chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My hand and fingers were swollen and, unable to stretch fingers; Fingers were very stiff; My hand and fingers were swollen and, unable to stretch fingers; Fingers were very stiff; Mild headache at back of neck; swollen lymph nodes; This is a spontaneous report from a contactable other-health care professional (patient). A 60-year-old non-pregnant female patient (not pregnant at the time of vacciantion) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via intramuscular route of administration in right arm on 04Feb2021 at 10:00 AM (at the age of 60 year old) as single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK4176), via intramuscular route of administration in right arm on 14Jan2021 at 10:00 AM (at the age of 60 year old) for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, seizures from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included vitamin c [ascorbic acid]; colecalciferol (D); zinc; elderberry [sambucus nigra]; paracetamol (TYLENOL), high blood pressure med, seizure meds, high cholesterol med. The patient had no other vaccine in four weeks. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 at 02:30 AM, patient experienced hand and fingers were swollen and, unable to stretch fingers; fingers were very stiff; mild headache at back of neck and swollen lymph nodes. The patient did not received treatment due to the events. The outcome of events was recovered on an unspecified date in 2021.   Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
After each injection I've experienced difficulty sleeping the first night, body/muscle aches, chills and feeling tired. After the second dose I also had a headache the next day. Side effects were bearable, but more significant than I've experienced before. I think people should be made aware.
Large (3 inch diameter), red, very bruised area extremely tender to touch on the upper right thigh where vaccine was administered.
Vaccination on Jan 6th 2021 had period on Jan 7th 2021.  I haven't had a period since 7/2019 as I am in postmenopausal.  I had incredible heavy bleeding and cramping till estimated Jan 25th.
SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. 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, expiry: Unknown) 1 total, first dose, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm after initial dose for which he took 2 doses of Tylenol (paracetamol) and the pain was resolved (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) 1 total, booster dose, dose and start therapy date were not reported for covid-19 prophylaxis. The patient took Tylenol before the vaccination to which he had no pain or sore arm following covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
injection site hurt worse with the first shot than the 2nd dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 82 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site hurt worse with the first shot than the 2nd dose".  Additional information: Caller stated her Mother's injection site hurt worse with the first shot than the 2nd dose, she felt it was the technique of the person giving the injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient went to the ER after a syncopal episode. In the evening on 7/17/2023 (day of the vaccine) he started to feel achy with body aches and just general malaise and nausea. He went to the bathroom after going to bed and had to urinate and then got lightheaded. He felt very hot and passed out without injury. His father found him- he was pale and diaphoretic and did not feel well. He had 1 episode of vomiting. No diarrhea, no abdominal pain, no headache. Temperature was 100.2 at home. Went to the ER at 4:30am on 7/18/2023.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GH7694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 16Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crontic obesity  " (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 27Jan2023 to 28Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
none, patient was given 0.3 mL as booster dose instead of 0.25 mL. No adverse effects.
Patient got a Bivalent Pfizer COVID vaccine as his 2nd shot instead of Pfizer primary
Stroke determined by clinical assessment (CMS/HCC) Facial weakness Thrombocytopenia, unspecified
Left shoulder frozen within hours. Could not lift arm for 3 days. Gradually easing one week later. Still sore spot on shoulder. Within 24 hours of injection developed rash on inner arms (both) and rash above breast to armpit on both arms. One week later not visible.
Body aches, night fevers, malaise for 1 week. Cough - last week 12/16/11, sore throat, ear ache. Malaise continues.
pain lasting 2 months at injection site, only  hurts when push on it, no other symptoms currently
Hot at injection site; Hardness at injection site; Redness at the injection site and darker in the middle/ Arm stayed red; Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site and darker in the middle/ Arm stayed red) and VACCINATION SITE PAIN (Soreness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site and darker in the middle/ Arm stayed red) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site and darker in the middle/ Arm stayed red) and VACCINATION SITE PAIN (Soreness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.   This case was linked to MOD-2021-253115 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow-up information received on 11-JUL-2021 contains non significant information.
I feel like I felt I had a like case. I wasn't feeling good, slight runny nose very so I thought would use one of my home COVID-19 test, It came back positive immediately. I called the doctor and let them know I had tested positive. The prescribed the Paxlovid that I started that evening, after the five days I was feeling much better.
The patient had swelling and hot to the touch.  Went to ER and Nurse there told patient that arm was infected.
