chrisvoncsefalvay/vaers-outcomes huggingface dataset:
0-24 hours after receiving 2nd vaccine: general aches, soreness at injection site, mild dizziness, slightly elevated body temp (WNL, but 1 degree F higher than my average) 24-48 hours: fever over 101F, chills, muscle aches (mostly upper body), moderate to severe lower back pain, moderate pain in both wrists, inappetence, moderate fatigue, dizziness upon sitting upright or standing . Took 500mg Tylenol at 7:30am, 12:30pm, and 6:00pm; fever went away but all other symptoms remained the same 48-72 hours: no fever, back pain or wrist pain, mild fatigue and mild dizziness upon standing or sitting upright, inappetence, Took 500mg Tylenol at 10:30am and 5:00pm 72-96 hours: inappetence and mild dizziness when hunched/bending over. Went back to work, experienced mild to moderate wrist pain when lifting or carrying moderate weight. Did not take Tylenol 96 hours - present: mild wrist pain when not in use/not moving, moderate to severe wrist pain when using/moving wrists 9 days post-second vaccine: moderate to severe bilateral knee pain that progressed to tightness in knee joint and muscles in lower legs, moderate pain in both wrists regardless of use. Pain now comes and goes but has never stayed this long nor has it been this severe without use. Felt normal
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional. This case involves a 4 months old male patient who was vaccinated with the 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (Batch number: UT6259KA and expiry date: 30-Jun-2019) via intramuscular route in the right thigh on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event occurred or not following the administration of the vaccine. The patient outcome is reported as Not Applicable for FLUZONE QUADRIVALENT 0.25ml prefilled syringe was administered to 4 month old patient. 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. Documents held by sender: none.
COMPLAIN OF CHEST BURNING, TIGHTNESS AFTER 5 MINS POST VACCINE. REFUSED TRANSPORT AFTER WATER AND DEEP BREATHING.OBSERVED FOR 45 MINUTES.  154/88, 67,98% 128/86, 69,99%
Indicates seriousness - Nov. 13, 1230pm, during sexual intercourse, blood, mixed w/ semen. Nov. 14, 7:00 am, headaches, chill, fever, chest and throat congested, wheezing, short winded, stuffy nose, nausea, and sneezing. Over-the-counter-drugs: CORICIDIN (cough/depressant) TYLENOL, THERA-FLU, SUCRETS throat lozenges (still no changes).
Patient experienced lightheadedness, sensation.  That skin was crawling 1-20 minutes after administration.  Followed by muscle tightness in arm, sore, inflammed, red.
Approximately 24 hours 4th dose of RUA pt states she developed tremors of hands, neck and jaw and a shaky anxious feeling in chest with some SOB. No fever, hives or swelling of face. Appt. to see internist 7/18/02. States headache for approx. 24 hours after each dose of rabies vac. Dr seen 7/11/02. Tremors continue-medications adjusted tremors stopped within 24 hours. 8/6/02 recovered.
Swollen arm, warm to touch, fever, itching at injection site, loss of appetite.
stinging rt arm crease-red raised area @ inj site;went home hr p/inj c/o skin sweaty, nauseated, sleepy, tired, h/a, vision doubled & fever;drank 15 or more glasses of H20;sweats & extreme arm pain, weakness in arm & under arm pain & tender
I developed a lot of pain in my elbow to the point that is is difficult to move my arm. and the pain has gone down my arm to my wrist and the bottom side of my arm down to my fingers are numb. I get a throbbing pain that comes and goes in my hand.
Husband reported her as being delirious....saying weird things. Said his wife did not know where she was. He said she came out of her bedroom with no clothes on. He said she was vomiting and had diarrhea.
10 days post vax pt experienced fever, swollen face esp right lateral, rash over body, loss of appetite, complained of headache, cough, sneezing, rhinitis. No prior illness. Three days post onset pt was feeling better. Still has cough, rash and swelling, right lymph glands (neck and face).
