chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer and a school nurse concerning 41 child pt's who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approx. 2003, the pt's developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the follow up information from the nurse indicated that 13 of the reported 41 pt's were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated pt's was a 9 y/o pt in the third grade with extensive allergies who on 02Jun98 was vaccinated with a dose of varicella virus vaccine live. On 28Feb2003, the pt developed chickenpox. The reporter noted that this case of chickenpox was not mild. The pt had been vaccinated in a different state.  The previously vaccinated pt's included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other pt's that developed chickenpox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Patient given SOLUMEDROL IM x 1 after developing rash following administration of zoster vaccine; also given prednisone dosepack.
General aches and pains and lethargy began roughly 16 hours after receiving the shot. These progressed into more severe aches, chills, and a fever. About 40 hours after the shot came waves of nausea and vomiting. Symptoms mostly disappeared by the morning of May 9th, roughly 66 hours after receiving the shot.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 69-year-old male patient who received SHINGRIX. In November 2017, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain was recovered/resolved. The reporter considered the pain to be related to SHINGRIX. Additional information was received as follows: The patient had complained of severe pain for 3 days, after receiving SHINGRIX. The pharmacist did not have lot number or expiry date of SHINGRIX as it was given elsewhere. It was reported that the patient took Ibuprofen without relief for this pain.
Developed twitching of Left eye on 12/20/20 which continues to 1/4/21
pt recvd vax; devel 4-5 days after inject small red area, now rash involves volar surface of upper arm from elbow to shoulder; warm raised path of erythema; itchy;
Case number PHEH2014US024355, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 22 Jan 2015. This report refers to a 74 year old female patient. Past medical history and concomitant medication were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 06 Nov 2014. It was reported that the patient received FLUVIRIN PFS thatwas stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 22 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Pt received a pneumococcal shot booster > 5 yrs since prev. dose. Same day 5pm he became cold with shivering. Shaking, clammy & sweaty, no swelling at injection site but sore, no temp (97.7).
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-OCT-2018 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot# N001007 and expiration date 19-SEP-2018) (dose, units, route and frequency unknown. No adverse effects were reported.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with her first dose of GARDASIL.  In January 2008, she was vaccinated with her second dose of GARDASIL and reported pain, nausea, fever and vomiting.  Subsequently, on an unspecified date, the patient recovered from pain, nausea, fever and vomiting.  The reporter also indicated the patient's sister had the same symptoms after receiving GARDASIL.  Additional information has been requested.
Extremely itchy palms, fingers and toes., started 8-9 days after 1st. Vaccine. I initially developed blister like skin eruptions. Day 12  pernio like skin on fingers and toes with skin turning red and purple and still very itchy Dr. Prescribed clobetasol steroid ointment, antihistamines
Redness, swelling, and a hard lump after receiving the diptheria, pertussis, tetanus shot at my OB-GYN's office.
Patient reports that she had a headache roughly 5 hours after the vaccination. Patient did not report to staff until she was due for her next dose in the series.
Nurse administered frozen Shingrix; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
12/19/2020 Received vaccine 12/20/2020 around 2am woke up with strong body aches, pain at injection site, chills, and fever 100.9. Continued with extreme fatigue, headache, body aches and high fever through out the day.  12/21/2020 fever gone,arm still sore and headache returned mid day.
On 10/29 she presented to an outside facility with c/o left hand and left foot numbness. No weakness or pain. Sensation persisted throughout the day, waxing and waning in severity. Presented to her local ED. No other focal symptoms. Had started a new exercise routine for her back the day prior. Per outside records, exam was unremarkable. She was admitted overnight for stroke work up.  CT of brain was read as normal. EKG normal. CT of the spine showed multi-level disc disease mostly in C-spine. MRI head negative for stroke. Diagnosis by outside hospital was that her sx were due to her spinal DJD. Of note she also received IPV the same day as yellow fever. Reason for yellow fever vaccine was that she is going abroad for a year to work in an orphanage. Risks/benefits of yellow fever vaccination at her age were discussed at length prior to administration of vaccine.
