chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within two hours of ingesting oral typhoid capsule/tablet, experienced severe stomach pain which was described as occurring intermittently. The pain had subsided by 6pm (dinner time). Appetite unaffected by experience. No report of abdominal pain thereafter.
stomach cramps; very constipated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) and CONSTIPATION (very constipated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps) and CONSTIPATION (very constipated). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) and CONSTIPATION (very constipated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUN-2021 had Telephone Contact Report attached and it contain no new information.
Pt felt lightheaded and sweaty about 10 minutes after 1st Moderna dose.  She fainted and then about 30 sec later became responsive.  She continues to feel lightheaded and sweating.  EMT is called and attended to pt.
Rash at location of shot on arm. Rash is about 2 inches by 3 inches in size.
Pt reported back to our clinic at 10:30AM on 04/25/2014 complaining of pain in the back of his head, fevers, chills, and local pain at the site. Pt had a 101.9 temp upon arrival.
Allergic reaction to Kinrix with early cellulitis likely. Start Zyrtec daily and cool compresses to area, Tylenol as needed for discomfort as well. If no improvement in 24 hours or any worsening or fever, start Cephalexin BID. Script given.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and drug allergy (not specified). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 28-MAY-2021 in left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer, dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 14-DEC-2021 in left arm for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 64 years old. Concomitant medications included acropolis met.  On an unspecified date in 2022, patient had confirmed covid-19 infection which led to confirmed clinical vaccination failure (dose number in series 2). Patient tested negative 2 times and then tested positive again 2 times 4 days apart and was still waiting on a negative test. The patient received Paxlovid (batch number: FY4422) from 27-JUL-2022 to 01-AUG-2022 for covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220844832- covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Bright red itchy spot approx 3 inches around site of injection. The site has been warm and the muscle was hard/there was a lump under the redness with hives. Treatment was done based on research found about a case study in which the patients had "COVID Arm". The study had patients an corticosteroid cream and an antihistamine such as Benadryl. Patient already had a corticosteroid cream Fluocinonide (LIDEX) 0.05% ointment that could be applied x2 daily to affected area not including the face. Patient started using the cream twice daily (morning and night) along with a daily Benadryl to help with the inflammation on 4/11 . Redness has reduced, but it is still itchy and somewhat warm. Patient stopped the Benadryl 4/17 but is continuing the steroid cream.
Exactly 24 hours after the vaccine patient developed: lump/rash appears on patient's hand. Within two hours, both arms covered, back, legs, chest, buttocks. By 7pm on 5/5, patient covered in burning, itching, red rash
Patient tested positive for COVID-19 on 9/13/2021. They were asymptomatic at the time, but on hospice for CHF.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Total 42 Dose were administered after 30-day Use By Date. Vaccine was administrated on 26-Jan-2023, 27-Jan-2023, 30-Jan2023, 31-Jan2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. Vial size was reported as 0.4 ml per vial. Vial did not undergone any temperature excursions.  No treatment information was provided.  This case was reported for patient 07 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:patient no. 01 (Master case)
fever 106.5 R, crying excessively, limp; given sponge bath & APAP;
High fever >101 degrees. Shaking. Aching; whole body, especially joints soreness at injection site and under arm on torso. Self Treated with Acetaminophen and Ibuprofen.
Rash on both arms, chest, sides, stomach and back.  Also just a bit on both legs.  Rash began  3 days after vaccine and has not abated.
Admitted for COVID pneumonia. Vaccine completed in Apr 2021. Treated w/ O2, rocephin, zithromax, steroids, plavix. He had been given his COVID vaccine given a few months earlier so was not given convalescent plasma. His symptoms improved and once he was stable arrangements made for him to be discharged to rehab
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 30-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 30-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 30-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 30-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 30-Jul-2022).    No concomitant product use was reported. Patient received half dose. Vial did not undergo any temperature excursions. No treatment information was provided.
rxn to vax rt leg red & swollen @ site 1 1/2-2cm;wheal, high pitched crying cont;cont APAP & apply cool compress;
12/07/2001 developed 3 hives on left leg. On 12/08/2001 hives itching developed arm, lower axilla, back and legs. Zyrtec D 120 mg q 12 hours for 4 days. Zyrtec 10 mg TID for 4 months.
