chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects; expire dose administered; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 10:23 hours, the patinet was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) with a valid lot # S023219 and expiration date on 03-MAR-2022 (expire product administered) at a dose of 0.5 mL intramuscularly (IM) on the right tight (RT) and with an improperly stored dose of rotavirus G1 P1 vaccine live (89-12) (ROTARIX) oral route and lot # Y5CN5, diphtheria toxoid, and an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # AT8585; for prophylaxis, however no adverse effects reported.   Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008890: US-009507513-2008USA008876: US-009507513-2008USA008889: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008909: US-009507513-2008USA008907: US-009507513-2008USA008906: US-009507513-2008USA008921: US-009507513-2008USA008904: US-009507513-2008USA008933: US-009507513-2008USA008932: US-009507513-2008USA008903: US-009507513-2008USA008901: US-009507513-2008USA008931: US-009507513-2008USA008930: US-009507513-2008USA008900: US-009507513-2008USA008899: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008890: US-009507513-2008USA008920: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008896: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008898: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2003USA002275: US-009507513-2008USA008875: US-009507513-2008USA008875: US-009507513-2008USA008877: US-009507513-2008USA008878: US-009507513-2008USA008880: US-009507513-2008USA008879: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008883: US-009507513-2008USA008884: US-009507513-2008USA008885: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008889:
Large hard bump at injection site, like all of the dose stayed there, arm is tender around that spot. Also, diarrhea starting 24 hours after injection . General warming/ clammyness (not sure if it was a fever, 18 hours after injection
A 44-year-old man presented with chest pain and ST-segment elevation 4 days after receiving the second dose of mRNA-1273 SARS-CoV-2 Vaccine. Emergent coronary angiogram showed minimal coronary artery disease. Cardiac magnetic resonance imaging confirmed acute myocarditis. Diagnosis of vaccine-associated myocarditis was made given the temporal relationship and supportive treatment initiated. The patient was started on supportive therapy for his symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. He was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4?5?days after presentation. He was discharged home after 5?days of monitoring without evidence of electrical or haemodynamic instability and with NYHA Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. He remained asymptomatic and off diuretics.
Symptoms Rapid Onset 12 Hours After Dose 3: Fever 4 Degree Rise Above Normal; Chills; Severe Muscular & Joint Aches; Overwhelming Fatigue; Difficulty Focusing Eyes (Eyestrain); Complete Appetite Loss; Moderate Headache; Erratic Heartbeat (Bradycardia to Brief Episodes of Atrial Fib); Sneezing; Runny Nose; Lethargy; Sleepiness. Duration: 36 Hours After Onset. Treatment: Bed Rest. Outcome: 95% Recovery So Far (72 Hours After Onset).
Menveo administered instead of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 52-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA571A, expiry date 30th June 2022) and (batch number AMVA571A, expiry date 30th June 2022) for prophylaxis.   On 28th September 2021, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 28th September 2021, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details provided were as follows: The reporter provided 2 different batch numbers for the same suspect Menveo as AMXA571A and AMVA571A. Licensed practical nurse called in to report that they inadvertently administered Menveo to a patient instead of Shignrix which led to wrong vaccine administered. The reporter consented to follow-up.
Pt has erythematous, blanching 2 cm of induration to R thigh at injection site, positive itchy. BENADRYL, hydrocortisone cream, cool compresses.
PT is a 39 y.o. male who presents to the ED with complaints of left ear pain upon awakening this morning.  Patient reports constant pressure inside his left ear.  Patient describes a "popping" sensation when he opens and closes his mouth. Patient recently underwent left superficial parotidectomy for pleomorphic adenoma on 07/09/2021 (ENT).  Patient states he was recently cleared from surgery to start showering.  Patient states swelling postoperatively was initially hard but has softened and increased over the past few days.  Patient reports that he did receive his 1st COVID vaccine on 07/23/2021.
Eight days following the injection, I experienced itchiness on and around the injection site, followed by one large hive-like bump surrounding the injection site (approximately 2 in. in diameter).
Patient stated that the night after the injections he experienced a massive reaction in his right arm involving redness, swelling, and pain. Patient wanted to have one shot in one arm and the other shot in the other arm. The pharmacist who gave the shots said that there would be no problem with both shots in the same arm. Patient sought treatment at the emergency department and got a steroid shot to calm the reaction.
sweating a little; sore arm; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 24Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided.  Patient received first vaccine shot the day before the report (reported as yesterday) and had no problem, just sore arm, that was not unusual but the day of the report (reported as today, this morning), after patient got up and walked around a little bit he/she was sweating a little bit. Patient did not feel bad, there was no fever. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
No AE reported; HCP called to report inadvertent administration of a third dose of PEDVAX HIB to a 6-month-old patient. The patient received PEDVAX HIB on 05/23/2023, 07/21/2023, and inadvertently on 09/21/2023. No additional AE/PQC.; This spontaneous report was received from a nurse, concerning a 6-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 23-MAY-2023, the patient was vaccinated with the first dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 21-JUL-2023, the patient received the second dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).    On 21-SEP-2023, it was reported an inadvertent administration of a third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, dose unknown by reporter/third dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  to a 6-month-old patient.  No additional AE/PQC.
