chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT CALLED TO REPORT A RASH UNDER HER ARM AFTER THE ZOSTAVAX VACCINE.  PATIENT TOLD TO TAKE BENADRYL.  IF REACTION WORSENS OR DOESN'T IMPROVE, CALL MD.  PATIENT ALSO CALLED MD AND WAS TOLD THE SAME THING.
Tendanitis; Bursitis; In bad pain; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Tendanitis), BURSITIS (Bursitis) and PAIN (In bad pain) 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 TENDONITIS (Tendanitis), BURSITIS (Bursitis) and PAIN (In bad pain). At the time of the report, TENDONITIS (Tendanitis), BURSITIS (Bursitis) and PAIN (In bad pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Arm pain for 7 days; migraine for 11 + days (still ongoing); nausea; sore throat for 3-4 days.
Pt called to say she became lightheaded and had a headache an hour after injection. She also had site tenderness and shoulder and backache. About 12 hours later complained of fever 101.6, chills, aches all over. Taking Tylenol every 4-6 hours. Has no fever 48 hours later but still aches.
ED for shorness of breath, nausea and diarrhea. Has had a cold for 1 week and not wanting to eat anything. Fever and cough with creamy sputum.
fatigue; really bad body aches; Brain fog; had 1st dose of covid-19 vaccine last 01APR2021 but not scheduled for the 2nd dose.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose of COVID-19 vaccine last 01Apr2021 but not scheduled for the 2nd dose. After her 1st dose of the vaccine, she experienced being on the couch for 2 days because of fatigue, really bad body aches, and brain fog. She would like to know if it is safe to get the 2nd dose of the vaccine. Th outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Extreme Headache, Rash on lower portion of both arms, felt like my skin was on fire from the inside out on my face, neck and arms, extreme fatigue, chills.  Lasted for a week.  Longer Effects, extreme fatigue and brain fogginess ( it's now March 15th, I am still having these effects)
5 minutes after getting the vaccine- arm went numb and tingly. Persisted for 9 hours afterwards.
Pt had severe pain at the injection site. Also big, red, swollen hive at the injection area & it run down her arm to the elbow.
This spontaneous report was received from a physician, via company representatives, and refers to a patient (Encounter key # 226428) of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 14-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced two temperature excursions one of 48 hours and other of 40 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius) and the highest recorded temperature was 47 F (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician referring to a 17 years old female patient. The patient had no medical history or drug reactions/allergies. On 10-JUN-2015 the patient was vaccinated with a dose of GARDASIL (lot # K009902, expire date unknown, dose, frequency were not reported) intramuscularly. Concomitant therapy included MENACTRA (manufacturer unspecified) on the same day. On 16-JUN-2015, the patient had a seizure (the type of seizure was unspecified). Then, on that same date, the patient went to the emergency room at Hospital, where "blood tests and a Computerised tomogram (CT) scan" were performed. The results of these tests did not show anything abnormal. It was unspecified if the patient recovered from the seizure before going to the emergency room or after entering the emergency room. However, the patient did recover from the seizure on 16-JUN-2015. No treatment was given for the event. Causality was not reported. Upon internal review, the event of seizure was considered to be medically significant. Additional information has been requested.
two flutter episodes in eight months; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history included COVID in Dec after which she had rate and rhythm heart issues for approximately 3 months. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. After being first Pfizer COVID vaccine, frequently and intensity of cardiovascular issues decreased. After second Pfizer vaccination the CV symptoms essentially stopped. On an unspecified date, the patient had two flutter episodes in eight months since being fully vaccinated. Event took place after use of product. The outcome of the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Her right underarm got swollen; Chills; Headache; Fever; Back of her neck swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Back of her neck swollen), AXILLARY MASS (Her right underarm got swollen), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant past medical history was provided.     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 SWELLING (Back of her neck swollen), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 22-Feb-2021, the patient experienced AXILLARY MASS (Her right underarm got swollen). On 07-Feb-2021, SWELLING (Back of her neck swollen), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) had resolved. At the time of the report, AXILLARY MASS (Her right underarm got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product details not provided. no treatment details reported.   This case was linked to MOD21-087211 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: F/U received on 06-MAY-2021,reporter contact details updated.; Sender's Comments:  MOD21-087211:follow up - contact information updated -email , address , phone
Pneumococcal vaccine given at 0907 IM prior to discharging. Pt. had no known allergies and not allergic to eggs. At 1015 pt c/o back and rt flank pain 4/10. Generalized rash to abdomen and chest noted. No SOB noted with or w/o exertion. Dr. informed immediately with orders given. Benadryl 25 mg IV given, troponin level sent. Rashes resolved and no c/o pain or discomfort noted after 10 min. VSS. No acute resp distress noted.  9/14/09 Hospital records received DOS 5/15/09 to 5/18/09. On the day of discharge received Pneumovax and developed severe rash and epigastric pain.