Site injection pain and swelling  Fever spiked to 102.6 24 hours later Chills, severe body aches, headache, swollen lymph node s have worsened
patient said she had numbness and tingling on left arm starting from elbow to hand afte 15 minutes post vaccination
After receiving a HPV injection, pts. color turned pallor, pt. became non-verbal, and began to slide from her chair. Pts. mother cuddled her & she did not slide from chair - within 30 seconds, pt. was alert and oriented and again verbal. Pt. never loss consciousness. Pt. was allowed to lye down in clinic room & observed.
Lethargy and tiredness to the point of refusing to move Fever Injection site and muscular site pain Nausea Vomiting Abdominal pain  Injection site pain most of the day Not exacly sure about the rest. He came home from school around 3:30 and was whiny, comaining of abdominal pain, and fell asleep on the couch for over an hour. He woke up and wouldn't move from the couch. He started feeling nauseous sometime after waking and began puking around 7 or 7:30 PM.  It's now 9 PM and he's puked 3-4 times but keeps screaming about abdominal pain.
Extreme pain in legs when walking or moving legs.  Child could only shuffle feet or waddle.  Expressed pain when knees were slightly bent.  Mild elevated temperature of 100 after acetaminophen.
Dizziness and lightheadedness 20 min post vax Observation and fluids Sxs resolved after 30 mins of close monitoring NKA, but does have hx of asthma
nine year old twin grand daughters. They have been vaccinated with the first two shots; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (nine year old twin grand daughters. They have been vaccinated with the first two shots) in a 9-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (nine year old twin grand daughters. They have been vaccinated with the first two shots). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (nine year old twin grand daughters. They have been vaccinated with the first two shots) outcome was unknown.            No concomitant medication was provided.  Reporter stated that, nine year old twin grand daughters had been vaccinated with the first two shots but so far there is no booster for 5-11 year old's. It was very concerning as by now the protection from the first two shots was waning.  No treatment information was provided.   This case was linked to MOD-2022-561278, MOD-2022-561266 (Patient Link).
This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Information about the patients' pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot number, expiration date, concentration, dose, route of administration and frequency were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected, as there was no permission to contact the physician.
Myalgia, Arthralgia, NauseaVomiting, experienced chills, aches on 10/12 @night, then also from 10/13 morning till 10/14 all day. Also experienced left axillary pain x 3 days (lymph nodes felt swollen and axilla was warm) Narrative: Arm and left axillary pain, chills and aches started on evening of 10/12/2021. Then continued as the day went by on 10/13/2021. On the night of 10/13/2021, the chills and body aches got really bad and I could barely get out of bed. Symptoms and swollen lymph nodes continued through Thursday (10/14/2021) late evening.
Pt had high temp 104 & 1 sz p/receiving immun earlier in day;
Rash R deltoid x 2 days, pain at injection site x 8 days; RX ibuprofen 600 mg TID.
After vaccines, child returned to office in approx. 2 hours.  She had started to c/o sore throat when they left the building, and by the time they got home (about 5-10 mins), she was developing a cough and swelling under her left eye.  Also c/o some abdominal pain. Also was noted to have some  wheezing that was cleared with Abluterol neb 0.083%.  Was given 10 mg Decadron by injection and 3/4 tsp of Benadryl 25 mg-she immediately vomited. Patient has not returned phone call to foup.
