chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical Assistant reporting on herself, a female patient of unknown age, medical history and drug allergies not reported, who on October 2012 (two months ago) had an accidental exposure while preparing drug for administration with PNEUMOVAX 23 (lot # H013581 exp: 03-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that (two months ago) when she was aspirating a dose of PNEUMOVAX 23 from a multi-dose vial, some of the solution sprayed onto her face after she withdrew the needle from the stopper of the vial. She reported that her face itched for a while, but there was no lasting adverse effect. She reported that she did not seek medical attention after this event. The patient did not receive any treatment for adverse event. The outcome of adverse event was unknown. The relatedness for adverse event was unknown for PNEUMOVAX 23. Additional information has been requested.
accidentally gave an expired dose of Fluarix from last flu season; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (expiry date 30-JUN-2023) for prophylaxis.   On 22-SEP-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 22-SEP-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: accidentally gave an expired dose of Fluarix from last flu season).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Sept-2023 Nurse stated that a staff member accidentally gave an expired dose of Fluarix from last flu season.  The clinic does not had Fluarix in private stock for this season but the staff member was not aware of this and found an old dose in the back of the vaccine fridge which was administered to the patient on the day of reporting. No further details provided on the call. Consent granted for safety to follow up.  The patient received an expired dose of Fluarix, which led to expired vaccine used.
First Became nauseous, then began throwing up , then had difficulty breathing and shortness of breath
A non-serious spontaneous report of headache has been received from a registered nurse, concerning a 14-year-old female, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST nasally on 23-Oct-2009. On the same day the vaccination, the patient got a headache. The adverse event resolved. The patient was back in class on 26-Oct-2009.
Patient was given Moderna  Covid  Booster instead Pfizer, pt too young for Moderna.. no adverse reaction.
This spontaneous report as received from a licensed practical nurse refers to a 1 or 2 unspecified patients of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (route and dose were not reported) (lot # L024255, expiration date: 01-JUL-2017). The (Oka/Merck) VARIVAX was stored in -10 Celsius degrees for 12 hours. There was no previous temperature excursion and the call was because of a data logger. This is one of two reports received from the same source. Additional information has been requested.
Injection site red and swollen (moderate) and warm to touch (left leg). Seizure at 24 hrs after vaccine. Eval at ER.
Extreme pain in arm that was injected.  Fever of 101 degrees. Joint pain. Symptoms lasted approximately 12 hours.
Received first dose SHINGRIX on 7/16/18, experienced excessive soreness extending under arm and nausea next morning and sweating.
C/o feeling fatigue, headache, and nausea. No treatment, Advised her to return to clinic Monday (this is Friday) if symptoms persist.  She agrees to this plan.
Myalgia  swollen lymph nodes, decreased ROM in injection arm, generalized muscle pain  Narrative:
Induration and erythema, erythema at DTaP injection site 9x8cm non-tender no lymphadenitis.
sore arm; feverish 101, MD gave Ibuprofen; shrivering, nausea, vomiting; VS ok by evening; sore arm, nausea lingered into next day, but pt went to pre-school;
Initially I didn't have many adverse outcomes of the shot, but after three weeks I have had a serious outbreak of shingles on my body at 31 years of age.
Swollen right upper eyelid (second patient: with this after follow up shot) Pupil and conjunctiva normal.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: Migraine headache
Severe headache, severe body aches, stiff neck, and arm swollen and painful. Some nausea.
Within about two minutes my head started feeling "off", my mouth started to go numb, my heart started to race, my face started itching/sweating and I could feel a headache coming on. I had a headache, chills, fatigue, increased body temperature (2+ degrees) and a sore arm for the rest of the day. I woke up this morning with a really sore arm. I could only lift my arm halfway up, due to the deep muscle pain.
pt recv vax 28FEB96 & 1hr p/vax pt exp sl swelling of both hands & severe itching of the backs of hands;no erythema or induration @ site of inj;tx DPH cream;
Chills, muscle pain, skin felt like it is prickly, headache, tiredness nausea  Had these within 24 hours and then in 48 hours still had fatigue and headaches.  on the 4th day had diarreha.  took Tylenol.  For fatigue on the 3rd day I had tea.   My arm is still swollen, hurts and has a red rash 4 days later.
Psoriasis of scalp; Patient had dose 1 on 20 Aug 2021 and dose 2 on 05 Jan 2022; Horrible high fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 20 Aug 2021 and dose 2 on 05 Jan 2022), PSORIASIS (Psoriasis of scalp) and PYREXIA (Horrible high fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1st dose (1 in 1). On 05-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 20 Aug 2021 and dose 2 on 05 Jan 2022). In January 2022, the patient experienced PYREXIA (Horrible high fever). On an unknown date, the patient experienced PSORIASIS (Psoriasis of scalp). In January 2022, PYREXIA (Horrible high fever) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 20 Aug 2021 and dose 2 on 05 Jan 2022) outcome was unknown and PSORIASIS (Psoriasis of scalp) was resolving.            Patient had Skyrizi which had cleared all but not her scalp. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, the patient experienced SKYRIZI not clear plaque psoriasis on scalp. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
PT is a foster child, with unknown immunization status. It was thought she was unimmunized. We checked the database and she was not in it. Vaccines were given: MMR due to recent outbreaks, flu due to local flu activity and Prevnar, #13. Later it was reported that pt was fully immunized. The system showed a different birthdate and when the MA started to enter the vaccines into the computer, a full report printed showing the that patient was up to date on vaccines. Most recent were done about 3 months ago.
