chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe lower back and bone pain. Sever Left elbow joint pain.; Severe lower back and bone pain. Sever Left elbow joint pain.; Severe lower back and bone pain. Sever Left elbow joint pain.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19May2021 at 09:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patients other medical history was reported as no. The patient had no known allergies to medications, food, or other products. The patient received other medication within two weeks prior to vaccination which included Prenatal (unspecified) from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 02:00, the patient experienced severe lower back and bone pain. The patient also experienced severe left elbow joint pain on 20May2021 at 02:00. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events severe lower back and bone pain, severe left elbow joint pain was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 64 year old female with chronic lymphocytic leukaemia who on 08-MAY-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) (Dose, route, and Lot # not reported). The physician reported that post vaccination, the patient had a mild topical reaction at the injection site. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested. No further information is available.
Hypoxia, Respiratory failure requiring ventilator, pulmonary hemorrhage. Recoeved from information in discharge summary, states pallor, choaking, apnea, bacterial infection and acidosis. msv
Ongoing menstrual changes. I have had a typical menstruation cycle for more than 30 years, 26-30 days between cycles, no spotting, lasting 6-7 days with a very predictable pattern. I have never spotted between periods, and never had more than one day of spotting at the beginning of a cycle. Since the vaccine, my cycles have been 20-35 days long, bleeding has varied from 5-8 days. Spotting has varied from 0-4 days. I have been told that there is no treatment and no testing that will "prove" that the vaccine had anything to do with it, or that would test for reasons for the sudden change.
Systemic: Allergic: Itch Generalized-Medium, Additional Details: Approx 7-10min after immunization pt complained of itching, redness on trunk/ neck. No difficulty breathing, MD called, pt went to urgent care after. Prednisone, famotidine and benadryl rx sent in.
Migraine headache, short time. Tylenol taken. Stomach aches till early evening after vaccination.
First day:chills, sore throat, nausea, fatigue, H/A starting about 2 pm Second day: fatigue, less nausea, chills, H/A Third day: Extreme fatigue and Fever 100.9 oral
Hospitalization for COVID/AFIB 8/17/21. Treated with Remdesivir for 5 days.
Excruciating pain in R arm; Shoulder was immobile; Shooting pain bone deep radiating down R arm; R arm still has limited mobility; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number:  EN6202, Expiration Date: not reported) via an unspecified route of administration, administered in right arm on 27Mar2021 at 08:30 (at the age of 50 years old) as dose 1, single for COVID-19 immunisation. Medical history included mitral valve stenosis and GERD (gastrooesophageal reflux disease), both from an unknown date. The patient has no known allergies and prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC) and esomeprazole sodium (NEXIUM), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 08:30, the patient experienced excruciating pain in right arm and patient's shoulder was immobile. Furthermore, the patient also experienced shooting pain bone deep radiating down right arm on the same day. The pain was so extreme the patient had to go to the emergency room. The pain increased throughout the day despite ibuprofen and naproxen sodium. The pain started on 27Mar2021 at 08:30 with the injection and the immobilization of the patient's right arm remained for 2 days after ER visit. The patient's right arm still has limited mobility. Treatment was given in response to the events which included ibuprofen, naproxen sodium, lidocaine patch, paracetamol (TYLENOL), hydrocodone bitartrate;paracetamol (NORCO) and diazepam (VALIUM). Since vaccination, the patient has not been tested for COVID-19. Events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of all events was recovering.  No follow up attempts are possible. No further information is expected.
3rd dose administered instead of booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (3rd dose administered instead of booster) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (3rd dose administered instead of booster). At the time of the report, ACCIDENTAL OVERDOSE (3rd dose administered instead of booster) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment medications were reported.
Patient presented to pharmacy on 9/22 showing me her swollen arm. She had both Fluzone HD and Arexvy in the same arm. The site of the flu shot was not inflamed only the site of the RSV vaccine. The swelling started near injection site and down near elbow. I referred her to call her primary. She sent them pictures. They recommended she be seen in an Urgent Care. The Urgent care doctor stated this may be an allergic reaction.
SQ injection RA-swelling-painful to the touch and hot. On 1-7-07, patient still c/o pain on 1-12-07. Arm red, warm to the touch and itching and purplish discoloration, larger than golf ball.