Feb 10th shot. Feb 18th round red circle around vaccine shot. Feb 23 went to doctor's office found out I had COVID arm (big rash around the shot area); warm to touch, itchy. Called pharmacy to report they told me to register my symptoms.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient with seizure disorder reports seizure one day following vaccination. No loss of conscioussness or speech. Seizure reported as arm weakness, incontinenece, and vomiting. Afterwards rested all day and able to eat and drink. Patient also reports fatigue, myalgias, arthralgias, and nausea.  Symptoms improving and no additional seizures documented.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history or concurrent conditions were reported. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of MMR II lot # L000459, expiry date 06-JAN-2017, therapy type rHA (dose and route of administration were not provided). The vaccine was stored in temperature 46.8 F for 15 hours. No concomitant therapies were reported. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Booster; coughing; fever; achy; very tired; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "recovered", described as "Booster"; COUGH (non-serious), outcome "recovered", described as "coughing"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "achy"; FATIGUE (non-serious), outcome "recovered", described as "very tired"; HEADACHE (non-serious), outcome "recovered", described as "headache"; NAUSEA (non-serious), outcome "recovered", described as "nausea".  Additional Information: The patient had no other vaccine in four weeks.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 08-DEC-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Discharge Provider: DO; Primary Care Provider :  PA; Admission Date: 9/27/2022; Discharge Date: 09/29/2022 PRESENTING PROBLEM: Weakness; HOSPITAL COURSE: A 64 y.o. male with past medical history significant for traumatic brain injury, cognitive decline, hypertension, type 2 diabetes mellitus, CAD status post CABG who lives at  home presents today with complaints of generalized weakness. In ER COVID-19 PCR came back positive, chest x-ray negative for any significant findings. Due to generalized weakness recent multiple falls for further evaluation and management placed as observation under hospitalist service. No hypoxia during admission and no respiratory symptoms. Fatigue improved with supportive care. PT recommended DC back to home.    Close follow up advised as noted below including following up with Network 180 & primary care provider, PA.  Guardian  expressed understanding and agreement with this plan.  Guardian in agreement with discharge on 09/29/2022.
At 01:30 AM, patient woke up crying and had a low-grade fever, she vomited, and then went back to sleep for approximately 30 minutes. She awoke again with a general sense of feeling bad, fever (100 degrees), headache, and arm pain. She continues these symptoms now and it is 06:15am. I will call the doctor when their office opens, but I wanted to report this adverse reaction.
We are reporting that the patient did not truthfully complete the vaccine consent form.  Patient did indeed receive a prior COVID vaccination on 2/4/21 as a Moderna.  She completed the form as not having received a prior dose.  She received a Pfizer COVID vaccine on 4/10/21.
Pt came in and left arm red, hot, swollen slightly hard. Dr gave antibiotic for possible cellulitis.
pt recv vax SEP96 & 2wk post vax began to exp numbness which started @ the knees & extended into upper torso & upper abd above the umbilicus;MD visit was required;pt found to have central nervous system inflammation & demyelinating disease;
Redness, swelling, itching, pain at site of injection (LD) for approximately 3 days. Day 3 developed hives on left arm spread to torso, neck, face, right arm & thighs. Day 5 still has hives. Taking BENADRYL.
We made an error and gave the Moderna COVID-19 vaccine to a 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We made an error and gave the Moderna COVID-19 vaccine to a 15 year old) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We made an error and gave the Moderna COVID-19 vaccine to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We made an error and gave the Moderna COVID-19 vaccine to a 15 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: No New Information.
p/vax pt exp a erythematous rash w/redness, swelling & pain @ inj site;pt seen by MD & recovered;
Terrible nightmare during night of injection.  Smothering and paralyzed feeling. Shouting out in my sleep.  Husband finally woke me .  When I got up to take a Motrin I was disorientated. Did not know where I was. .   Next day experienced several sudden feelings a syncopye.  Lasting a few seconds. Had to grab on to something due to a feeling that I was going to fall. It lasted just a quick second or two.  Happened several times that day.  Like what I would think a TIA would feel like.  Arm was just slightly tender and stinging the first day,.  In the night it was aching and hot up into my neck.  The next morning it was fine again. Just tender and a little stiff.  I attempted to report this on line at instructed on forms given me when I left the site. however the CODE that was to be sent to my phone never came. I then entered the wed site and attempted to report it there. .  Finally I called my primary Dr and he has instructed me to report this to the person giving the second injection.  I doubt they will know what to do seeing as they are volunteers with little experienc.e
Discomfort in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Discomfort in injection 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Discomfort in injection arm). At the time of the report, LIMB DISCOMFORT (Discomfort in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Patient reported that she experienced chills, malaise, and nausea and vomiting the night of her vaccine. Spoke with patient 8:15 pm on 9/13/2016 and she reports that she is starting to feel better with some intermittant chills.
