chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BACK PAIN GOTTEN WORSE; WEAKNESS IN RIGHT ARM; NUMBNESS IN RIGHT ARM; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 180 pounds, and height was 63 inches. The patient's concurrent conditions included: back pain, non smoker, and non alcoholic, and other pre-existing medical conditions included: The patient does not have any known allergies. The patient does not have any history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 21/DEC/2021) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-OCT-2021, the patient experienced back pain gotten worse. On 12-OCT-2021, the patient experienced weakness in right arm. On 12-OCT-2021, the patient experienced numbness in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in right arm, weakness in right arm, and back pain gotten worse. This report was non-serious.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-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) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
swelling of ring finger in the left hand; swelling in left leg; difficulty sleeping; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of ring finger in the left hand), PERIPHERAL SWELLING (swelling in left leg), INSOMNIA (difficulty sleeping) and ARTHRALGIA (Joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling of ring finger in the left hand), PERIPHERAL SWELLING (swelling in left leg), INSOMNIA (difficulty sleeping) and ARTHRALGIA (Joint pain). At the time of the report, PERIPHERAL SWELLING (swelling of ring finger in the left hand), PERIPHERAL SWELLING (swelling in left leg), INSOMNIA (difficulty sleeping) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning a female who on an unspecified date was intramuscularly vaccinated with the second dose of GARDASIL. Three weeks later the patient developed two seizures. The patient was given anti-seizure medications. At the time of reporting, the patient recovered from seizures. Upon internal review, seizures were considered to be other important medical events. Follow-up information was received from an office manager concerning the 19 years old patient who did not receive GARDASIL in the physician's office and is no longer seen by the physician. The patient's mother mentioned the adverse event to the doctor when she brought the patient's younger sibling for a visit. No further information is available.
This spontaneous case reported by a consumer, describes the occurrence of rash (a week later) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013L20A) for COVID-19 immunization. No medical history reported. On Jan 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 26, 2021, patient experienced rash (a week later). At the time of the report, rash (a week later) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. Reporter did not allow further contact.
Injection site left arm, redness and swelling. First notice3 inch oblong has grown 1/2 to 3/4 inches bigger.
Information has been received from a consumer referring to her son, a 12 year old male patient. The patient was allergic to KEFLEX. The patient received the first dose in the GARDASIL series in 2015 (reported as about one year ago) (lot #, dose and route unknown). It could  not be confirmed if this dose was GARDASIL or GARDASIL 9. The patient had no adverse reaction to the first dose in the GARDASIL series. The patient had the second dose in the series on 02-JUN-2016 (inappropriate schedule of drug administration, possible interchange of vaccine products). This second dose was confirmed as GARDASIL 9 (lot #, dose and route unknown). On 03-JUN-2016, the patient presented with hives from head to toe. The physician prescribed an unspecified dose of BENADRYL on that day. The hives were so bad that the reporter took the patient to see the physician on 04-JUN-2016. The physician prescribed an unspecified dose of prednisone (manufacturer unknown). No lab tests were performed for the event. The hives had cleared up on 08-JUN-2016. The reporter did not provide the causal relationship assessment. Additional information has been requested.
Severe headache on left side of head; Injection site a little sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (age reported as 83; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (INFLUENZA VACCIN) taken for antiviral prophylaxis from Feb2021. It was reported by the patient that she got the first dose of the covid vaccine on 12Feb2021 (Friday) and got a little sore because she also got a flu shot. Since Saturday she got headache in the left side of her head (the side of the body where she got the vaccine) and she would like to know how long it would last and when that would be expected to get better. She said that she took Tylenol last night for this since it is a severe side effect. She does not have an email and did not wish to complete report. No further details provided. The outcome was unknown for the event of vaccination site pain and patient was not recovered from the event of headache.   Information on the lot/batch number has been requested.   Follow-up attempts completed. No further information expected.