Severe chills/severe shaking, tiredness, headache, muscle pain, pain at injection site, nausea, not feeling well. I had to stay home from work the day after the vaccine, I stayed in bed all day with a space heater on to 90 degrees in my bedroom just to get rid of the chills, I took Motrin 800 mg around the clock, Zofran as needed and I drank a lot of water.
Given Td booster at 1:30pm Thursday.  Whole arm began throbbing approximately 50 hours later and has been constant since.  Neuro exam normal, pain controlled with tramadol!  T3.
On 10/04/19, patient woke up and felt pain in the right arm around the injection site. She states it was very sensitive to touch and painful if area was touched. She states no swelling or redness. She did not notice it hurting when sleeping. She states is hurts when showering , lifting arm and when getting dress. On 10/10/19, patient consulted pharmacist regarding the pain around the injection site and recommended she followed up with her primary care physician. She visited doctor on 10/10/19 at 1:45pm who examined her arm. She was diagnosed with neuritis and was prescribed Gabapentin 100mg (1QDx10). She states the once a day dosing did not work and on 10/13/19 increased to two daily but still did not get relief. On  10/16/19 she started taking Motrin 600mg every 8 hours which helped but pain continues to persist. She is waiting for doctor to follow up with her.
Migrain the night of shot and on/off for 3 days, then migraine decreased in severity until Nov 1. On Nov 1, 2021 had pain in arm and legs in evening then woke up Nov 2 with numb, swollen, drooping right side of face and frequent migraines throughout the day since then. Numbness and drooping slowly went away and was back to normal by Nov 3.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027LV0A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug effect.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 11-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Acute onset, lasting 24 hours, of severe depression, suicidal, tearful and resolved after 25 hours.
1/16/10 vomiting, runny nose, coughing, supportive care at home. Albuterol.
Profuse rhinorrhea beginning between 11 AM and noon.  It was clear and colorless.  It began to subside about 8 PM.  It had stopped by 10 PM.
Little sore at injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K2OA) for COVID-19 vaccination.     Concurrent medical conditions included Back pain. Concomitant products included MORPHINE for Back injury.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little sore at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE PAIN (Little sore at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Patient declined consent for further follow up
A was given to me. I didn?t show any initial reactions. Then about 24 hours later, I noticed redness around the injection site with extreme soreness and swelling. Is still present and inflamed after 48 hours since injection.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 40-year-old female patient who experienced abdominal pain and cramping, diarrhea and nausea. At 40 years of age, the patient received a dose on 08-Dec-2003. Medical history: The patient's concurrent illness includes back pain. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 08-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Concomitant therapy included Celebrex (celecoxib) and Wellbutrin XL (amfebutamone hydrochloride). Event details: The patient experienced abdominal pain and cramping (abdominal pain), diarrhea (diarrhoea) and nausea (nausea) on 15-Dec-2003. As of 15-Dec-2003, her symptoms continued. No additional information was available at the date of this report.
Patient reports the day after she got the shot, her arm was very red and sore, hot to the touch for 6 days. She did not seek medical advice and it resolved on its own
Starting with sore throat, coughing.  By 6:30, itchy red eyes with a white discharge- bilateral conjunctivis.  Onset of hoarseness, sore throat, stuffy nose and drainage.  Administered 50 mg of Benadryl and 600 mg of ibprofen at 7:00pm.  Urgent care visit at 7:30 PM with above symptoms.  Vitals and breathing within normal range.  8:00PM discharged with instructions to continue administering Benadryl.  9:00pm onset of fever, pain and soreness in middle of back and around the rib cage.  11:00PM waking from sleep with dizziness, increased back pain, and chills.  10/12/2011 1:30 am inability to sleep, bi lateral conjunctivis worsened, increased nasal congestion, increased fever, upset stomach and malaise.
This case was reported by a physician via call center representative and described the occurrence of fever in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced fever, myalgia, chills and malaise. On 17th July 2018, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the fever, myalgia, chills, malaise and activities of daily living impaired were not recovered/not resolved. The reporter considered the fever, myalgia and chills to be probably related to SHINGRIX. It was unknown if the reporter considered the malaise and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient (a social acquaintance) notified GlaxoSmithKline physician that, he presented fever, chills, myalgia, malaise (on the day of vaccination) and unable to conduct normal activities on the day of reporting. The vaccine was not discontinued. The patient was not died because of the event. The events were not required any surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events were not result in congenital anomaly, birth defect, life threatening, death, significant disability and hospitalization.
