chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 5 year old female patient with no illness at the time of vaccination and no pre existing allergies or medical conditions who on 10JUN1999 was vaccinated IM in the left upper arm with a first dose of varicella virus vaccine live. Concomitant therapy administered on 10JUN1999 included a third dose of poliovirus vaccine inactivated IPOL administered SC in the right arm. On 09JAN2004 the patient developed, " a few vesicles on red base on chin, back, extremities." The licensed practical nurse reported the patient recovered. Unspecified medical attention was sought. Additional information has been requested.
Rt deltoid swelling w/small central red papule. Tx w/ice/heat, MEDROL dose pack also numbness, tingling in hand
That afternoon my throat started to hurt a little as if i was getting strep. That evening i went to the doctors and they swab my throat for strep and everything came back negative. After running on tuesday my lower body started to feel a little achy, the pain started to cause swelling throughout my legs to my feet. Later that evening around bedtime my upper body started to have excruciating pain and my arms felt so heavy and were very painful to lift them up. I then called the doctor for an appointment and I was able to be seen the next day. They did blood work on me I don't recall the term they used but the results came back high for something that has to do with inflammation. I was prescribed Ibuprofen for the pain and the swelling.
Horrible itching; Redness; A spontaneous report was received from a Healthcare Professional concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events horrible itching, redness.  The patient's medical history was not provided. Concomitant medications reported were Alendronate, Simvastatin, Gabapentin, Keflex, Tramadol, Estrace, Aspirin, Lactate (before meals), Ellura, Probiotics, Vitamin D3 for drug use for unknown indication.  On 16 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced the events horrible itching. redness.  Treatment details included A cream (unknown)  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, horrible itching, redness was not reported.
1. On April 17, developed fever, muscle aches, chills, dizziness.   2. On April 18, swollen lump at injection site that is warm to the touch. Measures about 2" in width and length, circular in shape. Painful if touched.
The series were very painful; This spontaneous report was received from an unspecified reporter, via a company representative, concerning a female patient of an unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On unspecified dates, the patient was vaccinated with the entire series of GARDASIL (dose, strenght, frequency, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. It was reported that the series were very painful  (also reported as "she did not have any adverse reactions"). Neither the patient's outcome nor the causality assessment between GARDASIL and the adverse event was reported. This is one of several related reports.; Sender's Comments: US-009507513-1706USA000467: US-009507513-1706USA000483: US-009507513-1706USA000486:
Pt stated after Hep B immunization given, I have a plastic taste in my mouth, 12/01/2005 12:10 TC to Pt the plastic taste lasted 15-20 mins. I had a drink the taste went away.
Moderate lymph node edema in axilla, into the chest and up into the neck for 7 days. Started 1 week post vaccination.
Patient came in to receive her second COVID vaccine and reported that she has bruising in her left arm that lasted several weeks. Upon questioning she said that after she received her vaccine she decided to workout that day. She did not report any rashes/swelling/ or any other adverse event. When she came to the pharmacy she did not have any noticeable bruises on her arm.
Nose bleed; Dizziness; it left me little weak; This is a spontaneous report from a contactable consumer. This 75-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) at single dose for COVID-19 immunization on 09Jan2021. Relevant history included High blood pressure. Relevant concomitant drugs included Losartan for Blood pressure high, and hydrochlorothiazide. The patient had the first Covid 19 Vaccine on 09Jan2021 and she knew little bit dizziness was normal but she had a nose bleed in the next morning that she could hardly stop, she finally got it stopped it, it left she little weak so she just wanted to report that, she did not know if anyone had ever had that before (Hence, MI was made). Outcome of event Nose bleed was recovered, the outcome of other event was unknown.
