chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had lingering side effects for a week.  When I first got the shot I had a cold sensation in my arm, sweating, clammy skin, and felt I could possibly faint.  I started to feel better and I did not seek medical attention at the clinic as I wanted over 35 minutes and felt better.  The days following I've had stomach pains, diarrhea, achy joints especially lower back, chills, a feverish feeling and some nerve pain in the arm I had the shot.  I had nerve damage from a car accident years ago that was recovered but now the pain is back.  I intermittently have a weak feeling and feel like I could pass out.  It comes and goes.
Vaccine is administered to 16yr old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine is administered to 16yr old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine is administered to 16yr old). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine is administered to 16yr old) 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 product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Positive COVID-19 test after 1st dose of the Moderna Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Positive COVID-19 test after 1st dose of the Moderna Vaccine) 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 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 16-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive COVID-19 test after 1st dose of the Moderna Vaccine). At the time of the report, COVID-19 (Positive COVID-19 test after 1st dose of the Moderna Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     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 specific side effects were reported with the positive virus test. No concomitant medications were mentioned. No treatment details were reported.
Soreness in arm at injection site; This is a spontaneous report from a contactable consumer via Pfizer sales/company representative. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol which is controlled via unknown medication. The patient did not have any allergies to food, medications, or other products. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN) 10 mg/day for an unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Mar2021 at 19:00, the patient experienced soreness in arm at injection site. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event vaccination site pain. The clinical outcome of the event vaccination site pain was recovering at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Immediate sensation radiating down the left arm into the hands and fingers.  Immediate cold hands and feet which resolved after one day.  A month later still has some numbness and tingling in the fingers of the left hand.
Pt recvd flu vax & immed afterward pt exp redness & itching @ the inject site;
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 05-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reproter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & a couple of days later spot turned red & itched & itched & itched;started feeling sick-h/a, dizzy, & upset stomach;still has runny nose
Went to dentist thinking  i had a toothache  on Monday from the pain. it  was very painful  was on my whole left side of face did xray was referred to oral surgeon did exam and both confirmed it had to be a reaction to vaccine. was prescribed Flexural and Toradol Aleve. medication takes about an half hour to kick. been in bed for a week with ice on my face. Cant work at all.
pt recvd vax & 24 hrs later had an enlarged prostate & difficulty urinating;
Breakthrough Case  Patient received Janssen Booster vaccine on 11/18/2021 Lot #1855194 Facility: clinic
17JAN98 started in afternoon became red, swollen & itching 5cm x 5cm hard, red & warm to touch;
p/vax pt devel a fever 102-103 a rash all over body that Md says is a dermatitis kind of rash & a cough;pt began to break out in a pimply, itchy gen rash;contact dermatitis;ears very swollen blown up & had croupy type cough;maculopapular
Sore arm; Feeling "really sick"; Fever; Headache; Achiness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in August 2020, refer case US2020AMR229347).   On 14th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th November 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, sickness, fever, headache and pain. Rechallenge with Shingrix was positive. On 16th November 2020, the outcome of the pain in arm, sickness, fever, headache and pain were not recovered/not resolved.   The reporter considered the pain in arm, sickness, fever, headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced sore arm, feeling sick, fever, headache and achiness.   No lot number and date were known. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR229347:same reporter
Pt received 2 doses of Pfizer COVID-19 Vaccine (3/25/2021 & 4/15/2021). On/around 12/29/2021, pt developed SOB. On 12/22/21, she presented to the hospital. On 12/23/2021, she tested positive for acute COVID-19 infection.
contracted covid; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer-sponsored program . A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 18Mar2021 at single dose for covid-19 immunisation. Reporter and patient both received first dose of the Pfizer covid vaccine on 18Mar2021 and both contracted covid, reporter tested positive on 25Mar2021 and patient on 26Mar2021 (2 days later). Both were due for her second vaccine tomorrow and reporter wanted to know if they can take it. The case was reported as non-serious. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After the second shot I was very tired for one day. I had some soreness and redness in my arm. I didn?t feel like doing anything. I just rested. After that I was perfectly fine. In August my husband had fever and he was not feeling well. We gave it a day before we went to the doctor. I was pretty sure he had Covid because of his symptoms and he was not vaccinated. We had both been exposed directly to Covid. On Tuesday 08/30/2021 we went to urgent care. We both tested negative for Covid, strap, and flu. We both had sinus issues. Mine was worse. I had congestion. They also did a chest x-ray because I was having some chest pain. It came back normal. 2 days later my husband tested positive for Covid. I tested 4 times negative for Covid. I took some antibiotics and a shot of cortisone and I am fine now.
