chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever and chills, nausea, headache. ER consult 10/28/2014 (may be secondary to Flu vaccine). (Temp 102.5).
Approx. 5 minutes, post vax, pt developed cough, profuse diaphoresis, pulse increased to 100, numbness and tingling in jaw/teeth. Given 0.3cc of epinephrine on right thigh, 911 ambulance/EMT's took pt to hospital. Rx'd IV Benadryl and some other medication. Pt cannot remember none of the other medications that he was given at the hospital. Pt had complete and uneventful recovery.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts a little) and DIARRHOEA (Diarrhea) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts a little). On 31-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 01-Feb-2021, PAIN IN EXTREMITY (Arm hurts a little) and DIARRHOEA (Diarrhea) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient reported receiving second dose also. No specific events were reported, but patient mentioned events duration was just one day after the vaccination for both doses, events were resolved and , does not consent to any further follow-ups
Syncope. Pt fell backwards as he was leaving immunization room for waiting/observation area after receiving first dose of Moderna COVID-19 vaccine. Episode lasted roughly 15 seconds at which point patient regained alertness. It was determined no epinephrine etc was needed. Pt was observed following episode until he was clearly okay to leave on his own accord, and no further medical attention would be necessary. Discussed follow up with PCP post event and to discuss appropriateness of receiving second dose.  Out of an abundance of caution, contacted patient later in the evening (about 1.5 hrs later) at home to check up and make sure he was still okay.
Third dose of Moderna COVID-19 vaccine inadvertently; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Third dose of Moderna COVID-19 vaccine inadvertently) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Third dose of Moderna COVID-19 vaccine inadvertently). At the time of the report, EXTRA DOSE ADMINISTERED (Third dose of Moderna COVID-19 vaccine inadvertently) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.   Reporter did not allow further contact
The day after the first dose I began experiencing pre-menstrual symptoms including heavy cramping. I also began shedding from my vagina small clumps of skin, maybe the size of a pea. I started my period about a week later and experienced much heavier flow than normal in a much shorter period of time.  My second dose was received on 01/20/21 at 10am at the same facility. The day after I began similar feelings of cramping and experienced very heavy, opaque white discharge from my vagina with a couple of pea sized clumps of what looked like my vaginal wall the day or two after, but then none at all. I continued to see this odd discharge until today (01/31/21).  Neither experience was at all painful, but it was very alarming.
3-5 mins after injection I became dizzy, a feeling of weakness accompanied this. The affect lasted from early am through the day and night. Disappearing by next morning or I would have called my family doctor.
Herpes outbreak on nose, near left nostril.; Fatigue; Nausea; Chills; Headache; Sore left arm; Swollen left armpit lymph node; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 16Dec2021 at 12:45 (Lot number: FF8839) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3247, Anatomical location: Left arm), administration date: 23Feb2021, when the patient was 55 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3247, Anatomical location: Left arm), administration date: 16Mar2021, when the patient was 55 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 12:45, outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious) with onset 17Dec2021, outcome "recovering", described as "Fatigue"; NAUSEA (non-serious) with onset 17Dec2021, outcome "recovering", described as "Nausea"; CHILLS (non-serious) with onset 17Dec2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 17Dec2021, outcome "recovering", described as "Sore left arm"; LYMPHADENOPATHY (non-serious) with onset 17Dec2021, outcome "recovering", described as "Swollen left armpit lymph node"; HERPES SIMPLEX (non-serious) with onset 19Dec2021, outcome "recovering", described as "Herpes outbreak on nose, near left nostril". Therapeutic measures were not taken as a result of fatigue, nausea, chills, headache, pain in extremity, lymphadenopathy and herpes simplex.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Rash gets itchy and flares up and down; Rash still spreading; Developed rash from injection site to almost elbow / Rash still spreading; sore throat; mouth is swollen and feels like it is going down her throat; top lip went numb; sores on the roof of her mouth; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (top lip went numb), STOMATITIS (sores on the roof of her mouth), OROPHARYNGEAL PAIN (sore throat), MOUTH SWELLING (mouth is swollen and feels like it is going down her throat) and RASH PRURITIC (Rash gets itchy and flares up and down) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Coronavirus test positive in February 2021, Lichen planus and Biopsy.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced HYPOAESTHESIA ORAL (top lip went numb) and STOMATITIS (sores on the roof of her mouth). On 28-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and MOUTH SWELLING (mouth is swollen and feels like it is going down her throat). On 05-Jun-2021, the patient experienced RASH PRURITIC (Rash gets itchy and flares up and down), RASH (Rash still spreading) and VACCINATION SITE RASH (Developed rash from injection site to almost elbow / Rash still spreading). At the time of the report, HYPOAESTHESIA ORAL (top lip went numb), STOMATITIS (sores on the roof of her mouth), OROPHARYNGEAL PAIN (sore throat), MOUTH SWELLING (mouth is swollen and feels like it is going down her throat), RASH PRURITIC (Rash gets itchy and flares up and down), RASH (Rash still spreading) and VACCINATION SITE RASH (Developed rash from injection site to almost elbow / Rash still spreading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not specified. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Updated contact email address of the reporter. Added new events vaccination site rash, rash aggravated and itchy rash.