Fever; Headache; Vomiting; Fatigue; Pain behind eyes; Sore arm; Swollen lymph nodes over 48 hours; dose received :3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 18Dec2021 at 10:30 (Lot number: FL3197) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: Sulfa drugs. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8735, Anatomical site: Left arm; Administration time: 17:00), administration date: 30Mar2021, when the patient was 31 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: ER8731, Anatomical site: Left arm, Administration time: 17:00), administration date: 20Apr2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 at 10:30, outcome "unknown", described as "dose received :3"; PYREXIA (non-serious) with onset 18Dec2021 at 21:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 18Dec2021 at 21:00, outcome "recovering", described as "Headache"; VOMITING (non-serious) with onset 18Dec2021 at 21:00, outcome "recovering", described as "Vomiting"; FATIGUE (non-serious) with onset 18Dec2021 at 21:00, outcome "recovering", described as "Fatigue"; EYE PAIN (non-serious) with onset 18Dec2021 at 21:00, outcome "recovering", described as "Pain behind eyes"; PAIN IN EXTREMITY (non-serious) with onset 18Dec2021 at 21:00, outcome "recovering", described as "Sore arm"; LYMPHADENOPATHY (non-serious) with onset 18Dec2021 at 21:00, outcome "recovering", described as "Swollen lymph nodes over 48 hours". Therapeutic measures were not taken as a result of pyrexia, headache, vomiting, fatigue, eye pain, pain in extremity and lymphadenopathy.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Developed pruretic papules in the deltoid area bilaterally, rt>lt.  Hep B #3 placed in rt deltoid, Hep A #1 placed in left deltoid.  Lesions still visible when seen by the hospital on 13 Sep 04.
6/22/12 after 1 pm tetanus shot was given to me on upper left arm. Arm mildly sore, after administration, Sunday lips on and off numb, Monday chest area; rash and sensitive Tuesday broke out in a severe rash, chest, neck & face. Hands and arms itch, with slight sore throat.
they had a ultrasound done and found out I had a number of clots in that position; a sore Leg, Upper part of the left calf 2 inches below the knee on the backside; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 15:00 (Batch/Lot Number: En6207) as SINGLE DOSE for covid-19 immunisation. Medical history included Treatable Acid reflex, anxiety and mild depression. Concomitant medications included omeprazole, buspirone and alprazolam for unspecified indication. Patient had the Covid shot on 18Mar2021 at about 3 PM the next morning (on 19Mar2021 06:00) patient woke up with a sore Leg, Upper part of the left calf 2 inches below the knee on the backside. After it did not go away, he went to the doctor then they had a ultrasound done and found out he had a number of clots in that position. Treatment received for the adverse event includes they put patient on a blood thinner. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021. Covid test post vaccination done via nasal Swab, They had the results in 15 minutes, covid test result Negative, ultrasound scan: clots in that position on 19Mar2021 found out, had a number of clots in that position. Outcome of the events was recovering.
Vaccine administered after 12 hours. (Vial was first punctured on 1/4/22 at 8:18am. Vaccine was given at 10:19am on 1/5/22.) No adverse reaction.
GBS/CIDP. Profound loss of sensation, motor strength, reflexes 4-5 weeks after flu shot. IVIG/prednisone results in mild improvement. Has permanent weakness.
Severe crying/screaming for more than 12 hours. No nursing for more than 18 hours. No stool for 10 days. First bowel movement was black sticky tar like for 2 days. 103 fever for 3 days. Regression with eye contact a smile for a month.
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.   No adverse effects noted.
Hep A vaccine give 04/10/01 within 2 wks of injection client developed a round ball about the size of half dollar at injection site. About 6 months later if he lifts arm higher then shoulder he has pain in arm and neck. Went to see private doctor 04/15/02.
have extreme fatigue; lethargy; cramping; diarrhea; nausea; muscle and joint pain at the sites of previous injuries that had healed; headache and blurred vision; headache and blurred vision; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172), via an unspecified route of administration, administered in right arm on 04May2021 at 15:00 as a single dose for COVID-19 immunization. The patients past medical history included the 1st dose of bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EW0153) in right arm on 13Apr2021 for COVID-19 immunization. The concomitant medications were not reported. Patient was not taking other products. Patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. On 05May2021 at 03:00, (about 12 hours after the vaccine), the patient experienced extreme fatigue (worsened), lethargy, cramping, diarrhea, nausea, muscle and joint pain at the sites of previous injuries that had healed, headache and blurred vision. The patient still had side effects from the second dose 23 days later. All events persisted except for his extreme fatigue, muscle pain, joint pain, and blurred vision, which had worsened. Patient did not require emergency room visit. The patient had physician office visit. The patient was not given treatment. The clinical outcome for the events were not resolved.  Follow up (27May2021): This is a spontaneous report from a contactable consumer. This 40-year-old female consumer (patient) reported. New information included: dose information (first dose, on 13Apr2021; Lot Number: EW0153 in right arm and second dose on 04May2021; Lot Number: EW0172 in right arm).  Caller provided with report reference: 6FUIG32Y. INT-00267000.  Information on Lot/Batch number was available. Additional information has been requested.
