chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 2NOV97 & 5NOV97 states arm red, swollen in area of DT;instructed pt to ice area & call w/update;no fever;no warm to touch;6NOV97 called pt for update arm inc redness & warm to touch;came in & saw MD;
Severe headache, swollen lymph nodes underarm, swollen joint and pain, feverish
Patient after taking a nap and applying ice to swollen cheek. Also c/o red swollen tongue and swelling of Rt cheek last night at 2 am. The tongue is no longer swollen but it is still red and her cheek swelling has decreased. She also has a hoarse voice. No Benadryl in the house. Patient urged to go to ED immediately to be evaluated.
After vaccines were given patient started to vomit and she felt pale, recoverd in 10 min.
Miscarriage less than a week after the second vaccine with Moderna. Estimated due date 01/07/2022, started with extreme dizziness and ended with Contraction like cramps and bleeding. History of very healthy full term pregnancies.
Pt describes onset of nausea and vomiting, with cough, sneezing, belching and fever. Worse x2 days and progressively better since yesterday 10/6/14.
Redness, swelling, small pustular lesion left arm 1 day after vaccination.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2022 at 12:42 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Mar-2022 at 12:42 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  The Ethnicity of the patient was reported as white. The time of vaccine administration was reported as 12:42:40.   No treatment medication was reported by reporter.
pt started had inc temp p/vax;pt given Ibuprofen temp to 101 the highest;pt started w/a blood curdling screaming & crying & jerking a little;pt slept for only moments & awake w/screaming/crying;sz;pt clumsy & wobbling;dx feb sz, myoclonic;
COVID 19; COVID 19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 at 12:30 as dose 3 (booster), single (Lot number: FF2587) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Mar2021 at 11:00 as dose 1, single (Lot number: 036A21A), in left arm, on 06Apr2021 at 11:45 as dose 2, single (Lot number: 037A21B), in left arm, on 19Feb2022 at 10:15 as dose 4 (booster), single (Lot number: 083J21A), in left arm and on 09Sep2022 at 16:45 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "known allergies: Shrimp" (unspecified if ongoing), notes: known allergies: Food: Shrimp. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2021 at 12:30, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid (lot number: GFG450) from 03Dec2022 to 08Dec2022.
second dose of vaccine as far out as 3 months after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine as far out as 3 months after the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine as far out as 3 months after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine as far out as 3 months after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
The patient has had only watery stools since the day after the vaccination (over 3 weeks by reporting date). Patient is also experiencing drowsiness.
Fever 103 degrees, arm swelling at site (Prox. 3" by 4" patch) felt awful, achy, tired - went back to the doctor (9/14). CIPRO 9/12 - 9/16. CIPRO 9/18 - 9/22. 10/12/2017 still have a small lump (hard) on right arm.
Started out feeling out of energy about 12 hours after the 2nd dose along with having aching arms and legs.  Around 14 hours after the dose I got a fever, chills, hot flashes.  Took Tylenol and went to bed   Went to bed and kept waking up feeling hot or cold.    Woke up in the middle of the night and experienced a vivid hallucination.  This morning as I write this I still have a small fever and headache, running nose.  My arm became really sore at the site of injection.
Initially, post vaccination on 2/12/21, patient experienced pain, and swelling at the injection site which then resolved. Yesterday on 2/20/21, patient started experiencing discomfort, redness and swelling at injection site (left deltoid). referred patient to primary provider if symptoms worsen
A few minutes after receiving the vaccines the patient became lightheaded and nearly fell after losing balance/strength in her legs.  She was caught and moved to a chair where she was groggy and in a haze (consciousness appeared intact) for a few more minutes and sweating profusely.  BP was recorded at that time to be 101/73.  After smelling some alcohol pads, drinking some water, and eating a few pieces of candy, patient recovered a bit but remained tired until the paramedic checked on them.  Patient had recovered enough to deny further services with a witness present. Patient reported that this was not the first time they had had this reaction since she had a strong fear of needles but reported it was the first time it happened after a vaccine and it happened more often during/after blood draws for lab testing.
