chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post vax, pt bled briefly from the injection site. Immediately after administration, injection area surrounding site, swelled with indurated lump measuring 30mm at 16:35; 27mm at 16:40; 22mm at 16:46. Pt denied pain at site or SOB. No erythema at site. Pt left at about 16:50 without complaints. Advised to call at 15:45 and pt was advised to have husband observe about 24 hours for SOB and to go to ER if symptoms of worsening induration, pain or SOB.
24 hours after receiving vaccination- extreme fatigue that has not went away.   8/11/21 10pm- heavy Vaginal bleeding (not due for menstrual period)  8/12/21 moderate vaginal bleeding until 8/16/21  8/16/21 moderate dull stomach pain and nausea  8/17/21 extreme stomach pain and nausea- went to walk in clinic, transferred to Emergency department. Diagnosed with acute Appendicitis.  8/18/21 - Appendix removed.
TOOK TWO DOSES THAT WERE NOT STORED IN THE REFRIGERATOR; This spontaneous case report (PVX2019-2128) was received from a pharmacist on 19-Aug-2019. It described a 62-year-old male consumer who "took 2 doses that were not stored in the refrigerator" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer took first two unrefrigerated doses of Vivotif on 15-Aug-2019 and 17-Aug-2019, respectively. The dose was kept in the car over 77-degree Fahrenheit for a day.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took 2 doses that were not stored in the refrigerator" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 doses that were not stored in the refrigerator" was considered as not applicable.
This spontaneous report was received from a pharmacist refers to an unknown age and gender patient. Medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX lot number, route, strength and dosage were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patient was diagnosed with a case of shingles at unspecified amount of time later. The outcome of the event was unknown. Additional information is not expected.
Dtap booster given to my 12 year old. Swelling and itching of the area shot was given. Medication: boostrix 0.5ml
IN OCTOBER SHE STARTED HAVING BODY ACHES AND STOMACH PAIN. ABOUT TWO DAYS AGO THE SYMPTOMS STARTED HAPPENING AGAIN.
Redness in the arm that she received the vaccine, swollen, very itchy, not so painful, warm to touch, and fatigue for one day.  Redness went away but now is like a rash in a smaller area, still warm to touch, itchy, and very slightly swollen. This patient was recommended to contact doctor or pharmacist about taking an antihistamine with her escitalopram due to the slight interaction they have, and if this persists to see a doctor to get assessed and see if they can prescribe something else for the itching.(do not take any immunosuppressants until 2 weeks have passed from second dose.
Pain & stiffness in neck 2 days post inject; No local rxn; polyradiculoneuritis; Rec'd inject p/being bitten by horse;
Information has been received by someone in the physician's office concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. (Lot number not reported). It was reported stated that the patient was using GARDASIL and experienced vaginal lesions. The patient sought unspecified medical attention. The patient received unspecified treatment for this event. It was reported that the physician was aware of this. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Initial information received on 06-Dec-2018 regarding an unsolicited valid serious case received from a physician. This case is linked to case 2018SA339705 (same patient). This case involves a male patient of unknown age who experienced cellulitis and Peripheral swelling, while he received vaccine INFLUENZA VACCINE. The patient's past medical history included minimal egg allergy (Food allergy) identified post allergy testing. The patient's past vaccination(s) included influenza vaccine in JUN-2015 with no reaction, patient also had other unspecified vaccines. The patient's past medical treatment(s) and concomitant medication were not provided. On an unknown date in 2016, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed swollen arm and shoulder/upper back (Peripheral swelling) and later diagnosed and treated it as cellulitis following the administration of INFLUENZA VACCINE (unknown manufacturer). The event, cellulitis was assessed as medically significant due to important medical event. Other lab test was not reported. Final diagnosis was cellulitis and Peripheral swelling. It was not reported if the patient received a corrective treatment. Outcome of the events was not reported.; Sender's Comments: This case involves a male patient of unknown age who presented with cellulitis and Peripheral swelling after vaccination. Time to onset is not known. There is, moreover, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
1 hour post flu shot c/o redness to right arm, chest, face, back & stomach & c/o warmth. Transported to E.R. BENADRYL & PEPCID for 5 days. Hospital unknown.
