chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she felt like she got hit by a mac truck; body aches; FEVER/She had a fever between 101-104 throughout it; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she felt like she got hit by a mac truck), PAIN (body aches) and PYREXIA (FEVER/She had a fever between 101-104 throughout it) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (body aches) and PYREXIA (FEVER/She had a fever between 101-104 throughout it). On 16-Apr-2021 at 11:00 PM, the patient experienced FEELING ABNORMAL (she felt like she got hit by a mac truck). On 17-Apr-2021, FEELING ABNORMAL (she felt like she got hit by a mac truck), PAIN (body aches) and PYREXIA (FEVER/She had a fever between 101-104 throughout it) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 101-104 (High) fever between 101-104 throughout.         No concomitant medication information was provided.  It was reported that patient got the second shot around 1 PM in the afternoon.   No treatment information was provided.   This case was linked to MOD-2021-404296, MOD-2021-405023 (Patient Link).
7 hours after vaccination severe chills, pain, shaking, feeling cold  diffuse muscle pain next day, nausea/vomiting  left arm is red at injection site ~ 2 inches in diameter
Information has been received from a registered pharmacist (R. Ph.) concerning a female patient who on or about 04-MAY-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669535/1506Z and expiration: 02-FEB-2012). The pharmacist reported that the patient was vaccinated and several days later (approximately 5 to 6 days, in May 2011), one or both of the patient's arms (reporting pharmacist was not sure of this) turned red ("like sunburn") and became itchy. The patient went to her physician and was treated with BENADRYL. The pharmacist maintained that this was not a rash, just itchy and red. The patient sought medical attention by a called to the physician. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
Information has been received from a health care worker concerning a 10 year old patient who on 02-JUL-2007 was vaccinated with an unspecified vaccine, possibly varicella virus vaccine live (Oka/Merck). On 13-JUL-2007, patient sought medical attention due to spots all over. Subsequently, the patient experienced vaccine-related case of chickenpox. No titers have been drawn. Patient's recovery status was unknown. No product quality complaint reported. No further information is available.
This spontaneous report as received from a physician via a field representative refers to a male patient in his late 20's. On 12-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 due to Sinusitis (dose, frequency, lot# and expiration date unknown, therapy route injection as reported). Within an unspecified period of time following administration, the patient began to experience vomiting, chills, shaking and fever. Additionally, an injection site reaction was experienced, presenting as redness and tenderness. The patient sought medical attention and the physician noted that, while most adverse symptoms subsided by time of follow-up office visit, "several weeks later," the injection site remained sore, tender and red. Additional information has been requested.
8-8/07 7 PM slight bruising lt anterior thigh injection site. 8-9-07 3:00 PM Mother noted redness (8 1/2 cm x 6 1/2 cm with superficial purplish red bruising 3cm x 1 3/4cm within). Slight associated itching. 8-10-07 8:40 AM TC from father - injection site - size unchanged but decreased redness intensity and decreased warmth - no illness.
Have a cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Have a cold) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Have a cold). At the time of the report, NASOPHARYNGITIS (Have a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
1/31/21 - Light Headed all day. Nausea at 7:00 pm. Slight temperature rise at 8:00 pm. Arm sore at vaccination site. 2/1/21 - Light headed all day til now. Arm sore at vaccination site.
LUNG ISSUES; DIFFICULTY BREATHING AND CANT GET A FULL BREATH IN; A REACTION THATS PRETTY TYPICAL FOR SOME WITH THE  EXCEPTION; HIGH FEVER; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known drug allergies and drug abuse and had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: J9J202A21A, expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced a reaction that is pretty typical for some with the exception. On SEP-2021, the patient experienced high fever. On 09-SEP-2021, the patient experienced lung issues. On 09-SEP-2021, the patient experienced difficulty breathing and cant get a full breath in. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from difficulty breathing and cant get a full breath in, and the outcome of lung issues, high fever and a reaction that is pretty typical for some with the exception was not reported. This report was non-serious.
