chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm is tingling numb; droopy face; headache; nausea; left arm began bothering her and it was aching; vibration of the feet; left arm is tingling numb; sharp chest pain; dry mouth; metallic taste in mouth; dizzy; right hand got weak; prickly itch everywhere, and was on her chest and under neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (droopy face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VIBRATORY SENSE INCREASED (vibration of the feet), VACCINATION SITE ANAESTHESIA (left arm is tingling numb), CHEST PAIN (sharp chest pain), DRY MOUTH (dry mouth), DYSGEUSIA (metallic taste in mouth), DIZZINESS (dizzy), MUSCULAR WEAKNESS (right hand got weak), PARAESTHESIA (prickly itch everywhere, and was on her chest and under neck), NAUSEA (nausea) and VACCINATION SITE PAIN (left arm began bothering her and it was aching). On an unknown date, the patient experienced FACIAL PARALYSIS (droopy face) (seriousness criterion medically significant), VACCINATION SITE PARAESTHESIA (left arm is tingling numb) and HEADACHE (headache). At the time of the report, FACIAL PARALYSIS (droopy face), VIBRATORY SENSE INCREASED (vibration of the feet), VACCINATION SITE PARAESTHESIA (left arm is tingling numb), VACCINATION SITE ANAESTHESIA (left arm is tingling numb), CHEST PAIN (sharp chest pain), DRY MOUTH (dry mouth), DYSGEUSIA (metallic taste in mouth), DIZZINESS (dizzy), MUSCULAR WEAKNESS (right hand got weak), PARAESTHESIA (prickly itch everywhere, and was on her chest and under neck), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (left arm began bothering her and it was aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided.Treatment information were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received shot approximately at 3:30 PM. At around 9:00 PM the same day developed hives to bil forearms and then to bil upper thighs progressing to waist and trunk. Did not have welts or respiratory symptoms. Eyelids swollen next morning. Went to see a nurse practitioner next day and then to a dermatologist. Prescribed Prednisone for 17 days.
Patient arrived to drive through clinic to receive second dose COVID-19 vaccine. Clinical volunteer vaccinated client. According to the client, she developed 11/10 pain to her right arm, with complete immobility. Patient was taken to the emergency room where she was given medication. She was referred to an orthopedic surgeon. She attended her orthpodeic appointment and was given 2 weeks of steroids and an MRI was recommended. This RN called the client 2 weeks after vaccine was adminstered once notified. The client reported 'mild improvement' in sensation/pain to the area and intentions to follow up with her provider.   The client sent a photo of the injection site to this RN, and the injection was found to not have given into the deltoid muscle, but what appeared to be the shoulder. Client was provided with the vaccine claims website and encouraged to reach out with questions or any assistance needed.
CLIENT ATTENDED CLINIC TO RECEIVE DTAP BOOSTER.  DOSE WAS ADMINISTERED AS INDICATED BUT UPON INPUTTING DATA INTO COMPUTER IT WAS DISCOVERED DTAP HAD EXPIRED ON 10/11/2010.  CDC WAS CONTACTED AND ADVICED TO RE-VACCINATE.  NO ADVERSE S/S/ NOTED.
Headache, NauseaVomiting, General Symptoms: Headaches, joint pains, fatigue, nausea, vomiting. Narrative:
Ten days past administration in left thigh Hep A and MMR. Thigh noted to be red and a abscess at injection site was diagnosed. Clindamycin PO soln 75mg/5ml prescribed.
APR92 pt recvd 2nd dose of Engerix-B & w/in 24 hrs c/o diarrhea, didn't feel good, felt lousy;
stiffness at injection site, low-grade fever (temperature 99.3 compared to a normal 97.2); headache and nausea starting about 12 hours after injection and lasting about 24 hours
Four hours after receiving Prevnar 13, I all of a sudden felt a sudden heavy weight descending on me and then dizzy. I was alone so immediately called 911, unlocked front door and went to a chair. Next thing I knew a voice was talking to me on my phone - I had fainted. I was then aware of extreme pain in my left arm at the vaccine site, aching all over, and nausea. Ambulance took me to ER, admitted for heart tests, and ultrasound for possible blood clot. All was normal - appeared to be reaction to Prevnar 13.
Extreme fever and chills. Could not sleep. Full body aches and pains. Headache. Soreness in abdomen and under arm pits. All of this went away in 48 hours
Her joints hurt terribly on her right side; Fatigue 'slept all day and all night'; Fatigue 'slept all day and all night'; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing osteoporosis (she is known for osteoporosis in her knee) and ongoing allergy. Concomitant medications included denosumab (PROLIA) and allergy shots. The patient received the Pfizer Covid shot on 25Jan2021 and her regular allergy shots 2 days prior. She was told by that facility that it was okay to receive the allergy shot. However, she was told by the Physician where she gets Prolia infusions to wait 2 weeks after the vaccine. In Jan2021 she felt post-vaccine side effects of fatigue 'slept all day and all night' and her joints hurt terribly on her right side, although she is known for osteoporosis in her knee. She is 'fully active'. She took a Motrin for the pain and it eased up. The event join hurt was resolving, while outcome of other events was unknown.  Information on the lot/batch number has been requested.
no other AE occurred; The caller said they have a patient who inadvertently received an extra dose of PEDVAX HIB on 12/30/2021; patient who inadvertently received an extra dose of PEDVAX HIB on 12/30/2021/The patient was due for the meningiococcal B vaccine, Bexsero; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was first vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported). On 30-DEC-2021, the patient inadvertently received an extra dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 1 dose (lot # S021458, and expiration date 27-FEB-2022) for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported) (incorrect dose administered). The caller said the patient was due for meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) (wrong product administered). No other adverse event (AE) occurred.
