chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(1) I had the Moderna Covid booster on 10/25/21. On 2/27/22 I had a retinal hemorrhage in my left eye.   (2) On 4/15/22 I had another Moderna Covid booster.  3 weeks later on 5/8/21 I had another retinal hemorrhage in my left eye.  (3) On 9/6/22 I had the Moderna Bivalent booster. 3 weeks later on 10/6/22 I had my 3rd retinal hemorrhage in my left eye.
Was breastfeeding, noticed rashes developing in my 4month old 1 week after receiving the vaccine. Baby was already on a supplemented diet of formula and only receiving 2-3oz of breast milk a day until 9/27/2021. Correlation with ingestion of Vaccine-Breastmilk was only noted change following perfectly healthy 4month Pediatric Appointment.
15 min after injection my arm was tingling, I notified the pharmacist and was cleared to leave. 40 minutes after injection my hands and face went numb, my heart rate elevated for 10 minutes, I was unable to breathe through my nose. 1 hour after injection I regained  feeling in my face and hands; my hands shook for 2 hours after.
Mild rash on upper left shoulder and upper left quadrant of back.  Mild itching.   Scaly rash pinkish rash.  Treated with TRIAMCINOLONE 0.5% CR 1GM effectively cleared rash, but rash has since re-established.  Seeking more treatment.
Patient came in to get 2nd dose of Moderna and said her first dose caused her arm to swell up big and red. She said it went up almost into her armpit area. She said it didn't hurt any more than a tetanus shot. It lasted about a week, but the swelling did show up on her mammogram she had about a week after her first shot.
Patient was admitted for small bowel obstruction which eventually led to operative management which found intussusception.
This spontaneous report as received from a 71 years old male consumer reporting on himself, with no drug reactions or allergies and no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported) on 05-NOV-2012. No other co-suspects were reported. Concomitant medications included desonide (reported as "defonide"), triamcinolone acetonide and generic ZOCOR. On 29-NOV-2012, the patient had a rash all over his body. He noticed it a few weeks after receiving the vaccine. No treatment information was reported. No laboratory tests were performed. At the time of the report the patient's outcome was unknown. The relatedness for adverse event was not reported for ZOSTAVAX. The patient sought unspecified medical attention. Additional information is not expected.
severe knee pain has persisted/can't barely stand or walk my knees Ache/extreme soreness in all my joints; had cold chilies was extreme uncomfortable; can't Barely stand or walk my knees Ache and are just uncomfortable at all times; Fever; body aches all over; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8729, first dose) solution for injection intramuscular in the left arm on 16Apr2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 vaccination. Medical history included underactive thyroid. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had severe knee pain has persisted (considered serious for disability/incapacitating) and has not improved whatsoever/can't barely stand or walk my knees ache and are just uncomfortable at all times, and extreme soreness in all my joints (reported to primary care physician and orthopedic physician repeatedly), had cold chilies was extreme uncomfortable, fever, and body aches all over on 16Apr2021 at 15:00. The events resulted in a physician office visit. Treatment for the events included celecoxib (CELEBREX) and cortisone injections in knee. The outcome of the events knee pain, chills, can't barely stand was not recovered. The outcome of the events fever and pain was recovered in Apr2021. COVID test post vaccination via Nasal Swab was negative in 2021.
This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of HAVRIX (details unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced injection site pain. The subject did not require medical attention. The event was resolved 24 hours after the vaccination. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. The reporting healthcare professional stated that her practice had noticed an increased number of cases of pain at injection site with GlaxoSmithKline's vaccine versus the other competitor. She did not have further details regarding number of patients, etc.
lightheadedness, dizziness, h/a, local rxn on the day p/vax;
Initial unsolicited report received from a consumer on 20 September 2016. This case involves a 75-year-old female patient who was vaccinated with a dose Fluzone HD (batch number: unknown, expiration date, dose, site and route of administration were not reported) on 01 October 2015. Patient's Illness at time of vaccination was denied, pre-existing physician diagnosed allergies, birth defects, and medical conditions included diabetes. Any other vaccinations within 4 weeks of vaccinations was denied. Concomitant medications were not reported. On 01 October 2015, almost immediately following the vaccination, the patient had flu like symptoms including aches, fatigue, was sick for a month with deep cough, had fever (didn't remember how high it got), On an unknown date following the vaccination, patient felt she got RSV (Respiratory syncytial virus) from the vaccination. It was reported that patient required emergency room or doctor visit. it was also reported that patient required multiple visits to the doctor. Lab data and corrective treatment was not reported. On unknown date, patient recovered from the events. List of documents held by sender: none.
