chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse via company representative refers to a male patient in his 70's. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In 2009, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, (dose, injection site, lot number and expiration date were not reported). On an unknown date in approximately January 2016 (reported as "last week"), the patient was revaccinated with ZOSTAVAX subcutaneously, (dose, injection site, lot number and expiration date were not reported). No adverse experience was reported. Additional information has been requested.
Facial swelling, neck swelling, tingling in bilateral hands, headache (not relieved by medication), intermittent lip and mouth tingling, hand numbness (intermittent),  (asthma attacks occurred approximately an hour after injection lasting most of the day relieved by Benadryl and inhaler) all other symptoms not relieved with any medications tried.
1 day later area of inj became red & swollen, axillary lymph nodes swollen-put arm on sling;+ chills, pain in neck, back, then hives-rash;2 days later seen by MD;swollen glands ax;SOB, diff swallowing;tenderness;h/a;joint pain, sweat;
2/1/22 pt had a positive COVID test; was hospitalized (name of hospital not in record) for COVID; dc'd to Rehab for generalized weakness to receive OT and PT; pt was found without respirations and pulseless in the center
Pain on left lower side of stomach around at random times, this is the second day in a row. Feeling exhausted and sore the second day after the vaccine. Feeling hot and flushed and then cold at times Headache
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 16-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Dizziness, fainting. Days later legs, butt, and lower back experienced soreness. Approximately two weeks later night sweats, facial and neck/chest cramping, and eye twitching all day long with mild cardiac arrhythmias. All stimulants such as coffee were removed from diet and supplemental vitamins B6, B12, D, Calcium, Magnesium, Zinc were added to an increased daily fluid consumption. Symptoms are currently present, but have significantly decreased in strength and frequency over the last few days, as of 12/22/2009. The timeline and the symptoms suggest a mild case of the Miller Fisher variant of Guillain-Barré syndrome. The absence of fever and slow progression of symptoms caused a delay in reporting this as an adverse event relating to the vaccination.
Mother presented with pt to clinic to get siblings vaccinated and advised that pt had a reaction to the shot he received in his left arm. Pt has a 35mm x 35mm raised welt that is red in color and warm to the touch at injection site for Kinrix vaccine he received on 1/3/23. Pt advised that he woke last night with his arm hurting and he could feel the welt. Mother advised she has not given any medications at this time. Advised mother to treat with cold compresses and Tylenol/Motrin to relieve swelling and pain. Encourage to take to local Emergency Department if symptoms worsen and provided with address and contact information.
little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Gotten very sick from her 1st Covid vaccination that resulted in a visit to the ER.), for COVID-19 immunisation, reaction(s): "very sick". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "little tired".  Additional information: NDC number, expiry date was not provided. She received her second vaccination on 08Feb2021 and was just a little tired but otherwise fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & 14NOV93 devel a raised rash which was like pimples on chest, achiness on lt arm; sx persisted for several days & pt recovered; No further details were provided
7 yo f began vomiting 6 hrs after first pediatric comirnaty dose; 7 yo f began vomiting 6 hrs after first pediatric comirnaty dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 7 years 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: VOMITING (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 2021, outcome "unknown" and all described as "7 yo f began vomiting 6 hrs after first pediatric comirnaty dose".  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
injection site pain, swelling, and redness; injection site pain, swelling, and redness; injection site pain, swelling, and redness; This is a spontaneous report from a contactable consumer (patient). A 57 year old female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number/Expiration date: not provided), via an unspecified route of administration, on 28Dec2020 (at the age of 57 years old), at the hospital she works out of, as a single dose in the left arm for COVID-19 immunization. Relevant medical history included penicillin allergy. Concomitant medication was not provided. The consumer reported that she has taken no new medications, and did not receive any other vaccines when she got this one. On the same day, on 28Dec2020, the consumer experienced injection site pain, swelling, and redness. The consumer described the injection site swelling, and redness as a big bullseye, it is a raised knot, and the whole area is red. The consumer reported that she used a tape measure to measure it, and it was only 2 inches by 2.5 inches. The consumer reported that the redness, swelling, and pain she has does not interfere with her day other than she is sore and it is big. Treatment received for the events included icing it off and on. The outcome of the events injection site pain, swelling, and redness was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Left arm became red and feverish approximately 8 hours after pt was vaccinated on 7/17/17.  A 3" bruise developed across her arm. Reaction is still feverish to the touch on 7/20/17. Pt was instructed to use a cold compress on her arm in addition to taking her current medications.