Patient has redness, warmth, and general pain in the area of the injection site and surrounding area.
Moderna COVID-19 Vaccine EUA  Left upper arm became sore later in the afternoon. The pain increased during the night, despite taking ibuprofen. Pain became intense and made it difficult to sleep. By 7 a.m., bad pain had subsided but arm remains sore. Difficult to lift it above shoulder height.
syncope/seizure/vagal collapse after the two shots.  He got the Havrix first and felt bad but didn't say anything.  Then the MMR pushed him over the edge.
The patient had a rash that started on the left shoulder that started 3 days after she received the vaccine. The following day, she had a rash on the right shoulder and her thigh. She has been taking diphenhydramine and using hydrocortisone to treat the rash.
Patient received first pfizer covid vaccine at vaccine hub at 1:25 pm.    1:35 PM   Patient developed a dry cough and tightness in the upper chest and throat. O2- 100%, HR-75. RN gave 25mg liquid bendryl and requested urgent care to send a nurse.    1:46 PM    Dry cough and chest tightness improving. O2- 100%, HR-75. Patient reported feeling "tingly" in her hands and nauseous. Noted red blotchy rash on chest running down each arm. Triage RNs evaluated patient and advised she be taken to ED. Patient agreed and called her mother to pick her up and take her to ED.      2:30 PM   Patient no longer coughing and states the chest tightness is improving.  O2- 100%, HR-76, BP-153/101. Patient was driven to ED by her mom.
57 year old female who was seen today for her second  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience itching.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and skin changes.   PMH: prediabetes, copd.      ALLERGY REVIEW OF SYSTEMS:  Patient complains of itching of skin   Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash and dizziness       Previous Reactions: none. Did well with 1st dose of Pfizer but did have a headache that lasted for 5 days.     Objective    Vitals Vitals:   03/08/21 0906 03/08/21 0916 BP: 136/88 120/76 BP Location: Right arm   Patient Position: Sitting   Pulse: 97 90 SpO2: 96% 96%            Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is not diaphoretic.  HENT:     Mouth/Throat:     Pharynx: Oropharynx is clear.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Skin:    General: Skin is warm and dry.     Findings: No rash.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.     Gait: Gait normal.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: antihistamines Pepcid and Zyrtec Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Generalized itching.    She was observed in the medical bay for approx 15 minutes. She responded really well to the antihistamines. No further itching reported. No rash or other symptoms noted. She feels well to go home. Given handwritten instructions on medications received and when she can repeat if needed along with Benadryl use.  Pt voiced appreciation of her care today. PT walked out by pharmacist.
15 minutes post vaccine she stated that s h e felt unwell and anxious.  Vitals were taken at 12:25pm .  At 12:45pm she was given a bottle of water and vitals taken and alerted supervisor and took Pt. to ED and handed off for further evaluation.
No additional adverse event; PROQUAD was administered  during a temperature excursion.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-APR-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter, lot #W038815, expiration date: 04-JUN-2024, administered as prophylaxis (strength, and route of administration were not provided), during a temperature excursion at a temperature of 5.5 Celsius degrees that lasted for 60 hours (product storage error). No additional adverse events or previous temperature excursion were reported.
Pt got varicella vaccine on 12/20/00 and today on 6/08/01, presents with lesions of varicella on face and chest. Sent pt to lab to draw varicella IgM titers. Informed on the phone that there was a questionable failure of vaccine.
Breakthrough COVID first dose 1/21/2021.  72 year old female Admitted to hospital for COVID19, Acute Renal Failure, Crohn's Disease, Diarrhea, Dehydration, Elevated LFT's. and Thrombocytosis. Patient was in her usual state of health until last few days when she started having uncontrolled diarrhea.  Denies any fevers or chills.  No chest pains or shortness of breath.  No nausea vomiting.  No headache numbness or tingling.  Denies any cough.  Denies any melena hematochezia.  Does have her chronic abdominal pain.
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had vaccinated subcutaneously with a first dose of 0.5 ml of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected.
large blotchy rash on my neck and chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (large blotchy rash on my neck and chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (large blotchy rash on my neck and chest). At the time of the report, RASH MACULAR (large blotchy rash on my neck and chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported.
