chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very nervous/nerve-wracking; Patient received moderna booster dose after receiving two doses of pfizer; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (very nervous/nerve-wracking) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received moderna booster dose after receiving two doses of pfizer) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Lot Number ER8727 and Lot Number EW0162) from 26-Mar-2021 to 12-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received moderna booster dose after receiving two doses of pfizer). On an unknown date, the patient experienced NERVOUSNESS (very nervous/nerve-wracking). On 24-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received moderna booster dose after receiving two doses of pfizer) had resolved. At the time of the report, NERVOUSNESS (very nervous/nerve-wracking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient thinking that he should not have to a gotten a full dose.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
PATIENT LOST HEARING IN HER EAR; HAD A REALLY BAD EAR INFECTION; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's concurrent conditions included primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZM021B0101 expiry: 30/NOV/2023) 10 mg, every 1 day, frequency, and therapy dates were not reported for primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. Concomitant medications included tadalafil. On an unspecified date, the subject experienced subject lost hearing in her ear, and had a really bad ear infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the patient lost hearing in her ear and had a really bad ear infection was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 16-Mar-2021: upon review Opsumit (macitentan) updated from concomitant to co-suspect, labeling and causality for co-suspect assessed.; Sender's Comments: V1 Additional information received in this version is regarding amendment of co-suspect.  20210341336-Covid-19 vaccine ad26.cov2.s -Hearing loss. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE  20210341336-Macitentan -Hearing loss. Follow-up received regarding Other Information: Amended co-suspect. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
On 3/17/2023 the facility Quality Manager discovered the Moderna COVID-19 vaccine (lot # 060B22A) had been administered on 3/15/2023 beyond the manufacturer's expiration date of 2/26/2023 to 75 patients. The vaccines were removed from the freezer on 3/14/2023, and administered the next day on 3/15/2023 with no previous temperature excursion events. This was discovered while performing a reconciliation of on-hand vaccines through the state's database system. The Quality Manager contacted the CDC who advised the facility to contact Moderna. Moderna was contacted same day (3/17/2023) and a case was opened (case # MI-00018879). No adverse events have been reported by patients as of 3/17/2023.
presented to ED 2/12, day after vaccination and tested POSITIVE for COVID. Then full cardiopulmonary arrest w COVID pneumonia and ARDS on 2/17/21.
Information has been received from a physician concerning an 11 year old female who was vaccinated with the first 0.5ml dose of GARDASIL on "around 11-MAY-2009". Concomitant therapy included MENACTRA and hepatitis A vaccine (inactive) (MSD) (duration and dose not reported). On 10-JUL-2009 it was reported that the patient experienced back and knee pain after receiving first dose of GARDASIL "within the last couple weeks". The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
The night of vaccination, her upper arm near the injection site swelled and developed a large deep red rash. There was a deep red border around the rash. It was warm and tender to the touch. She took some pain reliever to elevate the swelling. Morning after the swelling had gone down, the red border had resolved, however still warm and tender to the touch as explained by patient. No sign of bruising or rash observed at the injection site. Patient feels no sharp or severe pain. Notes only feels typical soreness from injection site.
Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old female patient who was vaccinated with an expired 0.5 ml single dose of TENIVAC (Batch number: U5411AA and expiry date: 30-Jun-2018) (dose in series were not reported) via intramuscular route in the right deltoid on 13-Jul-2018. The patient's past vaccination(s) included ADACEL in 2010. The patient's past medical history, medical treatment(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used because patient received a dose from 20 doses of TENIVAC that has expired. It was unknown if any adverse event was occurred or not following the vaccination. 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. Documents held by the sender: None.
Two Janssen shots 1st shot Janssen 043A21A 09/08/2021 2nd shot Janssen 042A21A 09/28/2021  Refugee:  Has been requested to enter all COVID vaccines into System. The teams responsible for screening and administering vaccines to the refugees. Assisting with entering information into System and VAERS.
Immunization DTaP given 8/22/03. Mom called to advise on 8/24/03, left arm red, swollen, painful and feverish. Seen 8/24/03 for evaluation and diagnosed with immunization local reaction of DTaP.
