chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; devel fever & local rxn of soreness, swelling & rash at inject site;
Caller is pt's mother; not sure if fever and diarrhea are r/t vaccine or hx of Crohn's disease as he had a low grade temp of 99 at home yesterday prior to receiving vaccine.
I had a fever and chills the day after and it progressed to upper respiratory symptoms: sore throat, nasal congestion. I took some antibiotics. I was pretty sick and had to stay home from work. I ended up getting another sinus infection or allergy thing - nasal congestion, sore throat - sort of the same experience I had before. That was 10 days ago. I got tested and was negative for COVID-19.  That cleared up a little sooner. I had the flu shot on October 31st. I had it at Novant Health. I had it on the right deltoid.
This spontaneous report as received from a registered nurse via a company representative concerning a female patient two patients were also reported of unknown age who on an unknown date started therapy with [therapy unspecified] (THERAPY UNSPECIFIED) (dose, duration and indication were not reported). The registered nurse stated that on an unknown date the patient had 0 titres. It was reported that was unsure what products or vaccines the patients had received prior to the low titres count. Action taken with suspect therapy was unknown. The outcome of patient had 0 titres was unknown. Follow-up received. This report concerns a high school girl approximately 16-17 years of age. She received a puncture wound in school. She was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown). Patient had no antibodies to Hepatitis B. This patient was being revaccinated with the Hepatitis B Vaccine (Recombinant) (manufacturer unknown). No patient names were provided. The outcome of puncture wound was unknown. This is one of the several reports from the same source. Additional information has been requested.
FEVER SLIGHTLY OVER 100 DEGREES. HEADACHE. UPSET STOMACH. AS OF TODAY (1/12/15), PATIENT'S SYMPTOMS ARE GONE WITH EXCEPTION OF A LOW GRADE FEVER. PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR EVENT.
This spontaneous report as received from a licensed practical nurse (L.N.P.) refers to a patient of unknown age and gender. On 13-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as H017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1 degrees centigrade for 19 hours. This was one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006246, 1307USA006247, 1307USA006248, 1307USA006249, 1307USA006245 and 1306USA007793. Additional information has been requested.
Dizziness/feel like I'm falling; not able to drive; almost fell several times; hard time walking; feel nauseated; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness/feel like I'm falling), IMPAIRED DRIVING ABILITY (not able to drive), FALL (almost fell several times), GAIT DISTURBANCE (hard time walking) and NAUSEA (feel nauseated) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057f22a) for COVID-19 prophylaxis.     Patient had allergic to penicillium.  Previously administered products included for Product used for unknown indication: flu vaccine (for two days, 2 weeks before receiving the vaccine) in September 2022, flu vaccine (for two days and 2 weeks before receiving the vaccine) in September 2022. Past adverse reactions to the above products included Cold with flu vaccine; and Sore throat with flu vaccine. Concurrent medical conditions included Drug allergy (sulfa). Concomitant products included GABAPENTIN, METFORMIN, ATORVASTATIN and CALCIUM for an unknown indication.    On 09-Oct-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 11-Oct-2022, the patient experienced DIZZINESS (Dizziness/feel like I'm falling), IMPAIRED DRIVING ABILITY (not able to drive), FALL (almost fell several times), GAIT DISTURBANCE (hard time walking) and NAUSEA (feel nauseated). The patient was treated with DIAZEPAM (VALIUM) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness/feel like I'm falling), IMPAIRED DRIVING ABILITY (not able to drive), FALL (almost fell several times), GAIT DISTURBANCE (hard time walking) and NAUSEA (feel nauseated) was resolving.            On 29-Jan-2021, the patient received first dose of Moderna Covid-19 Vaccine, batch number 012l20a.  On 26-Feb-2021, received second dose of Moderna Covid-19 Vaccine, batch number 013m20a.  On 07-Nov-2021, received third dose (1st booster) of Moderna Covid-19 Vaccine, batch number 014f21a.  Patient had not been diagnosed nor tested positive for COVID-19.  The event does not cause the patient to seek medical care and patient had not experienced similar adverse event in the past.  The patient had not both acute and chronic illnesses at the time of vaccination.  At the time of reporting patient symptoms improving.
