chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 05Apr2021 as dose 2, single (Lot number: ER2613), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: EW0172) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 10May2022 as dose 4 (booster), single (Lot number: OS7MZ1A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There was no known allergies.Concomitant medication(s) included (Other medication in 2weeks): VOLNEA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after testing "not positive" on day 8; Positive, notes: Testing positive again on day 10 of symptom onset. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course include testing positive again on day 10 of symptom onset, after testing not positive on day 8. Other medication in 2weeks product Volnea, Viorele 28 day, Shingles booster from 30Aug2022 on 30Aug2022. Paxlovid was used for treatment of COVID-19 from 02Sp2022 to 06Sep2022 with lot no. GE1627.  No follow-up attempts are possible. No further information is expected.
I was given vaccine on 09/7/10 afternoon. That same night I started experiencing severe muscle pain. Itching in my lower extremities lasting about 6-7 hrs.
Fainted, unconscious for few minutes; Sweating; Funny feeling; Feeling very weak; A spontaneous report was received from a consumer who was also a 59-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced fainted, unconscious for few minutes/loss of consciousness, sweating/hyperhidrosis, funny feeling/inappropriate affect and feeling very weak/asthenia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) on 07 Feb 2021.   On 07 Mar 2021, approximately 2 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029A21A) via an unknown route in the left non dominant arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021, patient experienced sweating, patient felt funny, fainted and was unconscious for few minutes and patient felt very weak.   No treatment was provided.  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.  The outcome of the events were not reported.; Reporter's Comments: This case concerns a 59-year-old female who experienced a serious unexpected event of loss of consciousness along with nonserious events of unexpected asthenia, inappropriate affect and hyperhidrosis.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
After the vaccination  on 1/18/2021 , I had just pain at the site of injection in my left arm for the next 2   to 3 days  and headache.  Took Advil and it went away. After 3 or 4 days i started feeling very mild pain inside my arm muscles between  the injection site and my elbow  which continued till 1/25/2021.   Later this  very mild internal pain shifted  to my elbow  and   feel a mild numbing sensation in my pinky finger.  It also feels little heavy when I move my arm.  This  continues till  today as I am reporting on 1/30/2021 3:30pm.  Since it has not bothered much , I did not seek medical care, hoping this will  go away in few weeks.
Information has been received from a nurse practitioner concerning a 14 year old female who on 21-NOV-2007 was vaccinated with the first dose of Gardasil (lot # 658560/1062U). On 22-JAN-2008 the patient was vaccinated intramuscularly with 0.5 mL of a second dose of Gardasil (lot # 659437/1266U). There was no concomitant medication. On 28-JAN-2008 the patient was examined in the Emergency Room. She was experiencing dizziness, numbness in her extremities, tinnitus, shortness of breath, anxiety, chest discomfort and coughing. She was diagnosed as having a panic attack and anxiety. She was not admitted into the hospital and was released on the same day. The nurse practitioner did not know if she was given any medications. No product quality complaint was involved. At the time of this report the outcome of the events was unknown. Additional information has been requested.
pt recvd vax 7JAN93 & on 9JAN93 pt exp joint pain; sx persisted for 2 1/2 wks; No further details were provided;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 28-OCT-2015 the patient was inadvertently vaccinated with expired dose of MMR II (strength, dose, frequency were not reported) lot # J013131 expiry date of 17-OCT-2015. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Client c/o pain starting at injection site 9/26/07 but get more swollen and painful 9/27/07. Applied with compress x 1. Seen by private MD had fever x 2 days receive treatment of Zinnat 212 500mg and Motrin PRN. Temp normal.
Generalized body pruritis, swelling of lips & face. Given Benadryl in ER.
MD told patient to hold off on second shot due to prednisone tapering; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (MD told patient to hold off on second shot due to prednisone tapering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder since October 2020. Concomitant products included PREDNISONE for Autoimmune disorder.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced OFF LABEL USE (MD told patient to hold off on second shot due to prednisone tapering). On 21-Feb-2021, OFF LABEL USE (MD told patient to hold off on second shot due to prednisone tapering) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.
Pt. died in the hospital of complications of SARS CoV2 pneumonia.  Underlying h/o chronic end-stage renal disease requiring hemodialysis preceding her acute illness.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that the patient developed shingles like rash after vaccination.  The pharmacist reported that the patient may have been immunocompromised.  A product quality complaint was not involved.  Additional information has been requested.
4cm x 6cm patch of erythema at the vaccine site 3 days following Tdap injection.
