chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 90 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Recvd call 02DEC93; c/o muscle & joint pain "pins & needles" in hands & toes; stated was in ER previous weekend; they advised being admitted for further testing; pt refused; 06DEC93 f/u call to home: pt was admitted to hosp 1AM today;
This patient has a runny nose, persistent bronchial cough, Phlegm in throat and chest, headache, eye hemorrhage in the left eye, no vision, vision unclear.
-Pain at injection site (placed ice pack on site and took pain med)  -Lymph node pain on injection arm side ( took pain med)
Pt has swollen left upper arm/deltoid- cold compresses and Keflex.
High fever and chills starting 5 hours after vaccination. Took one ibuprofen 18 hours after vaccine. Symptoms lessened but remained. Fever persisted. Took one ibuprofen 42 hours after vaccine. Symptoms largely subsided.
Symptoms: Ongoing, significant and persistent shortness of breath during activities of daily living and upon exertion currently continuing at 7 months after vaccine administration. Significant and persistent fatigue inhibiting  ability to perform activities of daily living and prohibiting routine exercise walking 3 miles/day in 1 hour I have been doing for 15 years.  New onset of  cardiac arrhythmia diagnosed as Paroxysmal Atrial  Tachycardia.  New onset of Stage 2 Hypertension.  First ever episode of chest pain with Stage 3 Hypertension episode in Emergency Care facility  Treatment: Emergency Center care with chest pain where diagnosis of hypertension was made. Initiation of care under a cardiologist  and started on hypertension medications. Underwent cardiac evaluation procedures including nuclear exercise stress test, nuclear cardiac echo, Coronary CT scan Heart monitor worn for 2 weeks
Serum sickness; giant urticaria, fever 104 F, swollen wrist, body aches, cough (history of asthma). Swelling at site of Pneumovax but not flu shot.
I woke up with a sore and scratchy throat, I also had congestion and a stuffy head upon testing for COVID-19 it was negative. Into the night and very early in the morning I had sweating and all other symptoms persisted. On the next day I tested positive for COVID -19 and slept a lot that day as I was fatigued. I had a telehealth call with my doctor who asked a lot of questions and she prescribed me PAXLOVID and had me stop my simvastatin. I took the PAXLOVID for the prescribed five days although I continued sweating at night over the next five days. On Friday I felt better but by 11:30 AM I was tired again and it was the same on Saturday although the night sweating had stopped, on Sunday November the sixth I tested negative. I tested again on the ninth of November and it was negative again and I have incrementally gotten better since then.
My wife has had a lifelong struggle with seasonal After the second does her allergy completely went away for the first time in her life; At the time of second vaccination, the patient was at gestation period of 32 weeks; This is a spontaneous report from a contactable consumer. This is the second of two reports. A 34-year-old pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 31Mar2021 at 14:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy (reported as "lifelong struggle with seasonal allergy"), COVID-19 and pregnancy (Gestation period: 32 weeks). The patient's Last menstrual period (LMP) was 16Sep2019. The patient had earlier received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 34-year-old) as a single dose for COVID-19 immunisation (maternal drug exposure). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 At the time of second vaccination, the patient was at gestation period of 32 weeks. On 30Apr2021 at 15:00 after having second dose of vaccination, the patient's lifelong struggle with seasonal allergy completely went away for the first time in her life she started doing gardening with in April that was a miracle. Patient struggled with severe allergies. It was reported that would be where she would have a call in sick because her eyes would be happy and asthmatic since the second COVID-19 shot no allergies pollen allergies are no more. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The events were non-serious. The clinical outcome of the allergy completely went away for the first time in her life was recovered with sequelae and Maternal Exposure During Pregnancy, third trimester was unknown.  Follow-up (05Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Received pneumovax vaccine on thursday 11/8 @5pm in right arm, on friday 11/9 @5pm, started with violent chills, shakes, fatigued, spiked temp to 102.0 during night, diaphoretic, violent shakes, chills, right arm swelling, unable to move arm due to severe pain,unable to sleep due to symptoms, took tylenol pm at 5am to sleep! Slept til 10am, temp 101.0, took ibuprofen, unable to move arm/severe swelling/reddened--size of grapefruit, took benadryl on sat night to see if it would calm down "reaction", slept all night, temp 100.6 on sunday, cont with ibuprofen q6 atc, severe arm pain, by monday 11/12--was able to move arm by monday afternoon, continued with ibuprofen and by tuesday, redness was gone, still wild mild mod swelling, painful to touch but able to move arm.
This spontaneous report was received from a Registered Nurse referring to a 7 week old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 04-OCT-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ per oral route (dose, dose number, frequency, and anatomical location were unknown) with lot # N030364, and expiration date 06-MAR-2018 for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 13.3 °C degrees Celsius for 1 hour and 17 minutes. There was a digital data logger involved, but there was no previous temperature excursion reported. No adverse effects were reported. Sender's Comments: US-009507513-1810USA004453: US-009507513-1810USA004452.
