chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; arm cherry red; arm swollen down to elbow; arm hot; arm itching; nausea; teeth chattering chills; fever; body aches; head aches; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE REACTION (arm swollen down to elbow), VACCINATION SITE WARMTH (arm hot), PRURITUS (arm itching), NAUSEA (nausea) and CHILLS (teeth chattering chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INJECTION SITE REACTION (arm swollen down to elbow), VACCINATION SITE WARMTH (arm hot), PRURITUS (arm itching), NAUSEA (nausea), CHILLS (teeth chattering chills), PYREXIA (fever), MYALGIA (body aches), HEADACHE (head aches) and INJECTION SITE ERYTHEMA (arm cherry red). On 28-Feb-2021, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) on 27-Feb-2021 for Fever, at a dose of 650 milligram and METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Adverse reaction, at a dose of 4 milligram twice a day. On 27-Feb-2021, NAUSEA (nausea) had resolved. At the time of the report, INJECTION SITE REACTION (arm swollen down to elbow), VACCINATION SITE WARMTH (arm hot), PRURITUS (arm itching), CHILLS (teeth chattering chills), PYREXIA (fever), MYALGIA (body aches), HEADACHE (head aches), FATIGUE (fatigue) and INJECTION SITE ERYTHEMA (arm cherry red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 102.5 deg f (High) fever. On 28-Feb-2021, Body temperature: 105.5 deg f (High) fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
On 10/11, I had a sudden onset of chest pain that lasted about 30 seconds before retreating. In the weeks since then, I've had generally mild chest pain on an off. It's a slight tightness/soreness in the chest that's been very mild and lingers for a few hours at a time. Also about 2-3 times since then, I've had that same sudden onset of pain that lasts about 20-30 seconds.  There haven't been any other noticeable symptoms in the time since. The doctor put me on a 14-day treatment with Prilosec OTC. Today was my last pill and the mild pain still remains on and off. It's possible that the discomfort is caused by higher-than-usual stress and/or what I've eaten.
Fully vaccinated, not boosted.   COVID infection breakthrough.  Inpatient hospital stay.
Patient dropping off another prescription told RPH he had pain in back radiating to legs and went to ER. ER ran labs and found none abnormal and provided any diagnosis. Primary physician reported by pharmacist and MD determined to not provide boosters for vaccine. Patient states is currently fine at time of report
The day after the vaccine, I had weakness, fatigue, and shortness of breath with a fever and chills that lasted 24 hours. The fatigue and weakness lasted for 1 month. I did not have the strength that I usually had and it gradually got better. Then I got my 3rd dose of Pfizer on 12/20/2021, lot number FJ1611. I had fatigue and weakness at first that went away soon. About 3 weeks after, I noticed full body palpations whether laying down, stress, or exercise. I went to the ER and had an ultrasound and EKG which was normal and discharged. I went to a cardiologist and had an EKG, echocardiogram, Holter monitor, and stress test which was normal. My cardiologist prescribed a beta blocker. I do have Raynaud's syndrome and I do feel like it has triggered those symptoms. My fingers never were purple before and now they are purple.
Fatigue; Fever; Itchy body; Chills; Lower back pain; Received an underdose / Shot was spilled on the patient and the chair; Shot was spilled on the patient and the chair; Shot was spilled on the patient; interval too long; This case was reported by a pharmacist and described the occurrence of fatigue in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number J79G7, expiry date 27th August 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 18th january 2020, batch number 9H524, refer case US2020240927).   On 2nd December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced fatigue, fever, generalized pruritus, chills, low back pain, accidental underdose, inadvertent exposure to vaccine, exposure via skin contact and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue, accidental underdose, inadvertent exposure to vaccine, exposure via skin contact and drug dose administration interval too long were unknown and the outcome of the fever, generalized pruritus, chills and low back pain were recovered/resolved.   It was unknown if the reporter considered the fatigue, fever, generalized pruritus, chills and low back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix and experienced fatigue, fever, generalized pruritus, chills, low back pain. The health casre professional(HCP) was not aware what amount of vaccine entered patient's body which led to accidental underdose. The vaccine spilled out on patient which led to inadvertent exposure to vaccine and exposure via skin contact. The patient also experienced the same adverse effects after dose 2 but they resolved quicker within 24 hours. The reporter consented to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020240927:Same reporter. Case for dose 1
Information has been received from a registered pharmacist concerning a 67 year old female patient with hypertension, hypercholesterolemia and no drug allergy who was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) in the arm on 02-APR-2009. Concomitant therapy included LIPITOR and  lisinopril (manufacturer unknown). At night on 06-APR-2009, the patient developed one blotchy spot that was the shape of a spread out wing right above the chest. The spot resolved by the noon of the next day (07-APR-2009). Lab test was not performed. The patient spoke to unspecified health professional at the same practice for medical attention. Additional information has been requested.
