chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported On 05-Apr-2022, patient received the second booster dose which got expired on 24-Mar-2022 of Lot number 031H21A. Health care professional (HCP) mentioned that there was incident because of miscommunication as a coworker told that there were some lot number whose expirations dates had been extended. No treatment drugs were reported
Severe Hemolysis; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOLYSIS (Severe Hemolysis) in a 32-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Paroxysmal nocturnal hemoglobinuria.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMOLYSIS (Severe Hemolysis) (seriousness criterion medically significant). At the time of the report, HAEMOLYSIS (Severe Hemolysis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       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  Concomitant medications were not reported.  Treatment medications were not reported.  Company Comment: This spontaneous case concerns a 32-year-old, female patient with medical history of Paroxysmal Nocturnal Hemoglobinuria, who experienced the unexpected, serious (medically significant) event of haemolysis. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the vaccine induced severe hemolysis. No further details were provided. The history of Paroxysmal Nocturnal Hemoglobinuria, a rare blood disorder which occurs when part of the immune system attacks and damages the red blood cells and platelets, remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 32-year-old, female patient with medical history of Paroxysmal Nocturnal Hemoglobinuria, who experienced the unexpected, serious (medically significant) event of haemolysis. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the vaccine induced severe hemolysis. No further details were provided. The history of Paroxysmal Nocturnal Hemoglobinuria, a rare blood disorder which occurs when part of the immune system attacks and damages the red blood cells and platelets, remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
mom called fine red rash of trunk & face;8MAY spread to scalp;resolved on 10MAY;mom stated it looked like rash gets from sulfa med that gets;
On 7-30-2022 I started feeling hot so I took my temp that showed 100.4. It got up to 103 that day. I also had a sore throat, cough and head congestion. I used a home COVID-19 test with negative results. The following day, 7-31, I still had these symptoms so I used another home COVID-19 test with positive results. I called and left a couple of messages for my primary care doctor to return my call. They called me back on 8-2 and someone was supposed to call me back but never did. On 8-3, I went into the doctors office for a PCR test. It came back as positive. My pharmacy called me back and told me that they had a prescription for PAXLOVID. I started the medication on 8-3 and took it for 5 days. I am feeling a lot better today. I am reporting a breakthrough case of COVID-19.
pt recv vax; systemic fever for 2 days; T 100 w/ abd pain;
Aug. 14 - Patient came in with erythema and a raised induration around the area that was covered by the bandage. Aug. 18 - Patient came in after the weekend and the area that had the erythema and raised induration was covered with localized lesions.
Pt c/o feeling dizzy. V/S - HR 100/minute, RR 20, BP 100/60. Pt placed in supine position with feet elevated. Observed for other reactions. Pt reported not having eaten. No other reactions experienced.
Severe chills (woke me up) approximately 12 hours after receiving the vaccine with possible mild fever. Treated with ADVIL and no further issues other than soreness at injection site.
Patient had already had the completed series and titer was 55.39 reflecting he was immune and he received an extra booster
Numbness, tingling  and pain in arm from shoulder to fingers.   Stomach pain. On March 1,  early a.m.,  a mental breakdown occurred and was admitted to hospital.  Poor to no communication ability,  totally confused, doing bizarre things like turning on water and leaving room, stacking furniture, not knowing where he was.
I developed a rash over my body after 4 hours of receiving the shot, then took Benadryl to help-the Benadryl helped but the rash persisted into the night. 2 days later the rash reappeared-mostly under arm pits BUE and BLE's. Took more Benadryl, which helped. I also developed a painful and painfully itchy LUE below the site of the injection which lasted for a week. I used anti-itch lotion to help. I experienced the more common symptoms of fatigue and headache for a couple of days afterward. My husband is an M.D. who advised me to take the Benadryl.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 4th April 2018 14:20, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th April 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. In April 2018, the patient experienced fever and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever and fatigue were recovered/resolved. The reporter considered the injection site erythema, injection site swelling, fever and fatigue to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a doctor. The patient received SHINGRIX in the left deltoid. The night after vaccination, the patient experienced redness and swelling at the injection site. Less than month after receiving SHINGRIX, the patient also experienced fever and fatigue that lasted the next couple of days.
Pt describes reddened area around injection site that goes down arm to elbow.  Also reports pain under arm sore.  Knot increased from under quarter size to over quarter size in 24 hrs.  Tx'ed with BENADRYL & ice.  Saw M.D.
10/07/2003: Client reported severe headache during the night.  Did not take any medication.  Headache this AM is moderate.  Injection site swollen with bruising noted at site.  Swelling approximately 3 inches in diameter.  Instructed to take Tylenol and use ice packs on area.  To consult with MD about Benadryl since has glaucoma.
Pt reported lightheadedness and was found to be diaphoretic and pale after vaccine administration.  She was laid down on a gurney with legs elevated, V/S monitored for 45 minutes and given apple juice po.
