chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Body ache; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 29-Year-old non-pregnant female patient received first dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date in Mar2021 at 17:00(at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included IBS (as reported) and GAD (as reported). Concomitant medications were not reported. The patient previously received cefalexin (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dizziness, chills, fever and body aches 12Mar2021 at 18:00. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, pyrexia, ache and dizziness were recovered on an unknown date.   Information about lot number cannot be obtained. No further information is expected.
cataracts; This case was reported by a consumer via interactive digital media and described the occurrence of cataract in a male patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced cataract (serious criteria GSK medically significant). On an unknown date, the outcome of the cataract was unknown.   It was unknown if the reporter considered the cataract to be related to DTaP vaccine.  Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient developed cataracts after receiving the Dtap vaccine. As per the reporter, could not uninject the vaccine.
No adverse effect reported; on 7/23/2019, one female patient was administered properly stored but expired VARIVAX (lot N019840 & expiration 7/13/2019).; This spontaneous report as received from an office manager referring to a 36-year-old female patient.      The patient's concurrent conditions, medical history, previously drug reactions and drug allergies were not provided. Concomitant therapies included sterile diluent.  On 23-JUL-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency and anatomical location were not provided) lot # N019840 and expiration date 13-JUL-2019, for prophylaxis; which was properly stored and was reconstituted with a properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported.
Pt recvd Hep B vax in MAR91 & pt exp h/a; PE by neurologist & Otolaryngologist were neg; CT Scan was neg; tx Imipramine & APAP;
This spontaneous report was received from a physician via a company representative and refers to a male patient over 65 years old. The patient's concurrent conditions and medical history were not reported. Approximately in January 2017 (reported as "this past week"), the patient was vaccinated with a dose of PNEUMOVAX23 (concentration, dose, route, anatomical place of vaccination, lot # and expiration date were not provided), for pneumonia prevention.  Information regarding concomitant therapies was not reported. Approximately in January 2017 (reported as "the day after he received the vaccine"), the patient experienced achiness, soreness (pain), chills and fever (pyrexia). Therefore, the patient seek for medical attention by contacting the physician and subsequently a treatment was prescribed for the adverse events. At the time of reporting, the patient was recovering from pain, chills and pyrexia.    The reporter did not provide a causality assessment between PNEUMOVAX23, pain, chills and pyrexia. Additional information is not expected, as the reporter did not provide consent for further contact.
I received an adverse reaction to the 1st and 2nd shot.  The first was given to be on 3/13/21 at the same location and the lot number was 036A21A.  I got the shot at 11AM and by 6PM I was disoriented, felt anxious, headache, fever (98.9), chills and body ache.  I didn't feel better until the next day at 11PM (3/14/21).  I received an adverse reaction to the second shot almost immediately after I received the vaccine.  I was lightheaded, got an instant headache.  When I got home I had body aches, heart palpitations and began a slight fever (99.9).  I was disoriented and felt lightheaded.  I had chills and sweats through the night and had heart palpitations and it continued throughout the next day.  On Monday, 4/12 I had a headache and my ears began to hurt early morning. Throughout the day I began to get extremely itchy.  It is Thursday, 4/15 and my left ear stopped hurting but my right ear still hurts, I'm still itchy but not as much and have no fever.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022).    No concomitant product use was reported.  Patient received half dose. Vial was initially stored in the refrigerator on 04-Jun-2022.  Vial did not undergo any temperature excursions.  No treatment information was provided
Parents describe episode of lethargy/pale/limp 3-4 hours after immunizations. Had bowel movement after episode. Returned for reassessment 4-5 hours after immunizations, 1 hour per episode. Rexam WNL. Only Tx was Tylenol after immunizations and every 4 hours after.
