chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RADIATING HEAT SENSATION FROM THE FEET; SORE ALL OVER BODY; HEADACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included higher white blood cell count, and concurrent conditions included epilepsy, non alcohol consumption, and non smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced radiating heat sensation from the feet. On 10-APR-2021, the subject experienced sore all over body. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from radiating heat sensation from the feet, sore all over body, and headache on 13-APR-2021. This report was non-serious.
The patient reached down and grabbed the needle and the nurse then had to withdraw the needle out of the patient's thigh and some of it spilled; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6 years old female patient who reached down and grabbed the needle and the nurse then had to withdraw the needle out of the patient's thigh and some of it spilled (Underdose) while she received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE  (lot C5732AA;expiration date: 24-Apr-2022) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency) it was reported that patient who was on a delayed catch up schedule for Daptacel came for her second dose. The patient reached down and grabbed the needle and the nurse then had to withdraw the needle out of the patient's thigh and some of it spilled. The patient only got some of the Daptacel dose. They did not know how much. She was due for her next one in Dec.  It was not reported if the patient received a corrective treatment.  Outcome was not applicable.  No further infprmation was reported
Patients Daughter hugged patient on Sept. 24th 2005 and put right index finger on uncovered smallpox vaccination site.  Patient's daughter presented to clinic today 4 October 2005 with two lesions on right index finger.  Patients daughter also had swollen lymph gland left axillary.
Blind in my right eye; Terrible neurological pain, felt like worms crawling in my head; Got it after the first shingles shot; Terrible neurological pain, felt like worms crawling in my head; This case was reported by a consumer via interactive digital media and described the occurrence of blind right eye in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced blind right eye (serious criteria GSK medically significant), nerve pain and shingles. On an unknown date, the outcome of the blind right eye, nerve pain and shingles were unknown.   It was unknown if the reporter considered the blind right eye, nerve pain and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient got shingles after the first Shingles shot. The patient went blind in his/her right eye and had terrible neurological pain felt like worms crawling in patient's head. Additional Supportive Information: The follow up would not be possible as contact details were not provided.
Entire right arm site of pneumovax was edematous/erythematous, no other rashes ore edema (had flu vaccine in left arm). Resolved when seen 1 week later.
Information has been received from a health professional concerning a 27 year old female who on 28-MAR-2007 was IM vaccinated with her first dose of Gardasil (lot# 0210U). Concomitant therapy included FLONASE, LOESTRIN, and AMOXIBRON. On 14-Jan-2008 the patient received her second dose of Gardasil (Lot # 655327/1287U). On 15-JAN-2008 the patient experienced rash and some itching. Later the same day, the rash and itching spread to both thighs. On 15-Jan-2008 and 16-Jan-2008 the reaction was getting worse. On 18-Jan-2008 the patient sought unspecified medical treatment by contacting the physician's office. The patient was instructed to take Benadryl but the patient refused. The patient did not have any known reactions from the first dose. Additional information has been requested. Information has been received from a healthcare professional concerning a 27 year old female who on 28-MAR-2007 was IM vaccinated with her first dose of HPV vaccine (lot # 0210U). On 14-Jan-2008 the patient received her second dose of HPV vaccine (Lot # 655327/1287U). On 15-JAN-2008 the patient experienced rash and some itching. Later the same day, the rash and itching spread to both thighs. On 15-Jan-2008 and 16-Jan-2008 the reaction was getting worse. On 18-Jan-2008 the patient sought unspecified medical treatment by contacting the physician's office. The patient was instructed to take BENADRYL but the patient refused. The patient did not have any known reactions from the first dose. The patient recently finished taking AMOXICILLIN for a sinus infection. Additional informatio has been requested.
Case number PHEH2014US011247 is an initial spontaneous report from the nurse received on 02 Jun 2014. This report refers to a 47-year-old male patient. His medical history included splenectomy. On 02 Jun 2014, he was inadvertently vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: X13014) without reconstitution with Men A lyophilized component. No adverse event reported following this medication error (inappropriate preparation of vaccine).
