chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case was received from a nurse on 30 Dec 2009: This patient was received FLUVIRIN (batch no 102141P1) on an unknown date. He was injected into the thigh of a him, who was younger than 4 years. No adverse effect was reported. The case was assessed as not serious by the reporter. Significant case correction following internal review on 19 Jan 2010 of the data received on 30 Dec 2009: The event was recoded to off label use from earlier coded event inappropriate age at vaccine administration and PI labeling was added.
Information has been received from a nurse referring to a 53 years old male patient with HIV infection and drug reaction to STRIBILD (unspecified reaction). On 17-JUN-2015 the patient was vaccinated with PNEUMOVAX23, lot # K021881, expiry date 30-JUL-2016, 0.5 ml, intramuscular. On an unspecified date in June 2015, the patient developed  pain, soreness and difficulty moving the arm. The patient was evaluated at an unspecified emergency room, on an unspecified date in June 2015, due to fever of 101.5 F, sweating, and tachycardia. The patient was treated in the emergency room with SOLUMEDROL and TORADOL. The patient was sent home with a prescription for TORADOL. The patient was now recovering. The nurse was requesting a lot check.  Additional information has been requested.
My arm got little sore; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events my arm got little sore.  The patient's medical history was not provided. Concomitant medications reported were Propranolol 10mg, Methimazole 5mg for drug use for unknown indication.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) my arm got little sore.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
petechial rash on legs 3 days;abd pain 3 days; arthritis feet, knees, elbows 5 days;
Rehab facility contacted my company to vaccinate a patient who wanted Pfizer vaccine. My medical assistant reported to the nurses station to state she was there to vaccinate a patient, the nurses quickly replied yes and told my MA she would be in room shortly.  My MA states a rehab tech was in the room and informed the MA that patient was hard of hearing and blind so she needs to speak up louder when talking to her. My MA stated ok, she informs the patient that she is there to provide the covid vaccine Pfizer that her daughter wants her to get, the patient anwers ok, that is what they want. My MA then states is your name ? to which the patient nodded  yes. My MA did not wait for the nurse to sign the paperwork for consent since pt was blind, she thought the nurse would sign after vaccination.  As MA was going out to the room to nurses station with paperwork, the 2 nurses run inside the room and stated to MA that they gave her the wrong room number and that the patient was not the correct one.  Nurses called family to let them know that patient was vaccinated without consent. pt was going to bemonitored every 2 hours for any adverse effect.  as per nursing personel patient was doing well.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored ZOSTAVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions but, no information was provided on previous excursion. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 46-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0191),  at the age of 46, in right arm, on Aug 27, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient experienced fatigue (first dose: tiredness), onset Aug 28, 2021, with outcome of recovered (Aug 30, 2021). Additional information: Expiry date of Pfizer COVID-19 vaccine unknown. Prior vaccinations (within 4 weeks) reported as none. Follow-up attempts completed. No further information expected.
At the end of February, 99, the pt received his first injection with Lymerix. Sometime thereafter, the pt experienced a "full blown flu", headache, severe body aches, general lack of energy, and a low fever. No treatment was given, and the symptoms resolved after one week.   In late March, 99, the pt received the second dose of Lymerix with no ill effects.
Can't lift my arm up above my neck area without severe pain. Can't extend my arm backwards without severe pain. The pain shoots up my from my upper arm all the way up my neck, jaw and ear area, and across my upper shoulder area.  Twice I've experienced something similar with the pneumonia vaccine, but in those instances the pain gradually subsided each day and within a month was gone. This last Shingrx dose was injection in an area of my arm where I've never had an injection before so I thought maybe the pain lasting this long was due to the new area. Started researching online for ways to help relieve pain and discovered your site for reporting.
