chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 day of flu type symptoms; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (1 day of flu type symptoms) and VACCINATION SITE PAIN (soreness at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer (Had a radical Prostatectomy (04-OCT-2004)) on 14-Aug-2004. Concurrent medical conditions included Bee sting hypersensitivity and Drug allergy (Carry an EpiPen).    On 18-Jun-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 19-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (1 day of flu type symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (1 day of flu type symptoms) and VACCINATION SITE PAIN (soreness at injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient has been using Salonpas on shoulders to reduce soreness.  Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2021-355775, MOD-2021-355775 (Patient Link).
Woke up with a headache on 8/25/10 that lasted until 8/27/10. Had a headache on 8/28/10 & 8/29/10. Had a red area noticed on 8/26/10 and still there on 9/8/10 starting at 15cm down to 2 cm on 9/8/10.
No Appetite; Felt so bad and sick; Dizzy if she got up; Laid around all day; Sore arm; Sore Body; Swollen side of the neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Sore Body), SWELLING (Swollen side of the neck), DECREASED APPETITE (No Appetite) and ILLNESS (Felt so bad and sick) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal, Cholesterol total abnormal NOS and Allergy NOS.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Sore Body) and SWELLING (Swollen side of the neck). On 24-Feb-2021, the patient experienced DECREASED APPETITE (No Appetite), ILLNESS (Felt so bad and sick), DIZZINESS (Dizzy if she got up) and FATIGUE (Laid around all day). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Sore Body), SWELLING (Swollen side of the neck), DECREASED APPETITE (No Appetite), ILLNESS (Felt so bad and sick), DIZZINESS (Dizzy if she got up) and FATIGUE (Laid around all day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Heart rate: 110 (abnormal) 110 heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient took concomitant medication as unspecified Blood Pressure, Cholesterol and Allergy medication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 and updated outcome of the events.
Extreme pulsing pain, so severe he could not move his arm.  He also had intermittent fevers through the night.  He was not able to sleep due to the pain. He tried hot packs, cold packs, Tylenol with codeine, and naproxen with no relief in pain.
Slept for 1 to 2 hrs p/leaving MD office then awakened w/loud high pitched cry for 2.5 hrs; unusual cry;
On October 9, 2022, I started with a mild headache and then to sore throat which became severe. I got congested and had a stuffy nose. I tested positive for COVID-19 on October 9, 2022. I got a rescue inhaler because of history of bronchitis. I just stayed on the TYLENOL and no other changes to medications were necessary.
This spontaneous report as received from a licensed practical nurse refers to a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. Additional information has been requested.
Expired vaccine given-EXP. Date 10/2017. Remainder of lot removed from stock. Mom/Client had left clinic when event realized. Phone call to mom to notify. Advised of need to repeat dose.
Missed to take second dose of Vivotif; Spontaneous case was received from pharmacist on 21OCT2020.  A pharmacist reported that a 19-year-old male consumer "missed to take second dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunization. This male consumer took the first dose of Vivotif on 18OCT2020 and missed to take his second dose of Vivotif, which was due on 20OCT2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer missed to take his second dose of Vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer missed to take his second dose of vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is assessed as not applicable to vivotif due to the nature of the event.
Headache, Arthralgia, Fever, NauseaVomiting, chills/ fatigue Narrative:
Right arm was very swollen continued down to below elbow to mid-arm, arm very warm was itching.
This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL (dose, concentration, lot number and expiration date were not provided). The reporter stated that on an unknown date, an unspecified facility had not calibrate their thermometer in the refrigerator that was storing GARDASIL vaccine for approximately 10 months. During a recent audit by the health department, it was revealed that the GARDASIL vaccine had been exposed to 47F to 50F for this period of time. It was knot known whether or not any of the patients who received these improperly stored doses of GARDASIL vaccine had experienced any adverse effects. This is one of several reports received from same source. Additional information has been requested.
Chest pains that started on Monday August 9 that would last hours.  They would go away for a little while and then come back and last hours again. It was a throbbing pain in my chest.  On a scale on 1 to 10 it was most consistent at a 5 but could go up higher.  Went to medical facility for treatment. Left being told to take Aleve and call Cardiologist.
12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sleep entire night.
