chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain/arm pain at the injection; Arm discomfort; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3248, Expiration Date: Apr2021) at the age of 69 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: She is taking Amlodipine and Losartan but cannot recall the date the hypertension began; "prediabetic" (ongoing), notes: prediabetic began many years ago, maybe 4-5 years ago and she takes Metformin for that. Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); LOSARTAN taken for hypertension (ongoing). The following information was reported: LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Arm discomfort"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Injection site pain/arm pain at the injection".  Additional information: Patient cannot recall the date the hypertension began and it was all prior to receiving the Pfizer covid vaccine back in 2021 and prior to this booster vaccine that she got for 2023. The caller's mother and the caller both experienced that pain at the injection site but the caller had to seek medical attention for the other issues. It was just had the arm discomfort and she did not call it in because she expected that for the initial covid shots and that is what the package saID. The caller did not take Tylenol.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300347227 same patient, vaccine, different dose and event;US-PFIZER INC-202300347242 same reporter, vaccine, different patient and event;
was administered to an 18-month old by mistake due to the wording on the PI; vaccinator only looked at the top of the PI/vaccinator only looked at the top of the PI; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20-SEP-2023, the patient received Menveo (intramuscular). On 20-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: was administered to an 18-month old by mistake due to the wording on the PI) and wrong technique in drug usage process (Verbatim: vaccinator only looked at the top of the PI/vaccinator only looked at the top of the PI).The outcome of the inappropriate age at vaccine administration and wrong technique in drug usage process were unknown.   Additional Information: GSK Receipt Date: 21-Sep-2023 The report received from field personnel.  The Menveo one vial (pink cap) was administered to an 18-month old by mistake due to the wording on the PI, which led to inappropriate age at vaccine administration. The vaccinator only looked at the top of the PI which stated that it was appropriate for patients age 2 months to 55 years and they did not look further down to see that the one vial (pink top) presentation was only appropriate for patients aged 10 years through 55 years, which led to wrong technique in drug usage process. The reporter consented to follow up via email.
Swollen quarter sized bump on site of injection area, tenderness, pain and soreness at injection spot, arm bruised at injection spot, tired, scratchy throat.
Redness, swelling and warmth at injection site.  Lasted 4 days and then went away. No other reactions.
(L) lower deltoid 3in oval reddened area. pt c/o itching @ site started yesterday noticed red area this am.
pt recv vax FEB97 & 1wk p/1st dose pt devel a rash w/itching on both arms & spread to other areas;pt went to dermatologist & was treated w/DPH & hydrocortisone cream;rash cleared up in some spots & moved to others;
pt recvd vax; cries continuously when awakes from immun given 27oct94; no t; Lt leg red;
Pt described a 102 degree F temperature days after vaccine. She complains of multiple lumps at injection site and pain that still radiates up to neck. Her MD suggested ice which only temp. helps.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves (an elderly) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Documents held by sender: none.
Fever, pain, redness, warmth of arm occurred evening of IZ, redness and pain persist x 3 days. 7 x 16 cm on 10/4/13.
Patient reported a red/swollen site of administration and chills (with no fever) that began overnight after administration and have continued today.
swollen armpit with mild pain; swollen armpit with mild pain; booster (dose 3); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm right, administration date 23Dec2021 02:30 (Lot number: FE3598) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 2; Lot number: EW0162 in the right arm), administration date: 15Apr2021, when the patient was 53 years old, for COVID-19 immunization; BNT162B2 (Dose 1; Lot number: ER2613 in the right arm), administration date: 25Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021 02:30, outcome "unknown", described as "booster (dose 3)"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 25Dec2021 01:00, outcome "unknown" and all described as "swollen armpit with mild pain".  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
HAD RED AND WHITE SPLOTCHES ON HIS LEGS AND A RED LESION ON HIS FOREARM THE DAY AFTER DTAP VACCINE.  VACCINE WAS GIVEN ON HIS RIGHT THIGH. WENT TO ED AND TOLD BY STAFF THERE THAT IT WAS PROBABLY REACTION TO VACCINE.  GIVEN BENADRYL, AND RED SPLOTCHES ON LEGS DISAPPEARED AFTER SHORT WHILE.
Student's mother refers she had a allergic reaction to the first Flu Mist, she had red dots in all her body the same day she had the Flu Mist. No breathing difficulties reported.
Vaccine #6 3Oct11 within days fatigue/heartburn, neuropathy in legs & feet worsened. Migraines became more chronic lasting for longer period of time. Within 14 days hives in mid body treated w/Acyclovir.
