chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2-6-13 9:30 AM Approximately 30 minutes following vaccination c/o right eye swollen. Caregiver administered BENADRYL q4 hours x 2. C/o sneezing and runny nose. 5:00 PM approximately, c/o fever 101.3. Caregiver administered MOTRIN every 4 hours. 9:00 PM vomited, low grade fever 100. 2-7-13 1:00 AM vomited, low grade fever 100. Caregiver administered PHENERGAN Suppository. C/o low grade fever throughout day. 8:00 PM low grade fever 100. 2-8-13 Right eye swelling subsided. No fever. C/o achy. 2-9-13 through 2-11-13 Appetite good. C/o tired, agitated, cranky. 2-13-13 Fully recovered.
Nausea  (1 day) Vomiting (1 day) Chills (2 days) Body-aches (2 days) Fever (2 days) Injection site swelling  (4 days)
muscles aches; really tired; This is a spontaneous report from a contactable consumer (patient himself). A 37-year-old male patient received bnt162b2, via an unspecified route of administration at site of right arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history included lung surgery from 2019. There were no concomitant medications. The patient experienced muscles aches, really tired on 17Dec2020. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Swelling of left arm, knot at injection site, Lymph node swelling down the arm, tingling/numbess of left arm fingers.
FIVE DAYS AFTER RECIEVIENG THE VACCINE PATIENT DEVELOPED HEAVY ARM, PAIN, REDNESS AND SWELLING ABOVE INJECTION SITE. RECOMMENDED COLD COMPRESS , ACETAMINOPHEN AND ANTIHISTAMINE.  PATIENT INFORMED OF SIGNS OF ANAPHYLAXIS. INFORMED TO CALL EMS IF NEEDED.
10-5-03 1135 a.m. adm Varicella/ Hep A to patient about 2-3 minutes later patient began sneezing - left office but came back 5 minutes later, coughing and itching. Doctor informed also c/o chest pain - eye itchy and red. Nebulizer treatment with 1.25 Xopenex given + Zyrtec 10mgm given 12 noon Patient responded well to treatment and sent home on Benadryl 25mg PO q4-6 hours. Prednisone 20mg PO O.D. x 2 days return to office if not better.
Woke up next morning with a nasty cough -- made chest sore.; Woke up next morning with a nasty cough -- made chest sore; Major sinus pain and pressure / Felt like I had a major sinus infection -- pain was that bad; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the right arm on 19Jul2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cat dander and allergy to msg.  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. The patient did not receive any medication within two weeks of vaccination. The patient previously took iron (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the right arm on 28Jun2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 20Jul2021 at 05:30, the patient woke up next morning with a nasty cough that made chest sore. Cough lasted for 5-6 days. On 20Jul2021 at 05:30, the patient had major sinus pain and pressure- head, eyes, sinuses, teeth- that lasted 5-6 days. The patient took homeopathic meds to relieve pressure. The patient felt like she had major sinus infection as the pain was that bad. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events pressure head, eyes, sinuses, teeth, sinus infection which included homeopathic medicines (unspecified). Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021, the patient underwent antigen COVID test via nasal swab and the result was negative. The clinical outcome of the events nasty cough, chest sore, major sinus pain and pressure - head, eyes, sinuses, teeth were resolved on an unknown date in Jul2021.
Morbiliform rash all over the body with no fever no itching 2 days after HAV; HBV; One pneumococcal.
Tinnitus Vertigo  Nystagmus  Numbness and weakness of body Tingling in head and limbs  Migraines Neck pain  Brain fog  Dizziness
Sore arm. Sore underarm. Headache. Fever 101.9. Lack of appetite
Pt exposed to varicella 13Dec97. Pt recv vax 17Dec97 1st dose varicella vax. 27Dec97 Pt devel chickenpox. Less than 50 lesions from chest up & fever. Lesions lasted 7-10 days.
Got LURRY, DIZZY, COOL, CLAMMY-  legs raised, icepack applied to neck, apple juice and crackers given, fan air  patient felt better, patient mentioned not eating much earlier today
No Adverse event occurred. given after expiration date, no expiration date on vial or box.
Right arm swelling and pain(not arm injected), difficulty walking, very weak, some dyspnea, elevated blood sugars, total body aches, subjective fever, patient report fever 102 deg F.  S/S lasting >4 days. Sent by nurse to PCP for covid-19 rule out. Tested at clinic for covid 19, then sent into hospital for CXR and labs that were all "normal" No other treatment reported. Patient not admitted, sent home and remains a little better but still weak.