15OCT itchy eyes & upon arising this AM pt took DPH 1/2hr;
received both doses of the Pfizer covid vaccine and 4 weeks later became positive for covid; received both doses of the Pfizer covid vaccine and 4 weeks later became positive for covid; This is a spontaneous report from a contactable Physician. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot Number: EL1283) as dose 1, single, dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot Number: EN6200) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, reporter stated that she was a physician and had a patient who received both doses of the Pfizer covid vaccine and 4 weeks later became positive for covid and was hospitalized. HCP wanted to know how quarantining works. She stated she touched her without gloves. Reporter stated, vaccinated with both doses back in January and February. Physician did confirm both herself and the patient received both doses of the Pfizer covid vaccine. Currently physician was not positive for covid. Her patient was positive for covid. The patient underwent lab tests and procedures on an unspecified date in 2021 which included sars-cov-2 test: positive. The outcome of events was unknown.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. The case will be reassessed if additional information becomes available on the vaccination dates and the event onset date.
swollen lymph node under the arm; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, She states she has the original covid vaccine and booster 3 and 4), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, She states she has the original covid vaccine and booster 3 and 4), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN, She states she has the original covid vaccine and booster 3 and 4), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN, She states she has the original covid vaccine and booster 3 and 4), for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node under the arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Female consumer states that she had the bivalent Pfizer Covid 19 vaccine on 27Oct. She states she has the original covid vaccine and booster 3 and 4. She recently had a monogram that showed a swollen lymph node under the arm. She states that she has never had this result before and now she was having to have more testing with includes as ultrasound and possibly a biopsy. She states that many women are having panic attached before they get the vaccines and they cause swollen lymph node and then when they have monograms they show up. States that shouldn't go to get a monograph until 2-3 month after vaccines. Also makes her wonder if it could cause cancer. States she was almost 5 weeks out from vaccine when she got the monogram and she wasnt told to wait.   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.
Worsening of manic depression.   This is typically a depressed time of year, but this was beyond usual symptoms. May be just temporal, but crying very easily all day, agitated, enraged, depressed. Lasted one day.
"Pfizer-BioNTech COVID-19 Vaccine EUA"  I woke up the morning after my vaccine with diminished hearing in my left ear. I could feel pressure in my ear but hearing was distinctly muffled. I took 2 "DayQuil" cold capsules hoping an antihistamine might alleviate the situation. I had no relief until 8 hours later when I noticed the pressure in my ear was reduced and my hearing seems to be returning to normal.
I did not have any adverse reaction to any vaccine. I am vacinated and double boosted with the Moderna vaccine. On May 18th, I received my second booster and on May 25th I developed Covid symptoms although I thought it was allergies until someone I had been with on Sunday, May 22nd contacted me to say they tested positive for Covid at which time I took a test and tested positve also. This was on Friday, May 27th. I contacted by physician who prescribed paxlovid which I took for 5Sun days completing the medication. I isolated for 5 days. I tested negative on Friday June 3rd but continued to stay masked until Sunday June 5th
Patient felt extremely light-headed and fainted for a few seconds---came to when rph felt for pulse and patted him on shoulder. Rph had reviewed information on consent form including whether he had had any adverse effects to a vaccine that required immediate medical care. His notation on the consent form and verbal information provided to rph prior to injection was no. Immediately after the injection is when he said he should have mentioned that he has fainted in the past when receiving an immunization. EMS was contacted to assess patient and whether it was safe for him to leave pharmacy. EPS monitored blood pressure and other vitals and patient said he felt well enough to leave on his own after 30 minutes observation by rph
Information regarding PREVNAR 13 was received from a nurse regarding her 9 month old male son who experienced loose stools for several days. The patient received the first dose on an unspecified date. Relevant medical history was not provided. Additional suspect medication included IPV and HepB vaccine. Concomitant medications were not reported. The patient experienced loose stools for several days. Outcome was recovered on an unknown date. No additional information was available at the time of this report.
