chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered Menactra that was expired, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in the left arm on 24-Oct-2019, that was already expired on 24-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  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.  Information on the batch number was requested.
Itching all over my body; coughing like almost asthma attack like; Itching throat; tight chest; asthma attack like; This is a spontaneous report from a contactable consumer.  A 34-years-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Arm Right on 20Oct2021 16:15 (Batch/Lot Number: Ff2593) as single dose for covid-19 immunisation.  Medical history included fibromyalgia, arthritis, chronic migraine, known allergies to Iodine, shellfish, latex, mango, fennel, adhesives. Concomitant medications included Vitamins, tramadol; cetirizine hydrochloride (ZYRTEC R); tizanidine; iron and paracetamol (TYLENOL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 20Oct2021 16:45  the patient experienced itching all over her body, coughing like almost asthma attack like, Itching throat , tight chest. The events resulted in Emergency room/department or urgent care. Treatment received included Benadryl. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Started with chills, fever, malaise the night of administration. At bedtime on night of administration patient had severe facial pain in the trigeminal nerve. Patient can't even touch face or lay down on pillow due to facial pain. Patient has been taking TYLENOL for pain and it is getting better every day.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 04-AUG-2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, route of administration and anatomical location were not reported), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was unknown.
Information has been received from a consumer, a 34 year old Caucasian female who in June 1999 and on 7/22/99, respectively, was vaccinated with the 1st and 2nd dose of varicella virus vaccine live and subsequently in August, 1999, the pt found out she was pregnant. Follow-up information from an RN at the physician's office reported that the pt had an elective abortion in October, 1999. It was reported that there was no medical indication for the pregnancy termination but was the personal choice of the pt. No further information is available.
Information has been received from a medical assistant referred to several unspecified patients of an unknown age and gender. Medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with PROQUAD 0.5 ml, subcutaneously, lot# reported as K020749 and expiration date 30-APR-2016. There was no concomitant medication provided. No adverse effects reported. This is one of two reports from same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-DEC-2015 at 12:32, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 and 7.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I experienced on 04-07-2021 after the J&J vaccine, my blood pressure went up to 180/100. I had a bad headache, ringing in my ears so I went to the ER. They put me on the Amlodipine medication. My BP was still going up. My headache and ringing on my ears would not go away. I called my cardiologist to increase the Metoprolol medication. Then he added Spironolactone daily for me to take and my blood pressure came down to 120/70. I was then referred to a kidney and hypertension doctor and he has decreased the Amlodipine and so far, my BP is still stable.
2/16/16 - Patient called to report a recent diagnosis of congestive heart failure that she is relating to the shingles vaccination she received in 8/28/2014.
Information has been received from a certified medical assistant concerning a 21 year old female with a penicillin allergy who on 16-JAN-2007 was vaccinated with the first dose of Gardasil (lot #655619/1427F), single dose, IM. Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). On 16-JAN-2007, the patient had a pap smear performed and the results indicated "positive high risk HPV". The patient sought unspecified medical attention. On 14-MAR-2007, the patient was vaccinated with the second dose of Gardasil (lot #654702/0011U), single dose, IM. On 16-JUL-2007, the patient was vaccinated with the third dose of Gardasil (lot #657868/0523U), single dose, IM. At the time of reporting, it was unknown whether any symptoms have been reported. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.
Finger flange of the syringe broke which made a deep cut on the left pointer finger.; Finger flange of the syringe broke which made a deep cut on the left pointer finger.; the finger flange of the syringe broke/ PQC: Yes; The patient "was using a PNEUMOV AX 23 syringe and while injecting PNEUMOVAX 23 on 9/15/2019, the finger flange of the syringe broke which made a deep cut on the left pointer finger; This spontaneous report as received from a 40 year-old male pharmacy technician who is also the patient.   The patient did not have concurrent or historical conditions, drug reactions, allergies, or concomitant medications.    On 15-SEP-2019, the patient was was using a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S012244 with expiry date of 09-FEB-2021) syringe and while injecting the vaccine, the finger flange (at the end towards plunger not needle) of the syringe broke (syringe issue) which made a deep cut on the left pointer finger (skin laceration). The finger was treated by washing the site and applying a bandage. Then, another syringe of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered without difficulty. On 16-SEP-2019, the patient was recovered from the events. There was a product quality complaint involved, but the product would not be retrieved as syringe was used. Additionally, it was reported that the syringe tip cap was attached properly prior to use, the syringe tray intact and undamaged, the cellophane cover of the syringe tray intact and completely sealed on receipt and the syringe carton was not damaged prior to use.   The causality assessment between skin laceration, product quality complaint and syringe issue with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Information of this prospective pregnancy report has been received from a 23 year old female patient referring to herself. Concurrent condition and medical history were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (strength, lot #, expired date were unknown) intramuscularly. Then, the patient found out she was pregnant. The date of last menstrual period and the estimated date of delivery were not known. The pregnancy outcome was pending. No product quality complaint (PQC) was involved. Additional information has been requested.
