chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DCI ordered Pfzier 0.3ml Booster Vaccine.  0.3ml vial of pfzier equivalent to booster dose 0.3ml. There were no pre-drawn vaccines @9:20am  I administered the non- reconstituted serum to the patient @9:20 am had patient wait 15 min.  I was informed @ approx. 9:30 am the vaccine was not ready for administration as it had not bee n pre-mixed prior to admin. All protocol followed.  Pt informed by provider @9:50  Pt stayed for observation until approx. 10-11 am  Blood sugar checked 147  Bp checked 137/80 and documented  Pt verbalized he was feeling fine. Drove alone,  5min from clinic.  Pt wife notified to monitor husband/ pt  Chart documented.
Non-Responder to 8 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 50-years-old and a second hepatitis B series at 53-years-old.   A total of 8 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 60-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).  On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient experienced fever, chills, muscle pain, headache, majorly tired, injection site pain, feeling unwell.. Symptoms lasted about 12 hours, feeling better.
Pt describes red, warm, slightly edematous area at injection site. She has not taken her temp, but feels "feverish".
Within a few weeks from the time of the vaccination patient showed a loss in his alertness, attentive, and social interaction.  Soon after he started stemming, and exhibited obsessive compulsive traits.  He continued to regress thereafter.  Follow-up: Autism.  He was seen by a neurologist at 18 months of age and diagnosed with Autism.  Currently non-verbal.  Speech, occupational, developmental therapies.  3/14/08 Reviewed PCP medical records. FINAL DX: autism. Vax records confirm as reported.  Office vs of 6/16/2005 indicates patient on formula & refuses cup or to self feed, poor eater, was irritable, speaking 3-5 words.  7/2005 referred to allergist.  By 9/2005, no words & loss of receptive language.  Dx w/probable PDD & referred.  10/2005 dx w/autism, genetic disorder, egg allergy.  Receiving ST/OT.  7/2007 hyperbaric tx.  12/2007 dx w/Lyme's disease Follow-up: Chronic Diarrhea, Food allergies, No speech. This vaccine cause my sons Autism.
Patient received two doses of Janssen vaccine. No adverse event has been noticed at the time of reporting.  Patient is an inmate at Prison at the time of administration of the second dose of vaccine on 07/12/2021. When asked if the individual had received a COVID-19 vaccine, he stated he had not. The first dose was adminsitered on 04/07/2021.
(DTAP-IPV-HIB) administered in Rt arm on 4/5/11. On 4/8/11 pt presented in office with cellulitis vs allergy.
pain in arm; injection site sore to the touch; injection site is swollen (2in diameter); injection site is warm and hot; elbow to shoulder on right arm is puffy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is warm and hot), PERIPHERAL SWELLING (elbow to shoulder on right arm is puffy), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PAIN (injection site sore to the touch) and VACCINATION SITE SWELLING (injection site is swollen (2in diameter)) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site is warm and hot), PERIPHERAL SWELLING (elbow to shoulder on right arm is puffy), VACCINATION SITE PAIN (injection site sore to the touch) and VACCINATION SITE SWELLING (injection site is swollen (2in diameter)). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site is warm and hot), PERIPHERAL SWELLING (elbow to shoulder on right arm is puffy), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PAIN (injection site sore to the touch) and VACCINATION SITE SWELLING (injection site is swollen (2in diameter)) outcome was unknown.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up was received. Reporter's address was updated. New event pain in arm was included. Patient went to see a doctor. It contains significant information.
This spontaneous report was received from a Registered Pharmacist (R.Ph.) referring to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 14-AUG-2016, the patient was vaccinated with an unspecified improperly stored dose of ZOSTAVAX, at a dose of 0.65 ml, (lot number M019645 with expiration date of 18-JUL-2017 or lot number M020071 with expiration date of 18-JUL-2017, the reporter was not sure which lot was given to the patient) (strength, route of administration and anatomical location were not reported). Concomitant medications were not provided. No adverse effects were reported. The dose of the vaccine experienced a temperature excursion of 26 Fahrenheit (F) for 60 hours. Furthermore, no product quality complaint was involved. Additional information has been requested.
Staff C.N.A. was vaccinated with the Pfizer Covid-19 vaccine as above.  She tested positive on 4/21/21 with a PCR anterior nasal swab processed by LabCorp.
