chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning an 88 year old female patient with hypertension and reflux and no known drug allergies who on 13-OCT-2008 was vaccinated with the first dose of PNEUMOVAX (lot# 659199/1541U).  There was no concomitant medication.  On 13-OCT-2008 the patient experienced ill.  The patient stated that she was ill for two days.  No lab diagnostic studies were performed.  At the time of this report, she was improving.  The patient sought medical attention via telephone.  A standard lot check investigation was performed.  All in process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency.  Additional information has been requested.
After about 10 minutes after receiving vaccine patient complained of shortness of breath, tingling down to her fingers and feeling strange. I gave her 1 dose of EpiPen at site of injection. She did start feeling a little better. Paramedics came and she was transported to the hospital. I did speak with her later and she was feeling better. She did tell me that they didn't think it was an anaphylaxis reaction but a reaction to the vaccine
a very itchy rash on my neck lasted all day; woke up the next morning the rash was over my; diagnosed it with shingles; dose number=3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 02:00 (Lot number: FH8027) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Total mastectomy due to breast cancer" (unspecified if ongoing), notes: Total mastectomy due to breast cancer; "Shingles" (unspecified if ongoing), notes: I had shingles before that was mild like this about seven years prior; "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; CONCERTA. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose lot number= ER8729, Prev dose dose number=2, Prev dose vaccine location=Left arm), administration date: 10Apr2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose lot number= ER8727, Prev dose dose number=1, Prev dose vaccine location=Left arm), administration date: 20Mar2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 02:00, outcome "unknown", described as "dose number=3"; RASH PRURITIC (non-serious) with onset 24Nov2021, outcome "recovering", described as "a very itchy rash on my neck lasted all day"; RASH (non-serious) with onset 24Nov2021, outcome "recovering", described as "woke up the next morning the rash was over my"; HERPES ZOSTER (non-serious) with onset 24Nov2021, outcome "recovering", described as "diagnosed it with shingles". The events "a very itchy rash on my neck lasted all day", "woke up the next morning the rash was over my" and "diagnosed it with shingles" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of rash pruritic, rash, herpes zoster.  Additional information: There were no other vaccine taken in four weeks. The patient took the antiviral Valtrex as the treatment. There were no allergies.  No follow-up attempts are possible. No further information is expected.
Patient c/o nausea, headache, dizziness 1 hour after receiving Tdap.
LEFT ARM STARTED SWELLING AND TURNING RED, GETTING VERY HOT AT INJECTION SITE AND ALSO LOWER ON THE ARM ABOUT AN INCH OR SO BELOW THE INJECTION SITE. IT STARTED OUT WITH A SMALL REDNESS AREA THAT KEPT GROWING AND GETTING BIGGER THROUGH OUT THE DAY. THE FOLLOWING DAY (11/4/2010), THE ARM PIT AREA WAS BECOMING VERY PAINFUL AND THE REDNESS WAS STILL GROWING ON THE LEFT ARM. FRIDAY MORNING (11/5/2010, I COULD BARELY MOVE MY ARM AND THE PAIN HAD RADIATED OUT INTO THE LEFT CHEST AREA AND ALSO INTO THE UPPER LEFT SIDE OF MY BACK. THE REDNESS ON THE ARM HAD WAS STILL SPREADING AND THE LEFT ARM WAS VERY SWOLLEN. CALLED DRS OFFICE, THEY HAD ME SPEAK WITH A NURSE, WHO THEN TOLD ME TO GO STRAIGHT TO URGENT CARE. ONCE SEEN BY THE URGENT CARE DR, HE TOLD ME TO GO STRAIGHT TO THE EMERGENCY ROOM. MY HUSBAND TOOK ME TO THE E.R. THEY DID AN ULTRASOUND ON THE LEFT ARM, LOOKING FOR A BLOOD CLOT, NONE FOUND. ADMINISTERED PAIN MEDS VIA I.V. THEN TOOK A MARKER, DREW A LINE AROUND THE REDNESS ON THE LEFT ARM, TOLD ME TO KEEP AN EYE ON IT AND IF IT CONTINUED TO SPREAD, TO COME BACK IN. THEY THEN PRESCRIBED CEPHALEXEN 2000 MG PER DAY FOR 10 DAYS ALONG WITH PERCOCET. SATURDAY AND SUNDAY, WE NOTICED THAT THE REDNESS WAS STILL SPREADING, THE PAIN WAS UNBEARABLE IN THE ARM PIT AREA, BUT CONTINUED TO WATCH IT TRYING TO GIVE THE ANTI-BIOTIC A CHANCE TO WORK. MONDAY MORNING, CALLED THE DR'S OFFICE AND WENT IN AT 3:15 PM THAT DAY (11/8/2010). THE DR TOLD ME TO GO TO THE EMERGENCY ROOM. WENT TO THE EMERGENCY ROOM WHERE I WAS ADMITTED TO THE HOSPITAL. I WAS IN THE HOSPITAL FOR 2 NIGHTS (11/8/2010 AND 11/9/2010). THEY ADMINISTERED ANTI-BIOTICS THRU I.V. AND PAIN MEDS. FINALLY ON TUESDAY NIGHT, IT LOOKED AS THOUGH THE REDNESS HAD STOPPED SPREADING, ALTHOUGH STILL PAINFUL. WEDNESDAY MORNING, THE REDNESS WAS NOT SPREADING.