Information has been received from a medical assistant for the pregnancy registry for GARDASIL concerning an 18 year old female with no known allergies or pertinent medical history who on 31-OCT-2007 was vaccinated IM with the first dose of GARDASIL 0.5 ml. There was no concomitant medication. The medical assistant reported that on 31-OCT-2007 the patient received her first dose of GARDASIL and was subsequently determined to be pregnant. On 18-JAN-2008 Urine pregnancy test was performed (result:positive). Last menstrual period was reported as October 2007. The patient sought medical attention, "office visit". There was no product quality complaint. The patient has not received her second or third dose of GARDASIL. Follow-up information has been received from a physician concerning the patient. It was reported that the patient had a spontaneous vaginal delivery of a healthy normal-appearing male on 16-JUL-2008, at term. The baby's APGARS were 8 and 9. The mother had a normal prenatal course, with normal fetal anatomy survey at 20 weeks estimated gestational age, though the spine was not fully visualized due to the fetal positioning. The mother was treated with antibiotics in labor as she was found to be group beta strep positive in her urine prenatally. The mother was seen again for a postpartum visit in August 2008: she was doing well and reported that the baby was also doing well. No further information is available.
Approx 10 minutes after receiving immunization, patient was feeling faint and nauseous, couldn't feel left arm or leg.  Patient confused, delirious, laughing for no reason, lethargic.  Neuro exam revealed left side weakness.  Was sent to ER via car.  Parents did not take to ER stating patient improved.  Behavior lasted approximately an hour.
Chills, nausea, achy joints.  Sluggish feeling on day 2.
This spontaneous report as received from a 75 year old female retired healthcare worker (certified medical assistant) reporting on herself. the patient's drug reactions/allergies included flu-like symptoms with antihistamines and sulfa drugs. The patient had no pertinent medical history. On approximately 10-SEP-2014, reported as approximately 3-4 weeks ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported). There was no concomitant medication. On approximately 12-SEP-2014, within approximately 2 days of administration of ZOSTAVAX, the patient developed pain and itchiness at site. At some point over the past 2-3 weeks (unspecified date in September 2014), she developed a full blown case, not mild at all of shingles with multiple blisters which has been scabbed over. There was no treatment given for the adverse event. No laboratory tests were performed. The patient did not seek medical attention. All of the patient's symptoms have resolved (unspecified date approximately in October 2014). The patient also reported that the facility where she was vaccinated was given a "bad batch" of ZOSTAVAX. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information is not expected because the patient wants no follow-up.
At approximately 8 days post vaccine she developed headache, nausea, ringing in ears.  Objectively had a ring shaped rash around the site of vaccine that was described as itching and burning.  The ring was approximately 7cm in diameter.  This was treated on a visit prior to ED arrival with clindamycin and prednisone, and it worsened despite those treatments.
Pt. states that after receiving the 2nd dose of Moderna 02/19/2021, started experiencing symptoms 03/17/2021 of March 17th treated for ear infection, steroids and antibiotics,  Lost hearing in the right ear, ENT in , stated virus related, Sept. 1st ENT severe pressure and ringing. Still continuing losing hearing.
This report was received from Novartis and was assigned manufacturer report number PHEH2012US016500 refers to a patient of unknown age. The patient was vaccinated with M-M-R II (lot #, dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced swelling, redness, warmth at injection site. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. The original reporter is a nurse. Additional information is not expected.
The pt developed rash, fever, hives within 24hrs following the vaccination with DTap, HIB, IPV and Prevnar. Rash/hives are on theback and belly of the pt.
TINGLING SENSATION; This spontaneous report received from a patient concerned a female of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tingling sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling sensation was not reported. This report was non-serious.
Had a headache and when he took a deep breathe he had a tickle in his chest. Soreness in lower back.
Pt received vaccine at 10:52am and at 11:03 reported slight difficulty to breath and tingles throughout body. EMS took over with patient at 11:04 blood pressure 138/67. Pt received Benadryl IM at 11:10am on right deltoid. Pt released by EMS at 11:25am.
This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M018810, expiration date 28-MAY-2016 (route, dose and frequency were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Approx 12 hrs after receiving vaccine patient c/o dizziness blurred vision.  Also nausea, vomiting x2- local reaction at site to include redness, swelling- approx 5 cm x 3cm circular @ site.  Pt presented to clinic on 20 Aug 09- received 25 mg BENADRYL IV, 25 mg  IV, 1000 ml NS PHENERGAN IV, 1000 ml NS bolus & 24 hrs quarters.