ATRIAL FIBRILLATION IN LEFT ATRIUM; ATRIAL FIBRILLATION FLUTTER IN RIGHT ATRIUM; BLOOD GLUCOSE LEVEL WERE HIGH; INSOMNIA; DIGESTIVE PROBLEMS WITH  SYMPTOMS LIKE IRRITABLE BOWEL; This spontaneous report received from a patient via a company representative concerned a 6 decade old male of Asian race and unknown ethnicity. The patient's height, and weight were not reported. Patient's checkup in fall was normal prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose was not reported, 1 total administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, after two weeks the patient developed digestive problems, insomnia and symptoms like irritable bowel. Symptoms persisted for 6 weeks. The patient went to the doctor and was diagnosed with atrial fibrillation in left atrium and was hospitalized at the end of MAY-2021. The patient received Amiodarone for atrial fibrillation. The patient didn't tolerate medication and they tried cardioversion which worked and he was discharged. One week after the patient was diagnosed with atrial fibrillation and re-hospitalized where cardio ablation was performed. It worked and patient was discharged. One week later the patient was diagnosed with an atrial fibrillation flutter in right atrium and cardio ablation was performed that worked on patient. The patient was discharged and placed on Eliquis. The patient will be followed up with every 3 months. Blood glucose (BG) levels were high at the time of reporting and which was new for the patient. The levels were improved over the last month with exercise and diet. The patient had a well visit last fall and was completely health prior. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, and digestive problems with symptoms like irritable bowel on 12-MAY-2021, was recovering from blood glucose level were high, and the outcome of atrial fibrillation in left atrium and atrial fibrillation flutter in right atrium was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210800922- Covid-19 vaccine ad26.cov2.s- Atrial fibrillation in left atrium, Atrial fibrillation flutter in right atrium . 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).
33 YOF pt presented to the clinic on 4-1-19 for PPD and Tdap, HBV, MMR and Varicella vaccines. Pt was seen and counseled by Clinician. Vaccines on right side administered by clinician and vaccines and PPD on left side administered by CA. On 4-3-19 pt developed edema and erythema on left upper arm with central vesicular lesions. Pt presented on 4-3-19 at 6:35 PM for PPD reading (administered on left FA 01. mL intradermal inj, lot # C5563AB exp date 3/14/21). She then mentioned she had developed symptoms on the left upper arm. She denied SOB, chest pain, difficulty breathing or sensation of shocking. Localized edema and erythema noted. Area warm and tender to the touch. Blanching noted. No drainage. Erythema has poor margins but it measures approximately 7x7 cm. Centrally vesicular rash was noted. No drainage. Left upper arm diameter was 31 cm and right upper right diameter 30 cm. Pt in no distress. Pt was advised on 4-1-19 and today to go to ER in case of an emergency or localized reaction. Pt verbalized understanding. She left the clinic to go to an ER. She declined EMS activated. No distress observed upon discharge.
Chest pain and pain shooting down my arms before going  to bed. Sweats/fever. Went away after sleeping in chair each night. Felt tired next day. This went on four nights and subsided. No tightness now.
Patient reported head tingling and tongue tingling. Patient had an occasional dry cough. Reported having asthma and wanted to try inhaler that was on site. Patient took inhaler but still was not having any relief. Given 50mg of liquid Benadryl for relief of tongue tingling. Vital signs taken two times, cough not subsiding and breathing becoming more difficult for patient. EMTs evaluated and placed on supplemental oxygen for comfort. Taken to the emergency room via ambulance with medic assistance.
Began inc temp 20SEP91 to hosp 3AM; 21SEP91 w/t106.6 R & was DOA;
30 minutes post-injection, patient reported numbness in her feet similar to when she has PEG before. Pt. remained another 15 minutes and was advised to go to the ER and transported there, but wanted to go home instead and left without being seen.  She said she would see her doctor if she started to feel bad. She was called 2/1/21 and reported feeling great and denied any needs.
