chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in an 81-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The vial initially stored in the refrigerator was unknown. Number of doses/vials administered from this batch were 173. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received with non significant information.
Pt developed nausea and projectile vomiting with swollen abdomen. Pt seen in local ER and was treated with anti-emetic (Zofran).
I came down with a cold that provided enough symptoms for me to go to see a doctor. I have had a cold that will not go away since Thanksgiving. I have a lot of drainage down my throat. When I blow my nose I get a yellow/goldish colored. Initially I had a headache, sore throat and a thick feeling in my throat under my chin. I would say that the majority of my symptoms lasted a couple of weeks and got better after the antibiotic but I never felt like I was completely well. I was tired easily with a sore throat and a cough. I hardly ever have to use my inhaler. It does not hurt when I breathe, its just get a feeling in my chest and back that is more a noticeable discomfort than it is pain.
morning after first Vaccine dose started early menstruation, exhaustion, HA, myalgias, arthralgias without fever; + nausea and lack of appetite without v/d- lasted ~48-72 hrs - rash started 1/21 on LT upper arm at previous injection site - redness, swelling and warmth; + itchy and tender; can't lay on LT side due to pain; with some chest heaviness
Pt stated he was starting to feel dizzy and light-headed. While waiting on arrival on cot, pt had hypotonic-hyporesponsive reaction lasting approx. 1 min. Lowered to the cot, became alert immediately after. Pt drank juice and laid down for approx. 10 min until he felt better. Sat on side of cot and stood up with no further signs or symptoms. Advised to eat after leaving and rest.
pt recv vax;at time of report,recently donated blood & tested positive for syphilis;It was noted that the pt insisted she had not had intercourse in 2 yr & husband was impotent for some time;
My case of COVID-19 was very mild. On July 5th I had sore throat, redness, itchy throat. I felt congested, shortness of breath, and like I had a little sinus cold. It was gone by a week later, I felt 100 percent better.
Patient was given MMRV and Varicella subcutaneously in the right thigh .  No reactions or side effects from patient.
All lymph nodes on the side I received the vaccine in, my left size, were sore and swollen. There was pain, throbbing, severe soreness and knots you could feel. The largest knot burst and I received some relief.  There is still soreness deep in my left breast. I received my second dose today, 10/9/21, and it is beginning to feel like before only quicker.
About 7 hours after vaccine delivered had severe chills that lasted for 3 hrs.  Difficulty sleeping that night.  Next day tired but overall feeling fine.  A slight bruise at the injection site but not very painful.  No other adverse conditions after the initial ones.
Mother reported rash appearing 10/7/04 took child to ER doctor there instructed giving Benadryl which mom did give. Today 10/8/04 child c/o stomach pain. Mother denies any nausea, vomiting, diarrhea or fever. Mother will take child to see private physician.
Pt developed hives on entire body, post vax, approx. 6 hours. No other related causes. No seafood, no medication, no environmental cause. Cleared after a few days. Pt's sister was also injected at the same time and had no adverse reaction. Mom didn't think of this until now.
Extreme nauseous feeling; Extreme tiredness; Extreme tiredness/fatigue/feverish feeling with no fever; Extreme tiredness/fatigue/feverish feeling with no fever; headaches; foggy feeling; Dizziness; High glucose; This is a spontaneous report from a contactable consumer, the patient. A 58-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 30Apr2021 at 09:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes, diabetic retinopathy and gastroparesis. Concomitant medications included insulin lispro (HUMALOG), ascorbic acid (VITAMIN C), calcium citrate; cholecalciferol (CALCIUM CITRATE + D) and Xa (MANUFACTURER UNKNOWN); all for unknown indications on unknown dates. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. Prior to the 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 vaccination. On 30Apr2021 at 15:30, 6 hours after shot, the patient experienced dizziness. Everyday since first shot, the patient experienced high glucose everyday, extreme nauseous feeling, extreme tiredness/fatigue/ feverish feeling with no fever, some dizziness throughout the day, headaches and foggy feeling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events of dizziness, high glucose everyday, extreme nauseous feeling, extreme tiredness/fatigue/feverish feeling with no fever, headaches and foggy feeling were not recovered at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Muscle aches/Body aches; Minor side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Minor side effect) and MYALGIA (Muscle aches/Body aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 0021321A) for COVID-19 prophylaxis.     The patient's past medical history included Ulcer NOS (past medical history of ulcers, so patient could not take any NSAIDS and could only take Tylenol). Concurrent medical conditions included Fibromyalgia (Diagnosed about 15 years ago).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (Muscle aches/Body aches). In 2021, the patient experienced IMMUNISATION REACTION (Minor side effect). At the time of the report, IMMUNISATION REACTION (Minor side effect) and MYALGIA (Muscle aches/Body aches) outcome was unknown.            The patient was used to the body aches and achiness as the patient had a medical history of fibromyalgia.  No concomitant medications were reported.  The patient had the same minor side effect after the first two shots of Moderna vaccine. The patient had no leg weakness after the first two shots of Moderna vaccine.  About 7 or 8 hours later after vaccination with the two shots, the patient had some body aches and muscle aches.  No treatment medications were reported.   This case was linked to MOD-2022-637940 (Patient Link).
