chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shivering; muscle cramps; Extreme Neck and back pain; Extreme Neck and back pain; Left armpit pain with tinglingly sensation down left arm; Left armpit pain with tinglingly sensation down left arm; This is a spontaneous report from a contactable nurse. A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), via an unspecified route of administration on 11Jan2021 at a single dose in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 (brand: Pfizer, lot number: Ej1685, expiry date not reported) on 21Dec2020, intramuscular in the left arm for COVID 19 immunization. On 12Jan2021, patient experienced shivering and muscle cramps the first day; extreme neck and back pain x2 days post injection. On third day post injection, patient experienced left armpit pain with tinglingly sensation down left arm. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events shivering, muscle cramps, extreme neck and back pain and left armpit pain with tinglingly sensation down left arm was unknown.
axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; patient received the covid vaccine on the 30Dec had a sore arm; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at single dose on the arm for COVID-19 immunization. The patient medical history included "had classic symptoms of COVID, but had a negative COVID test" on Dec2020. Concomitant medications were not reported. The patient previously had a Tetanus vaccine 23 years ago. After receiving patient spiked a fever 101 and cellulitis at the site. Reporter explained she is not 100 percent sure. She is not sure if the nurse used the DTap abbreviation and truly administered the Tetanus shot. Reporter indicated she is not sure which preparation patient got. Patient received the vaccine on 30Dec2020 and her arm was sore that day when went to bed. The next morning (31Dec2020) the site was tender. She then noticed a nickel size (as reported) red lump that had disappeared on 03Jan2021 (The next day she had tenderness and redness that went away after two days). Patient noticed the 50 cent size (as reported) lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site the morning of 31Dec2020, an exact time was not specified. On 07Jan2021 he had a 50 cent size lump on the side of her arm at injection site in arm received injection that was raised, warm, red, and tender at the injection site. On 07Jan2021 her axillary was tender and occasionally painful. On 08Jan2021 it returned to injection site at 1. That day at 6:30 PM on 08Jan2021 she had an area she had a 50 cent size area that was raised, red, and warm. She took Benadryl the next day. The morning of 09Jan2021 she woke up and had more redness tenderness in her arm, therefore, she called her doctor. Her doctor ordered an antibiotic. On 11Jan2021 they entered in the follow-up notes she had slow improvement even though the axillary area is still painful. Reporter explained it sounds like events are slowly improving, they are not completely resolved. Reporter stated it is so weird that the sore arm went away, disappeared, and then came back again. The final outcome of the events was recovering. The adverse events di not require a visit to the emergency room or physician office. The events were as assessed as non-serious by reporter. The causality of events was considered as related by reporter.  Information on the Lot/Batch number has been requested.
A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 29-Jan-2015. It was reported that expired FLUMIST was administered inadvertently to the patient on 29-Jan-2015. The outcome of the event of INADVERTENTLY ADMINISTERED EXPIRED FLUMIST TO TWO PATIENTS is unknown. The report was considered to be non-serious.
Pt with 3 inch radius ery, sl raised rash. No S/S of infection - not warm, tender or painful to the touch. + pruritis Pt given 25 mg of BENADRYL with good success, pt was checked at 1 hour intervals.
Her right arm is sore/Her arm continues to hurt even at rest; Her right arm felt heavy; In pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her right arm is sore/Her arm continues to hurt even at rest), LIMB DISCOMFORT (Her right arm felt heavy) and VACCINATION SITE PAIN (In pain at injection site) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A and 034F21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 21-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (Her right arm is sore/Her arm continues to hurt even at rest), LIMB DISCOMFORT (Her right arm felt heavy) and VACCINATION SITE PAIN (In pain at injection site). At the time of the report, PAIN IN EXTREMITY (Her right arm is sore/Her arm continues to hurt even at rest), LIMB DISCOMFORT (Her right arm felt heavy) and VACCINATION SITE PAIN (In pain at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.         The  concomitant medications on use were not provided.  The patient stated that the pain seemed to go away then comes back. It was gotten worse.  No treatment information was provided.