reports taking 5mg once daily 23Aug2021 through 13Sep2021 for covid vaccine.  during this time patient reports an outbreak of shingles; This is a spontaneous report from a contactable other hcp from a Specialty Pharmacy. A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Aug2021 (at the age of 78-year-old) as dose 1, single; dose 2 via an unspecified route of administration on 13Sep2021 (Batch/Lot number was not reported) as dose 2, single, both doses for COVID-19 immunization; tofacitinib citrate (XELJANZ, Batch/Lot number was not reported) 5 mg at a dose of 5 mg twice daily via oral route from on an unspecified date in Oct2020 and ongoing, another dose at 5 mg once daily, via oral route on an unspecified date in 2021 for rheumatoid arthritis. The patient medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced reports taking 5mg once daily 23aug2021 through 13sep2021 for covid vaccine. During this time patient reports an outbreak of shingles. Describe Event, Problem or Product Use Error: patient reports taking 5mg once daily 23Aug2021 through 13Sep2021 for covid vaccine, md aware. During this time patient reports an outbreak of shingles. patient reports that she is now back on xeljanz taking her normal dose of 5mg twice daily, but she cannot remember the date she restarted her normal dose. md aware. no further information or details reported. The action taken in response to the event for tofacitinib citrate was unknown. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a RN concerning a 52 year old Hispanic female pt with no allergies and no past medical history who on 01/12/04 between 15:00 and 16:00 was vaccinated IM in the right deltoid with a dose of varicella virus vaccine live (Lot # 643596/0767M).  No previous doses were given at the same facility, but it was unknown if the pt received previous doses elsewhere. Concomitant vaccination on 01/12/04 between 15:00 and 16:00 included an IM dose in the right deltoid of DT (Lot # U0824AA).  No previous doses were given at the same facility, but it was unknown if the pt received previous doses elsewhere.  Concomitant therapy in Jan 2004 included tuberculin purified protein derivative. There was no illness at the time of vaccination. There were no adverse events following prior vaccination.  On 01/13/04 at approximately 5:30, the pt became red and swollen at the injection site and it became hard to move her right arm. On 01/14/04 it was still red and swollen and the pt developed little bumps at the injection site. On 01/15/04 in the morning, it was still hard to move her right arm. The redness spread to about 4 inches. The husband was advised to take the pt to the MD, but the pt did not seek medical attention and lab tests were not performed. By the evening of 01/15/04, the pt' symptoms improved. Subsequently, the pt recovered. Additional information is not expected.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 13-AUG-2021, the patient was vaccinated with an improperly stored GARDASIL 9 at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
She reports she is currently not feeling very well. Stated, "I got my covid booster yesterday...I guess that is what it is...I feel weak, tired, and have chills off and on." Patient reports she has not had as bad reactions to her previous covid vaccines as this one. Patient on Calquence for MCL.
Tdap was given for 4th dose.  DTAP and Tdap on same shelf, close in proximity.  Child behind on vaccines.  2 siblings at once, both behind on vaccinations.
they hit a blood vessel because blood ran down her arm; she had a knot and bruising; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 17:15 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Manufacturer Unknown), for Covid-19 Immuniztion; Bnt162b2 (Dose 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "they hit a blood vessel because blood ran down her arm"; VACCINATION SITE BRUISING (non-serious) with onset 13Nov2021, outcome "recovering", described as "she had a knot and bruising". Therapeutic measures were taken as a result of vaccination site bruising.  Additional information: The caller was calling about the Pfizer booster dose of the covid vaccine. The caller had it on Saturday and thinks they hit a blood vessel when they were giving it to her. Blood ran down the caller's arm, she got a huge knot on her arm and bruising. The Pharmacist asked her if she was on blood thinners, she was not. She checked with her mother who was an RN. The caller was questioning the efficacy because it hit the blood vessel not the muscle. The first day the caller iced her arm and the next day she put heat on it. The knot was down some and the bruise was still there. The caller cannot find the lot number on her vaccination card but provides the vial number as 3230BD. Other Products, Patient History and Investigation Assessment was reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Adverse events did not result in Emergency room or physician office visit. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): None. Relevant Tests: None. Additional lot numbers: Unknown, vial number provided as 3230BD. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient was vaccinated with medication from a vial that had last been used 42 hours prior to the vaccination.
