chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain chest; Swollen lymph nodes; GI pain; Arthritic pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain chest), LYMPHADENOPATHY (Swollen lymph nodes), GASTROINTESTINAL PAIN (GI pain) and ARTHRALGIA (Arthritic pains) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown Device. On an unknown date, the patient experienced CHEST PAIN (Pain chest), LYMPHADENOPATHY (Swollen lymph nodes), GASTROINTESTINAL PAIN (GI pain) and ARTHRALGIA (Arthritic pains). At the time of the report, CHEST PAIN (Pain chest), LYMPHADENOPATHY (Swollen lymph nodes), GASTROINTESTINAL PAIN (GI pain) and ARTHRALGIA (Arthritic pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Vaccine was refrigerated on 17-Feb-2022, expired on 01-Apr-2022 and later on administered on 05-Apr-2022; 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vaccine was refrigerated on 17-Feb-2022, expired on 01-Apr-2022 and later on administered on 05-Apr-2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was refrigerated on 17-Feb-2022, expired on 01-Apr-2022 and later on administered on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vaccine was refrigerated on 17-Feb-2022, expired on 01-Apr-2022 and later on administered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial was stored in refrigerator on 17-Feb-2022 at 10 am. The vial did not undergo any temperature excursion. The reporter stated that patients did not experience any adverse events. No treatment medication were provided. The analysis of the vials associated with storage excursion was completed and it was reported that the vaccine administered on 05-Apr-2022, 06-Apr-2022 and 07-Apr-2022, from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up contains significant information. The narrative was updated.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing), notes: other medical history: Coronary artery. Concomitant medication(s) included: ATORVASTATIN; BABY ASPIRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (15May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media and company representative concerned a patient of unspecified sex, age, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210666714-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Right Arm swollen from shoulder to elbow, red/hot/itchy, rash like developing. No Shortness of Breath. Patient taking BENADRYL and ice pack to right arm.
This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Meningococcal B vaccine for prophylaxis. In June 2018, the patient received Meningococcal B vaccine. In June 2018, less than a day after receiving Meningococcal B vaccine, the patient experienced tiredness and sluggishness. On an unknown date, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved and the outcome of the tiredness and sluggishness were unknown. It was unknown if the reporter considered the pain in arm, mobility decreased, tiredness and sluggishness to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her son got his shot last Thursday and his arm still hurts; he could barely lift it. He was tired and sluggish to but nurse said it would make him that way and to go home and rest.
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a white female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of reporting. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on 23-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered to left arm on 01-NOV-2021 for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JAN-2022, the patient experienced Slight runny nose (suspected covid-19 infection). On 26-JAN-2022, the patient tested positive on using the "Bi Nax Now take home" antigen test (suspected clinical vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0: 20220150499-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
No additional adverse effect; received a fourth dose of GARDASIL 9; This spontaneous report was received from a Medical assistant referring to a 19-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 03-DEC-2019, the patient was vaccinated with fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (extra dose administered) via intramuscular route in the right arm for prophylaxis (strength, dose, lot # and expiry date not reported), who was previously vaccinated with three dose series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse event was reported. No product quality complaint was involved in this report.
22AUG92 10 days p/vax mom reported fever, seizures x 4 occured; mom reported reaction on 24AUG92, 12 days p/vax; fever has not been t103 R; mom called MD & was told reaction probably from MMR but MD did not examine pt;
I developed intense full body itches and the hives all over my body. I went to urgent care where they prescribed oral steroids and an antihistamine.
I was hospitalized due to severe blood clotting for four days following surgery to remove scar tissue from the urinary/prostate area and am now on blood thinner medication.
