chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired FLUZONE QUADRIVALENT was given to six patients on 16 Sep 2020.; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case (reference number-US-SANOFI-00276414) received from a consumer.  This case involves a 20 years old female patient who was given 0.5 ml once expired dose of INFLUENZA QUADRIVAL A-B VACCINE [Fluzone quadrivalent] on 16-Sep-2020 [lot UJ295AA, expiration date-30-JUN-2020] via intramuscular route in the left deltoid for prophylactic vaccination.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired product administered. It was reported that expired FLUZONE QUADRIVALENT was given to six patients on 16-Sep-2020.  At the time of reporting, the patient had no adverse event.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Not Applicable.  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.
For ALL shots in series.  Local soreness, burning right after shot with golf ball size knot for 3-4 days. Headache for 2-3 days after, sore, achy and tired. Fatigue for 2.5 wks, irritability is also inc. pt recovered from the adverse event partially - Fatigue, headaches, occasional joint and muscle pain. Pt received another ANTHRAX shot since the reported event -Sx same as previously reported, more frequent headaches.
Rash fatigue; induration, pain and erythema at inoculation site on left arm Narrative: seen by MD on 12/28/2020 for persistent induration and erythema/pain though decreasing induration/erythema size
"I have a daughter who experience this same thing and, she is been out of commission for a day and a half that I was"/Similar side effects to those of reporter; Bed rest; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("I have a daughter who experience this same thing and, she is been out of commission for a day and a half that I was"/Similar side effects to those of reporter) and BED REST (Bed rest) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("I have a daughter who experience this same thing and, she is been out of commission for a day and a half that I was"/Similar side effects to those of reporter) and BED REST (Bed rest). At the time of the report, VACCINATION COMPLICATION ("I have a daughter who experience this same thing and, she is been out of commission for a day and a half that I was"/Similar side effects to those of reporter) and BED REST (Bed rest) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Added patient's demographic information.
Patient stated she felt faint, dizzy and hot after immunization was administered. Had what appeared to be a pinpoint blister appearing above injection site.
shivering; This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On 22nd October 2019, the patient received Shingrix (intramuscular). On 22nd October 2019, less than a day after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine and experienced  shivering just on same night of vaccination. The reporter stated that the patient might had shivering felt like a seizure.  The patient did not had seizure.
This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received TWINRIX for prophylaxis. On an unknown date, the patient received TWINRIX. On an unknown date, unknown after receiving TWINRIX, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: The age at vaccination was not reported. The Health care professional stated they started a vaccination with TWINRIX, however do not have any more TWINRIX, which led to product availability issue. And want to finished the patients vaccination with HAVRIX( batch number 595AS expiry date 30-AUG-2020). Did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. The Health care professional does not want to be contacted about this.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe
Initial report was received from a healthcare professional on 23 May 2013. A 14-month-old male patient had received a dose 3 injection in the left thigh of DAPTACEL, lot number C4006AA and an oral dose 3 ROTATEQ, Merck, lot number 0033AA on 20 August 2012. The patient also received a dose three injection in the right thigh of ACT-HIB, lot number H153-1 (corresponding Sanofi Pasteur Inc. lot number UH62AA). On 09 May 2013, the patient presented with hand, foot and mouth disease and was treated with BENADRYL and MAALOX. He returned to the doctor's office on 17 May 2013 with a tight cough and fever and was treated with prednisolone, a ZPACK and nebulizer with albuterol. He presented again on 20 May 2013 with no improvement. Nasal swab was obtained and was positive for Pertussis DNA. Treatment continued with the nebulizer and ZPACK for a 10 day course total. The patient was at home with family and other contacts were not sick. It was unknown if vaccinations were complete for the family. No other cases were known in the family. The patient received previous doses of DAPTACEL; lot number U3327AB on 16 April 2012 and C4006AA on 18 June 2012, 2 previous doses of ACT-HIB; lot number UH258AA on 14 May 2012 and UH485AA on 06 August 2012 and 2 previous doses of ROTATEQ; lot number 0920AA on 16 April 2012 and 18 June 2012. The patient had no illness at the time of vaccination or past medical history. Outcome was not recovered. Documents held by sender: None.
got shingles; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient took part in a shingles research program. The patient received Shingrix and had Shingles. The reporter doctor told it would had been more severe had not had the vaccine.
