chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after the second dose had some side effects; after the second dose had fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (after the second dose had some side effects) and PYREXIA (after the second dose had fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included LOSARTAN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (after the second dose had some side effects) and PYREXIA (after the second dose had fever). At the time of the report, VACCINATION COMPLICATION (after the second dose had some side effects) and PYREXIA (after the second dose had fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.         No treatment medications were reported. Patient's concomitant medication includes Atrial fibrillation medication 50Mg 2xDay.   This case was linked to MOD-2021-383416 (Patient Link).
Pt examined in office 8/22/06. +Papular bumps that progressed from initial date of onset 8/18/06 all over body. No fever. No petechiae, active, no other systemic signs and symptoms. Rash is consistent with varicella like lesions.
On 2/16, a few hours after the second shot, I started to feel exhausted. For 2 days I slept about 17 hours total. When I got up, I coughed nonstop and wheezed. Codeine cough syrup did nothing. On Mar 5, I was no better, so I went to Urgent Care. They said I had an exacerbation of COPD, but I have never had COPD. They prescribed erythromycin, prednisone, and a Wixela inhaler. On Mar 15, my PCP, Dr. put me back on prednisone for 10 days and added 2 OTC asthma meds. Within 10 days I was much better. On Apr 5, I had some breathing tests that were normal.  I saw pulmonologist Dr. on 4/16. He said it might have been a vaccine reaction. I have never experienced anything like this before.
Hands were bothering more; More aching shoulders/ache under the knees; Leg swelled up after the first and second vaccine; Aching after the first and second vaccine; Numbness in arms where vaccine was injected; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Hands were bothering more), PERIPHERAL SWELLING (Leg swelled up after the first and second vaccine), PAIN (Aching after the first and second vaccine), VACCINATION SITE HYPOAESTHESIA (Numbness in arms where vaccine was injected) and ARTHRALGIA (More aching shoulders/ache under the knees) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-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 ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In July 2021, the patient experienced PERIPHERAL SWELLING (Leg swelled up after the first and second vaccine), PAIN (Aching after the first and second vaccine) and VACCINATION SITE HYPOAESTHESIA (Numbness in arms where vaccine was injected). On an unknown date, the patient experienced LIMB DISCOMFORT (Hands were bothering more) and ARTHRALGIA (More aching shoulders/ache under the knees). At the time of the report, LIMB DISCOMFORT (Hands were bothering more) and ARTHRALGIA (More aching shoulders/ache under the knees) had not resolved and PERIPHERAL SWELLING (Leg swelled up after the first and second vaccine), PAIN (Aching after the first and second vaccine) and VACCINATION SITE HYPOAESTHESIA (Numbness in arms where vaccine was injected) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of numbness in arms where vaccine was injected, more aching shoulders/ ache under the knees, hands were bothering more, leg swelled up and aching after the first and second vaccine was not provided for Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
When I received the shot, I felt pain radiating down my arm to my wrist.  This continued for about 12 hours after the shot.  I also felt some numbness/tingling in my left hand.  Since this went away within 24 hours, I did nothing extra to treat it.  On the 4th day after the shot (1/19/21), I began to itch.  It started in my arm near the shot site and then spread throughout my left arm, up the left side of my neck, and on the left side of my face.  By the evening, my entire upper body was itching to the point that my skin felt like it was crawling/I wanted to rip my skin off.   I had to take Benadryl in order to sleep.  The itching has continued throughout today and seems worse on the left side of my body.  I cannot take Benadryl during the day as it puts me to sleep.  I cannot be asleep at work, nor can I take off of work in order to stay home to take Benadryl.  The itching is making basic tasks difficult.  I know I will have to take Benadryl again tonight or I won't be able to sleep due to the itching.  Is there any idea on how long this will last?  Is it safe for me to get the 2nd dose of this vaccine?
This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose a couple of years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable. The patient does not remember if she received a second dose, which led to incomplete course of vaccination. The patient contacted her pharmacy but they were unable to retrieve her records. The patient did not wish to provide any additional information. The consent to follow-up was denied.
Pfizer vaccine administered two days after the Beyond Use date expiration of 02/13/2023.