Initial pain at injection site, extreme fatique.  The pain has never gone away from the site and has limited my range of motion. I also get random shooting pains in that arm.  I find it difficult to get comfortable when trying to sleep as any pressure on that arm is excruciating. I often wake up in pain when I rollover onto that side.
This spontaneous report was received from a medical assistant referring to a 6 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored PROQUAD (lot: N025928, expiry date: 18-MAR-2019) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours, 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter. Sender's Comments: US-009507513-1804USA004755.
Vaccine was administer five days after the 30 day storage limit; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit).    No concomitant medications were reported.  No treatment medications were reported.
Tenderness under the armpits area 4 months later after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness under the armpits area 4 months later after the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness under the armpits area 4 months later after the second shot). At the time of the report, TENDERNESS (Tenderness under the armpits area 4 months later after the second shot) outcome was unknown.
Information has been received from a consumer concerning her daughter who in December 2008, was vaccinated with a first 0.5 ml dose of GARDASIL.  "Four weeks later", the patient developed hives and experienced itchiness and joint pain.  Unspecified medical attention was sought.  At the time of the report, 05-FEB-2009, the patient had not recovered.  No additional information was provided.
Body was itching; Headache; Body is aching; Body pain; Numbness; Rash is still on my face and my chest; Eyes are red and itchy; Eyes are red and itchy; I have to be shaking shaking my self something; Joints are hurting me; Face is little bit swollen; Throat, I can't even eat anything; Loose appetite; This is a spontaneous report from a contactable consumer (Patient reported for herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0187) via an unspecified route of administration, administered in arm left on 08Jul2021 at 12:10 pm (at the age of 51-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history related to event. The patient had no Family medical history related to event. There were no concomitant medications. No vaccination received 4 weeks prior to COVID 19 Vaccine. On 08Jul2021, at night after the vaccination, the patient experienced body was itching, headache and body was aching, body pain. On an unspecified date in Jul2021, it would be 10 to 12 hours time after the vaccination, the patient experienced, joints hurting, face was little bit swollen, throat she cannot even eat anything, loose appetite, numbness, rash still on her face and her chest, eyes are red and itchy. The clinical course of the events as follows: she stated she took the first dose of Pfizer Vaccine on Thursday on 8thJul. The very day she took it, and she waited there for 15 minutes and then she went to home in the night. She could believe it would be 10 to 12 hours time, I was (incomplete sentence). She felt that her body was itching and the whole night she felt headache and her body started aching. She continued having headache, body ache, and even her joints were hurting, it came to a point, her thigh, the leg to the bottom of her buttock was trying to be numb and she had to be shaking herself something. She stated that she put alcohol to stop the itching and then she takes Tylenol for headache almost every 4 hours, she said that she put alcohol on her face, the part which was itching the most and because of that alcohol she put it, her skin turned black. Her face was little bit swollen and her throat, she cannot even eat anything and she loose appetite. She stated the numbness would not stay for long but the itchy and rash was still on her face and her chest. She stated that she does not know if she is supposed to go to the ER. She stated that her second dose is supposed to be on 29thJul. She reported basically, it stays the same as the first time she experienced the rashes, it was the same and not going away and it was not getting worst either. No Investigation Assessment was provided. The outcome of the events body was itching, and rash was still on her face and chest was not resolved and the outcome of the other events was unknown at the time of this report.
1988 pt vax.  14Jun90 inadvertently vax w/ 2nd dose.  Lab exam revealed pneumococcal titer neg.  MD felt pt's suppressed response due to chronic steroid meds for asthma.
Erythema around injection site 15 minutes post administration. No hives/induration/serum opsonic activity. Benadryl elixir 12.5 mg given.
12 hours after injection patient experienced severe shot site pain, temporal headache, backache and nausea. Non Focal PE: No lymphadenopathy
Severe right ear pain, hearing loss, swelling lasting for 8 days requiring ER visit, 3 drs visits, and ct scan.
My ears began ringing (high pitched ring) and didn't stop for about two days. When the ringing DID stop, I then had never-ending buzz-type sound in my ears. It's never stopped.  No treatment available. Sleep with background noise machine running.
- Temporary dizzy spells and loss and minor loss of balance (~3 times total in the 2 days following the vaccination and each spell lasting not longer than 30 seconds). - Severe chills, fever, muscle aches, and uncontrollable shivering/trembling (occurred the 2nd evening following the vaccination and lasted from about 8pm to 3am).
sore; stiff arm; red around the site of injection; swollen around the site of injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN (sore), MUSCULOSKELETAL STIFFNESS (stiff arm), INJECTION SITE ERYTHEMA (red around the site of injection) and INJECTION SITE SWELLING (swollen around the site of injection) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (sore), MUSCULOSKELETAL STIFFNESS (stiff arm), INJECTION SITE ERYTHEMA (red around the site of injection) and INJECTION SITE SWELLING (swollen around the site of injection). At the time of the report, PAIN (sore), MUSCULOSKELETAL STIFFNESS (stiff arm), INJECTION SITE ERYTHEMA (red around the site of injection) and INJECTION SITE SWELLING (swollen around the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Days following the booster, I developed a case of shingles.  Taking a 7 day, every 8 hour, Valacyclovir for treatment.
