chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath; Fever 103.0; Chills; Nausea; Body aches; Severe pain in left side of head; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Severe pain in left side of head). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Severe pain in left side of head) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pyrexia: 103 High. On 03-Feb-2021, COVID-19: Negative.     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 was provided.
Huge swollen lymph nodes behind left ear and now the left side of my neck. Also giant cold sore on the right side of my face chin area
pt recvd vax; exp large inject site rxn;seen in ofc 5 days later; tx w/ decadron & dph
Headache; Myalgia; allergic reaction; This is a spontaneous report from a non-contactable other hcp. A 18-years-old patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache and myalgia on an unspecified date with outcome of unknown. It was reported "I spoke to Dr (name provided) at 2 pm on 29Jul2020 -provided information from Custom SRD on headache and provided info from (name provided), et al. Adverse Events Following Vaccination With Bivalent rLP2086 (Trumenba) - A total of 94% of subjects reported resolution adverse events, including headache and myalgia, within 7 days. The other info shared was number of events of severe (limiting ADL) (this is adolescent patient ,18 y.o.(year old))" Dr wanted to know how long it lasted for the other 6% vaccineated in (state name provided) study ad how they were treated. He's treating the patient with Flexeril and ibuprofen 800 mg - patient went to ER last evening and the ER told the mother it was an "allergic reaction". He suggested they did that so the mother would not continue the vaccine series.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No additional adverse events reported.; Patient received an improperly stored dose of ROTATEQ.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergy/ reaction and concomitant medications were not reported. On 22-APR-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (dose: 1 dose, frequency, route, lot#, expiry date was not reported) for prophylaxis. The vaccine was stored at a temperature of 35-degree Fahrenheit for 8 hours. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Pfizer vaccine given at 2:55pm. 3:10 Patient felt hot, diaphoretic, dizzy. Assisted patient to wheelchair.   Patient symptoms improved briefly. Continuously monitored oxygen saturation and pulse. 3:12pm 110/60, P 78, O2 98% RA. 3:15pm call 911 to requested EMS due to patient reporting shortness of breath, throat tightening, chest tightness.  3:18pm 130/80, P 101, O2 99% RA, administered oral diphenhydramine 25mg and 0.5mg Epi (1:1000) via IM injection in right deltoid.  3:25pm 130/80, P 85, O2 93%. Ambulance arrives at 3:28 pm received report and transports patient via ambulance to Hospital.
WEIRD SMELL THROUGH HER NOSE; WEIRD TASTE FROM FOOD; BODY ACHE; KNOT ON INJECTED ARM; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, and concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 100-101 F. On 05-APR-2021, the subject experienced severe headache. On an unspecified date, the subject experienced weird smell through her nose, weird taste from food, body ache, knot on injected arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache, and the outcome of fever, knot on injected arm, body ache, weird smell through her nose and weird taste from food was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
5pm tiredness 6pm achy 11pm 102 fever, chills 12pm 103 fever, chills, vomiting 1am 104 fever, chills, vomiting, took tylenol 3am 102 fever, chills, vomiting 4am 104 fever, chills, vomiting 9am 100 fever, took tylenol 12pm 101 fever, chills 3pm 103 fever, chills 5pm 103 fever, chills, took ibuprofen
fever, chills, light headedness, body aces, headache, fatigue, severe arm pain,  "couldn't think straight", brain fog, had been diagnosed with Covid November 2020.  Felt like had covid again.
The vaccine was not reconstituted. The pt was only injected with the diluent. No adverse effects were reported. Pharmacist error in reconstitution.
Face started to swell; Lips still tingly.; Lips became numb; Had itchy feeling in my throat; Shortness of breath; Nausea; Headache; Body chills; Aches everywhere; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face started to swell), PARAESTHESIA ORAL (Lips still tingly.), HYPOAESTHESIA ORAL (Lips became numb), THROAT IRRITATION (Had itchy feeling in my throat) and DIARRHOEA (Diarrhea) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Body chills) and MYALGIA (Aches everywhere). On 27-Mar-2021, the patient experienced SWELLING FACE (Face started to swell), HYPOAESTHESIA ORAL (Lips became numb), THROAT IRRITATION (Had itchy feeling in my throat) and DYSPNOEA (Shortness of breath). 27-Mar-2021, the patient experienced PARAESTHESIA ORAL (Lips still tingly.). The patient was treated with ACRIVASTINE (BENADRYL OTC) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Face started to swell), PARAESTHESIA ORAL (Lips still tingly.), HYPOAESTHESIA ORAL (Lips became numb), THROAT IRRITATION (Had itchy feeling in my throat), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Body chills) and MYALGIA (Aches everywhere) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-065332 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065332:Cross-linked with first dose
onset itching, mild swelling in rt eyelid 30min p/vax;swelling up-DPH (cold compress);3/3/99 AM hive like rash lt eyelid x 12hr3/4/99 eyelid swelling along w/lower extremity;joint pain;
The day after the shot my arm achedat shot site, but also my pointer finger swelled and hurt at the base where it joins the palm. As I write this day 2 post shot the pain is still there, swelling is going down.