NIGHTMARES; WAKING UP EVERY HOUR IN PAIN; EXTREME MUSCLE CRAMPS; STOMACH PAIN; DIARRHEA; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. 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 not reported, batch number: Unknown) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, treatment medications included: acetylsalicylic acid, and ibuprofen. On 17-AUG-2021, the patient experienced nightmares. On 17-AUG-2021, the patient experienced waking up every hour in pain. On 17-AUG-2021, the patient experienced extreme muscle cramps. On 17-AUG-2021, the patient experienced stomach pain. On 17-AUG-2021, the patient experienced diarrhea. On 17-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, diarrhea, nightmares, waking up every hour in pain, extreme muscle cramps, and stomach pain. This report was non-serious.
This spontaneous report was received from a pharmacist via a company representative and refers to a 69 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date in 2015, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced a full blown case of shingles and was in pain for 2 weeks. The outcome of the event was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the reported refused additional contact.
C/O pain in her L arm where she got the Gardasil injection (02/10/07). Pain starts when she rotates arm inward or lift it shoulder level or above.
Per family patient reported c/o nausea and vomiting at home post treatment on  3/30/2021, he went to bed and was found unresponsive on 3/31, EMS was contacted and pronounced deceased at home on 3/31/2021. (exact time unknown).
Sore shoulder; Extreme Diarrhea; Extreme vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme Diarrhea) and VOMITING (Extreme vomiting) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LOSARTAN, GABAPENTIN, GLIMEPIRIDE, FLUOXETINE, ATORVASTATIN, OMEPRAZOLE, VITAMIN D2 and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Extreme Diarrhea) (seriousness criterion medically significant) and VOMITING (Extreme vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, DIARRHOEA (Extreme Diarrhea), VOMITING (Extreme vomiting) and ARTHRALGIA (Sore shoulder) outcome was unknown.            Concomitant drug included Pilomisitone 50mg. Treatment medication included equate anti diarrhea (loperamide, and its controlling the symptom). This case concerns an 81 Y/O M with a serious unexpected event of severe diarrhea and vomiting along with nonserious unexpected arthralgia. Event onset on day 2 after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 81 Y/O M with a serious unexpected event of severe diarrhea and vomiting along with nonserious unexpected arthralgia. Event onset on day 2 after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
During administration of the second Moderna dose, vaccine leaked from the hub of the needle. The patient received over half of the vaccine dose.
Pain in right arm near shoulder, says pain radiates downward. Unable to move arm above head.
felt like upper respiratory infection; scratchy throat; cough; sinus problems; sore arm for a couple of days after both doses; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (felt like upper respiratory infection), OROPHARYNGEAL DISCOMFORT (scratchy throat), COUGH (cough), SINUS DISORDER (sinus problems) and MYALGIA (sore arm for a couple of days after both doses) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included VITAMINS NOS for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UPPER RESPIRATORY TRACT INFECTION (felt like upper respiratory infection), OROPHARYNGEAL DISCOMFORT (scratchy throat), COUGH (cough), SINUS DISORDER (sinus problems) and MYALGIA (sore arm for a couple of days after both doses). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (felt like upper respiratory infection), OROPHARYNGEAL DISCOMFORT (scratchy throat), COUGH (cough), SINUS DISORDER (sinus problems) and MYALGIA (sore arm for a couple of days after both doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information included blood pressure medications.   This case was linked to MOD-2021-280682 (Patient Link).
evening 1FEB93 felt itchy evening 3FEB93 states noted rash 3FEB pink erythema on face-red pin point rash abdo, clust back; 4FEB erythematous flat generalized rash; 3FEB DPH;
Pt exp flu-like sx following Hep B vax (recomb); No further details were provided;
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022). No concomitant product use was reported. Total number of vials used were 35. On 04-Jun-2022, the vial was initially stored in the refrigerator. Patient received half dose. Vial did not undergo any temperature excursions. No treatment information was provided.
ill; cold; Initial information received on 28-Dec-2021 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who had ill and cold while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious ill (illness) and cold (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (ill, cold).  At time of reporting, the outcome was Unknown for the event ill and was Unknown for the event cold.
