chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RN removed vials from Pyxis in error instead of Ativan (both vials have the same color blue top) and administered the Engerix-B (pediatric dose) intraveinously to the patient. Poison Control was contacted, patient was followed up with no adverse response noted.  GlaxoSmith was contacted by Poison Control pharmacist and they requested a MedWatch form be completed.
Patient complained of nose bleed Friday she received vaccine. Vaccine was administered in the morning, her nose bleed started that evening.
Had broken Hip on 4/24/20 - SurgERy to REpair. FiRst symptom occuRed on 5/4/20; Left side of tongue swells. Called MD - advised to take Benadryl 50 mg. Relief in 24 hRs. Second tongue swelling a week LAter. Again Benadryl taken. All this time extReme feeling of hot inside mouth, Like Hot Sauce. Using mouth wash - No help - Lips start to have "blisteRs" on inside of mouth - See MD - Blood work shows nothing. Another episode go to ER - told might hAve allergy to BP Medication (LOSARtoN) unconfirmed after stopping this Med. As of this date still experience some Heat - tongue And Lips doing Much better. QuestioN: Will this go away in a timely FashioN? Is there An Antidote? HAve there been other people Reporting this condition? Conclusion: After exam by primary physician, allergist, dentist, + ER doctor. Lab results - etc all negative! I researched side effects and found "SEVER" side effects: This is what happened to me - low blood pressure, hives (in mouth), lightheadedness, swelling of face, lips, tongue +, among others (weight loss)  I hope this report is of help in finding cause in my cause.  Condition has been ongoing for over 3 months now. Some progress is being made as frequency of events have lessened greatly with burning in mouth not as severe. Using pharmacy prepared mouth wash when needed.
Extreme burning from injection site along with ache shortly after injection. Difficulty moving arm without  strong pain. Though extreme pain has mostly subsided while standing. Burning pain lingering and very noticeable when arm is lifted upward or in differing positions. Sometimes burning pain can be felt at rest. Pain is centralized to injection site and travels to the back of left arm around upper shoulder area. Sometimes numbness can be felt and travels through arm to index finger. Extreme pain less noticeable after about 4 weeks 7/15/21. Burning, aching and numbness emits from injection area. No injuries have occurred sense receiving injection and no other health issues have been noticed. Burning, aching and periodic numbness still continues as of 8/03/21
Pt reports scattered pruritic rash, varicella lesions with fever, not allergic reaction.
spoke with patient she is experiencing an itchy arm, redness around the site, and soreness. she did notice a little swelling and has a lump the size of a plum. per Dr apply a cold compress, monitor for a fever, take ibuprofen and Zyrtec for pain and itching.
she has tested positive for Covid.; she has tested positive for Covid.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program and Follow-up (07Apr2021) was received from same reporter from a Pfizer-sponsored program processed together with initial information. A female patient of an unspecified age received first dose of BNT162B2 (Covid-19 Vaccine; solution for injection) via an unspecified route of administration as single dose for covid-19 immunisation. Second dose was scheduled on 15Apr2021. The patient medical history and concomitant medications were not reported. On unknown date the patient tested positive for Covid. The patient underwent lab tests and procedures which included Covid positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (26May2022) Negative, notes: Negative test following paxlovid on day 6 and 7 (26May, 28May); (28May2022) Negative, notes: Negative test following paxlovid on day 6 and 7 (26May, 28May); (30May2022) Positive, notes: positive test & covid symptoms started again on 30May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Just minor problems with the first and second dose; Pain where we had received the shot; Mentioned having chronic migraines; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Just minor problems with the first and second dose), MIGRAINE (Mentioned having chronic migraines) and VACCINATION SITE PAIN (Pain where we had received the shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic migraine and Drug allergy (allergic to Advil (Ibuprofen).). Concomitant products included METOPROLOL TARTRATE (METOPROLOL [METOPROLOL TARTRATE]) for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (Just minor problems with the first and second dose) and VACCINATION SITE PAIN (Pain where we had received the shot). In February 2021, the patient experienced MIGRAINE (Mentioned having chronic migraines). The patient was treated with SUMATRIPTAN for Migraine, at an unspecified dose and frequency. On 06-Feb-2021, VACCINATION COMPLICATION (Just minor problems with the first and second dose) and VACCINATION SITE PAIN (Pain where we had received the shot) had resolved. At the time of the report, MIGRAINE (Mentioned having chronic migraines) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-387017, MOD-2021-387044 (Patient Link).
