chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/25/15 at 3:30 pm swelling noticed. Swelling and redness notice on both arms. Treatment: Ice, rest, ibuprofen.
At area of injection - red, itching swollen area - ended up being up the size of patient's hand - started to resolve 3/3/3013 in the afternoon.
Client reported intense heart palpitations 30-40 min after receiving the booster J&J vaccine for Covid. He contacted his cardiologist who advised this was expected and not concerning. He recommended the client to take Tylenol for this and future vaccines, which he said had no effect. The client said he had been taking diltiazem for 3 mos when he received the Covid vaccine. Diltiazem was prescribed by his cardiologist to alleviate heart palpitations which occurred as a result of tapering him off propranolol.  The client reported his side effects from the vaccine felt as if the diltiazem was no longer working. The client also reported the expected side effects of nausea, fever, and weakness. The client reported he feels 95% better at this time.
This case was reported by a nurse via sales rep and described the occurrence of neuropathy in a 76-year-old male patient who received SHINGRIX (batch number 524S7, expiry date unknown) for prophylaxis. On 29th September 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 4 days after receiving SHINGRIX, the patient experienced neuropathy (serious criteria GSK medically significant), fever, injection site rash and back pain. On an unknown date, the outcome of the neuropathy, fever, injection site rash and back pain were unknown. It was unknown if the reporter considered the neuropathy, fever, injection site rash and back pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever and the body temperature was recorded over 40 degree. The patient experienced rash injection site, back pain and neuropathic in mouth. The reporter did not say there was a link with the vaccine.
Pt reported fatigue, headache, myalgias, and chills. Per appointment, pt is experiencing a fibromyalgia flare, has a migraine, and reports "burning pain on upper arms and lower extremities" to the point that she has been unable to wear clothing that touches her arms due to the pain.
Rash, itching, swelling, heat.  At 8:45 pm 2/15/2021 the red portion of the rash was approximately the size of a quarter with low level edema.  Light warmth.  Took Benedryl, lowest dose recommended on package.  1:00 pm 2/15/2021 the reddened portion of the rash was 2 1/4 inches, continuing to be itchy, red, warm.  The area of swelling has extended now to approximately 3/4 beyond the area of the redness.
Heart pounding, Heart Fluttering and Woken up from nap by heart pounding after second booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart pounding, Heart Fluttering and Woken up from nap by heart pounding after second booster dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 141M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Heart pounding, Heart Fluttering and Woken up from nap by heart pounding after second booster dose). At the time of the report, PALPITATIONS (Heart pounding, Heart Fluttering and Woken up from nap by heart pounding after second booster dose) outcome was unknown.            Patient received 4 doses of Moderna COVID-19 vaccine.   Patient stated that after the first 3 doses he did not had any side effects. Patient stated after second booster during night  he started heart pounding and fluttering and while taking a nap in afternoon, heart pounding woke him up.   Patient had no heart disease and never had COVID disease in the past. Patient was healthy   No concomitant medication provided.   No treatment information mentioned.
pt recv vax 27MAR96 & pt devel a rash & scabbing;the reporter was unsure if the pt exp was r/t therapy w/varicella vax;
ringing in ears; headache; sinuse infection.; having a tingling in her ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (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: PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "having a tingling in her ears"; TINNITUS (non-serious) with onset 07Mar2021, outcome "unknown", described as "ringing in ears"; HEADACHE (non-serious) with onset 07Mar2021, outcome "unknown", described as "headache"; SINUSITIS (non-serious) with onset 07Mar2021, outcome "unknown", described as "sinuse infection.". The events "ringing in ears" and "sinuse infection." were evaluated at the emergency room visit.  Additional information: Patient received the 1st dose of the Pfizer covid vaccine 3 weeks ago. She is supposed to get the next one tonight. 3 or 4 days after the 1st dose, she started having a tingling in her ears, like a white noise.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
diarrhea; nausea/feeling nauseous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Mar2021 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "slight head cold" (unspecified if ongoing); "cough" (unspecified if ongoing); "stomach gets sensitive once" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: breast cancer at the age of 46, radiation implant; "double mastectomy" (unspecified if ongoing), notes: At the age of 70; "breast cancer recurrence" (unspecified if ongoing), notes: At the age of 70; "Covid infection", start date: Dec2020 (unspecified if ongoing), notes: COVID infection was mild. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 09Mar2021 01:00, outcome "recovering", described as "diarrhea"; NAUSEA (non-serious) with onset 09Mar2021 01:00, outcome "recovering", described as "nausea/feeling nauseous". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had her 1st dose of the Pfizer Covid vaccine last Saturday at around 9:30-10:00 AM in medical center. Stated that she had no side effects until last night and thinks that it could also be because of what she ate. Mentioned that she had Cheese Ravioli ad coffee with half and half around 12:00-12:30 then at around 1:00 AM she started to have diarrhea and nausea until today which probably lasted for about 9-10 hours. It subsided a little bit from having to go to the bathroom in the beginning every 5 minutes to every 15-20 minutes. Stated that she didn't want to take Imodium for her diarrhea and have just been drinking a lot of hot tea to keep herself hydrated. Also mentioned that she previously had Covid and didn't even know that she had it. The vaccine was given in her left arm at the top, in the muscle, close to her shoulder. The patient stated that when in Dec 2020 she was Covid positive she had no fever, her oxygen level was 99, she just had a slight head cold and a cough. Then on 06Jan2021, when she went to be tested with her daughter in law and her son, her test was negative. She told them to take her blood because she wanted to see if she had the antibodies. Then 5 days later they said she found out that she had the antibodies. She says so she had COVID early Dec2020, and on 06Jan she had a negative COVID test, and then they took blood because she wanted to know if she had COVID or not and on 12Jan2021 they said she had the antibodies. No additional administered vaccines. The patient did not visit the Emergency Room or Physician Office, as she was taking care of herself at home. No prior vaccinations  taken within 4 weeks. She mentioned that she never had a flu shot.  No follow-up attempts are possible. No further information is expected.