Swelling in arm, then temp to 101 x 24 hrs. Tylenol and warm compresses.
Patient had a very large red, raised area on her left arm at injection site & radiating outward (of about 4" across). It looked bruised along the edges & was hot to the touch & itched alot. Patient was told to apply ice and take BENADRYL. Rph will follow pt. daily we followed up w/pt over next 2 days & rash not worsening.
Boyfriend received smallpox vaccination 12/03. He came home for Christmas when patient saw him. She denies direct contact with lesion and said it was covered with a shirt. On 01/06/04, she developed pimple on right face which is now about 6-8mm pustular lesion. Patient names boyfriend as vaccinee. Denies knowledge of branch of service, unit, etc. She did state she believes he is to be sent overseas. Denies ability to contact him.
Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: numbness on left arm
Woke up with sever headache during the night, dizzy. For the next 3 weeks had balance issues,.
the patient initially received the pfizer 2 dose series. she came in to get a booster shot and didn't specify which shot she needed. we administered the shot and she was okay. she panicked when she found out she got the Moderna shot. although the patient has no reaction,  told me to submit this form.
On 7/06/21 patient received her first dose Pfizer COVID vaccine (LOT#: EW0191 EXP: 7/29/21) at 1758. Patient alerted EMT's at 1812. Patient stated that she felt dizzy and anxious. Patient stated that she had eaten lunch around 1500. Patient stated that she felt very nervous about getting the vaccine. EMT assessed and took patients vital signs. BP:136/60, HR: 106, O2: 95%. EMT reassessed and retook patient vital signs at 1818. BP: 120/56, HR: 96, O2: 99%. Patient stated at 1819 that she was feeling a lot calmer and that the dizziness was subsiding. EMT reassessed and retook patients vital signs at 1823. BP: 130/58, HR: 81, O2: 99%. Patient stated that she no longer had any dizziness. EMT reassessed and retook patient vital signs at 1832. BP: 130/60, HR: 78, O2: 99%. Patient completed observation time. Patient was educated by EMT on worsening signs and symptoms of covid vaccine and when to go to the emergency room/urgent care. Patient verbalized understanding of education. Patient left vaccination site at 1834 unassisted and with a steady gait.
had delayed reaction. Threw up 2 hrs later. 7 hrs later aches, low grade fever increased to 103.5 overnight. Given Advil didn?t respond, switched to 2 extra strength Tylenol, slowly reduced fever. General feeling of aches, pain everywhere. Took 2 more Extra Strength Tylenol and reduced the fever to 100.2 mid next day. Felt better by end of second day. Left fatigued by 3rd day.
pt recv vax 27JUL93 & later that day pt exp a sz & was taken to ER;nurse indicated that this event resulted in permanent disability;
Patient was administer a Janssen vaccine on 09/16/21  at 10:30 a.m.. patient was walked over to the waiting area and started feeling hot with in 3 minutes. He was accompanied by his sister and father who also received the same vaccine.. his sister gave him some water...then in a few minutes pt had a blank stare look on his face, he had no response, head went backwards, hand clamped tight into a fist, pt was out and no response for a few seconds. I was assisted by the store manager who called 911.. patient came back and was responsive, he knew his name and where he was he was sweating profusely and very damp... I had patient lay down on the floor and gave him some orange juice. Patient had nothing to eat or drink that morning.. EMT arrived and assessed patient and pt went to the hospital.. I called pt to follow up but no answer, at arounf 12:00 pt and sister came back to pharmacy to let me know everything was ok and to thank me for helping..