Patient hasn't received 2nd dose yet.; eash was burning; 2 days after receiving 1st dose, she broke out in a rash on her arm/Rash was also on her neck/Rash was burning; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet.), RASH (2 days after receiving 1st dose, she broke out in a rash on her arm/Rash was also on her neck/Rash was burning) and SKIN BURNING SENSATION (eash was burning) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CHOLESTEROL for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced RASH (2 days after receiving 1st dose, she broke out in a rash on her arm/Rash was also on her neck/Rash was burning). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet.) and SKIN BURNING SENSATION (eash was burning). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of UNK dosage form and HYDROCORTISONE SODIUM SUCCINATE (HYDROCORTISONE SODIUM) for Rash, at a dose of UNK dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet.), RASH (2 days after receiving 1st dose, she broke out in a rash on her arm/Rash was also on her neck/Rash was burning) and SKIN BURNING SENSATION (eash was burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment include Anti-bacterial cream and Vaseline.
Redness at the injection site; Itchiness at the injection site; floaters in his left eye; arm muscle was swollen; A spontaneous report was received from a consumer concerning a 77-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness at the injection site, itchiness at the injection site, arm muscle was swollen, floaters in his left eye.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, after receiving the first dose of mRNA-1273, the patient experienced arm muscle was swollen.  On 28 Jan 2021, the patient experienced the event redness at the injection site, itchiness at the injection site and floaters in his left eye. The patient still experienced redness and itchiness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), redness at the injection site, itchiness at the injection site was not resolved.  The outcome of event(s), arm muscle was swollen, floaters in his left eye was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Case number PHEH2014US025088, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 40-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
C/O pain L arm post flu shot. Did not report for three months D/T she thought it would get better. Sending for neurology consult. Took Advil without relief. Thinks shot was given "too high."
This report describes the occurrence of polyarteritis nodosa in a 55 year old female who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received from the subject and has not been verified by a physician. The subject's medical history and concurrent conditions were not reported. Concurrent medications included unspecified hormone replacement therapy which was discontinued in 2001 because of legs. The subject reportedly received LYMErix on 4/27/99, 6/1/99, and 4/21/00. She reported that in October 2000, during a vacation, her legs were aching more than usual. She thought this was due to work self-treated with ibuprofen (Motrin). She stated that in March 2001, she felt lousy and by the end of March had a temperature of 100 to 101 degrees F. At this time, she sought medical attention from her physician. He referred her to a rheumatologist. The rheumatologist reportedly made a diagnosis of poyarteritis nodosa. The subject was reportedly hospitalized for 10 days in April 2001. She states that currently her feet and the sides of her legs to the knees were numb. She stated that her right hand and two fingers were numb and tingling with pins and needles sensations. She stated that her feet feel as though she is walking on rocks. *F/UP report on l2/17/02: Add'l info was received from the rheumatologist on 12/2/02. The rheumatologist confirmed that the onset of polyarteritis nodose was March 01, 11 mts post-immunization. Sural? nerve and gastroenemius biopsy performed on 4/26/01 demonstrated necrotizing vasculitis. The rheumatologist stated that the subject developed neuropathy 2ndary to polyarteritis nodosa. The rheumatologist considered the polyartoritis nodosa to be life-threatening, and to polyarteritis nodosa. The rheumatologist considered the polyartoritis nodosa to be life-threatening, and to have resulted in severe or permanent disability. The relationship of the event to LYMErix was not spec'd. As of 11/15/02, the polyarteritis nodosa had improved, the neuropathy persisted.*
I woke up between midnight and 2:00AM with nausea and vomiting for hours. I thought that I had food poisoning at first. I also experienced severe dizziness with weakness on my right side. I had issues getting out the bed. Between 5:00 am and 6:00 am, my husband had to help me get out of the bed and to the bathroom. I was pale and lethargic. I took an 500mg aspirin around 2:30am- 3:00am. I had loss of balance, and the room was spinning. By 8:30am - 9:00am, we called to see a physician. I didn't get to see a physician till noon and was admitted to the emergency room for 12 hours. My physician said I had a cardiac event and gave me medication to stabilize it. I went to get a CT scan the next day where I was told I had a minor stroke. I have since then limited taste and smell on the right side. I also have occasional memory lapses. I don't have the same kind of muscle strength.  I have muscle weakness on the left side. I can only sleep for about three to four hours. I also don't have the stamina I use to have.
shot caused a sort of knot under the skin; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (shot caused a sort of knot under the skin) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sensitivity to sulfa drugs.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and GABAPENTIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (shot caused a sort of knot under the skin). At the time of the report, VACCINATION SITE MASS (shot caused a sort of knot under the skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-129427 (Patient Link).
