chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physicians assistant concerning a 45 year old female who on Oct  12 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). On Oct 12 2004 the patient developed pain and edema at the injection site, high fever (as high a 101F), body aches and nausea. Unspecified medical attention was sought. The patients outcome was not reported. There was no product quality complaint. It was noted that the patient had been vaccinated previously with pneumococcal 23v polysaccharide vaccine in 2003. It was also reported that a male patient (WAES0411USA01403) had similar experiences following vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Fever up to 38.5 degrees Celsius, short of breath, chest tightness, palpitations, fast heart rate, headache, dizziness
Pt. reported this adverse event today (8/25/14). Pt. reported a red, swollen, "larger than a golf ball sized" bump at vaccination site. This painful bump lasted approximately 2 weeks but lessened in size and pain over time. It is now completely gone.
13 days p/vax pt devel a rash w/a total of 6 3'' lesions.
Taut/reddened feet, red splotches on legs and face, inconsolable crying.
Approximately 1 min. after the administration of vaccines the pt began c/o dizzines, nauseas, neck pain, weakness and tingling on both arms, pt was cold to touch, pale, sweaty. Immediately was place on the exam table on supine position, glucose fingerstick was perform which was 77 mg/dl, the doctor was notify of the reaction, vitals was taken BP- 148/80,P- 116,R- 30, SO2 Sat-100%, supplemental oxygen with mask was provided, the doctor ordered Epinephrine 0.3 cc SC which was administer on RA, MD called 911 to request an ambulance for pt to be transporter to ER, F/U call was made by MD the day after who spoke with the mother and mom state that pt is stable and that she was D/C the same day after a few tests in the ER.
Received vaccine in right upper arm 10/14/08. That evening developed marked swelling, redness, and itching in right arm. Seen in office visit 10/15/08 - started on PREDISONE will have recheck in office 10/16/08.
approx 4 1/2hr p/vax mom noted hives over thigh @ lt vax site & over entire body;t102.3-hive persisted >1wk;RN saw pt did note rash around inj site & 2-3hives;mom states hives left in 3-4 days;
Chills/shivering; Very slight fever 99.2; Felt a little achy; due date for the next shot: 26Jan2021; This is a spontaneous report from a contactable consumer. This 73-year-old male consumer (patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 08Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure, cholesterol and acid reflux. Concomitant drugs included hydrochlorothiazide for blood pressure, pravastatin sodium (PRAVACHOL) for cholesterol, omeprazole for acid reflux and famotidine (PEPCID) for acid reflux. Patient stated he had chills, shivering, a very slight fever 99.2, and felt a little achy yesterday afternoon (09Jan2021) with outcome of recovered in Jan2021. Patient had blood work with unknown results. Patient took a couple of paracetamol (TYLENOL) as treatment. Patient stated he was told that the side effects would be within 24 hours but this was 2 days later (not confirmed appropriately). It was reported the due date for the next shot: 26Jan2021.  Information on the lot/batch number has been requested.
Rheumatoid arthritis that is going from bad to worst.; Swelling; Nausea; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1st dose, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single both for covid-19 immunisation. The patient medical history included autoimmune disorder for which as treatment she received a shot of steroids and a prednisone packet, for a good time that kept the thing going but at times, she felt like she might not be able to walk, during the treatment but she was able to stand up and rheumatoid arthritis. The patient concomitant medications were not reported. On an unknown date, the patient experienced rheumatoid arthritis that was going from bad to worse, swelling and nausea. Reportedly, patient indicated to have swelling and nausea and stated that her symptoms reminded her of rheumatoid arthritis that was going from bad to worst. Patient stated that she would see her cardiologist and Primary care physician this month. She wants to be prescribed with Pfizer medications, she stated that she knows to much about Humira and Methotrexate as previous acquaintances. Patient also stated that when you get older you cannot hear anything. Patient wanted to know if Pfizer makes medications for inflammation and auto-immune diseases. The reporter assessed the case as non-serious. The outcome of all the events was unknown.  Information about batch/Lot number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Patient was given vaccine that was not properly diluted. We believe the vaccine was diluted with 0.8ml instead of 1.8mL.