Horrible migraine; bad asthma flair up; Dose 1 on 26Apr2021 and dose 2 on 10May2021; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Er8733, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Right on 10May2021 at 12:00 (age at vaccination: 36years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Historical vaccine included dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ew0164, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Right on 26Apr2021 at 12:00 as dose 1, single for COVID-19 immunization. On 11May2021 at 08:00 the patient experienced horrible migraine and bad asthma flair up. Patient took dose 1 on 26Apr2021 and dose 2 on 10May2021, where the patient was exposed to inappropriate schedule of product administration. Therapeutic measures were taken as a result of horrible migraine and bad asthma flair up. AE resulted in doctor or other healthcare professional office/clinic visit. Treatment with nebulizer treatment for asthma. The outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
"This is a 65y.o. female with hx renal transplant with CKD stage 3 at baseline presents with acute COVID symtpoms ongoing 1 week.  She has had headache, cough, myalgia, nausea and shortness of breath on exertion."    04/27/21 SARS-CoV-2 (COVID-19)
Drug dose administration interval too long; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on unknown date,for tolerance of 1st dose refer case US2021AMR089848).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported.   The patient received 2nd dose of Shingles vaccine, more than the recommended interval, which led to lengthening of vaccination schedule.. The case was linked with US2021AMR089848, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR089848:Same reporter
Fever, headache, dizziness, blood pressure dropping, extreme fatigue, mouth cold sores(aphthous stomatitis). All symptoms continue. Valtrex 1000mg - Doesn't help at least 5 doses taken over a period of 2 months. Nysratin 5ml since Sept. 25 -mouth sores go away for a few days then return. On going
Information has been received from a licensed practical nurse (LPN) concerning a 10 month old male who on 17-SEP-2008 was vaccinated PO with a 2.0 ml dose of ROTATEQ (lot# 656836/0876U). The LPN reports that she inadvertently gave the ROTATEQ and that the child is not experiencing any adverse effects at this time. The patient sought medical attention at the office. The LPN reported that this is a "staff error only". A product quality complaint was not involved. Additional information has been requested.
devel varicella like rash p/vax; all over body (upper), torso, head, arms, examined 6/23/99;
Sore arm, slight fever, chills, bad headache, didn?t sleep the night after getting the vaccine
Onset of seizures following DTaP at 4 months 4 days later. Given DTaP again at 6 months (against my wishes) on Dec 16 and has had 3 seizures since. Within 5 hours, then 14 hours and the last was the next day.
pt recv vax 20OCT95 & that same day exp inj site pain;the next day 21OCT95 pt exp vomiting, severe h/a, wheezing, sneezing, vomiting, fever, aches & pains, & cough;pt is self-treating w/Theraflu;sx cont as of 26OCT95;
pt recv vax; 24 hr later, redness, lump;able to move in 5 days; rxn in lt leg;
I woke up the morning after the vaccination with a rash between my breasts approximately 4 inches long. I have had shingles twice as well as the shingrix vaccine, but it looked and felt just like shingles. It was itchy, and it burned to touch or scratch the rash. After three days of no healing without treatment, I went to an urgent care facility on 5/2/21 where they said it appears to be shingles. They prescribed Valacyclovir as well as Triderm cream.
fatigue, sinus congestion, and a headache developed, tested positive for SARS-CoV-2 RNA; fatigue, sinus congestion, and a headache developed, tested positive for SARS-CoV-2 RNA; This is a literature report. The full publication has been requested.  Follow-up (14Jul2021): The initial case was missing the following minimum criteria: [unspecified product]. Upon receipt of follow-up information on (14Jul2021), this case now contains all required information to be considered valid. This is a literature report. The authors describe two fully vaccinated persons in whom subsequent breakthrough infections with SARS-CoV-2 variants harboring a number of substitutions of interest developed.   A 65-year-old female patient received BNT162B2, dose 1 intramuscular on 19Jan2021 (Batch/Lot number was not reported) as single dose, dose 2 intramuscular on 09Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was healthy previously with no risk factors for severe Covid-19 who received the first dose of BNT162b2 vaccine on 19Jan2021 and the second dose on February 9. Pain that developed in the inoculated arm lasted for 2 days. On 03Mar2021, her unvaccinated partner tested positive for SARS-CoV-2, and on 16Mar2021, fatigue, sinus congestion, and a headache developed in Patient. On 17Mar2021, she felt worse and tested positive for SARS-CoV-2 RNA, 36 days after completing vaccination. Her symptoms plateaued and began to resolve on 20Mar2021.  The patient underwent other lab tests and procedures in 2021 which included 69/70 deletion,  A570D, D138Y, D215G, D253G, D80A, delta 242-244, H655Y, all Not detected; A701V: Undetermined; D614G: Detected; D796H: Undetermined; del142-145: Detected (G142V, del144); E484K: Undetermined; F220I: Detected; K417T: Undetermined; L452R: Undetermined; N501Y: Undetermined; P681H: partial heterozygosity; R190T: Detected; R237K: Detected; R246T: Detected; S477N: partial heterozygosity; T95I: Detected; Historical examination: These data, together with the clinical history, provide strong evidence that this  patient probably had neutralizing antibodies  elicited by vaccination; pseudotype neutralization assay: Unknown result; RT-PCR: to determine the corresponding Ct values for each dilution approximately 400 copies per milliliter. The action taken in response to the event for bnt162b2 was not applicable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.
Headache & NauseaVomiting Narrative:  Employee reports headaches, nausea, and vomiting after receiving second dose of vaccine. Reports had headaches as well after receiving first dose. Reports using ibuprofen and Tylenol for symptom relief.
Bruise and swelling at injection sight. Also, swollen lymph nodes in under arm.
Nonstop vaginal bleeding ,since June1 with blood clots size of a quarter or larger.