Information has been received from a 21 year old female consumer reporting on herself for HPV rL1 6 11 16 18 VLP, a Pregnancy Registry product, who on 26-JAN-2012 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP (dose, route and lot # not reported). Concomitant therapy included "prenatal vitamins". The patient received a dose of HPV rL 1 6 11 16 18 VLP while she was pregnant. (LMP on an approximately 24-FEB-2011; EDD 24-NOV-2012). At the time of reporting, the patient had had no adverse event symptoms. Follow up information has been received from the certified nurse midwife via a pregnancy questionnaire concerning the patient with a history of genital wart, who on 26-JAN-2012 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP lot # 670048/0963AA). The patient's last menstrual period was on 17-FEB-2012 and her EDD would be on 23-NOV-2012. On 23-APR-2012, the patient underwent an ultrasound that was consistent with dates. It was reported that the patient did not have previous pregnancies full term deliveries, pre-term deliveries, spontaneous abortions, elective terminations or fetal deaths. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
Information has been received from a pharmacist concerning a 12 year old female with no pertinent medical history who in approximately January 2007, was vaccinated with a first dose of Gardasil. There was no concomitant medication. Subsequently the patient developed a lump at the injection site. It was reported that the lump at the injection site "recently" became painful. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. At the time of the report, the lump and pain at the injection site persisted. Additional information has been requested.
Drunk feelings; Light headed/dizzy; slightly nauseous; lower back pain (kidney area); very tired; in a fog state of mind; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 57-years-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL9267), via an unspecified route of administration on 10Feb2021 10:00 (age at the vaccination 57-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included uterine cancer, heart murmur, hepatitis, kidney issue (hepatitis as a child and kidney issues as a result of radiation) and Known allergies: latex from an unknown date and unknown if ongoing. Patient concomitant medication includes Prenatal vitamins and enzymes. The patient previously took morphine and experienced Known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 10Feb2021 10:30 patient experienced drunk feelings, lightheaded/dizzy, slightly nauseous, lower back pain (kidney area), very tired and in a fog state of mind. The patient did not receive any other treatment for the events. The outcome of the events was not recovered.  Follow-up (07MAY2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a physician assistant (P.A.) concerning to a 63 year old female patient. The patient's concomitant conditions included hypertension, thyroid disease, acid reflux and environmental allergies as concurrent conditions. The patient's pertinent medical history was not reported. It was reported that sometime in March-2016 the patient was vaccinated with ZOSTAVAX (lot #, dose, route and expiration date were not provided). Concomitant therapies include unspecified blood pressure and thyroid meds. It was also reported that 3 weeks later, in 2016, the patient developed a rash on her upper chest, neck and face which persisted. The patient south treatment from dermatologist who was treating the rash. The patient was treated with "oral and topical steroids, antivirals", and the physician offered a VZV packet and she accepted. There were not laboratory tests performed. The outcome of rash on her upper chest, neck and face was not recovered/not resolved at the time of the report. There were not product quality complaint (PQC), overdose or cancer involved. Additional information has been requested.
High temperatures (100.7-106.5), dizzy, body aches, vomiting
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Rash near injection site about 3 inches in diameter. Disappeared after 5 days.
nurse accidentally administered Flublok to a 17 year old patient, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old patient of unknown age who had accidentally administered with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number not reported) via unknown route in unknown administration site.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
sore throat; drainage; coughing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), DRAINAGE (drainage) and COUGH (coughing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DRAINAGE (drainage) and COUGH (coughing). At the time of the report, OROPHARYNGEAL PAIN (sore throat), DRAINAGE (drainage) and COUGH (coughing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Father called reported 4-6 cm hard, tender nodular area to left thigh posterior to site of injection.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with a dose of (Merck) VARIVAX (dose, units, route of administration, lot# and expiration date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
55 y.o. female in good health took the Moderna Vaccine & then experienced Hypoxia and a enormous saddle embolus in her lungs that had to be surgically removed. She was placed on Eliquis for lifetime. Clinic urges hospitalization into ICU & extraction of a HUGE saddle blood clot from her lungs.