Very sore arm for approx. 48 hours; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported; unable to locate or read the details) via an unspecified route of administration, administered in arm left on 04Feb2021 13:30 as first dose, single for COVID-19 immunization (at the age of 55-year-old). Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported (as other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination, no covid tested post vaccination. On unspecified date Feb2021, the patient experienced very sore arm for approximately 48 hours and after 2nd dose, slept for most of day. The patient not received treatment. The outcome for event was resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Pharmacist called another patient's name into the shot room.  This patient entered shot room under the assumption that she was the correct patient.  The Pharmacist proceeded to give the patient the Jansen Covid-19 shot.  After leaving the shot room, a technician brought attention to the Pharmacist that the wrong patient was given the Jansen Covid-19 dose.    Patient is under the approved age of 18 years old for the Jansen shot.
Information has been received from a physician concerning an approximately 30 month old twin female who on 14-sept-2004 was vaccinated with the first dose of measles virus vaccine live.  The physician reported that on 23-sep-2004 the patient developed fever and on 24-sep-2004 developed a measles like rash.  Unspecified medical attention was sought.  At the time of this report, the patient's fever and measles like rash was resolving. Additional information has been requested.   2/03/2010 follow up- follow up information received from physician stated that the patient "did not have adverse effects from vaccine". the physician also confirmed that the patient had a "fever of 102 and a measle-like rash for several days approximatelty 9 days following vaccine which was to be expected". it was also confirmed that the patient's sister did not experience the same reaction. it was noted that the patient recovered.
Subtle onset of tightening of jaw muscles, unable to meet back teeth to chew, tenderness of lower jaw muscles and parotid glands
PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at site of injection. This report was non-serious.
After injections, 18 year old male with cool, moist skin, did not respond when spoken to, slumped into arms of immunization nurse. No respiratory distress. Doctor was summoned, immediately responded. Within 5 minute period child was talking and taking fluids. BP 114/70, color improved - observed 10 min and left hospital. Re-examined by doctor before leaving with guardian.
Low grade fever p/shot; 8-2 began screaming 3 days; 8-4 broke out all over hives, not eating; low grade fever 102 down to 99 last night;
two hours after shot, temp 102 started shakeing gave him tylenol to lower fever,it did nothing would not eat has diarrhea,4pm temp 103 crying on and off did not want to stand on leg gave motrin did nothing 5pm cryed nonstop for an hour placed in cool bath, did not want to be touched, has not eating allday 10pm temp 104 spoke to on call nurse 4times by now thursday 7am temp 102 has not went pee in almost 24hrs has been drinking fluids but not eating still fussie 2pm take to doctors temp 100 4pm started eating a little friday morning temp normal 98.7 still has diarreah but feeling much better
Within 60 sec of completing vaccination pt. became pale with decreased LOC. Skin moist. C/o nausea. Difficulty focusing eyes. Pt later states 1hr 30 min after vaccination with c/o headache and slight visual disturbance.
tiredness; nausea; whole body was twitching; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, nausea and whole body was twitching. The outcome of the events was unknown.  This Follow-up is being submitted to notify that lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed. No further information is expected.
I have patient who got the 1st dose of moderna,Now they want second dose, can I give it to them after this long ?; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have patient who got the 1st dose of moderna,Now they want second dose, can I give it to them after this long ?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have patient who got the 1st dose of moderna,Now they want second dose, can I give it to them after this long ?). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have patient who got the 1st dose of moderna,Now they want second dose, can I give it to them after this long ?) 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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non significant follow up
Developed inconsolable crying about 6 hours after vaccine. Came to office, screaming and distressed, finally settled after p.o. acetaminophen and ice patch to left leg. Exquisite Tenderness w/ palpation and even light touch. No eyrthema or bruising.
elevated temp 104 x 2 days, dizziness, h/a, sleepiness;
really bad arm pain; This is a spontaneous report from a contactable consumer via medical information team. A female patient (pharmacist) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported) via an unspecified route of administration in arm, on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after receiving the vaccination the patient really had bad arm pain. Patient personally took Tylenol as a treatment for the event. The outcome of the event was unknown.  Information about batch/ lot number has been requested.
Syncopal episodes X 4 on 1/23 - transferred to ed  - admitted  Fever chills aches on 1/22/21 pm
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-JUL-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # lot # K011492, expiration date 31-JAN-2017). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 24,34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 176, 48 and R; 48, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Mother states that the pt complained of her left arm hurting immediately following vax. She did not attend school the following day because she did not sleep well and ran a low grade temp. The mother observed right arm redness from the injection site to the wrist. Seen in the ER with a temp of 101.9. Given antibiotics and released.
Pain, severe - right upper extremity about 2 hours after receiving PNEUMOVAX injection in rt deltoid.
