chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in the arm for over a week. Bothers so much during the night causing me to have sleepless nights. I get a tingling sensation starting on my elbow that runs down to my arm and causes some of my fingers to fall asleep. I was really groggy for a couple days almost as if I have a cold. I now get these terrible migranes that come and go.
Light headedness Narrative: Per MD note, "58yo man receive COVID vaccine #1 (Pfizer) on 3/4 and developed light headedness and BP change and sent to the ED. ER triage documentation showed a normal BP and a slowish heart rate. No intervention was given and patient was sent home....Reaction appears to be most consistent with a vaso-vagal reaction." MD recommended patients to receive 2nd dose of COVID vaccine.
Change in menstrual cycle after both first and second dose/Period occurred 5 days after 1st only 10 days after the previous menstruation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 13:00 (Lot number: FC3180) at the age of 42 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: MENSTRUAL DISORDER (non-serious) with onset Aug2021, outcome "unknown", described as "Change in menstrual cycle after both first and second dose/Period occurred 5 days after 1st only 10 days after the previous menstruation".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown that the patient diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. Device Date: 03Sep2021  Follow-up attempts are completed. No further information is expected
Woke up itching all over body (worst on hands, chest, neck, back, ankles), skin would become very red in areas itched, burning sensation in skin. Progressed over 5 days to intermittent hives that would resolve in 15-30 minutes, placed on OTC allergy meds that helped reduce symptoms. Currently, still experiencing all of the above symptoms when OTC allergy medication is not taken.
Broken ankle in 2011 and had surgery and slight arthritis in right hand prior to shot.  My arthritis increased greatly.  It is now in both ankles when I rise in the morning and I have to walk around in order to stop the pain.  My right hand is much worse when I ball my hand in a fist or drive any distance holding steering wheel.
Wife States had to go to state clinic and received a prescription for steroid. Had determined allergic reaction.
p/vax pt c/o pain @ the time of inject & steadily became worse thereafter. pt had redness w/142'' diameter hardness on lt arm, warm to touch.
Fifteen minutes after the shot I noticed that I couldn?t breathe. I had informed the staff of my allergies. My throat started to close and I couldn't  swallow. I tried to relax but I started to feel distressed. I was taken into the Emergency. I was given Benadryl Zofran and Hydrocortisone. I was prescribed Benadryl and an EpiPen and a Steroid in case it reoccurred. The medication seemed to work and I did not go into shock again. I have not had the second dose of the vaccine.
Severe Headache, Dizziness, Unstable on feet, Nausea, Neck Pain, Shoulder Pain.
Lump like feeling under armpit starting day 5-6, itching and raised area at injection site day 6 evening. Day 7- larger hardened red warm to the touch area at injection site.
This spontaneous report was received from a registered nurse and refers to a 31 year old female patient. The patient's concomitant medications included labetalol and her concurrent conditions included high blood pressure. The patient had not known drug allergies or drug reactions. On 17-MAY-2018, the patient was vaccinated with (Oka/Merck) VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine was reconstituted with MERCK STERILE DILUENT (lot number and expiration date were not reported). On approximately 24-MAY-2018, reported as "1 to 2 weeks post-vaccination", the patient found to have conceived a child. The patient sought medical attention but treatment was not given. The gestational age at the time of reporting was 6 weeks and two days; consequently the last menstrual period (LMP) was on 04-JUN-2018, the estimated date of conception was on 18-JUN-2018, the estimated date of delivery (EDD) was on 11-MAR-2019.
Got a notification that I had been around someone with COVID-19.  A couple days later I started getting congested with a slight cough. Then the next day it became worse, started having a fever, migraine, fatigue and muscle aches. Took a PCR COVID-19 test and it was positive. Reached out to my Dr and was prescribed Paxlovid. Tested 1 week later and the COVID-19 test was negative.
The patient presented with a swollen left arm and possible fever. I suggested the patient take benadryl and apap if needed. I tried to call pt about 3:30. no answer and no vm
nearly fainted twice; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; pains in chest; catching my breath; very cold and clammy; This is a spontaneous report from a contactable consumer (the patient).   A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0169), via an unspecified route of administration, on 14Apr2021 at 11:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing,  irregular heart beat  and depression from an unknown date and unknown if ongoing. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient did not have any other vaccines within four weeks prior to the vaccination.  The patient stated that  when he first got the shot he actually nearly fainted twice and had to lay on the floor for a while. It was very scary, he thought he was going to die.  He got very cold and clammy and had pains in chest and had a hard time catching his breath. They checked his vital signs a couple times and said they looked good. But he still felt sick and they said if he did not  feel better soon they may have to call for an ambulance for him. Eventually he felt better enough to where he was able to get up off the floor and on handicap cart to drive out of there. Also, he's been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. It's pain that is in spots, it feels like mini-charley-horses that lasts anywhere from 20 something to 30 something seconds. Now it's mostly continuous pains in his thigh muscles between his legs. And a pain in one spot in his left arm bicep. This has been happening for days."  The patient experienced "nearly fainted twice"  on 15Apr2021 with outcome of not recovered, chest pain, got very cold and clammy and had a hard time catching his breath on 15Apr2021 with outcome of not recovered. He also reported that he has been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his  left hand ring finger tip. it's pain that is in spots, it feels starting on 15Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included unspecified investigation: myalgias  on an unspecified date . Therapeutic measures (unspecified) were taken as a result of the events.