Nausea, vomiting, chills, fever, aches, severe pain at injection site, fatigue
Patient fainted about 2 or 3 minutes after walking away from pharmacy. She came back to consciousness a few seconds later but felt dizzy and had trouble breathing. After a few minutes, her breathing was becoming more normal. 911 was called by a front store employee and the paramedics arrived shortly after. Patient is fine now and patient most likely experienced an episode of syncope and not a reaction to the Pfizer vaccine.
pt recv vax 23SEP98 & started exp pain, swelling, low grade fever on 24SEP98;pain worsened on 26SEP98;swelling increased devel redness & red line extending from deltoid to armpit;exam revealed infect;
Dizziness; Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and DIZZINESS (Lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]), GABAPENTIN, LEVOTHYROXINE SODIUM (LEVOXYL), FOLIC ACID and KCL for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Dizziness) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Client c/o Headache & dizziness shortly post vaccine administration - he had not eaten since having a light breakfast that morning & the time was now 2:30 PM. We had him lie down until the dizziness subsided - he left stating he was much better just still had the headache. Advised to get something to eat to see if that would help the Headache & continue with Tylenol alternating with Ibuprofen every 4-6 hrs. His mother called 11-13-08 stating the child was still experiencing Headache, but now has Fever, Nausea & joint pain in the knees. Mother states he can keep fluids down & Tylenol is controlling the fever; thus she was should the client have further problems that could not be controlled to seek medical attention.
About 2 mins after receiving the vaccine pt developed dizziness and had a syncopal episode
Patient experiences syncopal episode within 10 minutes of dose. He was discharged after 30 minutes of steady recovery and was released after having returned to his baseline.
Fever; aches; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and MYALGIA (aches) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (aches). At the time of the report, PYREXIA (Fever) and MYALGIA (aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment details were not provided.  no signs of allergic reaction after receiving the first dose but took a laxative containing polyethylene glycol sometime after receiving the 1st dose, she had a reaction consisting of aches and fever and Medical Doctor states to  believes the reaction was due to the about of polyethylene glycol in the laxative the patient took.  polyethylene glycol allergy is contraindication to receive 2nd dose
This event happened during an offsite covid vaccine clinic. After receiving a vaccination, patient complained of shortness of breath, flushing, sweating, thirsty. @2:43 pm pharmacy team gave patient Benadryl 100mg. @ 2:45 pm patient's blood pressure was 145/91 mmHg. Pharmacy team continued observation and patient was doing okay. Pharmacy team also contacted Amazon first aid to assist. @ 3:15 pm blood pressure was 130/93 mmHg. Patient was feeling much and was released afterwards.
began to have a "foggy head" feeling and then started to feel chest pressure - was NOT short of breath
No adverse event; Inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) monovalent vaccine as booster dose to a 31 year old patient; expiration date 13Feb2022.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) monovalent vaccine as booster dose to a 31 year old patient), EXPIRED PRODUCT ADMINISTERED (expiration date 13Feb2022.) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR4504B, 037C21A and 014C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) monovalent vaccine as booster dose to a 31 year old patient) and EXPIRED PRODUCT ADMINISTERED (expiration date 13Feb2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) monovalent vaccine as booster dose to a 31 year old patient), EXPIRED PRODUCT ADMINISTERED (expiration date 13Feb2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) monovalent vaccine as booster dose to a 31 year old patient) and EXPIRED PRODUCT ADMINISTERED (expiration date 13Feb2022.).    No concomitant medications were reported. Clinic manager reported that they inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) as a booster dose to a patient on 24-Oct-2022. No treatment medications were reported.
Parents noticed a smooth indentation in the outer right thigh area, at or lateral to, the injection site where IPV was given, SC, previously (within a week or so). Never scabbed, red, swollen, blistered, tender. Father recalls some bruising appearance initially.
