chrisvoncsefalvay/vaers-outcomes huggingface dataset:
noticed a dime sized thing that looks like hive on her body going towards back and arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported) via an unspecified route of administration on 28Feb2021 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication was not reported. It was reported that she felt fine until yesterday, she noticed a dime sized thing that looks like hives on her body going towards her back and arm. She said there are more now. It's multiplying. She has second dose on 21Mar. She wants to know what to do and if it may be related to the vaccine. She does take a blood thinner. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Ongoing heart palpitations, fatigue, joint pain, can't catch breath when I am not active
pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
Headache Injection Site Soreness, Headache, Fatigue day1 Narrative:
Severe headache, nausea, red hot swollen 5" x 6" tender hard area on upper right arm where injection was given.
The patient experienced no symptoms.; a dose of PROQUAD was accidentally administered to a 6 month old patient instead of a dose of PEDVAXHIB.; a dose of PROQUAD was accidentally administered to a 6 month old patient; Route of Administration: "intramuscular"; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 20-JUL-2020, the patient at the age of 6 months old, was accidentally administered a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, by intramuscular route as prophylaxis (lot number S035100 which has been verified to be valid, expiration date reported and validated as 03-MAY-2021) (dosage, vaccination scheme, frequency and anatomical site of injection were not reported), instead of a dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (wrong product administered, incorrect route of product administration and product administered to patient of inappropriate age). The reporter did not know if the product confusion contributed to the error. The patient experienced no symptoms.
Fever started at about 6PM at about 100.6.  Took aspirin and then ibuprofen. Fever peaked at 103.2F at approximately 9PM and lasted until about 8AM on 8/10/2012. From then until 8/11/2012 I was able to keep fever under 100.8. Fever gone on 8/11/2012.
Left thigh reddened area 12.5 cm x 14 cm. Swollen, painful x 2 days. Diagnosed cellulitis left leg. Antibiotics given. No allergy previously to vaccines.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) for prophylaxis. On 25th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th October 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, chills, general body pain and sleeplessness. On 26th October 2018, the patient experienced headache, runny nose, mobility decreased and feeling cold. On 27th October 2018, the patient experienced erythema of extremities and feeling hot. On 29th October 2018, the patient experienced tenderness. The patient was treated with TYLENOL. On 26th October 2018, the outcome of the chills was recovered/resolved. On 27th October 2018, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the pain in arm and tenderness were unknown and the outcome of the sleeplessness, headache, runny nose, erythema of extremities, feeling hot, mobility decreased and feeling cold were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, general body pain, sleeplessness, headache, runny nose, erythema of extremities, feeling hot, tenderness, mobility decreased and feeling cold to be related to SHINGRIX. Additional details were reported as follows: On 25th October 2018 at around 9:30 AM, the patient received a first dose of SHINGRIX. On the same day, late that afternoon the patient experienced arm was really sore and at night she experienced chills, shivering and body aches that prevented her from sleeping. On 26th October 2018, in the morning the patient had a bad headache so she took TYLENOL. The patient also experienced runny nose and the patient felt she had a cold. The patient's shivering had stopped and the body aches were less, but her arm was very painful and she could not lift it above her shoulder. On 27th October 2018, the patient's headache and runny nose was less severe. The patient had no chills or body aches and her arm was less sore. The patient looked first time at her arm and noticed a red circle about 2 inches in diameter that was hot to touch. On 28th October 2018, the patient's symptoms continued to decrease, the red spot on her arm was only 1 inch in diameter though still warm to touch. On Monday, 29th October 2018, the patient was mostly back to normal.  There was no defined circle on her arm, but it was pinkish and tender to touch. No consent for follow up was given.
Patient stated that she was having pain in her arm and then it moved to her shoulders and her elbows.  Stomach was burning and liquid stool started. Started having flu like symptoms.