Patient return to office on 01/13/2005. Mother c/o patient having red area on his left thigh for 2 days. Patient had vaccination given on 01/11/2005. Nurse observed 3.5 cc induration on left thigh near area of where vaccination was given.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER7832) and on 24Apr2021 as dose 2, single (Lot number: ER8735) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Lot number: 076C21A) for covid-19 immunisation. The patient's relevant medical history included: "iron deficiency anemia" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Dec2021, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, latency 15 days after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 29Jun2023 to 04Jul2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250763 same reporter/patient, different drug/event;
Hospital Principal Problem (Discharge Diagnoses): Hyponatremia   All Hospital Problems (Other Diagnoses): Active Hospital Problems   Diagnosis o Principal Problem: Hyponatremia o Essential hypertension o COVID-19 o COPD with exacerbation (CMS/HCC) o Central retinal artery occlusion o Dyslipidemia
thin, red stripe/ line from vaccination  horizontal across arm...about 2.5 inches long
I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; Severe allergic reaction; I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; My body was red and I had blotches bumps all over me my back under my right breast; My body was red and I had blotches bumps all over me my back under my right breast; My entire body was inflamed; Started getting hives on my back, under my right breast, both arms and both legs and thighs and I started getting bump. I broke out in hives in sleep in middle of night; I woke up out of my sleep in the middle of the night like the wee hours of the morning itching; I had like difficulty breathing; I had severe headache and I had it like all week; severe headache; My pressure went up like 140 over 100; high blood pressure; This is spontaneous report from a contactable consumer (Patient herself). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unknown route route on 04May2021, as a single dose, for COVID-19 immunization. Patient's medical history included seasonal allergy (using an inhaler), Asthma and Diabetes. The patient's concomitant medications included insulin. On the same day of vaccination on 04May2021, at the first hour, the patient had a severe allergic reaction. The patient also experienced severe headache and I had it like all week and her pressure went up like 140 over 100 and then like the next day you know I had like difficulty breathing. On the third day, The patient also had a severe allergic reaction. The patient stated that her entire body was inflamed and then she started getting hives on her back, under the right breast, both arms and both legs and thighs. The patient also experienced bumps. The patient further stated that she had dizziness and was going to pass out when she had to walk down the stairs. The patient also stated that she broke out in to hives in her sleep in the middle of the night. The patient had itching at the wee hours in the morning. The patient stated that she went and looked in the mirror and her body was red and I had blotches bumps all over her back under my right breast. The patient wanted to know whether she can take the second shot. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The patient did not had any physician visit for the events. The patient used Benadryl as treatment medication for the events. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The outcome of the events was unknown.  Information about batch/lot number was available. Further information was expected.
pt recvd vax & was breathing fast & inc HR last PM; this AM had episode started shaking from legs extending upward to arms; pt had fever; pos cough & congestion; vomiting & diarrhea;
The shots to prevent did not help me I got a very bad case/ suspected vaccination failure; very bad case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot to prevent shingles, but it did not help, and the patient got a very bad case of shingles. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown.
Patient started running a fever that got up to 102.5 about 4 days after receiving the shots.  On the third day she ran a fever of 103.5 and that evening she woke up fussing.  We went in to get her out of bed and changed her diaper, then we sat her up on the changing table and that is when she threw herself backward and went in to a full seizure.  She was in full convulsions for about 2 min.