shingles; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, in 2014, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Pain on the administration site; chill without fever; Some aches and pains throughout my body; Some aches and pains throughout my body; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 08:00 (Lot number: EWO217) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Patient Medical History (including any illness at time of vaccination):, Illness/AE: Allergies/Asthma, stop date: Ongoing checked; "environmental allergies" (unspecified if ongoing); "Known allergies: Only penicillin" (unspecified if ongoing); "Allergies" (ongoing), notes: Patient Medical History (including any illness at time of vaccination):, Illness/AE: Allergies/Asthma, stop date: Ongoing checked. Concomitant medication(s) included: LEVOCETRIZINE HYDROCHLORIDE taken for hypersensitivity (ongoing); MONTELUKAST taken for asthma (ongoing); ADVAIR taken for asthma (ongoing); SPIRIVA taken for asthma (ongoing); NASONEX taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWS318, Location of injection: Arm Left, Route of Administration: Intramuscular, first 2 shots had very minor side effects only pain on the administration site), administration date: 23Mar2021, when the patient was 59 years old, for COVID-19 immunization, reaction(s): "Pain on the administration site"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWS318, Location of injection: Arm Left, Route of Administration: Intramuscular, first 2 shots had very minor side effects only pain on the administration site), administration date: 02Mar2021, when the patient was 59 years old, for COVID-19 immunization, reaction(s): "Pain on the administration site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Nov2021 01:00, outcome "recovering", described as "Pain on the administration site"; CHILLS (non-serious) with onset 06Nov2021 01:00, outcome "recovering", described as "chill without fever"; PAIN (non-serious), PAIN (non-serious) all with onset 06Nov2021 01:00, outcome "recovering" and all described as "Some aches and pains throughout my body"; HEADACHE (non-serious) with onset 06Nov2021 01:00, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of vaccination site pain, chills, pain, pain, headache.  Additional information: The patient reported that I had the booster dose on 25Nov2021 at 8:00 AM, and I started having pain at the of the injection site around 12 noon, and started having body ache and chill around 5 PM and lasted until the next day (05Nov2021) early night (9 PM). first 2 shots had very minor side effects only pain on the administration site. No other vaccine in four weeks. No covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
QUADRACEL was inadvertently administered to a 6 month old baby instead of the recommended vaccine for their age (with no adverse reaction); Initial information received on 10-May-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6 months old female patient to whom diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was inadvertently administered to a 6 month old baby instead of the recommended vaccine for their age (with no adverse reaction).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine (rotavirus vaccine); and pneumococcal vaccine conj (pneumococcal conjugate vaccine).  On 06-May-2022, the patient received a dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine suspension for injection at a dose of 0.5 ml total once (lot L5763AA; expiry date: 26-Aug-2022; strength: unknown) via intramuscular route in the right thigh as Immunization.  On 06-May-2022, the diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine was inadvertently administered to a 6 month old baby instead of the recommended vaccine for their age (with no adverse reaction) (product administered to patient of inappropriate age) (latency: same day).  It was reported that, the baby was born prematurely and they were catching up the series of vaccines.  Action taken : not applicable.  At time of reporting, the outcome was Unknown.  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 the guidelines. 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.; Sender's Comments:  01096752:
D-Dimer test results were 3.3 Horrible, itchy rash all over body. I have pictures if you need them.  Drop in blood pressure.  I have picture of the machine results if you need them.  Shortness of breath Dizziness
51 year old female patient, with a history of migraines and eczema, presents to ED with complaints of an allergic reaction. Approximately ten minutes after receiving her first Pfizer COVID-19 vaccination dose at the Vaccination Clinic (around 4:20 PM), patient developed swelling to her tongue, mild hoarseness of her voice, and very mild shortness of breath. Patient was not given any medications while in the vaccination clinic and was brought into the ED immediately. She only has one known medication allergy to Percocet. Patient has no other associated symptoms including cough, wheezing, chest pain, nausea, vomiting, diarrhea, or rash. She has no other pertinent past medical history. There are no other medical complaints at this time.