On April 9th, I received the J&J Vaccine. Based on recent news of the aggressive variants (namely Delta), as well as J&J's lower efficacy rates, I decided to boost my original J&J vaccine w/ one dose of Moderna. Approximately 8 hours later I developed severe and persistent pain isolated nearer to the left side of my upper chest and best described as the area around my heart. I took 800mg of IBP at 6:30 PM and the pain went away after an hour. The pain returned at 4AM this morning and again, I dosed w/ 800mg of IBP and it subsided. As I type, the IBP is wearing off and the chest pain is returning. The pain is more severe when I breathe deeply. I may seek medical attention if it does not subside after today.  I know it's a rare reaction in adults (and a rare reaction in general), but I suspect heart inflammation /  myocarditis.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursion but, no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Site: Redness at Injection Site-Medium, Additional Details: Patient has an indention at the site of the vaccine that is about an inch in diameter with some redness.
INCORRECT VACCINE GIVEN. NO TX, NO TX TO GIVE. MD SPOKE TO PEDS ID AND CONFIRMED THAT THERE IS NO SIGNIFICANT CLINICAL RISK TO THE CHILD. AND THAT THE CHILD WOULD HAVE TO BE RE-VACCINATED ACCORDING TO THE CDC STANDARDS.
Immediately after the shot I became dizzy and had the feeling of having drank several drinks and had a buzz.  My left arm was very sore this time and hurt to touch or lift it up.  The following day I began to have headaches and body aches and had a fever.  My fever lasted for 5 days and my fever on Sunday stayed in the 103 range.  On Monday, I had diarrhea for most of the day.  I tried getting into the doctor and the soonest I could find an appointment was Wednesday morning, 1/12/2022.  The fever, body aches, headache, shortness of breath and lethargic feeling continued through Wednesday. At Urgent care I was given a Covid and Flu test, however it was a 2-4 day turnaround.   Then on Thursday morning, 1/13/2022, I went to the ER with chest pains and shortness of breath.  There they gave me a covid and flu test and both of those came up negative.  Everything looked good on my EKG and chest X-ray and I was told that this was probably all from the booster shot.  I didn't start to feel better until, Saturday, 1/15/2022; which was a week and a day after the booster shot was administered.  I was called yesterday, Monday, 1/17/2022, from  Urgent Care and my Covid test results from Wednesday also came back negative.
On 04/21/2000, the patient developed "pustular lesions over the trunk of his body, a fever of up to 105F, and was not eating for 2 days. The patient was seen by a physician on 04/24/2000 and diagnosed with varicella. On 04/26/2000, the patient's fever persisted, 103F, and he was again seen by a physician. Additional information has been requested.
On 03/30 in the morning the pt presented fever and vomiting. In the evening, injection site swelling was noted. On 03/31, redness and increased swelling at injection site.
Hospitalization: 4/22/2023 - 4/27/2023 (5 days) Presentation to the ED: acute hypoxic respiratory failure COVID + date: 4/22/2023 Treatment: remdesivir & dexamethasone Discharge to: home.  013M20A 3/2/2021 046A21A 3/30/2021 032H21A 12/6/2021 001M21A 4/21/2022 Moderna BiValent AS7163B 10/31/2022
First time user of Levothyroxine 50mcg. Communicated with doctor, about possible risk because of having osteoporosis. Doctor okayed that I could decrease to 1/2 of 50mcg a day. I started taking on Dec 23rd., and took at 5:30 AM, and waiting until 7 AM to eat breakfast. Took until 01/01/2023. In middle of night woke up with leg pain that started from instep to thigh and hand tremors. Stopped medication. It took a couple days to subside, but still have pain in hip. Left message with doctor, (she was on vacation) but other doctor in office said to stop taking, which I had already did, and nurse said they will pass on to doctor when she gets back in office. I am a very energetic 74 year old woman, who is not on any other prescription medication, I just take a couple supplements which have no interactions with levothyroxine. I also years ago had a anaphylactic reaction to fosamax and also the second Pfizer covid shot Also allergic to tree nuts, some cosmetics, and detergents.
Case number PHEH2016US029726, is an initial spontaneous report received from a pharmacist on 09 Nov 2016. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported, Expiry date: Jun 2016) at a dose of 0.5 ml, intramuscularly, on an unknown date. A nurse reported to the reporter that expired FLUVIRIN was administered to a patient. The nurse thought that the expiration date was Jun 2017, but it was Jun 2016. No further information was provided to the pharmacist. No adverse event was reported following this medication error (expired product administered). The pharmacist assessed the case as non-serious.
Information has been received from a registered nurse referring to two unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The patients were administered improperly stored doses of GARDASIL (Lot # K007264, expiration date 02-MAR-2017, dose and route were unknown) on 06-JUN-2016. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT REPORTS 3 SPOTS ON ARM NEAR INJECTION SITE, SORE SWOLLEN ARM, AND ITCHING ALONG HER JAWLINE.
Sudden onset of severe upper abdominal pain with nausea and vomiting until about 1PM when it turned into lower abdominal pain with diarrhea. No evidence of anyone I came in contact with had a virus within weeks preceding vaccine.