Patient received dose 1 of the Pfizer COVID vaccine (lot EW0191) at approximately 1715. At 1730, Paramedic noted patient yawning and fidgeting with her mask. Paramedic approached patient who reported heavy breathing and anxiety. PHN approached to assess and noted no diaphoresis, work of breathing, or use of accessory muscles. Patient moved to zero-gravity chair, monitored by Paramedic and PHN, and was laid supine. Vital signs: O2 98%, pulse 96, respirations 18. At 1735, vital signs: blood pressure 130/76, pulse 76. PHN offered patient Benadryl but patient declined. Patient reported she has an anaphylactic allergy to Vancomycin, she takes a multivitamin, and she does not have any medical conditions. Patient reported she had eaten at 11am but only drank approximately 8oz of fluids. PHN provided water and patient drank it. At 1740, temperature 97.9 degrees F. At 1747, PHN noted a decrease in heavy breathing. Vital signs: blood pressure 124/82, pulse 76, O2 99%, respirations 16. Patient reported feeling "shaky," PHN noted no visible or palpable tremors. Patient provided and drank juice. Patient reported decreased anxiety and that symptoms had resolved. PHN encouraged patient to follow up with provider and when to contact 911. At 1757, vital signs: blood pressure 120/78, respirations 16, pulse 74, O2 97%. Patient stood up slowly, monitored by PHN and Paramedic, and reported no symptoms. Patient left walking with steady gait at 1800.
ARM SWOLLEN, DIFFICULT TO MOVE, DISORIENTATION, VERY PAINFUL, RED, FEVER WITH N/V TXED FOR CELLULITIS/PAIN WITH KEFLEX ON 1/12/11 WITH IMPROVEMENT BUT NOT RESOLUTION SO CHANGED TO CLINDAYMCIN WITH MEDROL DOSE PK, HEAT/ICE.
3 days after my 2nd dose I had massive bleeding  from my uterus accompanied by severe cramping; this went on for about 5 hours and then tapered off; I have continued to bleed (lightly) for the next 5 days
Red spot, 8-10 centimeters, 14 centimeters wrapping around my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot, 8-10 centimeters, 14 centimeters wrapping around my arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot, 8-10 centimeters, 14 centimeters wrapping around my arm). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot, 8-10 centimeters, 14 centimeters wrapping around my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
48 hours after my vaccination I developed a fever of around 100 degrees along with coughing and throat congestion and weakness. This has continued for 48 hours now.
Redness, swelling, pain. Hurtful to touch even if it is clothing like a sleeve. Started the night of the injection, inflamed the next day with redness and painful. The redness has come down a little bit but still painful. She is going to follow up with her PCP, she has already contacted her MD and has an appointment for Monday 4/1.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB from lot # M040423 with expiry: 03-JUL-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature excursion of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger. This is one of the three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA005936:
This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX. Concomitant products included flecainide and XARELTO. On 2nd May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 3rd May 2018, 1 days after receiving SHINGRIX, the patient experienced headache and influenza-like symptoms. On an unknown date, the outcome of the headache and influenza-like symptoms were unchanged. The reporter considered the headache and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient reported this case for herself. At 15:30, the patient received SHINGRIX in the left arm. On 3rd May 2018, the patient woke up with headache and flu like symptoms. The reporter provided limited information due to time constraint.
Before going to bed, I had chills. Throughout the night I woke up feeling extremely cold multiple times. In the morning I awoke sweating. My temperature in the morning was 98.2°.  Throughout the day on 03/13/21, I  was extremely sore in my hips and legs. The arm where I was administered the shot was also sore. In addition to the soreness, I felt cold throughout the day, and I had a headache until I ate around 12:00pm, but I did not have much of an appetite.
patient reported having joint pains about 3 or so weeks after the vaccine then was found to have DVT 4 months later.