Swollen, hot, pink painful arm of injection site (approximately 6 inches in diameter, temperature of 100.3 x2 days, body aches x3 days
Recipient c/o tingling sensation on injection arm and that side of face, increased heart rate. Water was provided. At 11:30AM, BP decreased. Recipient denied s/s of allergic reaction, hypertension, or other discomfort.
9 year old male with fall and syncope episode approximately 5 minutes after receiving first COVID 19 Pfizer vaccine.   Responded to mother calling for help after patient fell down to floor. On arrival to other side of room, patient was noted awake but lethargic, responding to verbal stimuli with spontaneous respirations. Mother reported LOC for "a few seconds" and is uncertain if patient hit his head.  Once patient more alert, encouraged to drink juice and assisted on to gurney. Patient reporting inability to move lower extremities and noted diaphoretic/pale.  MD called by Lead RN. MD team arrived to vaccine clinic. Initial BP 79/43, HR 61, RR 34, Oxygen Saturation 100%. Patient appears pale. FSBS 118 obtained by MD Team. Repeat VS 65/38, HR 56, RR 34.   Care taken over by MD Dr. and RN.  Please see their documentation for interventions done by MD team (IV insertion, IV fluid administration)  MD orders for 911 to be called for transport to ED at 1431.  Patient left Vaccine clinic at 1450 transported by EMS team.  VS at time of departure 103/74, HR 75, RR 26, 100% oxygen saturation. Patient denies pain. Skin color improving, skin is dry and no longer diaphoretic, patient awake and alert. Able to transfer self from clinic gurney to EMS gurney.
pt recvd vax & devel rash & a swollen arm; pt devel also multiple allergies & sensitivity to many things; pt devel hives & swelling;
Caller reported pain on his feet after 2nd dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Caller reported pain on his feet after 2nd dose of Moderna vaccine) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Caller reported pain on his feet after 2nd dose of Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Caller reported pain on his feet after 2nd dose of Moderna vaccine) outcome was unknown.            No Concomitant Medications details were provided. No Treatment Medications details were provided.   Reporter did not allow further contact
2 days post vax pt awakened with aching in ears, eyes and head, chills and fever of 101.2. Injection site was slightly sore.
My first Moderna COVID vaccine was on 4/12/2021.  Around 4/19/2021, I developed mild stiffness behind my knees and calves that resolved in a few days.  My 2nd Moderna COVID vaccine was on 5/10/2021.  Around 5/17/2021, I again developed mild stiffness in the back of my knees and calves, which resolved in a few days.  Around 5/24/2021, I began to feel a burning sensation in my knees and in my elbows, initially mostly at night, usually after lying in bed for about an hour, and the burning sensation would persist throughout the night, making it difficult to sleep.  It initially went away during the day, but after a few days, the burning sensation spread to other joints and began persisting at all times of the day and night.  By 6/2/2021, the burning sensation was affecting the following areas of my body, often moving around and affecting different areas at different times:  elbows, knees, hips, shoulders, shoulder blades, fingers, toes, ribs, and internal organs.  The burning sensation in my joints and body continued throughout the month of June.  I do not have health insurance, so I did not seek medical treatment until 6/26/2021 when I went to a medical facility. There they did blood tests and a urine test.  The tests came back normal, showing negative Rheumatoid factor and negative ANA, as well as ruled out any infection.  They gave me a shot of Toradol and a shot of Solumedrol, and prescribed 40 mg of Prednisone a day for 3 days, Naproxen, and Methocarbamol each twice daily for 7 days.  The steroids helped the most, and over time the burning sensations have decreased, though still occur in a milder form sporadically,  but other symptoms began shortly after I went to urgent care.  These include muscle weakness, fatigue, brain fog, slight changes to my vision, painful spasms behind my ears, tingling and burning sensations on my skull, mild burning sensation in the skin near the various joints that I experienced burning in, stiffness in my jaw, elbow, and knee joints, pelvis, and needing to wear a brace on my right elbow sometimes due to pain (my right arm is the arm I received the vaccine in because I am left handed). Even today, three months after my 2nd vaccine, I am still dealing with mild symptoms, mostly pain and stiffness in my elbow and knee joints, jaw, and occasional muscle weakness throughout my body.  I do not feel as well as I did before receiving the vaccine. It has greatly affected my ability to function in my life, especially from late May through the end of July, and I am still recovering.
