chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called clinic on 01/15/2016:  Pt experiencing swelling and warmth at Tdap injection site; immunization given on 1/11/16. Denies fever, itching, drainage at site. Complains of blisters in throat and general malaise. Advised cool compresses at site, Tylenol for comfort. No appointments available today; advised patient to go to walk-in clinic if symptoms increase or new symptoms develop. Pt verbalized understanding. Initial call taken by RN, January 15, 2016 6:07 PM. Patient called clinic on 01/18/2016: Pt called in regards to recent TDAP Whooping Cough. States she immediately got sick from said inj, and developed blisters in throat. Discussed symptoms with pharmacist and was informed there is latex in shot, which she is mostly certain she has an allergy to. Pt wanted to inform her provider and all other providers so as to make note for any future pts that might be susceptible to said reaction. Initial call taken January 18, 2016 12:38 PM. Added to allergies. Please be advised. Noted. Take Benadryl for a day orteo if still with sore throat (hopeflly not allergic to Benadryl). LATEX and TDAP added to allergies already MD, January 24, 2016 7:54 PM. Follow-up by CMA, January 18, 2016 3:21 PM. Spoke with pt. to be sure she got prior message, she stated she takes antihistamine 3xday and believes that helped with this reaction.  Per our Izzy Coordinator, she does not think our brand of izzy has Latex in it.  I spoke with the CDC and they confirmed there may be latex in the syringe cap but not in the vial itself. I spoke with pt. again and she stated she has never been tested for latex allergy, is allergic to tapes, and again said she got blisters on her throat.  I told her I would let her PCP know and we may test her at next OV.  Pt. verb. understanding. Action Taken: Provider Notified. Follow-up by RN, January 27, 2016 4:39 PM. Will consider referral to ALLERGOLOGIST. Electronically signed by MD on 01/27/2016 at 6:03 PM.
One week post vaccine, caller's mother started to feel "phlegm-y", coughing up clear phlegm.  The next day she was more lethargic, coughing.  Called her PCP, recommended Robitussin and Mucinex which she took.  Continued to feel worse.  No fever although she had cold sweats.  She felt a lot of GI pain, fullness, could not eat/drink.  Called PCP again by the 4th day of feeling bad.  Recommended Augmentin and she took 2 doses.  On 3/12 and 3/13, had difficulty breathing, coughing.  Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV.  Given morphine for pain.  She tried to take a  GI cocktail which she felt like she was choking on. That evening on her BP bottomed out.  They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14.
ill feelings; Still ill feeling; Down feeling; Tiredness; Sore throat once in a while; Nausea; I am unwell; Woke up and my right ear I could hear my heartbeat; I could hear my heartbeat I mean really, really loud that it kind of woke me up;; Chills; Eye was kind of swollen; in the right eye I had, all red, the white was red; in the right eye I had, all red, the white was red for somehow the middle thing pop; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a 2nd of 2 reports. This consumer reported for a female patient that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWO80), dose 1 via an unspecified route of administration on 28Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ill feelings; still ill feeling, down feeling, tiredness, sore throat once in a while, nausea, unwell, woke up and right ear could hear, could hear heartbeat i mean really, really loud that it kind of woke me up, chills, eye was kind of swollen, in the right eye i had, all red, the white was red, in the right eye i had, all red, the white was red for somehow the middle thing pop, some were just annoying; not really bad off, it is just annoying, the way i feel just not myself (irritability, and feeling abnormal) on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100962492 same product and event, different patients
right armpit and axilla swelling, pain in lymphnodes; right armpit and axilla swelling, pain in lymphnodes; headache; fever; fatigue; Vomit; Dizzy; rash not sure first time but within first 12 hours over chest and trunk; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 36-year-old female patient received second dose (lot number: Ek9231) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 36-years, on 08Jan2021 19:00 (07:00 PM) at single dose in right arm; first dose (lot number: Eh9899) on 18Dec2020 07:00 PM at single dose; both via unspecified route of administration for COVID-19 immunisation in hospital. Medical history included thyroid issues; allergies to latex and adhesives. No COVID prior vaccination. No other vaccine in four weeks. Patient is not pregnant. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA). The patient previously took thimerosal and experienced allergy to it. On 08Jan2021, the patient experienced vomit and dizzy within 1 hour of vaccine. Rash not sure first time but within first 12 hours over chest and trunk. On 09Jan2021 (next day) headache, dizzy, fever, fatigue. On 11Jan2021 (after 2 days), right armpit and axilla swelling, pain in lymphnodes. It was unknown if treatment was received or not. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. No COVID-19 tested post vaccination.
Gave vaccine Subcutaneous and not intramuscular. Pt had left arm pain, redness, tenderness to site.
Patient received booster dose one month too early according to the 6 month recommendation. Called to notify patient that she may have more side effects than normal such as nausea, fever, headache, arm soreness, body aches and pains, and fatigue. Patient was feeling fine at the time of the call.