On 3/5/2021 Patient had his first Covid-19 vaccine. He was sick for two weeks with severe fatigue. He slept a lot and complained about body aches and pains. On 4/28/2021 Patient had a bloody nose that lasted 4 hours. On 5/2/2021 until 5/19/2021 Patient had a sore throat , difficulty breathing, and very congested. On 6/3/2021 Patient had inflammation in his knees and had difficultly walking for 7 weeks. On 12/3/2021 Patient died after he had a bad cold/flu for 3 days (he was coughing up blood).
Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On an unknown date, the patient died 40 hours after her third shot of GARDASIL. The patient had been so healthy prior to the vaccination. The post mortem result stated cause of death unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient 1 received 3 doses; Headache; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient 1 received 3 doses) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient 1 received 3 doses) and HEADACHE (Headache). At the time of the report, EXTRA DOSE ADMINISTERED (Patient 1 received 3 doses) had resolved and HEADACHE (Headache) outcome 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.  Treatment information was not provided.  The patient went to the hospital and was advised Tylenol (acetaminophen) if the event persists. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-043192 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-043192:Case for patient 2
Local rxn 4 x 4 inches (L) arm rxn. Myalgia, fatigue (+), no fever, (+) glossitis,  (+) otalgia, (+) BOM on 8/17/11, (L) arm pain.
Tingling in scalp and hands/fingers, both hands, was unable to make a fist without effort - lasted for about 5 mins.
Massive venous thromboembolism (clot from distal leg veins, through inferior vena cava, through heart, to lungs with pulmonary embolus. Near fatal event. Requiring surgical thrombectomy. Requiring hospitalization for anticoagulation, and 6 months of further anticoagulation.
Intermittent severe tachycardia documented with light exercise. 192-195 without irregularity. Concern for possible vtach/unable to rule out.
A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm got very sore/pain in extremity, left arm was very tight/limb discomfort, left arm was red/erythema, left arm was hot to the touch/skin warm, there was a knot/vaccination site induration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 043L20A) in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event arm got very sore. On 5 Feb 2021, the patient experienced the event left arm was very tight, left arm was red, left arm was hot to the touch, there was a knot. On 12 Feb 2021, the patient mentioned the knot was still there. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events arm got very sore, left arm was very tight, left arm was red, left arm was hot to the touch, there was a knot, knot was still there was unknown.
Muscle aches @ 11:00pm day of injection  Low grade fever & headache starting at 9:00am following day
I had the usual sore arm, fatigue, and body aches. But the one side effect I had was insomnia for two days. I missed work the day after receiving the shot (Wednesday). Went to work on Thursday with no sleep. Missed on Friday due to not being able to sleep.
No additional AE reported; ccines were previously short dated for 1 month after excursion and then were administered after the short date; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 22-OCT-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T032321, expiration date 22-SEP-2022 (short expiration date reported as 15-OCT-2021) for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that that vaccines were previously short dated for 1 month after excursion and then were administered after the short date.  The vaccine was stored at the temperature that was reported as 55.9 degrees of Fahrenheit for 30 minutes. There was no previous temperature excursion reported. The date of excursion was provided as 15-SEP-2021.  No additional adverse event reported.
Felt like a truck ran him over; Headache; Pain all over the body; Tired; Fever 99.4 F; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Felt like a truck ran him over), HEADACHE (Headache), PAIN (Pain all over the body), FATIGUE (Tired) and PYREXIA (Fever 99.4 F) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Symptomatic COVID Disease) on 29-Dec-2020.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ADVERSE REACTION (Felt like a truck ran him over), HEADACHE (Headache), PAIN (Pain all over the body), FATIGUE (Tired) and PYREXIA (Fever 99.4 F). At the time of the report, ADVERSE REACTION (Felt like a truck ran him over), HEADACHE (Headache), PAIN (Pain all over the body), FATIGUE (Tired) and PYREXIA (Fever 99.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, COVID-19: (Positive) positive. On an unknown date, Body temperature: 37.4 degree Celsius (abnormal) (99.4) Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.  Treatment medication was not provided.
Rash at shot site and forehead , dizzy  for 3 days now,  bed ridden for 3 days heart rate 40 to 70, could not eat for two days.
Pt received Pneumococcal vaccination 28 Oct 2009. Reports fever (as high as 104.1), chills, throbbing frontal headache, myalgias and painful indurated area @ vaccination site left upper arm.