On evening of receiving vaccine, began feeling feverish, achy, lightheaded. The following day noticed intense pain of R arm (vaccine received in R arm) but from elbow to bicep.  Noticed spreading warmth and redness of bicep, tenderness of antecubital fossa.  Seen in clinic 11/12, area of R bicep appears cellulitic, patient tachycardic, wbc 11K, US negative for RUE DVT.  Given 7 day course of Bactrim.
Within 3 hours experienced significant ear noise and pressure, similar to clogged ears when sick. Within 2 more hours (5 from vaccine time), symptoms reduced to only low-level hissing equal across ears, i.e. tinnitus. During the 2 weeks since vaccine, hissing has remained exactly the same 24 hrs per day. Occasional much louder, higher frequency ringing has occured at least twice but only for short durations of 30 seconds.
Patient has a pruritic vesicular rash, around 50-60 lesions on his torso, arms, neck. The lesions do have a red base and resemble chicken pox. Symptoms presented 1-2 days before reported. (reported 10/28/08)Patient and family was instructed to give patient Benadryl as needed for itching and take oatmeal baths.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Additional Details: Pt. described botches on forearms. her Hands were swollen. Her arms and hands were painful and itchy. She took Zyrtec and APAP> Symptoms subsided but not fully resolved the day after the immunization.
first 3 were Moderna COVID vaccine and his 4th was Pfizer COVID vaccine.; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown", described as "first 3 were Moderna COVID vaccine and his 4th was Pfizer COVID vaccine."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Her husband was positive on Saturday.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201188416 same reporter/vaccine, different patient, similar event.;
pains; soreness at place at the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains) and VACCINATION SITE PAIN (soreness at place at the injection) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pains) and VACCINATION SITE PAIN (soreness at place at the injection). At the time of the report, PAIN (pains) and VACCINATION SITE PAIN (soreness at place at the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Email with outcome
RAPID HEARTBEAT; FEELING ANXIOUS; LOSS OF SLEEP; NAUSEA; SKIN FELT HOT; COLD; ACHYNESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 16:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced rapid heartbeat. On MAR-2021, the subject experienced feeling anxious. On MAR-2021, the subject experienced loss of sleep. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced skin felt hot. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced achyness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, feeling anxious, loss of sleep, nausea, skin felt hot, cold, and achyness on MAR-2021. This report was non-serious.
The day of the shot 5/28/21 I was nauseous and lightheaded, with injection site pain and felt warm but only had a mild fever for a short time in the evening. When I woke up on 5/29/21 my left ear felt slightly clogged and I had ringing in my ears. I felt fatigued and generally unwell for the whole day. And the injection site was warm to the touch and very painful. Upon waking up on 5/30/21 my overall symptoms improved a lot, arm was still sore but only to the touch, however tinnitus persisted. As of 5/31/21 all symptoms have  resolved  except the off and on feeling of fulless in the left ear (feels as though it needs to pop and usually does when opening jaw to do so) and the bilateral tinnitus.
This medically confirmed spontaneous report (initial receipt 02-Nov-2015) concerns a patient (unknown demographics). On an unspecified date, the patient received a dose of an unspecified influenza vaccine (Influenza virus vaccine, manufacture and batch number not provided). On an unspecified date following the influenza vaccine administration, the patient developed Guillain Barre Syndrome. No further information provided. The outcome was not provided. Follow-up information received on 13-Nov-2015 from the pharmacist: The cause of the GBS was not known by the reporter.