Flu-like symptoms (muscle ache, multi-joint pain) but no fever or congestion; excessive fatigue and sleepiness from about 16-48 hrs after receiving 2nd dose.  Resolved after 48 hrs
Inadvertently administered 3 vaccines while pregnant, pt did not realize she was pregnant at the time.
Pt reports a small amount of balance/equilibrium problems and some dizziness. Pt was concerned since was ongoing after 3 days post vaccination and wanted to know if vaccine could be cause and how long this may continue
Td update given 6/9/08.  Localized erythema + swelling and warmth developed on day 6 after immunization.  Area 8cm x 15cm on upper arm.  Treated with oral prednisone 10 mg BID x3 days.
patient complains of chills and headache.  Warm clothing and blanket and Tylenol for 6 hours
sore stiff neck; sore arm; area of injection is tender and sore; stiff neck, stiff on right side; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck, stiff on right side), NECK PAIN (sore stiff neck), ARTHRALGIA (sore arm) and VACCINATION SITE PAIN (area of injection is tender and sore) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck, stiff on right side), ARTHRALGIA (sore arm) and VACCINATION SITE PAIN (area of injection is tender and sore). On an unknown date, the patient experienced NECK PAIN (sore stiff neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck, stiff on right side), NECK PAIN (sore stiff neck) and VACCINATION SITE PAIN (area of injection is tender and sore) outcome was unknown and ARTHRALGIA (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Additional information received: Non-serious event of sore stiff neck was added. Reference case ID added. Narrative updated.
This spontaneous report as received from a nurse refers to a 15 month old patient of unknown gender. On 22-SEP-2014 the patient received the first dose of (Oka/Merck) VARIVAX (lot # K003412, expiration date 06-MAR-2016, dose 0.5 ml, once, subcutaneously) that was stored at -2.3C for 13 hours, 23 minutes. Concomitant medications were not provided. No adverse effects were reported. This is one of two reports received from the same reporter (other MARRS# 1409USA011805). Additional information has been requested.
When I received my vaccine doses, the injection site felt very cold and icy. This may be normal, and while that initial icy feeling has diminished, *it has not totally gone away in subsequent months.* Now, nearly 6 months later, I still have a constant, dull muscular pain and tenderness at the injection site, not unlike a muscle bruise, and if I rub or lightly massage the injection site, the icy feeling deep in the muscle returns and lingers for approximately ten minutes before subsiding back to a dull ache.    The sensation is not unlike of topical "Icy-Hot" muscle relievers deep in my arm's muscular tissue at the injection site. It is definitely not psychosomatic and has persisted since I received the vaccine, and continues now.
Most symptoms worst on 10/18 and 10/19. Muscle aches and pains (5 days), mild headache (2 days), mild nausea (6 days), minor wheezing (3 days). Blood in phlegm (first observed 10/19) and malaise continuing into 10/24 (date of report).
Skin itching, dizziness, nausea and lump in throat.  Not anaphylactic reaction.  Rest, Benadryl and claritin OTC and she was back to normal after 1 hour and monitored another hour before leaving.
Headache, Sedation, Myalgia, Arthralgia, Fever, chills and fatigue. pain, redness and swelling at the injection site. Narrative:
About 1 hour after H1N1 nasal vaccine administered pt developed severe headache and runny nose. Within 11/2 hour developed cough and shortness of breath. When seen in office diffuse decrease better sounds peak flow ,100 02 Sat S 94% - given Albuterol and Orapred.
HOSPITALIZATION; This spontaneous report received from a patient via a company representative concerned five adult female patients. 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, 1 total, start therapy date were not reported on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Non-company co-suspect medications included unspecified birth control pills (pills, oral) dose, start therapy date were not reported for contraception. No concomitant medications were reported.  On an unspecified date, the patients were hospitalized for heart transplant to be performed. As per their physician, this could be due to Janssen Covid-19 vaccine and unspecified birth control pills. Number of hospitalization days were not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  20210458940 -COVID-19 VACCINE AD26.COV2.S- Hospitalization. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
rash; arm was itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and VACCINATION SITE PRURITUS (arm was itchy) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm was itchy). On 12-Feb-2021, the patient experienced RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, RASH (rash) and VACCINATION SITE PRURITUS (arm was itchy) 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.   Concomitant product use was not provided by the reporter.
Presented w/ weakness, AMS X3 days, cough via EMS. Tx for pneumonia/COVID + w/ O2, Dexamethasone, zinc
Mother states child's arm became red, warm and had a rash 2 days after vaccination.
Extreme shivering to the point of not being able to walk. Vomiting, high fever, chills and excessive sweating. Had to wear 2 sweaters, 2 blankets and heating pad to keep warm. Pain at injection site and swelling under the arm
Patient states that her arms started hurting the day after the shot but thought it would go away after a few days. However it did not go away and the patient has been complaining about a painful tingling in her left arm since the shot was administered
Left thigh inflammation 16cm x 11 cm at area. Rx Benadryl, Motrin, cool compress.