Patient began feeling fatigue after receiving the 2nd dose of Pfizer vaccine.  One week prior to this call, patient received a shot in her knee because of pain and weakness.  The shot in her knee was done at clinic. On 5/26/2021, patient felt worse and daughter took her to ER and she was admitted.  Patient had a lot of fluid on her and was diagnosed with CHF.    Medical condition did not improve and patient was put in hospice program and discharged to her home on 6/1/2021.
Tender nipples; This spontaneous case was reported by a consumer and describes the occurrence of NIPPLE PAIN (Tender nipples) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced NIPPLE PAIN (Tender nipples). At the time of the report, NIPPLE PAIN (Tender nipples) had not resolved.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Patient called on 10-03-08 at 8:55 A.M. Complained of left arm being red, hot tender to touch with swelling. Stated she halos had a rash and was having tingling to same arm which was "getting worse".  Patient also complained of having a headache. Patient stated this was noticed some time on the A.M. of 10-03-08.Patient was prescribed Prednisone by her private physician.
Patient fainted away 1 min after she was given a flu shot. She recovered in 5 min.
This subject was reported by a nurse and described the occurrence of injection site soreness in a 43-year-old female subject who was inadvertently vaccinated with the incorrect dose of Engerix-B for prophylaxis. On 28 March 2006 the subject received 2nd dose of Engerix-B in the left arm (lot AHBVB185AB). The nurse reported that the subject inadvertently received the "pediatric dose" of Engerix-B. The pediatric, 10 mcg, dose of Engerix-B is recommended for immunizing individuals 19 years of age and younger. On 28 March 2006, less than one day after vaccination with Engerix-B, the subject experienced injection site soreness. The injection site soreness resolved on or after 28 March 2006 and on or before 21 April 2006.
symptoms: dizzy, light-headed, excessive sweating, hard to hear, hard to see called ambulance
8/8/21 Thumping heart beat on and off for 40 mins, thirsty/dry mouth, light headed, dizzy. Ambulance to hospital, stayed overnight. 9/8/21 Thumping heart beat, thirsty/dry mouth, light headed/dizzy for a couple of mins and then blacked out.
client complained of dizziness and anxiety after receiving 1st Pfizer Covid. Client informed EMT she needed to step out due to anxiety. EMT accompanied client to patio. Vitals at 1614: blood pressure 110/70, pulse 120, oxygen 98%. Per client history of anxiety and had been anxious the last few days due to vaccine appointment. No current medication, no allergies. Vitals at 1631: pulse 114, oxygen 98%. Client stated feeling calmer at 1642. Vitals at 1644: pulse 113, oxygen 98%. Client completed 30 min observation. Friend with client, would drive home. RN gave ER precautions. Client left facility at 1643 with steady gait.
Hives w/eye swelling, generalized itching 30 mins post inject; local react characterized by redness, pain, swelling warmth & itching; took DPH;
Headache, Fever, Chills, Body aches, sore arm, fatigue Narrative:
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Narrative:  04/17 Covid vaccine dose #1 04/18 @0230 pt. reports symptoms of chills, numbness on right facial area, right ear, right arm, rt side of body unable to move and talk, I reported it lasted about 5 mins acknowledges he didn't do anything after then; seen in non-VA ED and discharged on ASA, Possible TIA (no records in chart) 04/20@ 1420 pt. reports similar episode, same symptoms reported from before but milder, lasted only two mins and just resolved on each own, he didn't seek ER treatment and admits he just had his wife check his BP 143/67 and his resume normal activities. 04/20 Symptoms resolved; he is feeling fine.
Vaccines admin in an office at 945Am. FOC took child to school at 1035 school called pt B eyes were red and swollen - Benadryl was given to pt and swelling was subsided.
Myocarditis; This is a spontaneous report from a contactable physician through a Pfizer sales representative.   A patient of an unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination the patient experienced myocarditis. Treatment was received. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information and the plausible drug-event association, a possible contributory role of the suspect product BNT162B2 to the development of the event cannot be fully excluded.
I tested positive for COVID-19 after returning from a wedding, October 19, 2022.  I did not have symptoms at this time.  On October 22nd I went to the clinic for a PCR test.  I had a dry throat, not sore, just dry.  I began to have a lot of chest congestion and had trouble breathing.  This lasted about five-seven days of chest congestion.  After about 10 days I began to get a chronic, productive cough.  As of today, I still have the chronic cough, three weeks out.
patient started coughing/wheezing/nausea difficulty breathing- throat sore- face and eyes turned red. Pulse ox taken- Dr notified- breathing treatment albuterol given. o2 stat was 91 immediately upon symptoms  . After treatment o2 was 96-97.  patient observed for 2 hours after vaccine.