I experienced a cool feeling around my neck area, almost like I had rubbed Vicks Vapor Rub on my neck about 30 minutes after receiving the vaccine.  3.5-4 days after the vaccine, I developed a rash. First on my neck, (Sunday) the next day on my face, (Monday) and now the rash is all the way around my neck into my hairline at the back of my neck (Tuesday).  It?s itchy and feels hot.
PATIENT'S MOTHER STATES IMMUNIZATION ARM IS NUMB UP TO ARMPIT AND SPREAD GRADUALLY. NO REDNESS, SWELLING OR RASH AT INJECTION SITE.
Severe allergic reaction includes: hives swollen/grainy tongue, swollen face with pins on face, neck, both arms, and head. Feeling of electricity on head and face. Very fast heart beat, insomnia.
A report has been received from a Physician concerning a patient of unknown age and gender. On 16-Jan-2014 the patient received FLUMIST (intranasal) but the vaccine was expired on 13-Jan-2014. At the time of reporting, the outcome of the event of expired FLUMIST was unknown. The report was considered to be non-serious by the reporter.
Redness pain swelling and warmth, started Saturday.  Monday seen in clinic for symptoms, prescribed tylenol, lactobacillus and cephalexin
chills; fatigue; sore joints and muscles; sore joints and muscles; This is a spontaneous report received from a contactable consumer (patient's wife). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 11:30 (Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Patient took the first dose of vaccine in Arm Right on 17Mar2021 11:30 AM (Lot Number: EP6955) for covid-19 immunization. Medical history included hypertension. Concomitant medication included amlodipine taken for hypertension, start and stop date were not reported. The patient experienced chills, fatigue, sore joints and muscles on 08Apr2021 08:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. Patient was not diagnosed with COVID-19 prior vaccination nor tested COVID-19 post vaccination. No known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The case was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a licensed practical nurse referred to unspecified numbers of patients (age and gender were unknown). This nurse noted that due to a refrigerator malfunction, PNEUMOVAX 23 was exposed to -2 F for one month; this includes more than two cycles into and back out of the temperature range of below 0 F. This nurse noted that on unspecified dates an unspecified number of "patients might have been administered these vaccines (Lot #, dose/frequency, route and duration were unspecified)". No adverse effect reported. At the time of reporting, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient received the Pfizer COVID vaccine, when the needle was removed from the patient's arm bleeding occurred immediately at the injection site.  The immunizing pharmacist wiped the arm and applied pressure to the injection site with  a cotton ball.  When the cotton ball was removed the site had stopped bleeding and a Band-Aid was applied.  Patient remained in the waiting area for observation where it was reported by the patient that the site was very tender and bruising and swelling was noted by the immunizing pharmacist.  The patient was provided an ice pack to apply to the site and asked to remain in the waiting area.  After several minutes the patient left without notice.
Pt developed redness with mild swelling & hot to touch with decrease range of motion secondary to immunization. Pt given KEFLEX 250mg per tsp. 1 tsp QID x 7 days.
Pt recvd Engerix-B on 27APR90, 29MAY90, & 24OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Angioedema tingling on botton lip and chin Narrative:  Patient vitals were taken on two occasions - 15 minutes apart and were stable. Patient verbalized feeling ok. No signs of edema, pain or any other discomfort.
The symptoms started with a sore throat, I then developed fatigue, brain fog, sore muscles, shortness of breath, low but not critical 02 stats, ear pain, runny nose, my skin felt bruised all over my body. Symptoms started on the 30th and lasted the 5/6th of June.
Shivering, chills, fever, sweats, aches and pain for 25 hours.
Itchy feeling in arm, large red circle around injection site, hot to touch, skin is firm.