Patient is G2P1, 30w2d pregnant with singleton pregnancy EDC 08/20/22. Received routine Tdap in office 06/01/22. Patient contacted the clinic 06/08/22 and reported right arm pain and decreased mobility since receiving the injection. Provider reviewed patient's message and suspected SIRVA. Patient was referred to PT/OT. Patient was seen  for OT/PT evaluation 6/10/2022.
sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2022-445032, MOD-2022-445046 (Patient Link).
Patient reports that approximately 2 hours after receiving his shot a rash appeared on the back of his left arm. He came into the pharmacy to show the pharmacist on Sunday (5/24/20). The rash is about the size of a dime and has blisters. Patient reports in the past he has had shingles and this was the exact spot and looks exactly the same. Patient said he was fine and will not be going to the doctor for treatment, he just wanted to make us aware of what occured.
Received vaccines on 9-15-2017. On 9-16-17 mother noticed right upper thigh was red and inflamed. Inflammation increased during the day and into the next. Redness also increased and area became very warm to touch. On the evening of 9-17-2017 parents took child to the emergency room and child was diagnosed with Cellulitis. Antibiotics prescribed. On 9-19-17 child came to this office for follow up where diagnosis was confirmed.
p/vax pt devel ache muscles entire body; extreme fatigue x48hr; lt elbow pain, continues ache, moderate in degree; h/a, moderate in degree, x48 hr
employee tested positive greater than 14 days after fully vaccinated  Narrative: employee tested positive greater than 14 days after fully vaccinated
Side effects started 12 hours after 2nd dose of vaccine (lot EL1284). I got chills, body aches, nausea, enlarged  and swollen lymph node under left armpit that is warm to the touch and hurts.
MMR and varicella vaccine were administered at 4:45 pm (2 shots) and low grade fever started at 5:30 pm.  Fever escalated to 104.4 by 11:30 pm and mostly resolved within 24 hours.  Child complained of stomach pains but with no other symptoms within 4 hours of vaccine administration.
Patient reported bruising, muscle stiffness and swelling, loss of range of motion and that her doctor suspected a blood vessel was hit.
dry mouth; metallic taste in mouth and still having that metallic taste but it went away for several days and come back; On same day but few hours later he felt tightness around the lips; stretched near to cheek area; Twitching in lower jaw specially right under the base of his tounge; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth), DYSGEUSIA (metallic taste in mouth and still having that metallic taste but it went away for several days and come back), MUSCLE TIGHTNESS (On same day but few hours later he felt tightness around the lips), SKIN TIGHTNESS (stretched near to cheek area) and MUSCLE TWITCHING (Twitching in lower jaw specially right under the base of his tounge) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Reaction to preservatives (Allergy to Phosphate , food preservative). Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Prostate infection.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (Pain). On 14-Apr-2021, the patient experienced DRY MOUTH (dry mouth), DYSGEUSIA (metallic taste in mouth and still having that metallic taste but it went away for several days and come back), MUSCLE TIGHTNESS (On same day but few hours later he felt tightness around the lips), SKIN TIGHTNESS (stretched near to cheek area) and MUSCLE TWITCHING (Twitching in lower jaw specially right under the base of his tounge). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Dry mouth, Taste metallic and Twitching, at a dose of 1 dosage form. On 18-Mar-2021, PAIN (Pain) had resolved. At the time of the report, DRY MOUTH (dry mouth) and DYSGEUSIA (metallic taste in mouth and still having that metallic taste but it went away for several days and come back) had resolved and MUSCLE TIGHTNESS (On same day but few hours later he felt tightness around the lips), SKIN TIGHTNESS (stretched near to cheek area) and MUSCLE TWITCHING (Twitching in lower jaw specially right under the base of his tounge) was resolving. Unknown          No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable       Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09-JUN-2021.Patients medical information was updated.
Caller is unable to attend appointment for 2nd Pfizer shot today and wanted to reschedule due to feeling ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Caller is unable to attend appointment for 2nd Pfizer shot today and wanted to reschedule due to feeling ill".  Additional Information: Caller was unable to attend appointment for 2nd Pfizer shot today and wanted to reschedule due to feeling ill which was unrelated to initial Pfizer Covid vaccine. Read FAQs. Transferred to Covid Fact sheet Faxing adverse event's to Pfizer from Support CEP. It was unknown If the reporter's contact information available to you or a sub-contracted party.It was unknown If the Reporter a Healthcare Professional (HCP). It was unknown if the reporter the prescribing HCP. Suspect product start and stop dates were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a female with no drug reactions/allergies who was vaccinated with one dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) in the past. Lab diagnostic studies performed included: a recent titer was negative for mumps. Unspecified medical attention was sought, the patient was seen in the office. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
For two days post vax the pt experienced a temperature of 103-104 degrees and neurological irritability, i.e., she could not sit still. She felt wrung out for one week afterwards.  The most recent information received reports the condition of the pt is recovered.