Initial report received from a healthcare professional on 26 March 2013. A 66-year-old female patient, who had codeine allergy and concomitant medications were not reported, had received an intramuscular dose of ADACEL vaccine (Lot number : U4585AA0 in left deltoid on 19 March 2013. Illness at the time of vaccination "denies" by reporter. On 20 March 2013 i.e. 24 hours after vaccination, the patient developed a lump at injection site, no bruising or bleeding. No pain at injection site lump until 25 March 2013. Laboratory investigations were not reported. As per reporter the patient did not self treat for pain. The patient's outcome was unknown. Documents held by sender: none.
I had vaginal spotting 3 days after first moderna vaccine.  I have now missed my period. Not pregnant
Received Expired Dose; Initial Report Received on 30-Jul-2021  A certified medical assistant reported that a 41 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Medical history included previous vaccination for hepatitis B (vaccine not specified) but there was no titer. Therefore, a new series of hepatitis B vaccine was initiated. The patient was reported to be well and healthy.   No relevant concomitant medications were reported.  On 30-Jul-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933621, expiration date 26-Jul-2021, NDC # 4352800301, serial number not provided) in the left deltoid. There were no adverse reactions reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
08/16/2002 C/o swelling of face, body, feet, also experiencing stomach pains, muscle aches which have progressively worsened. since 08/14 when she received the typhoid injection. refered to ER and to private physician.
Patient was supposed to get varicella vaccine , and  instead received  ZOSTAVAX vaccine.
About 2-3 days after, I just started sneezing intermittently. And it wasn't that big of a thing. I was a little tired and thought it would go away. All of a sudden when I went to bed that night I couldn't get comfortable so I thought I would lay on my other side. And When I pushed myself up to wake up the next day, it was this searing pain under my breast more towards the side. The upper-mid rib cage on the side, not towards the heart. And that's how I've been ever since. I called my doctor because I was supposed to get an MRI of my lumbar and I mentioned that my upper back was hurting from upper back wrapping around to the side. And they said they would look at it. The only thing that really helps is taking a warm bath. Feels like a muscle pull. Still hasn't gone away. And I'm also still sneezing, but the sneezing doesn't bother me. I know it's not a cold, but the sneezing bothers me under my rib.
Sixteen year old female present to clinic for well child and was to received MENACTRA (MCF4) and Meningitis B (BEXSERO) vaccine. Pt was inadvertently administered MMR, Varicella and Hepatitis A vaccine. Pt did not develop any symptoms of reaction to vaccines. Spoke with mother on 1/5/2019 (4:28) and she reported that Patient was fine with no fever, rash or symptoms.
Very painful arm at injection site. Swelling. Weak and tired feeling fluish, feverish. Wednesday night shivering and cold. Needed extra blanket and socks. By Friday much better.
11/11/21 presents to ED ED for "Covid 19 related fatigue, poor oral intake (per family)". PMH of "advanced Alzheimer's disease".
Initial information was received on 27 October 2008 from a health care professional. A 54 year old female received an intramuscular left deltoid injection of FLUARIX (manufacturer GSK, lot number AFLUA3808AA) on 21 October 2008. On 22 October 2008 she received an intramuscular left deltoid injection of ADACEL (lot number C3030AA) and TWINRIX (manufacturer GSK, lot number AHABB132AC) given in the right deltoid. The patient noted that she received the Td injection in 2003. On 23 October 2008 the patient had a "big local reaction" at the injection site (arm not specified). The patient also had an indurated area which was red, swollen and measured at 7.25 x 7.5 cm. The patient stated that at one point it was larger than 7.25 x 7.5 cm. The patient was seen by her physician. The patient was not recovered at the time of the report. Follow-up information received on 24 November 2008 from a health care professional. The patient's reaction was at the site of the ADACEL injection in the left deltoid. She was re-evaluated in the clinic on an unspecified date and treated with over the counter ADVIL and warm soaks. She recovered from the events on 04 November 2008. List of Documents held by Sender: None.
