chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unable to walk due to extreme knee pain; unable to walk due to extreme knee pain; Extreme itchiness all over body; shooting muscle pain all over body; This is a spontaneous report from a non-contactable Healthcare professional (patient herself). A 30-year-old female patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on the left arm on 05Aug2021 at 03:30 PM (at the age of 30-year old) at single dose for COVID-19 immunization at pharmacy/drug store. Relevant medical history was none. Concomitant medications were not reported. On 07Aug2021, 24-48 hours after shot the patient was unable to walk due to extreme knee pain. One week after shot the patient experienced extreme itchiness and shooting muscle pain all over body. No treatment was received due to events. They resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
When giving MMR the MA accidentally used Menactra as the Diluent instead of a sterile Diluent. the combined MMR + Menactra was given to the patient
still getting some body aches and pain; still getting some body aches and pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Feb2021, as a single dose for COVID-19 immunization. The patient's medical history included arthritis. Concomitant medications included paracetamol (TYLENOL) and naproxen sodium (ALEVE). The patient explained he was "still getting some body aches and pain" on an unspecified date. He asked was that normal after the shot. He then added he stopped taking his pain medication, "Tylenol and Aleve", one day before the receipt of the first dose of the vaccine and hasn't taken anything since then. He specified he usually took those pain medications for his "arthritis". The patient also asked could he took pain medication such as Tylenol or Aleve with the vaccination. If so, how long before getting the second dose should I stop taking them. Outcome of the events was not reported.  Information on lot/ batch has been requested.  Follow-up attempts are completed. No further information is expected.
10 minutes after injection my left hand became numb.  Sensation returned about an hour later, but I noticed later that night that my left leg was tingly, trembling, slightly throbbing in the skin layer, kind of like electricity (nerves?).   My hands/fingers have felt numb before sometimes, not lately but I?m glad it stopped.  The leg thing is different, and I?ve been noticing it since the evening of the injection on the same side.  There were a few quick needle pains in calf.  Last night my left foot had a slight burning sensation.  I don?t notice it at all times, it?s sometimes noticeable through the day and more so towards evening.
1/25/2021 11:59:51 AM >  1145: BP 138/74, P 73, O2 98 Five minutes after receiving vaccine patient c/o numbness and tingling in L arm where vaccine was administered with radiating pain to L shoulder, RN added 10 minutes to observation and educated patient to go to the nearest ER if symptoms aren't resolved 1/26/2021 09:08:07 AM > called to check on patient, message left
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date in November 2013, the patient was vaccinated with GARDASIL dose 1, standard dose, intramuscularly. On 30-JAN-2015, the patient was vaccinated with GARDASIL dose 2. No adverse effect was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
dizziness; Foggy feeling in head; facial rash; fatigue; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness), FEELING ABNORMAL (Foggy feeling in head), RASH (facial rash) and FATIGUE (fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Hypertension.   On 09-Mar-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 and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In March 2021, the patient experienced DIZZINESS (dizziness), FEELING ABNORMAL (Foggy feeling in head), RASH (facial rash) and FATIGUE (fatigue). At the time of the report, DIZZINESS (dizziness), FEELING ABNORMAL (Foggy feeling in head), RASH (facial rash) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: 150/95 (High) Elevated. On an unknown date, Blood pressure measurement: 115 to 130 (Inconclusive) 115 to 130 and 70 to 80 (Inconclusive) 70 to 80.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included anti-hypertensive medication. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.
12/26/2020 The patient received the COVID vaccine. 12/27 the patient began noticing injection site swelling, fever, chills, body aches, and general fatigue that was helped with the use of Tylenol. These symptoms continued until 12/30 and decreased to bilateral knee and back pain. The patient denies any cough, or runny nose. During the end of the interview, the patient reported constipation.
Localized reaction at site injection 8 days after injection. Raised bumps, red, itchy.
Patient received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and indicated lot maintained activity necessary to protect against covid 19.  Patient also did not call in to complain of any adverse events.   This is administrative error without adverse event.
PT REPORTED ON 10/4/08 THAT HER UPPER ARM WAS SIGNIFICANTLY SWOLLEN TO THE ELBOW.  IT WAS ALSO VERY RED AND ITCHED. PT USED ICE ON THE ARM BUT DID NOT SEEK MEDICAL ATTENTION. ON 10/6/08 PT REPORTED THAT THE REDNESS WAS GONE. SHE WAS STILL EXPERIENCING SOME ITCHING, AND HAD SOME SWELLING IN THE UPPER ARM NEAR THE ELBOW.