the patient received an improperly stored dose of PROQUAD on 9/21/2020; This spontaneous report was received from a nurse, referring to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 21-SEP-2020, the patient received an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S021617, expiration date: 09-JAN-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (DILUENT MRK) used to reconstitute the vaccine was properly stored.  The vaccine underwent a temperature excursion of minus 3.1 degrees Celsius (C) for 12 hours and 10 minutes, and -7.4 C for 4 hours and 20 minutes. There was no previous temperature excursion. The call was not because of a data logger.
I read on the fact sheet that may be a sign I had an allergic reaction; Dull pain: Caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt; heart started to beat fast; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration, administered in right arm on 12Apr2021 12:50 (at the age of 42 years old), as single dose for COVID-19 immunization. The patient's medical history included high cholesterol from 2011 and ongoing. Concomitant medications were not reported. Patient stated that he got his shot on Monday 12Apr2021 (he confirmed it was his first dose of the PFIZER-BIONTECH COVID-19 VACCINE) and then went on 14Apr2021 his heart started to beat fast, he read on the fact sheet and he asked if that may be a sign he had an allergic reaction. He went to his doctor, her EKG came back normal, he saw a cardiologist. He asked if he should get second dose. Second was scheduled for 03May2021. He didn't know either. As per response it was reported that as noted in the fact sheet for recipients, patient should not get the PFIZER-BIONTECH COVID-19 VACCINE if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason could not be made by Pfizer. They referred him to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider knew his health situation and had access to information that could better help inform this decision. The patient experienced dull pain: caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt. The patient reported that the dull pain was not as bad. The patient had EKG on 14Apr2021 with abnormal result (as reported). The outcome of the event 'dull pain: caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt' and 'heart started to beat fast' was recovering; outcome of the remaining event was unknown.  Information about lot/batch number has been requested.  Follow-up (22Apr2021): New information reported from a contactable consumer (patient) includes: reaction data (additional event: 'dull pain: caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt'), suspect product details (administration site and time), patient details (medical history and lab data) and event details (outcome of the events updated).
Event occurred after 2nd vaccination. Patient was diagnosed with COVID Tylenol, Remdesivir In-patient
BODY ACHE; TEMPERATURE 103; HEADACHE; This spontaneous report received from a consumer concerned a 32 year old female. 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced body ache. On 25-MAR-2021, the subject experienced temperature 103. On 25-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature 103, headache and body ache was not reported. This report was non-serious.
3 hours after receiving vaccines, the pt sarted crying unconsolabley and continued crying for about 3 hours Baby was afebrile and had minimal redness at injection site.
seizure, headache,dizziness, weakness, stomach discomfort  12/17/09 clinic records received for DOS 07/31/07and 6/18/08 and vaccination list record received for DOS 12/09/1993 thr 06/18/2008. DX: Well Adolescent Care, Acne 07/31/07 office note docu. sports physical with unlimited participation. 06/18/08 office note notes c/o not sleeping well and insect bite X 1wk. Parent concerned about excessive sleep and sweats alot. Acne on face and upper back. Prescriptions given:clindamycin phosphate 1% TOP, benzoyl peroxide 6% TOP and differin 0.1% TOP. Vaccination rec reflect patient received HPV on 07/31/07, 10/09/07 and 06/18/08.
