chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning her 17 year old daughter with no pertinent medical history, who on 17-JUL-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  On 19-JUL-2007 the patient experienced tingling in her hands and feet.  On 22-JUL-2007, the patient recovered from tingling in hands and feet.  The patient did not seek medical attention spontaneously.  No laboratory or diagnostic tests were performed.  Additional information is not expected.
migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia and Arthritis.    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 MIGRAINE (migraines). At the time of the report, MIGRAINE (migraines) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-402744 (Patient Link).   Reporter did not allow further contact
Information has been received from a pharmacist via center referring to a 23 year old female patient. The patient's relevant medical history included smoking and she had a 5 month old child. Her relevant past drug history was unknown. On 21-AUG-2015 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # L007720, expiration date 08-JUL-2016), intramuscularly in the left arm. Other suspect therapies included FLUARIX QUADRIVALENT (lot#, expiration date, dose and route unspecified). Concomitant therapies included ethinyl estradiol, norgestimate. On 22-AUG-2015, the patient called pharmacy complaint of left arm swelling at the injection site, bright redness, tenderness, pain, puffiness and unable to lift arm. The pharmacist stated that the reaction might be worse because she received FLUARIX QUADRIVALENT on the same day. It was unknown if there was relevant lab data. As of 23-AUG-2015, the patient was not longer on PNEUMOVAX 23 or FLUARIX QUADRIVALENT, but the events continued. Additional information has been requested.
Deep sweat; Dizzy; Sore Shoulders; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), HYPERHIDROSIS (Deep sweat) and ARTHRALGIA (Sore Shoulders) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No Medical  History provided). Concomitant products included CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE (INVOKAMET), OMEPRAZOLE, LISINOPRIL, HYDROCODONE and AMLODIPINE for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced ARTHRALGIA (Sore Shoulders). On 08-Jan-2021, the patient experienced DIZZINESS (Dizzy). On 09-Jan-2021, the patient experienced HYPERHIDROSIS (Deep sweat). At the time of the report, DIZZINESS (Dizzy), HYPERHIDROSIS (Deep sweat) and ARTHRALGIA (Sore Shoulders) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature (low-Unknown): 93.5 (Low) degrees Fahrenheit and 95.2 (Low) degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received the Covid vaccination on 01/15 and on 01/22 noticed that her shoulder, where the vaccine was placed, was red, the size of a half dollar, itchy, warm to touch, shinny and growing larger. Today it is the size of her shoulder.
(R) thigh - cellulitis. Allergic rxn to PCV13. Rx Amoxicillin.
Prior to taking vaccine #2, patient was fine. patient had no reaction other than fatigue.; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 11Mar2021 18:30 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hemiplegic migraine" (ongoing), notes: life-long hemiplegic migraine patient.; "mitral valve prolapse" (unspecified if ongoing). Concomitant medication(s) included: IMITREX; EXCEDRIN MIGRAINE. Past drug history included: Reglan, reaction(s): "known allergies". The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Prior to taking vaccine #2, patient was fine. patient had no reaction other than fatigue.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient has no Covid prior to vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021380488 same reporter/patient/drug, different dose number/event
This spontaneous report was received via a company representative from a 45-year-old male patient, who is also a pharmacist and was reporting on himself. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. On an unknown date, reported as "some time on the past", the patient self-administered a dose of PNEUMOVAX 23, injection (dose, route of administration, lot # and expiration date were not reported) for that he could "know what the vaccine felt like". On an unknown date, the patient experienced injection site reaction that was very painful, itchy, red and swollen. No treatment was given for the adverse events. The patient did not seek a medical attention. No laboratory diagnostic studies were performed. The outcome of the events was reported as recovered on an unknown date. The reporter did not assess the relatedness between the events and PNEUMOVAX 23. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA004883.
After his flu vaccine, he had stomach flu (low energy levels) etc for 10 days. He is now autistic.