Localized soreness in injection site muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:00 (Lot number: EL3247) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid vaccine (Dose 1, Anatomical Location: Arm Left, Batch/lot number: EL3247, administration time: 14:00 ), administration date: 03Mar2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021 21:00, outcome "recovering", described as "Localized soreness in injection site muscle". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Pfizer had permission to contact you about this report. Pfizer did not have permission to contact the patient's healthcare provider about this report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Upon follow up on (27Mar2021) the Agency recently received the attached report submitted by the patient via RA. Please help to confirm event "Localized soreness in injection site muscle" start date since provided as 23Mar2021, the administration date of dose 2 is 24Mar2021, so this event occurred before dose 2. Please help to confirm the date that you became aware of the adverse event in this report as this effects regulatory reporting timelines. Apologies, the patient entered the date of the symptom incorrectly. She intended to enter 9 pm Wednesday 24 March 2021, the evening after her vaccination. This was also the awareness date.  No follow-up attempts are possible. No further information is expected.
Patient had swelling down her arm accompanied with redness. She took tylenol for pain and I recommended benadryl for the reaction.
Began covid-19 symptoms on 6/09/21 and tested positive for covid-19 on 6/11/21.
Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves three patients who were vaccinated with 1.0 ml dose instead of 0.5 ml dose of FLUZONE (lot: UJ005AE, expiry date: 30-Jun-2019) via unknown route in unknown administration site, on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to vaccine overdose. It was unknown whether the patient had any 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 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. List of documents held by sender: none.
Right deltoid erythema, slightly warm and edematous around injection site. Benadryl 1-1 1/2 tsp of 4-6 PRN
This case was reported in a literature article and described the occurrence of rhabdomyolysis in a patient who received Meningococcal B vaccine. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced rhabdomyolysis (serious criteria GSK medically significant). On an unknown date, the outcome of the rhabdomyolysis was recovered/resolved. The reporter considered the rhabdomyolysis to be possibly related to Meningococcal B vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of rhabdomyolysis in a patient of unspecified age and gender who was vaccinated with unspecified rMenB (manufacturer unknown). The patient was the part of vaccination campaign held from December 2013 to May 2014. Monitoring for serious adverse events (SAEs) was conducted from receipt of the first dose to 30 days after the second dose. SAEs were collected passively by phone, email, university clinic visits, and local hospital reports, and actively via questionnaires prior to the second dose and electronic surveys 30 days after the second dose. No information on the patient's medical or family history or concurrent condition was provided. No information on patient's concomitant medication was provided. On an unspecified date between December 2013 and May 2014, the patient received either one or two doses of unspecified rMenB vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date between December 2013 and May 2014, an unknown period after vaccination with unspecified rMenB vaccine, the patient had rhabdomyolysis. Treatment was unknown. The outcome was recovered. The authors commented that the rhabdomyolysis was possibly related to unspecified rMenB. The authors stated that "We described the first use of an unlicensed MenB vaccine to successfully control two institutional outbreaks. Safety monitoring demonstrated no concerning or unexpected patterns of SAEs and supports the sue of rMenB in response to future MenB outbreaks. Until a licensed MenB vaccine is available, prompt multi-agency coordination to facilitate the IND process should be established when a MenB outbreak is suspected." This is 1 of the 2 valid cases in the article. The article is not available for regulatory submission due to copyright restrictions.
This case was reported by a physician, via a GSK representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (GlaxoSmithKline). No information was available regarding the subject's medical history or concomitant medications. Previous and/or concurrent vaccination included hepatitis A vaccine inactivated (GlaxoSmithKline) given on an unspecified date. On unspecified dates the subject received complete series of Hepatitis B vaccine and Hepatitis A vaccine (details unknown). It was unknown whether the subject received ENGERIX B and HAVRIX, or TWINRIX. Approximately one and a half months after completing the vaccination series with Hepatitis B vaccine, the subject experienced not responding to therapy. The physician reported that the subject's antigens were evaluated and the subject's hepatitis A antigens were within normal limits, and the subject's hepatitis B antigens indicated that he had no antigens. There was no further information available.
Left upper arm from shoulder to elbow is red and swollen. Pt has temp of 100 per mother. Watch for increasing symptoms and if temp doesn't resolve with Tylenol. To be seen if not improving over the next 24 hrs. To use ice, Motrin, Tylenol as directed.
Aches in arms, legs, back, neck, wrists, headache. Started at 5am 3/10/21