did not complete vaccine series; negative reaction - 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not complete vaccine series) and ADVERSE REACTION (negative reaction - 1st dose) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not complete vaccine series) and ADVERSE REACTION (negative reaction - 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not complete vaccine series) and ADVERSE REACTION (negative reaction - 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No relevant concomitant medications were reported. Treatment information was unknown.
Pt recv vax on 3/30/99; on 4/5/99 pt exp tender area of right upper arm, lump at vax site
Not feeling well; This is a spontaneous report received from a Pfizer sponsored program and medical information team. A Non-contactable consumer (patient's parent, Caregiver) reported that  a 17-year-old male patient (her son) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced not feeling well (non-serious) on an unspecified date. Caller was calling on behalf of her son who is 17 years old and scheduled to get the 2nd dose today (20Jul2021) but he is not feeling well. Caller said that his son already received the 1st dose but she did not know the date. The caller was asking if her son needs to get tested before getting the 2nd dose. Resolution: Call got disconnected while providing Privacy Statement. No demographics gathered. There were not any medical questions unaddressed by this program forwarded/referred to Medical Information. This is to confirm receipt of inquiry. MI cannot follow-up due to no contact information provided. Unable to follow up with requester due to no contact information provided. Serious: No. The outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
PATIENT RECIEVED A MODERNA COVID VACCINE THAT IS NOT AUTHRORIZED FOR PATIENT AGE GROUP. FOR OFF-LABEL USE, PATIENT WAS ABLE TO RECIEVE A SECOND VACCINE IN THIS SERIES
Fever 99.8, chills lasting overnight.  The next day weak and tired and arm soreness for 2 days   Just took tylenol
No adverse symptoms reported; Reported improperly stored PROQUAD was administered to patient on 10/24/2019; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 24-OCT-2019, the patient was vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) injection as prophylaxis (lot number: S003176 with expiration date in 30-JUL-2020) (dose, route of administration, strength and anatomical location were not reported) (incorrect product storage).  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8 °C (3.4C) for the time frame of 98 hours and 45 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects reported.
report of under-age usage of Flublok in clinic- with no reported adverse event; Fluzone was ordered but Flublok was sent.; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 10 months old female patient who report of under-age usage of flublok in clinic- with no reported adverse event and fluzone was ordered but flublok was sent. while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 04-Apr-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2155; expiry date: 30-june-2022)  via unknown route in the left thigh for immunization.  On 04-APR-2022 the patient developed a non-serious report of under-age usage of flublok in clinic- with no reported adverse event (off label use) and fluzone was ordered but flublok was sent. (wrong product administered)following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken:not applicable.   At time of reporting, the outcome was Unknown for the event wrong product administered, off label use.  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.
Within 5 minutes of GARDASIL deltoid injection child had a brief loss of consciousness with body jerking < 1 min. Blood pressure was normal/ V.S. nl. She recovered completely. No postictal state.
Adding due to not being on side effect list: Horrible taste in month for first 12 hours,  Face numb 30 minutes after vaccine for 2 hours, Shoulder & neck pain, dizziness, nausea , sensation up back of neck from 30 minutes after for hour.   Did not see dr or have any treatment.
I began having frequent tachycardia events two days after the first shot.  They continued daily through the month and continued after the second shot.
soreness in left arm started around an hour and a half after receiving the vaccine. tiredness and achy body was also a symptom around the same time.
p/vax pt broke out in chickenpox this morning;taken to MD;dx chickenpox;
Pt's Aunt called and reports that patient reported a head ache and sore arm following shots, developed a "slight fever" in the night.  About 9:30AM today patient fainted and then had a "convulsion". She was taken to the clinic and was told she had a "shortage of sodium" and her "electrolytes were off and she was dehydrated".  They instructed the family to take her to the hospital but the family did not go since she has no insurance.  The Aunt reports they were then told to give her gatorade and salt tablets.  She was dismissed from the clinic to home with instructions for her to be observed by a family member for further fainting and possible seizures as reported by her Aunt.  Mother was not available per phone for this report.
Suspected Vaccination failure; was vaccinated but still got them!; been sicker but never so miserable!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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), shingles and sickness. On an unknown date, the outcome of the vaccination failure, shingles and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles.  The patient had been sicker but never so miserable. The patient stated that, now there was a much more effective vaccine to get it. He/she sure did. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.