chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles flare up; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles flare up) and PAIN IN EXTREMITY (arm soreness) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Acid reflux (oesophageal), Neck pain and Shingles. Concomitant products included ESOMEPRAZOLE for Acid reflux (oesophageal), CELECOXIB for Neck pain, VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, VALPROATE SEMISODIUM (DEPAKOTE ER), PALIPERIDONE PALMITATE (INVEGA SUSTENNA) and VITAMIN D NOS for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced HERPES ZOSTER (Shingles flare up) and PAIN IN EXTREMITY (arm soreness). At the time of the report, HERPES ZOSTER (Shingles flare up) and PAIN IN EXTREMITY (arm soreness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Aleve for arm soreness.   This case was linked to MOD-2021-089350 (Patient Link).
2/9/06 received vaccines at about 1615.  Pt reports at about 2200 starting having sharp abdomen pain and became lightheaded, everything in vision became red in color. Pt reports vomiting next AM 2x's. Then states saw spots in different colors at times in peripheral vision.
Patient is a 56-y.o. female with PMH of GERD who states that since receiving a COVID-19 vaccination 2 days ago has had progressive swelling, aching and redness in her left arm where she received the vaccination.  Complains of associated lymph node swelling under her left arm and into her neck.  Also complained of onset of phlegmy cough and some burning in her lungs associated with her asthma.  Additionally complained of burning discomfort in her upper abdomen.  Denied associated nausea, vomiting or diarrhea.  States she has had some low-grade fever and chills.  Musculoskeletal:        General: Swelling ( Left arm with mild swelling, erythema and tenderness) present. No deformity. Normal range of motion.     Cervical back: Normal range of motion and neck supple.  Lymphadenopathy:     Cervical: Cervical adenopathy present.     Left cervical: Superficial cervical adenopathy present.     Upper Body:     Left upper body: Axillary adenopathy present.  Skin:    General: Skin is warm and dry.     Findings: Rash ( Burning red rash on the outside aspect of both feet) present. No erythema.  56-y.o. yr old patient with PMH of hypertension and asthma presenting with adverse reaction to COVID-19 vaccination including acute pancreatitis. Lab work showed elevated lipase of 1000, and on examination she had epigastric tenderness: Admitted with acute pancreatitis, and was started on IV fluids
pt had onset of partial sz activity began the evening of vax;this progressed over 2wk to generalized clonic tonic sz & recurrent partial sz;pt had prev sz onset p/vax DTP/OPV/HIB;
A lot of arm pain rating 9 or 10 (from scale of 1 to 10) not constant at the injection site; Tenderness in the arm at the injection site after the second vaccine dose; Soreness in the arm at the injection site after the second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A lot of arm pain rating 9 or 10 (from scale of 1 to 10) not constant at the injection site), VACCINATION SITE PAIN (Tenderness in the arm at the injection site after the second vaccine dose) and MYALGIA (Soreness in the arm at the injection site after the second vaccine dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 025B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    Concomitant products included PARACETAMOL (TYLENOL) and ACETAMINOPHEN for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) (unknown route) at an unspecified dose. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (Tenderness in the arm at the injection site after the second vaccine dose) and MYALGIA (Soreness in the arm at the injection site after the second vaccine dose). On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (A lot of arm pain rating 9 or 10 (from scale of 1 to 10) not constant at the injection site). At the time of the report, PAIN IN EXTREMITY (A lot of arm pain rating 9 or 10 (from scale of 1 to 10) not constant at the injection site), VACCINATION SITE PAIN (Tenderness in the arm at the injection site after the second vaccine dose) and MYALGIA (Soreness in the arm at the injection site after the second vaccine dose) outcome was unknown.            Concomitant medication was not provided Treatment medication includes Cold pack .