Headache, muscle pain at injection site, fever, Chills, nausea, fatigue,
Bad taste; Clogged ears; Diarrhoea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Bad taste), EAR DISCOMFORT (Clogged ears), DIARRHOEA (Diarrhoea) and FATIGUE (Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Drug allergy.    On 04-Sep-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced TASTE DISORDER (Bad taste), EAR DISCOMFORT (Clogged ears), DIARRHOEA (Diarrhoea) and FATIGUE (Tired). At the time of the report, TASTE DISORDER (Bad taste), EAR DISCOMFORT (Clogged ears), DIARRHOEA (Diarrhoea) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Patient took Pfizer on 11-May-2022 for indication of Treatment of COVID-19.Device Date was reported as 12-May-2022 No treatment medications were reported
G62.9 PERIPHERAL NEUROPATHY 5/21/2021 UPPER GI HEMORRHAGE G62.9 PERIPHERAL NEUROPATHY 5/21/2021 BILAT OVARIAN CANCER
Right arm swelling - started the morning after vaccines given and worsened throughout the day. Moderate swelling and mild pain at time of exam that evening.
COVID 19 Treatment/ Had COVID rebound; COVID 19 Treatment/ Had COVID rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 as dose number unknown, single (Lot number: 33025bd) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disorder" (unspecified if ongoing); "food allergies" (unspecified if ongoing); "Known allergies: amoxicillin families" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; PROGESTERONE; MELOXICAM. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/ Had COVID rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: COVID rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (treatment start date: 01Aug2022; treatment stop date: 06Aug2022).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID 19 Treatment (Brand: Paxlovid). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 13Dec2022, Treatment stop date: 18Dec2022, Lot number: GE1627, Administrator route: Oral).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Case number PHEH2013US015420, is an initial spontaneous report received from a medical assistant on 18 Jul 2013: This case refers to an 11 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X12025 and expiry date: Jan 2015), intramuscularly without being reconstituted with Men A component on 15 Jul 2013. No adverse reaction was reported following this administration error.
Pins and needles; Very upset; This is a spontaneous report from a contactable other HCP (patient herself). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Batch/Lot number unknown), via an unspecified route of administration, administered in Arm Left on Jan2021 at 12 AM (age at 71-year-old ) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications were not reported as no. The patient have no known drug allergies. Patient received other pfizer vaccine in left arm on 05Jan2021. The patient did not have any other vaccine in four weeks. The patient did not have any other medications in two weeks. The patient did not have COVID prior to vaccination. On 02Feb2021, she experienced very bad reaction to Pfizer. She had pins and needles which she had it for one month. She was very upset. She reported that she still have pins and needles. adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.Therapeutic measures were taken in response to the events. She was not tested for covid post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
23AUg94 mom returned to clinic & reported adverse event following 1st taken to MD w/ 108 R; unable to reduce temp in MD office so taken to hosp ER;
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:46 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:46 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. The patient age was reported as 70.21. Batch number 035C21A underwent temperature excursion on 27-OCT-2021 with temperature 29 degrees Fahrenheit at  9:00 AM and with temperature 32 degrees Fahrenheit 10:00 AM . 2 vials moved to clinic on 29-Sep-2021, beyond use date for the vial was reported as 29-Oct-2021 and 4 vials moved to clinic on 05-Oct-2021, beyond use date for the vial was reported as 04-Nov-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
No adverse effects reported; the one 14-year-old patient was inadvertently administered one adult dose of VAQTA; This spontaneous report was received from a pharmacy technician and refers to a 14-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided. On 24-SEP-2019, the patient was inadvertently administered one adult dose of hepatitis a vaccine, inactivated (VAQTA) 1 dosage form, expiration date: 06-MAR-2020 (exact dose, frequency, route of administration and lot# were not reported). No adverse effects were reported.
