chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case received from a Healthcare Professional on 13 October 2010 under the local number 10-0721. Several patients (not specified) developed cellulites on an unspecified date after receiving a dose of ADACEL (batch number, route and site of administration not reported) on an unspecified date. Patient's outcome were not reported. Follow-up information was received 13 January 2011 from a health care professional. The reporter provided patient identifiers for one of the previously reported "several" patients who experienced the event of cellulitis. The patient was identified as a 51-year-old male who had received ADACEL (lot number, route and site of administration not reported) on 05 October 2010. According to the reporter, the patient recovered (date not reported). No further information was provided at the time of the report. Follow-up information was received 24 March 2011 from a health care professional who confirmed a total of two patients (previously reported as several patients) had experienced adverse events after receiving ADACEL. The reporter provided information pertaining to the second previously unidentified patient (captured in case number 2011-01693). Based upon new information received, it was determined the event experienced by the patient in this case now meets seriousness criteria, and this case has been upgraded from nonserious to serious. The patient had received an intramuscular left deltoid injection of ADACEL, lot number U3281CA (sanofi pasteur Ltd. lot number C3354) on 05 October 2010. On 13 October 2010, approximately one week post vaccination, the patient developed cellulitis of the left upper arm and was evaluated by their physician that same day. KEFLEX 500 mg was prescribed and the patient recovered within one week (date not available). The patient had no medical history, no concurrent illness and he had not been taking any concomitant medications. Several months later, the patient had been seen for a well visit at which time he had no complaints. No additional information was provided at the time of the report. The reporter for this case is the same as for case number 2011-01693. Documents held by sender: none.
dizziness, headache, naseau.   Sat. early evening after shot little lighted head and headache Sunday was constantly dizzy and some naseau  Monday having waves of slight dizziness and waves of naseau
Localized swelling and erythema and induration, initiating hours after injection and increasing until 24 hours after injection. Erythema: 6.75 cm x 5.5 cm; Induration: 6.75 cm x 5.5 cm; Edema: 6.25 cm x 8 cm.
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report as received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 14-JAN-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T025370 with expiration date: 01-DEC-2022 (also reported as 01-FEB-2022), route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced the temperature excursion below 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49. 1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2202USA003592:
Sore, swollen, red, itchy arm. From wrist to shoulder. MD suspects allergic Rxn, but gave Augmentin in case cellulitis was cause of swelling.
Patient had adverse reaction several weekes ago to Pfizer vaccine.  Per MD instructions, she was to get 2nd shot of J&J.  Within 10 minutes patient reported mild lightheadedness.  Given a bottle of water to drink and about 15 minutes post injection, patient reported blurry vision in her right eye.  Discussed situation and Hx with other staff on site and it was decided the best course of action would be to take patient to ED for further evaluation.  Patient was escorted by 2 RNs to the ED where SBAR was given to triage staff. at about 10:00am.  Patient and her daughter returned about an hour later to thank us and let us know her symptoms had resolved and that her BP in the ED was "a little high".
Patient passed out within minutes of the vaccine.  He stayed in his chair after complaints of feeling dizzy.  He came to and we called EMS.  The patient was hot, sweaty, and pale.  EMS came and patient's HR was 30s/40s with very low blood pressure.  Patient's HR stayed low and so did his blood pressure.  He was recommended to go to ER but refused.  Patient waited longer and ended up walking out on his own terms to follow up with a doctor later.
