chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Relapse in symptoms 2 days after testing negative. Tested positive 1 day later; Relapse in symptoms 2 days after testing negative. Tested positive 1 day later; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 02Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated blood pressure" (unspecified if ongoing), notes: Elevated blood pressure controlled with medication; "Known allergies" (unspecified if ongoing), notes: yes. Concomitant medication(s) included: ATORVASTATIN; ATENOLOL; LOSARTAN; GABAPENTIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PEPCID [FAMOTIDINE]; VIVISCAL [SILICON DIOXIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 01Jun2022, outcome "not recovered" and all described as "Relapse in symptoms 2 days after testing negative. Tested positive 1 day later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Relapse in symptoms 2 day after testing negative. Tested positive 1 day later; Positive, notes: Relapse in symptoms 2 day after testing negative. Tested positive 1 day later. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: COVID 19 Treatment, Brand: Paxlovid, Treatment start date:22May2022,Treatment stop date:26May2022, Indication: Treatment of COVID-19. Adverse event start date: 01Jun2022. If patient recovered: Recovering. If treatment ae: No. Known allergies: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
APPETITE LOST; SINUS INFECTION; PAIN IN ARM; FEVERISH ABOUT 24-48 HOURS; FATIGUED; SLIGHT FLUSHED; ACHES AND PAINS/ACHINESS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.   Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for rheumatoid arthritis.  Non-company suspect vaccine included: aciclovir (form of admin unknown, intramuscular, batch number was not reported) dose was not reported, administered on 2021, and dose was not reported, administered on 11-NOV-2021 for prophylaxis for shingles. Age at time of vaccination 60 years old.  No concomitant medications were reported.  On APR-2021, the patient experienced aches and pains/achiness. On an unspecified date, the patient experienced slight flushed, appetite lost, sinus infection, pain in arm, feverish about 24-48 hours, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from feverish about 24-48 hours, and the outcome of pain in arm, aches and pains/achiness, slight flushed, appetite lost, sinus infection and fatigued was not reported. This report was non-serious.
Fever, 101. Red in face. Could not be consoled for 3 plus hours and extreme fussiness for 3 days. Seizure like reaction - no control thrashing head forward beginning 2 to 3 hours after shot and getting worse next 2 days. Continued for 3 to 4 weeks. Caught on video. Arching back for 3 weeks where hard to sit up straight after vaccine. Same thing happened with extreme stiffness and back arching with dTaP and PREVNAR 13 given on 11/15/2017 for 3 weeks after. These vaccines also had side effects of not being able to console him for 3 plus hours, red in face, and high pitched cry. With dTaP and PREVNAR, his breathing also got worse, and his laryngomalacia symptoms were worse during the first night to 4 to 5 days after the vaccines.
swollen lymph node in armpit; This case was reported by a consumer via interactive digital media and described the occurrence of axillary lymph nodes enlarged in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th April 2022, the patient received the 2nd dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary lymph nodes enlarged was unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 13-APR-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had a swollen lymph node in his/her armpit. Additional Supportive Information: The follow up would not possible as no contact details were available.
Chills, sweats, low fever, can?t sleep, head ache....arm is NOT sore.
Slight headache; Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Feb-2021. On 26-Dec-2020, the patient experienced HEADACHE (Slight headache) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 26-Dec-2020, HEADACHE (Slight headache) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.; Reporter's Comments: This case concerns a 30-year-old female patient who experienced headache. The patient also was 32 weeks pregnant during the administration of mRNA-1273. The last menstrual period, method of contraception and date of conception was unknown. The patient's pregnancy due date was 21-Feb-2021.  The patient experienced NS, expected event of headache  the day the first dose of mRNA-1273 was administered.  Treatment for the event included Tylenol. 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.
Patient experienced severe dizziness to the point of almost fainting. She also had severe stomach pain, diarrhea, and vomiting. Fever also accompanied her symptoms and they all lasted for 2 days after the vaccination.
Patient received fourth COVID vaccine (second booster) less than 4 months after third dose (first booster) which was on 2/28/22. The third dose was not uploaded to database. Patient had no symptoms of adverse event at time of administration.
