chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm was sore at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (left arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (left arm was sore at the injection site) outcome was unknown.            concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-060917 (Patient Link).
radiating pain and tingling in the same arm; radiating pain and tingling in the same arm; This spontaneous report as received from an Office manager refers to a 40-year-old female patient. The patient's concurrent condition included immune system depressed due to kidney transplant, lupus (Lupus erythematosus) and pertinent medical history included kidney transplant. The had drug allergies to Sulfa, Mesna.  On 08-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S013490, expiry date: 06-MAR-2021 strength, dosage information and anatomical locations were unknown) intramuscular for prophylaxis.         On 09-AUG-2019, the patient experienced radiating pain and tingling in the same arm (paraesthesia)  rash, and pain.  The patient was advised to administer cold packs to site of discomfort and take Tylenol (Acetaminophen) as needed for pain. No additional information provided. No product quality complaint (PQC). The outcome of paraesthesia, rash and pain was reported as recovered/resolved. Causality was not reported.
Rash on right side of face lasting 1 day. Pt was treated with oral Benadryl on 5/13/02 and rash disappeared 24 hours later.
still feels a little bit hard to breathe; slight heaviness in my chest; numbness in my knuckle; can feel aching pain and numbness in my knuckle; joints were so stiff; about 45 minutes to an hour later, chest started tightening up/ felt like lungs were turning to concrete/ sensation of hardening; right hand joints were swollen; painful fingers; totally exhausted; injection site was very very hard on my right arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (about 45 minutes to an hour later, chest started tightening up/ felt like lungs were turning to concrete/ sensation of hardening), JOINT SWELLING (right hand joints were swollen), JOINT STIFFNESS (joints were so stiff), DYSPNOEA (still feels a little bit hard to breathe) and CHEST DISCOMFORT (slight heaviness in my chest) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arteriosclerosis.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced CHEST DISCOMFORT (about 45 minutes to an hour later, chest started tightening up/ felt like lungs were turning to concrete/ sensation of hardening), JOINT SWELLING (right hand joints were swollen), PAIN IN EXTREMITY (painful fingers), FATIGUE (totally exhausted) and INJECTION SITE INDURATION (injection site was very very hard on my right arm). On 05-Oct-2021, the patient experienced JOINT STIFFNESS (joints were so stiff). On 06-Oct-2021, the patient experienced DYSPNOEA (still feels a little bit hard to breathe), CHEST DISCOMFORT (slight heaviness in my chest), HYPOAESTHESIA (numbness in my knuckle) and ARTHRALGIA (can feel aching pain and numbness in my knuckle). At the time of the report, CHEST DISCOMFORT (about 45 minutes to an hour later, chest started tightening up/ felt like lungs were turning to concrete/ sensation of hardening), JOINT SWELLING (right hand joints were swollen), JOINT STIFFNESS (joints were so stiff), DYSPNOEA (still feels a little bit hard to breathe), CHEST DISCOMFORT (slight heaviness in my chest), HYPOAESTHESIA (numbness in my knuckle), PAIN IN EXTREMITY (painful fingers), FATIGUE (totally exhausted), INJECTION SITE INDURATION (injection site was very very hard on my right arm) and ARTHRALGIA (can feel aching pain and numbness in my knuckle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Cardiac Lab values (ECG, cardiac test, cardiac enzymes): none No history of myocarditis or pericardtis  No concomitant medications reported. No treatment information was provided.
She has arthritis in her hand and yesterday she hit her in the kitchen and have a lot of pain; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's Wife). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 29Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing arthritis in hand. Concomitant medications for patient were not reported. The reporter reported for his wife that she had shot on 29Jan2021, first shot. It was reported that she has arthritis in her hand and yesterday she hit her in the kitchen and have a lot of pain, on an unspecified date. And she wanted to know could she take Tylenol 500mg for that. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Swollen area left arm 5" diameter. Blisters itching, redness.  No bleeding. Treatment-Z Pack, Medrol dose pack
The patient was on hospice with Hospice care for Cirrhosis of the Liver.  The patient tested positive for Covid/-19 on 08/12/2021 at Healthcare and was diagnosed with Covid PNA and hypoxia.  The patient was transferred to Hospice care.  The patient expired on 8/18/2021.