SERIOUS HEALTH ISSUES; BLOOD PROBLEMS; This spontaneous report received from a patient via social media via a company representative concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced serious health issues, and blood problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from serious health issues, and blood problems. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Patient received first dose of Moderna COVID19 vaccine at 1030 via IM injection in left deltoid. Prior to injection, patient reported being nervous about fainting. She reported no prior history of fainting due to vaccination or blood draws; she "passed out" two years prior to dehydration at a music festival.  Approximately four minutes after injection, patient stated that she was going to "pass out" and had an episode of syncope. She exhibited pallor, dry heaving, and arm contractures. The nurse helped her to a supine position on the floor and called for assistance. The nurse team encouraged deep breathing and provided apple juice, pretzels, ammonia inhalent, and cool washcloths. EMS was called and arrived at 1045 for further assessment. Patient reported that she had not consumed any food or drink prior to vaccination and stated that her hands were "tingly". EMS took blood pressure and heart rate; both were within normal range. The patient was taken to the hospital by EMS at 1055, where providers determined that syncope was likely caused by anxiety. Patient returned home and reported feeling tired but stable when health department called to check in at 1400.
VACCINE WAS PUT IN SYRINGES AT 0.3ML INSTEAD OF THE AUTHORIZED 0.5ML; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAY-2021, the subject experienced vaccine was put in syringes at 0.3ml instead of the authorized 0.5ml. On 31-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine was put in syringes at 0.3ml instead of the authorized 0.5ml and medication error was not reported. This report was non-serious.
Pt came to ER c/o  weakness onset 3 days prior.  Tachypneic during ER exam.
temp was 104.4 R x 3 days p/immun; also had large red knot w/ inc heat about the size of a coke can on rt thigh; began on day shot was given & fever didn't dec even w/APAP; taken to MD 29FEB94;
Approximately 6 hrs after influenza vaccine began experiencing tingling/swelling to upper lip that progressed to the lower lip by the am.
Elevated temperature and increased heart rate.  Heart rate has been over 110 for more than 2 days.  It is starting to go back down.  Today it is 85-95.  Normal RHR is 68-70.
After receiving first anthrax shot symptoms were headache, fainting, kidney infection, severe joint and muscle pain. While stationed on board a ship fainted during an underway replenishment evolution. Was taken to medical and was prescribed 3 days sick in quarters for physical exhaustion and given Motrin for joint and muscle pain.
Inappropriate route of vaccination; some of the dose ran out down the patient's arm; some of the dose ran out down the patient's arm; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), DEVICE CONNECTION ISSUE (some of the dose ran out down the patient's arm) and UNDERDOSE (some of the dose ran out down the patient's arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     Medical history not provided by the reporter.  Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), DEVICE CONNECTION ISSUE (some of the dose ran out down the patient's arm) and UNDERDOSE (some of the dose ran out down the patient's arm). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), DEVICE CONNECTION ISSUE (some of the dose ran out down the patient's arm) and UNDERDOSE (some of the dose ran out down the patient's arm) outcome was unknown.            This case was linked to MOD-2021-187207 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: follow up information received on 28may2021 contains non significant follow up
lower back pain during sitting  that lasted about 20 hours . patient took ibuprofen 200mg  twice then resolved  for the most part except occasional twinge
Developed angina on exertion about two weeks after the second shot. This cleared in about 6 weeks. Have had a low grade peripheral neuropathy for many years that is well-controlled.  This was exacerbated by after the second shot. This cleared in about 6 months.