Information has been received from a physician concerning a 11 year old female patient who on 27-AUG-2007 was vaccinated with her first dose of VARIVAX (Oka/Merck) (lot # 638250/0467L).  The patient was vaccinated with her second dose of VARIVAX (Oka/Merck) (lot # 660658/0173X) on 02-JUN-2008.  On 19-JAN-2009 the patient developed chicken pox on trunk after getting her second dose of VARIVAX (Oka/Merck).  The patient had sought medical attention.  The outcome of the patient's chicken pox on truck was not reported.  Additional information has been requested. Follow-up information hab s been received from healthcare professional that on 27-AUG-2001 (not 27-2007) the 11 year old female patient with no allergies and no illness at time of vaccination was vaccinated with her first dose of VARIVAX (lot # 638250/0467L) SQ into her arm. On 02-JUN-2008 the patient was vaccinated with her second dose of VARIVAX (lot # 660658/0173X) SQ in her left arm. On 3:00 PM 19-JAN-2009 the patient experienced red papular lesions on trunk. There were approximately 20-30 lesions mainly on the trunk with moderate pruritis. The rash lasted for approximately 7-10 days. The patient was seen in office to visit physician 22-JAN-2009 with 3 days history of red papular lesions on trunk. No laboratory or diagnostic test was performed. At the time of reporting the patient had recoverd from these adverse events. No further information is available.
on august 10th, the following day after receiving the first dose, i started having heart palpitations everyday. on august 26th i recieved the second dose and started having palpitations a few times a day. i do have an underlining heart condition where i would have palpitations every few months. this amplified after the very first dose of the covid vaccine. i reached out to my cardiologist and he suspects that the vaccine gave me inflammation on my heart and i now have to take medication to see if it helps the palpitations.
Patient stated after 5 hours of receiving the vaccination, he was unable to breathe. He was sent to the hospital after no response for a few minutes. He was giving the treatment at the hospital on 12/1/2017. Patient is stable now.
Experienced scratchy throat and slight shortness of breath within an hour after receiving Moderna Covid19 vaccine.  MD advised not receiving second dose and proceeding with a non-mRNA COVID-19 vaccine.
Day of vax swelling in lt thigh 4 days later woke up w/macular red blotchy rash, indurated, swollen & warm to touch pruritic; afebrile;
Case number PHHY2013US106825 is an incomplete literature case received on 23 Sep 2013: in this article the author discussed about the high rates of influenza vaccination and decrease in safety concerns among pregnant women during 2010-11 influenza season. This report refers to multiple female patients whose identifiers were not reported. Their medical history and concomitant medications was not reported. On an unspecified date were vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) who are in the first and second trimester screenings. No adverse events were reported following this administration error. The results showed concerns about two thirds expressing about H1N1 influenza vaccine in particular and half expressing concerns about flu shots in general. The author concluded that influenza vaccination rates among pregnant women may continue to decline over subsequent post-pandemic years, as the memories of those severely ill pregnant women reported in 2009 continue to fade in the minds of both healthcare providers and the public. However, it is also possible that enough new infrastructures was created, such as nurse-driven vaccination protocols and enhancements in vaccine accessibility in new clinical settings, that influenza vaccination rates during pregnancy will be remain sustained.
Admission due to covid and death was due to covid+19. ER visit on 7/8 and complained of weakness. Diagnosed with covid on 7/7 by her physician. Death summary from medical records indicates COVI-19 viral pneumonia and acute hypoxemic respiratory failure
Dfficulty breathing, numbness of facial area especially mouth and tongue.weakness fainting, muscle weakness and joint pain
Severe body aches, and fever spiked up to 102.5 F before dropping.
Caller's wife experienced fatigue 48 hours after the second booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Single, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (1st Booster dose, Single., Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Caller's wife experienced fatigue 48 hours after the second booster dose". Additional Information: Caller's wife experienced fatigue 48 hours after the second booster dose. There's no information on the exact correlation between antibody level and reactogenicity/safety profile with additional doses. As far as the PI, it mentions immunogenicity profile of the second booster dose. Immunogenicity of a Second Booster Dose reported as: Among these individuals, approximately 11-fold increases in geometric mean neutralizing antibody titers against wild-type virus and variants, respectively, were reported at two weeks after the second booster as compared to 5 months after the first booster dose. In General, Side effects after the second shot may be more intense than the ones experienced after the first shot. Side effects vary among individual patients. These side effects are normal signs that the body is building protection and should go away within a few days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 12 month old female, with no pertinent medical history, who on 24-APR-2007 was vaccinated with 0.5 ml of ProQuad (Lot # 656548/0095U). Concomitant therapy that same day included tuberculin purified protein derivative (PPD) tuberculin test. Twelve to thirteen days after immunization with ProQuad, on approximately 06-MAY-2007, the patient developed a generalized "measles like rash". The patient was treated with diphenhydramine hydrochloride. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.