Small rash on BCG scar next to vaccine injection site. Rashes on little finger of right hand, Rash on inner upper right arm, small rash on inner right thigh. Mild rash and itchiness on both facial cheeks. Rashes on genitalia.; Mild rash and itchiness on both facial cheeks.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included lymes disease on an unknown date in 2003 and gluten sensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 12:00, the patient experienced "small rash on BCG scar next to vaccine injection site. Rashes on little finger of right hand, Rash on inner upper right arm, small rash on inner right thigh. Mild rash and itchiness on both facial cheeks. Rashes on genitalia". The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of widespread rash and itchy rash  was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Along with headache, injection site pain, body aches and joint pain, I experienced crippling anxiety, increased heart rate and paranoia with suicidal thoughts.  I thought the tv was sending me messages and  could hear the  voice of my dead father in my head  trying to communicate with me.  There was also another voice that was telling me to kill myself. This lasted for 10 days.  I have never experienced  anything like this before I had the shot.
Patient administered DTaP #5, upper right thigh. MMR #2 upper left thigh. IPV #4 lower right thigh via injection in our office on 9/11/02. Presented to office on 9/13/02 with right thigh red and swollen.
covid vaccine breakthrough case  dose 1 Pfizer 6/22/21 EW0191 dose 2 Pfizer 7/22/21 FA7485
This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received BEXSERO (batch number ABX657AA, expiry date 1st April 2019) for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. Previously administered products included MENACTRA (received a previous dose with no issues years before the time of reporting). On 20th August 2018, the patient received the 1st dose of BEXSERO .5 ml and MENACTRA. On 20th August 2018, less than a day after receiving BEXSERO, the patient experienced pain, feeling cold, headache, myalgia and wakefulness. On an unknown date, the outcome of the pain, feeling cold, headache, myalgia and wakefulness were not recovered/not resolved. It was unknown if the reporter considered the pain, feeling cold, headache, myalgia and wakefulness to be related to BEXSERO. Additional details were provided as follows: The reporter already reported this to VAERS. The age at vaccination was not reported. The patient received a dose of BEXSERO at the same time as MENACTRA. On 20th August 2018, the patient received BEXSERO and MENACTRA and had significant pain that night radiating down to her wrist and up to the right side of her face. The patient was having a cold sensation in her throat and a headache, she also had significant myalgias that kept her awake all night. The patient was back in their office on yesterday (on the day of reporting) for the complaints and they were still not resolved at the time of reporting. The reporter agreed to contact for follow up. It was unknown if the reporter considered the radiating pain, feeling cold, headache, myalgia and wakefulness to be related to MENACTRA.
Some of the vaccine leaked; Revaccinated in right arm with a partial dose; A spontaneous report was received from a consumer who was a 31-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dose leakage and possible overdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, during administration, some of the vaccine leaked (original site of injection was his left arm). In other to make up for the dose that leaked out, he was revaccinated in his right arm with a partial dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, dose leakage and possible overdose, was considered resolved on 06 Jan 2021.; Reporter's Comments: The case concerns 31-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine leak after the first dose. In other to make up for the dose that leaked out, he was revaccinated in his other arm with a partial dose. There were no reported AEs associated with this case and the case is unlisted and causality was assessed as not applicable.