shingles shot , had shingles /suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included covid-19 vaccine for prophylaxis.   On an unknown date, the patient received Shingles vaccine and covid-19 vaccine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had shingles vaccine and got shingles hurt big time. The reporter did not ever want them again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Information has been received from a registered nurse concerning a 45 year old black female employee with no allergies, no past medical history, no history of adverse events following prioer vaccination, no history of chickenpox and no recent exposure to chickenpox or herpes zoster who on 10MAR2003 at 17:00 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (lot 642877/0416M). There was no illness at the time of vaccination. Prior to vaccination on 25FEB2003, laboratory tests results included the following :varicella zoster virus  IgG antibody EIA 0.60 ISR (less than 0.91 is negative); measles IgG antibodies 3.03 ISR (greater than or equal to 1.10 is positive); rubella IgG antibodies 2.00 ISR (greater tan 1.09 is immune). On 19MAR2003, the patient developed pain (rated as 10 on a scale of 0 to 10), numbness and tingling in the abdominal and back area. On 22MAR2003, the patient was seen in the emergency room and was treated with naproxen (NAPROSYN). On 29MAR2003, the patient broke out with a rash of 20 lesions on her right side under the breast and on the lower back. On 01APR2003, the patient went to her primary medical doctor. Shingles and was diagnosed with an onset date of 19MAR2003. No laboratory tests were performed and a photo was not taken. A few weeks after onset, the patient recovered. Additional information is not expected.
clavical lymph node swelling on injection side; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686 and expiry date unknown) via unspecified route of administration at the right arm on 18Jan2021 08:45 at single dose for Covid-19 immunization in a hospital. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Historical vaccine included first dose of  BNT162B2 on unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 12:00, the patient experienced clavical lymph node swelling on injection side. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Covid test nasal swab: unknown results on 21Jan2021, PCR test: unknown results post vaccination (Jan2021). The patient did not receive treatment due to the event. The event was clavical lymph node swelling on injection side recovering. The event was reported non-serious; results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect; all no.
Localized redness, swelling,  and itching at injection site.  About 2" or so diameter.
The day following injection, patient became severely dizzy.  Needed to stay in bed for 36 hours until the reaction subsided.
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 45-year-old male patient who received MENVEO (batch number M17035, expiry date March 2019) for prophylaxis. On 27th September 2018, the patient received MENVEO. On an unknown date, less than a week after receiving MENVEO, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm was unknown and the outcome of the erythema of extremities was not recovered/not resolved. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to MENVEO. Additional details were reported as follows: The patient was administered the vaccine MENVEO and subsequently the patient's arm became red and swollen from the elbow to the shoulder. The patient called the next day complaining about redness. The reporter told the patient to call back if it still persisted in 2 days. The patient did not call back but was seen for something else a week later. The reporter noticed that the patient's upper arm was still somewhat red.
T104 R on 10DEC91-fever down during the day & elevated @ noc; fever lasted till 12DEC91;
10:20 within minutes of receiving Tdap shot, patient complained of "throat closing", mild SOB, felt palpitations.  10:34 BP=155/112, pulse=79.  10:44 Decadron long IV given & Pepcid 20 mg IV, also noted numbness & redness at injection site.  Signs/symptoms resolved within one hour.
Around September 5, 2021, I started to have menstrual cramping outside of the normal cycle. By September 7, 2021 I had started a menstruating and it has progressed since.  I should not have had menstruation until September 21, 2021. The cycle is different this time. Thicker and heavier.  Acne has progressed during the week of September 12, 2021
rash at injection site at day three proceeding to rash of both arms over the following three days
Hiccups began 5 1/2 hours after vaccine and lasted 36 hours
has a big ol round spot on her arm; really sore for a day or two; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 second dose at SINGLE DOSE  for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient "has a big ol round spot on her arm"  on Jan2021 with outcome of unknown and "really sore for a day or two" on Jan2021 with outcome of unknown. The action taken was not applicable. The reported stated "my sister actually, she took it. She took her second one about two days ago and she is been going through it with it. You know nothing terrible but you can tell she took it. You can tell her immune system is really working. She has a big ol round spot on her arm and she was really sore for a day or two". Information on the lot/ batch number has been requested.