Initial unsolicited report received from a nurse on 21 September 2015. This case involves a 54-year-old female patient who was vaccinated with a first dose MENACTRA (batch number: U5049AA, expiration date: 19 August 2016, dose was not reported) intramuscularly in right deltoid and a dose of TWINRIX (batch number: HZ9Z9, expiration date, dose were not reported) intramuscularly in left deltoid on 17 August 2015. Previously in January 2015 and February 2015, the patient received a dose of TWINRIX. The patient did not receive MENACTRA previously. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as no known drug allergies (NKDA), Chronic low back pain, hypertension, numbness in feet, borderline diabetes, cardiac murmur, allergic rhinitis, sciatica. The patient's illness at time of vaccination reported as chronic low back pain, chills. Concomitant medication was not reported. On 18 August 2015 (Friday) in evening, one day following the vaccination, the patient experienced pain and swelling in right upper arm. On same Friday night patient scratched the site, with some "pus" coming out. Had pain in right throat, right shoulder and right chest which started on 18 August 2015 (Friday) night. On 19 August 2015 (Saturday) and 20 August 2015 (Sunday), the patient had a fever. On an unspecified date, the patient had 16 cm long, 10 cm wide warm, red, hard area at injection site, on her right upper arm pain causing weakness of her right arm. The patient had some hard lumps on both arms and left leg and her fingers. The patient had joint pain in all her joints. Felt low energy, has muscle weakness to her legs and arms, dizziness, eye weakness and dizziness when she stands up suddenly. The patient had required ER or doctor visit. The patient had normal blood pressure limits. Other laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient recovered from hard lumps on both arms and left leg and fingers except on her right upper arm was not recovered. The patient had joint pain in all her joints, all resolved except in her elbows. The patient not recovered from pain in right throat, right shoulder and right chest. The outcome of the events eye weakness, low energy, weakness of her right arm, muscle weakness to her legs, pain and swelling in her right upper arm starting, 16 cm long, 10 cm wide warm, red at injection site on her right upper arm, scratched the site, with some pus, lumps right upper arm, fever, dizziness, hard area at injection site on her right upper arm were unknown. Upon internal review, company assessed the event of eye weakness as serious and important medical event. List of documents held by sender: none.
Swelling of the left hand and appearance of hives all over the body, he started taking benadryl but the hives increased and he switched to Zyrtec. Hives still appear, although in less quantity on arms, legs and back
developed chronic spontaneous urticaria after they were given the 3rd dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (developed chronic spontaneous urticaria after they were given the 3rd dose of the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient was not immunocompromised.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC SPONTANEOUS URTICARIA (developed chronic spontaneous urticaria after they were given the 3rd dose of the Moderna Covid-19 vaccine). At the time of the report, CHRONIC SPONTANEOUS URTICARIA (developed chronic spontaneous urticaria after they were given the 3rd dose of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Reporter stated that it was not specified if the third dose was a full third dose or the first booster dose. Reporter wanted to know if the patient can take the bivalent booster dose. No treatment drug was reported.
Patient phoned the pharmacy stating that she was experiencing really bad itching and swelling approximately five inches side. Patient advised to use BENADRYL and follow up with doctor or urgent care for steroids and further evaluation. Pt says she will use rubbing alcohol on the area and follow up with the doctor if the condition worsens.
knee and shoulder pain, insomnia, low back pain, chronic pain, fatigue, sleep related leg cramps
On day 2,3 became feverish, chills, body aches, fatigue On day 5- woke up with redness, itchy arm where vaccine was administered. Applied some hydrocortisone on it, redness is still there
Got 1st COVID vaccine on Saturday morning.  Early Monday morning around 5:30 AM, I woke from my sleep shaking/trembling all over, heart racing, and felt severe pains in my chest.  I felt like I was having a heart attack.  Then I started sweating all over entire body, drops pouring off abdomen and back.  Immediately felt nauseated, made it to the bathroom and sat for a while and had a bowel movement.  Afterwards, then experienced tingling down both left and right arms and at the same time numbness in my face cheeks.  Continued sweating at least over the next half our or longer, and chest pains continued all morning.  I managed to take a shower after calming down some around 7:30 AM ,and then made it to the ER around 8:30 AM.  Monday chest pain was severe, I could "feel my heart" all day long, along with sensation that my heart wants to cramp or "catch".  Tuesday was a bit calmer, but I have been monitoring my beats per minute, which are going up from 130-145 especially at night and when I am trying to sleep.  Sleep is being severely affected since Monday.  I am unable to lay down in bed and have to sleep on couch so that I can be oriented mostly sitting up.  Today (Wed) I am not "feeling" the heart all day long, but I still have strong episodes of wanting to cramp along with chest pains that can last up to 30 mins or longer, but very strong feelings of heart fluttering and almost like a feeling of "gas bubbles" in the heart (hard to describe, like how your stomach makes sound when digesting food, but I have that feeling in my heart and chest area). I am also very winded everyday when doing any activities and hard to breathe when trying to have long conversations.