chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Couldn't move arm correctly/Hurts; Inflammation under the armpit; Warm; Pain; joint pain; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), FATIGUE (Fatigue), ARTHRALGIA (joint pain), PYREXIA (Fever) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEUCOVORIN CALCIUM for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 06-Mar-2021, the patient experienced FATIGUE (Fatigue). On 05-Apr-2021, the patient experienced PAIN (Pain), ARTHRALGIA (joint pain), PYREXIA (Fever) and CHILLS (Chills). On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Couldn't move arm correctly/Hurts), VACCINATION SITE INFLAMMATION (Inflammation under the armpit) and VACCINATION SITE WARMTH (Warm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), FATIGUE (Fatigue), ARTHRALGIA (joint pain), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PAIN (Couldn't move arm correctly/Hurts), VACCINATION SITE INFLAMMATION (Inflammation under the armpit) and VACCINATION SITE WARMTH (Warm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
slight bruise; Regained her sense of equilibrium that was lost 4 years ago; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION and CONTUSION in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FEELING OF RELAXATION. On an unknown date, the patient experienced CONTUSION. At the time of the report, FEELING OF RELAXATION outcome was unknown and CONTUSION had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-JUN-2021. TCR form attached. New event was added.
Several days after receiving the 2nd Moderna vaccine for COVID 19, I began have pain in all the joints in my hands, shoulder.  Unable to use my hands due to excruciating pain.  The pain began  3-4 days after the 2nd shot, starting in 2 of my fingers and progressively moved to all the joints in all of my fingers, wrists and my shoulders.  In addition there is swelling. I have very little use of my hands, requiring assistance to care for myself.  I have never had joint pain in my hands before.  The pain has continued for 2 weeks non-stop.  At the doctors recommendation I have been taking Tylenol for Arthritis, however this does not alleviate the pain, only reduces some of the discomfort.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 30 year-old male patient. On 09-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
The patient was inadvertently administered a dose of VARIVAX, that had been improperly stored; No adverse effect reported; This spontaneous report was received from a physician assistant, referring to a patient of unknown age and gender. There was no information provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies.   On 19-MAY-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous, lot # R023513, expiration date on 16-AUG-2020 (dose and anatomical localization were not reported). The physician assistant reported that the patient was inadvertently administered a dose of with varicella virus vaccine live (Oka/Merck) (VARIVAX), that had been improperly stored. The lot of with varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored DILUENT MRK (unknown Lot# and expiration date). No adverse effect reported.  On unspecified dates, the doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent temperature excursions of -9 °C to 8 °C (1.7 °C)  for a time frame of 4 hours, which was called by the digital data logger. There were no previous temperature excursions reported.; Sender's Comments:  US-009507513-1906USA000538: US-009507513-1906USA000539:
people is getting very sick with the Covid vaccines; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (people is getting very sick with the Covid vaccines) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (people is getting very sick with the Covid vaccines). At the time of the report, ILLNESS (people is getting very sick with the Covid vaccines) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.  Caller mentioned that people were getting very sick with the Covid vaccines. She said that her daughter told her that someone from a pharmacy told her that they are getting lots of reports that people are getting very sick after vaccination. Caller could not confirm if this was specific form the Moderna vaccine.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to cases 2018SA292284, 2018SA292283 and 2018SA292285. This case involves a 57-year-old female patient who was vaccinated with a dose of USP FLUZONE HIGH DOSE lot UJ038AA via intramuscular route in the left deltoid on 18-Oct-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given at the time. It was an actual medication error due to Inappropriate age at vaccine administration and accidental overdose. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient stated that she received HD FLUZONE in L arm the afternoon of 10/25/18. She also received a PNEUMOVAX vaccine in the R arm at this time. The evening of 10/25 her L arm started to swell around the injection site and was described as a "tennis ball" like swelling that was warm to touch and sore, but not painful to touch. She stated that the next morning of 10/26 she noticed a rash around the injection site and the swelling and rash began to move to the inside of her arm. She stated she iced her arm, put hydrocortisone on the rash, and took ibuprofen for swelling. She called today (10/27) to report reaction and stated that the swelling and rash had since subsided substantially.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves female patient (36-37 year old ) who experienced allergic reaction while he  received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2014, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Exp. Date not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient has a documented egg allergy reported. Details of lab data not provided. Final diagnosis was allergic reaction. No information about corrective treatment reported. The event outcome was unknown. List of documents held by sender: none.