This case was reported by a physician via call center representative and described the occurrence of hypersensitivity reaction in a 16-year-old male patient who received MENVEO. On 15th May 2017, the patient received the 1st dose of MENVEO. On 15th May 2017, less than a day after receiving MENVEO, the patient experienced hypersensitivity reaction, purpuric rash, sore throat, fever and vasculitic rash. On an unknown date, the outcome of the hypersensitivity reaction, purpuric rash, sore throat, fever and vasculitic rash were unknown. It was unknown if the reporter considered the hypersensitivity reaction, purpuric rash, sore throat, fever and vasculitic rash to be related to MENVEO. Additional details were provided as follows: The physician reported that the patient experienced a rash that started on his feet and moved his way up his entire body within an hour of 2 after the injection and rash spread to his legs, arms, neck. The physician reported that it was a purpuric rash or vasculitic type rash. On 18th May 2017, the physician observed the patient and the rash had started to get better from when the patient first experienced the rash, but the rash was still there somewhat. The physician reported that the rash spread very quickly. No further information was provided.
Continues to have temp inc to 101 on 3rd day p/shot rt thigh is still red, swollen, hot & large knot; Seen by MD 23JUL91 placed on EES; MD states was site rxn per mom no fever 24JUL91;
Eight days after having the shot, my left arm developed a bull's eye type rash and was hot to touch.  Furthermore, the site is itchy and I have taken Benadryl to calm the effects of the itching.
This spontaneous report as received from a physician via Pfizer refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose and lot # was unknown). On an unknown date the patient experienced pneumonia (reported as pneumo). the reporter queried that if a patient received pneumococcal vaccine polyvalent (23-valen) (Manufacturer unknown) and developed pneumo and required a booster do we give booster with pneumococcal vaccine, polyvalent (23-valent) (Manufacturer unknown) for PREVNAR 13. The outcome of the event pneumo was unknown. The relatedness of the event with the therapy pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided. Additional information has been requested.
Couldn't sleep; Aching; Fever; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), MYALGIA (Aching), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had COVID-19 and was hospitalized in OCT 2020) in October 2020.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INSOMNIA (Couldn't sleep), MYALGIA (Aching), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, INSOMNIA (Couldn't sleep), MYALGIA (Aching), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient said that she is on a lot of medications concomitantly. No other details were provided. Treatment Took tylenol and zofran to treat symptoms
After 2 days of vaccination, there are continuous pain around joints all over the body and especially on the back. In the extreme case, I can only fold like a shrimp.   Also I feel like my heart is being grasped hard and therefore the whole body is weak, this happens like once a week.
dizzy; fell down; hit my face on the ground; i am not feeling well; my immune system has been affected; i feel unbalanced and head not the same; i feel unbalanced and head not the same; was unconconsious for a second; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "was unconconsious for a second"; DIZZINESS (non-serious), outcome "recovered", described as "dizzy"; FALL (non-serious), outcome "recovered", described as "fell down"; HEAD INJURY (non-serious), outcome "recovered", described as "hit my face on the ground"; MALAISE (non-serious), outcome "recovered", described as "i am not feeling well"; IMMUNE SYSTEM DISORDER (non-serious), outcome "recovered", described as "my immune system has been affected"; BALANCE DISORDER (non-serious), FEELING ABNORMAL (non-serious), outcome "recovered" and all described as "i feel unbalanced and head not the same". The patient became dizzy and fell down and was unconconsious for a second and patient hit face on the ground with first shot. it happened after two hours since patient got the shot. this happened just for the first one and 2nd and booster were ok. nothing at all. Patient was not feeling well since then. Patient immune system has been affected and patient felt unbalanced and head not the same can someone inform what to do.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore arm not only at shot site but entire upper arm was sore and challenging to move. That started on the day of the shot (3/27). Fatigue started in the evening on 3/27. Nausea started around 6p the following day on 3/28. Nausea improved upon waking on 3/29 but is still coming in waves. Arm is still store.