7/21/21 - ANGIOEDEMA, INIT -  12/30/21  - HYPOXIA -
she was on chemo and is immunocompromised that they don't think she has had enough of an immune response to the vaccine.; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EN6202) as dose 1, single, then via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: ER8733) as dose 2, single for covid-19 immunisation. Medical history included ongoing stage 4 cancer and was taking chemotherapy.  The patient's concomitant medications were not reported. Patient had stage 4 cancer and was taking chemotherapy at the time she received both doses. Her primary care physician and oncologist both said that she should get the booster dose and she has called the health department and her local hospital to get more information regarding being able to receive a third dose. The patient's doctors are concerned that since she was on chemo and was immunocompromised that they don't think she has had enough of an immune response to the vaccine on an unspecified date in 2021. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Covid test result: Positive; Covid test result: Positive; body rash; shortness of breath; This is a spontaneous report received from a contactable reporter Other HCP (Nurse) from product quality group. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Jan2021 (Lot number: EL0142) at the age of 48 years as dose 2, single and administered in arm right, administration date 26Dec2020 (Lot number: EL1284) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies: Penicillin" (unspecified if ongoing). There was no covid prior vaccination. Concomitant medication(s) included: TYLENOL; BENADRYL in two weeks. There was no other vaccine in four weeks. Past drug history included: Carrot, reaction(s): "Allergy"; Morphine, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Oct2021, outcome "unknown" and all described as "Covid test result: Positive"; RASH (non-serious) with onset 16Jan2021, outcome "unknown", described as "body rash"; DYSPNOEA (non-serious) with onset 16Jan2021, outcome "unknown", described as "shortness of breath". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Oct2021) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, rash, dyspnoea. Clinical course: full body red rash with slight shortness of breath on first dose when he got the 2nd dose a month later he took 1000mg tyl and 50 mg Benadryl 1 hour prior to vaccine and still ended up with body rash and shortness of breath. both time this was with in less then 5 minutes of getting the Pfizer vaccine. Facility type vaccine was reported as in Hospital.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: (Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
From initial information received on 17/Jun/2005 from a physician, it was reported that a 22-year-old male patient received a dose DECAVAC, lot number U1563BA, administered intra-muscular in the left deltoid on 15/Jun/2005. The next day at 12:00pm, the patient developed injection site pain, joint pain, tight muscles, the jitters, warm flushes, cold hands, cramping and muscle twitching in his abdomen. The patient was seen by a physician who prescribed Valium. The patient's recovery status is listed as unknown. Follow-up information received on 11-July-2005. The patient was fully vaccinated as a child (last dose at age 4). The patient experienced cramping of the finger and hand flexors. He experienced muscle twitching - especially of the abdominal flexors. He had spontaneous remission of symptoms within approximately 18 hours. The case is closed.
Symptoms began two weeks after flu vaccine. Sudden onset sensory deficit with ascending weakness and numbness bilaterally from feet to knees. 2 episodes of syncope that morning as well. Admitted to Medical Center. CSF culture on 12/4 showed high protein count (micro-total protein = 67 mg/dL). On 12/5 was diagnosed with Guillain-Barre Syndrome by neurology physician at Medical Center. IVIG was started for treatment of Guillain-Barre Syndrome.