Information has been received from a 74 year old female patient with no allergies and high blood pressure who on 07-FEB-2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant medications included "other medications, nothing new" (not further specified). In approximately the end of April 2007 the patient experienced an itchy rash that lasted for about 5 to 6 months. A biopsy "showed something but the dermatologist could not determine what it was." The patient's skin still dry and itching and the "the rash seems to be coming back (flat red bumps) again." The patient also mentioned that she visited the dermatologist and her physician and they both said "it does not seem that the zoster vaccine live (Oka/Merck) vaccination could have caused it" but the patient had not been on any new medication, other than the zoster vaccine live (Oka/Merck). The rash is on the patient's upper legs, trunk, and arms, and where the old rash was she now has purple patches (skin discoloration). No product quality complaint was involved. Additional information has been requested.
No adverse event; patient received the bivalent Moderna booster instead of 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the bivalent Moderna booster instead of 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the bivalent Moderna booster instead of 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the bivalent Moderna booster instead of 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the bivalent Moderna booster instead of 2nd dose).    No concomitant medication were reported. On an unknown date, patient received first dose of Moderna vaccine (batch number 0530322A) No treatment information was provided by the reporter.
Fever of 101.5F; headache; chills; Body aches; Nausea; This is a spontaneous report received from a non-contactable Other Healthcare Professional (HCP). The patient reported for self.  A 27-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: solution for injection: Lot/Batch number: EP 6955, Expiration date: not reported), via an unspecified route of administration on 27Mar2021 09:15 (at the age of 27-year-old) administered in the left arm as dose 2, single dose for COVID-19 immunisation. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: solution for injection: Lot/Batch number: EN 6202) via an unspecified route of administration on 06Mar2021 at 10:00 administered in the left arm as dose 1, single dose for COVID-19 immunisation. Patient medical history included IBS (Irritable bowel syndrome) and allergy to mangoes both from unspecified dates and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications with in two weeks of vaccination included: Skin supplement, Trazadone, lactobacillus nos (CULTURELLE), melatonin for unspecified indication and unknown if ongoing. Patient was not diagnosed with COVID prior vaccination. COVID post vaccination was none. On 28Mar2021 at 05:00 am, the patient experienced fever of 101.5F, headache, chills, body aches, nausea. Since the vaccination, the patient has not been tested for COVID-19. The patient did not visit emergency room or a physician for the events. The patient was treated with ibuprofen for the events. The events were reported as non-serious. The outcome of the events was Not recovered.  No follow-up attempts are needed. No further information is expected
child got a red rash over cheeks, spread down to trunk then extremities, now resolving but on arms & legs;this started the day of vax;no fever or other sx;pt was exposed to 5th's disease;
Moderna Covid vaccine.  Covid arm stron g reactions. 2/11- 2/13  Swelling, bruising, redness, extreme itchiness, pain to to tightness.  Treated with Benadryl, hydrocortisone crepe, ibuprofen, rest.  Three day duration.  Another brief reaction 2/17.  Same symptoms milder and shorter duration of i.5 days.
Woke up that day and felt Nasally and had a slight cough. I started to feel bad, and had a slight fever of 100.3 just before bed. The next 4 days I had just slight congestion and a cough.
Closed left hip fracture. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Pfizer Bivalent COVID vaccine for 12+ given to 10 year old in error.   She had high fever the next day which was responsive to OTC antipyretics and went home from school.
I received the second injection of SHINGRIX on Thursday August 20 at noon. I had no bad reaction from the first injection a couple of months age, but this time it was different. Around 8:00 pm, I started shivering as if it was very cold, and I had very loose diarrhea. I felt very tired so I went to bed. The shivering got worse and I couldn't warm up and I started to have muscle and joint pain from head to toe, and I had a fever of 100, and could not get any sleep.
4:30pm C/O discomfort in left arm where vaccine was administered. 4:35pm Cold compress administered to L.D. and provided water to drink.  Patient reported feeling better.
(L) arm - 10cm x 10cm erythema, swelling, pruritus. Treatment - ice, BENADRYL, Ibuprofen.
Rash on same arm as shot received but not at injection site; rather outer arm closer to elbow.  Mostly circular approximately 3-4" in diameter.  Itchy a little when first noticed but not for long.  The rash was gone after 4-5 days.
Severe stomach pain; vomiting; Dose 1: 09Jul2021, Dose 2: 10Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Sep2021 (Lot number: FC3183) at the age of 13 years as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history included: "Spinal cord injury" (unspecified if ongoing), notes: Spinal cord injury at birth that affects muscles. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EW0171, Location of injection: Arm Left), administration date: 09Jul2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (medically significant) with onset 11Sep2021, outcome "recovered", described as "Severe stomach pain"; VOMITING (medically significant) with onset 11Sep2021, outcome "recovered", described as "vomiting"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Sep2021, outcome "unknown", described as "Dose 1: 09Jul2021, Dose 2: 10Sep2021". The events "severe stomach pain" and "vomiting" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of abdominal pain upper, vomiting with IV fluids and nausea medication.  Follow-up attempts are completed. No further information is expected.