1/30/21: 20 minutes after injection, complaints of lightheadedness  and numbness left side of face orbital region; Patient states she returned to clinic area and the staff  gave no advice to manage symptom  & ?just continue to carry epilepsy?; 1/21/21: Patient stayed she received  a telephone call from the pharmacist who administered shot who instructed her to  file a report with CDC;  1/21/21 5:25pm Patient reported that her  sight in right eye has become blurry and feels pressure in eye  I recommended to  go to ED and contact physician
Case number PHEH2014US022816, is an initial spontaneous report from a health care professional received on 13 Nov 2014. This report refers to a 69-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with prefilled syringe (PFS) FLUVIRIN (batch number: 146401) intramuscularly which was stored at 33 F for approximately 11 hours on 12 Nov 2014. No adverse event was reported.
At first my arm became sore as I was told by the administering nurse would happen so I ignored it. Next the muscles in my middle back began to lock-up the next day.  Soon it moved to my lower back and hips, then to sciatic and thighs where it remains presently.
REDNESS, SWELLING AND ITCHING TO L ARM; X3 DAYS; TOOK BENADRYL AND PEPCID
Covid positive on 10/25/22, Admitted 11/1/22 with Weakness and Fatigue
Approx. 2 hrs after the shot, I felt disturbances in the chest heart area. Taking pulse, felt "skip beats". These sometimes were occurring at 5 beats or so intervals. I had no prior history of heart palpitations. Went to Emergency room at for evaluation at approx. 11:00 pm. The attending doctor was .  Diagnosis: Premature Ventricular Contractions that the DR stated were likely from the COVID-19 vaccine.   AS of today, 04/01/2021, I am still having occasional episodes of the PVCs.
1/7/00, notified by child's dad, of redness to abdomen & upper arms & has h/o "raised bumps" to touch but no redness. No temp or lethargy. Referred to PCP if worsens. 1/10/00, dad says child is fine, redness has goine but raised area remain
SINCE THE SHOT THE FOLLOWING MORNING THE PATIENT STATES SHE HAS EXPERIENCED EXTREME NERVOUSNESS THAT HAS NOT COMPLETELY SUBSIDED AS OF 10/19/2021
I developed urinary frequency and urgency which has improved after about 1 week although symptoms persist. There is also some discomfort with urination. I have no risk factors for UTI or STI. I've never had similar symptoms.
Information has been received from the reporter who stated that she was told by a doctor. An 80 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665402/1339Y). On 16-MAR-2010 the patient's arm where she was given the dose in was extremely swollen and very red. The doctor prescribed an antihistamine and told the patient to use ice packs. The adverse event lasted for about a week and it was finished (on approximately 23-MAR-2010). The doctor told the reporter that he had 3 patients who all had the same reaction to injections given from the same 5 dose vial. Follow-up information was received which reported that the adult patient was vaccinated and had severe local reaction which appeared to be allergic. The patient was treated with ice packs and CLARITIN and the patient did well. The final outcome of the patient was not reported. Follow-up information received from a physician concerning the 80 year old female who on 16-MAR-2010 had a reaction to PNEUMOVAX 23. The injection site on the patient's arm became extremely swollen and very red. The physician described the look of reaction as "awful". The physician stated "never saw reactions so severe in all the time he has been administering this product". The physician prescribed an antihistamine and had the patient put cold packs on the arm. The swelling and redness lasted about a week and the patient was fine as of 30-APR-2010. This is one of several reports from the same source. Additional information is not expected.
Client reports that 3 weeks after receiving Hepatitis B vaccine #1 she developed lymphedema extending from her left neck to hip, noticed her left hip and left arm and fingers were puffy, also noticed a mild tingling on R side of face which she recognizes as a symptom of lymphedema as well.  Client states this recent lymphedema was "worse" than after her mastectomy/lymph node resection 5 years ago.  Client reports she received treatment from her chiropractor care in the past couple weeks which has resulted in improvement of the lymphedema.  Hand/fingers do not appear puffy today 4/14/09.