10 minutes after administered vaccine, pt reports having tightness in her throat and some tingling in her mouth.  She was escorted to the ER. When arrived at the ER she reported slight shortness of breath.
I had a runny nose; I live in Texas. I thought get best tested. I went to the health department and got a PCR test. I had no symptoms only a clear runny nose, which I get normally when I have allergies. My doctor recommends staying home for 10 days. I did a virtual visit with my doctor. I went ahead got extra K-95 mask. I was prescribed a course of Zithromax, mega vitamin therapy. He also up the Vitamin C and Magnesium and I took between a four-week course. He also is a believer in Ivermectin which I did take. I checked my pulse oximetry everything was fine. I did a home test 3 weeks after that and I tested negative.
pt recvd vax 26DEC96 & pregnancy test neg 22DEC95;LMP 28DEC95 pt became pregnant approx 2wk later 1JAN96;unk effect in fetus
Sore arm at injection site 1 hour post vaccination, severe headache 6 hours post vaccination, low-grade fever (99.7 to 100.7) 6 hours post vaccination, extreme fatigue 12 - 14 hours post vaccination, body chills 36 -38 hours post vaccination. All symptoms except low-grade fever were gone 48 post vaccination, low-grade fever was gone 52 hours post vaccination.
Approximately 12 hours post vaccine she had a fever, dizziness, vomiting and joint and muscle pain. As of today she still has pelvic pain, and neck pain.
Found lump on left breast same side as injection site.  Went to doctor to get it checked out on June 11, 2021.  Was referred to Radiology to get a Diagnostic Mammogram on June 24, 2021.  During this visit, three lumps were found in Mammogram, and Ultrasound determined that they were cysts.  One large one and two smaller ones.  The technician asked if I had the shot in my left arm, and said it looks like your lymph nodes are doing there job, in other words, this is what you would expect them to look like.  The results were confirmed that is was not breast cancer, but cysts.  Note, my older sister also reported that she has breast cyst(s), but this was prior to Covid-19 Pandemic.
Information has been received from a healthcare worker concerning a 17 year old female patient with no medical history or drug allergies/reactions who on an unknown date was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly. Concomitant therapy included DEPO-PROVERA. The healthcare worker reported that the patient "a few days after she received GARDASIL "developed fatigue, malaise and generalized body pain (more severe in hips and legs). Complete blood counts (CBC), Comprehensive Metabolic Panel (CMP), sedimentation rate, Infectious mononucleosis (IM) test were performed however the result were pending. The patient sought medical attention via an office visit. At the time of the report the patient was recovering. Follow-up information has been received from a healthcare worker and a pharmacy tech reported that the GARDASIL prescription was filled on 14-AUG-2009. But it was unknown where the patient took the GARDASIL to be administered. The health care professional contacted during telephone follow-up could not supply the following information: date of vaccination, lot number, date of event, name of HCP who administered the vaccine. Follow-up information has been received from a healthcare worker and a physician concerning a 17 year old female with no illness at time of vaccination who on 04-SEP-2009 had a doctor visit after receiving her first dose of GARDASIL. It was unknown who and where the patient got the injection. It was reported a few days after the vaccination, the patient experienced pain everywhere, most in the hips and legs. She felt more tired, worn out and slept more. The patient denied new sexual contacts, runny nose or allergies. She had no bites, skin rashes and fevers. The pain in the limb showed no trauma but appeared arthritis in nature. The general examination indicated nothing abnormal was detected. Complete blood cell count (CBC) and comprehensive metabolic panel (CMP) revealed normal values except a low platelet count of 124 and a high albumin/globulin ratio of 2.3. The evaluations for hepatitis and mono screen were negative. The results of thyroid-stimulating hormone test and sedimentation rate were within normal reference range. The physician felt that malaise and fatigue were possibly a vaccination reaction. The follow-up visit would be scheduled one week after as needed. Follow-up information has been received from the healthcare worker who reported that the patient's pre-existing allergies, birth defects and medical conditions were none. The patient experienced abdominal pain, heart palpitations, still ongoing. The patient had had echo performed and labs were still ongoing. No further information is available.
