chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she cannot lift over 9 pounds.; diagnosed with left breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 25Sep2021 as dose 2, single (Lot number: FF8839, Expiration Date: Dec2021) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dense breast tissue" (unspecified if ongoing), notes: Been followed by a breast specialist for the past 1.5 years  . The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Batch/lot number: FC3182, Expiration Date: 02Oct2021, Dosage text: Unknown dosage shot left arm), administration date: 28Aug2021, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: BREAST CANCER (medically significant) with onset 01Apr2022, outcome "unknown", described as "diagnosed with left breast cancer"; ASTHENIA (non-serious), outcome "unknown", described as "she cannot lift over 9 pounds.". The patient underwent the following laboratory tests and procedures: Biopsy breast: (unspecified date) Negative, notes: Stated that she has to get a mammogram every six months and was previously biopsied and both were negative; (Mar2022) Positive, notes: Stated that at the end on March she had a biopsy and came back positive for early stage breast cancer; (Apr2022) Positive, notes: Stated that she got a mammogram and biopsy since vaccination and both came back positive for carcinoma in Apr2022; Mammogram: (unspecified date) Negative, notes: Stated that she has to get a mammogram every six months and was previously biopsied and both were negative; (Feb2022) Positive, notes: Stated that she had a mammogram at the end of Feb2022. Stated that at the end on March she had a biopsy and came back positive for early stage breast cancer; (Apr2022) Positive, notes: Stated that she got a mammogram and biopsy since vaccination and both came back positive for carcinoma in Apr2022. Therapeutic measures were taken as a result of breast cancer.  Additional information: The patient was diagnosed with left breast cancer on 01Apr2022. She did not know if this was a trigger. She got the Pfizer BioNTech Covid 19 vaccine in Aug2021 and the second dose in Sep2021. She had been followed by a breast specialist for the past 1.5 years because she had dense breast tissue. She had to get a mammogram every six months and was previously biopsied and both were negative. She got a mammogram and biopsy since vaccination and both came back positive for carcinoma in Apr2022. She had a mammogram at the end of Feb2022. At the end of March, she had a biopsy and came back positive for early stage breast cancer. It was pretty quick between the time of vaccination and her diagnosis. She got a double mastectomy on 11May2022. She was on work leave for one month and cleared to go back one month later. They took all of the breast tissue and that she could not lift over 9 pounds. She had other reconstruction pending.
Acute onset nausea and abnormal throat sensation shortly after receiving  COVID vaccine.  Hemodynamically stable in ED, saturating well on RA, did receive Epi .3 mg IM for concern of throat sensation, tolerated well.
Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-year-old on 12Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. patient has gotten her first shot of the Pfizer Covid 19 vaccine last 12Apr2021 and on 17Apr2021, she experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts. Asking if this is normal and as to how many days it usually lasts. Outcome of headache and fever was not recovered, outcome of chill was recovered and outcome of cold feet was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Breakthrough case admission after 5 vaccines Moderna 2/16/21 Lot# 004M20A;  Moderna 3/16/21 Lot# 031L20A;  Moderna 12/10/21 Lot# 045J21A;  Moderna 5/11/2 Lot# 057M21A;  Pfizer 11/10/22 Lot#GJ6738
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 12:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Patient called later stating that about 30 minutes after receiving the vaccines, she was in the store rest room and felt very weak. Husband took her to the hospital. She was there waiting to see a doctor. She will update us if they find anything.  Husband received same vaccines with no problem. She had Moderna before and now Pfizer so she suspected that she might be allergic to Pfizer or since she had 3 vaccines at the same time, it might be too much.
Tested positive for COVID-19 11/17/2021 after being fully vaccinated.
Symptoms began just after midnight the following day of shot. Between midnight and 2 am Isuffered from severe chills and sweating. When I woke up at 5 Am I suffered from severe headache. Remainder of the day I had extreme digestive issues that continued over the next several days. At the conclusion of the second day I developed a fever of 101. Pinpointed severe pain developed at the base of my neck between my shoulder blades. That pain remained for approximately 24 to 48 hours that lead to extreme pain and stiff neck on my right side. Chills and periodic fever developed for two days past shot. By day three I had extreme right side neck pain that continued down into my right shoulder blade. By day four and five I suffered from extreme neck pain and severe headache that was focused from my right eye through my head down the right side of my neck to my right shoulder blade. By day 4 this continued with dizziness and blurred vision. I had inability to eat and strong feelings to vomit but only didn't because I hadn't consumed any food that day. I continued to suffer from extreme headaches and complete physical exhaustion with inability to stay away. In addition, I continued to have periodic chills but with no fever.  As I submit this in day 5 I still suffer from lack of energy and the stiff neck remains down through my right shoulder blade.