Shortness of breath; Sneezing, itchy, runny, or blocked nose; Itchy, red, or watering eyes; Swollen lips, tongue, eyes, or face.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; BLURRED VISION; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 290 pounds, and height was 71 inches. The patient's concurrent conditions included non-smoker, and no alcohol use, and other pre-existing medical conditions included no known medical history. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAR-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the patient experienced blurred vision (both eyes) one week after receiving vaccine. His vision is getting worse. On 30-JUL-2021, the patient was diagnosed with with COVID-19 (suspected COVID-19 infection, suspected clinical vaccination failure). On 30-JUL-2021, Antigen test was performed that was positive. Symptoms of COVID-19 also getting worse.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid 19 infection, and blurred vision, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187995.; Sender's Comments: V0: 20210801741- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report has been received from a nurse, and refers to an unknown number of patients of unknown age and gender. No information was provided regarding medical history, concurrent conditions or concomitant medications of the patients. On an unspecified date, the patients were vaccinated with a dose of vaccines following a temperature excursion. The involved vaccines were GARDASIL 9 (lot # M041990, expiration date 28-JUN-2017 and lot # N019923, Exp date 28-APR-2019), M-M-R II (HSA) (Lot #M045402, Exp date 14-NOV-2018, Lot # N009800 Exp date 24-MAR-2019 and lot # M045101 exp date 10-NOV-2018), PNEUMOVAX 23 (lot #N010488, Exp date 22-JAN-2019), ROTATEQ orally (lot # M042169, Exp date 22-JUN-2018) and VARIVAX (lot # N001530 Exp date 13-JAN-2019). The temperature excursion time frame was 14.9 °C for 4 hours for all the vaccines, except to VARIVAX with - 4.1 °C for 3 hours. There was not a previous excursion and the event was call because the digital data logger. There was not adverse event or product quality complaint involved. Lot number N010488 is an invalid lot number for Pneumococcal Vaccine, Polyvalent (23-valent).
C/o head spinning, sl. nauseous 30" after immunization - hydrated well. T 97 degrees.
Patient came to pharmacy for Pneumovax vaccine. Vaccine was administered in left deltoid. Patient called back to pharmacy 7 hrs later with complaints of sore arm, difficult to move & rapid Heart beat, patient advised to go to hospital.
A nurse reported that a 5 month old infant received Acel-Immune, IPV, and Comvax vaccines on 05/31/2000.  That evening, the infant developed an injection site reaction characterized by redness and swelling at site of Acel-Immune administration. The infant was treated with Acetaminophen and recovered. This is 1 out of 4 patients from this facility who had an adverse experience following receipt of Acel-Immune lot 469-396 or the concomitantly administered vaccines.
A few hours after my Pfizer COVID-19 booster shot on Aug. 27, my hearing suddenly was muffled, and then ringing in my ears started and hasn?t let up since. It is now Oct. 6, 2021. It seems like tinnitus, and it seems most prominent in my left ear. I did not notice this after my Pfizer COVID-19 shots on March 26 and April 16.
TDAP and MENACTRA admin in right deltoid 9/27 in AM. Evening 9/27 some pain in arm took TYLENOL x 2 pills. 9/28 AM redness size of quarter with some pain - took TYLENOL x 2 pills. 9/29 2:15pm 3 inch red area rt upper arm. Mother taking her to med express for evaluation.
severe joint pain and arthritis; severe joint pain and arthritis; Hair loss; 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 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Sep2021 (Lot number: FD8448) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "neck issues" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; HYDROCHLOROTHIAZIDE; VITAMIN D NOS; FISH OIL. Vaccination history included: Bnt162b2 (Dose 1, Lot: FC3180), administration date: 09Aug2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), ARTHRITIS (non-serious) all with onset Oct2021, outcome "unknown" and all described as "severe joint pain and arthritis"; ALOPECIA (non-serious) with onset Oct2021, outcome "unknown", described as "Hair loss". Therapeutic measures were taken as a result of arthralgia, arthritis, alopecia. Additional information: Four weeks after the patient had the injection she started experiencing severe joint pain and hair loss, she was still on treatment for hair loss she was on Finasteride, she was also taking vitamin that's called Viviscal (Treatment) and she was also taking Nutrafol (Treatment) so for the bone and joints she had have neck issues (Intent: history) so she had already been taking Tizanidine which is muscle relaxant and also take Diclofenac then she was going to rheumatologist as well too so that appointment has gonna make. No follow-up attempts are possible. No further information is expected.