About 1 day after the shot experienced fatigue, myalgias, fever, night sweats, chills, and sleepiness.
patient complained of her eyes swelling and turning red, as well as the feeling that her throat was closing up.  She took a benadryl which helped.  Appeared to be some type of allergic reaction.  Overnight she experienced symptoms of fever such as chills.  By the next morning she was feeling better.
Mom noted right thigh was red, hot to touch on 8/8/2012. C/O itching and child was scratching it.
pt c/o acute groin ache;diff sitting;increasingly more severe manifestations over several hr;temp elevated to 104.3;edema & erythema, testicular region;referred to urologist;dx mumps orchitis/pt missed school x 2wk;
Bruising; swelling; burning; itching; peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):   A 46-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; poly-L-lactic acid (SCULPTRA), since 06Oct2022 (Batch/Lot number: unknown). The patient's relevant medical history included: "Immunoglobin G deficiency" (unspecified if ongoing), notes: Immunoglobin G deficiency. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Patient received COVID vaccine (Pfizer), 1st Vaccination: 21Apr2021), administration date: 21Apr2021, when the patient was 44-year-old, for COVID-19 immunization; BNT162b2 (Patient received COVID vaccine (Pfizer), Boosters: 12May2021; 03Dec2021; Apr2022), administration date: 12May2021, when the patient was 44-year-old, for COVID-19 immunization; BNT162b2 (Patient received COVID vaccine (Pfizer), Boosters: 12May2021; 03Dec2021; Apr2022), administration date: 03Dec2021, when the patient was 45-year-old, for COVID-19 immunization. The following information was reported: CONTUSION (non-serious) with onset Oct2022, outcome "recovered" (16Oct2022), described as "Bruising"; BURNING SENSATION (non-serious) with onset Oct2022, outcome "not recovered", described as "burning"; PRURITUS (non-serious) with onset Oct2022, outcome "not recovered", described as "itching"; SKIN EXFOLIATION (non-serious) with onset Oct2022, outcome "unknown", described as "peeling"; SWELLING (non-serious) with onset Oct2022, outcome "recovered" (16Oct2022). The action taken for poly-L-lactic acid was unknown. Therapeutic measures were taken as a result of contusion, swelling, burning sensation, pruritus, skin exfoliation.  Attached please find an adverse event report regarding a patient that received the COVID vaccine. Reference is made to the FDA Guidelines for Post-marketing Reporting of Adverse Drug Experiences dated March 1992, requires "Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant." In accordance with the guideline, we are forwarding the below information related to an adverse drug experience received.  Patient injected with Sculptra to temples, nasolabial folds, jowls, and cheeks on 06Oct2022. Bruising and swelling following the procedure as well as burning and itching, peeling. Treated with ice, massage, and OTC hydrocortisone. Bruising and swelling resolved by 16Oct2022. Burning and itching are ongoing. Patient has not contacted HCP yet but plans to. HCP information included above. Patient received COVID vaccine (Pfizer), 1st Vaccination: 21Apr2021, Boosters: 12May2021; 03Dec2021; Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Over the  weekend of Jan. 9-10 I had a headache and chills, but no fever. After that everything was fine until the evening of Wednesday Jan. 20th when I got very itchy all over my body.  Then in the morning Thursday Jan. 21st I noticed a small rash at the injection site that hadn't been there the night before. over the next two days the rash increased in size.