I have experienced eczema on my shoulders, lower back, legs and arms. I seem to be overly sensitive to small irritations to the skin. Scratching makes it worse leading to red raised bumps and worse itching. My primary care physician has treated the symptoms with Triamcinolone Acetonide Cream USP, 0.025% plus additional instructions per online conversation: Instructions - Suggest using Dove or Aveeno soap. * Switched to Dove. Works OK - Suggest using Sarna lotion. * Have been using a Loreal Moisture cream on non-affected areas. - Consider Benadryl at bedtime and Zyrtec during the day (if itchiness is intolerable). * Have been taking Zyrtec. - Return if symptoms worsen or fail to improve.
tested positive for COVID-19; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), PYREXIA (Fever) and CHILLS (Chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 01-Mar-2021, the patient experienced COVID-19 (tested positive for COVID-19). The patient was treated with IBUPROFEN for Fever and Chills, at an unspecified dose and frequency; VITAMIN D NOS for Fever and Chills, at an unspecified dose and frequency and ZINC for COVID-19, at an unspecified dose and frequency. On 10-Mar-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, COVID-19 (tested positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: unknown (Positive) positive. On 15-Mar-2021, SARS-CoV-2 test: unknown (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Antibiotics were also reported to be given for treatment of COVID-19.
Information has been received from an employee health nurse concerning a 31 yr old female certified nursing assistant with an allergy to levofloxacin (Levaquin), no history of chickenpox,  and who had an initial titer on 09Aug05 which returned a result of 1.2 eu/ml, who on 24Aug05 was vaccinated SC with a 0.5mL first dose in the left arm of varicella virus vaccine live (lot9103907) and a second SC 0.5mL dose in the left arm of varicella virus vaccine live (lot 9103907) on 28Sep05. There was no concomitant medication. There was no illness at the time of vaccination. On 14Dec05 she had a titer drawn, which returned on 21Dec05 as negative. The nurse reported that negative is defined by the laboratory as less than 15 eu/mL and the employee was 8.7 eu/ml. No ELISA units were specified in the measurement. The employee is presently well and has been well. There was no product quality complaint reported. Unspecified medical attention was sought. Follow up information indicated that no additional information was available. Additional information is not expected.
Day 2 after ADACEL administration c/o headache numbness in arm and difficulty speaking.
Having reactions to both prior Pfizer Covid 19 vaccines, my doctor asked I take Benadryl before having the shot.  At 6:55 AM, I took 2 Benadryl and 1 Tylenol.    On 09/23/2021, the shot was received at 7:45 AM. At 7:55 AM on 09/23/2021, my tongue began to swell along with tingling on the left side of my tongue.  The tongue was swollen to the point of biting it when speaking.  However, I continued breathing and swallowing sufficiently.    The swelling was reduced and tingling ceased at 1:00 PM on 09/23/2021.     The first dose of the Pfizer vaccine was administered on 03/09/2021 with lot number EN6202.  Within 10 minutes of receiving the vaccine, my tongue was swollen and had significant tingling on the left side.  My left jaw also hurt.  Breathing and swallowing continued uninterrupted.    The second dose of the Pfizer vaccine was administered on   03/28/2021 with lot number ER8730.  Within 10 minutes, my tongue tingled. My throat hurt but did not decrease my breathing. Over the next 30 minutes and after taking Benedryl, the reaction continued to cause my face to begin going numb on the left side from the jawline to above my left eye and my head hurt above my left eye. The face, tongue, and throat returned to normal within 12 hours. The headache continued off and on for 2 weeks.
Patient Bled, said she had bruising, + lots of pain. Ended up with tingling sensation. Saw her doctor, they & she believes a nerve was hit.
TOOK VIVOTIF AFTER PLACING IT IN THE FREEZER; A spontaneous case report was received from a nurse on 12-Sep-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX201909-000734 (PVX2019-2370; male) and PVX201909-000735 (PVX2019-2371; female) were created and cross-linked in the database.  This case report (PVX2019-2370) describes an elderly male consumer (over 65-year-old) who "took Vivotif after placing it in the freezer" (PT: Product storage error), while being on oral Vivotif capsule (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif, which was kept in the freezer for 12 hours at an unknown temperature. The remaining doses were kept in the refrigerator. The dosage dates remained unknown.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif after placing it in the freezer" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif after placing it in the freezer" was considered as not applicable. US-PaxVax Berna GmbH-PVX201909-000735:
Client found on floor with head against door. Client noted to be unconscious. Security notified. Client repositioned & placed flat on back with feet slightly elevated. Client noted to be diaphoretic & crying with eyes closed. Client asked if she knew where she was, did not remember. BP 122/72, HR 80, RR 30. Client asked to slow breathing. Client completed. RR 16. Client calmed & got up & sat in chair. Client orientated x 4. PA examine client. Client given juice, had nothing to eat or drink this AM & is afraid of shots. Client stated she was up most of night worrying about shots this AM. 0951 Client dc'd home awake/alert & oriented x 4 with Mom.