20 minutes after the dose patient felt a little sore arm and an itchy feeling all over; 20 minutes after the dose patient felt a little sore arm and an itchy feeling all over; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over) and PAIN IN EXTREMITY (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced PRURITUS (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over) and PAIN IN EXTREMITY (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over) had not resolved and PAIN IN EXTREMITY (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over) outcome was unknown.            No concomitant medications were reported.  Patient previously had received Moderna COVID-19 vaccines by Intramuscular Injection on 02-Mar-2021 with lot number 030A21A, on 30-Mar-2021 with lot number 019B21A, and on 20-Nov-2021. Expiration dates were not known. Patient took a Benadryl which helped, though itching had persisted. After last dose patient had no troubles while breathing.   This case was linked to MOD-2021-031887 (Patient Link).
ERYTHEMA AROUND INJECTION SITE AND AS DAYS WENT ON IT GOT MORE SWOLLEN AND MOVED DOWN THE ARM (DIDNT THIN OUT, ONLY GOT MORE SWOLLEN), INTERMITTENT SHORTNESS OF BREATH UPON ACTIVITY. STARTED ON 1/6 AND ARM GOT PROGRESSIVELY WORSE. PT EXPERIENCES SHORTNESS OF BREATH OCCASIONALLY THROUGHOUT THE DAY BUT DOESN'T STOP HER FROM NORMAL ACTIVITY
Pain in left arm, entire arm not just injection location, started approx 8:30 pm 2/25/21 Nausea started approx 11pm 2/25/21 Vomiting started approx 3am 2/26/21, nausea and vomiting throughout the day, unable to keep solids or liquids down
Vaccines admin. 03/31/17 at 4pm. 4/1/17 child slept most of day. Woke at 9pm w/104.7 fever. Over the course of the next week made 3-4 trips to Dr office for tests (urine, blood, check for flu) as fever continued. No for sure cause identified. Gave antibiotic 4/5 for 10 days for possible/unsure UTI. Fever last had on Thurs 4/6 at 7am of 102.0. No fever since. Still on antibiotic. Child now also has cold symptoms. (cough runny congested none)
GOT SHOT ON THAT WEDNESDAY MORNING. BY THAT NIGHT HAD CHILLS, CONFUSION, BODY ACHES, HEADACHE. NEXT DAY COULD NOT GET OUT OF BED DUE TO FATIGUE. I TOOK COVID TEST BECAUSE I THOUGHT SHOT WAS GIVEN TO ME ON TUESDAY AND SYMPTOMS WERE STILL SO SEVERE. IT WAS NEGATIVE. BY FRIDAY SYMPTOMS STILL GOING STRONG. I HAD NOT EATEN SINCE WEDNESDAY. I HAD UPSET STOMACH SHAKING DIZZINESS CINFUSION CHILLS BODY ACHES, ETC. SATURDAY MADE M YSELF TAKE SHOWER AND TRY AND MOVE AROUND. I WAS OUT OF BREATH AND DIZZY. SUNDAY WORN OUT TOOK ANOTHER HOME TEST IT WAS NEGATIVE. MONDAY WAS A LITTLE BETTER, NO CHILLS STILL TIRED. TUESDAY WOKE UP WITH HEADACHE, SON HAD SORE THROAT. WE BOTH WENT TO GET TESTED AND BOTH CAME BACK POSITIVE. I DONT KNOW WHEN IT STARTED FOR ME BECAUSE NOT SURE WHEN IT WENT FROM SIDE EFFECTS FROM BOOSTER TO COVID. I WAS FINE PRIOR TO THE SHOT TO THE BEST OF MY KNOWLEDGE.
shingles, two weeks after shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's daughter/son. The age at vaccination was not reported. The patient developed shingles two weeks after her shingles vaccine. The follow-up would not possible as no contact details were available.