Fever; severe chills; severe body pain; deep cough; headaches; extreme fatigue; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172), dose 1 via an unspecified route of administration, administered in Left Arm on 29Apr2021 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included fibromyalgia, breast cancer female, breast inflammation, arthritis, drug hypersensitivity and covid-19 from an unknown date and unknown if ongoing. The patient previously took codeine and experienced drug hypersensitivity. The patient had allergies : Penicillin, sulpha. She was not pregnant at time of vaccination. The patient had received other vaccine in four weeks prior to the COVID-19. The patient received other medications in two weeks. Prior to vaccination, the patient had been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received in response to the adverse events. On 02May2021, the patient experienced fever, severe chills, severe body pain, deep cough, headaches, extreme fatigue. The outcome of the event Cough was not recovered. The outcome of other events Fever, severe chills, severe body pain, headaches, extreme fatigue was recovered/resolved with Sequel.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. Current conditions and medical history was not reported. Between 26-OCT-2014 to 29-OCT-2014, the patients were vaccinated with GARDASIL (dose, lot number and frequency were not reported), intramuscular. Concomitant medications were not reported. The patients received GARDASIL that was improperly stored. On an unknown date, GARDASIL was exposed to 11.1 Celsius for 1 hour 18 minutes (all doses supported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
chest is feeling Tighter and sore  then the first shot which was very minor; my chest is feeling Tighter and sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest is feeling Tighter and sore  then the first shot which was very minor) and CHEST PAIN (my chest is feeling Tighter and sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced CHEST DISCOMFORT (chest is feeling Tighter and sore  then the first shot which was very minor) and CHEST PAIN (my chest is feeling Tighter and sore). At the time of the report, CHEST DISCOMFORT (chest is feeling Tighter and sore  then the first shot which was very minor) and CHEST PAIN (my chest is feeling Tighter and sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       THERE IS NO CONCOMITENT MEDICATIONS USED IN THE TREATEMENT
Vertigo; Tinnitus; 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 male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset Jan2021, outcome "unknown", described as "Vertigo"; TINNITUS (non-serious) with onset Jan2021, outcome "unknown", described as "Tinnitus".   Additional information included: As per caller he received his "1st dose at the beginning of Jan2021 and 3 weeks later the 2nd dose and it started since after the 1st dose. Patient had seen the doctor and they said there was no cure for the tinnitus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reaction to the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Reaction to the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Sulfa allergy) since an unknown date.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Reaction to the vaccine). At the time of the report, ADVERSE EVENT (Reaction to the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Temperature of 101F. Right leg swollen with erythema and welt. Left leg swollen with erythema, within 24 hours.
CHILLS; JOINT PAIN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and joint pain was not reported. This report was non-serious.
pt was given a normal dose flu on 12/3/2019 and a high dose given on 1/6/2020. NO reactions or symptoms
Low-grade fever (99.5) with muscle aches started at around 4pm, Aleve was taken at 4:30.  Fever spiked to 100 at 6:00p.  600mg of Ibuprofen was taken, fever spiked to 101 at 10p with muscle aches worsening.  800 mg of Ibuprofen was taken at 10p, fever spiked to 102.5 at midnight.  Nausea began and had to vomit.  Low-grade fever in 99-100 range remained until 36 hours post-vaccination.  Experienced sporadic, but mild palpitations in the chest area throughout the symptomatic period
Ovoid erythematous rash  over lateral left deltoid with minor swelling and transient, intermittent pruritis; approx. 7cmx5cm. Equivocal concurrent ipsilateral axillary lymphadenomegaly. First noticed late afternoon Feb 27 when incidentally glanced in mirror. Symptoms progressed slightly by morning of Feb 28, then remained static that morning, then gradually resolved with complete resolution by 72h. TX - Iced the area x10min two or three times, took a single dose of NSAID, and took my normal antihistamine.
Left side peripheral vision become wavy and spotted over with light blotches. Happened the night of the injection so far. Lost sense of taste in eating food for 5 days after injection.
She report had vaccine in AM 12/18 then later that night developed fatigue, muscle aches, and head ache.  This has worsened overnight and this morning 12/19 had new symptom of sore throat that has persisted.  Given sore throat has been advised to follow-up with employee health prior to potential return to work.
At injection site there is a red area that is warm to the touch and sore for the patient. The redness is not itchy at all and there are no visible hives.
Right arm: rash, hot, swollen and had bruising 7/23/02. Started on Prolone by ER physician. 8/1/02 Called to mom; child fully recovered from event.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out range of 13.25 hours. Last temperature recorded -17. (It was reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 07-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Hard lump/bump at injection site about 2 inch diameter.  Rash/redness (feels warm) at injection site about 3 inch diameter.  Pain at injection site.  Joint pain everywhere. The joint pain was resolved with Ibuprofin, but the pain came back the next day, and was again resolved with Ibuprofin. Some fatigue.
Case number PHEH2012US011951 is an initial spontaneous report received from a medical assistant on 11 Jun 2012: This report refers to a 12-year-old female patient. She was given only the CYW-135 liquid component MENVEO (batch number: A11075) intramuscularly on 11 Jun 2012. No other adverse reaction was reported.