Between August 27, 2015 and August 30, 2015 we noticed our daughter began having seizures. The seizures became more frequent and for longer periods of time over the course of a few days. I called our pediatrician each time a seizure occurred and on September 2, 2015 she recommended we bring our 2 month old to the ER. She was admitted to the hospital where she was given Keppra to stop the seizures and was hooked up to an EEG for monitoring. It was confirmed that she was having seizures and was diagnosed with epilepsy.
body aches; Developed side effects including, fatigue; Joint pain; headache; bad chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), FATIGUE (Developed side effects including, fatigue), ARTHRALGIA (Joint pain), HEADACHE (headache) and CHILLS (bad chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (body aches), FATIGUE (Developed side effects including, fatigue), ARTHRALGIA (Joint pain), HEADACHE (headache) and CHILLS (bad chills). At the time of the report, PAIN (body aches), FATIGUE (Developed side effects including, fatigue), ARTHRALGIA (Joint pain), HEADACHE (headache) and CHILLS (bad chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication was reported. No treatment information was reported.
15MAR93 pt given HIB vax @ clinic 930AM; 5PM pt cranky, t103, red area rt thigh; 16MAR94 9AM pt taken to MD stated that pt reacted to vax; t101, cranky no ENT sx;
Patient's mother was instructed by Dr. to come get 2nd Covid vaccine by December 7th. After patient received vaccine it was noted that the first vaccine was given on 11/23/21.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 5:43 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 5:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month.  On 19-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.   This case was linked to MOD-2021-402935 (Patient Link).
This is about a pneumonia shot I received from my Dr. and NOT at my request. I never get sick and I sure regret 100% getting that shot in my right arm biceps area 6 inchs below the injection site became so swollen it was like 2 baseballs inside my arm. It was swollen clear around my arm above the elbow. One hour later the arm above the elbow turned bright red in color and extremely hot to the touch. The redness spread over to the middle of my chest and under the right arm pit. I could not bend my arm. the pain was horrific. My heart rate was so fast I was unable to sleep at all that Saturday night. Being the weekend there was no one at Drs. office to report this to so I suffered it out until Monday a.m. when I drove to Dr.'s office to prove to them what had occurred. I did take pictures.  if there is a class action suite going on over these pneumonia shots I need to know where to sign up. my Dr. recommended an antibiotic med. but now I am afraid to take any that contains penicillin or sulfa. NEVER have I been allergic to anything ever, now thanks to that injection I am at risk. HERE IT IS 2 WEEKS LATER AND MY INJECTION SITE STILL BURNS AND IS SNSITIVE TO TOUCH.  I HATE IT.
On 02/13/2023 I tested positive for COVID-19 and experienced congestion, sore throat and fatigue. I contacted provider and was prescribed Paxlovid. I completed full 5 days of treatment and tested negative for COVID-19 on 02/18/2023. Tested again for COVID-19 on 02/24/2023 and it was negative. I also had a head cold on 03/25/2023 and I ended up in the emergency room on 03/29/2023. Still recovering at the moment.
Pt's dad came to clinic on 11/1/02 said he had a reaction to vaccine that L deltoid started turning red in a circular motion and area began getting larger. Vaccine was given on 10/29/02 parents said on 10/30/02 they took him to ER due to her case in swelling and redness. ER gave on dose  prednisone, Tylenol and Benadryl and sent home to follow up with us on 11/1/02. We gave Motrin, and Benadryl area observed in clinic was a 9cm oval shaped area on L deltoid, area hot to touch no raised area. Pt not in any acute distress.
lip swelling, tingling, numbness. improving after 1 dose of benadryl.
First 24-48 hours, experienced arm soreness and fatigue. Starting 1/26 (12 days after vaccine) hives or rash type of reaction not around the injection point but lower on the arm. The rash is raised and in a defined area. It is also itchy. Visited the dermatologist 1/27 and she confirmed that this rash is not indicative of anything else (not eczema, psoriasis, etc.) also said she had a similar reaction on her arm 8 days after receiving the first dose.
Soon after receiving the first COVID  booster, I was diagnosed with Anemia.  I don't know if my Anemia was related to the booster, but I want to report it in case others have experienced a similar diagnosis.  I have been taking an Iron supplement since the diagnosis, and the Anemia is now under control.
pt recvd vax 8DEC95 & started w/red,lumpy & swollen area where inj given;9DEC95 redness & swelling had gone to elbow;10DEC95 hand,wrist & fingers were involved;11DEC95 these sxs disappeared & achiness of joints started & has had them since
Arm really hurt for about 15 min., then went away. Intense cold, couldn't get warm with multiple layers of clothes and blankets. Fever. Restless sleep ~ hot, then cold. Sunday am woke with a headache that lingered and felt like I was in a fog ~ dizzy if I turned my head quickly, and then really tired. About 7pm I felt fine.
