chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Chills; Body aches; fever that last about 12 hours and got up to 101.6degrees.; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in left arm 23Mar2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within 2 weeks of vaccination. The patient had no allergies to food, medications, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in left arm 03Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. 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. On 24Mar2021 at 11:30, the patient experienced headache, chills and body aches. Then it quickly progressed to a fever that last about 12 hours and got up to 101.6 degrees. On 25Mar2021, woke up at 5 am with the fever, chills and body aches gone, but a headache was still lingering. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for adverse event. The clinical outcome of the events chills, body aches and fever were recovered on 25Mar2021 and headache was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
pain, all over the body; shivering; fever; not feeling good for 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of generalized aching in a patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized aching, shivering, fever and feeling bad. On an unknown date, the outcome of the generalized aching, shivering, fever and feeling bad were recovered/resolved.   It was unknown if the reporter considered the generalized aching, shivering, fever and feeling bad to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter called to report that a lot number for Shingrix has caused too many adverse events for patients and that they would stop administering this lot since this was very unusual. The patient received vaccine and reached back complaining about pain, all over the body, shivering, fever and not feeling good for 2 days. The reporter knew that these were common side effects and was aware that this happens but was concerned due to the fact that 3 patients received doses from the same lot and they all 3 felt bad enough to call the pharmacy. The reporter consented to follow up. The reporter stated that they can share patient information but during follow-up by safety. This is 1 of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021128010:Same reporter
Swelling at the injection site; Heat at the injection site; Pain at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's comments:  This case was reported by the patient's wife via interactive digital media.  The patient got the Shingrix shots, it was 2 shot deal and had a higher rate of effectiveness. After vaccination, the patient had swelling, heat and pain at the injection site. The reporter hope that you feel better soon and asked to check with your doctor about whether or not you should get the newer vaccine. Additional Supportive Information: The follow-up would not possible as no contact details were available. This case was linked with case US2022AMR076122, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076122:Same reporter.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored injection of ZOSTAVAX lot # M042850, expiration date 18-JAN-2018 (strength, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT). The patient's concomitant medication was not reported. On an unspecified date, the ZOSTAVAX was exposed to a temperature ranges between 6° Fahrenheit (F) and 14°F during a time frame of 45 minutes , which was called by a data logger. There was not previous temperature excursion. Adverse effects were not reported. Additional information has been requested. Lot number M042850 is a valid lot number for ZOSTAVAX.
This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, nausea, fatigue and injection site pain. On an unknown date, the outcome of the fever, nausea, fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, nausea, fatigue and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. For tolerance of 2nd dose of SHINGRIX, refer case: US2019GSK027744. This case was one of the 6 cases reported by the same reporter.
Salty bitter after taste by back of tongue; headache; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207), via an unspecified route of administration in the left arm on 27Mar2021 at 11:15 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. The medical history of the patient was reported as 'Yes'. The patient did not have any allergies to medications, food, or other products. Prior to 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 vaccine within 4 weeks prior to the COVID-19 vaccine. The patient received unspecified medications within two weeks of COVID-19 vaccination. On 27Mar2021 at 11:15, the patient experienced salty bitter after taste by back of tongue, headache and sore arm. The patient did not receive any treatment for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of salty bitter after taste by back of tongue, headache and sore arm was recovering at the time of this report.  No follow up attempts are possible. No further information is expected.
Patient describes symptoms as red, swollen, warm to the touch and itchy. Patient was seen in clinic on 25 Jul 07 for symptoms and prescribed Dicloxacillin 250mg 1 tab BID x and follow up on 30 Jul 07.
Initial report was received 29 June 2010 from a consumer, who is also the patient. A 27-year-old female patient with a history of "numerous allergies" (not specified), had received an injection of ADACEL, lot number C3032AA (route and site of administration not reported) on 19 January 2009 and within several minutes of vaccination, she experienced difficulty swallowing, difficulty breathing and lip tingling. The patient returned to the doctor's office and was noted to have an elevated blood pressure, she felt faint and almost passed out. The patient received unspecified treatment and was released. It was further noted the patient developed a rash (time and date of onset not reported). The patient's medical history included multiple unspecified allergies. According to the patient, she has been seeing an autoimmune / allergist for the symptoms she experienced after vaccination. It was further noted that the patient experienced symptoms of right arm numbness and a rash following a previous vaccination with FLUZONE, lot number U2452AA on 27 October 2007 (captured in case number 2010-03648). At the time of the report, the patient's outcome was unknown. Documents held by sender: None.