Swelling, redness, and pain at injection site. Low grade fever. Body aches. Fatigue.
received vaccine reconstituted with non GSK diluent; received vaccine reconstituted with non GSK diluent; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA751A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent.  After this conversation, a medical Information agent contacted the nurse by phone and confirmed the situation.  The reporter stated that, they have noticed that, patient that could possibly have gotten a partial dose of Menveo along the past week.  The patient that received Menveo powder reconstituted with saline diluent. The reporter consented to follow up by email. Additional Supportive Information:The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR137840:Same reporter US-GSK-US2022AMR137841:Same reporter US-GSK-US2022137202:Same reporter
Woke up in middle of night feeling truly awful, feverish and as sick as I?ve ever experienced.  Went on for at least 3-4 hours.  At end started to feel my heart straining very hard just to beat, felt chest pain, then later soreness when taking a full breath.  Since then have had fever, swelling, shortness of breath & chest pain for 10 days and counting.
Patient reported that she was experiencing local redness, itching, swelling, and heat around the site of administration. It was more than she was expecting, and different from anything she had experienced with other vaccines.  She also said that she had felt "winded" while shopping for her groceries after her vaccine, but  that she already has some breathing issues.  She stated that the discomfort had not spread, and she was not having any problems with any other area of her arm.
From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA). Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.
This spontaneous report as received from a nurse practitioner refers to a 7 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 30-DEC-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008680, dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). The lot source was public. No information on patient's concomitant medication was provided. No adverse event was experienced. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # K007781 with expiration date 28-MAY-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Local reaction. Client came to HD/Imm. clinic for services on 3/13/14. Travel/Immunizations and blood work for HBsAB. 1) Yellow fever and Hep-B #3, 2) blood work for HBsAB. F/U PCP 4/1/14. 1 wk irritation at site of injection, 2nd wk redness and tender, 3 wk 3 lumps (LA) swelling (L) armpit.
Patient experienced syncope the night after receiving the second Moderna vaccine for COVID-19 on 06/04/2021. She got up at 2AM (~8hrs after shot) on 06/05/2021 to use the restroom and loss consciousness and fell and hit her head on the floor. Patient reported a headache that lasted several days after incident, but is now resolved. Patient called clinic after hours on 6/14/2021 to report these events and she was advised to seek medical attention ASAP for a neurological evaluation.
COVID-19.  Tested positive by rapid antigen test on May 7, 2022.  Upper respiratory symptoms started during week prior to test.  Started taking prescribed doses of Paxlovid on May 8 and took last dose on May 12.  Tested negative on May 13.
BRUISING AT THE SITE OF INJECTION (SMALL BLACK BLUE MARK); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included neuropathy, restless leg syndrome, allergy to peg in miralax, and root canal infection.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAR-2021 15:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included hydroxychloroquine phosphate for drug used for unknown indication, paracetamol for neuropathy, and root canal infection, and amoxicillin for root canal infection. On an unspecified date, the subject experienced bruising at the site of injection (small black blue mark). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising at the site of injection (small black blue mark) was not reported. This report was non-serious.
PT COMPLAINED OF REDNESS AND SWELLING A FEW DAYS AFTER RECEIVING VACCINE.  AFTER A FEW DAYS PT SAYS THE SWELLING AND REDNESS WENT AWAY BUT HAD A RASH PRESENT FOR A FEW WEEKS THAT WAS NOT GOING AWAY.  RASH WAS LOCALIZED IN ARM AND UNDERARM IN THE INJECTION SITE.
Starting on 2/24 patient had altered mental status, headache and BP was in 200s.  Patient went to hospital and was treated for viral pneumonia and discharged 3/1.  On 3/5 patient began having severe headache, nausea, vomiting and altered mental status.  She was then transferred to Neuro department.   2/25:  LP (negative). 3/5:  Head CT (negative) 3/11:  MRI:  Restricted diffusion in bilateral frontal, parietal, occipital and temporal lobes as well as Right Cerebellum.   3/12:  CTA head:  Moderate to large infarction in bilateral cerebral hemispheres with diminished venous flow.    Patient was intubated upon admission to neuro critical care for protection of airway.
