chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling and numbness into the right shoulder neck and head; tingling and numbness into the right shoulder neck and head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 16Feb2021 (Lot number: EN6200) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Vitamin c for allergy, notes: She took a massive dose of Vitamin C in the past because of an allergy. Vaccination history included: Bnt162b2 (Dose:1, /EXP: Unknown, LOT: EL9262, Dose: Unknown, Route: injected into right shoulder), administration date: 25Jan2021, for COVID-19 Immunization, reaction(s): "little bit of pain in the right shoulder". The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 16Feb2021, outcome "recovered" (16Feb2021) and all described as "tingling and numbness into the right shoulder neck and head".  Additional information: No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She had no relevant tests. AEs did not require a visit to Emergency Room or Physician Office.  Follow-up attempts are completed. No further information is expected.
had some chills; fever broke and came back; shoulder in pain; Felt "wiped out"; had the shakes; very lethargic much more so than first shot; could barely eat; felt pretty crappy; fever up to 103; lethargic; sore shoulder; Had to change shirts due to sweating throughout the night; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), TREMOR (had the shakes), LETHARGY (very lethargic much more so than first shot), FEEDING DISORDER (could barely eat) and FEELING ABNORMAL (felt pretty crappy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (under control) and Type 2 diabetes mellitus (under control). Concomitant products included NYSTATIN (STATIN [NYSTATIN]) and LISINOPRIL for Hypertension and Type 2 diabetes mellitus, SEMAGLUTIDE (OZEMPIC) and METFORMIN for Type 2 diabetes mellitus.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced NIGHT SWEATS (Had to change shirts due to sweating throughout the night). On 12-Jan-2021, the patient experienced LETHARGY (lethargic) and ARTHRALGIA (sore shoulder). On 09-Feb-2021, the patient experienced PYREXIA (fever up to 103). On 10-Feb-2021, the patient experienced TREMOR (had the shakes), LETHARGY (very lethargic much more so than first shot), FEEDING DISORDER (could barely eat), FEELING ABNORMAL (felt pretty crappy), PYREXIA (fever broke and came back), ARTHRALGIA (shoulder in pain) and FATIGUE (Felt "wiped out"). On 12-Feb-2021, the patient experienced CHILLS (had some chills). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 200 mg and PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, LETHARGY (lethargic) had not resolved, TREMOR (had the shakes), LETHARGY (very lethargic much more so than first shot), FEEDING DISORDER (could barely eat), FEELING ABNORMAL (felt pretty crappy), NIGHT SWEATS (Had to change shirts due to sweating throughout the night), CHILLS (had some chills), ARTHRALGIA (shoulder in pain) and FATIGUE (Felt "wiped out") outcome was unknown, ARTHRALGIA (sore shoulder) was resolving and PYREXIA (fever up to 103) and PYREXIA (fever broke and came back) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, Body temperature: 96.1 to 101 (High) fever ranged from 96.1 to 101 degrees fahrenheit. On an unknown date, Body temperature: 103 (High) went up to 103 degrees F overnight.         Treatment medications included 2 acetaminophen 500mg and 4 ibuprofen 200mg. Both were taken 2 times.
soreness in arm that moved to collar bone; heaviness; as the night went on it was a little heavy and sore and soreness went into collar bone and a little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness in arm that moved to collar bone), LIMB DISCOMFORT (heaviness) and FATIGUE (as the night went on it was a little heavy and sore and soreness went into collar bone and a little fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (soreness in arm that moved to collar bone), LIMB DISCOMFORT (heaviness) and FATIGUE (as the night went on it was a little heavy and sore and soreness went into collar bone and a little fatigue). On 10-Mar-2021, PAIN (soreness in arm that moved to collar bone), LIMB DISCOMFORT (heaviness) and FATIGUE (as the night went on it was a little heavy and sore and soreness went into collar bone and a little fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Treatment for the events were not provided   This case was linked to MOD-2021-070615 (Patient Link).
leg pain and hand pain; back pain; vertigo; difficulty walking; difficulty sleeping; arthritis gotten worse; hip pain and knee pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain and hand pain), BACK PAIN (back pain), VERTIGO (vertigo), GAIT DISTURBANCE (difficulty walking) and INSOMNIA (difficulty sleeping) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle fracture and Arthritis.    On 13-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 PAIN IN EXTREMITY (leg pain and hand pain), BACK PAIN (back pain), VERTIGO (vertigo), GAIT DISTURBANCE (difficulty walking), INSOMNIA (difficulty sleeping), ARTHRITIS (arthritis gotten worse) and ARTHRALGIA (hip pain and knee pain). At the time of the report, PAIN IN EXTREMITY (leg pain and hand pain), BACK PAIN (back pain), VERTIGO (vertigo), GAIT DISTURBANCE (difficulty walking), INSOMNIA (difficulty sleeping), ARTHRITIS (arthritis gotten worse) and ARTHRALGIA (hip pain and knee pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.   This case was linked to MOD-2021-257873.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non significant follow-up. On 14-Aug-2021: Follow-up information contains action taken update from  Unknown to No change.