Left thigh became red 9-13-12. Parents had taken pt. to urgent care at beach after noticing redness. Pt started on antibiotics for cellulitis. Rechecked at our office 9-17-12. Redness better. Recheck today 10-1-12. Left thigh with skin color change, not hot, not tender.
I felt queasy at 5:15am.  Had severe vomiting and diarrhea throughout the day, with a fever of 100 degrees. Tried taking a Pepcid, but got dry heaves. Had nine episodes of diarrhea. Called the doctor at 1:40pm who recommended tablespoons of water every 10 minutes.  The nausea and dry heaves  would not stop so my husband called the doctor again at 7:00pm who recommended the emergency room for an IV.  But at 7:30pm, the nausea lifted, and I was able to sleep.
On August 12, 2022, donor received her first Hepatitis B immunization at 11:42am. At approximately 12:05pm, the donor approached the medical staff stating she felt like she 'was going to pass out.' Donor was taken into an examination room where she reported felling weak and dizzy. Donor then lost consciousness 2 times, each episode lasting less than 10 seconds. Donor then quickly became coherent. Donor reported she only ate some toast and watermelon prior to donation.  She was diaphoretic and had facial pallor.  Medical staff attempted to obtain blood pressure manually but was unsuccessful. At 12:15pm, EMS was called. nurse attempted to start an IV on the dorsal side of the left hand and was unsuccessful. EMS arrive at 12:18pm, blood pressure was obtained as follows: 70/30 at 12:24pm, 94/50 at 12:26pm and 98/59 at 12:29om. Donor was provided oral fluids and cold compress, she stated feeling fine and refused to be transported by EMS.  Blood pressure was checked again as follows: at 12:52pm BP 120/72 HR 78, at 1:04pm BP 105/65 HR 69; at 1:09pm BP 162/114 HR 75 and at 1:12pm BP 133/100 HR 71. Donor was provided a total of 1182ml of oral fluids with a snack. Donor reported feeling better and was able to leave on her own denying any symptoms at the moment of departure.
Unknown of any adverse events from the vaccine in 2021.  However, per medical examiner, patient died of COVID-19 complications.
i've had tachycardia before but this was extreme; shaking; headache; chills; joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (i've had tachycardia before but this was extreme), TREMOR (shaking), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joints hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Tachycardia. Concomitant products included CARVEDILOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced TACHYCARDIA (i've had tachycardia before but this was extreme), TREMOR (shaking), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joints hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (i've had tachycardia before but this was extreme), TREMOR (shaking), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joints hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, COVID-19: positive 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.
Pt recvd vax 13AUG92 & on 30SEP92 lab eval revealed an increased SGOT & SGPT; no further details were provided;
I got dizzy and stayed dizzy for 3 weeks after the Moderna shot in March. I would almost pass out. I got my booster yesterday. At 5:50 pm today, I started feeling nausea, then dizzy like I was drunk. I don?t drink.  I feel like.  Exactly as I felt with the second shot.
Information has been received from a nurse concerning a 72 year old female patient who on 17-SEP-2009 was mistakenly vaccinated SC by the nurse with 0.5 ml dose of VARIVAX (Merck).  The patient was supposed to receive ZOSTAVAX (Merck).  There were no adverse effects reported.  Follow-up information has been received from a nurse practitioner indicated it was about a male patient.  The nurse would have to call back with any additional information about the medication mistake.  Therefore a message was left for the nurse to return the call about whether or not the VARIVAX (Merck) administration was a case of human error or product confusion.  The health care professional contacted during telephone follow-up could not supply the following information: date of birth, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information.  Additional information has been requested.
Sore arm for two days after the shot was administered. Overall lethargy, fatigue and unwell feeling for a week (but no fever, no chills) Swelling  around the vaccine site after Day 6 Itchiness in the vaccine site after Day 7 Visibly red (inflamed) around the vaccine site after Day 7-9
As the nurse was giving me the shot, a severe pain went creeping down my arm. When it reached my hand, it felt like an explosion going off. I have had a very painful arm for the past six weeks. At first, I had to carry my arm around. It does seem to be getting better.