Patient is a 76 y.o. male patient of Provider Not in System with history of HTN, CKD, OSA, hearing loss who presented to the ED with COVID pneumonia. He improved with supportive care and one dose of IV lasix with increase of his losartan. He was discharged back to his group home on 1/2.    Covid-19 Virus Infection Date of onset of symptoms: 12/30 Symptoms present on admission: short of breath Date of covid positive test: 12/30 Vaccination status: vaccinated Imaging: CXR bibasilar opacities Oxygen requirements on admission: 87% RA > 95% 3L Current oxygen requirements: 95% RA Medical therapy: not indicated; CrCl too low for paxlovid Consultants following: None Anticipated special isolation end date: 1/10   Hypertension, uncontrolled BP up to 210/103 on arrival Home regimen: coreg 25mg BID, nifedipine 90mg BID, losartan 25mg daily,spironolactone 25mg daily, lasix 40mg daily Continue home regimen but increased Losartan 50 mg    Peripheral edema -- improved 1+ edema to lower shins, POC BNP 444, lab BNP pend Per case manager, usually does not have any edema Likely 2/2 CKD, no other e/o CHF S/p IV Lasix x 1 Continue home PO lasix and aldactone   Chronic kidney disease stage 4 Baseline Cr appears to be around 3.0 Follows with CNP Cr. 2.48 on admission Follow after IV lasix dose, stable at 2.58 Continue home Bicarb and Lokelma 3x/wk   Dysuria New complaint 1/2 UA pending If concerning for infection, will start Keflex and send urine Cx   Developmental disability Hard of hearing Schizophrenia Bipolar disoder Has 24 hr home health care and case worker Receptive language via lip reading limited by mask, reading ability appears limited Continue home medication
Throat swelling caused choking when attempt to swallow. Food was lodged in tbroat and choking occurred for appx one minute before food was  dislodged preventing severe circumstance
facial swelling, generalized body rash, feeling of sore throat. Epinephrine and Benadryl.
pt recv vax 4MAY98 & had T103.9 that noc;it was controlled w/APAP & cool shower;had soreness in lt arm;
Starting on the day of the vaccine 1st dose,  just a sore arm.  3 days after the vaccine, I got dizzy, tachycardia and my blood pressure was very high around and starting racing.  I was put on blood pressure medication metoprolol.  I took the medication for a week and I now take it if needed.  I have also noticed an adverse reaction  after the vaccine everytime I drink or consume alcohol, I get elevated blood pressure, palpitation and sweats.    I  also had the same adverse reaction with the 2nd dose vaccine ( lot # 006M20A  IM Right Arm).
extreme side effects from 2nd Shingrix shot - complete exhaustion with shivers and chills; headaches with twitching/piercing pain in neck; and worse of all terrible muscle pain in back muscles that would not allow me to roll over in bed or get out of bed. Not exaggerating to say it took at least 30 minutes to get out of bed moving a faction of an inch to try to roll over and get in position to get up from bed. I was so cold that I turned up the house heat and took long naps under the electric blanket. Problem started the day after receiving the injection (2 22 2020 and continued til today (Sunday 2 23 2020)
I feel that thought this all started after the first dose. I felt a loss of stamina and strength. The 3rd dose, I noticed all the symptoms I had got worse more quickly. The progression of symptoms seemed to escalate and increase in severity over time. They symptoms that I'm talking about are losing words, generalized pain which includes aching and sharp shooting pain in the limbs, weakness, incoordination, mild ataxia, wooziness bordering on vertigo, headaches, decrease fine motor skills of my hands, forgetfulness. This prompted me to get thoroughly evaluated. I've been seen multiple times by my primary, neurology, and a spine specialist. I've had all kinds of lab work and imaging studies. The labs have been normal. I had a MRI of my brain and MRI of my neck and lower back. There were changes in the neck and lower back that would account for some of my symptoms, but not all of them. I had steroid injections in neck to see if it would help. All I can say is that I feel as though since I received the vaccine, things have precipitously gotten worse. The tinnitus got really bad. too.