This is a spontaneous report from a contactable consumer. A 71-year-old female patient received PREVNAR 13 (Lot number and Expiration date were not reported), with route of administration unspecified in Oct2017 at a single dose as pneumonia vaccine. Medical history included cancer and high blood pressure, both were ongoing; and a family history of pneumonia (husband died from pneumonia). Concomitant medications included an unspecified blood pressure medication. In Jan2018, the patient had ear ache; and a lot of mucous. On an unspecified date, the patient had flu-like symptoms; and had some discomfort in her arm when getting a flu shot; and had an upper respiratory infection. The outcome of the events was not recovered for 'ear ache' and 'a lot of mucous'; and was unknown for all the other events.
patients left neck , jaw, is exremely swollen and hurts to swallow. Recommended for patient to go to urgent care and I followed up with her primary care doctor  within a hour of her reporting.
The patient had a her primary series of covid vaccination completed with the pfizer vaccine. She reported no issues with the first dose but experienced tingling in the left arm and face immediately after the second injection in the Spring. She chose to get the moderna booster just in case the adverse event was due to the pfizer vaccine. After receiving the moderna booster she started experiencing the same tingling in the entire left arm, neck, and left side of the face just like before. The tingling was unilateral in presentation. Patient described the sensation to being similar to the sensation of a novocaine injection. The event started within 5 minutes of the injection and lasted a few hours before resolving.
has epilepsy due to seizure following MMR II vaccination.; This spontaneous report was received from a physician and refers to her daughter, a 16-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).   On an unknown date, the patient has epilepsy due to seizure following measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination. At the time of reporting, the outcome of the event was unknown.  The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  Upon internal review, the event epilepsy due to seizure was determined to be medically significant.
PSORIASIS SYMPTOMS INCREASED IN INTENSITY AND SPREAD OVER LARGER PORTIONS OF BODY; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, and other pre-existing medical conditions included: The patient had relatively healthy and strong except from psoriasis. 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 26-JUN-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 26-JUN-2021, the patient experienced psoriasis symptoms increased in intensity and spread over larger portions of body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis symptoms increased in intensity and spread over larger portions of body. This report was non-serious.
Patient sought treatment in the ED.  Chief complaint includes chest pain, body aches, headache, and generalized fatigue all beginning 25 minutes after vaccination.  Symptoms resolved and patient was discharged from ED.
Urinary tract infection; A spontaneous report was received from a consumer who was also an 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a urinary tract infection (UTI).  The patient's medical history included voice larynx disorder "frozen".  Concomitant product use was not provided.     On 01-Feb-2021, prior to the onset of the event, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24-Feb-2021, the patient developed a UTI. Treatment included antibiotics prescribed, but not taken by the patient.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event of UTI was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, patient's advanced age may have been contributory.
a red area around where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a red area around where she got the shot) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (a red area around where she got the shot). At the time of the report, VACCINATION SITE ERYTHEMA (a red area around where she got the shot) outcome was unknown.            Reporter did not allow further contact
Patient developed CP/SOB approx 10 days post vaccination with SPV, CP occurred mostly with running PT. Continues to have some CP and SOB with exertion. Symptoms: Chest Pain, Dyspnea (shortness of breath). 10/09/2008 Office records received.  Pt presented 9/5/08 with c/o sharp chest pain while running as well as knee pain. PE (+) for L pectoral tenderness to palpation. Assessment:  Muscloskeletal chest pain. Tx with Motrin. F/U 9/12/08 -feeling much better.
Patient presented to pharmacy two days after vaccine with redness, swelling, and itching at injection site
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUL-2016, the patient was treated at an urgent care facility, (by an unspecified healthcare professional), for a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Fever 102 for 24 hours; Nausea; This is a spontaneous report from a non-contactable consumer. A male patient of 15-year-old received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Jul2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Jun2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On 18Jul2021, the patient experienced fever 102 for 24 hours and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. On 18Jul2021, the patient underwent body temperature and the result was 102(Units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever and nausea was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red spot after Moderna shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spot after Moderna shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Red spot after Moderna shot). At the time of the report, RASH MACULAR (Red spot after Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Severe myalgias arms, legs, back began w/in 24 hrs persisted unchanged x 17 day pain inc; ESR 41; temporal artery neg; no arthralgias;
body malaise, back ache. muscle pain, joint pain, fever as high as 102F started  4 hrs after receiving the vaccine . treatments- rest, back massage, tylenol
rash, red, raised difused, warm to touch on cheeks, fore arms, to a lesser degree on upper arms and legs, does not itch. No fever or other symptoms.