4 months after the second vaccination Patient began to develop hyperglycemia which in July of 2022 resulted in a diagnosis of Type 1 diabetes, which is an autoimmune disorder that hadn't been diagnosed previously
Adacel, menquadfi were administered to patients after excursion with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who were administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] And Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] after excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Jun-2023, the patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (suspension for injection) and Meningococcal A-C-Y-W135 (T Conj) Vaccine (solution for injection) (expiry date and lot number: not reported) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) and  temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes with no reported adverse event (Poor quality product administered) (latency: same day). Information regarding batch number was requested in the case.   It was reported, "Adacel, Daptacel, IPOL, Menquadfi, Pentacel, Quadracel, Tenivac, Vaxelis. Product activated/prepared? NO Due to a human error: NO and Does extended stability data cover the excursion: NO These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Wrist sprain; Swollen joint; Vaccination site swelling; Vaccination site pruritus; Vaccination site erythema; Vaccination site warmth; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), LIGAMENT SPRAIN (Wrist sprain), JOINT SWELLING (Swollen joint), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided by the reporter.  Concurrent medical conditions included Alcohol use (One glass of hard liquor every month), Macular degeneration, Rheumatoid arthritis, Blood pressure high and Adhesive tape allergy. Concomitant products included ADALIMUMAB for Rheumatoid arthritis, PERINDOPRIL ERBUMINE and AFLIBERCEPT for an unknown indication, METHOTREXATE.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On an unknown date, the patient experienced LIGAMENT SPRAIN (Wrist sprain) and JOINT SWELLING (Swollen joint). On 03-Mar-2021, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved. At the time of the report, LIGAMENT SPRAIN (Wrist sprain) and JOINT SWELLING (Swollen joint) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Mycobacterium tuberculosis complex test: unknown (Inconclusive) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered JOINT SWELLING (Swollen joint) to be not related. No further causality assessments were provided for VACCINATION SITE WARMTH (Vaccination site warmth), LIGAMENT SPRAIN (Wrist sprain), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema).    No Treatment medications were reported.   Reporter did not allow further contact
No adverse events, signs, or symptoms noted as yet. Pt was given the incorrect vaccine. He was given VARIVAX instead of PREVNAR.
On March 10, 2021 I received the first Pfizer vaccination.  On March 13, 2021 at 5:30 a.m. I began to have chest pain. I was hospitalized at Hospital, Troponin levels were high indicating a heart attack.  They performed an angioplasty on March 15th.  100% blockage occurred in the RCA Circ.  I was put on blood thinners, statins, aspirin regimen and cardiac rehabilitation. On August 29th I was hospitalized again at another Hospital for chest pain.  They also did a second angiography and determined that I had an 80% blockage in my LAD distal.  They placed a second stent.  I am currently in cardiac rehabilitation 3 days a week.   Please contact me if you need further exclamation.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported in two weeks..It was reported that  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (13May2022) Positive, notes: Relapse 5 days after finishing paxlovid. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NauseVomiting hot flashes and sweating Narrative: taken by car to the emergency room, event occured on 1/12/21 and was reported on 1/12/21. System would not accept with out a change in date.
Sudden hearing loss with vertigo. Placed on prednisone within 36 hours of first symptoms. Today is 4 days after first symptoms, minimal improvement.
fine papular rash all over body. Rash started on the trunk and spread to the extremities. MMR 10 days prior. No fever.
Information has been received from a RN who is the cousin of a 9 year old female child who on 01/15/98 was vaccinated with a dose of varicella virus vaccine live. In the 'spring of 2002', the child developed a mild case of chickenpox. Unspecified medical attention was sought. It was noted that "everything resolved without sequelae". There was no product quality complaint reported.  The registered nurse also reported on another sibling who experienced a similar reaction (WAES # 0305USA01894).  Additional information has been requested.
6/15/2020 In the am I noticed a small rash on my chin and neck - itchy.  The following day rash was on my forearms and cubital areas.