No adverse event; Adult patients received pediatric doses 6 years to 11 years doses of the Moderna COVID19 vaccine instead of bivalent booster doses; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patients received pediatric doses 6 years to 11 years doses of the Moderna COVID19 vaccine instead of bivalent booster doses) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patients received pediatric doses 6 years to 11 years doses of the Moderna COVID19 vaccine instead of bivalent booster doses). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patients received pediatric doses 6 years to 11 years doses of the Moderna COVID19 vaccine instead of bivalent booster doses) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patients received pediatric doses 6 years to 11 years doses of the Moderna COVID19 vaccine instead of bivalent booster doses).    Concomitant medication information was not provided by the reporter.  It was reported that patient received pediatric dose of Moderna covid-19 vaccine instead of bivalent booster dose by accident.  Treatment information was not provided by the reporter.  The case consisted information for the fourth adult patient.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651017:This case pertains to Adult 4
Immediately my left arm went numb and then when i got home I had fever of about 101. After that my hands and legs were shaking with pain in my legs. Exhaustion was horrible - slept for over 20 hours.
48 hours after the 1st COVID vaccine I woke up this morning to severe ringing in my ears (tinnitus).  I had no clue this was a side affect, but I googled it and it appears others have had it.  It's been happening since 8 am today, all day long.  When the ringing begins, I have been automatically shaking my head and at the same time I feel light headed and dizzy.  I have been sitting down closing my eyes waiting for the ringing to stop.  It has been happening all day today.
Been up all night with dizziness; A sore arm; The injection site is red and harden; The injection site is red and harden; The area is very sore; A headache; Nauseas; Both had their second dose probably two months later; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Been up all night with dizziness), PAIN IN EXTREMITY (A sore arm), INJECTION SITE INDURATION (The injection site is red and harden), INJECTION SITE ERYTHEMA (The injection site is red and harden) and INJECTION SITE PAIN (The area is very sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Both had their second dose probably two months later). On 03-Nov-2021, the patient experienced DIZZINESS (Been up all night with dizziness), PAIN IN EXTREMITY (A sore arm), INJECTION SITE INDURATION (The injection site is red and harden), INJECTION SITE ERYTHEMA (The injection site is red and harden), INJECTION SITE PAIN (The area is very sore), HEADACHE (A headache) and NAUSEA (Nauseas). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Both had their second dose probably two months later) had resolved. At the time of the report, DIZZINESS (Been up all night with dizziness), PAIN IN EXTREMITY (A sore arm), INJECTION SITE INDURATION (The injection site is red and harden), INJECTION SITE ERYTHEMA (The injection site is red and harden), INJECTION SITE PAIN (The area is very sore), HEADACHE (A headache) and NAUSEA (Nauseas) outcome was unknown.            No Concomitant medication was reported.    No treatment medications were reported.  The reporter was calling on behalf of their husband who after getting their booster dose on the 03-Nov-2021 experienced side effects. After vaccination, the patient was up all night with dizziness and developed a headache, nauseas and the injection site were red and harden. Reportedly the area was very sore, and the patient experienced a sore arm.
Gave 2nd Moderna shot too early, Received first 4/30/2021 and second on 5/22/2021 --should've gotten it on 5/28/21 (4 weeks out) or possible 5/24/21 would have been 4 days early.
This spontaneous report was received from an approximately 61 year old male patient regarding himself. The patient's medical history included heart murmur. The patient had no drug reaction or allergies. On 20-OCT-2014 the patient was vaccinated with ZOSTAVAX, 1 injection (route, lot# not provided). Concomitant therapies included influenza virus vaccine (manufacturer unknown) in different arm (left arm). On 20-OCT-2014, the patient experienced soreness, tenderness and saw that the injection site after receiving ZOSTAVAX was swollen and a little red. The patient says his arm has been feeling like this for three days, he first noticed this side effect when he was out for his morning run. He was treated with ibuprofen for the events. Lab diagnostic studies were not performed. The patient called pharmacist to inform about the events. No product quality complaints reported. The outcome of the events was reported as recovering. Causality of the events was not specified. Additional information has been requested.
This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a registered nurse concerning several young girls with allergies or medical history who "several months ago" were vaccinated IM with a 0.5 ml dose of GARDASIL. There were no illnesses at the time of vaccination. Subsequently, "several young girls passed out or were nauseated and lightheaded" after receiving vaccine. It was also reported that some patients' passed out and laid down to receive the second and third doses from this experience. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On an unspecified date, the patients' recovered. No product quality complaint was involved. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Severe pain at injection site. Muscle spasm. Pt went to ER and was hospitalized for 2 day for pain. Pt reported will need physical therapy for her left arm.