Infertility. First vaccine dose in January 2021, second dose 3 weeks later, booster October 2021. Diagnosed with azoospermia in October 2021. Zero sperm count.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.  No Medical History information was reported. On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not provided. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and POOR-QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).  No concomitant medications were reported. No treatment medications were reported. This case contains information for the 27 of 100 patients. This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report). Sender's Comments: MODERNATX, INC.-MOD-2023-697752:Master case.
Every day since February 21st, I have chills and a low-grade fever.  When I get the chills, my skin is cold to the touch.  I have to get under several blankets and an electric throw on the highest heat setting to get warm.  This may take several hours.
vaccinated a female patient wit Varivax diluet with Lidocaine instead of Sterile Diluent; This spontaneous report has been received from a pharmacist, concerning a 5-year-old female patient.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 08-JUL-2019, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis which was diluted with lidocaine(LIDOCAINE) (dose, frequency, route, lot number, expiration date and indication were not provided) instead of sterile diluent (wrong technique in product usage process).
I had a mild fever and chills, nausea, dizziness and headache.  I was so cold that my teeth started chattering.  The next couple of days I had sever fatigue, muscle pain and digestive issues.  The worst part I experienced a racing heart but my BP was normal.  My lymph nodes under my left arm started to swell and my lymph nodes in my neck got bigger.  I experienced extreme itchiness in my throat, my hair and my skin. It took about a month for me to start to feel normal.
pt recvd vax & 36 hrs p/inject stopped breastfeeding; exp abdo pain as a two week old;
No adverse event: PPD inadvertently substituted for flu vaccince.  0.5ml of PPD given deep IM in deltoid.  No adverse events.  No local reaction.  Patient recently PPD negative prior to this event.
This spontaneous report as received from the nurse refers to unspecified number of patients. No medical history and concurrent conditions were reported. On an unknown date, the unspecified number of patients were inadvertently vaccinated with improperly stored M-M-R II (lot number, dose, frequency and route of administration was not reported) and did not experience any adverse event. The outcome of the reported events were unknown. The reporter considered incorrect product storage to be not related to M-M-R II. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
rash around inj site;19MAR95 c/o pain in both knees;would not walk or navigate stairs
24 hrs p/vax unconsolable crying; red rash over entire body, eyes swollen shut; temp 102, pt seen by MD;
Swollen leg possible blood clot, couldn't walk for days. got antibiotics and its coming along still swollen but able to walk again somehow
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 05-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L037924, expiration date 22-JUN-2017, orally; exact dose was not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature at 48 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided. On an unknown date, the patient was vaccinated with the first dose of VAQTA intramuscular injection (strength, dose, route of administration, lot number and expiration date were not provided). Subsequently, on an unspecified date 5 months following the first dose, the patient was vaccinated with the second dose of VAQTA (strength, dose and route of administration were not reported), lot number L004745 with expiration date on 28-APR-2017. Leading to an inappropriate schedule of drug administration; no adverse event or product quality complaints were reported. Additional information has been requested.
Received Tdap left arm and PPD R forearm on 8/23/14 at 4PM. 5 hours later B/L upper arm pain. Left arm pain resolved by 8/26/14. R upper arm pain persisted, associated with progressive pain and inability to raise right upper arm. Pt. received previous Tdap 3/24/09/.
On March 28th, 2021 I had a TIA and had to go to the emergency room via ambulance and was admitted to Hospital.   I was having trouble speaking and was very confused.  I had no risk factors for stroke and they have since found no reason for my TIA.
On 5/13/2000 localized redness and sore area was noted on left deltoid. On 5/14/00 redness had spread on upper left arm and soreness was noted in axillary area. Raised red rash was also noted local site. Complaint of headache and nights sweats. Did not take temperature.
Pt experienced chest pains, vomiting and nausea. Diagnosed with ulcers.