Panic attack; Impaired work ability; Anxiety; She did not receive the 2nd dose between day 25-35 of getting the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), PANIC ATTACK (Panic attack), IMPAIRED WORK ABILITY (Impaired work ability) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did not receive the 2nd dose between day 25-35 of getting the 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did not receive the 2nd dose between day 25-35 of getting the 1st dose). In May 2021, the patient experienced ANXIETY (Anxiety). On an unknown date, the patient experienced PANIC ATTACK (Panic attack) and IMPAIRED WORK ABILITY (Impaired work ability). The patient was treated with SERTRALINE HYDROCHLORIDE (ZOLOFT) at an unspecified dose and frequency and LORAZEPAM at an unspecified dose and frequency. On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did not receive the 2nd dose between day 25-35 of getting the 1st dose) had resolved. At the time of the report, ANXIETY (Anxiety) had not resolved and PANIC ATTACK (Panic attack) and IMPAIRED WORK ABILITY (Impaired work ability) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANXIETY (Anxiety), PANIC ATTACK (Panic attack) and IMPAIRED WORK ABILITY (Impaired work ability) to be possibly related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did not receive the 2nd dose between day 25-35 of getting the 1st dose).    Concomitant product use was not provided. Treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events anxiety, panic attack and impaired work ability, a causal relationship cannot be excluded. This report, also, refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 021B21A..; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events anxiety, panic attack and impaired work ability, a causal relationship cannot be excluded. This report, also, refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 021B21A.
Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.
Vertigo, pain in toes, feeling of fullness but different than one with have with a cold starting about 4 days after the second injection.  I had been diagnosed with BPPV in 2007 by  (EENT) following what was suspected as meningitis.  I was deaf initially and after a year of prednisone treatment recovered all hearing but the vertigo and tinnitus remained.  The vertigo stopped after physical therapy and the tinnitus dropped from a 10 to a 4 at that time.  After the second dose of the vaccine the tinnitus went back to a 7 and the vertigo was similar to experienced in 2007.  The tinnitus is now is back to 4-5.  The pain in the toes started about the same time.  I have never had that type of severe, sudden jabbing type before in my toes and it affected three of them on either foot off and on for several days.  It has also stopped.  I disregarded the fullness thinking maybe springtime pollen but I don't have allergies and the tinnitus was markedly increased.  I didn't seek medical advice since I hadn't been aware of any adverse affects of the vaccine like this and thought it must be just an odd happening and since it went away I was okay.  My husband read on NPR today that my symptoms were reported in rare cases and we looked at the date the vaccine was given and thought perhaps they might be related.
p/vax T101 w/shakiness (flu-like) body aches;rt side of throat was swollen;?swallowing was difficult;pt explained it felt like a lump;called ER advised to take DPH & Ibuprofen;
irritable & crying w/very brief periods of consolability for 4 days p/immun;
After alchol swabbing and placing inject-safe barrier bandage on patient's left deltoid  in appropriate area. Administered patient's vaccine with no issue. Her husband was also in the booth--I then proceeded to give him his vaccination. After finished with both, I asked if there was any questions and notice patients bandage was very swollen with blood. I asked if she took any blood-thinners, she responded just Naproxen occasionally for joint pain. She told me she wasn't in pain and this had happened to her before when she received a pneumonia vaccine. I got some more alcohol swabs, cotton balls, and band-aids to clean up the injection site and investigate. The injection site was in the appropriate area of the deltoid, but she had developed a swollen knot with black and blue coloring area around the injection site. The bleeding stopped after being cleaned. I encouraged the patient to follow-up with a doctor for further investigation, but she said she did not feel it was necessary since she wasn't in pain and has happened to her before. I still strongly encouraged her to go and let her know that I would report her reaction VAERS as I found it highly unusual.
Large pontine hemorrhage without hydrocephalus is considered incompatible with meaningful survival.  Repeat CT of the head pending.  There is no indication for neurosurgical intervention.
has arthritis but this made it worse; three fingers on the arm of the injection are not working...can't straighten them; Three fingers are really sore; Arm is swollen; Face is swelling; Joint pain (hip); Calves hurt; A spontaneous report was received from a 82-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events three fingers on the arm of the injection are not working, three fingers are really sore, can't straighten three fingers, has arthritis but this made it worse, arm is swollen, face is swelling, joint pain (hip) and calves hurt.  The patient's medical history included congestive heart failure, atrial fibrillation, arthritis and neuropathy on her feet.  Relevant concomitant medications were reported as apixaban, immunoglobulin injection every week and gabapentin.  On 15-JAN-2021, prior to the onset of the events, the consumer received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date, the consumer experienced the three fingers on the arm of the injection were not working and the three fingers were really sore and she could not straighten the three fingers.  Additionally, she reported that the vaccine had made her arthritis worse, that her arm was swollen, her face was swelling, she had  joint pain in her hip and her calves hurt as well.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events, three fingers on the arm of the injection are not working, three fingers are really sore, can't straighten three fingers, has arthritis but this made it worse, arm is swollen, face is swelling, joint pain (hip) and calves hurt, were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
10 days after her second dose of Moderna Vaccine she developed a full body rash.  Hydrocortisone is not sufficient.  She is referred to her primary care provider.