arm became sore with knot-raised, red and itchy ( x 2 weeks) from dose #1
Patient received a booster vaccine out of approved age range. She was only 14 at the time of the booster, approval is only for 16+.
Tightening and selling in throat and face, difficulty swallowing, heat and pressure in neck and head, dizziness and weakness, chills and sweating,  all within 10 minutes of vaccination, Increase in heartrate and blood pressure and itching. Later, a sunburn like rash on chest, neck and face that lasted for 2 days.  Itching lasted for days. After 30 mins, patient received 50 mg of Benadryl. In ED patient received Epinephrine and a steroid and vitals were monitored and was observed for hours. Dizziness slowly subsided and lasted for a few days..  Patient is being treated with Prednisone for a few days. This triggered patients POTS, including tachycardia, fatigue, weakness. Moderna COVID 19 Vaccine EUA.
I felt like I had bad cold on my way back home. I did a telehealth visit with my doctor Monday and was prescribed Paxlovid. I did not have a bad headache, it lasted for 3 days and I felt great after taking the medication.
Pt was admitted on 2/11/2022 for femur fracture following syncopal episode and fall with prolonged downtime and rhabdomyolysis, Covid 19 PNA with superimposed bacterial PNA.  . He denied any headache, chest pain, shortness of breath, dizziness, nausea, vomiting, neck or back pain. He did not remember falling or why he fell. He denied any change in medications, recent illness, fever, or chills.    On arrival to the emergency department his vitals were: blood pressure 118/66, heart rate 121, temperature 99.9, respiratory rate 22, pulse ox 95% on room air.     Patient was shown to have a left hip fracture on X-ray and orthopedic surgery was consulted by the ED. Patient  underwent a left hip screw placement 2/12/22. He developed atrial fibrillation at this time in the hospital.  02/17 patient developed increasing respiratory distress and mental status changes, so critical care consulted. Patient intubated and transferred to ICU. Extubation was done on 02/21. Patient was weaned down oxygen supplementation from 4L nasal canula with biPAP at night to 2L nasal canula on 02/23. He was transferred out of ICU.  For COVID pneumonia, ID was consulted. Patient received various courses of antibiotics including ceftriaxone (received 3 days after started 2/11, then restarted 2/26), azithromycin (received 3 days after started 2/11), cefazolin (x1 dose on 2/12 and 2/17), vancomycin (x1 dose 2/17, discontinued after MRSA negative). Dexamethasone course and taper completed.  Fungitell collected 3/1/22 resulted positive and respiratory cultures collected 2/19 grew candida albicans. Micafungin started and ceftriaxone discontinued 3/3/22. Patient to complete 2 weeks total antifungal therapy, transitioned to voriconazole to be administered via G tube through 3/17. Cefepime discontinued and ceftriaxone resumed due to concern for metabolic encephalopathy. Patient self-discontinued his right IJ central line, bleeding controlled with direct pressure, hemostasis obtained. He also repeatedly pulled out his NG tubes requiring bilateral mitt placement. Mental status improved as of 3/2/22 and patient more alert, able to participate in therapy activities though still occasionally drowsy and requiring redirection/ reorientation.   NG tube was placed 2/17/22 while in ICU and patient received nutrition via this. After extubation and transfer out of the ICU, patient had difficulty with swallowing so was followed by SLP.  Patient not a candidate for MBS per SLP due to ongoing confusion.  3/1/22 after discussion with patient's wife, consult to surgery. PEG tube placed 3/4/22.
Reported feeling lightheaded, BP: 176/109, unsteady on her feet. Sent to ED for observation.