Rash left arm adjacent to injection site.  Currently 2 inches in diameter.  Itchy with slight underlying soreness.
syncopal episode of adolescent female; This spontaneous report was received from a nurse via a company representative and refers to an adolescent female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown date, reported as more than a year ago, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, she experienced syncopal episode. It was reported that the patient recovered in the office and was able to walk out to go home.  Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of syncope was considered to be medically significant.
Fever of 101.6, Muscle/Body aches, joint pain lasting ~24 hours. Continued redness and swelling of injection site, which is painful. Continued fatigue.
Injection caused redness, swelling, tenderness to left arm, below deltoid up to the elbow.   injection was given in left deltoid region.  Patient came back to pharmacy 2 days after injection to show the reaction
administered the lyophilized portion only with a non-approved diluent; administered the lyophilized portion only with a non-approved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered the lyophilized portion only with a non-approved diluent) and inappropriate dose of vaccine administered (Verbatim: administered the lyophilized portion only with a non-approved diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 09-AUG-2023 The health care professional (HCP) reported that they had 4-vials of Menveo lyophilized vials and no matching diluents in their supply.  The HCP did not know if diluent only was provided to patients or if vials were broken and not reported. The HCP was not sure if patients were administered the lyophilized portion only with a non-approved diluent. The HCP gave permission for Safety follow-up so perhaps the HCP could provide additional clarity. No additional details are available. The reporter consented to follow up.  The patient potentially received lyophilized portion with a non approved diluent of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
pt recvd vax on 21AUG92 & on 30AUG92 devel bilateral wrist pain; 6SEP92 devel a cold runny nose w/no appetite but no fever;
This spontaneous report as received from an unknown age, female consumer reporting on herself with no pertinent medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (route and dose not reported, in the left arm). No other suspect therapies or concomitant medications were reported. On an unknown date the patient experienced pain in the left arm where shot was given, it was low in the muscle, pain on upper back and shoulder area, next day from shot until now. No treatment information was reported. Additional information has been requested.
Just over 30 minutes after receiving the injection this year 10/12/2023, I experienced dry throat, Globus sensation and throat clearing sensation that ended up lasting 36 hours. I treated with 50 mg of Benadryl, 10 mg of Claritin, 10 mg of Zyrtec for 2 days in a row. There was no trismus, drooling or hives. However, last year when I received the seasonal influenza shot (manufacturer ID Biomedical, Lot # Y72ZZ, received on 10/13/22 to right deltoid), about 4 hours after receiving the injection, I experienced whole body itching and hives to chest. This resolved about 24 hours later after taking 10 mg of Zyrtec and 50 mg of Benadryl.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.   No Medical History information was reported.   On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.
Round hot red circle around injection site developed within 18 hours of shot surrounding injection area; upset digestive system, abdominal pain and gassiness, nausea, feeling jittery. Persists at time of filing report at same intensity (48 hours later).
Starting feeling hot face was itching, heart rate  and BP was increased  Benadryl 25mg IM given
I always have had mild tetanus, but a about a week after the shot my left ear started to get more sensitive to loud noise.  On the 27th of March I woke up with a very loud constant lower tone in my left ear.  It continued until today, April 2 when about 10 a.m. it started to fade.  I still have it but not as bad.  Hearing still seems to be a little sensitive, especially to loud noise.  I wear hearing aids in both ears.
2 days after 10/25/04 MMR, Td, Typhoid and Hep A, developed severe mouth pain which led to inability to chew-bilateral masseter muscle tenderness which resolved improved by 10/29/04. Resolved first on L sides, then at right side. Temp 99.2. No oral pathology (acute). Also had severe local Left arm injection tenderness, erythema.
reaction at the injection site "very light pink color"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown", described as "reaction at the injection site "very light pink color"". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had a side effect from first dose, she had a reaction at the injection site "very light pink color, imagined it was the first time, it will go away".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12/10/12 Pt reports: Right upper arm, reddened x 10 days, knot & bruise at injection site. Left upper arm, large bruise, reddened x 14 days, knot & bruise at injection site; itchy front of left upper arm for 4 weeks. Eve of 11-14-12 chills & sweat x 1.
Mon 12/09/02 -Right increased arm, sore & achy, Tues 12/10/02 right increased arm, sore,red, warm and swollen, white patches (hives) Called dr, Benadryl taken, Arm red, rashy on 12/11/02 has dr appt 12/11/02
no other AE occurred; the first dose of Varivax and MMR II at 3 years old and the second dose of Varivax and MMR II at 7 years old; This spontaneous report was received from a registered nurse and refers to a currently 18-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in an approximately 2006, at 3 years old, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX), (for both: formulation, strength, dose, route of administration, lot#, expiry date were not reported), both for prophylaxis. On an unknown date in an approximately 2010, at 7 years old, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX), (for both: formulation, strength, dose, route of administration, lot#, expiry date were not reported), both for prophylaxis. No other adverse event occurred.