Discharge Provider: MD Primary Care Provider: NP Admission Date: 8/12/2022 Discharge Date: Aug 28, 2022  PRESENTING PROBLEM: Respiratory failure with hypoxia [J96.91] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is an 84y/o man with HFpEF, mixed RLD and COPD baseline 3L O2 at home. Previously admitted and discharged this month for  pseudomonas pneumonia and heart failure exacerbation. The patient had a negative COVID test at that time.  The patient was diuresed at that time and completed a course of antibiotics and was sent home on a tapered dose of steroids.  The patient presented emergency room on 08/12/2022 with complaints of orthopnea and worsening hypoxia with oxygen saturation of 70% on 4 L.  COVID test was positive.   In the emergency department, the patient was started on BiPAP, methylprednisolone, DuoNebs and magnesium.  He then was switched to high-flow nasal cannula he and initially required 6 liters/minute of 70% FiO2.  His requirement increased and he ultimately required 95% HFNC.  The patient was afebrile and hemodynamically stable.  Chest x-ray showed improvement in bibasilar airspace disease.  Patient ultimately was admitted to intensive care unit.  Duplex scan was ordered and was negative for DVT but showed likely reactive lymph node in the left groin.   Once his oxygenation requirement decreased to 70% patient was transferred to CC2.  Pulmonary Medicine was consulted, they recommended to stay on dexamethasone 6 mg daily for total of 10 days.  The course was completed on 08/21/2022.  Additionally they had recommended to complete a 7 day course of antibiotic with vancomycin and Zosyn which was completed on 08/18/2022.   Patient's oxygen requirements were trending down and he was eventually transferred out of the CC2 when he was requiring 45% of 30 L HFNC.   The patient remained stable and was weaned down of oxygen slowly. He was weaned to 5L of NC (baseline was 3L). PT/OT was consulted and had recommended subacute rehab initially but while awaiting for SAR he improved significantly and was abe to be discharged home   Of note, the patient glucose level has been elevated during his stay.  Insulin was titrated accordingly to better control his glucose levels.   The patient was discharged home on 08/28/2022 is stable condition.  He was provided with a BiPAP q.h.s. and had respiratory events was informed 5 increase and oxygen requirement.
This spontaneous report as received from a nurse refers to a 11 month old male patient. Patient's concurrent conditions and relevant medical history was not reported. On 02-JAN-2003, 8 days before the patient's 12 month birthday, the patient was vaccinated with first dose of M-M-R II (lot number, dose, frequency and route unspecified) (inappropriate schedule of drug administration). Concomitant medications were not reproted. No adverse effects were reported. The outcome of the events was unkonwn. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. Additional information has been requested.
Information has been received from a 23 year old female patient who "just" (approximately in March 2010) was vaccinated with the third dose of GARDASIL (lot number not reported). The patient stated that on the final injection she had a reaction and her arm became swollen. The patient did not state that she received any medical attention or if the reaction continued. Follow-up information was received from a registered nurse (R.N.) via medical records who reported that on 14-AUG-209, 29-OCT-2009 and 01-MAR-2010, the female chef with no known drug allergies was administered the first, second and third doses of GARDASIL IM in the right arm, respectively (Lot # of 1st and 2nd dose: 661846/1312X, expiration date 11-MAR-2011; Lot # of the 3rd dose: 662529/1317Y, expiration date: 30-MAY-2011). Secondary suspect therapy included DEPO-PROVERA 150 mg administered IM in the left deltoid on 14-AUG-2009, 29-OCT-2009 (Lot #0A2BX, expiration date March 2012) and 19-JAN-2010 (Lot #0A3SA, expiration date May 2012), respectively. It was reported that the patient did not have any problems with the two shots of DEPO-PROVERA on 29-OCT-2009 and 19-JAN-2010 and tolerated well. On 30-OCT-2009 the patient was seen in the department (also reported as patient did not require emergency room/doctor visit) with a complaint of pain at injection site from DEPO-PROVERA. Patient was able to move arm and grip. It was reported that the patient did not typically have pain with the shot. Physical examination showed patient had no redness, and the full range of motion was in the left arm, equal grip bilaterally. The assessment was pain to injection site. Patient was offered alternate water/ice to the affected area, and encouraged arm movement to disperse medications. Therapy with MOTRIN as needed was prescribed and patient was to be followed up if no improvement. The outcome of the events was not provided. Follow-up information was received from the R.N. who reported this was a GARDASIL adverse event from 29-OCT-2009. The patient complained that her left arm was sore but GARDASIL was given in the right arm. DEPO-PROVERA was given in the left arm. The nurse further reported that the patient had not been seen at the office since that time and she had no other updates on this patient. She might contact the patient and would call back if she had any other follow-up. Additional information has been requested.