50-cent size hard knot and swelling around injection site. Increasing pain and loss of range of motion in left arm in days following. Dr. visit on 11/17/2015 prescribed Prednisone 10mg in a decreasing dose over 6 days between 11/17 through 11/22/15. Some pain relief while on the Prednisone but returned after med. was finished. Dr. visit on 12/1/15 with plan to start Physical Therapy to decrease pain and increase range of motion. Was referred for this and first visit on 1/15/2016 with visits continuing at this time. Have had some decrease of pain but wake up at night with pain in left arm. Have regained some range of motion but not to point of pre-vaccine. Having some loss of sensation in left hand and inability to always maintain a grasp/grip of items picked up.
blood clots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced THROMBOSIS (blood clots) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information included blood thinners.  This a case of a male patient of unknown age who had blood clots and was hospitalized after receiving a dose of Moderna COVID Vaccine. Very limited information has been provided at this time.; Sender's Comments: This a case of a male patient of unknown age who had blood clots and was hospitalized after receiving a dose of Moderna COVID Vaccine. Very limited information has been provided at this time.
Began as dull chest ache or pressure at night and heart flutter when in supine position by end of week causing discomfort while falling asleep. Acute episode of chest pain, palpitations, rapid heart beat, and restlessness at one week. Intermittent espisodes at least once per week of the same types of symtoms and pain, weakneass, or discomfort around body originating in chest area such as sharp pain in left shoulder blade or shooting up left arm.
Day after vaccine stabbing lower back pain. Don't know if it's kidney or liver or organ spasm or actual lower back pain. Feels like sudden kick in lower back. Often instinctively i yell "oof!" so loud, embarrassed if neighbors hear
Pt presented to ER w/numbness on the lt side of her face, lt arm & trunk; c/o hyperventilating;
PAIN AT INJECTION SITE AND IN SHOULDER.  PATIENT STATED SHE WAS SEEN IN AN URGENT CARE CENTER ABOUT 12 HOURS AFTER THE INJECTION.  PATIENT DID NOT HAVE ANY RECORDS AND WAS UNSURE OF WHAT TREATMENT WAS ADMINISTERED AT THE URGENT CARE.
24 hours later pain in right neck, shoulder and jaw, limited ROM with neck and right arm/shoulder. As of 10/30/23 pain  has not resolved. Did have enlarged lymph nodes that resolved in 3 days.
Eight days after shot given woke up with severe headache.  About noon that day my left arm started itching real bad and was itching it.  One of the nurses I work with said there was welts on my skin.  I could feel 3 lumps and was warm to touch and red. I notified my supervisor and was told to contact my doctor's office.   They called me later and told me to take anti-histamine and cool compress to the area, which I did.  Was very tired and went to bed early.
The day after receiving the vaccine, some balls appeared in my chest at the level of the clavicle which have presented a lot of pain and inflammation that until today, Tuesday 06-02-2021, has not diminished.
May 21 Ocular migraine lasting 30 min.,  exhausted and lightheaded for 1 month. June 25 Ocular migraine lasting 20 min., constant headache and exhausted since then.
Pt recvd vax & exp painful stinging upon injection; next day the arm of inject was inflammed; Other pts recvd injects from the same lot w/o adverse reaction;
Symptoms: Dizziness, myalgia, nausea vomiting & sudden onset of profound weakness Treatment: Globulin,immune 600ml IV daily x 4 days ML every day
Beginning about 12 hours after administration, I began experiencing severe and progressive joint pain. Pain presented bilaterally in knees, ankles, hip joints, shoulders, and wrists.  Pain worsened over 2 hours and was managed with two doses of 5mg oxycodone spaced two hours apart.  Pain persisted over two days and was managed with 5mg oxycodone PO q6-8 hours before subsiding.
completely impotent/unable to achieve an erection; no feeling in penis; unable to achieve orgasm; This is a spontaneous report received from a contactable consumer (patient). This 54-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ew0175) at single dose on 29Apr2021 10:00 AM via an unknown route in left arm at 54-year-old for Covid-19 immunization. Medical history included diabetes, hypogonadism, slight hypertension. Patient had no known allergies. There was no any other medications the patient received within 2 weeks of vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ew0150) on 08Apr2021  10:00 AM in left arm at 54-year-old for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient become completely impotent. He had no feeling in private area. He was unable to achieve orgasm. Even taking Ed medication he was unable to achieve an erection. The event onset date was 01May2021 at 12:00 PM. The event resulted in Doctor or other healthcare professional office/clinic visit due to disability or permanent damage. No other treatment received for the adverse event. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: nasal Swab PCR on 21Jul2021 and 23Jul2021, both were negative. Outcome of the events was not resolved.    The event was reported as serious with disabling/Incapacitating.