Shoulder and arm where shot was administered was extremely sore. Began breaking out in hives on arms, legs, and back.  Took Zyrtec (cetirizine) - 10mg as a histamine blocker to treat hives overnight.  They only got worse and within 24hrs covered my entire body.  Began taking Benadryl (Diphenhydramine) - 25mg, which reduced the swelling of the hives significantly.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 22-Jun-2021 at 12:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 12:01 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 18.68.  Concomitant product use was not provided by the reporter.  Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature 35 degrees Fahrenheit from 08:00 AM. This vial was moved to fridge on 27-May-2021 and beyond use date for the vial was reported as 26-Jun-2021. Product moved to clinic on 22-Jun-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Patient is a 17 year old male with asthma and obesity who came into the clinic for a booster shot for Covid. He was given a 3rd dose booster of Pfizer before the age of 18.  Patient waited in the waiting room with his mother for 15 minutes and had no reaction.
While attending graduate school, this 40 year old member reported receipt of hepatitis A #1, influenza, and typhoid vaccinations on 11/7/1997. Medical records show tetanus-diphtheria given 8/5/1997 not 11/7/1997. He remembers experiencing flu-like symptoms that evening that worsened the next day to resolve within 24 hours. Day 2 post vaccination (11/9/1997) he began to experience a dull ache to neck near base of skull. This discomfort gradually increased over the next 1 1/2 weeks until he was unable to rotate head side-side due to pain but he could shake it "yes" without pain. He denied any other symptoms (headache, n/v, muscular weakness, speech or visual disturbance). He presented to medical where he was treated for muscle strain and placed on muscle relaxer and MOTRIN. He took one "muscle relaxer" and developed a severe headache. He didn't take any more and represented to medical where he was advised he was given a vasodilator instead of muscle relaxer. His medications were changed with resolution of all neck pain for 4 days. On Thanksgiving day he rapidly hyperextended his neck to "knock back a shot of whiskey" with family members at home when he suddenly "felt weird". He was reported to go pale, his coordination was off, and he had a headache. He was unable to stand due to muscle weakness and was assisted to the floor. He denied any paralysis, respiratory or visual complaints. He was taken to an emergency room, admitted and diagnosed with dissected cerebral artery. He remained in ICU for 1 week then in rehab for 3 weeks with full recovery except for mild residual pain/temperature deficit to his right side. He received his second hepatitis A vaccine 9/2 2005 with hepatitis B given 9/8/2005, 2/11/2006, 9/11/2006, and 3 influenza vaccinations (2005, 2006, 2007) with no adverse events. Symptoms: Gait abnormality, Weakness, Headaches, general, Inability to turn head (CN X1), Flu-like symptoms<96 hours, Pain.   4/14/09 Received medical records of 4/1/2009. FINAL DX: CVA/dissected cerebral artery Records reveal patient experienced flu-like symptoms after flu, hep A #1 & typhoid #2 vaccinations on 11/7/1997.  (Had received Td on 8/5/1997.)  Developed basilar HA 2 days s/p vax which increased over 10 days.  Seen in clinic & given muscle relaxer for muscle strain.  HA increased & meds changed w/complete resolution for 4 days.  Then on Thanksgiving day, after neck hyperextension became pale, uncoordinated, HA, unable to stand & assisted to floor.  Admitted to ICU x 1 wk w/dissected cerebral artery, then rehab x 3 wk w/full recovery except for mild residual pain/temperature deficit on right side.  Received subsequent vaccines w/o adverse events.
About 8 hours after receiving the vaccine I started to feel extremely cold, even though the room temperature was normal (72 degrees F). I got into bed to try and get warm, but still felt very cold. I started shivering intensely under the covers. My girlfriend nearly called 911, as my whole body was shivering violently and I could barely speak, but I told her to wait. She got under the covers with me to help me get warm again.  After about 5 minutes of shivering and cuddling I felt warm again and we went to bed. The next morning I woke up and felt like I had a mild cold. Body aches, sore throat, headaches and brain fog lasted about 48 hours, similar symptoms to when I had Covid-19 in Nov. 2020, but much milder.