Rash immediately following injection.  Started at injection site and went up neck, down back.  Went to ED and was given Solu Medrol, Benadry, Pepcid, Decadron.  Took Benadryl 50 mg by mouth that evening.  Rash resolved by next morning.
achiness; sore arm; small headache; spikes a low grade fever every night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), PAIN IN EXTREMITY (sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), PAIN IN EXTREMITY (sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night). At the time of the report, PAIN (achiness), PAIN IN EXTREMITY (sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-100 (High) 99-100F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-054620, MOD21-088814 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: AE contact information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054620:for second dose MOD21-088814:
Mother called HD with report that pt has blisters on his feet and arms. Also running temp approx. 100 degrees. No other symptoms. Described blisters as sort of fluid filled. Saw MD at hospital an dtold was allergic to shots. Given Benadryl. No other problems. Cleared up in 2/3 days.
Case completed the Pfizer Covid vaccine series on 2/18/21, then was admitted to hospital for treatment of Covid Pneumonia on 8/3/2021.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 9:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.37 for dose administered on 22-Jun-2021.  No concomitant medications were reported.  Batch number 008C21A underwent temperature excursion on 22-JUN-2021 with temperature 35 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 27-MAY-2021 and beyond use date for the vial was reported as 26-JUN-2021. Product moved to clinic on 22-JUN-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Poss allergic reaction to vaccine after dose (1) developed sig red hives all over body and more on the arm of injection site. Severe redness/tenderness to arm (injection site)
pt recvd vax & on 11jan94 had fever of 105; seen by PA, PE nl; dx: probable virus; pt OK next day;
fever, sz 30NOV98 PM; vomiting, diarrhea, fever, thrush 1DEC98;seen by MD given ATB;
Two days after vaccine patient noticed left arm swollen, red and warm to touch. Diagnosed by physician assistant with cellulitis of left arm. 500mg of ZITHROMAX given in office and script for KEFLEX 500mg three times a day sent to pharmacy. Patient informed if not getting better to follow up.
Redness, swelling at injection site. Tenderness, swelling of arm of injection achiness generalizes.
Tired; headache; achy; This is a spontaneous report from a contactable other healthcare professional (hcp).  A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL1283, expiry date not reported), intramuscular in the left arm on 07Jan2021 11:45 at a single dose for Covid-19 immunization. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination (not diagnosed with COVID-19). Concomitant medication included pantoprazole. The patient had the first dose of BNT162B2 (lot EK5730, expiry date reported) for Covid-19 immunization on 17Dec2020 16:00 at a single dose in the right arm intramuscularly. The patient had no other vaccine in four weeks. Both Covid-19 vaccinations were administered in the hospital. On 08Jan2021 12:00, the patient was tired, had headache, and was achy. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatment was received in response to the events reported. Since the vaccination (post vaccination), the patient has not been tested for COVID-19. The outcome of the events tired, headache, and achy was recovering.
Patient reports hours later he was extremely anxious, wanting to "pull his hair out." He does not have history of anxiety. Later that night and for another 3 days had sever exhaustion during the day time and insomnia at night.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medication, drug reactions or allergies was provided. The patient was administered 5 doses of Haemophilus influenzae type b (Hib) containing vaccines on the following dates. On 04-JAN-2016, he was given the first dose of PENTACEL (dose and route of administration not provided). The second dose was administered on 11-MAR-2016. On 16-MAY-2016, the patient was vaccinated with the first dose of LIQUID PEDVAXHIB (dose, lot #, expiration date and route of administration not provided). He received subsequent two doses of LIQUID PEDVAXHIB on 29-DEC-2016 and 03-MAR-2017. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 10:00 as dose 1, single (Lot number: EN6204), in left arm and on 27Mar2021 at 10:00 as dose 2, single (Lot number: ER2613) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Nov2021 at 09:45 as dose 3 (booster), single (Lot number: 012H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate aplastic anemia" (unspecified if ongoing), notes: Moderate aplastic anemia; "minor PNH clone" (unspecified if ongoing), notes: minor PNH clone; "low WBC" (unspecified if ongoing), notes: low WBC; "known allergies: bee stings" (unspecified if ongoing), notes: known allergies: bee stings. The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim"; Codeine, reaction(s): "known allergies: codeine". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Positive; (28Jul2022) negative; (30Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Prescribed Paxlovid on 21Jul2022, first day of positive test (exposed by husband who was also put on Paxlovid two days prior). Symptoms were fever 100.4, cough in upper chest, chills, body aches, headache. Symptoms improved 2 hours in to the 2nd dose. Finished all 10 doses, symptoms greatly improved. Tested negative on 28Jul2022. Only symptoms at that time were slight cough and exhaustion. 3 am on 30Jul2022 woke up with swollen glands and sore throat. Tested positive by 9 am and symptoms worsened to heavy sinus congestion, very raw throat, coughing, sneezing, swollen glands. Started maximum doses of Tylenol and Motrin (alternating), Sudafed, Mucinex with little to no relief. Temperature 96.6. No doctor appointments available until 02Aug so continuing with over the counter medications for now. Still extremely congested in sinuses, clogged ears, dry and unproductive cough, bad headache, swollen glands, very sore throat on Day 3 after second positive test. the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.
pt recv vax & 12hr later began to itch all over body;pt had no rash @ the inj site or anywhere else on body;pt had no acute distress, moist mucous membranes;no audible wheezing, no visible resp distress;no facial swelling;
half Moderna dose was accidentally given; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (half Moderna dose was accidentally given) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (half Moderna dose was accidentally given). At the time of the report, ACCIDENTAL UNDERDOSE (half Moderna dose was accidentally given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details was reported. No treatment details was reported.