PATIENT RECEIVED SHINGRIX VACCINE, RETURNED TO PHARMACY AFTER 10 MINUTES COMPLAINING OF TONGUE FEELING SWOLLEN/TINGLING AND ODD TASTE. PATIENT BEGAN TO GET AGITATED; BLOOD PRESSURE WAS TAKEN AND IT WAS ELEVATED. EMS WAS IMMEDIATELY CONTACTED. PRIOR TO EMS ARRIVAL PATIENT WAS GIVEN TWO 25MG BENADRYL TABLETS (50MG) BY ORAL ROUTE. ONCE PARAMEDICS ARRIVED, VITALS WERE TAKEN AND EMS DETERMINED SHE WAS STABLE AND IN GOOD CONDITIONS TO GO HOME WITH A MILD ALLERGIC REACTION.
Janssen COVID-19 Vaccine EUA Approximately 9 hours after vaccine administration side effects of fever (101F) and severe muscle and body aches began and lasted approximately 24 hours.
101 Fever; This is a spontaneous report from a contactable consumer. A 25-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in left arm on 25Mar2021 at 08:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in left arm on 04Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 (evening of the second dose), the patient experienced 101 (unit unspecified) fever. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event fever was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
The patient reported a possible injection site reaction due to vaccination. Patient was diagnosed as having cellulitis on the site of injection by her physician. Patient is taking antibiotic therapy.
Cellulitis - redness, swelling, hot to touch treated w/ cephalexin 25mg/kg BID Follow up in office 1 wk.
This spontaneous report was received from nurse practitioner referring to patients of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patients received improperly stored PNEUMOVAX 23 exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, and 1408USA000853. Additional information has been requested.
On 11/17/22 I had a stroke, on 11/19 I had a stroke, ischemic stroke of the Basilar Artery. The clot was removed and a stint put in. On 11/20 ihad another is ischemic stroke in the same basilar artery and another surgery.  On 12/28 I had two more strokes. I am perfectly healthy and the doctors had no reason for the strokes except one doctor telling me it was from the covid vaccine.
Headache, Cough, fever, shortness of breath, weakness, nasal congestion, sore throat, fever and chills, abdominal pain, muscle aches
blood in stool, Dark red/gelatenous No pain/vomiting/bloating Resolved after 2 days.
This spontaneous report was received from a registered pharmacist via a company representative concerning an approximately 63 year old female patient. Approximately on an unknown date in April 2013 (reported as within the last week), the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified), subcutaneously. No concomitant medications were reported. Around 06-APR-2013, arm of the patient swelled up, she had pain in her elbow after receiving the vaccination and she had a fever. The patient sought medical attention (spoke with pharmacist). The patient was treated with pain or anti-inflammatory medicine (unspecified). It was unspecified if any lab tests were performed. The patient was recovering from all the events at the time of reporting. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Large wheal flare reaction at injection site. Treated with ice and Benadryl.
Patient has not received the second dose of Moderna vaccine within the appropriate window of time between two doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of Moderna vaccine within the appropriate window of time between two doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of Moderna vaccine within the appropriate window of time between two doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of Moderna vaccine within the appropriate window of time between two doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that Patient was getting close to day 42 after the first dose was received at the time of report.  No relevant concomitant medications reported.  No treatment information was provided.    Reporter did not allow further contact
pt woke 23JUL w/rasied red spots in armpits & @ waist like chickenpox; next Am had larger raised welts on a abdo, back, legs; face & eyes are puffy; resolves & hands & ears are puffy; appetite is depressed & needs more sleep;
Second vaccine administered from vial stored in the refrigerator for 35days/pT WAS INJECTED WITH A VIAL OVER 30 DAYS OLD; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Second vaccine administered from vial stored in the refrigerator for 35days/pT WAS INJECTED WITH A VIAL OVER 30 DAYS OLD) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 04-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Second vaccine administered from vial stored in the refrigerator for 35days/pT WAS INJECTED WITH A VIAL OVER 30 DAYS OLD). At the time of the report, PRODUCT ADMINISTRATION ERROR (Second vaccine administered from vial stored in the refrigerator for 35days/pT WAS INJECTED WITH A VIAL OVER 30 DAYS OLD) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Nurse states the patient came in for 2nd dose of Moderna vaccine on  04JUN2021.  The vial used had been in the refrigerator for 35 days. Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information was Received on 04-JUN-2021 contains No New Information On 07-Jun-2021: Follow-up information was Received won 07-JUN-2021 contains No New Information
The patient became red and inflamed at the site of the injection, it also felt hard to touch.  There was a hard knot that lasted 3 weeks even though the redness diminished in 36 hours. The patient's appetite was diminished and he was a bit listless for about 72 hours.