Around 4:30 PM, 01/19/2021 developed headache, very bad chills and temperature of 101 degrees. Took Tylenol and by 9:30 PM chills gone, headache remains and temperature 99.9 degrees
Sore arm; Pain has radiated out; Sore arm (radiated out); Tenderness and extremely painful on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Pain has radiated out), MYALGIA (Sore arm (radiated out)) and VACCINATION SITE PAIN (Tenderness and extremely painful on the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00TM200A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sciatic nerve injury (sciatic nerve problem). Concomitant products included GABAPENTIN for Sciatic nerve neuropathy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Pain has radiated out), MYALGIA (Sore arm (radiated out)) and VACCINATION SITE PAIN (Tenderness and extremely painful on the injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PAIN (Pain has radiated out) outcome was unknown and MYALGIA (Sore arm (radiated out)) and VACCINATION SITE PAIN (Tenderness and extremely painful on the injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use also included anti-inflammatory medications.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up information included reporter details was updated.
Pt. reported "ocular migraine" a few hours after receipt of vaccine.  Reports visual disturbances.  No hx of migraines. Resolved without intervention.
little dizziness in the Morning/slight dizziness/starts in the morning and weans out, slight dizziness, not staggering, dizzy feeling; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (little dizziness in the Morning/slight dizziness/starts in the morning and weans out, slight dizziness, not staggering, dizzy feeling) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included EXEMESTANE, LISINOPRIL and AMLODIPINE for an unknown indication.  On 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced DIZZINESS (little dizziness in the Morning/slight dizziness/starts in the morning and weans out, slight dizziness, not staggering, dizzy feeling). At the time of the report, DIZZINESS (little dizziness in the Morning/slight dizziness/starts in the morning and weans out, slight dizziness, not staggering, dizzy feeling) outcome was unknown.      No medical history was reported.  The patient received the second Moderna booster dose on 25-Jul-2022.  The  patient reported that Moderna vaccine was the only thing that was new that patient had. The patient did not took any medication for the dizziness.
17cm x 20cm area of erythema and edema around DTAP injection site 24 hours after immunization. 2cm difference in thigh circumference. Afebrile. Tx'd Cefzil 250/5 BID by another MD in practice.
Immediately after the injection of the vaccine, patient eyes started to close and body started to slightly slack.  I called out to the patient and roused him. He was able to open his eyes slightly.  I asked if he was ok and he answer in a slurred speech.   He was able to tell me his name.  I remembered that before the injection, he said he didn't like shots and he made a point to look away.  I asked if he was holding his breath when I gave him the injection.  He said yes.  His mother also admitted that he had a fear of shots since he was young but he has never fainted or blacked out.  He then said that he could barely see; he also saw black dots.  All the while, he could barely keep his eyes open.  We kept talking to him to get him talking.  His color looked normal to me.  We suspected maybe look sugar level since he didn't eat a proper meal and maybe low blood pressure.   I took his blood pressure and it was 75/50 mmHg with a HR of 56.   Mother did not know his normal BP level since he doesn't regularly visit a doctor.  We gave him a candy just in case his sugar level was low.  A few minutes later, the patient resumed his normal vision.  He was able to keep his eyes open.  He was able to stand up and walk.
Headache, Arthralgia, NauseaVomiting, Localiz3d pain, chills Narrative:
Onset of Petichae on Bilateral Forearms, Unexplained Bruising Bilater Lower Extremities and Bilateral Upper extremities, Burning pain Bilateral lower extremities
Presented for J&J COVID vaccine. Pt States she is an emancipated minor, received documentation of emancipation. Educated on preference of MRNA vaccine. Pt confirmed desire for J&J vaccine. Pt waited in lobby 15 minutes per policy. After administration realized patient did not qualify for J&J due to her age. Notified patient, supervisor and Agency.
About two weeks after first dose it's hard for me to take deep breathe. Doctor stated I have asthmatic symptoms and now on the inhaler. It's ongoing and feels like a heavy feeling on my chest.
pt. c/o of anxiety attack after the 1st vaccine of Pfizer.      pt. was advised to notify her doctor when she get home.
Pt became dizzy immediately after administration. Sat in chair learning over, and vomited once. Place cool pak on back and neck for apporx 10 minutes. Pt recovered, and wished to leave him and his mother to wait at least another 15 minutes in store as precaution. Pt did not report back.
Extreme  body ache in all joints, headache, fever over night. This morning the fever is gone, and aching is much less. Note gone, bur much better.