Information has been received from a physician concerning a female who was vaccinated with three doses of GARDASIL, a Pregnancy Registry product, (IM, 0.5ml, lot # not reported). She was currently 4 months pregnant. The patient was told by her OB/GYN physician that she was HPV positive. The patient came to the office. Additional information has been requested.
Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        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.   This case was linked to MOD-2021-080348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: No new information
vaccine administered to a 11-year-old patient; vaccine administered to a 11-year-old patient; permanently disabled; This is a spontaneous report from a non-contactable consumer. A 11-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: unknown) via an unspecified route of administration on an unspecified date (at the age of 11-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were reported as unknown. Other vaccine in four weeks, covid prior vaccination, covid tested post vaccination, known allergies were reported as unknown. It was unknown if the patient received any other vaccines within 4 weeks prior to the covid vaccine or any other medications within 2 weeks of vaccination. On an unspecified date, the patient was permanently disabled. The reporter described that it happened to a granddaughter of her friend. Adverse event resulted in disability or permanent damage. Treatment was reported as unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax; inject site devel erythema, warmth & 100 mm induration; site was painful; all sxs resolved approx 4 days after vax;
Pain, redness, hard lump, warmth at injection site still going on at day 2.
Janssen COVID-19 Vaccine EUA.  Starting around 8pm after receiving the vaccine about 5 pm, I started getting severe chills. The chills were causing vigorous full body shivers. My body temp began to rise and I maintained a fever of over 101 degrees until after 1pm the following day. All through the night I had diarrhea, nausea, a headache, and dizzyness with a racing heart rate when I tried to stand. I had muscle aches through the night, particularly in my calves and soles of my feet. After taking 800mg of ibuprofen, my fever dropped below 100 degrees and my body aches subsided until about 6 pm day after injection, then fever began to rise again, chills and nausea returned. So I took another 800 mg ibuprofen before returning to bed and going back to sleep. Major symptoms were gone by the second morning after injection with some lingering fatigue, loss of appetite, and mild body aches. Injection site in arm is also still tender and sore.
On 2/4/2022, in the course of receiving treatment for gastrointestinal symptoms, I was given a blood test which resulted in the finding that I had subclinical hypothyroidism.  A follow-up test was administered by my PCP on 5/16/2022 and the condition persisted.  This resulted in my being prescribed levothyroxine 25 mcg once a day for a 30 day period. I will go into my PCP's office this Saturday (7/16/2022) for blood testing to see the result of this treatment.
Started feeling achy and feverish, took a home COVID-19 test and it was positive. Was sick for about 3 days with fever, chills, fatigue, body aches. After 10 day I retested for COVID-19 and it was negative. Since then I've started to have severe headaches daily,  Dr. ordered a CT Scan without contrast. Results were clear. I was prescribed Amitriptyline and it has helped with my headaches, but now they're starting to come back.
Face swollen around the left eye; sore arm-left; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swollen around the left eye) and VACCINATION SITE PAIN (sore arm-left) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SWELLING FACE (Face swollen around the left eye) and VACCINATION SITE PAIN (sore arm-left). At the time of the report, SWELLING FACE (Face swollen around the left eye) and VACCINATION SITE PAIN (sore arm-left) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Erythema, induration 4 x 6 cm left deltoid area tender.
Child had 2nd booster for Varicella on 3/14/11. Site now has 9 ea 2 to 3 mm and 1 ea 6-8mm vesicles.
Pt reported that slight itching started on 4/22/2021, after he got the vaccine.  This continued to progress into extreme itching and rash with swelling all over his body, including his face and eyes.  He went to the emergency room on 4/25/2021.  He was given medication in the ER, and was given a prescription for Prednisone to take for 1 week at home.