A day after I received my second Pfizer shot, I experienced loud tinnitus in both ears.  A month later, I went to an ENT for a hearing test and an exam. He did not find anything to cause it and recommended that see a neurologist. The neurologist sent me for MRIs of my ears, my head, and my brain. She did not find any cause of the tinnitus.  Now, five months later, the tinnitus is still deafening and debilitating. I believe it was caused by my second  shot.
Telephone call for patient on 11/01/2004, complaints of hives and small rashes all over body; injection site when yellow fever was given "has a huge swelling about 3 inches wide." Advised to call PCP for follow up. Telephone call to patient today. She was advised to take Benadryl for itch which she hasn't taken any. She felt fine.
devel swelling under skin p/vax (later in day) that has persisted;pt recv vax 30MAR98;area sl tender;no redness, no inc warmth;denies fever, chills;advised warm soaks, advil PCN;pt to return to clinic if inc size, inc warmth fever or rednes
Fever 99.6, body aches, headache, cold chills, hot flashes
pt recvd vax & ache all over esp down spine; site enlarged 3" in diam red & hard & warm; pt felt immediate pain w/ sensation of vax mvt through arm;
10/13/04 Employee received influenza vaccine. 10/14/04 she reported to me 8AM on 10/14. Sx itching, whelps, raised red areas over body including scalp. Escorted to ER. Solumedrol injection and Benadryl injection sent home with Rx for Zyrtec.
15 minutes after the 2nd dose was given, my left hand was tingly like it had fallen asleep.  By the time I got to my car, maybe 5 minutes, it was back to normal.  It continues to do this randomly for about 5 minutes or so before it stops.  It's only ever my left hand. It doesn't hurt but it's random and continues to happen.  I didn't think anything of it until my husband had his second shot on 4/19 and his hand did the same thing on the evening of 4/20.
hands and feet are beet red; hands and feet are swollen; not been able to sleep; severe sunburn that is very very painful and feels like she is on fire; severe sunburn that is very very painful and feels like she is on fire; severe sunburn that is very very painful and feels like she is on fire; rash hot and burning; big red rash on back that spread over entire body / rash on the back/ rash all over from stomach to legs/rash on arms/rash on chest; extremely exhausted; nervous; pain at the injection site; red at injection site; chills; shakiness /feels like has the shakes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (hands and feet are beet red), PERIPHERAL SWELLING (hands and feet are swollen), INSOMNIA (not been able to sleep), PAIN OF SKIN (severe sunburn that is very very painful and feels like she is on fire) and SUNBURN (severe sunburn that is very very painful and feels like she is on fire) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at injection site). On an unknown date, the patient experienced ERYTHEMA (hands and feet are beet red), PERIPHERAL SWELLING (hands and feet are swollen), INSOMNIA (not been able to sleep), PAIN OF SKIN (severe sunburn that is very very painful and feels like she is on fire), SUNBURN (severe sunburn that is very very painful and feels like she is on fire) and SKIN BURNING SENSATION (severe sunburn that is very very painful and feels like she is on fire). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Adverse event, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (hands and feet are beet red), PERIPHERAL SWELLING (hands and feet are swollen), INSOMNIA (not been able to sleep), PAIN OF SKIN (severe sunburn that is very very painful and feels like she is on fire), SUNBURN (severe sunburn that is very very painful and feels like she is on fire), SKIN BURNING SENSATION (severe sunburn that is very very painful and feels like she is on fire) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: No specific follow-up information recorded.
Redness to injection site.  Swollen lymph node to the armpit of injected extremity.  Tender to the touch.  Mother of patient instructed to give patient benadryl and tylenol as needed.  Also instructed to make an appointment to see a provider if symptoms persist or get worse.