TINGLING FROM SHOULDER DOWN THROUGH THE ARM; NUMBNESS IN HAND (SIDE OF INJECTION); MUSCLE STRAIN (CONSTANT AND INTENSE SHOULDER PAIN, MUSCLE NOT RELAXED AT ALL, COULD NOT LIFT ARM, COULD NOT TURN HEAD, COULD NOT BALANCE BETWEEN HEAD AND SHOULDER, COULD NOT CARRY PURSE, IT HURTS TO DRIVE); FEVER; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included neurological, seasonal allergy, medical marijuana, non alcohol user, and cigarettes smoker. The patient experienced drug allergy when treated with bupropion hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-JUN-2021, the subject experienced fever. On 29-JUN-2021, the subject experienced tingling from shoulder down through the arm. On 29-JUN-2021, the subject experienced numbness in hand (side of injection). On 29-JUN-2021, the subject experienced muscle strain (constant and intense shoulder pain, muscle not relaxed at all, could not lift arm, could not turn head, could not balance between head and shoulder, could not carry purse, it hurts to drive). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from fever on 29-JUN-2021, and had not recovered from tingling from shoulder down through the arm, numbness in hand (side of injection), and muscle strain (constant and intense shoulder pain, muscle not relaxed at all, could not lift arm, could not turn head, could not balance between head and shoulder, could not carry purse, it hurts to drive). This report was non-serious.
This spontaneous report was received from a physician via a company representative refers to two unspecified patients of an unknown age and gender. The patients concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX and developed shingles on an unspecified date. The outcome of the event was unknown. The reporter did not provide the relatedness of the event with ZOSTAVAX. This is one of two reports received from the same reporter. Additional information has been requested.
Patient experienced dizziness and fell out of chair during observation period after vaccination. Patient brought into triage area and examined by MD. Patient started feeling well shortly after laying down. Per MD, observe Patient for 30 minutes before sending home.
onset shingles within 5 days of first dose of vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation at workplace clinic. The patient's medical history was not reported. Concomitant medications within 2 weeks of vaccination was reported as unknown. Patient did not receive other vaccine within 4 weeks of COVID vaccine. On an unspecified date, the patient experienced an onset of shingles within 5 days of first dose of vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the event. The patient had no COVID prior vaccination and unknown if patient tested COVID post vaccination. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approx 10x12cm warmth, tenderness and induration on left anterior upper thigh. No streaking KEFLEX x10 days for treatment.
stomach pain since starting on the kevzara; Kevzara - medication does not seem to be working; Initial information received on 28-Sep-2021 from other health professional (processed as a non-case) and follow up information regarding an unsolicited valid  non-serious case  was received on 24-Nov-2021 from  patient.  This case involves a 54 years old male patient who experienced stomach pain since starting on the kevzara and kevzara - medication does not seem to be working while receiving vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT] via unknown medical device and SARILUMAB [KEVZARA] via sarilumab pen.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In September 2021, the patient started taking DUPIXENT (DUPILUMAB) with an unknown dosage, strength, formulation, route, frequency, expiration date, batch number and indication and KEVZARA (SARILUMAB) injection with strength 200mg/1.14ml at dose of 200 mg every other week subcutaneous (lot - 1F140A, 31-May-2023) for Rheumatoid arthritis. On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. Due to covid-19, batch number and expiration date for dupilumab were not requested.  In SEP-2021 the patient developed a non-serious event "stomach pain since starting on the kevzara" (abdominal pain upper) (latency- same day) following the first dose intake. In 2021 the patient developed a non-serious event "kevzara - medication does not seem to be working" (drug ineffective) (unknown latency) following the first dose intake.  Action taken- unknown for abdominal pain upper; not applicable for drug ineffective.  Corrective treatment- not reported  Outcome: unknown for both the events.   Additional information was received on 24-Nov-2021 from the patient via specialty pharmacy: Case was updated to a valid case from a non-case.
Patient stated painful arm, then body aches started and also nausea and diarrhea.  Patient said symptoms continued all weekend but feels better today, arm still hurts.
Arm pain developing into joint and neck pain. Swollen gland in left side neck. Not improving after 1 week.
Child developed involuntary head tics.  Within 24 hours of receiving Prevnar 13 vaccine. He would intermittently shake his head back and forth and in all directions while sitting or crawling.  The involuntary head tics were the most pronounced within the first weeks of receiving the vaccine.  It was startling, as our child had NEVER done this motion before.  We were afraid it might be permanent. After a few weeks, the tics appeared to subside. After receiving previous vaccinations, between the ages of 3 months and 9 months, he had eczema and was later diagnosed with a nut allergy.  He had his first allergic reaction to nuts at 12 months and then again at age 3 (11/12/2013).  He was officially diagnosed with a nut allergy at age 3 (11/2013).