The pt reports that seven days after 1st doses of Hep A and Hep B and again 2nd dose 7 days after she began experiencing hard chills (temp. not taken), headache, enlargement and tenderness in submandibular lymph nodes, neck, extreme weakness, dizziness, aching in bones. Onset of symptoms 05/05, worst day was 05/07. On 05/10 left arm at site raised, reddened and tender to touch 7 x 8 cm.
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 02-JUN-2014, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX vaccine, the patient suffered an outbreak of shingles including nerve damage. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient experienced serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses, the loss of accumulation and other economic and non-economic damages. Outbreak of shingles and nerve damage were considered disabling. Additional information has been requested.
Covered head to toe with a red rash, treated with benadryl and ER doctor prescribed Fexofenadine HCL 180mg once daily, still currently treating rash.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
boiling blisters; This is a spontaneous report from a contactable consumer (Patient) based on the information reported to Pfizer by company, (Mfr. Report Number: LRN4255056). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient's medica history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient experienced boiling blisters. The clinical outcome of the event was reported as unknown.   No further information was reported. Information on lot/ batch has been requested.   Follow-up attempts completed. No further information expected.
This spontaneous case reported by a consumer, describes the occurrence of arthralgia (joint pain from neck to toes still ongoing 2 weeks after the second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045B21A and 031B21A) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 27, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 4, 2021, patient experienced arthralgia (joint pain from neck to toes still ongoing 2 weeks after the second dose). The patient treated with Advil (ibuprofen) for joint pain, at an unspecified dose and frequency. At the time of the report, arthralgia (joint pain from neck to toes still ongoing 2 weeks after the second dose): not resolved. Concomitant medication list not provided. Action taken with mRNA-1273 in response to the event: not applicable. The patient stated the pain in her fingers is constant. When she wakes up, it's the worst with joint pain. Ibuprofen did not help the patient relieve the pain.
No adverse effects; an expired dose of GARDASIL 9 was administered to a patient today on 8SEP2023; This spontaneous report was received from a medical assistant referring to a 17-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were reported.   On 08-SEP-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5 ml/ once, lot#: U008316, expiration date: 15-AUG-2023; strength and route of administration was not provided) for prophylaxis (expired product administered). No adverse effects were noted. No additional information was provided (no adverse event).
Headache has lasted for upwards of a day, intermittent nausea, lethargy/feeling tired.
my arm 3 months later can not bend if I try to pick things up it's sends a sharp pain right at injection site.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 12-APR-2011, the patient was vaccinated VARIVAX dose 1, lot # 0552Z (dose, route, vaccination site, expiry date unknown). On 01-JUN-2011, the patient received improperly stored VARIVAX dose 2, from lot # 669223/1564Z, expiry date 11-NOV-2012 (dose, route, vaccination site, route unknown). No adverse effects were reported. The reporter started that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Non-control of previously controlled hypertension, worsened tinnitus, loss of high range hearing
Left arm pain radiating from shoulder down to forarm. Constant ache in arm and sharp pains with movemnet. Started day after vaccine administration and has worsened since.
3 CCU RNs called in sick the following day after receiving their 2nd dose of the vaccine; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for three patients. This is the second of three reports.   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization on an unknown date. The patient (a CCU RN (nurse)) called in sick the following day after receiving the 2nd dose of the vaccine on an unknown date. The outcome of the event sick was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021039437 Same reporter, same product, same event, different patients.;US-PFIZER INC-2021039442 Same reporter, same product, same event, different patients.