Patient at first fine, then complained of feeling light headed. After a few minutes head became wobbly. Eyes, became dilated, hands became very cold. Seemed to be going in and out of conciousness. Patient also became very pale. Speech became very quiet also. Checked blood pressure and was very low. Initial reading was 70/47. Then on second reading 77/58. Third reading 86/59, Final reading 91/67. Readings done over a 15 minute period. Did use ammonium salts to wake up patient. EMs was called at start of reaction. On arriving patient was looking better. She did get checked over by EMS and they cleared her.
Client called 7/24 as he had received 4 dose treatment and client c/o of nausea, "feeling achy like the flu", lightheadedness about 24 hr after 7/6 vaccination - 24 hr later client stated and symptoms a24 hr after 7/10 and 7/17 (nausea and flu like achy ness")
Information has been received from a healthcare worker (also an office manager) referring to unspecified patients of unknown age and gender. There was not medical history or concurrent condition reported. On unknown dates the unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (therapy type, dosage, strength, lot# and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reported received from the same reporter. Additional information has been requested.
45 Minutes after injection, patient experienced chest pain, and felt cool and clammy.  This lasted for about 3 hours.
I had my first Covid vaccine (Pfizer - Lot ER2613) on March 17.  No issues other than a soar arm the next day.  In fact, I went on a hard 7 mile run the next day as part of my normal training routine (currently training for a half Marathon.)  This past Thursday, April 8, at 6:00 pm EST, I had my 2nd shot (Lot EW0161).  For about the next 18 hours, I was fine other than the arm being a little sore in the morning. Late in the morning I noticed my back was getting very stiff and a bit sore when I moved around.  I have a desk job and spend a lot of time in front of the computer, but I normally stretch and move throughout most days, so I don?t have many back issues.  This was a bit worse than normal.  Usually, when I feel something like this, my go to remedy is an easy run.  I had a 5 mile easy run planned for that day, so later in the afternoon, after some dynamic stretching, I went for a run.  As I started, I felt some of the worse back pain I could remember and stopped running after about 50 yards.  I stretched a little more, questioning if I should continue, but decided that movement would be better than doing nothing.  I started running again and although the first mile was much more uncomfortable and painful than normal, I continued on for the 5 miles with everything eventually loosening up as the blood starting flowing.  I felt pretty good the rest of the day and into the evening.  In the middle of the night, I awoke numerous times with a bad ache in my back, which is very unusual for me. I tossed and turned all night from side to side, from front to back but could not stop the burn and pain in my lower back.  I took 2 Advil, but that did little to help.  I got out of bed about an hour earlier than normal and after a little light stretching, my back felt fine again.  I went for my weekly long 14 mile run an hour later and everything was good again and for the rest of the day.  The next 3 days / nights have been similar.  I continue waking each night with a burning and aching in my lower back and it continues all night long.  Once I stand up, get out of bed and start moving around, the pain and burning go away almost immediately.  I?ve never felt anything like this before.  I?m 57, male, am very healthy and fit (aiming for a 1:30 half marathon in 10 days.)  Never had issues with sleeping before this and haven?t experienced any back pain in a very long time.  I can?t think of anything I?ve done recently to trigger this other than the coincidence of the 2nd Pfizer vaccine shot.
Patient reports after she received the vaccine she reported to the observation area for the 30 minute monitoring period and reported feeling her heart racing.  Patient with hx of histamine intolerance and angioedema, so carries epi pen with her.  Patient notified monitors of her symptoms and her medical hx and that she had her epi pen with her.   Patient reports ?heart racing? and recorded 130 BPM on activity tracker.  Pt endorses history of anxiety and panic attacks.  Patient reports resolution of symptoms at approximately 8:15 am, resting HR at that time 97-98 BPM.  Patient denies any other symptoms.
This spontaneous report was received from a nurse and refers to a 71-year-old male patient. There was no information about the patient concurrent conditions, concomitant therapies or medical history provided. On 24-FEB-2017, the patient was inadvertently vaccinated with an expired single dose of PNEUMOVAX23 injection (lot # L024132 with an expiration date of 21-JAN-2017) intramuscularly for prophylaxis (anatomical location was not reported). There was no adverse effect reported. There was no product quality complaint involved. Additional information is not expected because there was consent to contact with the reporter.