Systemic adverse reactions (grade 3, defined as interfering with daily activity), including fatigue; Systemic adverse reactions (grade 3, defined as interfering with daily activity), including muscle pain; Systemic adverse reactions (grade 3, defined as interfering with daily activity), including chills; Systemic adverse reactions (grade 3, defined as interfering with daily activity), including injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8BS) via an unspecified route of administration in the right arm on 24Apr2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 27Mar2021 at 16:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 10:00, the patient experienced systemic adverse reactions (grade 3, defined as interfering with daily activity), including fatigue, muscle pain, chills and injection site pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, muscle pain, chills and injection site pain was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Patient who is allergic to flu shot, stayed for 30 minutes observation.  After she left the hospital she came back because she did not feel well.  Patient felt nausea, vomiting and pounding head.  Admitted patietn to ER
brief episode of faintness; Unexpected severe abdominal (large intestine) and rectal pain lasting three days.; Unexpected severe abdominal (large intestine) and rectal pain lasting three days.; Rapid heart beat for 1-2 days; fatigue; chills; joint pain; nausea; low fever; headache; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 28-year-old via an unspecified route of administration in the left arm on 08May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included IBS-D (irritable bowel syndrome - diarrhea), generalized anxiety, and on birth control. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included paroxetine for an unspecified indication; and ethinylestradiol, norethisterone (BALZIVA) for contraception, both therapy dates were not reported. The patient previously took metaxalone (SKELAXIN) as muscle relaxer but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 27-year-old on 17Apr2021 in the left arm for covid-19 immunisation. The patient did not receive other vaccine in the last four weeks prior to vaccination. On 10May2021, the patient had an unexpected severe abdominal (large intestine) and rectal pain lasting three days. The patient also had rapid heartbeat for 1-2 days and brief episode of faintness. It was further reported that there was a combined with expected side effects which included fatigue, chills, joint pain, nausea, low fever, headache, and swollen lymph node. The adverse events did not require treatment. The patient has not been covid tested post vaccination. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Sudden onset of difficulty speaking, difficulty finding the words he wished to speak and speaking the wrong word.  Also developed kaleidoscope vision of the left eye.  Lasted approximately 30 minutes and then resolved.  No prior history of stroke.
Woke up from sleep having Uncontrollable shivering for approx 1 hour, could not get warm.  Temperature was 100.5 degree Fahrenheit. Eventually stopped shivering but elevated temp continued for approx eight hours.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age. A physician reported to the pharmacy student that an unspecified patient came to the primary care office on an unspecified date to receive an unspecified vaccination (that was not supposed to be ZOSTAVAX). By mistake, a syringe that contained ZOSTAVAX was inserted into the patient's arm but not administered. While inserted, an unspecified healthcare provider realized it was the incorrect vaccine and immediately removed the needle from the patient's arm. Though the patient did not actually receive any ZOSTAVAX vaccine, she reported soreness at the injection site and chills. According to the pharmacy student, the patient was no longer feeling these symptoms and recovered. Additional information has been requested.
vision impairment immediately, seeing dark shadows, blurry vision, next day body aches, legs felt swollen,  and by day 4 my eye balls were bulging and had a different shape for 24 hours.  Day 5 Plantar fasciitis suddenly returned, which I had only once before after breast cancer radiation treatment in 2018.  Had phone appointment with general doctor at hospital on 11/3/2021 and they said "well it's in you now we cannot remove it"..
This spontaneous report was received from a licensed practical nurse concerning a 5 year old patient of unknown gender. On 14-DEC-2007, the patient was vaccinated with dose 1 of RECOMBIVAX HB (2.5/0.5, units unspecified) (lot number, expiry date, dose and route unspecified). On 31-JUL-2008, the patient was vaccinated with dose 2 of RECOMBIVAX HB (2.5/0.5, units unspecified) (lot number, expiry date, dose and route unspecified). On 12-SEP-2008, the patient was vaccinated with dose 3 of RECOMBIVAX HB (2.5/0.5, units unspecified) (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
all the patients who received a vaccine which was more than 30 days in the refrigerator; all the patients who received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-126929 (Patient Link).
This is a booster of the J&J vaccine.  Shot at 9:11am.  20 minutes later - experienced facial numbness -- lips, cheeks, eyelids, chin.  (Did not experience this with the first J&J shot).  Ate something, took a Benadryl and waited 20 minutes more for symptoms to abate -- left the facility 45 minutes after injection.  Two days later, there was a knot in my arm sore to the touch, a small hive and itching.  Six days later, knot in arm still there, area still sore to the touch.