nausea; her daughter has the same tightness; very irritated yesterday; it was not tangible like a rash; This is a spontaneous report from a contactable consumer. This consumer (patient Mother) reported for a female patient. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. Consumer reported that, on an unspecified date, her daughter has the same tightness and was okay, she does not indicate that she had the akathisia - but she had it too with the same drugs. Caller adds she had not talked to her today, which she needs to. Her daughter got very, very irritated yesterday. She had to take her daughter's son who was 2. Her daughter was like okay mom I noticed I am getting uptight and this thing they get, it was not tangible like a rash. There are no symptoms on the body, like okay, it was more of a mental reaction if you want to rip an IV out or move weird to get out of a room, moving weird. Caller clarifies that this was something bother and her daughter get. Reglan was when it happens to caller. They do not have antipsychotics, they take nausea that they have with it and are also given Phenergan with that. Her daughter gets very, very irritated with the same things like that, she has the same thing that happens with the drugs that do that. It was certain antibiotics that do this. She noticed yesterday that her daughter was the same way, hostile. Caller adds that her daughter was the same way, hostile. It was weird in the hospital, they are pacing and talking like how she was talking now. They have to get stuff in the IV that calms them down. If they make a mistake or have a reaction, they tell us where they can see it, moving feet on the bed, and they have to give them something to use. Genetically, they have the same reaction. The outcome of the events was unknown.  Information on Lot/Batch information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/14/21 2nd dose02/05/21 Diagnosed covid positive:09/08/21 Symptom onset:09/08/21 Exposure:community Symptoms:sob,loss of smell,runnynose
3 minutes after receiving her first Moderna covid-19 vaccination in her left arm, she got hot and felt like she was going to throw up. She never did actually throw up and within 5 minutes all symptoms resolved on their own without any intervention. She denied any chest pain, shortness of breath, difficulty swallowing, lip or tongue swelling, and itching/hives.
Information has been received from a physician concerning a 9-week-old patient with no medical history or allergies who on 06-SEP-2007 was vaccinated PO with a dose of ROTATEQ. There was no concomitant therapy. The physician reported that on 06-SEP-2007, about 20 seconds after being vaccinated, the patient regurgitated. The patient was examined in the physician's office. No laboratory/diagnostic tests were performed. The patient did not require treatment and fully recovered on that same day. No further information is available.
patient presented to ED with chief complaint of facial/tongue swelling. pt reports she had swollen glands left side of throat which has shrunk "externally but now internally having problems with my tongue since yesterday". denies any trouble breathing of swallowing. but has swelling feeling increased in size. took 2 Benadryl 1 hour ago and ProAir inhaler. patient admitted to observation status with diagnosis of allergic rxn to covid vaccine and submandibular gland swelling.
Joint pain in fingers and toes.  2 days later, it was better except for 2 fingers. (Left thumb and left ring finger). Now after 2 months, both fingers still have pain and limited mobility. (Can not make a closed fist)
approx 10mins p/vax pt devel erythematous rash on the face & upper chest;no acute distress but somewhat tachycardia 160/min; took to ER & treated w/solumedrol & DPH;
Onset of "shakiness" and facial flushing, generalized "hot" feeling which persisted all day. Went to sleep @ 5 pm day of vaccination, slept all night, then woke with symptoms resolved @ 8:48 am next morning. VS at clinic when reported symptoms at 2:55 pm on day of vaccination were: T (O) 97.9, BP 147/86, P 70. No other c/o, no s/sx anaphylaxis.
Noticed red bumps on neck shoulder area and left lower leg. Reported to facility on Wed 17 Nov for initial evaluation. Patient asked to return today, 18 Nov. Red bumps seem to have gone away except for lower leg bump. Photo taken. Patient seen by Flight Surgeon.
0940 7/30/22  Patient was unresponsive, blue across bilateral upper eyes with back slightly arched. A cool compression was applied across the patient's forehead and chest. After applying cool compression  patient became responsive to name and touch stimuli.  administrated EpiPen 0.3mg in upper right thigh at 0942. Vital signs obtained patient legs elevated and more cool compression was applied as transport arrived.  Report was given to ER Provider . Patient was taken to the ER via wheelchair with his mother holding him in her lap patient was alert and orited x3.
This spontaneous report was received from a medical assistant and refers to an unspecified number patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. No adverse reactions were reported. On an unknown dates, the unspecified patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M034195, expiration date 14-MAR-2019 for prophylaxis (strength, dose, route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004019: US-009507513-1701USA005954: US-009507513-1701USA005955: US-009507513-1701USA005956.
Sweats; chills; headache; kidney pain; difficulty taking deep breaths; pain in eyes when looking to the side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 10:45 (Lot number: FF2588) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 21Aug2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "Sweats"; CHILLS (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "chills"; HEADACHE (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "headache"; RENAL PAIN (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "kidney pain"; DYSPNOEA (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "difficulty taking deep breaths"; EYE PAIN (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "pain in eyes when looking to the side". Therapeutic measures were not taken as a result of hyperhidrosis, chills, headache, renal pain, dyspnoea, eye pain.  Additional information: Facility type for Vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No Covid prior vaccination. Did not test for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to cases 2018SA269762, 2018SA274520, 2018SA274507, 2018SA274523, 2018SA274521, 2018SA274519, 2018SA274522 and 2018SA274524. (Same reporter). This case involves a 72 years old female patient who received vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 15-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due incorrect product storage. It was reported that vaccine shipment took 3 days and doses were not viable from shipping excursion, doses were given to nine patients. It was not reported that if any adverse event occurred or not. 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.
