chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen left arm; Swollen breast; Sore on left arm; Sore on breast; Pain in injection site; A spontaneous report was received from a female patient concerning herself, of unspecified age, who received Moderna (mRNA-1273) and developed swollen left arm (peripheral swelling), swollen breast (breast swelling) and pain in injection site (injection site pain) on 15 Jan 2021.   The patient's medical history was not provided. Concomitant product use was not provided.   The patient received the first of two planned doses of mRNA-1273 (Batch number not provided) on 14 Jan 2021 for prophylaxis of COVID-19 infection.   Treatment for the event was not provided.  The events swollen left arm and pain in injection site were considered to be non-serious and listed and the event swollen breast was found to be unlisted.  The consumer did not assess the causality of events.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events swollen left arm, swollen breast and pain in injection site were unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected events of pain in extremity, peripheral swelling, breast pain, breast swelling and nonserious expected vaccination site pain.  The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
About five hours after I got my second booster I feeling a little off with flu like symptoms. By 2AM I was flushed and turning red, I was achy and feeling the spins and had heart palpitations. I woke up Friday and could not even sit up and ended up staying in a Benadryl coma. I was vomiting and having diarrhea. I even took a Covid and that came back negative. I started feeling this impending doom. I became flush and my heart rate sky rocketed into the 140's I was on hold trying to talk to my doctor and then my throat starting closing and I had to use my EpiPen and called 911.
mild trouble breathing; sore arm; fatigue; flu like symptoms; Three concussions; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (mild trouble breathing), CONCUSSION (Three concussions), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Hypertension (Patient is on some blood pressure medication) and Crohn's disease. Concomitant products included WARFARIN for Atrial fibrillation, PROBIOTICS NOS for an unknown indication, TURMERIC [CURCUMA LONGA RHIZOME].   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue). In March 2021, the patient experienced CONCUSSION (Three concussions). On an unknown date, the patient experienced DYSPNOEA (mild trouble breathing). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (mild trouble breathing), CONCUSSION (Three concussions), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) outcome was unknown. Not Provided          The treatment included paracetamol, ibuprofen and menthol drops for the pain.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine was administered to a child under the age of CDC and  manufacturer guidelines. The vaccine was not administered by the person or store that is filing this event. There are no known adverse affects from the vaccine.
Arm is sore; Really cold when she went to bed and really hot when she woke up; Headache all across the front of her head; Chills; Has a temp that ran to 101F; Shot hurt the muscle a lot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), FEELING OF BODY TEMPERATURE CHANGE (Really cold when she went to bed and really hot when she woke up), HEADACHE (Headache all across the front of her head), CHILLS (Chills) and PYREXIA (Has a temp that ran to 101F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore), FEELING OF BODY TEMPERATURE CHANGE (Really cold when she went to bed and really hot when she woke up), HEADACHE (Headache all across the front of her head), CHILLS (Chills), PYREXIA (Has a temp that ran to 101F) and MYALGIA (Shot hurt the muscle a lot). At the time of the report, PAIN IN EXTREMITY (Arm is sore), FEELING OF BODY TEMPERATURE CHANGE (Really cold when she went to bed and really hot when she woke up), HEADACHE (Headache all across the front of her head), CHILLS (Chills), PYREXIA (Has a temp that ran to 101F) and MYALGIA (Shot hurt the muscle a lot) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-031684 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-031684:crosslink -Husband case
unilateral cervical lymphadenopathy; seemed to start developing within 24-48 hours after the shot, more noticeable at 72 hours with the pain already improving; myalgia; headache; chills; This is a spontaneous report from a non-contactable physician. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The healthy female patient complained about a unilateral cervical lymphadenopathy (self-examined) on the left side (the same side as the 2nd vaccine shot on Friday 08Jan2021), yesterday evening (Sunday, 10Jan2021). It seemed to start developing within 24-48 hours after the shot, more noticeable at 72 hours with the pain (Jan2021) already improving. She also developed myalgia, headache and chills 12-18 (Jan2021) after the shot. All the other symptoms were somewhat anticipated, but the lymphadenopathy was not. She doesn't have any other conditions. The outcome of lymph node pain was recovering, while the outcome of the remaining events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Shingrix Vial / final volume was 0.4 ml / Pharmacist requesting credit for low fill vial; Administered the / vaccine / does not know how much the patient actually received; Vaccine leaked from the syringe and on to the patient; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis. This case was associated with a product complaint.   On 28th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .4 ml. On 28th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, accidental exposure while administering drug and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, accidental exposure while administering drug and exposure via skin contact were unknown.  Additional details were provided as follows: The reporter reconstituted the Shingrix vial and the final volume was 0.4 ml. The reporter advised the patient that the vial was not 0.5 ml and she did not have another vial on hand. The patient requested to administer the vaccine even though the fill was low. The reporter administered the Shingrix vaccine in the left arm and did not know how much the patient actually received due to the faulty syringe, but it was less than 0.4 ml, which led to accidental underdose. The reporter states she drew up the dose with a faulty syringes, the vaccine leaked from the syringe and on to the patient, which led to accidental exposure while administering drug and exposure via skin contact. Reporter contacted GSK to see if patient needed to be revaccinated and to report the low fill of the vial.  The reporter was unable to return the vial as she has thrown the vial and syringe away. The reporter was requesting credit for low fill vial. The reporter consented to follow up.