Vertigo and muscle aches both legs especially thighs muscles and feet muscles. The aches started about three days after the first vaccine. I woke up with a bad case of vertigo and it took about a minute to find my balance. After about an hour, the sense of spinning went away. But I then noticed that my leg muscles were aching. The aching continued for four days. The pain was never bad enough for me to seek medical attention. I notice today on March 30 that the muscle aches are gone.
Within 2 hours of receiving vaccination I had a very mild bout of diarrhea that lasted around 20 minutes, had to go to the restroom twice. The next morning at 4:45 am I woke with chills and moderate muscle , joint aches and random sharp muscle pains all over my hips, arms, and legs. Chills, aches, and fever continued until 8:30pm the same night. My fever would go to 102.8 as a high to 100.2 depending on how close I was to my next timeframe to take Tylenol.  I took 4 extra strength Tylenol (2000 mg) every 4 hours, give or take 30 minutes. Around 8:30 pm my fever broke and I sweated mildly Until around 10:30pm
This non-serious initial spontaneous case was received from other non-health professional (consumer) on 04-Oct-2017, concerning a 31-year-old adult female pregnant patient. The patient had no relevant medical history. The patient's concomitant medications included metformin and prenatal vitamins for an unknown indication. The patient had no previous pregnancy, maternal medical history relevant to pregnancy and paternal medical history (hereditary disease). The patient was permitted to enroll in the pregnancy registry. The patient's last menstrual period was beginning of September (unspecified date and year) and estimated date of delivery was beginning of June (unspecified date and year). The patient did not use any contraceptive method and no medications received by the father prior to conception. There was no any evidence of a defect/adverse finding from a prenatal test. On an unspecified date, (last week) (as reported), the patient was administered with influenza vaccine (batch number, dose: 0.5 ml, route of administration: intramuscular, batch number, expiry date, manufacturer, trade name, anatomical location: not reported). The patient administered the vaccine during her pregnancy, which was considered as vaccine exposure during pregnancy. It was reported that, and unspecified adverse event was experienced by the patient and no any adverse event was reported in the fetus. The reporter assessed the event as non-serious.
The patient reports that about 2 days after vaccination with his Pfizer booster shot, he began feeling weak and fatigued. Patient is acutely short of breath. On initial presentation to the ED, patient was 94% on RA, but patient continuously decompensated during ED stay progressing from RA, to nasal cannula, to high flow nasal cannula, and finally to requiring intubation. The patient has received dexamethasone and is admitted to ICU.
It has been 11 days since my vaccination and i have a lot of pain in my upper left arm, especially when reaching out or up.  Sometimes the pain is very intense.
Middle finger become numb and she can not bend it; Middle finger swollen too and itchy; Right ring finger swollen/Middle finger swollen too and itchy; Rash on left arm at shot site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Middle finger become numb and she can not bend it), PERIPHERAL SWELLING (Right ring finger swollen/Middle finger swollen too and itchy), PRURITUS (Middle finger swollen too and itchy) and VACCINATION SITE RASH (Rash on left arm at shot site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash on left arm at shot site). On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (Right ring finger swollen/Middle finger swollen too and itchy). On 16-Apr-2021, the patient experienced PRURITUS (Middle finger swollen too and itchy). On 19-Apr-2021, the patient experienced HYPOAESTHESIA (Middle finger become numb and she can not bend it). At the time of the report, HYPOAESTHESIA (Middle finger become numb and she can not bend it), PERIPHERAL SWELLING (Right ring finger swollen/Middle finger swollen too and itchy), PRURITUS (Middle finger swollen too and itchy) and VACCINATION SITE RASH (Rash on left arm at shot site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. In regards to the anthrax vaccine. My son was conceived 4 months after parent (father) had had the AV and was born missing a large portion of left side of the brain. AV receiver fainted twice since last two shots and lost feeling in left foot/ankle for 3 days. (OMIC)