This case was reported by a consumer via out of hour services and described the occurrence of swelling in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced swelling, general body pain, headache, rash, pruritus and tiredness. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the swelling, headache, rash, pruritus and tiredness were recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the swelling, general body pain, headache, rash, pruritus and tiredness to be related to SHINGRIX.  Additional details were reported as follows: The age at vaccination was not reported. Less than a month after vaccination, the patient experienced tiredness. This case has been linked with case US2018GSK127930, reported by the same reporter for the husband.
started coughing on 03/27/2021 and was taking to hospital on 03/30/2021. There he was treated for blood clots with anticoagulants and a filter placed in the vena cava.
COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-025817 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains no new information. On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains no new information.
Nausea, vomiting, diarrhea, myalgia, jaundice, weakness. Pt given anti nausea med and allergy med.
Cold symptoms. Arm where vaccine received extremely red, swollen, tender. Pain radiates from shoulder to elbow. Lethargy. Loss appetite. Dehydrated. Temperature went up - 102 degrees. Went to Emergency Room Friday afternoon.
Pt received vaccinations on 02/11/2002. On the next day afternoon while pt was in his car seat, mom noticed pt falling asleep then suddenly had "passing out" episode. Body went limp, eyes closed. Mom had to shake and rub the pt's cheeks then pt woke up.
This spontaneous report was received from a physician refers to a 12 year old female patient. There were no drug reactions/allergies, pertinent medical history, and concomitant therapies for the patient. On 04-AUG-2017, the patient was vaccinated with a second dose of GARDASIL 9 (lot # M017083; expiry: 01-JUN-2019) via intramuscular route in the left arm, to prevent human papilloma virus (HPV). Since receiving the vaccine on the same day, the patient experienced pain. She required medical attention. Physician reported that the patient's mother called in to the office and was told to give Ibuprofen and apply warm compresses to the injection site. No lab diagnostics/studies performed. Outcome of the event was reported as not resolved. Causality assessment was not reported. Lot # M017083 is an invalid lot number for GARDASIL 9.
Sweating, difficulty breathing, increased heartbeat, passing out, nausea. Given water and crackers, was coached on breathing Recovered breathing and conscious within 2 min. Was held longer in order to be monitored for any repeat symptoms was released after 40 min
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
Adacel was prepared on Friday and administered on Monday by another medical assistant, but the patient changed their mind with no adverse event; Initial information received on 27-May-2021 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 35-year old male patient who got DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was prepared on Friday and administered on Monday by another medical assistant, but the patient changed their mind with no adverse event (product use issue) [lot number: UH949AA and expiration date: 18-Nov-2022] via intramuscular route in the left deltoid unknown route in unknown administration site for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to product use issue (latency: unknown).  It was reported that he said that a needle was attached to the syringe and that they placed the syringe with the needle attached in the refrigerator.  At the time of report, no adverse event was reported.  It was unknown if there were lab data/results available.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding batch number in this case.
Thrombocytopenia; hx of acute lymphoblastic leukemia; platelet count 178,000 on 18OCT94; 25OCT93 dec to 18,000; treated w/IV Ig & platelets returned to 104.000; No other info expected;
flu sx 16NOV-pain, legs following wk-progressed diff breathing-went to hosp dx w/ GBS 26NOV;
10/14/2017 0400hrs - had red welt on right breast. Later in the morning, welts had spread across chest and abdomen. Started Benadryl and calamine lotion. Later that afternoon, went to urgent care,  was put on meds. Welts spread to arms, legs, and feet even on the meds. Went to ER on 10/15/17 afternoon. Was treated and released early evening.
Pneumococcal vaccine polyvalent Pneumovax 23, 0.5ml single dose vials. The expiration date is ambiguous. Lot number 0751P. It is depicted on the vial as 07Jun06. Interpreted as expiring June 6 2007 and June 7 2006.
Information has been received from a physician concerning his 65 year old wife who on 27-SEP-2010 was vaccinated with a subcutaneously with a dose of PNEUMOVAX 23 (Lot # no reported). On the same day, the patient received a dose of flu vaccine (manufacturer unknown). The physician reported that on 27-SEP-2010 8 hours after the vaccination, his wife experienced chills and severe malaise. The next day, on 28-SEP-2010 there was induration to the elbow, red macular rash generalized and temperature 101.5F. She saw her physician and was treated with aspirin and BENADRYL. On 29-SEP-2010 the rash has faded, temperature was down but her arm was still hot, swollen and tender. The physician also reported that the patient received a dose of flu vaccine in the same arm there were not reactions noted around the flu shot. The patient sought medical attention. Additional information has been requested.
PFIZER DILUENT - SODIUM CHLORIDE 0.9 % INJECTION, 0.3 ML WAS GIVEN TO PT.
On 9/24/12 she reported body aches, headache and chills "all weekend". States "I'm feeling much better today".
Pt became extremely irritable, decreased awareness, had behavior change, not cooperative, eating was a challenge, personality change, "autistic like behavior per mom", aggressive behv - lasted for 9 days.
Itchy, welty rash on my thighs. Started the day after and lasted about a week, but subsided as days went by. I have had this same reaction to a sulfa based antibiotic.
I needed a root canal but 2 dentist, 5 shots of painkiller did not deaden the tooth.