Covid-19; sneezing; sore throat; loss of taste; loss of smell; post nasal drip; Cough; lack of drug effect; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (loss of taste) and ANOSMIA (loss of smell) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced COVID-19 (Covid-19), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (loss of taste), ANOSMIA (loss of smell), UPPER-AIRWAY COUGH SYNDROME (post nasal drip), COUGH (Cough), DRUG INEFFECTIVE (lack of drug effect) and FATIGUE (fatigue). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 24-Apr-2021, DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (Covid-19), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (loss of taste), ANOSMIA (loss of smell), UPPER-AIRWAY COUGH SYNDROME (post nasal drip), COUGH (Cough) and FATIGUE (fatigue) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable. All other events are in consistence with COVID-19.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Up on internal review on 09-AUG-2021, An event lack of drug effect has been added. Treatment medication coded.; Sender's Comments: This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable. All other events are in consistence with COVID-19.
suffered and was diagnosed with painful shingles on her face as well as persistent headaches and balance problems all caused by Zostavax.; suffered and was diagnosed with painful shingles on her face as well as persistent headaches and balance problems all caused by Zostavax.; suffered and was diagnosed with painful shingles on her face as well as persistent headaches and balance problems all caused by Zostavax.; This initial spontaneous report was received on 11-OCT-2019, from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 17-MAY-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2012 (also reported as "within two or three weeks of receiving zoster vaccine live (ZOSTAVAX)"), the patient suffered and was diagnosed with painful shingles on her face as well as persistent headaches and balance problems all caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) vaccine, mental an emotional distress due to  resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work, severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress. Loss of enjoyment of life, physical impairment and injury. At the time of the report, the outcome of balance disorder, headache and herpes zoster was not recovered. The reporter considered herpes zoster, balance disorder and headache to be related to Zoster Vaccine Live (ZOSTAVAX).  The events balance disorder, headache and herpes zoster were considered to be disabling.
Red, warm area around the injection site. Area measures 1 inch by 3.5 inches. Soreness around and above the injection site extending into the upper shoulder. No pain or soreness below the injection site.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (sore arm), PYREXIA (fever(102F)) and COUGH (coughing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (body aches), PAIN IN EXTREMITY (sore arm), PYREXIA (fever(102F)) and COUGH (coughing). At the time of the report, PAIN (body aches), PAIN IN EXTREMITY (sore arm), PYREXIA (fever(102F)) and COUGH (coughing) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications provided by the reporter.
About 5 minutes after receiving the vaccine I developed a headache.  Chills, lost of taste in my mouth, nausea, loss of appetite, body aches all over (joint pain), headache, fever. I also have pain at the vaccine injection site. Last night my fever was 102 so I called EMS and they took me to the ER. I was transferred by EMS. I was just in ER they gave two Tylenol and a bag of IV fluids.  Doctor said it was the side effects from the vaccine.   Today I am feeling much better, my headache is better and I was able to eat but still no taste.
Injection site reaction: red, painful to touch, hot to touch, 6 mm diameter swelling 48 hours post injection. Started approx. 6 hours post injection. NP suggested the use of BENADRYL and ice. No treatment at time of visit.
sore arms; A patient received an expired fluzone quadrivalent; Initial information was received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA271521 and 2020SA272379 (same reporter).  This case involves a 7 years old female patient who had sore arms (pain in extremity) and was inadvertently administered an expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no concomitant vaccines.  On 29-Sep-2020, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6756NA and expiry date: 30-Jun-2020, strength: standard) once via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore arms (pain in extremity) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was an actual medication error case due to expired vaccine used (latency: same day).  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment for pain in extremity  At the time of report, the outcome of pain in extremity was unknown.   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.
pt recv vax 29JUL96 & following day had a red swollen arm & vomited once;lightheaded but did not lose consciousness;31JUL arm was still red  & itchy;
Left arm pain, angina equivalent, woke up after going to bed with left arm pain, radiating from shoulder down the arm.
1st dose FEB2021, 2nd hasnt been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th February 2021, batch number ey93j, expiry date 30th April 2021).   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 age at vaccination was not applicable for this report. The patient wanted to get 2nd dose of Shingrix but till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's current condition and medical history were not reported. On 05-JAN-2016 the patient was vaccinated with VARIVAX (Merck) (dose# and route not reported) of lot # K002921, expiry date: 26-FEB-2016. On 26-JAN-2016, the same unspecified patient was again administered VARIVAX (Merck) (route not reported) of same lot # K002921, expiry date: 26-FEB-2016. Hence the patient experienced inappropriate schedule of drug administration on 26-JAN-2016. No adverse event was reported. Product quality complaint was not filed. Additional information has been requested.