chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an expired dose of pentacel with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 1 years old male patient who had received an expired dose of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant vaccinations included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13); and hepatitis A vaccine both for Prophylactic vaccination (immunization).  On 26-Jun-2023, the patient received 0.5 mL dose 3 of expired suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (lot: UJ671AA; Expiry date: 13-May-2023) via unknown route in the left thigh for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event received an expired dose of pentacel with no reported adverse event.  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 the 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.
I had no symptoms but I tested positive for Covid-19 on Jan 4th. The only thing I had was a sore throat.
This spontaneous report as received from a physician reporting a 53 years old male patient with hypertension and diabetes and a medical history of insertion of stents who on 21-AUG-2012, was vaccinated SQ with 0.65 ml dose of ZOSTAVAX (lot# not reported). No other co-suspects were reported. No concomitant medications were reported. On 22-AUG-2012 the patient had "chest pain and flu like system". The patient went to the emergency room (ER) and was admitted to hospital. The patient had unspecified lab work in hospital and received an unspecified treatment. At the time of the report, the patient recovered (date not reported). The relatedness for chest pain and flu like system was unknown for ZOSTAVAX. Additional information has been requested.
Moderna 1/26/21, 2/19/21, and 10/28/21. Positive on 1/20/22
This spontaneous case reported by a consumer, describes the occurrence of dizziness, nasal congestion (stuffy nose) and myalgia (muscle pain) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dizziness, nasal congestion (stuffy nose) and myalgia (muscle pain). At the time of the report, dizziness, nasal congestion (stuffy nose) and myalgia (muscle pain) outcome: unknown/not provided. The action taken with mRNA-1273 in response to the events was not applicable. Concomitant product use and treatment information not provided. Most recent follow-up information incorporated: On Jun 14, 2021: Follow-up received on Jun 14, 2021. No new information received. Patient denied further follow-up.
Collapsed in house; Chills; Total Weakness; Memory problems; Racing heart beat; This is a spontaneous report from a contactable consumer.  A 78-year-old male consumer reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 23Feb2021 at 01:00 PM at single dose for COVID-19 immunization. The patient had Covid prior vaccination. No other medical history. Concomitant drugs were unknown. On 23Feb2021 at 04:00 PM the patient experienced chills, total weakness, memory problems, collapsed in house and racing heart beat. The patient was hospitalized, he was in hospital 4th day now. Cannot get out of bed or walk. the patient was treated with Physical Therapy. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223394 similar report from same reporter
Shortly after pt received vaccine said felt fine, got up to walk to chair, became pale, slumped forward with LOC, within seconds he began to convulse for approx 10-15 seconds.  Soon afterward regained consciousness and was oriented times 3. Entire event lasted 1 minute or less. Pt was taken to ER by ambulance. Prior to immunization pt denied allergies, previous adverse reaction or seizure. Post the event pt said this had happened to him 2 times in his own country.
DVT right lower extremity and pulmonary embolism: was hospitalized for 2days with a Heparin Drip and discharged home with Eliquis 10mg twice a day. Home meds discontinued: all BP meds, Ibuprofen, Tylenol, and Torodol. Follow up appointments with Dr. oncologist. Also had to cancel upcoming ventral hernia repair after having to wait 3 years due to complications with bowel obstructions and had to lose weight before surgery due to high risk. Now will have to wait longer until cleared medically, primary physician instructed me that it would be 6months or more before being cleared.
Fever, Chills, body aches, head ache, joints hurt, upset stomach, red injection site, hard and swollen injection site and fever in arm at injection site
Patient received Fluzone quadrivalent influenza vaccine 0.5ml IM in left arm at 0911 am on 09/03/2019 as part of her wellness visit.  Patient's mother called at 0915 on 09/04/2019 to report that patient had a possible seizure while at school that morning.  Mom reported to nurse that she was told by school that patient "tensed up and fell out of her chair and hit her head."  Patient c/o dizziness and HA pain following incident.  Mother reports that she was told patient was able to answer questions correctly after incident.  No previous history of seizures reported.  Mother was advised to report to ER immediately.
COVID like respiratory, hard to breath; Headache; achiness symptoms; got exposed to a person who got COVID positive; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (got exposed to a person who got COVID positive), DYSPNOEA (COVID like respiratory, hard to breath), HEADACHE (Headache) and MYALGIA (achiness symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPOSURE TO SARS-COV-2 (got exposed to a person who got COVID positive). On an unknown date, the patient experienced DYSPNOEA (COVID like respiratory, hard to breath), HEADACHE (Headache) and MYALGIA (achiness symptoms). At the time of the report, EXPOSURE TO SARS-COV-2 (got exposed to a person who got COVID positive), DYSPNOEA (COVID like respiratory, hard to breath), HEADACHE (Headache) and MYALGIA (achiness symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had an appointment for second dose Moderna COVID-19 Vaccine on 21-May-2021. She got exposed to a person who got COVID positive on 11-May-2021. She was planning to go for COVID test.  Concomitant medications were not provided. Treatment information was not reported.