Accumulation of fluid in left breast area.  I do have a breast implant from a reconstruction after breast cancer August 2016.
had mild symptoms chills; body ache; This is a spontaneous report from a contactable nurse (patient). This 45-year-old patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 29Jan2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in April2020 and a positive COVID-19 test on 28Jan2021. Concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced mild symptoms, chills and body aches. On Saturday (30Jan2021) the patient didn't go to work. The patient was concerned because she found out after receiving the vaccine that she had COVID-19 when she received the vaccine. She wanted to know if there were any issues regarding her health with being positive and having gotten the vaccine. The outcome of mild symptoms, chills, and body aches was recovered on Sunday (31Jan2021).   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Extremely sore arm at site of injection , onset 12 hours after injection. Lasted 24 hours.  Body aches onset 12 hours after injection, lasted 24 hours.  Slightly felt amped up as well 12 hours after injection, restless. Lasted 24 hours.  Urinated more then average. Onset 12 hours after injection. Lasted 12 hours.
Day 8 red raised  itchy. 3x3cm  injection site reaction. Some tightness in the muscles as well.
pain is on his right leg with a pain scale of 8.5/10; Feels lethargic; Joint pain on right leg; Flu-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (pain is on his right leg with a pain scale of 8.5/10), LETHARGY (Feels lethargic) and ARTHRALGIA (Joint pain on right leg) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (Feels lethargic) and ARTHRALGIA (Joint pain on right leg). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain is on his right leg with a pain scale of 8.5/10). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (pain is on his right leg with a pain scale of 8.5/10), LETHARGY (Feels lethargic) and ARTHRALGIA (Joint pain on right leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. No treatment medication was reported.
Evening of vaccine: headache First day after: felt cold and tired, brain fog, some injection site pain Second day after: felt tired, brain fog, some injection site pain, fever of 100C in the evening Third day after: felt tired, brain fog, fever of 100C, rapid heart rate Fourth day after: fever gone and felt mostly normal but still tired
Patient 68 year old male was suppose to receive his bivalent booster but instead regular dose of Pfizer was given.   Will contact patient and let them know that they received third dose of Pfizer instead of bivalent. Per CDC guidelines: Providers may administer 1 bivalent booster dose as a repeat dose based on clinical judgement and patient preference. In this case, space the repeat dose after the dose given in error by at least 2 month.
PT C/O FEELING WEAK WOOZY 10 MINUTES AFTER VACCINATION "VISION  GOING BLACK" HANDS TINGLY/ SWEATY BP 72/58 HR 76 2:35 BP 80/54 STRONGER INIDCATES "SHOT PHOBIA"   2:34 BP  100/52  2:40 EMTS ARRIVED-  3;15 PT LEFT ON OWN AFTER OBSERVATIONBY EMT STAFF    4/6/2021 RET'D DOSE 2 WITH NO ADVERSE EFFECTS
She developed worsening localized left shoulder pain, she had numbness /tinging of the shoulder radiating to the neck and down to  the left middle and 4th fingers. She had difficulty moving the left arm due to  pain.  Warm compress and Naprosyn with transient help. She refuses to  take Gabapentin and Naprosyn due to  fear of side effects. She was  sent for X-rays of the Cervical spine, left shoulder and left wrist and has not found bony  abnormalities, has signs of spasm of the neck. She was referred to a neurologist who planned to do shoulder MRI and EMG and are  still pending
Headache, congestion, sore throat initially.  Within 12 hours, experiencing muscle pain all over body and weakness.
Patient reported nerve pain throughout arm vaccine was administered shortly after administration last more severely for a couple weeks. Pain has subsided, but not completely.
Employee described experiencing itching of palms, fingers, soles of feet, arms and back as well as "gunky" eyes and lips swelling after receiving influenza vaccine.
Pain at inj site-radiating to back and down to elbow, continuing 27 days after inj. Tx-ice area, shower massage.
Patient has sore on L deltoid, and unable to raise his arm after get PCV13.
2nd dose was given 7 days early - 2nd dose was due on 2/18/2022 but was given 2/11/2022 - patient did not have any adverse reactions
Hepatitis A vaccine administered on wrong schedule: 1st dose on 3/29/23 and 2nd dose on 5/2/2023