After both doses of Covid-19 vaccine, I had little patches of hives all over my body.  14 days after the 2nd dose, I took Prednison, 50 mg each for 7 days.  The hives went away.
Big round red itchy circle at injection site; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Big round red itchy circle at injection site) and NAUSEA (nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included COPD.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Big round red itchy circle at injection site) and NAUSEA (nauseous). At the time of the report, INJECTION SITE ERYTHEMA (Big round red itchy circle at injection site) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment and concomitant medication provided
Administered Moderna Covid-19; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Administered Moderna Covid-19) 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 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Administered Moderna Covid-19). On 24-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (Administered Moderna Covid-19) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided. Treatment medication information not provided .
woke up with severe lower back pain; have swollen and tender lymph node in left armpit; have swollen and tender lymph node in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer"), for COVID-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset Oct2022, latency 46 hrs after the suspect product(s) administration, outcome "unknown" and all described as "have swollen and tender lymph node in left armpit"; BACK PAIN (non-serious) with onset 22Oct2022, outcome "not recovered", described as "woke up with severe lower back pain". Therapeutic measures were taken as a result of back pain.  Additional information: Description of Event: 24 hours after bivalent booster in left shoulder, woke up with severe lower back pain, necessitating heavy NSAIDS and a lidocaine patch.46 hours after booster woke up with lower back pain again, and have swollen and tender lymph node in left armpit. Optional Information: Booster provided at Withheld site health services, obtained after 8 am on Friday 21Oct. Did not have any unexpected issues until yesterday morning. Event took place after use of product.  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.
2/22/03 - 4 p.m. PT presented to center with redness, swelling and warm to touch - Right arm - reports had pneumo vax injection day before.
Vomiting, diarrhea, fever, chills started within 6-8 hrs of receiving vaccine, 5 lb wt loss w/i 24 hrs.
Pt states 10/20 pm if felt like somebody had stomped on me.  My neck, arms, and back starting hurting and felt really sore.  Wednesday 10/21 was about the same & Thursday 10/22 I felt better so I didn't call the office.  But Friday 10/23 about 4 AM I woke up drenched in sweat with a bad headache & soreness.  I could feel a migraine coming on so I went to Urgent Care.  They sent me to the ER for a spinal tap.  The ER said I had a reaction to the flu shot.
Fever over 101 degrees F., chills, dizziness, headache, sweats, body aches, and swollen glands lasting for 24 hours. Headache and swollen glands persisted for 7 days. Continue to have headaches and swollen glands come and go daily.
5 cm left neck mass became very noticeable fairly rapidly on Thursday three days after vaccination.  left ear pain, left jugulodigastric neck mass, and headache.
Tues PM 5NOV91 low stomach cramps hurt to sit; no fever; sl diarrhea @ first; not seen by MD; Husband has similar sx but did not last as long; 13NOV cramping & lots of gas but feeling much better;
2nd dose of Pfizer on Feb 27th 2021, I experienced extreme vertigo, dizziness even with my eyes closed, tinittus, extreme fatigue, for 6 months, irregular bleeding-very scary. Migraines increasing to daily occurrence. I took medication for vertigo and saw doctors often
got the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (got the vaccine while pregnant) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Jul-2020 and the estimated date of delivery was 09-Apr-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (got the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (got the vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's last menstrual period was recorded as 7-3-2020 with a positive pregnancy test on 7-29-2020.The estimated date of conception is recorded as 7-17-2020.  Before the patient was administered MDRNA COVID Vaccine, the patient had undergone 4 pregnancy ultrasounds each one at 6 w,15w,20w and 26w and a glucose tolerance test as part of her pre-natal care regime.  Patient has no history of sub-fertility.  Patient reported prior use of alcohol.