Next morning diarrhea; Next morning for 2 hours nausea; Fatigue that day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Next morning diarrhea), FATIGUE (Fatigue that day) and NAUSEA (Next morning for 2 hours nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep disorder NOS. Concomitant products included TRAZODONE for Sleep disorder NOS, FLUOXETINE HYDROCHLORIDE (PROZAC), LAMOTRIGINE (LAMICTAL) and VITAMIN B COMPLEX for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Fatigue that day). On 10-Mar-2021, the patient experienced DIARRHOEA (Next morning diarrhea) and NAUSEA (Next morning for 2 hours nausea). On 09-Mar-2021, FATIGUE (Fatigue that day) had resolved. On 10-Mar-2021, NAUSEA (Next morning for 2 hours nausea) had resolved. At the time of the report, DIARRHOEA (Next morning diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took coffee for fatigue and it  went away.
Rash to immunization site - 7 days after vaccination, also having low grade temps -99-100: unusual fussiness. Area is raised and hardened.
significant pain at the site of injection. Started 12 h after admin. Still present 5 days later. Full ROM which has improved. Awaiting CPK isoenzymes. Administered at a different clinic. We are dealing w/ the side effect.
About 1 hr after admin, erythema developed at site of VARIVAX injection 10cm diameter - sore. Saw Dr given antibiotic - told to take TYLENOL or Ibuprofen.
Information has been received from a physician concerning a 20 year old female who, on 29-MAY-2007 was vaccinated with a 0.5mL dose of Gardasil (Lot# 657737/0522U). On 08-JUL-2007 the patient experienced dizziness "on and off." An MRI, Chest X ray, EKG, and lab work were performed. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician and a nurse concerning a 20 year old female who, on 29-MAY-2007 was vaccinated intramuscularly in the left arm with a 0.5mL dose of GARDASIL (Lot# 657737/0522U). Concomitant vaccination on 29-MAY-2007 included VAQTA (657304/0246U) administered intramuscularly into the right arm. On approximately 07-JUN-2007 the patient complained of dizziness (previously reported as 08-JUL-2007 the patient experienced dizziness "on and off"). The signs and symptoms worsened with movement. On 15-JUN-2007 the patient complained of feeling hot. On 19-JUN-2007 an MRI, Chest X ray, EKG, and lab work were performed and were all negative. The patient sought unspecified medical attention. In August 2007 the signs and symptoms resolved on their own and the patient recovered. No product quality complaint was involved. Additional information is not expected.
1 inch knot located in center of arm/knot above her arm pit inside that is visible/knot is an inch big/knot moves with the arm; knot is extremely sore; woke up this morning to the AE; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (1 inch knot located in center of arm/knot above her arm pit inside that is visible/knot is an inch big/knot moves with the arm), NODULE (knot is extremely sore) and SLEEP DISORDER (woke up this morning to the AE) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included Nerve damage and Back surgery. Concurrent medical conditions included Diabetic, Epileptic seizure, Asthma and COPD. Concomitant products included PREGABALIN (LYRICA), LAMOTRIGINE, TOPIRAMATE (TOPIRAMAX), ATORVASTATIN, OMEPRAZOLE, ALBUTEROL [SALBUTAMOL], ERTUGLIFLOZIN PIDOLATE (STEGLATRO) and Breathing Treatments for an unknown indication.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced AXILLARY MASS (1 inch knot located in center of arm/knot above her arm pit inside that is visible/knot is an inch big/knot moves with the arm), NODULE (knot is extremely sore) and SLEEP DISORDER (woke up this morning to the AE). At the time of the report, AXILLARY MASS (1 inch knot located in center of arm/knot above her arm pit inside that is visible/knot is an inch big/knot moves with the arm), NODULE (knot is extremely sore) and SLEEP DISORDER (woke up this morning to the AE) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medication included breathing treatments 3 times a day.  Treatment information was not provided.