Rash began forming soon after injection on the neck and chest, by the 1hr mark tongue was swollen, Benadryl was taken and side effects seemed to subside. The next day low heart rate and chest pains began to occur with other side effects, headache, fever, loss of appetite, and dizziness.  A doctor was contacted about the symptoms as they have remained steady throughout the day. 9
Bad Chills; headache; This is a spontaneous report from a non-contactable consumer. An elderly female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration on 17Feb2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in Jan2021 for covid-19 immunisation. She had no COVID prior to vaccination and was not COVID tested post vaccination. It was unknown if patient received other vaccine in four weeks. On 17Feb2021, the patient experienced bad chills and headache. Treatment was not given. The patient recovered from the events.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Patient received Tdap and Varivax in left arm on 8-5-08.  On 8-8-08 patient returned with post left upper arm 10cm x 9cm erythema, warm to touch, plus 2cm nodule under skin.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 11/13/2022 MEDIASTINAL LYMPHADENOPATHY
This 39 yo civilian ctr reported being in good health 1/27/2021 when he received his 2nd Pfizer Covid vaccination.  He states about 3-4 hours after his vaccination (mid day) he felt "very hot" from head to chest, and his upper lip region under nose was red and sore.  That evening he noticed small circular fluid filled blisters above left upper lip and below left lower lip in chin area.  He began to treat with hydrogen peroxide and wipe with alcohol.  This cased area to begin to dry and crust over.  It's been 2 days and while drying out, these blisters are not increasing.  He denies any fever, myalgia, arthralgia, n/v/d, or any other systemic symptoms.  He denies any trauma to his lips/face, burns or recent illnesses.  Patient request VAERS filed by clinic team.
Started with soreness in arm during the first 12 hours.  Resulted in Cellulitis below the injection site, and caused extreme pain in the whole arm at about the 24 hour period.  Pt was seen in the ER, and received antibiotics such as Levaquin 750 mg.
This is a spontaneous report from pharmacy technician for a consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administered at single dose on unknown date. The patient medical history and concomitant medications were not reported. On unknown date, the patient developed swelling, redness, it rose a little bit, it was warm whenever you touch it and it was also itching. The outcome of the events was unknown. Follow-up (19Dec2014): Follow-up attempts completed. No further information expected.
I gave high dose flu vaccine to a 55 yo.  No treatment needed.  Patient had no adverse side effects
Hi issues; freqwuent twinges, diarrhea   Right sided substernal pain
Received 2nd booster and on Wednesday had severe, severe pain in my left thigh and left hip
developed some tingling, kind of a shock that comes and goes in her arms and in her back; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the vaccine yesterday on 23Dec2020 and she developed some tingling, kind of a shock that comes and goes in her arms and in her back. She watched it for a long time, as nurses like to watch, and she finally feel asleep, so she wanted to tell this, she didn't know if this is any danger to her, she didn't think so, she was breathing well and can talk, but she was concerned because the tingling was almost like a little shock that comes and goes, not permanent. The reporter wanted to know if anyone has reported this. She was about to go out, but decided to call, agent can't say if this is something reported and she need to go to the local hospital. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
torso and upper arms became blotchy, red and very itchy; torso and upper arms became blotchy, red and very itchy; torso and upper arms became blotchy, red and very itchy; so itchy she scratched so much; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 80-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (80-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included blood clot due to knee replacement last year from an unknown date and unknown if ongoing. It was reported as she had a clot due to knee replacement. She wondered if it could be attributed to the regular tylenol which she took for months post knee replacement. Stated tylenol is toxic to the liver; it did not take away the pain. The patient stated that she developed a blood clot when she had her knee replacement late last year. The patient's concomitant medications were not reported. On an unknown date, the patient's torso and upper arms became blotchy, red and very itchy. It was reported that, 6 days after receiving the first dose, her torso and upper arms became blotchy, red and very itchy. The patient stated it was so itchy she scratched so much. She saw her hcp who prescribed pepcid and zyrtec which resolved the reaction quickly. The patient stated she had a screen test and it was discovered she was not allergic to anything so her hcp attributes her reaction to the vaccine. It was reported that reaction occurred to the first shot but nothing to the second shot. Therapeutic measures were taken for the events. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration as dose 2, single for covid -19 immunisation. The outcome of the events were resolved.  Information on the lot/batch number has been requested  Follow-up attempts are completed. No further information is expected.