1325  Pt lost consciousness and feel to the floor from a sitting position.  Per reports, pt hit his head on the floor.  EMS team activated.  POD   Director at pt side along with NP.   1326  911 called and emergency services activated 1327  Pt is not A/O x4 and answering all questions appropriately.   1340 Fire dept arrived.  Pt sat up and being transferred to fire care 1341  Patient placed in a sitting position, A/Ox4 and swering all questions appropriately  Vitals 1326  HR 50, RR 16, Sat 93% 1328  HR 85, RR 16, Sat 98%,   BP 139/83 laying position 1331  Glucose 90 1338  HR 89, RR 16, Sat 99%,    1341  HR 69, RR 16, Sat 98%,   BP 140/87  Sitting position 1343   BP 136/83
At 1:28PM the client asked RN, "Is it normal to feel nauseous?" and then stated "I was pretty nervous though." RN provided the client with water and the client began drinking it. The client ambulated unassisted and sat down in the anti-gravity chair in a high-fowler's position. RN asked to check the client's vital signs and the client declined. The client denied any other s/s of anaphylaxis. The client denied any previous allergies. RN provided the client with an emesis bag.. The client reported feeling "nausea, shortness of breath, and dizziness." RN asked if the client's vision was clear. The client reported that her eyes were "shaking and a white fog." Vital signs obtained at 1:39 PM were as follows: HR 115 and BP 103/68. The client reported "nausea, excess saliva, heartburn, and dizziness." The client reported a history of anxiety, but does not take any medications currently. The client reports a history of seeking care at the hospital related to her anxiety. The client stated that all of her current symptoms are typical for her when she is experiencing anxiety. The client denied any itchiness in her throat or swelling of her tongue. The client stated that vomiting does sometimes occur related to anxiety. RN responded at 1:40 PM. The client finished drinking the bottle of water provided by RN. The client stated that "water helps." The client began drinking out of her personal water bottle. The client stated it contained a "pink powder drink like Vitamin Water." Repeat vitals obtained at 1:44 PM were as follows: BP 113/67, O2 100%, HR 103. The client began performing breathing exercises. The client stated her symptoms were "mild, I just need to breathe." The client reported that her symptoms related to anxiety typically last 1-2 hours. At 1:48PM RN noted the client coughing and drinking out of her personal container. The client stated "I feel good." The client requested to be reclined. RN and RN  reclined the anti-gravity chair to a low-fowler's position. Vitals obtained at 1:50PM were as follows: BP 108/73, HR 111, O2 100%. The client stated "I can take a deep breath." The client denied any current nausea and stated the heartburn comes and goes. Rn educated the client regarding s/s of anaphylaxis and when to seek EMS. The client voiced understanding of this education. The client stated, "my throat is feeling scratchy." The client stated her throat gets dry with anxiety and that it felt dry at 1:57 PM. The client stated that she is able to swallow. RN offered the client Benadryl, the client declined. The client stated "I don't feel anxious anymore." Vitals obtained at 2:02PM were as follows: HR 104, O2 100%, BP 107/63. RN and RN adjusted the anti-gravity chair to a high-fowler's position. The client denied any nausea. The client left the vaccination site at 2:04PM. She ambulated unassisted with a steady gait.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 21Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 68 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: ACETAMINOPHEN, start date: 01May2022, also reported as, other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19 (Treatment start date: 12May2022, Treatment stop date: 17May2022). Clinical course was reported as, on 19May2022 the patient had rebound after Paxlovid. Patient was recovered and no treatment received for the event.; Sender's Comments:  As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
LEGS FELT "HEAVY" BILATERALLY, LEFT MORE THAN RIGHT; PAIN IN THE ARM; FEVERISH; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient does not have diabetes, circulation problems, and is not overweight. she is not taking birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain in the arm. On 12-APR-2021, the subject experienced feverish. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced legs felt "heavy" bilaterally, left more than right. Laboratory data included: Body temperature (NR: not provided) 100.1 (unit unspecified). Treatment medications included: paracetamol. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) UNKNOWN (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 16-APR-2021, had not recovered from legs felt "heavy" bilaterally, left more than right, and the outcome of pain in the arm and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.
injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 20Feb2021 at 08:45 at a single dose in the right arm for COVID-19 immunization. Medical history included stage 4 breast cancer and thyroid cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) and lorazepam. The patient previously took sulfur and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 21Feb2021 at 04:30, the patient experienced injection site pain, nausea, fatigue, joint and muscle pain, headache, and chills. The patient did not receive any treatment for the reported events. The patient underwent lab tests and procedures which included Nasal Swab/COV-2 RNA (RT-PCR) NAAT with negative result on 09Oct2020. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Had the shots, got shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 01-Mar-2023 Reporter's Comment: This case was reported by patient via interactive digital media. The patient had the Shingles shots and still got shingles after. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Erythema/induration/itching at vaccine administration site. Treated with cold compresses, H-1 blockers and NSAID.
Pt and her parents filled out her vaccine form as being 12 years old (3/1/2009).  The confidential system has the same patient listed as 11 years old (3/1/2010).  Patient is adopted and the parents said they have  multiple birthdays listed for their child.  They will look for the birth certificate and will try to get the date clarified with the State.
Information has been received from a physician concerning a 44-month-old female with burkitt's lymphoma and no known drug allergies who sometime in 2000 was vaccinated with a first dose of varicella virus vaccine live. Concomitant therapy included chemotherapy for the burkitt's lymphoma. This included cyclophosphamide, "adnamyai", piperacillin sodium (+) tazobactam sodium, acyclovir, sulfamethoxazole (+) trimethoprim (Bactrim), vincristine sulfate, granulocyte colony stimulating factor (unspecified), methorexate, tobramycin, vancomycin, and cytarabine (ARA-C). In May 2003, the child subsequently developed what was diagnosed as chickenpox (exact date unknown), and was hospitalized for treatment with acyclovir as a precaution due to her concurrent burkkitt's lymphoma. It was noted that four weeks prior, the patient was exposed to family who had "natural chickenpox". The physician indicated that the patient is currently doing well, and has not developed any complications. The physician obtained 2 swab specimens (DFA positive) on 20-May-2003 in viral transport media, and has submitted them for PCR analysis. The results of the PCR analysis revealed that the specimen contained the wild-type varicella zoster virus. It was noted that the specimen was obtained on 20-May-2003 and sent to the laboratory on 22-May-2003. The source of the specimen was a lesion and the type was a vesicle. The specimen arrived in the laboratory on 23-May-2003. The results indicated that  VZV DNA was amplified and the VZV strain identification showed wild-type. Additional follow up information indicated that the patient did recover. It was noted that the patient was newly diagnosed with Burkitt's lymphoma. The patient developed varicella during hospitalization for treatment of burkitts lymphoma. The distribution of lesions was on the face, scalp, shoulders, and upper extremities. Additional information has been requested.
PT PHONED SQUADRON ON 08/14/2007, AND AT THAT TIME SPOKE TO SELF. PATIENT AT THAT TIME EXPLAINED ALL SIGNS/SYMPTOMS HE WAS HAVING AT THAT TIME. PT RECIEVED SMALL POX VACCINATION ON 05 AUGUST 2007. ALL PROPER PRE-SCREENING WAS COMPLETED BEFORE VACCINATION, MEMBER QUALIFIED FOR ADMINISTRATION OF VACCINE, AND WAS VACCINATED PER PROTOCOL BEFORE HIS SHCEDULED DEPLOYMENT TO A CLASSIFIED AREA. PT RECEIVED THE VACCINATION IN UPPER LEFT ARM, WITH 2.5 MCL OF SMALLPOX INOCULATION/3 JABS. PT PHONED (SELF) AND EXPLAINED HE WAS HAVING A SLIGHT FEVER (101-102), MALAISE, REDNESS AT SIGHT, MULITPLE RED LINES TRAVELING DOWN HIS LEFT EXTREMITY, AND SEVERE PAIN FROM THE INJECTION SITE ALL THE WAY DOWN TO HIS HANDS. PATIENT HAD A SCHEDULED APPOINTMENT WITH HIS PHYSICIAN IN 2 HOURS WITHIN HIM TALKING TO ME. PT SAW HIS PHYSICIAN, RECEIVED ANTIBIOTICS, AND A CONSULTATION. PT THEN PHONED BACK AT THE CLINIC (SELF), AND REPORTED WHAT THE DOCTOR HAD ORDERED. MEMBER IS NOT ABLE TO COME IN AND SEE OUR FLIGHT SURGEON, SO I INSTRUCTED HIM ON MEDICATION COMPLIANCE, SIGNS/SYMTOMS TO REPORT, AND ANY OTHER CONCERNS TO GO STRAIGHT TO THE EMERGENCY DEPARTMENT. PT UNDERSTOOD, AND WILL BE SEING IN SEPTEMBER RED FLIGHT (SEPTEMBER 14/15). DOCUMENTATION IN THE MEDICAL RECORD HAS BEEN DATED AND RECORDED AWARE OF PATIENTS CONDITION, CHEIF NURSING OFFICER ALSO NOTIFIED.