Patient inadvertently received the Fluad vaccine for patients over 65 despite being <65 years of age.  Patient reported feeling pain at injection site the evening he received the vaccination (11/10/23). He stated his arm was still slightly sore the next morning  (11/11/2023) but then resolved. He states his symptoms were not severe enough for him to find it necessary to take anything to help with the pain. He has completely recovered from the adverse event.
11x11cm erythematous swelling with warmth over R deltoid area after Td vaccine (+) pruritus. Tx: Zyrtec 10g, hydrocortisone 1% cream, Lytin 500 bid x 10d.
Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR), AMLODIPINE, MELOXICAM, METHOTREXATE, SULFASALAZINE, ONDANSETRON, VITAMIN D2 and FOLIC ACID for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (chills). At the time of the report, PYREXIA (Fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient had high fever and chills 7-8 hrs after vaccine.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Gout Breakout; This spontaneous report was received from a consumer on 04JAN2021 refers to a female patient who received the Moderna COVID-19 vaccine and experienced a "gout breakout".  The patient's medical history was not provided. Concomitant medications were not reported.   On 02JAN2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: not provided). Two days later on 04JAN2021, the patient developed a gout flare, reporting, gout breakout.  The patient agreed to safety follow-up as she stated that she has not taken the medicine for the gout, fearing a potential drug interaction.  The action taken for Moderna COVID-19 Vaccine was not reported. The outcome of the event, gout breakout, was not reported. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, interruption of medicine for the gout is considered a confounder.
Started with arthralgias and myalgias. POTS. Lower extremity edema. Neuropathy with burning sensation in legs. Entire body itching. Fatigue.  Tried Aspirin(helped), Plavix (stopped after 3 weeks since no improvement), Pepcid +Claritin helped but did not continue.
Red itchy blood shot right eye with pain and pressure. Pressure to bilateral eyes apx 1 week later. On this date still has intermittent bilateral eye pressure , itchiness and rt eye scratchiness.
Slow onset of facial edema, pruritus & hives to face, neck, axillary spaces & antecubital spaces. Sx's started 2 hrs post/vax. TX: Benadryl 50mg, given deep IM and 1 dose of EPI 1-1,000 0.3ml sq.
Complaint of elevated temperature, sore/scratchy throat, headache, runny nose/congestion, myalgia and malaise.
Narrative: COVID infection following COVID vaccine series 03/24, Moderna, dose #1 04/22, Moderna, dose #2 08/13 pt cc: cough, fever, sore, throat, exposure: unknown 08/26 COVID swab, result: detected 08/26 COVID swab, result: not detected.
Pt was due for HepB, hib, IPV. I gave Pentacel overlooking the fact that it has DTaP in it when she was not due for DTaP.
Fatigue; Chills; Brain fog; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) on 13Jan2021 16:15 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. On 13Jan2021 17:45, the patient experienced Fatigue, chills, brain fog, headache. No treatment was given for the events. The outcome of the events was recovering. The patient has no Covid prior vaccination and was not tested post vaccination.  Information on the Batch/Lot number has been requested.
The pt experienced a large area around the injection site that was still red and swollen. The DTaP was given at that injection site.
Shortness of breath; Runny nose; Cough off and on; Fever; Headaches; Fatigue; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick), DYSPNOEA (Shortness of breath), RHINORRHOEA (Runny nose), COUGH (Cough off and on) and PYREXIA (Fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Jan-2021, the patient experienced MALAISE (felt sick). On 09-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), RHINORRHOEA (Runny nose), COUGH (Cough off and on), PYREXIA (Fever), HEADACHE (Headaches) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 16-Jan-2021, RHINORRHOEA (Runny nose), COUGH (Cough off and on), HEADACHE (Headaches) and FATIGUE (Fatigue) had resolved. At the time of the report, MALAISE (felt sick), DYSPNOEA (Shortness of breath) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.. In January 2021, Body temperature: 100-101 (High) between 100 to 101..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicationswere not provided.
This is a spontaneous report from a non-contactable healthcare professional. An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), intramuscular in right arm, on 25Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15-minute waiting period after the injection on 25Jan2021, the patient began to experience burning in her throat. The patient denied difficulty breathing, difficulty swallowing, and throat tightness. They were monitoring the patient for severe reaction symptoms, including but not limited to treatment including antihistamines. Follow-up response to treatment was good. The patient was discharged - stable to go home and was asked to follow-up with primary care physician for rapid progression of symptoms and respiratory distress (if observed). The patient recovered from the event on 25Jan2021. No follow-up attempts are possible. No further information is expected.