undiagnosed chronic health condition - when standing legs turn blue and mottled from the mid thigh down
FELT LIKE SOMEONE WAS PUSHING DOWN BACK OR SPINE COMPRESSION OR TINGE; BACKPAIN; SORE KIDNEYS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced felt like someone was pushing down back or spine compression or tinge. On APR-2021, the subject experienced backpain. On APR-2021, the subject experienced sore kidneys. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the backpain, sore kidneys and felt like someone was pushing down back or spine compression or tinge was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
24 HRS POST VACCINATION DEVELOPED, FATIGUE, MUSCLE ACHES, AND FEVER RANGING FROM 99.7 TO 102.2 FOR 8 HRS. TREATED WITH ONE DOSE OF TYLENOL APPROXIMATELY 4 HRS POST SYMPTOM ONSET. SORE ARM AT INJECTION SITE 2 DAYS. NO FURTHER COMPLICATIONS OR TREATMENT
Developed redness, swelling, and "itchy" at site of injection on left deltoid. Do not have full chart to varify other immunizations the child had in the past.
p/ pt recv vax approx 8 mo later pt exp fever 102f & headache., chickenpox w/approx 50 lesions 2 days p/ later.
Cellulitis of left arm. Tx with Rocephin IM and KEFLEX (po) pain, swelling, heat, streaking 4 in 24 h.
sore arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 04A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE (She has had half doses of the flu vaccine in the past.). Concurrent medical conditions included Atrial fibrillation, Asthma, Non-Hodgkin's lymphoma (cancer: non Hodgkin's lymphoma), Cancer anaemia and High cholesterol. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, AMLODIPINE for Blood pressure high, ATORVASTATIN for Hypercholesterolemia, FLUTICASONE PROPIONATE (FLOVENT), SODIUM CHLORIDE (AYR SALINE), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), POLYVINYL ALCOHOL, POVIDONE (REFRESH CLASSIC LUBRICANT EYE DROPS), LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) and GUAIFENESIN (MUCINEX) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, 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 experienced MYALGIA (sore arm) and CHILLS (chills). The patient was treated with METOPROLOL at a dose of 2 weeks. At the time of the report, MYALGIA (sore arm) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Blood test: increased (High) high cholesterol.         The patient had took an unspecified pill for upset stomach as needed and has a rescue inhaler for asthma.   This case was linked to MOD-2021-293445 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Followup received on 23 Aug 2021 and included Concomitant medications.
Narrative: COVID infection following COVID vaccine series 05/05, Pfizer, dose #1 09/20, Pfizer, dose #2 12/24 COVID swab, result: detected 08/03 pt cc: exposure: unknown 12/24 pt admit ED cc: exposed to COVID from student dx: VIRAL SYNDROME LOS: 1 day 12/24 SARS-COV-2 Variant Sequencing: pending
After nearly two months both arms stillhurt when I wake up at night or in the morning; The stiffness wears off after the pill and during the day, and returns at night.; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on an unknown date in Jan2021 at 08:15 (at the age of 77-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the right arm on 06Feb2021 at 08:15 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to bee sting. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The patient previously received varicella zoster vaccine (MANUFACTURER UNKNOWN) for immunisation on unknown date and experienced allergy to vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in Jan2021 at 12:00, the experienced pain in arm and stiffness. After nearly two months both arms still hurt when patient wake up at night or in the morning and patient has taken naproxen sodium (ALEVE) to take away the pain. The stiffness wears off after the pill and during the day and returns at night. Both pains started after getting the vaccinations. The patient had the second shot in right arm because didn't want to double up any pain the left arm. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with chiropractic medicine, heat pad and massage machine. Since the vaccination, the patient had tested for COVID-19. On 19Jan2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events pain in arm and stiffness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt was 16 years old at the time of vaccination. Moderna is only approved for 18 and over. Pt inadvertently received Moderna vaccine and pt completed the 2 dose series.
pt recvd vax & devel a bad case of hives; MD wants pt to have ped Td vax to supplement for DTP;
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 1st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st April 2018, 6 hrs after receiving SHINGRIX, the patient experienced pain. On 2nd April 2018, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the left arm. The batch number and expiry date were not available. The patient experienced pain 6 to 8 hours after vaccination and that went away a day later. The reporter consented to follow up.