Received Rota-shield vaccine 2 days prior. Presented to pediatric ED on October 26 and diagnosed with intussusception.  11/9/06 Received medical records from 1st hospital which reveal patient to ER on 10/26 w/vomiting & diarrhea to include bloody currant jelly stools.  Barium enema revealed extensive colocolic intussusception only partially reduced.  Intussusception remained in ascending colon & patient was transferred to second hospital for probable surgical intervention. 12/12/06 Received medical records from hospital which reveal patient admitted after vomiting & bloody diarrhea which started on day after vax. Multiple attempts to reduce with barium enema were unsuccessful & patient taken to OR.  No d/c summary available but HIM confirmed patient d/c to home on 10/28/06. Final Dx: ileocolic intussusception s/p exp lap with reduction & appendectomy.
cough; can't eat; difficulty breathing; feeling weak; headache; extreme pain on back of neck; extreme pain on arm; could not sleep; extreme pain on shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (extreme pain on back of neck), VACCINATION SITE PAIN (extreme pain on arm), INSOMNIA (could not sleep), COUGH (cough) and EATING DISORDER SYMPTOM (can't eat) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  Concurrent medical conditions included Hypertension and Cholesterol.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 19-Feb-2021, the patient experienced NECK PAIN (extreme pain on back of neck), VACCINATION SITE PAIN (extreme pain on arm), INSOMNIA (could not sleep) and ARTHRALGIA (extreme pain on shoulder).   On 20-Feb-2021, the patient experienced EATING DISORDER SYMPTOM (can't eat), DYSPNOEA (difficulty breathing), ASTHENIA (feeling weak) and HEADACHE (headache).   On an unknown date, the patient experienced COUGH (cough). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Pain, at an unspecified dose and frequency.   At the time of the report, NECK PAIN (extreme pain on back of neck), VACCINATION SITE PAIN (extreme pain on arm), INSOMNIA (could not sleep) and ARTHRALGIA (extreme pain on shoulder) had resolved and COUGH (cough), EATING DISORDER SYMPTOM (can't eat), DYSPNOEA (difficulty breathing), ASTHENIA (feeling weak) and HEADACHE (headache) had not resolved.      Patient's treatment medications included high blood pressure and cholesterol medications.
Patient is experiencing headache, chills (not sure if feverish), diarrhea, vomiting, and nausea.
I had Chills, Felt Nauseated, Light Headedness, and a Slight Fever (100) approximately 24 hours after receiving my shot. It lasted overnight and I felt fine the next morning on 3-13-21. No Medical Treatment Required.
Swollen Face; Potential Allergic Reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen Face) and DRUG HYPERSENSITIVITY (Potential Allergic Reaction to the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SWELLING FACE (Swollen Face) and DRUG HYPERSENSITIVITY (Potential Allergic Reaction to the vaccine). At the time of the report, SWELLING FACE (Swollen Face) and DRUG HYPERSENSITIVITY (Potential Allergic Reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter. No relevant concomitant medications reported.   Reporter did not allow further contact
Myalgia, Arthralgia, Fever, Abdominal pain, weakness, fatigue
Patient states started experiencing shortness of breath ~5 days after vaccination leading to 3 day hospitalization for pulmonary embolism; no other risk factors for PE so best guess was combination of long-standing raloxifene therapy and recent vaccination combined (or coincidence)
Chest tightness, tingling in mouth. Vitals wnl. Resolved with deep breathing technique.
I got the vaccine and shingles twice/Suspected vaccination failure; Shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got vaccine and experienced shingles twice.  Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
I felt light halo in both eyes, visual artifact.    At the ER they performed lab work and ultrasound of the eyes.  My symptoms to my eyes resolved on its own.   I am at 35 weeks pregnant with high risk twin pregnancy, many medical factors being monitored.
Leg had extensive swelling; After a bath had a red blotching pattern on face; Initial information received on 22-Dec-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 3 years old female patient who had leg had extensive swelling and after a bath had a red blotching pattern on face while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received an 0.5 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation, administration site, lot number and expiry date was unknown) via intramuscular route for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "leg had extensive swelling" (peripheral swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date the patient developed a non-serious event " after a bath had a red blotching pattern on face" (rash macular) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Leg had extensive swelling, After a bath had a red blotching pattern on face).  At time of reporting, the outcome was Unknown for the event leg had extensive swelling and was Unknown for the event after a bath had a red blotching pattern on face.