12 hours post-injection recipient developed a low-grade fever, body aches, and headache that lasted about 24 hours.
Extreme arm soreness; Chills; Fever; Headache; It felt like he got the flu; This is a spontaneous report from a non-contactable pharmacist (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), via an unspecified route of administration in left arm, on 12Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior to vaccination). There were no concomitant medications. No other vaccine was administered in four weeks. The facility where the vaccine was administered was in a nursing home or senior living facility. On 12Jan2021 at 10 PM, the patient had extreme arm soreness that did not go away with ibuprofen or paracetamol (TYLENOL). The patient had chills and a fever the night he got the injection. The patient also had a headache for 2 days after the injection (Jan2021). It felt like he got the flu in Jan2021. Post vaccination on 12Jan2021, the patient underwent COVID-19 nasal swab and PCR tests that was negative. Therapeutic measures were taken as a result of "Extreme arm soreness" including ibuprofen and paracetamol; no treatment was administered for the other events. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Consent form was reviewed with patient. Patient stated that he was receiving his first Janssen vaccine. Patient was seated in the chair. I went over the possible side effects he might experienced and handed a VIS form to the patient. Patient was given the immunization in the left arm. Patient felt lightheaded and lost consciousness for a brief moment (15-30 seconds). I asked him if he had trouble breathing and he shook his head "no". Patient demonstrated tremor, with possible seizure. EMS was called per protocol and emergency kit was available if necessary. I asked the mother regarding prior episodes. She stated that the patient has passed out when blood was drawn. This is possible vasovagal response. EMS arrived to take over the situation. I gave my statement to EMS. I assessed the patient and he stated he was fine. I made him wait for additional 15 minutes to monitor any reaction. I referred them to the nearest hospital if any complications should arise.
Initial report received from a healthcare professional on 01 October 2013. The patient over 65-years-old received FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
41 years of very regular menstrual cycles (5 bleeding days every 29 days) -- no signs of perimenopause.   First period after the first vaccine was delayed, and then was 28 days of bleeding (received the second the shot during this time).  11 days later I had another period with four days of bleeding that were heavy enough that my husband encouraged me to call the doctor (clots the size of golf balls).  Since then (48 days and counting) no period.
have irregular menstruations; This is a spontaneous report received from contactable reporter (Physician) from a sales representative. A 12-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, 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, single; lot number: unknown), for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "have irregular menstruations". Description of Event: After second dose, the patient began to have irregular menstruations and after 1 year the problem continues. No other doses were administered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/07/21Lot#EL3248 2nd dose 01/28/21,lot#EN5318 Diagnosed covid positive:08/12/21 Symptom onset:08/10/21 Exposure: Symptoms:Muscle aches,cough,runny nose.
Erythema, itching, raised circular area 6 cm in diameter, warm to touch.
Dose administered from a vial that was more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021 at 2:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021 at 3:26 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge). On 20-Sep-2021, PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2021-326226, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow-up was  received on 23-SEP-2021 and contains initials, race, ethinicity and vaccination facility details added.
SOB with chest tightness and syncope episode with loss of consciousness. c/o elephant sitting on the chest. O2 92%, BP 160/ 90, AED no shock advised. EMS arrived and transported to ED
Extreme vertigo, unable to focus vision, unable to walk upright for any distance. Accompanied by headache and general body pain. Vertigo still present on 10/12/2014 but lessened.
Shot given too high in the shoulder causing pain for 2 days. Shoulder still experiencing pain, but not intense. So condition improving. SIRVA event.  Pt went to emergency room because she could not get into car with her walker and drive - she called the squad because she could not get seen anyother way.
Tactile and auditory hallucinations, just at bedtime.  Have recurred several nights now.  Not sure if related to her depression or vaccine. No other signs/symptoms of encephalitis.
2 hr p/vax pt presents to clinic w/soft edema to upper lip & eyelids; no resp distress, no local rxn @ inj site; referred to MD; tx DPH