Sleepy; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 74-years-old male patient received BNT162b2 (Pfizer BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EL9262; Expiration Date: May2021 and NDC number was unknown) via an unspecified route of administration, administered in left arm on 26Jan2021 as dose 1, single (at the age of 74-years-old) for COVID-19 immunization. Medical history included lung transplant on an unspecified date (both lungs, exactly 11 months ago, patient was in that medical fragile category) and slightly anaemic from an unknown date and unknown if ongoing. Concomitant medication included iron taken for slightly anemic, start and stop date were not reported. Patient had no other vaccines on the same days as COVID-19 shot. On 27Jan2021, the next day after the first dose, patient had no problem, but he was just sleepy, he got up for coffee and then went to bed for 5 hours. Patient asked if this was common side effects and for how long will they usually last. Patient had blood work done this week, within the last week, as he gets it done twice, once for his annual physical and the other was because he gets blood tested every three weeks for his transplant team. Patient had not received the results from his bloodwork from this past week yet. On the whole, patient stated that most of his tests, there were 52 tests he had done regularly, he was in the green on 48 of those tests, but he was just slightly anemic, but he was taking iron to bring that up. Patient stated that there was nothing else remarkable on his usually blood work. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Stiffness, headache, fever (99.3), nauseated. Fever (98.7) 20 minutes later
Case number PHEH2014US012576 is an initial spontaneous  report received from a nurse on 11 Jun 2014. This report refers to a 12 years old male child. He was given only MenA component of MENVEO (batch number: M13013 and expiry date: Sep 2014) reconstituted with sterile water instead of MenCYW-135 on 10 Jun 2014. No adverse event was reported following this administration error.
my glucose levels were so incredibly high, I had NEVER had these high levels (320 mg/dL) before; woke up drained/ fatigue; product: COVID 19, brand: Pfizer, dose number: 3; 101.3oF fever; chills; body aches; shooting pains in my left arm  and wrist.; shooting pains in my left arm and wrist.; This is a spontaneous report from a contactable consumer (patient). An adult female patient (age unspecified) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 22Oct2021 09:00 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation.  Medical history included diabetes 1 from an unknown date and unknown if ongoing (Diabetes 1 as noted above).     The patient's concomitant medications were not reported. The most recent COVID-19 was administered in hospital. The patient was not pregnant at time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient had no known allergies. Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in the left arm on 20Mar2021 03:00 PM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE, and the second dose of BNT162B2 (start date and lot number: pending clarification) as DOSE 2, SINGLE for COVID-19 immunisation. On 22Oct2021, on the night of the injection, the patient  had 101.3oF fever, chills, body aches, shooting pains in her left arm and wrist. On 23Oct2021, 06:15, she woke up drained, fatigue lasted 2-3 days. The patient got the booster mostly due to her diabetes type 1. Over the last 3 days, when she woke up her glucose levels were so incredibly high (medically significant) from 23Oct2021 06:15. The patient had to take double dose of insulin just to bring it down before breakfast. She had never had these high levels (320 mg/dL) before, since her A1C was 6.4 at her last doctor's visit in Sep2021. As treatment received for the adverse event glucose levels were so incredibly high, she had to inject repeated doses of insulin.  The outcome of the event woke up drained, fatigue was recovered in Oct2021, while outcome of the rest of the events was recovering at the time of the report.
Hoarseness, intense coughing with phlegm, "lump" in throat sensation, headache, red eyes, sore arm at injection site, jaw pain on same side of body as injection.
Mother reports an hour after receiving vaccines, pt. was starting to cough, no obvious resp. distress.  Mother  pt. was exchanging air ok.  Noticed rash over chest, top of head & face.  Describes rash as welts.  She gave pt. some Benadryl.  Also called the ER, but did not take pt. out to ER as logs told.  No need to as long as pt. breathing ok.  Pt. had rash 1 wk later yet with runny nose & seeing a doctor.
runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) had not resolved.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-154197 (Patient Link).