Adacel, Menactra that reached 33.5C; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 11 years old patient who was vaccinated with  0.5 ml of first doses of vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6273AA and Exp. Date 24-Apr-2021) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site on 09-Jul-2019. These vaccines were reached at 33.5C.  The patient's medical history not reported .  Concomitant vaccination included 0.5 ml dose of HPV VACCINE (HPV VACCINE) received via intramuscular route on 09-Jul-2019 (lot number and Exp. Date not reported) for Immunisation.  It was an actual medication error case due to incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
Pt developed redness 15-20 min after injection on lower forearm on Right side where injection was given. Pt instructed to stay extra 15-20 min to further evaluate.  States no others symptons other then redness.  instructed to take Benadryl & monitor. After leave pharmacy to Follow up with PCP.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 17:00 as dose 1, single (Lot number: HD9876) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL0142, Anatomical location: Arm Left), administration date: 04Jan2021, for COVID-19 Immunization; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EL3247, Anatomical location: Arm Left), administration date: 25Jan2021, for COVID-19 Immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FK9894, Anatomical location: Arm Left), administration date: 01Apr2022, for COVID-19 Immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: CRJ2524, Anatomical location: Arm Left), administration date: 30Sep2022, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (16Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Negative; (18Oct2023) Negative. Therapeutic measures (Paxlovid therapy start date: 12Oct2023, stop date: 16Oct2023) were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event vaccination failure and COVID 19 cannot be ruled out.    ,Linked Report(s) : US-PFIZER INC-202300335901 same patient, different drug and event;
Received shot at approximately 2pm and was in observation chairs.  Around 205pm I took a dose of tylenol to attempt to prevent fever.  I immediately noticed that the medication felt stuck in my esophagus and it was hard to swallow them down.  Being a nurse I began to monitor more closely my breathing.  I was able to take air into my lungs easily.  Next I noticed that my nose became very stuffy and was difficulty to breath through but my airway continued to seem ok and I was breathing without difficulty through my nose.  By about 210pm I had noticed that my face felt strange. As another few minutes progress my entire face felt numb like when your dental lidocaine is wearing off.  It was a very disturbing feeling.  I never had difficulty breathing but the throat and nasal swelling lasted about 1 1/2 hours.  The facial numbness lasted at least 4 hours and my nose and tongue still feel a little strange even at this moment.  I stayed in the observation area for about 35 minutes just to make sure I was not going to lose my airway before leaving.  I am a nurse and I didn't want to get sent to the ER for hours just to be given benadryl since my airway was ok so I didn't report it at the time of incident.  I had preloaded with zyrtec, pepcid and ibuprofen the morning prior to injection to try and avoid reaction or side effects that others were reporting.  I think if I had not had antihistamine in my system I would have had anaphylaxis for sure.  I went straight home and took more antihistamine.  Contacted my doctor so she knew of the symptoms.  She told me to continue the antihistamines for a few days and to go to the ER if severe issue happened.  This was a VERY VERY scary incident.   For a little history: after my first vaccine I noticed itching on my chest but couldn't see any rash.  About day 3-4 a rash appeared.  I was unsure if this was vaccine related since it took 3 days to appear.  It was cleared after a few days of steroid cream.
Fatigue; neck stiffness and pain; extremely sore occipital bone; ; inabilityto move my neck from left to rightwithout pain; nauseated;; inner ear pain; eye sensitive to light; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: D46207) via an unspecified route of administration in the left arm on 15Mar2021 at 16:30 as a single dose for COVID-19 immunisation. The patient's medical history was not specified. Concomitant medications were Flonase, Levothyroxine, Lexapro, Xyzal, Nexium and Met started on unspecified dates. The patient had a history of allergies to food, medications or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient has received Flonase, Levothyroxine, Lexapro, Xyzal, Nexium and Met within 2 weeks of the vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 16Mar2021, the patient experienced fatigue, neck stiffness and pain, extremely sore occipital bone, inability to move her neck from left to right without pain, nausea, inner ear pain and eyes that are sensitive to light. Events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fatigue, neck stiffness and pain, extremely sore occipital bone, inability to move my neck from left to right without pain, nausea, inner ear pain, eyes that are sensitive to light were resolving.  No follow-up attempts are needed. No further information is expected.
12 cm diameter redness, warmth, swelling, with superficial oozing of serum.
Caller reports that a patient was administered the first dose of GARDASIL 9 at the age of 50 years old; No additional AE reported; This spontaneous report has been received from a nurse prescriber via a company representative, referring to a 50 years old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not reported.   On an unknown date, the patient was administered the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot number and expiration were unknown) for prophylaxis at the age of 50 years old (Product administered to patient of inappropriate age). No additional adverse event (AE) reported.
Palpitations; I have something wrong with my atrial; Blood pressure also has increased significantly; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration in left arm on 09Mar2021 at 10:15 (at the age of 51-year-old) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received cefadroxil (CEPHADROXIL) and experienced drug allergy, varenicline tartrate (CHANTIX) and experienced drug allergy. Known allergies: Supposedly CEPHADROXIL and bad reaction to CHANTIX. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19 or not. Since the vaccination, the patient has not been tested for COVID-19. On 09Mar2021 at 21:00, the patient experienced palpitations. Went to doctor who ran an EKG and now she have something wrong with her atrial. Patient blood pressure also has increased significantly. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The events were considered as non-serious by the consumer. The patient underwent lab tests and procedures which included EKG (electrocardiogram): Now she have something wrong with her atrial on an unspecified date, blood works: Unknown results on an unspecified date, blood pressure: Increased on 09Mar2021 at 21:00. The patient was treated with BP (blood pressure) medications at the moment for adverse events and blood work done. The outcome of the events was not resolved.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Body aches the following day after immunization.  Skin and muscles hurt when touched.  Some dizziness.   Feeling similar to when you come down with the flu.   Took 2 Tylenol for pain.