I noticed a small nodule under my left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NODULE (non-serious) with onset Apr2021, outcome "unknown", described as "I noticed a small nodule under my left arm". The event "i noticed a small nodule under my left arm" was evaluated at the physician office visit. No follow-up attempts are possible. No further information is expected.
Vaccines administered ( DTaP, IPV,MMR) in late AM. Parents called approximately 2-2 1/2 hours later reporting child developing red, raised spots all over, difficultly breathing, "almost passing out". Ambulance called for transport to ER. ER TX with Benadryl IM and steroid PO and pt recovered completely. DX: hives.
Approximately two weeks after I received the COVID vaccine I started to experience symptoms that could best be described as a combination of hypoxia, brain fog, nausea and light headedness.  At first I attributed it to the ongoing chronic stress brought about by the pandemic, but the symptoms persisted for several weeks and got worse.  It came to a point where I thought that flying and exercising the privileges of my First Class medical while experiencing these symptoms would come into question.  I reached out to my doctor the third week of October and scheduled a checkup.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced headache, myalgia, shivering, stomach pain, injection site pain and fever. On an unknown date, the outcome of the headache, myalgia, shivering, stomach pain, injection site pain and fever were recovered/resolved.  It was unknown if the reporter considered the headache, myalgia, shivering, stomach pain, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced myalgia, headache, shivering, light fever, bad stomachache and stomach cramps. The symptoms lasted through the night before resolving. The patient also had soreness at the injection site for a couple days. The reporter consented to follow up.
Usual fever, fatigue, aches hit after 24 hour mark and then by  30 hour mark, chest pain, racing heart , brain fog (trouble  problem solving clearly).
It started out with coughing and congestion. She felt really bad and she got diarrhea. She had felt bad for a couple of days before I took her to the hospital. They didn't diagnose her with COVID-19 at first. They didn't test her. I also started feeling bad around the same time and I was tested by my doctor and I was positive. I called the hospital I took her to and I told them I was positive and they said to bring her back. She was tested for COVID-19 and she was positive. They did not give her any treatment for it because she had COVID-19 for too long. Her symptoms went away over time. She felt okay, but the coughing and congestion lingered the most and she stayed in quarantine for 10 days. We did also have headaches off and on.
Pt developed R arm rash concerning for herpes simplex vs herpes zoster, culture pending.
Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; night sweats; under left armpit tenderness; enlarged swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM6201), via an unspecified route of administration at arm left on 05Mar2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. Medical history included heart bypass.  The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 79-years-old, via an unspecified route of administration at arm left on 12Feb2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. The patient experienced cellulitis and red hot swelling upper arm and lower arm, also night sweats, under left armpit tenderness and enlarged swollen lymph nodes, all on 12Mar2021 10:00 pm. Treatment with prescription of Bactrim DS 2x daily 160 mg & Tylenol. Events outcome was recovering. No covid prior vaccination. No covid tested post vaccination.
After getting 2nd DTP shot on 9/30/97 pt started behaving different. He stopped looking at me and avoided my gaze, started screeching instead of his normal happy coo's. Cried unconsolably.  Annual follow up on 03/22/04: "Pt has not recovered from adverse events. Autism."
Injection site red, swollen, itching, arm sore to touch 4 days after injection.
Migraine (severe throbbing headache, light sensitivity, nausea, vomiting) began approximately 7 days after receiving my second dose and had mostly resolved by the end of that day.
FEEL LIKE RUNNING A 103 F FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported)  1 total dose, start therapy date were not reported for prophylactic vaccination. It was unknown if the patient experienced any adverse event after following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects and feel like running a 103 F fever (event occurred in Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel like running a 103 F fever was not reported. This report was non-serious.
Bivalent Covid booster was administered prior to the completion of the 2-dose Pfizer series.
Fever, complaining of being sore on 2/22/01. Seen my MD on 2/26/01 and dx'd with viral syndrome and right serious otitis media. On 2/27/01, triage for cough, decrease in po intake.
8/15/2007 After Immunes were given in upper Vaseus Lateralis, child crying and not weight bearing.  10 minutes later child stopped crying and was bearing weight. Later in day after child woke from nap, child had difficulity weight bearing. Child taken to pediatrician who stated that the vaccines were given too posterior and this traumatized the nerve - child should recover in a few days to a few weeks.  Child slept throught night on 8/15 and was able to walk with a limp on 8/16.  Pain was relieved with ibuprofen.
Mom noticed a few lesions approximately 4 days after receiving varicella vaccine, now with approximately 25 lesions. Tx: Neosporin ointment.
Systemic: tongue-Severe, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tongue tingling and weakness (severe) and headache (mild), but patient can still talk.
Redness, pain, swelling hardness injection site  Ice/Cold compress, Ibuprofen