If affected the cerebellum part of her brain and she lost control of her movement and speech abilities, she was hospitalized for  6-8 months 4 months at one hospital and 3 months at another hospital. Hospital where MRI and where she stayed until the swelling in her brain went down, then to children hospital to learn how to walk and talk all over again. A lot of therapy
patient has to take one of her own benadryl, she brought her own allergy meds, expecting full allergy.
Difficulty breathing; Allergic reaction; Pain in the arm that radiated up to the neck; Hot and cold flashes; Hot and cold flashes; A spontaneous report was received from a consumer, who was also a 43-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an allergic reaction, hot and cold flashes, difficulty breathing and pain in the arm that radiated up to the neck.  The patient's medical history, as provided by the reporter, included asthma and allergies.  Concomitant medications were not reported.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 026L20A; expiration date: 28 Jul 2021) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, four hours after vaccination, the patient experienced hot and cold flashes and pain in his arm that radiated up to his neck. He had some food and went to bed.  The next day, on 16 Jan 2021, the patient had an "adverse reaction, allergic reaction". This event was considered to be medically significant. treatments at home but had no relief.  The patient still had trouble breathing so he went to the emergency room as his physician told him to.  He was given three more nebulizers of ipratropium bromide (+) albuterol sulfate, steroids, diphenhydramine hydrochloride, and famotidine but he still had trouble breathing.  Therefore, the patient was admitted into the hospital for observation.  The patient was discharged on 17 Jan 2021 with two to three bags of normal saline and four bags of "lactose ringers".  In addition, his physician put him on a steroid and inhaler.  Action taken with mRNA-1273 in response to the events were not reported.  The outcomes of the events, allergic reaction, difficulty breathing, hot and cold flashes, and pain in the arm that radiated up to the neck, were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's significant medical history included asthma and allergies.
PCP received records related to patient ER visit for chest pain after COVID-19 vaccine. Was seen in the local ER.
Itchy, watery eyes. Sneezing. Severe sinus pressure, runny nose, swelling of nose, lips, gums. Treated with BENADRYL for 24 hours.
5 inch by 3 inch rash that is warm to the touch; Left arm started to feel a little different; 5 inch by 3 inch rash that is warm to the touch; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (5 inch by 3 inch rash that is warm to the touch), LIMB DISCOMFORT (Left arm started to feel a little different) and VACCINATION SITE RASH (5 inch by 3 inch rash that is warm to the touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (5 inch by 3 inch rash that is warm to the touch), LIMB DISCOMFORT (Left arm started to feel a little different) and VACCINATION SITE RASH (5 inch by 3 inch rash that is warm to the touch). At the time of the report, VACCINATION SITE WARMTH (5 inch by 3 inch rash that is warm to the touch), LIMB DISCOMFORT (Left arm started to feel a little different) and VACCINATION SITE RASH (5 inch by 3 inch rash that is warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unspecified by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot # and expiration date unknown). On an unknown date, the patient was diagnosed with shingles. The patient sought medical attention - she visited the physician's office on an unknown date. The outcome of the adverse event was unknown. The relatedness between the adverse event and the vaccination with ZOSTAVAX was not reported. Additional information has been requested - as the information was not reported clearly.
2/13/04 1300hrs Received Vaccine         1500hrs Extremely Exhausted         2200hrs Shaking, Fever 103 2/14/04 Fever continued during the day, "broke" in the evening 2/15/04 Headache all day, stopped by evening, then felt okay.  NO NAUSEA OR VOMITING
24hr events: Patient received 2nd covid vaccine yesterday and is now A&Ox1 SUBJECTIVE: Patient was A&Ox4 yesterday but now only knows his name. Does not  know the year, where he is at, or the president. Responds only in mumbles.  Cannot open eyes. Cannot get out of bed. Fever 102
Patient should not have received these immunizations. She is only 4 years old. The patient's sister (12 years old) was also in the clinic today, and she was receiving her shots. The shots the patient received were meant for the sibling. They were on the same tray as the patient's 4 year immunizations (KINRIX, PROQUAD). The mother opted not to have patient receive her 4 year immunizations after I advised her of the accidental mix-up.
Had 2nd shingles vaccine on Friday 9/28/18. That night he started developing some pain and sensitivity on the left side of his forehead. Red dots on his eyelid one on his scalp w/radiating pain on left side of head. Eyes are watering. Valacyclovir given to treat.