Our client received vaccines January 16, 2007. On January 22 she noticed a rash on her stomach, which moved on her back and up into her armpits. It was still moving when she called on January 25th. She had no hives, no fever, no chills. I spoke with the PA-C, who said it sounded like a histamine reaction and we advised her to try an antihistamine or see a doctor or go to the emergency room, if it concerned her. Also, she and another person, who received vaccines at our clinic the same day, both had a tooth that had become sensitive. We advised her to see a dentist.
Expiration date: 10/14/2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HBV (Engerix B) (batch number YL2L3, expiry date 14th October 2021) for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Engerix B. On 19th October 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharmacist administered by error to a 19 year-old female colleague an Engerix-B expired pediatric dose, which led to expired vaccine used. The reporter consented to follow up.
PT REPORTED WITH LOCALIZED RASH, APPROXIMATELY 3 INCHES IN DIAMETER, AROUND INJECTION SITE. ALSO EXPERIENCED HEADACHE BEGINNING AT MIDNIGHT THE NIGHT AFTER INJECTION THAT CONTINUED FOR ABOUT 12 HOURS. NO TREATMENT WAS GIVEN, PT WAS INSTRUCTED TO MONITOR RASH FOR ANY SIGNS OF WORSENING.
Shortness of breath, chest pain, sweats, fever off and on, fatigue, nausea
pt recvd vax & w/in 2 hrs, lethargic-slept next 24hrs, pale;no fever, szs or crying;MD visit @ 40 hrs appeared fine;2 days later vomiting, watery stool;stool pos for adenovirus, Guaiac pos;seen by ped ID MD;dx acute gastroenterology
A little swelling or redness; Only left and lower, feel like "I am being blown by a blow to torch; The pain is horrible; A little swelling or redness; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported a little swelling or redness, only left and lower, feel like "i am being blown by a blow to torch and the pain is horrible on an unspecified date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1 day after receiving dose #1 MMR, dose #1 varicella, dose #1 Hep A patient developed a maculopapular-patchy rash that first started on abdomen & then extended to rest of torso & extremities.  Patient also developed urticaria like lesions on LE B where vaccines were given.  No fevers.
Sometimes sweats; Chills; 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 HYPERHIDROSIS (Sometimes sweats) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sometimes sweats) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sometimes sweats) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
bell's palsy; facial weakness; drooping; Initial information regarding an unsolicited valid serious case was received from a nurse via consumer/non-healthcare professional via  Medical Information (Reference number- 00847325) and transmitted to sanofi on 08-Nov-2021 .  This case involves a 50 year old female patient who experienced bells palsy, facial weakness (facial paresis) and drooping (facial paralysis) after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE for Prophylactic vaccination.  On 18-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  produced by Sanofi Pasteur (lot number: U6737AA and expiry date: 09-Jul-2022) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious bells palsy with symptoms facial weakness (facial paresis) and drooping (facial paralysis) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.   These events were assessed as medically significant.  A Nurse stated they had a patient have an adverse reaction to the ADACEL vaccine. Nurse was looking to report the adverse event (AE) as well as for more information into the Bells Palsy side effect of ADACEL. She was seen in the emergency department (ED) on 05-Nov-2021 for left sided facial weakness and drooping. She was diagnosed with bells palsy and it was attributed to ADACEL. She was followed up on 08-Nov-2021. Caller stated that she called the office to get more information to see how it is being linked. She was also told the patient recently received the flu shot but she did not see it documented. She will contact. She asked whether there was a correlation between Adacel and Bells Palsy and a correlation between flu vaccine and bells palsy.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome of the events was unknown.; Sender's Comments: This case involves a 50 year old female patient who experienced bell's palsy, facial paresis and facial paralysis after receiving ADACEL. The time to onset is compatible. Concomitant medications included INFLUENZA VACCINE for Prophylactic vaccination. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
I had a break through case of Covid-19. I has chills muscle ache and stiffness, had a high fever the after two days It felt like severe flu symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Onset of chills followed by feeling not well.  Not able to eat and get out of bed.  Lasted 36 hours
On 3/10/97, pt had a fever of 104.4F and started within an hour of administration. He was lifeless, no body movement, limp, no response to any activity (such as his name). No seizure or convulsing of any type. Right leg where shot was given, was hot to touch for several hours. From 3/10/97, he lost speech, eye contact, response to name, etc. Has been dx'd with autism. Doc 204502, 60-Day follow up states the followings: No speech, no distinguishable language, constant supervision, requires one on one assistance. Before vaccine, patient could speak words. After the vaccination, he gets no response to verbal communication or eye contact. Follow up information received 09/18/02 states "(The child) has not recovered from this event, He is now labeled autistic, He has no speech and has to have 24 hours 7 days a week adult supervision. My child was a normal, healthy, little boy until the date the vaccine was given. He regressed so fast it was unbelieverable. His regression which included speech, which he has not gained any to this day, eye contact, normal body function,bowel movement, etc,and repetious behavior all started after his vaccine was administered on this date above. The annual follow-up states "pt has not recovered from this event, he is now labeled autistic, he has no speech and has to have 24 hour 7 days a week adult supervision. My child was a normal, healthy little boy until the date the vaccine was given-he regressed so fast it was unbelievable. His regression which included speech, which he has not gained any to this day, eye contact, normal bodily functions, bowel movement, etc. and repetitious behavior all started after his vaccine was administered on this date above."