On 13-May-2022, An adult female patient of declined age contacted Medical Information Center via phone reporting the following verbatim terms:  sick for 10 days, heart felt like it would fly out of my chest, chills, severe respiratory infection, other people sick, and some hospitalized after using Type 4 and Adenovirus Type 7 Tablets. The patient concomitant medications are unknown and her medical history is she received multiple vaccines in 2015. The indication and dosage are unknown. The patient stated after receiving the Type 4 and Adenovirus Type 7 Tablets she was sick for 10 days and further described it as my heart felt like it would fly out of my chest, I had chills, a severe respiratory infection, and it was a huge reaction to the virus. I wasn't the only one sick from it. There were a lot of other people who were sick in my group and some were even hospitalized. She is wanting to travel and is trying to get exemption. If she is considered fully vaccinated and doesn't need the COVID vaccine, she'd prefer not to have to take it because of her previous reaction. No additional information provided. Patient declined to provide her last name, age, date of birth or to be contacted for follow-up.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L011846; expiration date 16-JUN-2017) (dose, route of administration, anatomical location and strength were not reported). There is no concomitant medication reported and no adverse effects were reported. Additional information is not expected as the reporter didn't consent new follow-up attempts. This is one of 3 reports received from the same reporter.
Right arm (where vaccine was given) and whole back swole up, and got stiff and store. Could not move and was bedridden for 8 days.
Mother reported severe right knee pain, onset 2/16/22. Mother gave Tylenol 500 mg and later Ibuprofen 400 mg. Mild soreness following morning that didn't require any pain medication.
Selected Peds/adolescent  dose of Hep A and administered. Noted error and contacted Immunization coordinator who directed to give Hep A adult dose as well. No adverse outcome  noted at this time. Client tolerated vaccine administration without difficulty.
The day after receiving the vaccinations patient had her second seizure, the first seizure being 2 weeks after receiving the first dose of vaccinations. Her left thigh where the vaccines were injected was very hot to the touch, went from bright red to dark red and spread to half her thigh area, around 4-5 inches in diameter. She was unable to walk all of Saturday, 08/11/2018, this persisted for 5 days. Although the swelling has gone she still has a hard lump in the area and is sore to the touch.
Extremely intense stomach ache, beginning 52 hours after vaccination, lasting 4 hours.
rxn @ site of inj including marble sized nodule surrounded by 6cm bruising;below that (distally) a 2cm x 6cm area of redness & warmth;started 5hrs p/vax w/subsequent worsening over last 4 days;injected lt deltoid;
6/5 after dose I had a sore arm, headache and fatigue, 6/10 I woke up with fatigue dry cough and headache, 6/11 congestion, headache, dry cough, fatigue, 6/12 fatigue, dry cough, congestion, 6/13 fatigue, headache, severe dry cough, body ache, fever, chills.
Information has been received from a physician concerning an 8 week old patient who was vaccinated with an oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  On the same day as vaccination the patient experienced intractable vomiting.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Dreams, dreams, dreams. Love what you are doing and my dreams are more realistic, has clarity, etc.; seeing things in my bedroom that arent there; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient in her 50's (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABNORMAL DREAMS (non-serious), outcome "unknown", described as "Dreams, dreams, dreams. Love what you are doing and my dreams are more realistic, has clarity, etc."; ILLUSION (non-serious), outcome "unknown", described as "seeing things in my bedroom that arent there".  Additional information: Action taken as result of reaction: If patient take a full Tylenol pm, she start to sleep walk. After her 2 vaccines, she noticed her dreams was almost in same state. She believed she had a frog on her blanket. She had having full length conversations in her dreams that she would not have before. She believe she was seeing things in her bedroom that was not there. No enquiry involve a report of exposure during pregnancy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient began having muscle spasms on Friday 2/7/2020. They were sporadic, becoming less frequent each day to the present. On Saturday evening the injection site became inflamed, hard, red, and hot to the touch. By Sunday morning the redness and the swelling had disappeared but still had a knot at the injection site. Today upon awakening she noticed red, blotchy area on arm below the injection site and to the left that was hot to touch. She had three spots that measured approx 4 x 6 cm, 5 x 6 cm, and 2 x 4 cm but all congrued together(not separated).
5 mins after receiving Vaccine Flu booster., Pt started  having trouble breathing with blue lips and patches on skin. Unsure why Pt was sent by ambulance to the nearest Hospital.
EE states she felt "Woozy" dizzy.  Took her coat off and provided water.  Felt better after 30minutes.