25JUL91 pt recvd vax; 26JUL91 devel fever unk amt; 27JUL91 rash-face & torso; 28JUL91 taken to ER for rash given meds;
Immedicately nauseated. Hypertensive event, reddness on neck and upper chest and hands, moment of visual disturbance.  Initial BP 157/100 . Diphendhydramine 50mg IM administered and symptoms resolved within 15 min. BP 144/79  which is patients normal reading O2 sat 100 throughout episode. Patient had no further symptoms over the next 24 hours
severe muscle spasm; Cannot turn the head to the right, left or up, it had a very limited range of motion; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (severe muscle spasm) and MUSCULOSKELETAL STIFFNESS (Cannot turn the head to the right, left or up, it had a very limited range of motion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 80777 0273-99) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LOSARTAN, ROSUVASTATIN, CLOPIDOGREL, PROPRANOLOL, ATENOLOL, FLUOXETINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced MUSCLE SPASMS (severe muscle spasm) and MUSCULOSKELETAL STIFFNESS (Cannot turn the head to the right, left or up, it had a very limited range of motion). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIAZEPAM (VALIUM) for Muscle spasm, at a dose of 10 milligram. At the time of the report, MUSCLE SPASMS (severe muscle spasm) and MUSCULOSKELETAL STIFFNESS (Cannot turn the head to the right, left or up, it had a very limited range of motion) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Swollen and painful lymph node under left armpit. Started on Friday evening with pain. Noticed swelling on Saturday evening. Woke up on Sunday with swelling the same but pain more constant. Treated with Tylenol and heat pack when pain got too much to handle. Attempted to try ice but found no relief.
I had the first shot with mild symptoms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient. A 52-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I had the first shot with mild symptoms.".  Additional information: The patient wanted to share her experience with Pfizer Covid vaccine series for your research. She was normally healthy 52-year-old woman. She had the first shot with mild symptoms.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received MMR-VZV combination vaccine on 4/28/15 to the left deltoid during routine WCC. Developed some itching to the left arm later that night and then developed a localized allergic reaction with swelling, warmth, erythema in a welt that was 2.5cm in radius (clear circle with the puncture of the vaccine in the center). No lip swelling, shortness of breath, wheezing, throat swelling or other signs of anaphylaxis. Had a rash prior from a vaccine, mother not sure of the vaccine type or date.
Raised swilled knot measuring 2in wide and about 2 in long. Warm to touch and bruising
Info regarding Prevnar injection was received from a healthcare professional regarding a male pt who received a dose of Prevnar on an unspecified date and experienced developmental issues. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. Event Details: The pt received a dose of Prevnar on an unspecified date and experienced "developmental issues" (developmental delay). The pt's recovery status is unknown. No additional info was available at the time of this report.
Patient is asymptomatic but has tested positive for COVID-19 upon being hospitalized for unrelated needs. She is fully vaccinated as of 4/20/2021
Arm started to feel sore; Arm became so heavy it was hard to even lift it up; Arm became so heavy it was hard to even lift it up; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 01Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 01Mar2021, 10 minutes after the shot, the patient's arm felt sore and then had minor soreness throughout the day on and off, the biggest issue she had even with no soreness was her arm became so heavy that it was hard to even lift it up; on 02Mar2021 (day 2), it was better but still similar. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events arm started to feel sore and arm became so heavy it was hard to even lift it up was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Headache,  fever, chills, nausea, fatigue,  severe pain in amputation stump
68 year old male received a dose of Adacel / no AE; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68 years old male patient who received 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6512AA (Expiry date 23-Oct-2021) via intramuscular route in the right arm for Prophylactic vaccination on 19-Feb-2020.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.   At a time of reporting no adverse event was reported.  It was reported that pharmacist reported that a 68 year old male received a dose of Adacel due to this is the only Tdap presentation that the pharmacy carries.  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.
Narrative: Patient passed away due to COVID-19. He was on hospice and had received the COVID-19 vaccine,
She has been having itching all over and hives that began almost immediately after the administration of the shot and has continued for the past 2 weeks now
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (Lot number and expiry date were unknown) via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took shingles shot (unspecified medication) about 3 or 4 years ago for immunization. The patient stated "I got the Pfizer Vaccine last Wednesday (30Dec2020), then now that "I am in bed" and four days later (Jan2021) my rib cage started hurting on the left side, the side I got the shot on. I went to the doctor and she thought I was starting to have shingles or Intercostal neuritis. I just wondered if the shot could cause you to have shingles." The patient also stated, "I had the shingles shot (unspecified medication) about 3 or 4 years ago. The doctor thought I might have shingles or Intercostal neuritis which is infection in between the ribs." Outcome of the events was unknown.  Information about lot/batch number has been requested.
Dizziness, nervous, hypotension, loss of vision/hearing, pale. BP 97/41, HR64, RR16. Symptoms improved, drank orange juice, BP improved. Patient generally historically hypotensive. Stable and released from vaccination site.
My period cycle was messed up for 6 months straight. I got it earlier and it was heavier. It would be bad for three days, completely stop then start all over again after a day break.
Chest pain with Myocarditis/pericarditis onset 3 days after vaccine administration