chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tenderness of arm; stiffness of the muscle; Injection site area was red, bump; Injection site area was red, bump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TENDERNESS (tenderness of arm), MUSCULOSKELETAL STIFFNESS (stiffness of the muscle), INJECTION SITE ERYTHEMA (Injection site area was red, bump) and INJECTION SITE SWELLING (Injection site area was red, bump) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced TENDERNESS (tenderness of arm), MUSCULOSKELETAL STIFFNESS (stiffness of the muscle), INJECTION SITE ERYTHEMA (Injection site area was red, bump) and INJECTION SITE SWELLING (Injection site area was red, bump). At the time of the report, TENDERNESS (tenderness of arm), MUSCULOSKELETAL STIFFNESS (stiffness of the muscle), INJECTION SITE ERYTHEMA (Injection site area was red, bump) and INJECTION SITE SWELLING (Injection site area was red, bump) outcome was unknown. Not Provided      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.   No concomitant medications were reported.  No treatment medications were reported.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 15-JUL-2015 the patient was vaccinated with one dose of improperly stored PEDVAXHIB, lot # L002867 with expiration date of 11-NOV-2015 (strength, dosage, frequency and route unspecified)(incorrect product storage). No adverse effects were reported. This is one of 4 reports received from the same reporter. Following review, it was determined that the report did not meet criteria for a quality investigation. Incorrect product storage was not considered a true Adverse event and there were no reported adverse effects. Additional information has been requested.
Chest Pain and chest hurts if deep breathing; Nausea after booster shot; Pain on the injection Site Right Arm after booster; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain and chest hurts if deep breathing), VACCINATION SITE PAIN (Pain on the injection Site Right Arm after booster) and NAUSEA (Nausea after booster shot) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 039K20-2A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Asymptomatic) on 26-Nov-2021.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection Site Right Arm after booster). On 01-Dec-2021, the patient experienced NAUSEA (Nausea after booster shot). On 02-Dec-2021, the patient experienced CHEST PAIN (Chest Pain and chest hurts if deep breathing). At the time of the report, CHEST PAIN (Chest Pain and chest hurts if deep breathing), VACCINATION SITE PAIN (Pain on the injection Site Right Arm after booster) and NAUSEA (Nausea after booster shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2020, SARS-CoV-2 test: positive (Positive) PCR  test was positive and positive (Positive) Rapid test was positive.         No concomitant and medication information provided. No treatment information provided.
I started to develop a migraine the next day (12 March 2021) and by the morning of the 13th, it was at its worst and lasted several hours before the pain subsided.  While I had previously had migraines once every month or two starting in late 2018, it had been some months since I had a migraine.  Normally, my migraines were triggered by heat or staying up late, neither of which occurred before this migraine.  The only unusual event was the vaccine.
Intense Pelvis Pain / Infection followed by lightheaded and dizziness, arm and leg numbness when laying down, anxiety, sporadic blood pressure, heart race, flutters, chest pressure, shortness of breath, sporadic aches and pains, fatigue
Shot site was warm to the touch for several days. Shot site developed a lump, approximately 1 and 1/2 inches in diameter. There is no redness or ring around the swelled area.
Patient states that about 12 hours following her 1st dose of this vaccine she began to experience side effects including nausea, diarrhea, vomiting, and a headache. Patient states that these effects lasted throughout most of the following day and then began to dissipate .
This spontaneous report as received from a registered nurse refers to a 4 year old female patient. The patient had no pertinent medical history and no known drug reactions or allergies. On an unknown date, the patient was vaccinated with the second dose of PROQUAD (Merck) (route, lot # and expiration date were not provided). There was no concomitant medication. On an unknown date, 2 weeks after PROQUAD (Merck) administration, the patient was diagnosed with chickenpox. The nurse reported that the patient was covered from head to toe with varicella like lesions and that the patient had chickenpox really bad. The nurse stated that the patient was seen by an unspecified physician and the only treatment recommended was BENADRYL and oatmeal baths (also reported as no treatment was given for the adverse event). There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Immediate pain in injection site.  1-2 hours later weak  Next. Day 3 pm severe Fatigue, muscle pain b/l legs spasms, migraine that lasted for 7 days. Tiredness. Weak. Chills. Back pain.  Blurry vision on n off. Decrease appetite all still current but 40% improved.  Couldn?t walk for a week
Resident received J & J vaccine on 4/10/2021, on 4/13/21 noted to have mild pain and edmea to left lower extremity. 4/14/21 MD ordered doppler which showed DVT to left popliteal and left posterior tibial veins, orders for anti-coagulant given.  4/15/21 resident stating mild pain, no other adverse effects noted.