There was no treatment on the patient they left the clinic didn't know I had made the mistake until another patient came to ask me about vaccines and that when I realized I had made the mistake that I had gave the vaccines to the wrong patient.
Around 12 hours after receiving the vaccine,  I was hit with intense fatigue almost to the point of passing out. I went to bed and extreme chills began. For about an hour I had bad chills and difficulty falling asleep despite my fatigue. It felt almost exactly like having COVID (since I had it back in December), but condensed into a few hours. My arm also started hurting about 5 hours after receiving the vaccine but it is not noteworthy.
on 6/3/2021 We received a notification from Pfizer.  Patient reported that on 4/4/2021 she started to itch. the next day she noticed bumps and she felt a sharp pain on her chest every 10 minutes it complicated into PHN. (shingles)  6/3/2021 Patient had not made us aware of her symptoms.
Red welt about 4 inches wide and 3 inches long around injection site 3 days after injection.
The day after my vaccine I developed around the site of vaccination. It lasted 4 days and went away for three days It was very sore and hot the second time it came back it was really itchy. It was bigger when it came back. I saw a doctor and they advised that I take Zyrtec and Cortisone cream with ice. The rash went away after six days. I have Psoriasis and it flared up in places that it has never been before. It is still a little worse than normal.  I have had my second dose and there were no side effects with that one.
I received a dose of shingrix 50 MCG INJ (!M) sngdse vl10pk administered .5 ML in the muscle of left arm. My arm is red swellen and hot at the point of injection.
Patient received PREVNAR 13. She reported redness, warmth and swelling below injection site starting day after. Patient was told to apply ice and take BENADRYL. Patient said she was going to the doctor, but we never heard back from pt.
pt devel fever & irritability 1 wk p/vax w/persistent lack of appetite;
I have been on my period for 84 days, 2nd vaccine 08May2021, period started 27May2021, still bleeding; Horrible cramps; It's has clots; This is a spontaneous report from a contactable consumer. This 48-Year-Old female consumer(patient) reported. A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 08May2021 12:30 (age at the time of vaccination was 48-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic kidney disease from an unknown date and unknown if ongoing , meniere's disease from an unknown date and unknown if ongoing , facet joint syndrome from an unknown date and unknown if ongoing , spinal deformity from an unknown date and unknown if ongoing , fibromyalgia from an unknown date and unknown if ongoing , balance disorder from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing, Migraine from an unknown date and unknown if ongoing, Gastrooesophageal reflux disease from an unknown date and unknown if ongoing, Impaired gastric emptying from an unknown date and unknown if ongoing, Irritable bowel syndrome from an unknown date and unknown if ongoing, experienced drug hypersensitivity to Sulfa Antibiotics. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm right on 17Apr2021 03:00PM (age at the time of vaccination was 48-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient had been on her period for 84 days, period started on 27May2021, and was still bleeding. The patient had been checked for cancer; it was clear. Horrible cramps on27May2021, worst the patient ever had and the patient had gone through boxes and boxes of feminine products. It's has clots on 27May2021, the patient had gone to urgent care, gynecology, general doctor. They even gave the patient medication to try and stop it and it did not work. The patient had biopsy, ultrasounds and it just kept bleeding. Treatment medication included Norethindrone Acetate (AYGESTIN) 5 mg Oral Tab. Outcome of all the events was reported as not recovered at this time of the report. Device Date reported as 18Aug2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.