Mom reports some redness to R arm injection site the day after shot but notified clinic on 10-30-09 (2 days later). Reports right arm was "bright red 12x12cm - hardened area that was hot to touch". Mom instructed to take pt to ER (no doctors available at clinic). Pt was started on Prednisone by ER doctor. Problems resolved on 11-3-09 when F/U was done with mother by phone.
For 48 hours following injection, mild to moderate injection site pain was experienced. 5 days after the injection, symptoms including headache, body aches, fatigue lasting 24 hours.
Patient was nervous to get vaccine. She tolerated well. She moved locations to a chair and began feeling like she was going to pass out. She was bradycardic, diaphoretic and pale. She did pass out and came to a couple of seconds later. She did not fall. She was placed in a recovery position. Ice pack place on her neck. 11:45 Pulse 44,  O2 Sat 99%, Resp 12 . She was on floor for 2nd assessment in recovery position. Color was better. She was talking. Pulse 60, O2 Sat 98%, BP 88/52, Resp 12. Reassessed at 11:56 Pulse 68, O2Sat 100%, BP 95/58, Resp 12. Asked how she feels on a scale of 0-10. 0 is horrible and 10 is feels great. She states she is an 8. Had a sucker and some water. Sat up on Floor. Later sat in a chair. was feeling good. Instructed to seek medical attention if she worsens.
3 weeks after Patient got this shot he got blood clots in his leg and amputated next week .The problem is he has ITP platelets were 12,000 He can't make blood clots!!!
Whole left hand was numb; cannot feel pinky; Hand is cold; could not open the last two fingers, the ring finger and the pinky; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (Whole left hand was numb; cannot feel pinky), PERIPHERAL COLDNESS (Hand is cold) and MUSCULOSKELETAL STIFFNESS (could not open the last two fingers, the ring finger and the pinky) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Supraventricular tachycardia. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), VERAPAMIL and CHLORPROPAMIDE (GLUCAMIDE) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HYPOAESTHESIA (Whole left hand was numb; cannot feel pinky), PERIPHERAL COLDNESS (Hand is cold) and MUSCULOSKELETAL STIFFNESS (could not open the last two fingers, the ring finger and the pinky). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Whole left hand was numb; cannot feel pinky) and PERIPHERAL COLDNESS (Hand is cold) outcome was unknown and MUSCULOSKELETAL STIFFNESS (could not open the last two fingers, the ring finger and the pinky) had resolved. Not Provided      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.   Treatment for the events included warm compresses.
STINGING AND TINGLING SKIN; HEADACHE; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180898, and expiry: UNKNOWN) dose was not reported, administered in right deltoid on 06-APR-2021 12:28 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced stinging and tingling skin. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stinging and tingling skin, and the outcome of headache was not reported. This report was non-serious.
Resting heart rate increased (130's) for a few hours, approximately 24 hours after the vaccine.
Vaccine jammed in shoulder joint; Tingling of the fingers; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine jammed in shoulder joint) and PARAESTHESIA (Tingling of the fingers) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine jammed in shoulder joint) and PARAESTHESIA (Tingling of the fingers). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine jammed in shoulder joint) and PARAESTHESIA (Tingling of the fingers) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-103156 (Patient Link).
Patient's daughter called on 10/15 and advised her father received shot earlier during day. That night he was vomiting and reported loss of appetite. Patient did not seek medical care. Pharmacy called and checked on patient following day - pt felt better but still nauseated.
pt recvd vax for prophylaxis & next day exp swelling & itching of hands/feet & welts;took po dph; sxs resolved w/in 24 hrs;
Initial misuse report received from a healthcare professional on 15 February 2013. A patient (No information was provided regarding the patient) had received only the diluent from the ACT-HOB. No adverse event was reported. List of documents held by sender: none.
pt recvd vax; lab tests done & revealed neg HepB profiles, 04-apr-93 pt found to be anti-EBC positive, anti-HBe positive & anti-HBs ratio 122.
Employee tested Covid Positive on 4/11/21 after receiving Covid Pfizer vaccine 1st dose 12/21/20, 2nd dose 1/23/21 .  Onset of symptoms of headache, loss smell and taste on 4/11/21. Employee symptomatic, denies any need for medical services. Headache treated with PRN Tylenol.