This case was reported by a nurse via call center representative and described the occurrence of urticarial in a 34-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7KK33, expiry date 30th April 2017). Previously administered products included influenza vaccine (never experienced event). On 29th September 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular). On 29th September 2016, 5 min after receiving FLULAVAL QUADRIVALENT, the patient experienced urticarial, paresthesia lips, formication and taste altered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the urticaria, paresthesia lips, formication, taste altered and pharmaceutical product complaint were unknown. The reporter considered the urticarial, formication and taste altered to be almost certainly related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the paresthesia lips and pharmaceutical product complaint to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case not previously reported to anyone. This case was reported by a registered nurse. the reporter stated that a multidose vial of FLULAVAL may be suspect. the patient received Flu Seasonal QIV on right deltoid and experienced funny taste in her mouth, paresthesia around the lips. It caused various adverse drug events in several patients with similar adverse drug event pattern. The suspect vial was available for return. Replacement or credit was not requested by reporter. This case is 1 of the 3 cases reported by the same reporter.
Patient began to have red flat rashes on chest and abdomen with itching. This progressed to face and bilateral inner arm. Patient also had facial flushing. The ems were called but patient and his parents declined help. The patient stated that he felt better right before he left the health department.
Had an unusual cry that lasted for 3 hrs; started episode approx 4 hrs p/receiving vax;
This is a spontaneous report from contactable Pharmacist via a Pfizer Sales Representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling on an unspecified date with outcome of unknown.
Slight clough, body aches, joint pain, headache, fatigue, chills, fever 100.2, sore throat.
Redness and swelling on underarm down pass the elbow. Soreness in axilla and chest - painful. Used aloe to decrease redness and swelling.
pt recvd vax;devel pain, warmth,swelling & erythema at inject site;
pt reported an area of 3" diameter of redness & swelling w/in 3 days p/vax; several pts (not identified by reporter) exp inject site react; sx included redness, swelling & a considerate amount of pain w/in 3 days p/vax
Patient called pharmacy on 07/06/2021 around 550 pm to report that he is experiencing side effects from the Janssen shot he recieved on 07/03/2021. He said he started to experience side effects the following day after shot (7/4/2021 - specific time unknown) and they have not improved. He said he is experiencing muscle pain and muscle spasms in his neck, back and arms. Also experiencing shortness of breath, nausea and chest pain. I instructed patient to seek immediate medical care. He said he was going to go to ER.
Pt recv vax on 10/26/98;on 10/27/98 pt exp raised erythematous indurated, warm, sore area > 1wk
Child received Dtap 7-9-07 seen in office 7-11-07 with rash noted where Dtap given on thigh - large rash right thigh. No cellulitis. Fever was present at visit. No itching at site.
swelling/pain in hands; swelling/pain in hands; also limits her mobility; occasional bruising; had some weight gain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 03Sep2021 (at the age of 55-years-old) at dose 2, single for COVID-19 immunization. Ongoing medical history included rheumatoid arthritis, fibromyalgia. Concomitant medication included tofacitinib citrate (XELJANZ XR). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunization. Patient hasn't taken her Xeljanz since 03Sep2021 as she got her second COVID vaccine dose. She had some swelling/pain in hands that caused her to not hold things as well and that also limited her mobility in sep2021. She also has occasional bruising, and has had some weight gain in sep2021. She stated that her MD ran tests and determined all of her symptoms are from her rheumatoid arthritis and fibromyalgia. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Received vaccine on 11/19/2021. Felt tired on 11/20/2021, and stayed on couch most of day. During night 11/20-11/21/2021, patient got up from bed to go to kitchen. He felt very dizzy. He fell to his knees in living room, striking head on coffee table leaving a contusion; no bleeding. Patient able to walk to kitchen where he sat for about 4 hours until he felt steady enough to go back to bed. He slept all day. The arm where he received vaccine is still very sore. Dizziness still present at times but very minor compared to Saturday night/Sunday morning. No fever, no chest pain and no SOB. Patient took BP/pulse during dizzy spell. He stated both were "normal."
I had a sore throat, cough, headache, and nasal congestion. I tested negative that night. The next day I tested positive and I called my doctor and she was busy. So, I went to the pharmacy and they thought I just had allergies and prescribed me ZYRTEC. Then, on 09/21/2022 I tested again and was positive. I still have a cough.
Patient was tested for COVID prior to seeking admission to a nursing home. Patient was asymptomatic at the time of testing but the test result returned positive.