Can Moderna Vaccine cause diarhea/Can it cause diahrea"; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Can Moderna Vaccine cause diarhea/Can it cause diahrea") 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 DIARRHOEA (Can Moderna Vaccine cause diarhea/Can it cause diahrea"). At the time of the report, DIARRHOEA (Can Moderna Vaccine cause diarhea/Can it cause diahrea") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up included no new information.
lingering muscle weakness; pain in her arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULAR WEAKNESS (lingering muscle weakness) and PAIN IN EXTREMITY (pain in her arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (lingering muscle weakness) and PAIN IN EXTREMITY (pain in her arm). At the time of the report, MUSCULAR WEAKNESS (lingering muscle weakness) and PAIN IN EXTREMITY (pain in her arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient was experiencing the events since receiving the COVID vaccine (many month ago, the patient did not report whether it was from Pfizer or Moderna). The negative experience had prevented the patient from getting her child vaccinated, Patient reported symptoms to primary care physician, but was dismissed.  No treatment medication was provided.
headache; chills; weakness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 16:45 (Lot number: Ew0173) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand:Pfizer, administration time 04:30 AM, dose number:1, vaccine location: Left leg), administration date: 06Apr2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 30Apr2021 02:00, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 30Apr2021 02:00, outcome "not recovered", described as "chills"; ASTHENIA (non-serious) with onset 30Apr2021 02:00, outcome "not recovered", described as "weakness".  Therapeutic measures were not taken as a result of headache, chills, asthenia.  No follow-up attempts are possible. No further information is expected.
Injection site : Itching, large pink blotching area, hot to touch, nausea
Pt states about 6 hours after taking the vax his left arm and shoulder became extremely sore. He states the pain is over and above normal for a vaccination. Pt states it has been over 48 hour so he has taken some pain medicine and symptoms are now starting to subside.
Patient says that her legs, hands & one side of face is swollen. No trouble breathing. She says she is prone to swelling but his occurred more quickly than usual.
3/15/17- redness (2cm) and swelling (R) arm at site of VARIVAX inj. /gf and fussy, sensitive to touch. treating w/ cephalexin to cover possible cellulitis.
lt deltoid, warm to touch & edematous (fever) temp 101-102, weakness;apply ice, oral DPH, may recv tetanus (diphtheria)
Initial unsolicited report received from a consumer on 28 September 2016. This case involves male patient (age not reported) who was vaccinated with dose of Fluzone High Dose (Batch number, expiration date, route and site of administration was not reported) on 27 September 2016. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination patient experienced strange reaction. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
at 6 PM - Nausea at 8:30 PM uncontrolled shivering lasting for 2 1/2 hours at 12 AM severe headache - went to sleep milder headache in morning
I had a small tickle in my throat starting on Friday afternoon. I ended up waking up the next day with the cough sore throat and a runny nose. I took a home COVID-19 test because I was supposed to have an event with my students. I had walked away from it thinking the test was negative but about an hour later I saw the line on the test. So I did a second test and checked it right at the time but the line showed up right away. This was Sunday so I went to urgent care and I was positive on the COVID-19 test there as well. Monday I called my PCP and they gave me Paxlovid and all my symptoms other than my runny nose and the head ache went away. The cough stopped which was a relief and then a day or two later my headache was gone along with the runny nose.
early 1999, p/vax#1 pt c/o acute stomach cramps & other bowel sx; pt hosp w/diverticulitis that required surgery; sx resolved; later recv vax#2, exp similar sx however, not as severe; outcome not provided
Pt became very fatigued w/malaise, headache, mental "fogginess" as if a "concussion", muscle pain, dizziness while driving. No redness, no local reaction or fever. SX onset within 24 hours - 7 days similar complaints following first dose of TRUMENBA.
Tdap injection given on 6/18, area approx 2" around injection site hot to touch raised red, numbness and tingling down to fingers, throbbing pain in armpit. Symptoms still persist 6 days after injection.
On 11/16 am patient reported that  after receiving her flu shot at approximately 3pm she felt nauseous.  (symptoms started around 9pm) She reported dizziness and her husband reported that he found her unconscious perhaps from a fall.  Pt  presented with bruising around her right eye.  Patient says she did not seek medical attention.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985.
Pt. rec. flu vaccine 9-13-12 - with mother - pt. went to father's house - mom didn't see her for 2 days - pt. returned home c/o itching to site - mother noticed red rash.
Bells Palsy, Left side.  Sent to Emergency Room for evaluation and given steroids and antiviral medication.  Followed up with Primary Care Physician.
Devel dermatopolymyositis 5 days p/flu vax; devel swollen face & rash;
Information has been received from a 31 year old female medical assistant with no known history or drug allergies who was vaccinated with a first and second dose of varicella vaccine in April 1997 given SC and June 1997 given IM, respectively. On September 13, 2001, a antibody test titer revealed that the pt did not serocovnert. Follow-up info from the physician indicated that the pt's titer was 0.18 and <0.91 was negative. The pt was vaccinated agaiin with the varicella vaccine SC on 09/18/2001 in the left upper arm and on 11/02/2001 in the left upper arm. The pt was scheduled for an antibody test in the beginning of December 2001. Additional info has been requested.
Case number PHEH2017US008279, is an initial spontaneous report received from a consumer on 17 May 2017. This report refers to a years old male patient. Historical condition was not reported. Past medications included HUMIRA and ENBREL. Current condition included psoriasis. Concomitant medication was not reported. The patient received Influenza virus vaccine Seasonal INN (manufacture unknown, batch number not reported) on an unknown date, recently. After receiving flu shot the patient got sick for period of time. Outcome oft he event was unknown. Seriousness of the event and causality was not reported.