Few days later, developed pain in the deltoid area.  Persists still, now 1 month later.
The patient fainted and fell after 10 minutes of injection according to the observation staff. The patient became alert and oriented immediately when I got to her side.  The patient was talking and said she felt fine.  Vitals: 110/72, pulse 56. The patient was positioned in supine with pillow under her head.   Applied cold water towel on her forehead. She was then able to sit up and stand without any problem  after 5 minutes of observation on the floor. The bleeding from the superficial split lower lip stopped immediately with gauze pressure. A superficial abrasion on the left knee was not bleeding.  There was no bleeding lesion on other area of the face or the head.  The patient was evaluated by medics by calling 911 upon patient husbands request .
Pt states losing vision in one eye and has optic nerve inflammation This was reported to pharmacy on 5/11/20
Headache, whole-body muscle ache, chills , fever, fatigue, loss of appetite - after 2nd shot Moderna 030B21A Pharmacy 4-7-21
Left deltoid pneumococcal vaccine site swelling with erythema.  Treatment ice packs, then moist packs, then warm packs.  Decreased swelling by 10/17 area resolving Keflex 500mg every 6 hours for 5 days.  Patient discharged to home 10/18/2003.
PATIENT HAD PFIZER VACCINE 12/23/2020: 01/13/2021, AND TESTED POSITIVE TO COVID.
Parent stated 18 hrs after vaccine child was sitting in cart at Kmart and fell over and was very pale and appeared to have fainted. This lasted 15 min then child was fine; had color change and was limp; was o.k. in 15-20 min.
light headed, stomach hot, feet tingling, sweating throughout the night, lymph nodes swelling
Light headed, cold, nausea, extremely tired, low fever 99.1,blood pressure up to 154/94, faster heartbeat 92
Urticarial rash around injection site over Rt. upper arm with itching and pain. Fever of 102 on 10/28/2015.
Breakthrough case admission after 5 vaccines Moderna 1/12/21 Lot# 026L20A;  Moderna 2/9/21 Lot# 031L20A;  Moderna 11/4/21 Lot# 051F21A;  Moderna 4/29/22 Lot# 056A22A;  Moderna 11/7/22 Lot# 062F22A
Vaccine was incorrectly mixed with 1.5ml of normal saline and not 1.8ml, resulting in a slightly higher dose
somebody hit me with a hammer; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (somebody hit me with a hammer) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History was reported).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (somebody hit me with a hammer). At the time of the report, FEELING ABNORMAL (somebody hit me with a hammer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information regarding treatment was provided.
Extreme pain in joints, reduced mobility, inability to move legs, arms, hands; increased white blood count.  Was hospitalized four different occasions for 2-5 days each. Various tests and medicines were tried.  Pretizone was used for 4 months.
Information was received on 12-JUL-2017 from a nurse practitioner via a company representative concerning a 47 year old female patient. Current medications included valacyclovir  hydrochloride(VALTREX)(indication unknown). No medical history was reported. On 10-JUL-2017, the patient was administered a dose of VARIVAX (lot N001528, unknown expiration date)(route, dose and site not reported) for prophylaxis. After receiving the vaccine, the patient developed a herpes type rash by the mouth 20 minutes after receiving the vaccine. "Rash is non painful and non itchy and is the size of a golf ball."  A cream was prescribed but the  patient could not afford it so the patient was not treated. Titer was checked prior to receiving the vaccine and the titer was low. The patient was taking valacyclovir (VALTREX) and was instructed by the nurse practitioner to stop the medication on the day she received the vaccination and to remain off of the medication for 2 weeks, based on the research of the 2 medications. A viral culture was performed on 10-JUL-2017 (no results reported). The nurse practitioner believes "the rash is from stopping the valacyclovir (VALTREX) and not from the vaccine."  No other information was provided. As of the time of reporting, the patient had not yet recovered. Additional information is not expected. No consent to contact reporter.
Tingling and numbness at injection side and spreading to arm and hand of same side. Strong for 1/2 hour but continued in and off ( more mildly) for several days
Patient had a seizure within 2 minutes after administration of vaccine. While she was seated, her arms and legs started moving, eyes rolled back, she kicked off her shoe. She never left the chair. I had my technincian call EMS. I took her blood pressure and it was 74/50. EMS tended to her and took her out of pharmacy on stretcher. When they got outside to ambulance, she and her husband denied further treatment and refused to go to hospital. She rested in a chair then left after 15 minutes of feeling ok.