covid vaccine breakthrough  dose 1 Pfizer 1/31/21  EL9261 dose 2 Pfizer 2/21/21  EM9810
dorsum of both hands edema2+ with erythema; Dorsum of both hands edema2 with erythema and left food had; edema and erythema painful; This is a spontaneous report received from a contactable reporter(s) (Other HCP). Other Case identifier(s): US-PFIZER INC-202101642289 (Pfizer).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 13Nov2021. The following information was reported: OEDEMA PERIPHERAL (non-serious) with onset 21Nov2021, outcome "unknown", described as "dorsum of both hands edema2+ with erythema"; ERYTHEMA (non-serious) with onset 21Nov2021, outcome "unknown", described as "Dorsum of both hands edema2 with erythema and left food had"; PAIN (non-serious) with onset 21Nov2021, outcome "unknown", described as "edema and erythema painful". The events "dorsum of both hands edema2+ with erythema", "dorsum of both hands edema2 with erythema and left food had" and "edema and erythema painful" were evaluated at the physician office visit. Therapeutic measures were taken as a result of oedema peripheral, erythema, pain.  Additional information: It was unknown that patient receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient received oral Benadryl for the treatment of the event. Patient did not have covid prior vaccination, have not tested covid post vaccination and was not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site pain; Recurrent Fever (37.8C to 40C); Myalgia; Arthralgia; Migraine; Insomnia; Light headedness and dizziness; Loss of appetite; Nausea; Sternal chest pain, non-radiating; Tachycardia; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 11May2021, at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to prawn and shrimp. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins nos and minerals nos (CENTRUM ADULT) and fish oil (MANUFACTURER UNKNOWN); all from an unknown date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 20Apr2021 at 11:00, (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 23:00, within 12 hours after vaccination, the patient experienced the following symptoms (in order of occurrence): injection site pain, recurrent fever (37.8C to 40C), myalgia, arthralgia, migraine, insomnia, light headedness and dizziness, loss of appetite, nausea, sternal chest pain, non-radiating, tachycardia and anxiety, and it was reported as the patient had to go on leave from work because of the symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of events. On 05Jan2021, the patient underwent Reverse transcription polymerase chain reaction (RT PCR) nasal swab COVID-19 test, and the result was negative. On 11May2021, the patient underwent body temperature test and the result was 37.8 to 40 degrees centigrade. The clinical outcome of the event recurrent fever (37.8C to 40C) was resolved on 13May2021 while migraine, insomnia, loss of appetite, nausea, anxiety and tachycardia was resolved on an unknown date in May2021. The clinical outcome of the event injection site pain was not resolved while the outcome of myalgia, arthralgia, light headedness and dizziness, sternal chest pain, non-radiating was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Approximately four weeks, May 2021, after the second vaccine on 4/21/21 I noticed a lump under my left arm pit. Saw PCP and advised to monitor growth. October 2021 growth was the size of a tennis ball other areas of enlarged lymph nodes visible in chest and neck. Referred to a surgeon for imaging and biopsy. November 2021 biopsy was confirmed by three different sources as Hodgkin?s Lymphoma. Referred to oncologist for treatment. Began chemotherapy treatment December 2021. Spent eleven days in CCU/ICU January 2022. Resumed chemotherapy treatment February 2022. Stopped treatment of chemotherapy June 2022. Severe chemo-induced peripheral neuropathy and body wasting. Unable to perform minor and major life functions and self-care. Unable to walk or use hands. Extreme pain in extremities. Vision changes. Brain fog. Heart function issues. Lower GI issues. Muscle loss. Weight loss. June 2022 at-home nursing, PT and OT prescribed. July 2022 two weeks in-patient OT/PT rehabilitation facility. August 2022 at-home PT and OT. September 2022 referred to neurologist. September 2022 referred to out-patient PT and OT multiple times weekly. March 2023 CT/PET scans reflected remission of Hodgkin?s Lymphoma. Stopped OT and PT April 2023 reaching functional improvement with remaining peripheral neuropathy in hands and legs/feet. Unable to perform dorsiflex movement in either foot and severe contractures in both hands. With the aid of AFO?s (leg braces) I can walk using a walker or cane. I have not worked since May 2022. I was terminated from employment in November 2022.
The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 16-Feb-2022; inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in refrigerator); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in refrigerator)) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 16-Feb-2022) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 004F21A, 032L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in refrigerator)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 16-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in refrigerator)) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 16-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA. The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.
Having shortness of breath; back aches; constant burping; sudden weight loss; This is a spontaneous report from a contactable consumer (Patient). A 80-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 17Mar2021 (at the age of 80-year-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications taken in two weeks included amlodipine; atorvastatin; pantoprazole; metoprolol. The patient previously took percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 19Mar2021, the patient experienced having shortness of breath, back aches, constant burping, sudden weight loss. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was unknown that, treatment was received as a result of events. The outcome of the events were not resolved.
pt recv vax 2FEB98 @ 11AM & that evening 6PM, 8PM & 1030AM pt had episodes of what seemed like infantile spasms-stiffened arms, went straight out, pupils dilated, face suffused, then relaxed & cried loudly-episode lasted 3-5sec;
very upset stomach; ended up with diarrhea; nose was running; nauseated/feeling funky/stomach is still a little funky; low grade fever; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (very upset stomach), DIARRHOEA (ended up with diarrhea), RHINORRHOEA (nose was running), NAUSEA (nauseated/feeling funky/stomach is still a little funky) and PYREXIA (low grade fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ONDANSETRON for Nausea, RIVAROXABAN (XARELTO), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), DILTIAZEM HYDROCHLORIDE (CARTIA XT), CARVEDILOL, LISINOPRIL, GABAPENTIN and FAMOTIDINE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (very upset stomach), DIARRHOEA (ended up with diarrhea), RHINORRHOEA (nose was running), NAUSEA (nauseated/feeling funky/stomach is still a little funky) and PYREXIA (low grade fever). At the time of the report, ABDOMINAL DISCOMFORT (very upset stomach), DIARRHOEA (ended up with diarrhea), RHINORRHOEA (nose was running), NAUSEA (nauseated/feeling funky/stomach is still a little funky) and PYREXIA (low grade fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
8.15.2021  runny nose, congestion, headache for 5 days
Increasing pain in shoulder joint.  Pain is sharp and limits range of motion.  Due to pregnancy, treatment has been icing and Tylenol.