Tuesday night got a terrible headache and and neck pain on left side of neck, same side I got my vaccination. Swollen lymph nodes on left side of neck. Wednesday neck and back of skull pain stemming from the left side of my head and neck.
Extreme malaise upon waking this morning. At 9:00 am, I began feeling very hot but was having chills.  Following, the chills I began to feel nauseated and very thirsty, but only drank 16 ounces of water from the time I woke until 11:00 a.m.  At 10:00 I begin feeling pressure, pain and tightness in my chest as well as a fluttering feeling in my chest cavity. I left work not feeling well at 11:10 and upon getting home continued to have the same symptoms.  In addition I started urinating frequently, about once every 30 minutes although I had no other liquids to drink nor did I eat.  At 7:00 p.m. I took my temperature and it was 100.1.  It is almost 10:00 p.m. and most all symptoms have subsided.
arm pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; manufacturer unknown), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 21Sep2022, outcome "not recovered"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". Therapeutic measures were taken as a result of headache, pain in extremity.  Additional Information: Patient mentioned that she received the vaccine on the 21st of September and she mentioned that she had a headache as well arm pain. Patient added that the headache did not run away and she is calling to have that reported. Patient stated that she had her bivalent shot, her booster on 21Sep and she had a headache since 21Sep, and it was terrible headache. Anatomical site, Reporter stated,  It was in her right arm. Treatment: Reporter stated, she have been taking Advil and Tylenol. Other Conditions: No; Other Products: No.  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.
What I know so far is they gave her the shot her heart stopped for about 3-4 minutes they did cpr until the ambulance got there they took her to main. They are going to do a bunch of test . They are going to keep her she has too see the cardiologist they are going to do an eco cartogram and an ultrasound of her heart. They had to my  mom on a ventilator because they where putting the defibrillator in and she started throwing up and they had to do compression again cause her heart stopped again and she stopped breathing
Admitted for cough/sob; CXR L basilar infiltrate; + covid in ED; Labs: D-dimer 6.11; CRP 22.13 Ferritin 234; Tx: Decadron, Remdesivir, Rocephin, Doxycycline, Lovenox, FiO2 @ 2 LPM initially, down to room air at d/c;
Dark circles under eyes that developed after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: EW0165) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Narcotics" (unspecified if ongoing). Concomitant medication(s) included: MINOCYCLINE; VITAMIN D3; ATORVASTATIN. Vaccination history included: Bnt162b2 (previous dose product: COVID 19, brand: Pfizer, lot number: EW0182, dose administration time: 02:00 PM, dose number: 2, dose vaccine location: Right arm), administration date: 02Jun2021, for Covid-19 immunization; Bnt162b2 (previous dose product: COVID 19, brand: Pfizer Covid Vaccine, lot number: EW0165, dose administration time: 12:15 PM, dose number: 1, dose vaccine location: Right arm), administration date: 05May2021, for Covid-19 immunization.  The following information was reported: DARK CIRCLES UNDER EYES (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Dark circles under eyes that developed after receiving the vaccine". The event "dark circles under eyes that developed after receiving the vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of dark circles under eyes.  Additional information: Patient had no other history. Patient did not receive any other vaccine in four weeks. Patient was not tested COVID positive prior and post vaccination. Event was assessed as non-serious.  Follow-up attempts are completed. No further information is expected.
pain to lt deltoid area w/large amt of redness 4cm x 13 1/2 cm size; warm to touch;
Fridge temp went out of range by 4 degrees overnight on Sunday due to storm, facility was closed 1/17. Vaccine was administered to patient
No futher adverse events; Caller is reporting administered dose of expired VAQTA.; This spontaneous report was received from the office manager referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies was not provided.  On 29-JUL-2022, the patient was vaccinated with one expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered as prophylaxis (exact, dose, vccination scheme frequency, anatomical vaccination site and route of administration were not provided; lot number T023913 has been verified to be a valid lot number hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, expiration date reported and upon internal validation established as 31-MAR-2022) (expired product administered). There was no previous temperature excursion. No adverse events reported.