Fully vaccinated patient admitted for COVID pneumonia.  Provider discharge note:  "Admitted to the hospital on September 20, 2021 for hypoxia.  She was fully vaccinated against COVID-19.  At that time she is requiring high-flow nasal cannula oxygenation.  On 09/20 for a CT scan was done which showed a possible nonocclusive emboli in the left lower lung.  She was started on heparin. She was transferred to the intensive care unit on the morning of 09/30/2021.  She developed bilateral pneumothoracies that time.  She was intubated and chest tubes were placed.  Over the next 5 days she developed worsening ARDS with multiorgan system failure.  This presented initially with AFib with RVR and progressed to kidney failure.  On the morning of 10/04/2021 the patient's family decided that they did not want to pursue additional care.  Her respiratory cardiac function decreased until 9:45AM on 10/5/2021 when she passed away."
Hip pain; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in hip in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in hip. On an unknown date, the outcome of the pain in hip was unknown.   It was unknown if the reporter considered the pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had pain in hip. The reporter wanted to know was hip pain associated with the vaccination.
seiler had a high fever of 100- 103 degrees for 4 days. he also had severe diarea
The patient received Pfizer vaccine as his tertiary series for COVID-19 vaccination. He arrived with his wife and two sons for vaccination. He received Moderna as the booster. He was immunized first, followed by his wife and then the two children. While the nurse was immunizing the first of the two children, she looked over and noticed he was very pale. She asked him if he was OK. He replied that he just needed "some fresh air."  He got up to go outside and his wife followed him. As he exited the building, he slumped against the brick wall and slid down the wall to a sitting position.  He told his wife that he felt like he "was going to faint." He did not hit his head or hurt himself in any way. Staff brought him water to drink. The nurse finished immunizing his children. After 15 minutes, he said he felt better and got up. His wife stated "he does this after every shot and blood draw." He was accompanied to his car by his wife and sons.
Woke up at 8am with the following reaction: coughing up blood, extreme nausea, very unsteady gait, severe headache, tired
Patient c/o pain and swelling in L upper extremity, located at site of PNEUMOVAX, he denies any fever or chills, states swelling started yesterday and has gotten progressively worse. L uppe arm with induration and redness from shoulder to elbow and extending aroudn to medial aspect, warm and tender to palp. Circulation intact to distal aspect of L UE.
Coughing; Fever; her head has been hurting/Headache; she started to feel hot; She has high blood pressure; She has kidney disease; Chest pain; Shortness of breath; She is an immune, her immune system is low; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2022 18:00 (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: COUGH (non-serious) with onset Feb2022, outcome "unknown", described as "Coughing"; PYREXIA (non-serious) with onset Feb2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset Feb2022, outcome "unknown", described as "her head has been hurting/Headache"; FEELING HOT (non-serious) with onset Feb2022, outcome "unknown", described as "she started to feel hot"; HYPERTENSION (non-serious) with onset Feb2022, outcome "unknown", described as "She has high blood pressure"; RENAL DISORDER (non-serious) with onset Feb2022, outcome "unknown", described as "She has kidney disease"; CHEST PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious) with onset Feb2022, outcome "unknown", described as "Shortness of breath"; DECREASED IMMUNE RESPONSIVENESS (non-serious) with onset Feb2022, outcome "unknown", described as "She is an immune, her immune system is low".  Additional information: Clinical course: It was reported that patient was 11 and she got her vaccine yesterday in the afternoon, like 6:00 pm and she was a patient, she has kidney disease. In the middle of the night, she started coughing, she developed a cough that she didn't have before all these symptoms started after the vaccine. So, cough, fever she went to school like normal, it was just regular cough but she just, she said she feels, she started to feel hot. So, now she has fever, and she said her head has been hurting and could have a meeting with the nurse. She said she just thought maybe it was going to go away. So, concern is she has kidney disease, and she has high blood pressure. She has all these other concerns; she takes a lot of medications. She is an immune, her immune system is low. Reporter stated, whatever they could when, I guess there is, she is 11. So, they put the one that they have been putting to, if they are under 12. Reporter want to know whether need to take her to the ER, like is this like normal because it says the side effects are headache and fever and chest pain, shortness of breath and cough think, believe, to call that number, the number that reporter calling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was diagnosed with a breakthrough case of covid-19 on 9/13/21 despite getting vaccinated with the covid vaccine on 2/25/21 and 3/25/21.
She received the second dose of the Pfizer Covid19 vaccine yesterday morning. Yesterday mid-day she was hit with a wave of sleepiness. She slept a full night's sleep, and woke up feeling really bad.: Overall body 'aches and pains'. Headache that comes and goes. Then, throughout the day she's been hit with sever tiredness. She's been sleeping most of the entire day, and it's 3:40pm currently.  No fever or nausea, currently.
Patient got second Moderna vaccine May 12th, 2020. On May 17th, 2020 patient left palm started with a painful blistering rash. Patient had for 6 weeks until being seen by our Dermatology office. Patient was given antiviral Valtrex and oral Gabapentin. Patient had Shingles outbreak post second vaccine.
had temperature of 100; This is a spontaneous report from contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported had temperature of 100 on an unspecified date. Patient had second vaccine and then had temperature of 100. Wanted to know how to bring temperature down. Patient disconnected before reading Isi. The patient underwent lab tests and procedures which included body temperature: 100. The outcome of event was unknown.  Information on the lot/batch number has been requested.