Patient reported her left upper arm (arm of vaccination) is painful and hard to move 10/31/2015 and has been since vaccine administration on 10/12/2015. Nothing has helped to ease her pain including heat, ibuprofen, Tylenol, or ice.  Pain has been ongoing for 3 weeks.
Nausea, abnormal menstrual bleed outside of normal cycle, headaches, body ache, chills, fatigue, brain fog
swelling on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling on her arm). At the time of the report, VACCINATION SITE SWELLING (swelling on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was administered for the event at the time of the report.
Not sure which Pfizer I got, but it was my updated second booster.  About 12 hours later, my body started to ache, I than had trouble catching my breath, and my legs were almost paralyzed.  I could barely turn over in bed.  I wanted to call emergency, but could not even move or think clearly.  Broke out into a sweat.  The next morning, I was able to make it to the chair, my legs felt very heavy.  Took until about Noon to start to feel better.  Lasted about 12-14 hours.  The first booster I got, my legs did same thing for about 6 hours, but to a much less extent than this time.
A report was received from a healthcare professional on 10/02/2003 concerning a male vaccinee in his 50's who inadvertently received expired Fluvirin vaccine on 09/30/2003. On 09/30/2003 the vaccinee inadvertently received expired Fluvirin vaccine.  No adverse reaction had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment.
Soreness; Weakness; A spontaneous report (United States) was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness, weakness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) soreness, weakness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness, weakness was unknown.
achy; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2019, the patient received Shingrix. On 12th October 2019, 1 days after receiving Shingrix, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain was resolved with sequelae and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's daughter. The reporter stated that, the patient felt achy and tired the day after the injection. The patient stayed in her pajamas all day and rested. The next day she felt much better. The reporter did not consent to follow up.
Caller states she still has tiny bumps on her toungue and it feels like she ''burned it on hot liquid''; When I got home I had hives on my neck and jaw, I woke up and all down the left side of my neck and heading to my chest area were hives again; This is a spontaneous report received from a contactable consumer (patient herself). A 56-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration on the right side (unspecified) on 30Apr2021 (at the age of 56-year-old) at single dose for COVID-19 immunisation. Relevant medical history was not reported. Historical vaccine included the first dose of BNT162b2, administered at the age of 56-year-old and with no events reported. Concomitant medications were not reported. The patient reported that on 30Apr2021 when she got home she had hives on her neck and jaw, so she washed the area and it went away. Then, at midnight, she woke up and all down the left side of her neck and heading to her chest area there were hives again. She took Benedryl and it went away. She still had bumps on her tongue and it felt like she "burned it on hot liquid", as reported. Benedryl relieved the tongue discomfort. Urticaria resolved on 30Apr2021, while outcome of bumps tongue was unknown.  Information on the lot/batch number has been requested.
The next day, I had short term memory loss. I went to the hospital, and they said I had some type of heart episode. I was taken by ambulance to the hospital and was told I had a blood clot in my brain and had suffered a mini stroke. I was hospitalized for 4 nights. I was given blood thinner and I improved.
Symptom onset within 10 hours after vaccination: Swelling >5cm at injection site, significant pain and throbbing in extending down the arm of the injection site, swelling extending down to the forearm. Syncope and loss of consciousness occurred with trauma to the forehead and nose causing nose bleed. Unable to determine how long patient lost consciousness. When patient woke up, she was laying in a pool of blood from nose bleed and patient described shaking/rigors that were only relieved by taking Ibuprofen 800mg Q8H for 6 days. Denies fever. Due to syncope and head trauma, patient suffered concussion with symptoms of HA, blurry vision, difficulty concentrating, and fatigue.
Pfizer 1/5/21, 2/19/21, 10/22/21, 5/17/22, 11/9/22. Positive on 2/21/23
nausea and vomiting-5:30am-9:30pm high grade fever-102 F headache soreness and pain at injection site
Wheezing - admitted 7/31/09 for 24 hour ear infection. Treated with oxygen, albuterol, atrovent, steroids and amoxicillin.   9/8/09 Hospital records received DOS 7/31/09 to 8/1/09. Assessment: Reactive airway disease. Acute otitis media.  Patient presented with a one day history of wheezing, congestion, and cough. Mild respiratory distress. Nasal congestion, bilateral tympanic membranes red and boggy. Bilateral diffuse expiratory wheezes, mild subcostal retraction. Eczematous erythematous plaques on knees. Supplemental O2 via BNC.
pt. states Sx of numbness in facial area. provider stated it was bell palsy after hearing full report of Sx.