5/11 Had Hep B Booster after low titer after possible blood exposure Had wrist swelling 24 hour later 72 hour later shoulders knees ankles swollen red all joints hurting no fever red and swollen hands and knees and ankles 1 week later better 5/25 various joints continue flair up and be painful red and swollen
She and twin sister presented with seizures (GTC) several hours after receiving 4 month immunizations.
This spontaneous report as received from a physician via company representative refers to an 80 year old female patient. The reporter stated that after administered a dose of ZOSTAVAX (lot# unspecified) (dose, route and location unspecified) and an unspecified flu vaccine (manufacturer unknown) concomitantly on an unspecified date, the patient developed a high fever and had to be hospitalized overnight. The reporter reported that the patient responded well to the unspecified treatments given at the unspecified hospital and went home on an unspecified date the next day. The outcome was unspecified by reporter. Additional information has been requested.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 08-NOV-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005169: US-009507513-1612USA005168.
Large bruise and swelling at injection side, headache, body aches, nausea, numbness/tingling in left arm. Persisting for at least a week after injection date.
Initially sure with small erythema 36-48 hours after. Later arm tender with 6cm swelling noted. This doubled in size by 72 hours. After 5 days pain resolved. Swelling remains, but seems to decreased.
a rash began to appear on my right hip area; it was itchy; red; It was all over my backside/The rash is up to my neck/shoulders now,; hot/angry; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 15:15 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing); "Allergies." (unspecified if ongoing); "known allergies: Ceftin spores" (unspecified if ongoing), notes: known allergies: Ceftin spores. Concomitant medication(s) included: FLU, administration date 21Oct2021. Past drug history included: Doxycycline, reaction(s): "known allergies: doxycycline". Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=Phizer,, prev_dose_brand_unknown=False,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Una, ble to locate or read the details,, prev_dose_administration_date=01May2021, prev_dose_dose_number=2,, prev_dose_vaccine_location=Left, arm},), administration date: 01May2021, when the patient was 39 years old, for Covid-19 Immunization; Bnt162b2 ({prev_dose_product=COVID 19,, prev_dose_brand=Phizer,, prev_dose_brand_unknown=False,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Una, ble to locate or read the details,, prev_dose_administration_date=03Apr2021, prev_dose_dose_number=1,, prev_dose_vaccine_location=Left, arm}]), administration date: 03Apr2021, when the patient was 39 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Nov2021 15:15, outcome "unknown", described as "booster dose"; RASH (non-serious) with onset 06Nov2021 20:00, outcome "recovered with sequelae", described as "a rash began to appear on my right hip area"; PRURITUS (non-serious) with onset 06Nov2021 20:00, outcome "recovered with sequelae", described as "it was itchy"; ERYTHEMA (non-serious) with onset 06Nov2021 20:00, outcome "recovered with sequelae", described as "red"; RASH (non-serious) with onset 06Nov2021 20:00, outcome "recovered with sequelae", described as "It was all over my backside/The rash is up to my neck/shoulders now,"; FEELING HOT (non-serious) with onset 06Nov2021 20:00, outcome "recovered with sequelae", described as "hot/angry". The events "a rash began to appear on my right hip area", "it was itchy", "red", "it was all over my backside/the rash is up to my neck/shoulders now," and "hot/angry" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of rash, pruritus, erythema, rash, feeling hot. The lot number for bnt162b2 was not provided and will be requested during follow up.
On 10/21/2022, patient was inadvertently vaccinated with a dose  of COVID-19 monovalent vaccine which had expired on 9/30/2022. No known adverse effects experienced by the patient, to date.
I had a mild sore throat that maybe last a day and a half. And I also had a headache here and there over the day abd a half or so. The first day, I did begin to take Paxlovid.
Received initial dose of the new shingles vaccine in left arm. By early the next afternoon, I had a headache and chills which continued for several hours. My left arm was very red and swollen. It remained red and swollen for the next 6 days.
Loss of smell; Congestion on  nose; Very thick phlegm; Difficult to breath; Tiredness; Body ache; Felt like he was running a fever; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), NASAL CONGESTION (Congestion on  nose), PRODUCTIVE COUGH (Very thick phlegm), DYSPNOEA (Difficult to breath) and FATIGUE (Tiredness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Diabetes.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ANOSMIA (Loss of smell), NASAL CONGESTION (Congestion on  nose), PRODUCTIVE COUGH (Very thick phlegm), DYSPNOEA (Difficult to breath), FATIGUE (Tiredness), MYALGIA (Body ache) and PYREXIA (Felt like he was running a fever). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) at an unspecified dose and frequency. On 26-Apr-2021, ANOSMIA (Loss of smell) had resolved. At the time of the report, NASAL CONGESTION (Congestion on  nose), PRODUCTIVE COUGH (Very thick phlegm), DYSPNOEA (Difficult to breath), FATIGUE (Tiredness), MYALGIA (Body ache) and PYREXIA (Felt like he was running a fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication for blood pressure, diabetes and cardiovascular system.
Parkinsons Disease diagnosed Jun03. Tremor began Jul99, 4 mo after AVA #3.