Had heavy bleeding/ she started with heavy menstrual bleeding again/started a menstrual period with spotting again; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Had heavy bleeding/ she started with heavy menstrual bleeding again/started a menstrual period with spotting again) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Had heavy bleeding/ she started with heavy menstrual bleeding again/started a menstrual period with spotting again). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Had heavy bleeding/ she started with heavy menstrual bleeding again/started a menstrual period with spotting again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.   The treatment information was not provided.  Post second dose patient had spotting from 04-JUN-2021 which then started to heavy bleeding on 15-JUN-2021 until 21-jun-2021.Again heavy bleeding started on 26-JUN-2021.The patient had an appointment with gynecologist on 22-jul-2021.  The action taken with mRNA 1273 with the events was considered as not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-238523 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I have an IUD and have infrequent or no periods over the last year, and after receiving the vaccine, I have started a regular monthly period.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 10:00 (Lot number: ER8733) at the age of 27 years as dose 1, single and administered in arm left, administration date 29Mar2021 (Lot number: EW0170) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Monistat, reaction(s): "Known allergies: Monistat"; Levofloxacin, reaction(s): "Known allergies: levofloxacin". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 31Mar2021, outcome "unknown", described as "I have an IUD and have infrequent or no periods over the last year, and after receiving the vaccine, I have started a regular monthly period.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Facility type vaccine was other. No other vaccine in four weeks. Other vaccine received in two weeks. Patient had an IUD and had infrequent or no periods over the last year, and after receiving the vaccine, patient had started a regular monthly period. Is there any information on the long term effects on her hormones or other female-specific side effect? No treatment received for event. No covid present prior vaccination. No covid tested post vaccination. Known allergy was monistat, levofloxacin. Other medical history was ADHD.  No follow-up attempts are possible. No further information is expected.
sore arm; This is a spontaneous report received from a contactable consumer (patient's aunt). A male patient of an unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced sore arm. It was reported all reporter knew was that they just complained of a sore arm, but really didn't have much besides that for the second shot. It was pretty mellow. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
this event did not happen at the time of vaccination. this report /event happened Several years later end of May 2022 into early April. I was expiring a pain behind my right ear. I went to the Dermatologist or annual visit and skin irritation was noted as dermatitis. Post that visit the pain behind the right ear increased and was painful to touch and felt hot discoloration was observed.   On 5/28 I started to have a tingle /numbness in mouth. On 4/3 started eye iteration which eye started to water.  on 4/5 on the AM noticed right face features were week could not raise eyebrow or clos eye and smile cheek would not raise up like left side.  4/6 saw primary physician walked through all the above. Determination of diagnosis was Ramsey Hunt Syndrome that was caused by a mild case of Zoster "shingles"
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerning a 32-year-old, adult, male patient. The patient had no relevant medical history. The patient did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235 and expiry date: 30-Jun-2019]. The patient had not experienced any adverse events after the vaccination. This case 201804685 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The lower level term of the event (received 1.5 ml dose instead of 0.5 ml) was corrected from extra dose administered to overdose in the event tab. The narrative and case comment were amended accordingly.