Swelling on both cheeks below eyes.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Apr2021 at 09:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and potassium low. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), and ascorbic acid, biotin, retinol, copper, zinc (HAIR SKIN NAILS V). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Apr2021 at 06:00, the patient experienced swelling on both cheeks below eyes. Therapeutic measures were taken as a result of adverse event and included treatment with unspecified steroids from unknown date. The clinical outcome of the event swelling on both cheeks below eyes was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Concurrent condition, medical history and concomitant medication were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX, (Lot # L019127, expiration date 27-MAY-2017; lot# L036830, expiration date 24-SEP-2017; lot# L029467, expiration 06-AUG-2017; lot# M002063, expiration date 12-JAN-2018) (strength, dose, route and indication were unknown). No adverse effect was reported. It was unspecified if the patients sought medical attention. This is one of three reports received from the same source. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71-year-old female patient . The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On 17-FEB-2009, the patient was vaccinated by a physician with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided), for long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a heathcare provider for shingles. The outcome of the events was not reported. The reporter considered the events to be related to ZOSTAVAX. Additional information has been requested.
Pt recvd vax on 9JUN92 & exp local arm pain, swelling down hand, tenderness which spread to involve lt shoulder & lt upper back; nausea & vomiting;
Pt developed symptoms of fatigue, body aches, congestion, diarrhea on 7/4/2021. Tested on 7/5/2021 at Urgent Care, when progressive loss of tastes, smell, developed a cough, fever- results were positive for covid-19. Yesterday 7/9/2021, Pt symptoms worsened - vomit, body aches, fever, cough- went to the ER- was diagnosed with Pneumonia. Pt symptoms are worse today, he is taking the medication to provide by the ER, and we provide chronic symptoms of covid-19 to Pts spouse. We recommend contacting the primary Physician to follow up with ER visit ( we stated that we are not Physicians, but we want Pt to monitor his condition and seek medical attention if symptoms worsen).
This patient received 1st dose of SHINGRIX vaccine and reported severe side effects continuing 6 days post-injection. Side effects, as reported by the patient, include, fever of up to 103, significant swelling of the arm, significant general malaise, severe headaches, lack of appetite, dizziness, blurry vision, patient was unable to work the day after injection and had to take a sick day. She also spent over 2 days following injection in bed, too unwell to be able to do much more than use the restroom.
After administration  of all three vaccines, patient's  feel to floor from chair, body still and appeared to have seizure like activity with body tensing. At this point she was none responsive with eyes rolling back. After about 30 seconds, patient regained consciousness. She was alert and oriented. EMS and parents called. EMS evaluated calling episode a vasovagal response. Patient and family refused transport to ED.
Patient had previously received the 2 doses of Shingrix back in 4/2018 and 7/2018.  Patient was not aware that she had gotten the first 2 doses because it was not in her app for her doctors office.  Dr told her she should get the vaccine.
pt says he is not feeling well.  He has become light headed, dizzy, and has severe stomach pain.  He has developed some diarhea and has a sour taste in his stomach.  He says when he stands up he feels like he may fall and he feels like he has a buzzing in head.  He has back pain on this lower right side of his body.  He has been taking anti-diarhea medicine medicine and Tylenol.  He is not getting any better and will have to contact his PCP.
Patient complained of generalized itching at 0900. Denied shortness of  breath, sweating, hives. 25 MG of IM Benadryl given at 0936. Patient observed observed after. Patient stated denied itching following Benadryl administration.
pt recv vax 15DEC97 &  21DEC97 pt devel a varicella-like rash on both elbows & one wrist w/burning & itchy vesicles;
24hrs p/vax bruise & swelling w/tenderness;3wks later same-saw MD & decided to watch area as of now there is no improvement area remain tender w/lump or nodule present-to have surgical removal of nodule 15APR96
pt exp dizziness, severe flushing of face, diff swallowing, dry mouth & feeling that something was in throat; sxs started w/in 6mins of vax;given Epi;