Itchiness around the area the shot was given. Hardening of the same area .  I did not take any medication. It went away after 2-3 days
This spontaneous report as received from a pharmacist refers to a 65 years old female patient with high blood pressure. The patient was vaccinated with a dose of ZOSTAVAX on 24-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. In July 2012 date the patient developed a little bump, a burning sensation and a larger area around the injection site after vaccination. The reporter said the red area was the size of her palm. The patient had visited the office for medical attention and was treated with KEFLEX. At the time of the report, the patient had not recovered. Additional information has been requested.
3/1/12 Employee seen for Tdap reaction. Induration and swelling from acromion process to elbow.  Erythema measures 30 cm x 28 cm, induration measures 13 cm x 14 cm. Temp 38.3, c/o Pain 7/10. No epitrochlear or axillary lymphedema. Regular s1s2, @ 80 BPM, BP 118/72, lung sounds CTA. Hep C positive, takes no daily meds. Currently being treated at a clinic. VAERS completed. Evaluated by ARNP.
I received my first Moderna 3 days prior to obtaining a positive pregnancy test. EDD: 09/21/2021. 2nd vaccine received at about 8 weeks of pregnancy. No medical history, two previous normal spontaneous vaginal deliveries, no diabetes, no HTN, no complications. Normal initial OB labs at 12 weeks, normal ultrasound for confirmation at 9wks and 3 days of gestation. At 18wks and 1 day during an ultrasound the baby was found to not have a heartbeat. At 18.2wks (on 04/22/21) I delivered my daughter stillborn without gross deformity.  She weighed 5.2oz and was 7.5in long.
Sick with fever for days after each shot for days, body aches and severe headaches that stayed for between 2 and 3 months.  I developed hypertension that did not exist before for which I've now had to medicate.  And now, my immunosuppresant mess which had been stable for nearly 3 years are now off and will have to be adjusted. I am very frustrated with doctors who are following CDC guidance pressuring patients into taking these vaccines and then no one wants to acknowledge the ACTUAL side effects patients are REALLY having. I do not trust the CDC any longer.  This is not a VACCINE.
Pt recvd 1st dose of Hep B approx 15MAR91; Pt devel serum sickness, fever, arthralgia, nausea & h/a; pt exp papular rash w/scaling on arms, elbows, knees, & buttocks;
On 11-1-07 received flu vaccine and noted left arm with pain, burning, itching, warm to touch area of 6 X 2 cm.  Advil taken with ice applied.
Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3246, expiry: unknown), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included lupus SLE and known allergies with Stadyl. Concomitant medications included ascorbic acid (ESTER-C [ASCORBIC ACID]) and prednisone. The patient had no other vaccine in four weeks. The patient experienced severe migraine, blurred vision, dizziness and nausea on 12Jan2021 at 14:00. The patient was tested for Covid prior to vaccination but was not tested post vaccination. The events were not treated. The outcome of the events was recovering.
Patient received a flu shot on 1/10/13. Came back and showed a lesion where shot was administered. Patient is taking COUMADIN.
warm; bruise; knot in the arm; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE BRUISING (bruise), VACCINATION SITE INDURATION (knot in the arm) and VACCINATION SITE ERYTHEMA (red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE BRUISING (bruise), VACCINATION SITE INDURATION (knot in the arm) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE BRUISING (bruise), VACCINATION SITE INDURATION (knot in the arm) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
Breakthrough case admission after 2 vaccines Pfizer 3/31/21 Lot# ER3732;  Pfizer 4/21/21 Lot# EW0164
I had a sinus drainage and cough that night. I took my temperature, which I had a fever. I went to the doctor and received PAXLOVID. I took the pill for 5 days.
ADMINISTERED THE ENTIRE VIAL OF THE JANSSEN COVID-19  VACCINE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced administered the entire vial of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered the entire vial of the janssen covid-19 vaccine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.