No adverse effects; two patient were administered one dose of PEDVAXHIB before 2 month of age; This spontaneous report has been received from a physician concerning  an approximately 7 week old patient of unknown gender and ethnicity.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 25-MAR-2019, the patient was vaccinated with 2 doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), (frequency and anatomical location were not reported) (lot # R021083 and expiration date 13-JUN-2021) for prophylaxis.  At the vaccination time, the patient had approximately 7 weeks old (product administered to patient of inappropriate age). No adverse event reported.; Sender's Comments:  US-009507513-1905USA014123:
On right side, swollen nymph nodes in under arm and pectoral lymph nodes. Noticed symptoms about 36 hours after dose. Minimal pain, but swelling is still present 4 days after vaccine was administered.
Experienced chest pain.  Went to ER.  Was rushed in and determined to have Pericarditis - swelling and irritation around the heart.
Pink raised itchy 5x3 cm firm palpable patch below (distal to) left deltoid, lasting 2 days. Moderately itchy but not painful.
Extreme racing of heart for 2 hours starting about 45 minutes after injection. Slight asthmatic cough for one week. Brain fog for one day. Heart irregularities still occurring two weeks later.
Narrative:  Patient received four doses of Pfizer COVID 19 Vaccine. Pt had his 4th shot booster for COVID 19 with the Pfizer vaccine in April 2022 at an outside facility. About 1-2 days after that, he started developing some generalized weakness, cough with white phlegm, runny nose/congestion, myalgias and arthralgias. The patient tested positive for COVID 19 on 27 April 2022. The patient presented to the ED with symptoms above and was admitted with COVID pneumonia, cough, and chest pain. The patient was treated with iv antibiotics. The patient was discharged on 29 April 2022 in stable condition. Reported per EUA.
Information has been received from a nurse and refers to unspecified patients of unknown ages and genders. There was no information about patient's concomitant medications and pertinent medical history. On an unknown date, the patients were vaccinated with  improperly stored doses of GARDASIL 9, lot number  M028323 and expiration date 26-SEP-2018 (route of administration and anatomical location were not reported) for prophylaxis, which was stored at a lowest recorded temperature of 32F (0 Celsius) and highest 36F (2.2 Celcius) for 4 hours due to a data logger issue. No previous temperature excursion was reported.  No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Severe right arm pain, chills, low grade fever, body aches, nausea. Most severe symptoms lasting 24 hours
The parents believe there may possibly be blood in the patient's stool; Faeces discoloured; This spontaneous report was received from a physician concerning a 4-month-old patient, gender unknown. No concurrent conditions, medical history, historical drug, concomitant therapies and drug reactions/allergies were provided.  On and unknown date, the patient was vaccinated with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, for prophylaxis (  lot number and expiration date were not reported). Other suspect therapies included acetaminophen (TYLENOL) for an unknown indication (dose, frequency, lot number and expiration date were not reported).  On an unknown date, it was reported that there was "possibly blood in the patient's stool" (Haematochezia) and discoloration to the patient's stool (Faeces discoloured). It was unknown by the reported if treatment was given for the adverse events. At the time of the report it was unknown if the patient had recovered from the haematochezia and faeces discoloured. The causal relationship between Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and the events was not provided.  Upon internal review, the haematochezia was considered to be medically significant.