Patient was administered the Covid-19 Pfizer Pediatric dose on 10/6/2022 at 7:07 PM as booster dose (0.2 mL). Patient was monitored for 15 minutes after injection. No adverse reaction noted at time of discharge. Patient left facility with no complaints or concerns. On the following day (10/7/2022), it was discovered by staff that the expiration date of the vaccine administered was 9/30/2022.
myocarditis; myopericarditis; pericarditis; 30% decrease in my diving performance approximately.; This Initial case was previously missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on 12Dec2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; MYOPERICARDITIS (medically significant), outcome "unknown"; PERICARDITIS (medically significant), outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "30% decrease in my diving performance approximately.".  Additional information: world's current top static breath-hold freediver - he officially held his breath for 10 minutes and 30 seconds - has been diagnosed with myocarditis and pericarditis 40 days after his second dose of the Pfizer vaccine and can't even get close to his record anymore. I also have a family member who had a heart attack after his second dose of Pfizer then ended up getting covid anyway and spreading it to his household. I'm genuinely curious how common heart issues/inflamation/blood clots are. On 11Nov2021 it was reported, world record for static apnea, diagnosed with myocarditis after Pfizer injection possibly it will be the end for his sports career 30% decrease in my diving performance approximately.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
intermittent headache and blood pressure is erratic sometimes going as high as 170/130.  Eye floaters and eye flashes and high BP caused ER visit on Sunday 3/14/2021.
pt recv vax 30APR99 & swelling noted <24hr later;seen by clinic progressive sx inc swelling elbow & extension to proximal forearm;
Hives, relieved with use of BENADRYL. MR received documenting TC from pt's mom to office RN re: hives over body following Flumist.  Treated with po Benadryl. No other tx.
Reoccurring headaches, joint pains, and dizzy spells intermittently.
Myalgia& NauseaVomiting Narrative: dose 1: day 1-3 sore arm dose 2: day 1-2 sore arm; day 2 nausea chills muscle pain day 3-4 swollen LN
Bilateral tinnitus (non-stop); This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 21Dec2020 at 10:15 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included chronic sinus infections in the past. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE), strength reported as 1/28, azelastine HCI nasal spray, montelukast sodium tablet. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 21Dec2020 at 12:00 (reported as since the vaccination), the patient experienced bilateral tinnitus (non-stop). The patient did not receive treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the bilateral tinnitus (non-stop) was not resolved.   Information on Lot/Batch number has been requested.
facial swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (facial swelling) and HEADACHE (headache). At the time of the report, SWELLING FACE (facial swelling) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021 contains NNI On 26-Jul-2021: Follow up received on 26-Jul-2021 and contains no new information.
Low blood pressure 79/52 post 16 hours of vaccine and increased resting heart rate 152 post 24 hours of vaccine.
Patient received vaccine (Covid) second shot on 03/04/2021. developed upper lip swelling 03/07/2021
T-DAP given on 1/25/11. On 1/26/11 felt nauseated, headache, dizzy, and rash on left arm. Slight headache & dizzy on 1/27/11. No rash or swelling of arm. No treatment.
Swelling, redness, and rash around Anthrax vaccine site, unable to raise right arm, swelling down right arm and bilateral swelling to hand.
Small, red pinpoint dots rash all over body on hands, feet, body. Petechiae present on body developed Saturday morning after vaccine given Friday afternoon. Itchiness started Friday night, no prior h/o itchiness in child and then Saturday morning rash appeared and spread to rest of body. Seen in office on Monday rash not spreading anymore. No swelling, no difficulty breathing, no facial swelling, no SOB, no itchy throat, no other sxs. Pt is eating, peeing, pooping normally.
This spontaneous case report was received from a registered nurse regarding unknown number of patients of unknown age and gender. No concurrent conditions and medical histories of the patients were not reported. On an unknown date the patient was vaccinated with the GARDASIL stored outside the recommended temperature range (0.3 degree for 45 minutes (incorrect product storage) with a lot number # K006124 (expiry date: 02-FEB-2017) (dosing regimen, strength and frequency was unknown. Concomitant medications of the patients were not reported. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Patient wasn't surprised by the headache, malaise, and weakness she felt the night after the first dose but within 3 days began having significant anxiety, sleeplessness, and depression symptoms which continue. Also, her menstrual period, which was due within a few days of the vaccine, didn't appear for 10 days and was longer/heavier than normal. Her cycle has been about 10 days longer with heavier flow since the first vaccine dose.