Doesn't have any feeling in pinky; tired; tingling pinky/tingling hand; Left pinky was completely numb; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 21Apr2021 at noon, (Lot Number: EW0158; Expiration Date: 31Jul2021), as 0.3 mL single, for COVID-19 immunisation. Medical history included hyperthyroidism from Aug2013 and ongoing, illness anxiety disorder (grandmother), ongoing brain neoplasm, ongoing drug hypersensitivity, ongoing hypersensitivity (a lot of unspecified allergies). Concomitant medication included methimazole (unknown manufacturer) for hyperthyroidism from Aug2013 and ongoing. The patient experienced doesn't have any feeling in pinky (non-serious) on 21Apr2021 with outcome of unknown, tired (non-serious) on 21Apr2021 with outcome of not recovered, tingling pinky/tingling hand(non-serious) on 21Apr2021 with outcome of unknown, left pinky was completely numb (non-serious) on 21Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood test: unknown result (all the time for hyperthyroidism ), blood test: unknown result in Apr2021, diabetes mellitus: unknown result (two times), diabetes mellitus: 600 in Apr2021 (considered prediabetic), thyroid function test: slightly high on unknown date (but under control).  Therapeutic measures were taken as a result of left pinky was completely numb and included rub and shook. Clinical course: within 10-15 minutes after vaccination the patient started to feel pinky tingling, then her hand started tingling. 30 minutes after the pinky, she started to have a tingly hand. She also felt tired.  No follow-up attempts are needed. No further information is expected.
Vaccine Error: Pharmacist was supposed to administer the influenza vaccine and gave the bivalent covid booster, which was a second bivalent booster to the one given on November 5, 2022. Reporting since 14 year old patient had 2 bivalent boosters within about 30 days. Immunization Information System not verified.
NauseaVomiting, Severe Fatigue, milld pain at the injection site. Narrative:
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient suddenly fainted while seated during observation, about 5-10 minutes after moderna shot.I (RPh) tried to catch his fall but did not catch him in time, he fell and hit his head on the floor.Regained consciousness within about a minute or so,but had a small cut in his head which stopped bleeding quickly.Had him seated while waiting for 911 but he got lightheaded again,had him lie down on floor till EMS arrived.
Had the two shots for it, they made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine with an associated reaction of illness (received 1st dose on an unknown date and experienced sickness, refer case - US2021AMR137802).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself The age at vaccination was not reported. The patient had received Shingrix shot and got sick. No other information was reported. For tolerance to 2nd dose, refer case US2021AMR137802.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137802:Same patient, Same reporter, 1st dose
he got the Pfizer vaccine last Thursday and on his right arm his Joint, and the Elbow the upper arm a little bit, he is having pain; he got the Pfizer vaccine last Thursday and on his right arm his Joint, and the Elbow the upper arm a little bit, he is having pain; This is a spontaneous report from consumer (patient's wife) reported for a patient (patient's husband). A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0169, Expiration Date: 31Aug2021) via an unspecified route of administration, administered at an unspecified anatomical location on 15Apr2021 (age at vaccination was 77 years) as dose 1, single for COVID-19 immunization. The patient's medical history included pain. Concomitant medications included paracetamol (TYLENOL) taken for pain (he takes some 2 tablet 3 times a day) and warfarin taken for an unspecified indication. On 16Apr2021, the day after the shot, the patient experienced little bit pain in joint elbow upper arm. The patient had a side effect, he got the Pfizer vaccine last Thursday and on 16Apr2021, the patient's right arm his Joint and the elbow the upper arm a little bit, he was having pain. He was just on his regular medication, but he had been taking Tylenol. He hasn't had any medical test late or right now or lab work. He was prominent he was on Warfarin blood thinner. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
on 9/3/19, I had the first dose of the SHINGRIX 50 MCG vaccine. Within hours, the injection site was beginning to swell. Within 24, I had a headache, nausea, fever, and chills. These symptoms lasted about 36 hours. 5 days later, the injection site is still swollen, red, and warm.
Headaches, chills,  continuous nausea, several days of vomiting, continuous brain fog, and continuous extreme fatiguel