Patient complained of "a lot of itching" on injection site; BENADRYL 25mg was ordered by provider and cold pack was placed on left arm for symptom relief; patient left 2 hours later stating she felt better. On 4/7/17 at 10:37 AM patient called clinic complaining of arm swelling and difficulty moving arm. Patient denied any other symptoms: fever, shortness of breath. After consulting with patient's medical provider patient was referred to ER.
found out vaccine was only 22 days apart; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out vaccine was only 22 days apart) in a male 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out vaccine was only 22 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out vaccine was only 22 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Initiative, reporter is asking for clarification on which patient to provide FU
Redness, swelling, firm lump, and pain at vaccine site.  Size of lump approx 4 cm diameter.  Worsened over 1-2 days with gradual decrease in size over the next 4-5 days.
Employee stated that she felt dizzy after the vaccination. Employee was put in the supine position with feet elevated. Vital signs was taken: BP was 125/83; Pulse was 79; and temp was 96.8 oral. Ice was placed at nape of neck.
At 0920 I felt severe tingling in my lips and tongue. Was quickly triaged, it was getting harder to breathe, my BP was high, my SPO2 did not drop, my pulse was around 80. Tiny red hives started to appear on my forearms. I had taken 25 mg of benedryl, however an epic pen was recommended and given. I felt better immediately, although my chest still felt tight. I was not wheezing. I asked for and was given an albuterol inhaler which really helped, so I did to need admission to the hospital. I was there for about 2 hours. I was sent home with 2 epic pens in case I had a relapse.
Fever, Coughing, Body ache, headache, sleeping a lot.  These symptoms continued for several weeks flaring her lupus back up.  She is on best rest now, still has pains and lupus flare is still ongoing.
Approximately 2 - 3 hours after receiving injection for deployment, pt experienced onset of abdominal pain, nausea, chills, and headache.
For 2 weeks post vax, had severe aches and pains. Had no local reaction. Twelve to fifteen times since then, pt has had a 'hurting' in her arm lasting 5-10 minutes in the same area shot was administered. After each 'hurting' episode, she stated that she generally does not feel well for the next couple of days. Pt has not been to the doctor.
April 2021 - Increased frequency and severity of headaches May 2021 - Headache frequency became daily and severity continued to increase, began having increased blurry vision and difficulty reading/writing. Unable to perform duties at work and began missing days. 05/28/21 - visit with primary doctor, prescribed sumatriptan 50mg for migraine. Medication did not alleviate symptoms of headache.  06/02/21 - Prescribed Nortriptyline 25mg to 75mg  for migraine . After 4 week trial no improvement in headache symptoms. 06/10/21 - Requested formal leave of absence from work after exhausting sick time. 06/30/21 - Stopped nortriptyline. Prescribed propanolol 80mg for migraine, increasing to 240 mg over 6 weeks. Mild improvement in headache symptoms but still unable to work but also experienced fatigue and low heart rate side effects. 08/13/21 - Stopped propanolol. Prescribed verapamil 120 mg for migraine. Mild improvement in headache symptoms but still unable to work, but suffered severe constipation requiring ER visit and urgent care visits, enema and laxatives to clear. 09/08/21 - Transferred care for headaches to Neurology. Prescribed rizatriptan 10 mg for migraine. No improvement in headache symptoms. Prescribed Xeomin injection. Stopped Verapamil. 10/20/21 - Xeomin injection for headache. Temporary worsening of symptoms, then returned to similar levels as before injection. 11/08/21 - Transferred care for headaches to different doctor. Started gabapentin burst. Mild improvement in headache symptoms.
Patient complains of left arm pain, with limited range of motion along with pain when arm is touched. No redness or swelling at injection site.
First dose of vaccine administered to pediatric patient; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of vaccine administered to pediatric patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of vaccine administered to pediatric patient). On 01-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of vaccine administered to pediatric patient) had resolved. Not Provided      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 drugs were not reported.  Treatment information was not provided.  This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # 025A21A  with no associated AEs.; Sender's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # 025A21A  with no associated AEs.
pt recvd vax & exp itching, redness, & burning @ inject site; 28JUL94 exp an erythemic rash mostly on trunk w/areas of hyperpigmentation in axilla; sx are being self-treated w/Hydrocortisone cream & persist;
All symptoms occurred later that night or the next day after injection.  Intense arm pain around injection site, fatigue, headache, diarrhea, fever, sharp pain around urethra area
My daughter went in for her four year checkup was supposed to get a varicella, MMR, DTAP, and polio shot. An hour later the doctor called and said the nurse accidentally gave he the varicella and MMR combo which is PROQUAD and gave her the single dose of varicella and MMR, therefore she has two doses of each in her system. I hope she dose not have any negative effects, and no on else has to go through this. I am trusting the doctor did report this as well as they told me they were.