3 days of fever (102F), body aches, vomiting, head aches, nausea, chills, fatigue, lack of appetite, sore/pressure ear drums. Fatigue, headaches, and nausea continued for another 6 days (9 days total since vaccine). Menstrual cycle  also affected, where period started 5 days early.
erythma-swelling-itching over the lt deltoid area surrounding the inject site shortly p/inject; gradual improvement over few days; cont 6 wks later to have subcutaneous 2x2 dense fibrous nodule, non tenderness around the site of inject;
This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of injection site pain in an unknown number of subjects of unspecified age and gender who were vaccinated with FLUARIX (GlaxoSmithKline). In 2013 the subjects received a dose of FLUARIX (unknown details, unknown deltoid). In 2013, either immediately after vaccination or within the same day as vaccination with FLUARIX, the subjects experienced injection site pain. The nurse stated that she recently conducted a flu clinic. She believed that "it is possible that the FLUARIX vaccine contributed to the events because approximately 80 percent of these patients experienced pain at injection site either immediately after vaccination or within the same day." The nurse stated that "at some point" during the flu clinic, she "changed the size of needle going from a short to long one and believes that helped." The exactly number of subject was unknown and no further details were known at the time of reporting. At the time of reporting the event was not resolved. The nurse stated that "each event only lasted a brief period of time." The healthcare professional considered the event was possibly related to vaccination with FLUARIX.
A week after vaccination, injection site was extremely tender and felt like a burning sensation until current date (about two weeks time) and is not subsiding
Dry tongue, fast heart beat, redness and inflammation on vaccination area, inflammation of node in the vaccination arm and joint and muscle pain. Chills, headache and change of taste.
Father stated: Had fever 102 degrees F highest. Started on Sat. 11/28/2009, lasted Sun and Mon. Student back to school 12/2/09.
My temp went up from 96 to 100. I woke about midnight and had a terrible migraine and I had to stay in total darkness. It continued for about 14 hours and started to go away.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster) single (Batch/Lot number: unknown) and as dose 4 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Mental illness" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 18Mar2023.
Swelling in face, hands and ankles.; Swelling in face, hands and ankles.; Swelling in face, hands and ankles.; Mild numbness and redness in hands; Mild numbness and redness in hands; rash in veins; This is an Initial (PRD/SRD 07Apr2021) and Follow-up (PRD 07Apr2021/SRD 09Apr2021) spontaneous report from a contactable reporter (patient, self-reported). A 64-year-old female patient (age at vaccination:64 years) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7533 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Apr2021 at 09:45 AM, as a single dose for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: PAA165969 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 05Mar2021 at 07:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included Hashimoto's disease, hypotiroidism, arterial hypertension, and allergies to medications, food, or other products: Penicilina. Concomitant medications included levothyroxine and lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05Apr2021 at 17:30, the patient experienced swelling in face, hands and ankles and mild numbness and redness in hands and rash in veins. The patient did not receive treatment for the adverse event. No lab data was available. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
pt recvd vax 16NOV92 & 17NOV92 exp lightheadedness, nausea, fever w/aching of the injected arm;
Left shoulder pain started the day after the injection. This is not uncommon for me, but it is still ongoing even today. The course went as follows: 1 week = shoulder discomfort similar to past flu shots, wk 2 = extreme pain, barely able to undress, wk 4 = pain and extreme weakness, barely able to blow-dry my hair, wk 6 = pain with full arm rotation or extension with aerobic exercise and wt lifting, currently (almost 60 days later) pain with full arm extension over my head, but otherwise much improved.
it gave the flu; not feeling well; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (internal employee) via Medical Information (MI) via call center (Reference number- 00339572) and transmitted to Sanofi on 30-Oct-2020.  This case involves a female patient (age not reported) who experienced flu (influenza) and was not feeling well (malaise), after she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and was not feeling well (malaise) unknown latency following the administration of INFLUENZA VACCINE.  The caller does not know any details about the flu vaccine she had received.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.