8x8cm erythemas, induration left biceps and 101.1 fever.
Severe malaise, chills, sweats, weakness through the night. Next day was very weak. This precipitated a migraine. After about 36 hours, symptoms abated.
Pt was given Pediarix instead of DTaP and also given IPV. Error in reading label.
The child was exposed to a friend who had chickenpox and then developed a fever and broke out with lesions the next day. Has 20+ lesions at present.
This spontaneous report was received from an office manager who referred to 50 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as N009798, expiry date 19-FEB-2019 (exact dose and route of administration were not reported) for prophylaxis; and VARIVAX lot# N019840, expiry date 13-JUL-2019, lot# N023960, expiry date 01-SEP-2019, lot# N030407, expiry date 03-OCT-2019 (also reported as 30-OCT-2019) (exact dose and route of administration were not reported). Lot and expiration for properly stored sterile diluent was unknown. The doses of vaccine were stored between 15 degrees Fahrenheit (F) to 46 F (15F) for 2 hours. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. Lot number N009798 is an invalid lot number for PROQUAD. This case is non-valid due to lack of patient's identifiers. Follow up information has been received from a Licensed Practical Nurse on 22-MAY-2018 and confirmed that there were no vaccine adverse experience to report.
Diagnosed at 26 months with PDDNOS.  Confirmed mercury toxicity, mitochondrial disorder, measles, immune dysfunction, gut dysbiosis by board certified pediatrician, board certified medical doctor, board certified pediatric neurologist, board certified neurologist and psychologist between 42 months and 53 months.   Currently being treated with DAN! protocol to support immune system and repair gut dysbiosis and chelation to remove mercury poisoning caused by thimerosal in vaccines.
This recently retired M was referred to VHC by Rheumatologist for risk/benefit analysis after voicing concerns with past influenza vaccine. He advised in the 1982 he received a flu vaccine and within a few moments his ears began to ring, lips were numb, heart rate increased and he had a metallic taste in his mouth, and he felt very sluggish. He denied any breathing difficulty, tongue/oral swelling, no throat swelling or itching, rash, headaches, visual changes, dizziness or any other symptoms. He advised he was monitored by medical and all symptoms resolved in 30-45 minutes. These symptoms reoccurred again following an MMR vaccine 8/31/1988 and with the use of DEPOMEDROL (not related to vaccines). He advised he was evaluated by Dr who advised he was allergic to MMR. He has not received a flu shot or MMR vaccine since 1988. He denied any recurrence of symptoms since. Other vaccines received from 1995-2008 include yellow fever, typhoid (IM x2), Td, and Tdap. No reported reactions occurred with these immunizations. No medical records of events/immunizations available.
swollen lymph nodes; very swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (very swollen arm) and LYMPHADENOPATHY (swollen lymph nodes) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 21-Jan-2021, the patient experienced PERIPHERAL SWELLING (very swollen arm). On 22-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On 24-Jan-2021, PERIPHERAL SWELLING (very swollen arm) had resolved. On 25-Jan-2021, LYMPHADENOPATHY (swollen lymph nodes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided Patient on BRAT diet (bananas, rice apple sauce, tea).
PT CAME IN WITH SWOLLEN LIKE RASH AT INJECTION SITE-- STARTING TO GET INFECTED. TOLD PT TO KEEP AN EYE AND APPLY TOPICAL ABX, NEXT DAY IN THE PM BECAME ALOT WORSE AND LARGER-- SENT PT TO URGENT CARE -PT THEN RECIEVED ORAL ABX.
Client received an unneeded 3rd dose of the COVID vaccine on 04/23/2021.  Client had received two previous doses of Moderna on 03/25/2021 and 04/22/2021.  Client reported on her vaccine administration form that she had not received any previous doses of Moderna.  When we checked the Immunization Registry on 4/23/2021, we identified that the client had previously received a dose of the COVID vaccine.  On 4/23/2021, the only COVID vaccine listed for the client on the Wisconsin Immunization Registry was for a dose administered on 03/25/2021.  The 04/22/2021 dose was not yet entered by the other vaccination site.
On Christmas eve of 2021 I started having itching on my scalp and neck. I took BENADRYL for it. On Christmas I woke up with facial swelling and itching all over my body. I went to urgent care because my eyes were swelling shut. They put me on prednisone, BENEDRYL, ALLEGRA and hydroxyzine for itching as needed. I was still having itchy and hives/redness from itching. It continued for 4 months then I had an additional month of just itching no hives after that. I had allergy testing but it didn't comeback with any contact allergies. I have been tapering off the use of each medication. About 5 months post booster I feel as though it has resolved and haven't experienced symptoms since. I also experienced fatigue and decreased productivity for the first two months. I also had Lymphedema under both arms.
Patient called on 11/25 and stated that starting the morning after vaccine both legs and hips felt like they had "knives in them". Skin was very tender to touch on different parts of the body. She had nausea/headache and no energy or appetite. Now using ibuprofen and has a dull headache. Other symptoms have resolved.