15 mins post vaccination of pfizer vaccine, pt stated she feel her heart beat was racing fast. Vital signs checked 158/94 P 116 R 18  T97.8, O2 Sat 98% RA. Pt encouraged to relax, fluid oftered + tolerated well. vital signs rechecked 20mins later BP 146/90,P 82 R 16,T97.8, O2 sat 100% RA. Patient stated "I feel better now". As per patient and husband pt has history of Anxiety. RN encouraged patient to relax for few minutes so patient left the floor in stable condition accompanded by her husband and son. No further complain reported.
Headache, low grade fever, exhaustion, 5-6 inch small rash on spine
Whole-body rash; Itching; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06May2021 at 16:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and escitalopram oxalate (LEXAPRO); both for unspecified indication from unknown date and unknown if ongoing. The patient previously 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 03Apr2021 at 11:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07May2021 at 14:00, the patient experienced whole-body rash, itching and tingling tongue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of whole-body rash, itching and tingling tongue and included treatment with Benadryl. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events whole-body rash, itching and tingling tongue was recovered on an unspecified date in May2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Redness, swollen warmth to touch itchiness, 9mm x 7mm erythema, tender.
Substantial swelling, red discoloration to surrounding tissue as well as heat and pain to the injection site accompanied severe headache which lasted all day unresponsive to Ibuprofen/Tylenol for tx of symptoms. Symptoms onset 03:00 on Thursday 1/28/2021 Narrative:
Had appointment at 09:45 on 12/3/02 at clinic. Was given 2 vaccines at approximately 10:30; same day - pneumococcal and influenza. By 13:00, I was running 103 fever with joint and body pain and severe headaches. I called clinic that gave shots on 12/4/02 to talk to nurse about problems and she said come in on 12/5/02 about 13:00 and she would try to work me in. I've been through this before so I didn't go, since also I was on crutches and had so much swelling and soreness on right arm below arm pit where they gave both shots in some place I could not use crutch. By late Thursday night, 12/5/02, I started getting rash from right arm, arm pit, across entire back to waist, around sides and started to go to chest. The lowest I got my fever was 102.8 taking Tylenol every 4 hours, and my lower back, kidneys started hurting real bad and hard to urinate, and or burning. Early 12/6/02 Friday morning, I had bad sweats to where my night clothes were sopping wet and then my fever went down to 99.5, the lowest it had been since I had shots. I called the ask a nurse at hospital where I had got shots from  their clinic that morning and the RN said I need to be seen. So I was there by 10:00AM on 12/6/02 Friday after being seen at the hospital clinic, I was sent to ER, after being seen by their RN and waiting longer I was sent back to another part of the ER to see a doctor. When the nurse saw my rash and other things and said I needed to be admitted to ER about 15:30, they put IV's in my arm, took blood, gave shots in IV and left arm, EKG, X-Rays. By about 22:00, my fever was down and headache better and they let me go saying I had the flu. That is BS; they just didn't want to file paper work as required by law. My BP was 175/96 at first clinic and temperature was 99.5; this was never either one again all night long. By 03:00 Saturday, 12/7/02, my fever was up to 99.5 again and my rash rash was burning, itching and hurting. This was until Sunday afternoon. My fever is down, my kidney's are finally not hurting but till this day, I still have leftovers of the rash though its not hurting and getting better. I know now why you show a low percent of problems these affects are never reported by doctors.
One week after injection arm has fist size angry red swollen place around injection site.  It is painful, and itchy.
Tested positive for COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19) outcome was unknown.        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.   Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
10X10CM INFLAMMATION AROUND INJECTION SITE. PT TOOK A PREDNISONE TAPER (HAD SOME AT HOME) AND HAS BEEN FEELING BETTER. NO ANAPHYLACTIC EVENT REPORTED
Developed COVID. Detected by PCR.  Had fever, chills, muscle aches, runny nose, nausea, headaches, fatigue, loss of taste and smell.
No additional adverse event information; Vaccine administered two days after labeled expiration date; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported      On 22-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD), (0.5 unit not reported), lot # t032147, expiration date 20-MAR-2022 (route not reported) for prophylaxis (expired product administered). No additional adverse event information and no product quality complain reported.
Dose 3 of Hepatitis B vaccine administered to patient on August 27, 2018 was one day past expiration date. Expiration date of vaccine was August 26, 2018. Patient with no adverse reactions at this time per mother.