Client received vaccines, has passed out before from immunizations mother reported.  After receiving vaccines client turned a little pale, client was laid down on a bed and given apple juice to drink.  She stayed down for approximately 10 minutes, then mother and daughter left, stating that she was feeling fine.More than 20 minutes after vaccination, Client returned to clinic with mother and sister to have sister receive vaccinations.  Client stated that she didn't feel well and laid down on the chairs in waiting area.  She mumbled something to mother and had a seizure and rolled off the chairs she was laying on.  Mother caught her and eased her to the floor.  The seizure lasted less than a minute.  Offer to call an ambulance was refused. Cold cloth was applied to forehead and arms. Mother was encouraged to take her to the doctor.  Mother was called 06-05-07 am, mother stated that patient had a doctors appointment today to be seen.  She stated that she was acting normal today and that she would call if the doctor stated  anything wrong.
Severe tinnitus in the right ear, almost no sound, and there is a heartbeat frequency.
Dizziness,    numbness in hands and feet,     difficulty walking (resolved after a week),    headache,    fatigue,    increased blurry vision,    aching pain in solders and hips that still persists to today (10-25-2023).
The day after the shot, patient developed low-grade fever which lasted 3 days.  For 3 days, the patient was lethargic and had no energy to perform normal household duties.  On the 3rd day after the shot, patient developed tachycardia for several minutes, became feverish with a clammy sweat and had vertigo saying the room was spinning and said she felt like fainting.  She could not recognize her son, asking him, "Who are you?" Patient lost site in her eyes which was recovered several minutes later.  Patient felt better starting the 4th day.
Developed Shingles affecting left trigeminal nerve within 2 weeks of receiving initial dose.  No patient history of prior shingles case and patient has not received the Shingles vaccine.    May not be causitive.  Reporting for statistical purposes
Case number PHEH2014US010455, in an initial spontaneous report received from a pharmacist on 20 MAY 2014. The report refers to a 37 or 38 year old male patient. Pharmacist reported that the he administered an expired dose of FLUVIRIN 2013/2014 (batch number: unknown) intramuscular to the patient on 19 MAY 2014. The patient had no complaints of adverse reaction. No further information was provided.
patient received 4th dose at aged 12 months of age/no AE; Initial information received on 24-Jan-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12-month-old patient of unknown gender who experienced received 4th dose of IPV (VERO) [IPOL] at inappropriate schedule. Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due inappropriate schedule of vaccine administered.   At the time of report, it was unknown whether adverse event was experienced 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 and Module VI of the 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.  Information on the batch number was requested.
Dizziness, headaches, extreme tiredness, losing vision and feeling dizzy when sitting up or standing
ON 1/1/21, DEVELOPED A RED RASH AROUND INJECTION SITE.
About three hours after receiving the vacine I had a bout of explosive diarrhea. I did not correlate this with the vacine at that time. Later that evening I started to experience symptoms (chills, feeling feverish, head congestion and body aches) very similar to my first and second doses.  The next morning I woke feeling OK, did garden work for a couple hours but continued with diarrhea.  That night, Saturday the 25th I started a cough that was continous, racking, dry and sometimes productive along with a fever over 99 which is very unusual for me, and intensifing congestion, body aches, chills, diarrhea, headache.  The symptoms continued thru Monday the 27th when I called my doctor and received a tele-visit for the 28th.  When I talked to the doctor the symptoms were still coninuing at about the same intensity. I was prescribed a Azithromycin, Oseltamivir Phosphate and a decongestant.  Today, 10/1/2021 I am improving but still have times of coughing, chills and diarrhea.
possible ITP; nose bleeds; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced possible ITP (Idiopathic thrombocytopenic purpura) on an unspecified date, nose bleeds on an unspecified date, right after vaccine administration. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Client stated that 4 days after 1st dose Pfizer COVID vaccine received in Right arm 04/24/21 (LOT EW0172) she developed redness, itching, swelling and pain at injection site. Client stated she also developed inflamed gums, bumps in her mouth and a bump under her tongue  Client took Benedryl with no relief. Client stated the symptoms lasted approximately 24 hrs and resolved on their own. Client denied shortness of breath, chest pain, dizziness, headache or difficulty swallowing.  Denied pain anywhere else and denied trauma to the area. Client stated positive for allergies to eggs and dairy with skin inflammation response, denied allergy to medication/environment and denied any other medical history or medication use. She stated she did not consult with a PCP because Google stated it was a common reaction for her age group.