A lump and rash formed to the right of the injection site causing numbness on the back of the left hand including the thumb and first two fingers and palm of the left hand. Initial impression is that swelling is placing pressure on the radial nerve.
FLUBLOK was given to two patients under 18 years of age with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA393474(CLUSTER).  This case involves a 7 years old female patient who was under 18 years of age and given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2022, the patient received 0.5 ml, once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ887AA, exp: 09-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 21-Sep-2022 the patient developed a non-serious "Flublok was given to two patients under 18 years of age with no reported adverse event" (product administered to patient of inappropriate age) (latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was unknown for the event.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Flu like symptoms; Low grade fever; achy; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TOPIRAMATE; OMEPRAZOLE; SIMVASTATIN; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid- 19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for Covid- 19 immunization.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "Flu like symptoms"; PYREXIA (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "Low grade fever"; PAIN (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "achy"; FATIGUE (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "severe fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza like illness, pyrexia, pain, fatigue.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
can barely walk/dragging their feet; slowly getting reactions; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (can barely walk/dragging their feet) and IMMUNISATION REACTION (slowly getting reactions) in an 80-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 039021A and 1006HZIA) for COVID-19 prophylaxis.     Patient was in good health.  The patient's past medical history included Sneezing. Concurrent medical conditions included Thyroid disorder (Patient had thyroid and was taking medication for it.) and Seasonal allergy (Patient was allergic in the beginning of the summer and they start sneezing.).   On 25-Oct-2021, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 17-Apr-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (can barely walk/dragging their feet) and IMMUNISATION REACTION (slowly getting reactions). At the time of the report, GAIT DISTURBANCE (can barely walk/dragging their feet) and IMMUNISATION REACTION (slowly getting reactions) had not resolved.            Concomitant product included unspecified medication for thyroid.  It was reported that patient had Moderna vaccination for Covid 2 years ago and slowly getting reactions and at the time of reporting patient could barely walk. Patient was having trouble walking. Patient got the vaccine 2 years ago and it was affecting their walking. Patient was dragging, had no numbness, just dragging her feet. Patient went to the hospital to check and see if she had Parkinson and she did not.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-749086, US-MODERNATX, INC.-MOD-2023-749085 (E2B Linked Report). This case was linked to MOD-2023-749086, MOD-2023-749085, MOD-2023-749085 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749086:same patient Bivalent case
CANCER HAD COME BACK MUCH WORSE AND HAD RAPIDLY SPREAD; This spontaneous report received from a consumer via social media from a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: cancer, for which the patient was declared cancer free. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that "My niece had cancer and beat it, she was declared cancer free. She received the shot two weeks later and a month later at a check-up they discovered the cancer had come back much worse and had rapidly spread. Her doctor verified the covid shot had caused it to come back. She is again fighting for her life because it came back so fast and with a vengeance". (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cancer had come back much worse and had rapidly spread was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260912-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Cancer had come back much worse and had rapidly spread. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
patient called pharmacy around 5:15 PM and stated that her arm was hurting.  She said it had been hurting for about 15 minutes and hurt from wrist to shoulder and had pain under her arm.  She said she took some naproxen and was going to rest.  She denied any symptoms of an allergic reaction.  She said she would follow up with us/ her doctor tomorrow if she wasn't feeling any better.
I experienced sore throat 2 days after the dose, and swollen lymph nodes and glands on day 3, stuffy ears, postnasal drip, congestion, sinus pressure, productive cough, with fatigue and body aches. On October 20, 2022, I began to experience hearing loss, with some sounds more amplified at times. I had a visit with my physician where both ears looked normal, congestion, mucous membrane was moist, lymph glands swollen, and I was diagnosed with acute reoccurring sinusitis, and chronic pansinusitis, and was prescribed prednisone  along with cefuroxime. My symptoms have not resolved, and my hearing has not recovered yet.
Very fussy and crying all day long until early evening, decreased appetite, won't take naps well.
At vaccine site I experienced an acute event of shortness of breathe, tunnel/blurred vision, heart palpitations, increased heart rate, brain fog. Had 9 episodes since then. Three days after I had an ER visit, no diagnosis. Given EpiPen and muscle relaxers. Occasional chest pain, tightness in chest and neck. difficult to sallow. Very short winded, shortness of breathe. Currently on heart monitor.