Immediately after the vaccine was administered the patient's eyes rolled back in her head and she closed her eyes then passed out.  She clenched her hands and had tremors or minor convulsions for a few seconds then began to regain consciousness.  She lost bladder control.  She became very pale.  She then proceeded to drift in and out of consciousness for the next several minutes.  HR was 60bpm per Apple watch the patient wor into the pharmacy.  EMS was notified at the suggestion of the pharmacist and request of the parent.  Upon arrival EMS measure blood pressure which was approximately 88/54 mm/hg seated and standing.  Patient was alert and awake when transported to the hospital after getting examined by EMS.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 22-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt's right arm began to to swell about 24 hours after administration of vaccine.  Pt reported edema and erythema to wrist of r arm.  Pt also c/o r elbow and wrist pain.  Pt denied fever/chills.  No difficulty breathing or swallowing.  When I evaluated pt 4 days after vaccination, he had minimal edema and erythema surrounding r elbow.  Otherwise, PE was unremarkable.  Pt denied trauma to r arm.
Swollen and painful lymph node in left armpit about 12 hours after 2nd dose but gone after a few days, fatigue and body aches for about 2 days after shot, headache everyday after shot for 6 days straight, swollen and painful lymph node under chin (submental lymph node) on 6th day after shot. I?ve never had swollen lymph nodes in my life until after the 2nd dose.
Got COVID after having vaccine; Got COVID after having vaccine; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (reported as "COVID 19 vaccine"), via an unspecified route of administration on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got covid after having vaccine on an unspecified date. The outcome of events was unknown.  Pfizer is a marketing authorization holder of COVID 19 vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID 19 vaccine has submitted the same report to the regulatory authorities.  The lot number for the vaccine, [Vaccine, BNT162B2], was not provided and will be requested during follow up.
The child begin to break out with bright red blotches on his chest, neck, arms.  He showed no signs of being in distress.
I started my period 10 days early 2 days after I received my first dose. I track my period and I have never started earlier it?s very abnormal. Also the blood  was thick and with a weird substance.
an eight year old patient received two does of Daptacel vaccine/no AE; Initial information received on 12-Feb-2020 and additional information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from the nurse.  This case involves an eight year old patient (gender unknown) who received only two doses of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number and expiry date not reported via unknown route in unknown administration site on an unknown date for prophylactic vaccination [Product administered to patient of inappropriate age]  Medical history, medical treatment, vaccination and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  It was reported that 8 year old patient's parents have chosen to do alternative vaccine scheduled. The patient has only received 2 doses of the Daptacel. Parents have chose to do delayed immunization schedule and patient has only received two doses of Daptacel.  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 and Module VI of the 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.  Information on the batch number was requested.
Swelling, pain, and rash on upper arm followed by approx 36 hours of intense flu-type symptoms: headache, body ache, high fever, and finally swelling of lymph node in left arm (which is the only ongoing symptom five days later).
Pfizer-BioNTech COVID-19 Vaccine EUA  Second dose of Pfizer vaccine received Friday afternoon (4/2/2021). Went to bed Friday evening with "normal" side effects of mild fever and sore arm at injection site. Woke up Saturday morning with no sense of smell or taste. Called primary care provider who conducted a video visit and expressed concern that he may have had an asymptomatic case of COVID-19 prior to injection (no symptoms displayed at all in weeks prior). Order a COVID test for Sunday morning. Woke up Sunday morning with sense of taste and smell back. Proceeded with PCR test, which came back as "negative" on Sunday evening. No other symptoms observed, and other side effects noted above (sore arm, fever) resolved by Sunday morning as well. Seems to suggest loss of sense of taste and smell likely due to vaccine since there was a clear temporal relationship which resolved in approximately 24 hours.
had to have 3 units of blood. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: Not Provided) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "had to have 3 units of blood. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.". The patient underwent the following laboratory tests and procedures: investigation: haven't found out anything. Clinical course: Caller states she is calling regarding the Pfizer Covid vaccine booster. While caller was reporting on her experience after getting the booster, she mentioned that she does have customers that have had similar reactions to this. She had one lady who had to have 3 units of blood afterward. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.  The lot number for [BNT162b2], was not provided and will be requested during follow up.