THE PATIENT COMPLAINED OF PAIN IN THE ARM THE FOLLOWING DAY OF RECEIVING THE VACCINE. THE PATIENT WAS SELF-TREATING THE SYMPTOMS USING IBUPROFEN AND ICE BUT IT GRADUALLY BECAME WORSE. THE PAIN SPREADED TOWARDS THE RIGHT HAND THE FOLLOWING WEEK. THE PATIENT WAS SEEN AT THE ER IN THE MORNING OF 9/8/21 AFTER THE PAIN BECAME UNBARERABLE.
arm was itchy; arm was red; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was itchy), MYALGIA (soreness in arm) and VACCINATION SITE ERYTHEMA (arm was red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K2) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CANDESARTAN, thyroid pill and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MYALGIA (soreness in arm). On 09-Feb-2021, the patient experienced PRURITUS (arm was itchy) and VACCINATION SITE ERYTHEMA (arm was red). The patient was treated with CORTISONE at an unspecified dose and frequency; HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (arm was itchy), MYALGIA (soreness in arm) and VACCINATION SITE ERYTHEMA (arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A day after vaccine, extreme nausea, vomiting uncontrollably, swelling and redness at injection site, arm looked like a golf ball, no appetite, dizzy, extreme joint and muscle pain, fatigue. Was diagnosed as an allergic reaction to vaccine at urgent, given liquid tylenol to cut down fever and joint/muscle pain, anti-nausea pills.
PATIENT WAS SUPPOSED TO RECEIVE THEPEDIATRIC PFIZER BIVALENT BOOSTER SHOT BUT INSTEAD HE RECEIVED THE PEDIATRIC MONOVALENT PFIZER BOOSTER SHOT. PATIENT HAD NOT REPORTED ANY REACTIONS OR CONCERN FROM THE VACCINE.
Sore arm for 2 or 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 2 or 3 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 2001 and Enlarged prostate since 2019. Concomitant products included LISINOPRIL for Blood pressure high, TAMSULOSIN for Enlarged prostate.    On an unknown date, 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 (Sore arm for 2 or 3 days). At the time of the report, PAIN IN EXTREMITY (Sore arm for 2 or 3 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-079696 (Patient Link).
Dizziness; left arm was numb; fingers moved by themselves; felt like his tongue was swollen; lips were numb; slight headache; This is a spontaneous report from a contactable consumer (patient's wife). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 06Mar2021 13:00 (Lot Number: EN6206) (a the age of 76-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes and when his sugar dropped, he got dizzy and weak. Concomitant medications included metformin; rivaroxaban (XARELTO); metoprolol succinate; simvastatin; borago officinalis oil, fish oil, linum usitatissimum oil (TRIPLE OMEGA 3 6 9); cyanocobalamin (VITAMIN B12); colecalciferol (VITAMIN D3); all taken for an unspecified indication from an unspecified start date and ongoing. The patient did not have any prior vaccinations within 4 weeks. The patient was fine on 06Mar2021, day of vaccination. Towards the morning on 07Mar2021, he was feeling a little dizzy. His left arm was numb, and his fingers moved by themselves, his tongue felt like it was swollen, his lips were numb. He also had a slight headache. He slept until 4:30pm and took a nap for 5 hours. The reporter gave him a Tylenol as treatment. When the patient started seeing the doctor, he took blood work. He received a lab report, but reporter was unable to provide results. The event did not require emergency room visit but required physician office visit. The reporter was unsure if these are side effects. The outcome of dizziness, twitching and headache was unknown, and outcome of all other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt recv vax on 2/17/99; on same day pt exp difficulty walking, semi-conscious state, headache, stomach pain, pale, erratic breathing, glassy eyes & unable to remain upright
Abdomen: cramps, abdominal pain, ache bones, ache joints, ache joints and muscles, aches muscles, aches whole body, acid reflux, acne, amblyopia, amnesia, blisters in mouth, face, neck and back, concentration difficult, loss of concentration, concentration trouble, cramps legs, depression, loss of energy, low levels of energy, head rushes, headaches continuous, impotence, insomnia, bad memory, trouble remembering recent, pain legs, pain lower back, pain right shoulder, hips and leg, pain groin, pain back, stiffness, pain eye, pain, pain neck, pains in feet like electrical shocks, rashes burn type on entire body, itching, sores down right side of body, infection with rash, rash, trouble finding words, walking difficult and weight gain.