Pt came to ER c/o back pain, right mid calf pain.  Weak, falling, unable to ambulate without assist.
Pt. received 5 vaccines. 3 to LLE, 2 to RLE. 2 days later with fever, limp, Rt. upper leg swelling, continued x 1 week. Ultrasound done of Rt knee and thigh. Dx=probable infected hematoma. Treated with Emergency Dept. with antibiotics.
Information has been received from a physician concerning a 69 year old female patient who in 2001 was vaccinated with the first dose of PNEUMOVAX 23. After the patient received the first dose she did not have adverse reactions. "Last week" (appropriately on 05-OCT-2009) the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot number unspecified). On approximately 06-OCT-2009 the patient experienced vomiting the morning after she received the second dose of PNEUMOVAX 23. At the time of the report the patient had recovered from vomiting. The patient sought unspecified medical attention. Additional information has been requested.
My second dose triggered cluster headaches, which I have not had for almost 40 years. They began the day after my shot and have intensified over the last 12 days
o Patient reported mild headache after receiving Moderna vaccine. Vital signs taken BP 114/44 P 90 R 17 o2 sat on room air 97%. Bottle of water given to patient. Patient stated "I feel fine,just have a small headache". Retook BP 105/40 P 92. Relayed to patient to the need to go to walkin. Patient refused Contacted Nurse manager, nurse manager consulted with Walkin provider. Dr recommended patient go to ER to receive IV fluids. Patient refused stated she is feeling better. Two more water bottles given to patient. Waited 15 minutes, retook vital signs 123/70 P 83 R 17 o2 sat 98% . Patient reported she is feeling better. Transported patient to car. Advised patient to go to the nearest ER if she experiencing any chest pain, dizziness, severe headache, SOB. Patient verbalized understanding and had no further questions. Patient declined to have further evaluation. Unclear etiology of patient's symptoms.
full body rash like hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (full body rash like hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-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 URTICARIA (full body rash like hives). At the time of the report, URTICARIA (full body rash like hives) outcome was unknown.            No concomitant medications were reported.   The patient took Benadryl as treatment for the events.   This case was linked to US-MODERNATX, INC.-MOD-2021-081658 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081658:CROSSLINKED WITH DOSE 1
runny nose; cough; sinus congestion; Cold; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283, expiry date was not reported) (at 66 years of age), via an unspecified route of administration in the left arm on 12Jan2021 (at approximately noon) at a single dose for COVID-19 immunization. Medical history included blood cholesterol abnormal. Concomitant medication included simvastatin for cholesterol. The patient has no any other vaccines within four weeks prior to the covid vaccine. The patient got the first dose of the vaccine and he is due to get the second dose tomorrow. However, he has a cold. He does not have a fever; but he has a runny nose and a cough, both on an unknown date. He wanted to know if it was safe for him to get the vaccine; or if not, if it is delayed, how long. He commented that he did not know what to do. Patient has had the cold for ten days. It was getting better, but not rapidly getting better. He had been taking cold medicine as treatment which was not prescribed, it was over the counter. The time of onset for cold was at bedtime like ten days ago (22Jan2021), at around bedtime started to feel the drainage. On 01Feb2021, it was reported that the patient was due for his second dose of the vaccine tomorrow but he has a cold. He has no fever but has a cough and sinus congestion. The outcome of cold was recovering while unknown for runny nose, cough and sinus congestion. Therapeutic measure was taken as a result of cold with the use of cold medicine (unspecified).
Tachycardia? measured heart rate consistently 20 bpm or more than normal lasting for over one day
reporting painful burn like blisters on right hand. manily thumb and ends of fingers. wife goes everywhere with him and they use the same hand sanitizers in home and in public
Mother states son received Varivax in 1995.  Beginning of June had 4-5 days fever (highest 101.6 F) with lesions on back (over 100), chest, face, mouth, scalp, all over.  Concerned with bad lot.  Given Acyclovir.  Sister also had lesions in 1995 and had varicella.
Left side of my lips paralysis, affecting my ability to use American Sign Language accurately and to smile; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:00 (Lot Number: ER8729) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history reported as none. The patient's concomitant medications were not reported.  The patient previously took morphine for drug hypersensitivity.  The patient experienced Left side of lips paralysis on 02May2021 06:00, affecting ability to use American Sign Language accurately and to smile. The patient was told by Dr. to go into the ER to rule out, Bell Palsy or a Stroke. The patient had an MRI done with and without contrast in 2021. All looked good. This leaves the COVID vaccine as the cause of my problem. The patient received treatment for the event. The outcome of event was not recovered. No other vaccine in four weeks; Prior to vaccination, the patient was diagnosed with COVID-19.