DISCHARGE SUMMARY    Admit Date: 7/31/2022 Discharge Date: 08/02/22 Primary Care Physician: DO      Clinical Summary Patient is a 67 y.o. female with PMHx of ESRD s/p DDRT on immunosuppression, chronic HFpEF, HTN, T2DM, osteoporosis, and OSA. She presented to hospital on 7/31/2022 for shortness of breath, cough, fever, and fatigue. Found to have COVID. Chest imaging showed bronchitis and cardiomegaly with probable mild vascular congestion. Patient was treated with decadron while admitted due to brief O2 requirements. Improved with supportive care. Stable for discharge home.     Comments/Problems to be Addressed After Discharge ? Follow up with PCP for resolution of COVID symptoms. Repeat CBC once recovered from COVID to evaluate thrombocytopenia. ? Ensure follow up with renal and transplant physicians.      Discharge Diagnosis and Associated Hospital Course   Acute hypoxemic respiratory failure, resolved -Secondary to Covid-19 infection. No concern for superimposed bacterial infection or CHF exacerbation at this time. Inflammatory markers elevated. Chest imaging as above. Required brief O2 while admitted. Completed few days of decadron. Patient requested holding further decadron while admitted. Weaned to room air days prior to discharge.    COVID-19 infection in immunosuppressed patient COVID pneumonia, sepsis ruled out -With symptom onset 07/28/22. Tested positive on 07/31/22. Chest imaging as above. Briefly required O2 and decadron. Dry lung strategy maintained during admission. Continue OTC supportive care. Weaned to room air shortly following admission. Discussed with patient, will hold further decadron on discharge. Advised to wear mask around others through 8/6/22.  ESRD s/p DDRT -Per history. On mycophenolate and tacrolimus. Follows with Dr. Baseline Cr ~1.35, stable on admission. Continued immunosuppression. Recommend continued outpatient follow up.    Thrombocytopenia -Suspect due to COVID. PLT 105 on admission. No concerns of bleeding during admission. Recommend repeat CBC once COVID resolves.    Chronic HFpEF -Per history. Heart Association class III. Follows with Heart Clinic. Not on diuretics. Trace LE edema on exam. Echo on 11/2019 with EF 60-65%, grade II diastolic dysfunction. Pro-BNP 2078 on admission. Dry lung strategy maintained while admitted. Monitored for volume overload.    Essential HTN -Per history. On home nifedipine, carvedilol, clonidine,continued during admission. Continue losartan during discharge.   Osteoporosis -Per history. Diagnosed after recent DEXA scan. Takes calcium and vitamin D supplements at home. Continued.   Left Bell's palsy -Per history. With subsequent facial never paralysis.    T2DM -Per history. A1c 4.8 on admission. Diet controlled. Continue current lifestyle modifications   OSA  -Per history. Previously on CPAP. Not currently using. CPAP offered inpatient.
About 10 hours after receiving the injection I experienced flu-like symptoms of fever, headache, nausea and severe body aches and pains. The symptoms were so bad that I was confined to bed the next day, sleeping all day. The symptoms improved after 40 hours and were pretty much gone by 48 hours after onset.
sore throat; intense body pain; back pain is sharp, from the back of shoulder blades, mid back; back is burning; pain in legs, arms; haven't slept since Friday even with the medications; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PAIN (intense body pain), BACK PAIN (back pain is sharp, from the back of shoulder blades, mid back), BURNING SENSATION (back is burning) and PAIN IN EXTREMITY (pain in legs, arms) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herniated disc since an unknown date. Concomitant products included HYDROCODONE HCL and HYDROCODONE BITARTRATE (HYSINGLA) for Back pain.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PAIN (intense body pain), BACK PAIN (back pain is sharp, from the back of shoulder blades, mid back), BURNING SENSATION (back is burning), PAIN IN EXTREMITY (pain in legs, arms) and INSOMNIA (haven't slept since Friday even with the medications). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PAIN (intense body pain) outcome was unknown and BACK PAIN (back pain is sharp, from the back of shoulder blades, mid back), BURNING SENSATION (back is burning), PAIN IN EXTREMITY (pain in legs, arms) and INSOMNIA (haven't slept since Friday even with the medications) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided Treatment of the event included using the conmeds of Hydrocodone and Hysingla that the patient was using for herniated disc pain.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15APR2021 date included no new information.
Case number PHEH2013US023934 is an initial spontaneous report received from a health care professional on 13 NOV 2013. This case refers to a 21 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A11076 and expiry date: APR 2014) at a dose of 0.5 ml intramuscularly on 08 NOV 2013, which was reached 0 C for about 1.5 hours on 06 NOV 2013. No adverse event was reported following this administration error.
Pt reports chest discomfort with associated feelings of shortness of breath about 45 minutes after receiving vaccine. Symptoms have now lasted for over 12 hours .