Other than perhaps a touch of fatigue, some mild soreness only at the injection site (left arm), and mild shoulder joint pain, I had no notable reaction to my first Moderna vaccine (April 20, 2021; Moderna Lot #047B21A).   On the evening of the day I received the second Moderna vaccine (injection around noon on May 18, 2021; Moderna Lot #017C21A) I experienced chills, fatigue, significant muscle aches (especially in entire left arm, shoulder, neck, and very significantly in my legs), as well as joint pain. The following day, May 19, the fatigue grew much worse, and the muscle aches and joint pain continued, but the chills subsided. The following day, May 20, an approximately 3" x 6" swath of my upper left arm began to painfully swell and was VERY hot to the touch; visually, it was very slightly red but not dramatically so. I was still fatigued and achey, with some joint pain. By today, May 21, the area remains very painful and weirdly hot to the touch, and in addition *has turned a bright angry red color*. The hot, swollen area begins exactly 4" below the injection site, as measured from the edge of the bandaid to the edge of the affected area. As the skin reaction grows worse, my other symptoms have improved. Other than the skin reaction, I have mild fatigue and very mild aches and joint pain.
PATIENT HAD SYNCOPE REACTION TO RECEIVING SHOT AND APPEARED TO HAVE A SEIZURE THAT LASTED A FEW SECONDS. PATIENT CAME TO AND WAS CONSCIOUS AND COHERENT.
Flu like symptoms with fever and respiratory illness within 48 hours of vaccine administration; previously without symptoms.
No Adverse Event; Patient received Bivalent Moderna COVID-19 vaccine instead of first dose Monovalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine instead of first dose Monovalent) and NO ADVERSE EVENT (No Adverse Event) in a 22-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine instead of first dose Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine instead of first dose Monovalent) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine instead of first dose Monovalent).    Concomitant Medication use information was not provided by reporter.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient was not received any other vaccines and did not report any adverse reactions.   Treatment Medication use information was not provided by reporter.
Vaccine was out of the 31 days fridge recommendation when given. Patient remained in clinic for 15 min after injection. No reaction noted while in clinic.
This spontaneous report was received from a health professional referring to a 20 year old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 15-JUN-1999, the patient was vaccinated with the first dose of M-M-R II and the first dose of VARIVAX, on 06-OCT-2003, the patient received the second dose of M-M-R II and on 04-JUN-2007, the patient received the second dose of VARIVAX (Captured in MARRS 1810USA000814). On 01-OCT-2018, the patient was vaccinated with PROQUAD rHA lot number R008206 and expiration date of 16-SEP-2019, subcutaneously, for prophylaxis (dose and anatomical location were not reported). This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA000814.
Left arm numb 5" below joint usually does not radiate, sometimes when I sleep on it I feel it in the joint and wake unable to feel the arm.
Swelling; Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (received 1st dose on an unknown date and experienced severe pain).   On 12th November 2019, the patient received the 2nd dose of Shingrix. On 12th November 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling and injection site pain were recovering/resolving.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain and swelling at the injection site after vaccination. The patient also reported similar but more severe reaction following first dose at an undisclosed date or time frame. The reporter declined to provide further demographic information. There is a discrepancy with respect to the primary reporter type, whether the primary reporter is a pharmacist or a consumer, the clarification was raised to confirm the type, however no clear information available for the same hence the clarification has been raised to seek more information regarding that the primary reporter type.
two weeks after the second injection (er 8737) a full breakout of hives that lasted 4 months 04/18/2021-08/30/2021 i was positive for covid-19 antibodies in 04/2020. asymptomatic. i was vaccinated a year later. my sars - cov -2 semi-quant level as of 09/21/2021 is 701.0.  i have had clear skin for four weeks as of today
after which he experienced a lot of ear infections; sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (after which he experienced a lot of ear infections) and SOMNOLENCE (sleepiness) in a 1-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced EAR INFECTION (after which he experienced a lot of ear infections) and SOMNOLENCE (sleepiness). At the time of the report, EAR INFECTION (after which he experienced a lot of ear infections) and SOMNOLENCE (sleepiness) outcome was unknown. Not Provided          No concomitant medication was provided by the reporter.  It was reported that the patient had received 1st dose of the Moderna COVID-19 vaccine, after which patient experienced a lot of ear infections due to which they had to delay 2nd dose of the Moderna. After the first dose, patient only experienced excessive sleepiness. There were not other symptoms.  No treatment medication was provided by the reporter.
Two days after my wife received the moderna  vaccine she showered significant cognitive impairment and memory loss . She cannot recall words and is experiencing delirium. Both her internist and her neurologist are convinced it was the result of the vaccine e. She had a complete Nueromosych evaluation done two months ago snd the results were completed normal.  I want you to be aware of this snd if it does not resolve I may sue the federal government and moderna. Thanks a llot