Patient received dose for ages 5-11 instead of 12+. Pt also had knot to L arm with redness that went away.
I have received the Moderna shot, and I would like to register my pregnancy.; vaccination exposure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (I have received the Moderna shot, and I would like to register my pregnancy.) and IMMUNISATION (vaccination exposure) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and MAGNESIUM for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Jul-2021. On an unknown date, the patient experienced PREGNANCY (I have received the Moderna shot, and I would like to register my pregnancy.) and IMMUNISATION (vaccination exposure). At the time of the report, PREGNANCY (I have received the Moderna shot, and I would like to register my pregnancy.) and IMMUNISATION (vaccination exposure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound abdomen: normal NORMAL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has a history of prior alcohol intake. No treatment information was provided
I developed a rash on my back and in axillary region.  It spread to my stomach and thighs.  I started treatment of prednisone and hydrocortisone cream.  The rash cleared up within 4 days after treatment began.
Information regarding Prevnar was received from a consumer regarding a patient who developed high aluminum blood levels. Data of administration was not provided. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On unspecified date, a patient reportedly developed a high aluminum blood level (blood aluminum increased). The outcome is unknown. The reporter indicated that 2 patients experienced this event; however, they are not presently identifiable. No additional information was available at the time of this report.
Blisters at the left thigh noted after vaccines given. Mother states that similar reaction occurred after 1/30/12 vaccines (she did not report). Received HIB/PCV-13 at left thigh.
paresthesia in fingers and toes; Fatigue; swollen lymph nodes in neck and underarm; headache; pain in arm; chills; joint pain; myalgia; low-grade fever; sore throat; This is a spontaneous report from a contactable female consumer (patient herself) of 35-years-old (non-pregnant) received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, lot number: EL9262, Expiration date: unknown) via unspecified route of administration in left arm on 26Jan2021 10:30 AM (at the age 35-years-old) as a single dose of covid-19 immunization. Patient had allergic history to environmental allergies and asthma. The patient received medications within 2 weeks of vaccination which included Cetirizine, prednisone, fluoxetine, fluticasone and did not receive other vaccines within 4 weeks 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. On 27Jan2021 at 12:00pm, patient experienced fatigue, swollen lymph nodes in neck and underarm, headache, pain in arm, chills, joint pain, myalgia, low-grade fever, sore throat, paresthesia in fingers and toes. Treatment received for the adverse events which included ibuprofen, paracetamol. Outcome of the events was recovering.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Injection site soreness and tense area; Injection site soreness and tense area; Cannot lift the arm up from tightness and slight pain; Pain only when attempting to lift arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 15Apr2021 at 13:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included hydrochlorothiazide, losartan (HYDROCHLOROTHIAZIDE; LOSARTAN) for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021 at 21:00, the patient experienced injection site soreness and tense area, could not lift the arm up from tightness and slight pain and experienced pain only when attempting to lift arm. The patient felt as if got hit in the area and had resulted in soreness. The patient was keeping arm down, but rotating hand rotor cuff resulted in muscle movement at the injection site (upper arm) and caused slight pain at site. Thus, patient needed to keep arm down and tucked to body. The patient had no other effects at the time of reporting. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event injection site soreness and tense area, cannot lift the arm up from tightness and slight pain and pain only when attempting to lift arm was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient presented to ER with fever & flu like symptoms (headache & myalgia) with 24 hrs of MENACTRA booster.
08/10/2005 Given Menactra intramuscularly left arm.  08/12/2005 Mom called, arm is red, slightly swollen, hot to touch.  Afebrile, has not given Tylenol.  PHN C/T normal potential problems.  If Mom concerned more than normal call doctor.  08/12/2005 child went to doctor.  He assessed not reaction to vaccine - maybe infection.  He prescribed antibiotic.  08/15/2005 Mom states patient was doing better even on 08/12/2005 after seeing doctor.  Doing well now, no more problems.