I received vaccine on August 1, 2021. Two weeks after getting vaccine, I developed intermittent sharp chest pains and difficulty taking deep breaths. My exercise tolerance decreased and I had difficulty doing my usual treadmill exercises. The symptoms persisted so I eventually reached out to my Cardiologist who did an EKG on September 2, 2021, which showed ST elevation in V4, V5, V6 suggestive of pericarditis. I was advised to take anti-inflammatory medications so I took ibuprofen and refrained from exercise and eventually symptoms resolved.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of improperly stored (Oka/Merck) VARIVAX (lot # K015971, exp. date: 23-SEP-2016, 3 doses: lot# K010339, exp. date: 22-JUL-2016, 1 dose, lot#L000454, exp. date: 06-JAN-2017, 6 doses) (strength and frequency were not reported) 0.5 ml, subcutaneously. No adverse event was reported. The outcome of patient's event was not reported. This is one of two reports from the same source. Additional information has been requested.
Within 24 hrs left arm from 4" inches below shoulder to elbow became red, painful, hot and swollen. 48 hrs later symptoms have decreased but redness still present approximately 14 cm around injection site.
A 47 year old nurse, with prior history of asthma, reported that she began to experience chest tightness, wheezing, scratchy throat, tiredness, nasal congestion, headache, runny nose, body ache and dehydration, 3 days after she received FluMist on Oct 7 2005. She was seen by her primary physician and was given nebulization treatments for her wheezing. She was also prescribed an unspecified antibiotic which had to be changed to Avelox (moxifloxacin) and oral decongestants. She also received intravenous hydration as she felt dehydrated. As of Oct 28 2005, the patient continues to have nasal congestion, headache, runny nose, tiredness and body aches. All other symptoms have resolved. The patient also stated that other members in her family received FluMist but did not experience any adverse event. The reporter assessed the events as possibly related to FluMist.
HEADACHE; BODY ACHES; FEVER OF 102.4; SWOLLEN ARM SIZE OF TENNIS BALL; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE), MYALGIA (BODY ACHES), PYREXIA (FEVER OF 102.4), PERIPHERAL SWELLING (SWOLLEN ARM SIZE OF TENNIS BALL) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (HEADACHE), MYALGIA (BODY ACHES), PYREXIA (FEVER OF 102.4), PERIPHERAL SWELLING (SWOLLEN ARM SIZE OF TENNIS BALL) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (HEADACHE), MYALGIA (BODY ACHES), PYREXIA (FEVER OF 102.4), PERIPHERAL SWELLING (SWOLLEN ARM SIZE OF TENNIS BALL) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 102.4 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter.
After Dose 1 the night exp chills, body aches went to bed early. The next day I woke up arm was sore. Then 6 days around 11pm  I was laying on my left side arm was hurting the injection site appeared as if I got stung by abee and warm to touch. I seen in the paper to contact Ohio State about reactions was not given much information to seek medical attention. I took Benadryl for teh symptoms.
My dad started to experience acute atrial fibrillation in September of in 2023. Before the COVID shots my father was healthy and robust and only got sick once in my 32 year memory of him. Now he is hesitant to travel for fear of getting ill, he will pick up colds with the most minimal of human interaction. It is like his immune system no longer works. The AFIB started in fall 2023 and has reduced his quality of life, he is more often out of breath, has to wear a heart monitor and was presribed Eliquis and blood preasure med.
Hyporesponsive, hypotonic reactions with vomiting, fever and diarrhea that occurred acutely, 8 hours, post vax of DTAP. Called 911; because could not arouse and brought to ER.
Moderna Vaccine vial in refrigerator a few days. Staff ready for inoculation. Dr. called for opinion vial brought to room temperature, 0.5 ml drawn up and injected IM to 5 staff. Later, Dr. gave order to use this vial and 5 doses were administered. Later that same day Dr. discovered that the vial had been punctured. Therefore the doses were spoiled. In consultation with The Health Department and the Moderna company, it was agreed that we need to re-inject the five staff. We contacted the 5 and 3 elected to get the shot again right away. Two came back in 2 days to get the re-vaccination. This time we chose to inject the five on the opposite side. There were no side effects reported. N.B.  This form doesn't allow the flexibility needed to report the details of the 5 staff who had to be re-vaccinated AND at the end wouldn't allow me to finish without filling in all boxes. By the time I tried to find a fix, the form timed out. I have now completed another form but in order to get through the form, I put in my own personal.   information. Therefore, even if there was a way to include all five, I don't have the information to fully complete any of them. We have written a detailed narrative of the event and hope it will suffice. Medically, all is well. MD, PhD
Lg red lump under skin, nausea, vomiting, lump red and warm to touch.
Patient was crying excessively and very irritable for 2 full days from the time the dose was administered.