Patient came to the pharmacy 3 days after immunizations were given, the injection site was swollen and red and reached down to his mid forearm.  Pt stated that he felt sick went to the ER a few days prior to get treated.  He was given benadryl, fluids, and a course of bactrim.
Patient stated she felt pain in the arm/shoulder area following vaccine. Following a doctor visit and work-up, it was determined to be SIRVA.
This spontaneous report as received from a registered nurse also a 60 years old female patient with allergy to sulfa. The patient was vaccinated subcutaneously with "a standard dose" 0.65 ml dose of ZOSTAVAX in her arm on 28-JUN-2012. No other co-suspects were reported. "A lot of medications" were reported as concomitant medication. On approximately 28-JUN-2012 the patient experienced severe local injection site reactions that lasted more than a week. The nurse reported that the area was very red and painful and size was about 8 inches by 5 inches around upper arm. She also reported that the injection site was very hot to touch and about egg size area, right around the injection site was very hard and had "a white ring around the edge of the red arm" and she also experienced itching around injection site. The patient did not seek for medical attention. BENADRYL and ice packs were given as treatment. At the time of reporting, the size of the affected area was much smaller but she still had some itching and inflammation. Additional information has been requested.
COVID clinic - Moderna  Patient feeling lightheaded, slight tightness in throat, heart feels like racing  0755 BP 104/62 Pulse 90 0815 unchanged   0830 Dizzy - in Recliner chair 0835 122/72 Pulse 106 Throat still tight able to swallow, some tightness in chest, short of breath 0840 Emergency called  Report given to ER and house supervisor transferred via wh/chair to ED  No epi given  (patient history of allergic reaction to allergy shots as well as pertussis shot).
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.  Patient did not experience any other adverse reactions.   This case was linked to MOD-2021-395985 (Patient Link).
Patient received Covid-19 (Moderna) vaccine at approximately 11am. At approximately 3pm on same day, patient called pharmacy and reported that he had developed a red rash on the arm that he received the vaccine as well as his back and chest. Patient stated that the rash was not itchy. Patient stated that the rash was not painful. Patient denies having any breathing issues or any other symptoms. Patient was advised to take two 25mg Benadryl capsules immediately and to report to ER or call 911 if the symptoms worsen or if any kind of breathing issue occurs. A follow-up call was placed to patient at approximately 530pm. At that time patient states that he still had the rash, but that it had subsided slightly. Pt denies any new symptoms developing.
Approximately 6 weeks after initial COVID vaccine patient experienced her first menstrual cycle ever.  6 weeks after her 2nd dose of vaccine she was diagnosed with a 3x3 inch ovarian cyst via a visit to the emergency room.  Since her first period in early July, she has only had a total of 2 periods (as of 9/30/21).  The ovarian cyst is still present and latest ultrasound shows the cyst is not resolving.  Surgery likely to resolve the cyst in November.   Concern is the vaccine impacted her menstrual cycle and ovarian tissue.
pt recv vax & 24-36 hr p/vax pt exp a swelling @ the lt deltoid inj site, & sl blurring of vision;pt was examined by a MD who observed a bumpy rash on face;tx DPH;
Nose bleeding; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeding) and HYPERTENSION (high blood pressure) 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 EPISTAXIS (Nose bleeding) and HYPERTENSION (high blood pressure). At the time of the report, EPISTAXIS (Nose bleeding) and HYPERTENSION (high blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product used was not provided by the reporter. Treatment medication used was not provided by the reporter.
headache; 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2/fever; chills; muscle aches; nausea; This is a spontaneous report from a contactable Other Health Professional reported for herself (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302; expiration date not provided), intramuscular (left arm) on 02Feb2021 13:30 at SINGLE DOSE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported.  The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Patient is not pregnant. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140; expiration date not provided), intramuscular (left arm) on 13Jan2021 for COVID-19 immunisation. The patient experienced headache, '9.5hrs after the 2nd vaccine dose a fever set in', chills, muscle aches, and nausea all on 02Feb2021 at 23:00. Patient's clinical course is as follows: 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2. To accompany the fever were chills, muscle aches, nausea, and a headache. After taking a fever reducer, the nausea stayed and the fever returned approximately 8hrs as did the chills, muscle aches, and headache. It was reported that patient took a fever reducer again and now waiting to see if that helps again. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included body temperature with result of '101.2 (9.5hrs after 2nd vaccine dose a fever set in, and climbed to 101.2)' on 02Feb2021. The patient has not received treatment for headache, chills, muscle aches, and nausea. Facility where the most recent COVID-19 vaccine was administered was reported as 'Workplace clinic'. Outcome of the events was not recovered.
feeling cold; stomach pains; coldness was in hands and feet; headache; This is a spontaneous report from a contactable consumer (patient's daughter).   A 96-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number: EW0164 and Expiration Date was not reported), via an unspecified route of administration in Arm on 16Apr2021, as 1st dose, single dose for COVID-19 immunization. Medical history included hypertension from Oct2009 and ongoing, cardiac disorder from Oct2009 to an unknown date, myocardial infarction from an unknown date and unknown if ongoing, stent placement from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban (ELIQUIS); metoprolol (METOPROLOL); simvastatin (SIMVASTATIN); isosorbide (ISOSORBIDE); acetylsalicylic acid (ASPIRINE) all taken for an unspecified indication from an unspecified start date and ongoing. It was reported that within the week prior (Prior to death), she complained of being cold, and had stomach pain, coldness was in hands and feet, she also mentioned headache. The outcome of the events was unknow.  Follow up needed, further information has been requested.