lichen planus immune disease , white spot on tongue , gums turned white , butt and penis got itchy.
sore arm; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP).  A 90 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 13:00 (Lot number: EN6205) at the age of 90 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: 08Feb2021, when the patient was 89 years old, for covid-19 immunisation, reaction(s): "had a sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Patient came in for a well check up about 9Am at 13 months.  She looked great but had just started some URI symptoms the day before.  No fever.  She was given the following immunizations: IPV, Comvax, Prevnar, and Varivax.  Later that evening she had a grand mal seizure that lasted >20Min. and was taken to the ED where she was descibed as having eyes deviated to the left and tonic clonic movements of her extremities.  She received 2 dose of Ativan and it stopped.  Because of the benzodiazepines her breathing became shallow and she was eventually intubated and was in the PICU but extubated by morning.  Her head CT and LP were normal. Her rectal Temp. in the ED was 37.8.  She was discharged on 10/12/03 on  Phenytoin. The seizure occurred within 12 hours of being vaccinated.  She did well without further seizures and was weaned off of the medication.  She was given an MMR on 4/9/04 and I held off on the DTaP as the neurologist recommended.  On 1/18/05 she had another prolonged seizure, Status and was again intubated and admitted to the PICU.  She was discharged on 1/21/05.
Patient returned 30 minutes following visit due to development of red bumps to extremities and face. She did not show any signs of difficulty breathing, oral or lip swelling. She was given 2.5 mg of loratadine and monitored for 45 minutes. Rash present along extremities, and face erythematous, blanching papules. Rash seemed to improve, although still present. She remained well appearing.
Headache, Dizziness, Congestion, Exhaustion, Stomach Pains, Hard to hear out of left ear, and chills.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Lymph nodes were swollen after 2-3 weeks after 2nd dose), RASH (rash), PRURITUS (itching) and DERMATITIS (Doctor described it as Dermatitis as he wasn't sure if it is coming from vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included LOSARTAN, APIXABAN (ELIQUIS), AMLODIPINE and SOTALOL for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RASH (rash). On 12-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes were swollen after 2-3 weeks after 2nd dose). On 01-Apr-2021, the patient experienced DERMATITIS (Doctor described it as Dermatitis as he wasn't sure if it is coming from vaccine). On an unknown date, the patient experienced PRURITUS (itching). At the time of the report, LYMPHADENOPATHY (Lymph nodes were swollen after 2-3 weeks after 2nd dose), RASH (rash), PRURITUS (itching) and DERMATITIS (Doctor described it as Dermatitis as he wasn't sure if it is coming from vaccine) outcome was unknown. Not Provided. Patient was treated with Prednisone Ointment. This case was linked to MOD21-086834 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: AE contact Information Updated/lot number and date updated; Sender's Comments:  MOD21-086834:
Fever, body aches, headache, tingly limbs. Symptoms started around 4am, so about 17 hours later. Symptoms were gone by 48 hours later.
At the time of vaccination, patient experienced a vasovagal reaction of nausea, headache, near-fainting. After eating a snack and drinking water symptoms improved over about 1 hour and patient returned home. Pharmacist call to check on patient the next day, she said she was feeling better, not 100%, but Ok. Since then, she had a headache for 4 days and started having mental distress (out of body feeling, memory loss, and covid-like symptoms). She also states she has had excessive sweating since a week ago and feels very unstable on her feet. She went to a doctor who tested her for covid. It came back negative. The doctor advised if the symptoms continue to get worse, she should go to the hospital. She was at work today, we discussed all these things here. She said she couldn't even remember her name or walk straight. I told her she needed to go to the hospital ASAP and not to work the rest of her shift.
Nausea, muscle pain in body, joint point especially at arthritis sites, fatigue. One bout tinnitus (white noise) about 3am. All symptoms good late afternoon the following day.
Left arm redness. ABX given KEFLEX 500mg tid. TAC 0.1% ointment.