Patient appeared to be fainted for 1-2 seconds. After having water and snack, he became ok.  Patient was asked to wait for 45 minutes. Family members said that he did not have breakfast and he is scared of seeing needles or blood.
Shingles on leg; Acanthoma (cancer) on her leg; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on leg) and ACANTHOMA (Acanthoma (cancer) on her leg) 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 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HERPES ZOSTER (Shingles on leg) and ACANTHOMA (Acanthoma (cancer) on her leg). At the time of the report, HERPES ZOSTER (Shingles on leg) and ACANTHOMA (Acanthoma (cancer) on her leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
approx 2mos p/ vax pt devel herpes zoster w/dermatomal cluster. rpt MD felt the herpes zoster was not related to therapy w/varicella virus. treated w/acyclovir.
Initial unsolicited misuse report received from a Physician on 26 April 2016 and additional information received on 26 April 2016. This case involves a 53-years-old female patient who was vaccinated with an intramuscular dose of ADACEL (batch number UI543AC, expiration date, dose was not reported) in right deltoid on 21 April 2016. Patient had no illness at time of vaccination but had a fall and lacerations. Pre-existing physician diagnosed medical conditions was reported as  congenital heart disease. Pre existing allergies and birth defects were not reported. Concomitant medications were not reported. On an unspecified date post vaccination, the patient experienced pain at injection site. Patient had body aches, which could be a result of her fall per the physician. Patient had previously received a dose of ADACEL 7 months prior (date not specified). It was an extra dose administered case. Lab data and corrective treatments were not reported. The patient had not recovered from events. List of documents held by sender: none.
Within 10 days of receiving vaccine, client noted onset of painful shoulder joint - limited ROM - affecting ADL's. Aching pain has continued to be present with some improvement. Client feels pain is slowly resolving. No site redness or tenderness. No treatment sought.
Husband tested positive for COVID-19 and so he brought it home to me. I started having symptoms of headache, congestion, brain fog, and major fatigue. I have developed a cough as well and the headache and congestion have gotten worse. I ended up going to urgent care as well for a test. I have had body aches as well and then the fatigue has just been horrible; I have never been this tired from an illness before.
Pain at site, surrounding and upper shoulder. Sore throat and a bit swollen , coughing, congestion,  coughing up thick discharge, bad headache, extremely tired. This is in just less than 48 hrs. Have not seen a dr at this point, will treat sx and see if it gets worse, if its not better over next couple days will go to urgent care.
Pt was given vaccine from a vial that had been punctured over 12 hours, thus expired
Pt's mom called 4/23/2021 connection call center regarding of pt fell down in 5 hours after covid vaccination yesterday. Verified pt with 2 identifiers. Pt denies emergency s/sx. Pt states she felt dizziness and leg lost power after covid vaccine(Pfizer) at clinic @ 3pm 4/22/2021 then pt fell down in 5 hours. Pt intervened to lay down by herself and drank water. Pt also mentioned she had stomach aches after vaccination yesterday. Pt states she does not have dizziness, leg weakness, stomach aches at this time, it happened yesterday in 5 hours after covid vaccination. Pt advised to follow-up with PCP at  Pt made aware. Pt is educated for covid 19 vaccine side effects. Pt agreed and verbalized understanding.
Local reaction to smallpox vax (large area of redness - 2 palms in diameter)
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-AUG-2022; No adverse event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-AUG-2022) and NO ADVERSE EVENT (No adverse event) in a 17-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-AUG-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-AUG-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-AUG-2022).    No concomitant medications were reported.   The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  The vial did not undergo any temperature excursions.  No treatment details were reported.
pt recv vax;exp pain at inject site;addl f/u:devel redness & palpable nodule at inject site immed p/ vax;tx w/ ice packs,sx resolved w/in 15 mins;