Information has been received from a healthcare worker concerning a female (age unknown) with no allergies who, on an unspecified date, was vaccinated intramuscularly with a 0.5mL dose of Pneumovax 23 (651401/0619F).  Subsequently, on an unspecified date, the patient developed redness all over the injection site down to the elbow.  At the time of this report, the patient recovered.  No product quality complaint involved.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
TINGLING IN HANDS, FEET, FACE, EARS, SLIGHT CHEST TIGHTNESS
This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and the inflammation spread to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is eight of eight. See A0956566A, A0956567A, A0956568A, A0956569A, A0956570A, A0956571A and A0956572A for details regarding the additional cases.
pt recv vax 8JAN98 & 20JAN98 pt exp temp 101 & a bumpy maculopapular rash on trunk & anterior legs;the rash was pruritic;pt also devel acne;pt was seen by MD;pt recovered;
Severe local reaction with swelling to baseball size in left leg. Treated with ice initially, FOC took child to an ER they gave child Denicef. Child had a PPD same day as immunizations developed no reaction.
coughing; swelling under his left arm; kept him up; yelling at my wife is a side effect too; eight hours later patient had fever; chills; lymph nodes are swelled up; Frequent pain in knee; still has a fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too) and PYREXIA (still has a fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PYREXIA (still has a fever). On an unknown date, the patient experienced COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too), PYREXIA (eight hours later patient had fever), CHILLS (chills), LYMPHADENOPATHY (lymph nodes are swelled up) and ARTHRALGIA (Frequent pain in knee). The patient was treated with PARACETAMOL (TYLENOL) on 02-Sep-2021 for Adverse event, at a dose of 1 dosage form and IVERMECTIN for Adverse event, at a dose of 1 dosage form. At the time of the report, COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too), PYREXIA (eight hours later patient had fever), CHILLS (chills), LYMPHADENOPATHY (lymph nodes are swelled up) and ARTHRALGIA (Frequent pain in knee) outcome was unknown and PYREXIA (still has a fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medicine: Patient took advil on 03-sep-2021 for fever  No concomitant medicine were reported by the reporter
This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EL0142), via an unspecified route of administration on 12Jan2021 at a single dose on the right arm because she doesn't want to get Covid. Medical history includes the patient being sick before she got the shot, she had the flu since an unspecified date in Dec2020 during Christmas time. She didn't feel well before. She thought it was Covid and her friend was also sick that time and did have Covid. She stated that her own symptoms were like the flu, no fever, just regular flu symptoms. There were no concomitant medications. The patient reported that got her first vaccine this past Tuesday, 12Jan2021. She has been fine, but her arm is quite red since an unspecified date in Jan2021, and was tender since 13Jan2021 but was not hurting. When she took off the band aid the next day to take a shower, everything was okay. On Thursday, 14Jan2021 when she woke up she noticed redness and it was tender. SHe added that her arm is quite red and tender to the touch. She was asking if she should put hear or ice on it or just leave it alone. She wanted to know if this was normal. She stated that she has had a dull headache since an unspecified date after receiving the vaccine. Her arm was also swollen on an unspecified date after receiving the vaccine  and sore. The patient wants to know if there are any recommendations for treatment. The outcome of the event vaccination site erythema was not recovered, the outcome of the event vaccination site pain was recovering the outcome of the other events was unknown.
Information has been received from a physician concerning a 19 year old male who on 07-FEB-1994 was vaccinated only with a first dose of MMR II.  On 09-JAN-2010 the patient experienced mumps.  The patient was diagnosed with mumps on 11-JAN-2010.  Other symptoms presented by the patient included parotitis in both sides.  The patient was afebrile.  First blood work test performed on 11-JAN-2010 included IgM (0.28), IgG (3.81) and amylase (184).  The final outcome for mumps was not reported.  This is one of several reports form the same source.  No further information is available.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In SEP-2021 (last week from date of report), the patient felt flu-like symptoms which quickly resulted in what patient could only describe as the worst flu patient had ever experienced. It was confirmed through PCR (polymerase chain reaction) testing that patient was positive for COVID (confirmed clinical vaccination failure and confirmed COVID-19 infection). It was 5 consecutive days of being mostly bed-ridden with fevers, chills, and body aches. On 15-SEP-2021 was the first day that patient started to feel better, although could not smell or taste anything. The experience of catching COVID did not result in hospitalization.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed COVID-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0 20210936258-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. 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: SPECIAL SITUATIONS.
Patient complained of itching from the shoulder to the elbow in the arm where the injection was given after one minute.  Patient was given 50mg of Benadryl orally 2 minutes after complaint.  Patient remain in the pharmacy area for 40 minutes before going home.  Patient reported that her arm was not itching as much but just felt very drowsy.
patient was admitted on 8-15-22 with weakness which was found to be acute inflammatory demyelinating polyneuropathy. The patient was then transferred to the Inpatient rehab unit on 8-30-22.