This was dose #2 but pt received Menactra as her 1st dose years ago so this was her first dose of MENVEO. Pt was sweating, light headed, felt warm/feverish, pale in color, blurry vision. We gave patient a glass of water and after 15-20 minutes of resting and sipping water she slowly began to feel like her normal self. Mom was told her monitor her for the rest of the night and let us know if she has any more issues over the next couple of days.
Information obtained from the Hospital. Began to not feel well the next day, SOB, diarrhea and fatigue. Was admitted to hospital on 4/9/21, diagnosed with COVID, placed on a vent and died on 4/19/21.
3/11/21 Got injection at 9:30 a.m.  Started getting chilled by 7:30 p.m. Body aches and pain throughout night. Still chilly 3/12/21 until about 7:30 p.m. when began to get sweaty.  Hot throughout the night. Almost back to my normal self by morning of 3/13/21.  Please not the when I received the first Moderna shot in right arm on 2/11/21 my only reaction was a red, warm welt on the upper arm starting 2/18/21 and lasting 4-5 days.
Both times after my son received his Covid-19 vaccine, we noticed that his feet swelled up a few days after and have been periodically swollen since.
axillary lymphadenopathy starting 2 weeks after second vaccination and persisting at 6 weeks after. She also had a non itchy rash on chest starting 2 weeks after vaccination which lasted about 5 days.
swelling, fever, lump @ inj site, redness from shoulder to elbow, joint pain, nausea, h/a, red measles type rash over body;
Fever and dry heaving. Full body numbness that lasted 10 minutes night of vaccine.  103.5 fever lasting 3 days.
A non-serious spontaneous report of administration of expired FLUMIST to 2 males was received from a health professional concerning two 16-year-old males after receiving FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 08-Dec-2010. The patient received the expired FLUMIST on 20-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 09-Mar-2011: no late occurring adverse events.
Body aches, fatigue, soreness at injection site July 25-26. Rash occurring on arms, legs, and chest July 27-August 2
18 year old male started experiencing lightheadedness, muscle stiffness, sweating profusely within 10 minutes of his first dose of Pfizer vaccine. Patient was made to lie down on the ground with ice applied to back of neck and forehead. His blood pressure reading was 77/64.  Patient was coming in and out of consciousness for about 60 seconds then became alert and regained full consciousness. He also appeared to be experiencing an episode of muscle tightness (possibly a seizure) for a few seconds while he was unconscious.  His mother who states that she is a nurse, was present with him as he experienced unconsciousness and prevented him from falling to the ground. She states he does not have a history of seizures or other conditions and has never had a reaction after an immunization. Paramedics arrived within 15 minutes, EKG and BP, blood glucose appeared normal. Patient was alert and able to stand unsupported prior to being taken to the hospital.
Received RABAVERT at 10:08 am and sent to waiting room for 15 minutes. After 15 minutes elapsed, RN inquired if client had any side effects. She stated no and RN stated she could leave. At 11:10 am, RN went to waiting room and client was sitting in a chair. She stated that she left the clinic, got into her car and drove around 5 minutes when she began to experience a "tingly" dry throat. Contacted place of employment and took 50 mg BENADRYL. Returned to clinic. RN escorted client to lab area and had client sit in a chair. BP 120/76, HR 78. Breath sounds clear, no wheezing, able to talk, no diaphoresis. Mouth area slightly reddened. Physician consultant contacted and recommended that client be observed and it symptoms increase, send to Emergency Room. At 11:20 am, BP 116/78 and HR 72. Client stated throat felt "scratchy", no shortness of breath, able to talk and drink water. Client called her mother to come to the clinic to pick her up. At 11:40 am, BP 110/66, HR 70. Client's mother arrived at the clinic at 11:45 am. Mother instructed on symptoms to watch for and if symptoms worsen, go to Emergency Room. RN contacted client later in the day and she stated that her throat began to swell and mother took her to the Emergency Room.