Throat Closing; Trouble Swallowing; Dry nose; Slight Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Throat Closing), DYSPHAGIA (Trouble Swallowing), NASAL DRYNESS (Dry nose) and HEADACHE (Slight Headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD. Concomitant products included LOSARTAN POTASSIUM (COZAAR), AMLODIPINE BESILATE (NORVASC), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and NICOTINAMIDE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced THROAT TIGHTNESS (Throat Closing), DYSPHAGIA (Trouble Swallowing), NASAL DRYNESS (Dry nose) and HEADACHE (Slight Headache). At the time of the report, THROAT TIGHTNESS (Throat Closing), DYSPHAGIA (Trouble Swallowing), NASAL DRYNESS (Dry nose) and HEADACHE (Slight Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
DVT behind left knee detected at ER on 08Apr. Pain behind left knee started on 4Apr; This is a spontaneous report from a contactable consumer (patient himself). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 02Apr2021 at 12:00 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunization. Relevant medical history included prior deep vein thrombosis (DVT) behind right knee from an unspecified date in 2010 to an unknown date. Concomitant medication included finasteride (PROPECIA) taken for an unspecified indication, start and stop date were not reported. The patient previously took ibuprofen (ADVIL), acetylsalicylic acid (ASPIRIN), and unspecified salicylates, from which the patient had known allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 at 12:00 PM (lot number: EN6204) at the age of 47 years, administered in the left arm for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient had DVT behind left knee detected at the emergency room (ER) on 08Apr2021; the pain behind left knee started on 04Apr2021. The adverse event (AE) resulted in an emergency room/department or urgent care. Therapeutic measures were taken as a result of the event, which included that the patient was prescribed apixaban (ELIQUIS). The patient was not recovered from the event.
When adminstering BOOSTRIX vaccine used 18 gauge needle instead of 25 gauge, pt bleed at injection site (right deltoid) and believe lost most of the vaccine.
Hoarse voice, throat clearing, chest tightening, tongue felt "strange", itching chest and back approximately 1-2 hours after vaccines; epi given SQ 1 hour after sym. started - also gave KARBINAL 15ml x 1and 30 mg prednisone po.
pt recv vax 11JUN96 & pt exp raised red area the size of a quarter @ the inj site;by next morning area was the size of a golf ball;12JUN96 pt visited the ER & was given an unk topical ATB;
Pt given Pneumovax, developed fever, vomiting and shortness of breath within 1 hour after receiving. Came back to clinic with acute asthmatic symptoms, bronchospasm.
Pain on the arm; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain on the arm for 3 days, no other reactions. Her second dose was intended for Monday, but she received "Pexol chemotherapy", and she was told they would call her to arrange the second dose appointment. She got a call yesterday but they did not schedule her. The outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age with no known drug allergies. The patient's pertinent medical history was none. On an unknown date the patient was vaccinated with ZOSTAVAX (Dose/Frequency: Unspecified, Therapy Route: Unspecified). Concomitant medications were none. On an unknown date the patient had flare ups of eczema that come and go. The pharmacist stated that the patient saw an unspecified physician, on an unspecified date who prescribed TOPICORT. The pharmacist reported that they filled TOPICORT around the beginning of April 2014. The pharmacist stated that the patient was in the pharmacy on 29-MAY-2014 asking if ZOSTAVAX was the cause of flare ups of eczema. Lab diagnostics studies performed were none. The outcome of flare ups of eczema was unknown. The relatedness of eczema with ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 58-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection (dose and route of administration were not reported) lot # N015627 with expiration date 04-JUL-2018. The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of -11.4 degrees Celsius for 2 hours and 55 minutes. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Breastfeeding; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021. The most recent information was received on 22-Jul-2021 and was forwarded to Moderna on 22-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy in 2020.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2020, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) 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.   No concomitant medication taken. .  Patient second dose 2 scheduled on 28-March-2021.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up
Lupus; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (From COVID, patient could not breath, went to the hospital, got a chest x-ray) in March 2020.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus) (seriousness criterion medically significant). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: result not reported (Inconclusive) Result not reported. On an unknown date, Blood test: result not reported (Inconclusive) Result not reported.         Patient was on no concomitant medication.  On an unknown date in Oct-2021, the patient started to experience a skin rash. Patient had pretty severe skin rash. Patient was seeing a dermatologist specialist and everything. They have no idea what it was. They have done biopsies, given patient a topical steroid cream, prednisone, and blood tests. The doctors were saying that patient had an autoimmune deficiency, and diagnosed with Lupus.  Company Comment: This spontaneous case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Systemic lupus erythematosus. The patient developed a severe skin rash after the vaccination for which biopsy and blood tests were performed and the dermatologist prescribed topical steroid cream and prednisone; it was further diagnosed as Lupus. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Systemic lupus erythematosus. The patient developed a severe skin rash after the vaccination for which biopsy and blood tests were performed and the dermatologist prescribed topical steroid cream and prednisone; it was further diagnosed as Lupus. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
GOT SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, 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 got side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got side effects was not reported. This report was non-serious.