NO signs/symptoms/adverse effects. Patient received wrong vaccine. He should have received Original Pfizer as start of series, however, actually received Pfizer Bivalent Booster. Once discovered, Clinical team verified with CDC guidance that booster for Pfizer can count as primary dose. Second dose was given as original (non Bivalent) Pfizer to complete series at appropriate time (greater than 3 weeks from first dose).
Patient developed significant swelling/pain along with a rash that spread down arm and across the chest.
Initial unsolicited report received from a consumer (patient herself) via other company (Pfizer) (Manufacturer Report Number: 2016578249) on 23 Dec 2016. This case was linked with case 2016SA236043 (same vaccine). This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Shot) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date and also received PREGABALIN (Lyrica) (Batch number, expiration date, dose and route of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, 12 days following the vaccination, the patient got sick. On an unknown date, unspecified timeframe following the vaccination, the patient had cramps all over her body and was also sick right now and was dehydrated. The patient had an appointment with her doctor. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. It was reported that the patient was not sure if the side effects were caused by the Lyrica or not. List of the documents held by sender: none.
1st dose MENACTRA given 02-16-11 (L) deltoid, pt not anxious, did not "jerk" (tolerated well). She noticed her arm next afternoon to be sore, swollen, warm to touch, pink->red. Brought into office. I marked area of swelling (5x7cm) no fever. No vomit or diarrhea. No chest pain or wheezing. Inst on TYLENOL or MOTRIN for discomfort/warm or cold compresses & to return if worsens. Returned 02-18-11 to Dr with affected area double in size. 2-18-11 cont to have minimal pain at site/is pink->red/swollen approx 10x14 cm now. No streaking, no bruise, no further systemic symptoms. To cont to watch. 2/21/11 - I called to check on pt -> arm "better" per parents over weekend. Inst. to call if further questions/concerns.
Pt states that after his vaccination, he was in bed for 3 days feeling miserable with a fever. He couldn't lift his arm at all for the first day but now can lift it halfway. It doesn't hurt as much now but the site is tender to the touch.
SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN and expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe headache was not reported. This report was non-serious.
Severe chills, fever, body aches, headache, cough, extreme fatigue.
Information has been received from a retired 72 year old female registered nurse with no medical history and drug allergy who in July 2007 was vaccinated with a dose of ZOSTAVAX vaccine (Merck). There was no concomitant medication. On 22-APR-2009, ten days ago, the patient developed shingles after receiving ZOSTAVAX vaccine (Merck). She developed the lesions on her back and around the front right of her chest. The lesions looked like "spider bites" and were very painful. At time of reporting, the patient was recovering. The patient saw the physician for medical attention. Additional information has been requested.
pt recvd vax;on 4jul95 broke out on rash of approx 100 or more lesions;fever of 101.5dermatologist felt it was varicella;reporting MD not sure if pt exposed to disease & getting chicken pox before vax took effect or vax rxn;
the nurse mistakenly gave patient 6 times the recommended dose of pfizer/biontech. She was taken by ambulance to the local hospital to receive an EKG and monitor her blood presssure. Later that afternoon we met with our family pediatrician. Her bllod pressure was monitored.
Pt admitted from residential facility with respiratory distress.  She previously had COVID 10/12/2021, and is again positive after negative testing.  The was intubated for hypoxia and not protecting her airway.
Two Janssen shots 1st shot Janssen 043A21A 09/07/2021 2nd shot Janssen 042A21A 09/12/2021   Agency has been requested to enteral all COVID vaccine into registry. The teams responsible for screening and administering vaccines to the individuals at the vaccine clinic were/are employed.  Agency is assisting with entering information into registry and VAERS.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 828 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
REINFECTION FOLLOWING BOTH DOSES. PATIENT ADDMITED WITH GI ISSUES NON RELATED TO COVID