2wk p/vax having numbness in lt foot;during next wk progressed up to knee, lt hand & lt side of face;during the next 2mo sx improved then reappeared w/joint pain being constant;dx vaccine toxicity;4wk p/sx resolved x/sl numbness in lt foot;
pt recv vax 18AUG98 & exp a bloated feeling in the lower rt side;pt  was not treated for the event;
Fever and fatigue for around 24 hours after second round. Ibuprofen and water helped a lot.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 66 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, were not reported for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s more than 3 weeks ago. The batch number was not reported and has been requested. No concomitant medications were reported. On an unknown date, the patient experienced suspected immunological vaccine failure. The patient had no side effects. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative, SARS-CoV-2 IgG antibody test (NR: not provided) negative, and SARS-CoV-2 IgM antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210400318-covid-19 vaccine ad26.cov2.s -Suspected Immunological failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Vesicular lesion x2 developed at the site of the vaccination around 10 days after administration. 3/17/10 spoke with mother, pt did not develop more pox.
Pt died.  She had a difficult course with no sustained progress, overall remaining very weak and frail. 1/5 she developed AMS then frank sepsis then septic shock and lactic acidosis. Situation discussed in detail with her sons, who felt transition to comfort care would be most appropriate.
Tachycardia (150 bpm), Fever (101.8), SOB, and Uncontrollable Shaking for more than 12 hours
Woke up next morning in pain from head to toe. Every joint in body hurts .both shoulderd and going up the neck painful . non-stop headache for 4 weeks . Nausea really bad . Went to urgent care. EKG was done SED rate was elevated 28.
DISCHARGE DIAGNOSES:  1. COVID-19 viral pneumonia 2. COPD exacerbation due to #1 3. Insomnia 4. GERD   HOSPITAL COURSE: This is a 56-year-old woman who has a past medical history of COPD, insomnia, GERD who presented with complaints of shortness of breath.  She tested positive on 1/17/2022 for COVID-19 with her symptoms starting with a sore throat and feeling unwell on 1/15/2022. Patient did not have any clear documentation of hypoxia but her chest x-ray did show some bilateral infiltrates that were likely related to COVID-19 and were viral in nature versus any bacterial component.  Her procalcitonin was negative hence noting that no antibiotics are necessary to treat.  She was started on IV steroids transition to Decadron and will discharge home with an additional 3 doses starting today.  She was excellent that proning and using positional changes along with using her Aerobika.  She is encouraged to continue using those techniques along with ambulating in her home and spending as much this time out of bed as possible.  In regards to her COPD we continued her PTA medications of Flovent substituted Arnuity, tiotropium-alodaterol inhalers.  Of note she did have a history of being intubated in the ICU in August 2021 stated with that intubation she did develop some vocal cord paralysis.  She does take prednisone 5 mg daily.  She should continue her PTA regimen for insomnia with her Ambien along with her Protonix for her history of GERD.
Muscle pain in my left leg only; on and behind knee cap; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 17:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 05:00, the patient experienced muscle pain in left leg only; on and behind knee cap. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient underwent SARS-Cov 2 rapid ag (COVID 19) test (nasal swab test type) and the result was negative. The clinical outcome of the event muscle pain in left leg only; on and behind knee cap was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The night after I got the shot I had a pulsating migraine, a fever of 103.9, really bad chills and was extremely nauseous and weak. Here it is 6 days later and I have developed a rash all over my body. On my back, my legs, my arms. It is very red and very itchy.
45 min after vaccine was administered, pt exported hives on face and neck; denied SOB; p: 72 R- 12: No hx of adverse reaction to seasonal flu vaccine; reports past reaction to allergy shots" advised to offer future flu shots with being tested for sensitivity to them. urged to contact MD.
vaccination site swelling; Not able to extent her arm more than 90 degree; Painful right elbow; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling), LIMB DEFORMITY (Not able to extent her arm more than 90 degree) and ARTHRALGIA (Painful right elbow) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling), LIMB DEFORMITY (Not able to extent her arm more than 90 degree) and ARTHRALGIA (Painful right elbow). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling), LIMB DEFORMITY (Not able to extent her arm more than 90 degree) and ARTHRALGIA (Painful right elbow) outcome was unknown. Not Provided      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.   Reporter did not allow further contact