This case was reported by a nurse and described the occurrence of injection site redness in a 20 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 11Jan06 the subject received 4th dose of Infanrix in the right thigh (lotAC14A007AA). On 11Jan06, less than one day after vaccination with Infanrix, the subject experienced injection site redness and injection site swelling. The nurse described the size of the injection site redness as 6 inches by 4 inches. The events resolved on 13Jan06. The nurse considered the events to possibly be related to vaccination with Infanrix.
swollen arm; severe swollen axillary lymph node; A spontaneous report  was received from a consumer concerning a 48 year  old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and developed swollen arm, severe swollen axillary lymph node.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.   On 07 Jan 2021, with onset latency of two days, the patient developed swollen arm and a severe swollen axillary lymph node.  No Laboratory details were provided.The Treatment medication included Acetaminophen.  Action taken with mRNA-1273 in response to the other events was unknown.  At the time of this report, the outcome of the events, swollen arm, severe swollen axillary lymph node was resolving/recovering.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Pt was administered a vaccine that had expired June 6.. No side effects or adverse reaction.   Opted to get revaccinated.
This case was reported by a consumer via call center representative and described the occurrence of decreased white cell count in a adult male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 6 days after receiving SHINGRIX, the patient experienced decreased white cell count. On an unknown date, the outcome of the decreased white cell count was unknown. It was unknown if the reporter considered the decreased white cell count to be related to SHINGRIX. Additional details were provided a follows: The age at the vaccination was not reported, however the patient was in the 50 to 60 age range. The patient received a dose of SHINGRIX 3 weeks ago. Six days later the patient had a routine well visit with his physician and normal blood work was drawn. The reporter stated his white blood cells (WBC) was half of what it was normal, providing a 3.2 value. The reporter believed this was a result of the SHINGRIX vaccine. The reporter noted he had a follow up appointment in a month with his physician to test again. The patient felt fine and no other events otherwise.
PROQUAD vaccine was administered 23AUG2021 following a supported temperature excursion; This spontaneous report has been received from a healthcare business professional, a chief executive officer, referring to a 4-year-old male patient. No information regarding the patient's medical history, concomitant medications or concurrent conditions was provided.  On 23-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (dose, route of administration, vaccine scheme and anatomical site of vaccination were not reported; lot number T031603 has been verified to be valid, expiration date reported and established as 15-MAR-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 8.4 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes (product storage error). There was no previous temperature excursion.
09/16/22 presents to ED for "back pain". PMHx of "chronic back pain status post L3, L4 fusion"
This spontaneous report was received from a physician, via a company representative, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. On an unspecified date, the patient experienced an anaphylactic reaction while on therapy with GARDASIL. The physician indicated that the patient recovered on an unspecified date. The relatedness between the anaphylactic reaction and GARDASIL was not reported. Additional information is not expected as the reporter did not wish further contact.
Worst head pain I have ever had; Suspected vaccination failure/I have them now and had the double dose vaccine; I have them now too!; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and headache were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and headache to be related to Shingles vaccine.     Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient have had them now too. The patient had the double dose vaccine that was 90 percent effective. The patient stated that the worst head pain he/she have ever had and for over 2 weeks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
After I received the first vaccine my right arm hurt but not very much at all. The second vaccine that I received was also in my right arm. I had breast cancer and it was in my lymph nodes in my left breast so I had to take the vaccine in my right arm only. My right arm still hurts to this day. At first I thought the pain would go away but it still hurts.
Mild IZ reaction to Tdap - expected and very common Notable achiness in left arm where IZ was given with surrounding redness and firmness of the skin.
Information has been received from a registered nurse concerning an unspecified number of male pediatric patients of various ages who were vaccinated with a second subcutaneous 0.5ml dose of varicella virus vaccine live (Oka/Merck). The patients developed an injection site reaction the following day and the area was red and hot to touch. All patients have recovered. Unspecified medical attention was sought. No other details were available. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
I administered both the FLUZONE HD and PNEUMOVAX, one in each arm, after patient stood up she said she didn't feel well. I sat her down and she was unable to breathe. Her heart rate increased and blood pressure increased and she was dizzy and sweating.
fever 102 x 2 days; chills, severe shakes x 1 day, congestion-nasal 3 days, swollen nose x 4 days, tender sub-lingual glands x 4 days;
Redness around shot area within 4 hours. Swelling and itchiness started 24 hours later, and persisted for 2 days.  The surrounding shot area has become redder and more raised 1 week later.
Low grade fever, Chills, Headache.  Improved with Tylenol initially.  Resolved after 12 hours.
Other specified abnormal uterine and vaginal bleeding [fibroid] (Final) - Disseminated intravascular coagulation [defibrination syndrome] (Final) - Acute posthemorrhagic anemia (Final) -Subserosal leiomyoma of uterus (Final).
This is a spontaneous report from a non-contactable other health professional (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. Medical history was none, the patient was not on any meds. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient experienced shingles, painful rash on the flank on 09Jan2021 with outcome of not recovered. The patient took valacyclovir as treatment. The events resulted in doctor or other healthcare professional office/clinic visit. No follow up attempts are possible. No further information is expected.
Dizziness and shortness of breath for 10 minutes, dissipated, then came "whoosing" back for 5 minutes, 3 more times over the next 40 minutes.