Confusion on room location and got pretty angry with redirection, which is not normal for her.  She was noted to have hallucinations last night, had a fall out of bed and stated she was trying to lift her mattress up.
Vaccines given @ pharmacy on 10/20/21. She was seen in the doctors office on 10/28/21 for SOB. She had testing and was admitted for bilatera PE
From mailed correspondence received at manufacturer from a research group on 3/4/02, it was reported that a male PT received Ipol vax on 6/28/01. PT developed fever, redness and swelling at the inject site. These events required unspecified treatment in the ER. PT recovered.
Initial misuse report received from a healthcare professional on 30 October 2013 and the case was received on 21 March 2014. A 8-year-old patient (gender was not provided) had received a dose of FLUZONE on an unspecified date. It was reported that the FLUZONE was projected out of the site immediately on administration to a child. No adverse event was reported. List of documents held by sender: none.
Patient was given a bivalent booster dose instead of the monovalent Pfizer for primary series completion.  No adverse reactions noted.
developed shingles on the same arm; nerve pain that lasted several weeks; This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles and nerve pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the nerve pain was recovered/resolved.   It was unknown if the reporter considered the shingles and nerve pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. A nurse reported that the patient received dose of shingrix and after 1 week after experienced shingles on the same arm. The patient also experienced nerve pain that lasted several weeks. She had never had shingles prior to receiving the vaccine. She was unsure if this reaction was related to receiving her first dose of Shingrix.
Developed Headache that progressivly got worse with facial pain.  10/30/09 Medical records received DOS 10/28/09.  HA x4  days radiating to right eye, face  and teeth. Whistling in R ear.  Nausea when severe. Neuro exam WNL except for slight speech articulation, improved with repetition. Brain  MRI  abnormal.  Subdural hemorrhage with subarachnoid hemorrhage and intracerebral hemorrhage, , cephalgia, hypertension.  Grand mal seizure witnessed after admit.
About a month after the second dose I started to have extreme dry mouth, frequent urination which last about a month. I lost about 20 lbs. in that month. I made a doctors appointment on 04/02/2021 and I had some bloodwork and urinalysis done. The next day I went to the emergency room. After about I week and a half I received my results and it showed I had type 1 diabetes. I have no family history of diabetes or autoimmune conditions.
Fever, pain, hardness and fever at injection site. Pretty severe body and muscle aches.  Upset stomach and lack of appetite.  Pretty bad headache mainly in my forehead.   All but the pain and soreness at the inject.ion site subsided by the next day  Arm is still tender today.  Only had mild tenderness with the first shot similar to a regular flu shot.
I was in the store right after my vaccine dose and the lights seemed like they were dimming, then really bright, so I asked an employee and she said no that they were not doing anything with the lights, and saw her face was swollen. She went to the pharmacy at the store and got Benadryl, Tongue was swollen also by the time they got the to ER and the ER gave her Kalkenalong-40 for the swelling. I woke up at 2am the next morning and my feet and palms were so itchy, and took more Benadryl. The next day, I did not have any more reactions, and the swelling had gone down. The ER prescribed prednisone, but I didn't take it.
Fever and covid arm  for five day post second covid vaccine. Started the day after vaccine. Two weeks later developed a rash at the injection site that lasted a week
Patient complained of feeling dizzy and blurred vision, headache and eyes hurting. Denies any c/o nausea.  BP 114/64  HR= 99 O2 Sat= 99% Patient/mom verbalized that she had a half of subway sandwich prior to her vaccination. Placed patient in supine position, took vital signs and instructed to remove her jacket since the observation area was warm. Gave her cold drinks, bar of candy and Tylenol 500 mg  1 tablet for headache. Continued to monitor patient then 30 minutes later RN walked her on the hallway. Still a little wobbly . Instructed to take some deep breaths. Mom did mention that her menstrual period is almost due. 10 minutes later she claims she is doing better but still  have mild headache and sleepy.  Discharged home with her mom and was instructed RN will follow up on her. Instructed if headache persists and start having dizziness to go to ER.