Adverse reaction to SHINGRIX 50 mcg/0.5 inj glas - 101.4 fever upset stomach and aches.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with GARDASIL (lot number: KK007828 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effect (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with the GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter.
Severe nausea followed by violent vomiting. Must have been the lunch I ate 2 hrs prior to this. My throat was very sore and hurting for the next 36 hrs.
Oth complications following immunization, NEC, init on 2015-09-24.
Five days after the first dose of the vaccine I experienced a sudden onset of tinnitus in my left ear.  When it continued for more than a few days I did some research and found that others have experienced the same side effect.   I started taking fish oil and a decongestant as suggested treatments for tinnitus but the ringing is still constant with only mild improvement.  I have not experienced a  hearing loss at this time.  It has been 29 days since I had the first vaccine and 24 days since the onset of tinnitus.
The next morning  I had trouble breathing and I went to the urgent care.  They diagnosed me with COVID Pneumonia. The prescribed me an antibiotic shot, steroid shot, cough medicine, and nasal pill.  I might have picked it up from the facility I received the vaccine.
numbness; tingling in ankles and lower legs; Low grade fever; Nauseous; Major back tension; throat has gotten suddenly sore; not her face per se, but her throat, around her glands is swelling; difficulty swallowing, it is not blocked or anything, but is definitely not her normal; loss of feeling in lower calves and ankles; fast heartbeat; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported ) via an unspecified route of administration on 11Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection) via unknown route of administration as 1st dose, single dose for covid-19 immunization and experienced a little tiredness. Following the second dose she waited 30 minutes. Probably about 1 hour and 15 minutes later when she got home On 11Jun2021, the patient experienced numbness, tingling in ankles and lower legs, low grade fever, nauseous, major back tension, throat has gotten suddenly sore, not her face per se, but her throat, around her glands was swelling, difficulty swallowing, it was not blocked or anything, but was definitely not her normal, loss of feeling in lower calves and ankles, fast heartbeat. The events were considered as non serious. She didn't know if allergic reaction included swelling of the throat or face or just one. She was not too concerned about the fever or tension-like feeling throughout her back. The numbness in legs and swelling of the throat; she did not see side effects being any sort of loss of feeling in lower calves and ankles. She asked do you guys cover the cost of the emergency room visit. She mentioned when she goes to the emergency room and tells them; she has a fast heartbeat as well; did she submit that emergency room ticket to Pfizer or not. She mentioned the information sheet in front of her, asked was that who she should contact regarding emergency room cost coverage. She reported her dad was an attorney and she would just have him handle this. She did not need this in her life; she had no expectation of it being this bad considering the first one was maybe a little tiredness. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Fever, chills, nausea, vomiting, body aches, joint aches. 48 hours
Systemic: Fainting / Unresponsive-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild
They have administered an expired DAPTACEL to a 1 year and 6 months old patient with no reported adverse event.; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old female patient who was administered an expired diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] with no reported adverse event.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (HIBERIX) for Prophylactic vaccination.  On 30-Sep-2022, a 1 year and 6 months old patient received an expired 0.5 ml, (once) dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot C5774CA, expiry date 18-Sep-2022, strength: standard) via intramuscular route in the left thigh for immunization with no reported adverse event. (expired product administered).  Action taken: Not applicable.  Outcome: Unknown  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.
Pt reporting on 11/25 (4 days after vaccine administration): Woke up on 11/22 with feeling of fever (heat) in the shoulder/upper arm.  When asked, no fever reported for the whole body.  Over the next two days, the red swelling made it down to about an inch above the elbow joint and swelled up "like a fat sausage" and was not able to lift the arm above shoulder level for that time.  Swelling had since resided to normal on the 25th, though some redness was reported to remain.   I was not able to directly observe the rash, but informed pt that if the swelling or rash were to get worse to report to the Dr.  Following up with the dr about the appropriateness of a second observation was also suggested.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 10-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
He had very sore muscle aches the next morning; This is a spontaneous report from a contactable consumer. An adult male patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 2020 at a single dose, for covid-19 immunization. Medical history included covid-19.  The patient's concomitant medications were not reported.  The patient stated that he had very sore muscle aches the next morning (2020). The outcome of event was recovered.    Information on the lot/batch number has been requested.