Macular rash began developing around site of inject w/in 10 minutes; MD was called & ordered DPH & Advil; The rash was around the inject site of the MMR; pt went to MD office;
I had a sore throat, flu feeling, congestion in head and nose, and coughing because of tickling in my throat. I tested positive for COVID-19 at home. I talked to my doctor and was prescribed PAXLOVID. 7 days after taking PAXLOVID I started having the same symptoms but milder. I tested myself again for COVID-19 but I never tested positive again. I still am having mild sore throat, fatigue, and sneezing.
Res c/o mild nausea this AM. Res declined breakfast, et any interventions by staff.
Pt returned to clinic at 4pm with swollen left eye and coughing. Varivax site was swollen and mild redness noted. Epinephrine .15mg give. Coughing stopped. Told to take Benadryl for allergic reaction and to return to clinic or ER for any problems.
Reaction consisted a region of discoloration about 1 inch in diameter around the injection site and continued several inches down below the injection site. The shot was given on the upper part of left arm, left shoulder. Neither pain nor discomfort was experienced by the pt. By the 5th of March the symptoms resolved. Physician advised that it was simply an infrequent reaction resulting from Prevnar vaccinantion.
This spontaneous report as received from a consumer refers to a 68 year old female patient. Concurrent condition included high blood pressure. On 06-SEP-2013 the patient was vaccinated with ZOSTAVAX. Lot number, dose, route and frequency were not provided. Concomitant therapies included LIPITOR, NORVASC and DIOVAN for an unknown indication. On 10-SEP-2013, the patient experienced swelling around the injection site and redness around the injection site. No treatment was given. The outcome of swelling a round the injection site and redness around the injection site was reported as recovering/resolving. The reporter causality was unknown. Additional information is not expected.
Edema, erythema and warmth at the site of injection. Began 2-3 hours after injection and lasted at least. Treated with Benadryl, NSAIDs and Ice.
One week after I received the second dose of Pfizer-BioNtech, I developed intense inflammation in my left inner ear. This inflammation reduced hearing significantly and persisted for about 4 days. When the inflammation dissipated, I developed constant high pitched tinnitus in the same (left) ear. This tinnitus has continued constantly until the present, approximately 8-9 months after onset.
headaches; feel fatigue; Asks if Vaccine could cause a little bit of lapse of memory for short period of time.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GH9693) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series Completed, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; FATIGUE (non-serious), outcome "unknown", described as "feel fatigue"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Asks if Vaccine could cause a little bit of lapse of memory for short period of time.".  Additional information: Can get headaches and feel fatigue. Which is normal. Would the Pfizer MRNA Vaccine BA.4-BA.5 cause a little bit of lapse of memory for short period of time? The symptoms patient had didn't last long, wondering how normal the symptoms were? The patient mentioned that he had to go to another room since the music was driving him crazy. Mentioned that he did not normally fear for the virus but he wanted to know since he will be going to a nursing home. He mentioned that he will have a risk of exposure. The person at the nursing home has the virus. He will go to a nursing home to sign paperwork. It was reported that the staff may have transmitted it to the person. Lot: GH9693 Caller also stated that he had headaches and felt tired. There were a few things he couldn't remember clearly after receiving the vaccine. Caller stated that he is 70y/o. Caller later mentioned that on the day the he received the vaccine, he had trouble remembering some things. Caller mentioned that it may be caused by him feeling fatigue or having headaches. Caller stated that he has been very lucky during the early stages when there were still no vaccines. Caller mentioned that he was exposed to people. Caller mentioned that another person, their mom, and their baby got it. Caller mentioned that he never got it. Caller mentioned that he had read it will take 2 weeks for the vaccine to take full effect. Caller mentioned that he can be corrected if he's wrong. Caller mentioned that he is very active. Caller mentioned that he took a very physical job deliberately and hopes that it would help the vaccine take effect faster. Consulted with (Name) of Pfizer Customer Service.
he had indigestion after 2nd dose; nauseous after 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of DYSPEPSIA (he had indigestion after 2nd dose) and NAUSEA (nauseous after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Patient was immunocompromised with health conditions since birth).   On 11-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (he had indigestion after 2nd dose) and NAUSEA (nauseous after 2nd dose). At the time of the report, DYSPEPSIA (he had indigestion after 2nd dose) and NAUSEA (nauseous after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No Treatment medication information provided. cross linked with MOD21-143355   This case was linked to MOD-2021-319756 (Patient Link).