were unknown. This pharmacist reports similar events for 4 patients. This was the fourth of 4 reports. Additional information has been requested.
pt recvd vax 30JAN; 30JAN-2FEB inc pain/redness/swelling; 3FEB to MD; 4FEB-diff breathing, to ER via amb; intubated; dx acute resp failure, pneumonia bilat
02-11-2021, evening.  Sudden onset extreme left hip pain (total hip replacement 10/2018)  with weight bearing on left lower extremity.  Able to limp with help of furniture to my bed.  No pain if not standing but unable to roll onto right or left side while supine due to extreme pain.  Eventually fell asleep and when I awoke in morning the pain was gone.  Less severe episode early afternoon, 02-22-21 upon getting out of car.  Was able to walk with limp to get into house and sit down.  Within an hour the pain was gone.  My 2nd Moderna vaccine was 02-26-2021.  Thirteen days later (first episode of hip pain was also 13 days after first vaccine) on 03-11-2021, approximately 1:00 p.m., while getting out of the car I had onset of excruciating left hip pain, severe enough I couldn't stand unsupported and needed crutches to get into house.  After sitting about an hour the pain eased enough that I could walk with  slight limp and by evening, no pain.
Myalgia; Fatigue; Emesis; Headache; Fever; Chills; slightly elevated blood pressure; unable to complete their daily activities due to symptoms; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2022, the patient received the 1st dose of Shingrix. On 12th September 2022, less than a day after receiving Shingrix, the patient experienced myalgia, fatigue, vomiting, headache, fever, chills, increased blood pressure and activities of daily living impaired. On an unknown date, the outcome of the myalgia, fatigue, vomiting, headache, fever, chills, increased blood pressure and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, fatigue, vomiting, headache, fever, chills, increased blood pressure and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: The caller was the patient.  The patient reported that received first dose of Shingrix, in the left arm.  The patient experiencing myalgia, fatigue, emesis, headache, fever, chills, and slightly elevated blood pressure during the night of 12th Sep 2022 and all symptoms were ongoing.   The patient reported being unable to complete their daily activities due to symptoms. The reporter did not consent to follow up.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EW0217), in left arm, on 18Apr2021 as dose 2, single (Lot number: EW0196), in left arm and on 07Dec2021 as dose 3 (booster), single (Lot number: EW027) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetics" (unspecified if ongoing), notes: Other medical history: Diabetics, hypertension; "hypertension" (unspecified if ongoing), notes: Other medical history: Diabetics, hypertension. Concomitant medication(s) included: LAMOTRIGINE, start date: 06Sep2021; METFORMIN, start date: 05Oct2020; TOPIRAMATE, start date: 06Sep2021; PRAZOSIN, start date: 06Sep2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "covid-19". Therapeutic measures were taken as a result of suspected covid-19.  Additional information: If vaccine received: Yes; Other medication in 2weeks: Yes. Known allergies: No.  Follow-up attempts are completed. No further information is expected.
Arm that had PNEUMOVAX vaccine is very sore 4 days later. Began 9-24-16 in the evening, taking Ibuprofen.
Systemic: Tachycardia-Mild, Additional Details: Patinet reported slight increase in heart rate, indicating likley due to a little anxiety from getting vaccincation. Provided patient with 7Up and observed patient longer, patient reported hr decreasing shortly after 7up. Patient reported no symptoms of heart rate increasing before leaving. Follow up call with patient at the end of my shift, patient reports no increase in HR and felt normal.
TWO DOSES of the same MODERNA COVID-19 VACCINE were ACCIDENTALLY administered to the same patient within 30 minutes of each other (on March 3, 2021)--one dose in the left shoulder/arm (1st) and one dose in the right shoulder/arm (2nd)
The pt experienced vomiting, wheezing, seizures, encephalitis, acute disseminated encephalomyelitis. Was taken by lifeline EMS to the hospital. The pt remains in rehab.
vaccination site itching; Rash around the injection site; Injection site felt warm; burning at site of vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Injection site felt warm), VACCINATION SITE PAIN (burning at site of vaccination), VACCINATION SITE PRURITUS (vaccination site itching) and VACCINATION SITE RASH (Rash around the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism. Concurrent medical conditions included Food allergy (Allergies to gluten).    On 29-Dec-2020 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE WARMTH (Injection site felt warm) and VACCINATION SITE PAIN (burning at site of vaccination). On 30-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (vaccination site itching) and VACCINATION SITE RASH (Rash around the injection site). At the time of the report, VACCINATION SITE WARMTH (Injection site felt warm), VACCINATION SITE PAIN (burning at site of vaccination), VACCINATION SITE PRURITUS (vaccination site itching) and VACCINATION SITE RASH (Rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
This is a spontaneous report from a contactable pharmacist via a sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunization (protection against pneumococcal pneumonia). The patient medical history and concomitant medications were not reported. A couple of years before this report, the patient experienced a very swollen arm due to vaccination with Prevnar 13. She went to the doctor and the swelling went down and swelling resolved.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 03-DEC-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Stated that he felt tingling in his tongue and was shaky. Drank some water and felt better.
Approximately 3-5 days after my 4th dose vaccination I experienced the following symptoms: extreme diarrhea, difficult digestion. I went to the doctor and she did some test but she can't find any abnormalities in my system. She prescribed me with an antiviral (I can't remember the specific name) and it did help my diarrhea (being controlled but not fully addressed the issue). As of today 07/13/2022 I am learning to cope up with my new condition and haven't been feeling like my old self, I have been feeling fatigued and lost my endurance.
Patient was vaccinated with booster dose before five months. Patient was evaluated during the observation period and days after vaccination, he the patient reported no adverse reaction.
It started with topical pain from my left nipple to my left under-armpit. the pain became extremely uncomfortable because it felt like someone was ripping duct tape off my skin then setting fire to it. It would last for about 3 seconds. When I got into certain positions while sitting or standing or jogging  it would trigger something and then it would start to burn. I wrapped my upper chest to keep compression around it to keep it from spasming. Ibuprofen 600 did not help, ice and heat did not help either. Then the pain moved to the other side.
Fever of 102 for 26 hours; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 102 for 26 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 102 for 26 hours). At the time of the report, PYREXIA (Fever of 102 for 26 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever of 102.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
After receiving the vaccine, I had the typical feverish reaction. On 12/11/2022, I started not feeling well with a sore throat, nasal headache, nasal pressure, swollen glands, congested, postnasal drip and feverish. I tested positive for COVID-19 with a home test on 12/13/2022. I contacted my doctor and was given the prescriptions PAXLOVID and FLONASE. I tolerated the medication without any side effects.
Possible "COVID arm" with 3-inch diameter redness, swelling, pain, and itching at the injection site. Treated with oral ibuprofen and acetaminophen, as well as ice packs. Still being treated at the time of this report.