chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My adverse event was NOT in response to a vaccine.  I got a breakthrough case of COVID approximately 5 months after my 3rd vaccine (1st booster).  All vaccines I received were Moderna.    I had a severe sore throat, low grade fever (never above 101), headache, body aches, severe nasal congestion, brief chest congestion/cough (1-2 days), fatigue but inability to sleep, low appetite, and muted sense of smell and taste.  All of these symptoms resolved after 5 days with the exception of the nasal/head congestion.  The nasal/head congestion lingered for about 5 days more.  At day 10 I still tested positive for COVID, although the home test line was very faint.  By Day 15 I tested negative for COVID.
Information has been received from a consumer regarding her daughter who was vaccinated with three (0.5 ml) doses of GARDASIL. There was no concomitant medication. The patient experienced minor injection site pain after first and second doses of GARDASIL, fainted and bruised knee after third dose of GARDASIL. At the time of reporting, the patient had not recovered. The lot numbers were not provided. Unknown medical attention was sought. No product quality complaint was involved. Additional information has been requested.
right parietal stroke--transient left-sided hemiplegia, dysarthia, agnosia, denial
12 hours after injection I had a very high fever of 103  chills, sweating.  Same time next  night same thing high fever 103 chills sweating. For the next 3 nights, same time 8pm, severe chills fever103.  at 11pm chills fever.  Drenched the bed in sweat, had to change sheets and clothing several times.  Same thing happened for the next two nights and same time.  6th night 8:00 and 11:00 chills and sweat.  Changed bedding.  Felt temperature was   not as high did not take it.  This is my 7th day will find out tonight what happens.  Tylenol was used all times.
It started with just a really bad stomach ache and going to the bathroom more frequently. From there my stomach and going to the bathroom a lot kept getting more painful with a burning sensation. I went to see a doctor and they did many test on my, but they couldn't find anything. They said it could be from stress but they don't know. In May 2021 my tonsils have started to go crazy. Now I have to get my tonsils removed. I could see my swollen tonsils from the outside of my throat. I have had a loss of appetite. I could go days without eating a meal but only snacking. Other days I could just eat and eat. I have also gained 20lbs without changing my appetite. I have had a IUD.  I have been having more frequent palpitations of the heart. Occasionally I would have a hard time breathing. I have a lump on my uterus or ovaries that causes me to have stomach pain. The doctors are still trying to figure out what's going on with me.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020) for prophylaxis. On 25th May 2018, the patient received the 1st dose of SHINGRIX. On 27th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, shivering, cold sweat and blistering of mouth. On an unknown date, the outcome of the injection site erythema and cold sweat were unknown and the outcome of the shivering and blistering of mouth were recovering/resolving. It was unknown if the reporter considered the injection site erythema, shivering, cold sweat and blistering of mouth to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness at injection site, shivers, cold sweats and mouth blisters a couple days after receiving the SHINGRIX vaccine in the right deltoid. The patient was still having the symptoms however was recovering. No further information was reported regarding the event.
Patient received the Fluzone quad shot. She stated she had an egg sensitivity but reported having the flu shot every year with no problems. Call the clinic today stating she had localized swelling at the injection site and lip swelling starting the evening of 10/06/2015.
PATIENT  STATED INJECTION SITE IS  RED, SORE, RAISED AND ITCHING.  SYMPTOMS STARTED ON 10/12/20 EVENING AROUND 8:00PM.  CALLED PHARMACY ON 10/13/20. NO OTHER ISSUES. RECOMMENDED PATIENT TO CONTACT DOCTOR.
The patient received a high-dose Fluzone on 10/16/2023. The patient did not disclose she had received a vaccination two days ago when receiving the flu vaccine on 10/18/2023. When followed up with patient, she stated that the vaccine she received on 10/16/2023 was expired. After looking on the system, the vaccine on 10/16/2023 was not expired. Patient was informed that the vaccine was not expired. Patient was informed of possible adverse symptoms. Patient stated she does not have any adverse side effects.
Patient complained of having feelings of weakness and chills shortly after receiving his vaccine. He states that he had a similar reaction when he received his first vaccine on 10/20/18. He stated that the weakness and chills started "a little while" after receiving the vaccine and lasted for about one day and then they resolved.
HCP listed below who reported a 4 y/o female was administered a dose of PROQUAD that was reconstituted with an expired diluent; HCP listed below who reported a 4 y/o female was administered a dose of PROQUAD that was reconstituted with an expired diluent; No additional AE  reported; This spontaneous report was received from a pharmacist referring to a 4-year-old female patient. Information regarding the patient's medical history, concomitant medications, drug allergies or reactions were not provided.   On unspecified date, the patient was vaccinated at a pediatric clinic with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported/unknown by the reporter) which was not expired; nonetheless, the vaccine was diluted with an expired diluent, lot #T018038(expiration date 22-DEC-2022) (expired product administered and product preparation issue).  No further adverse events were reported (No adverse events).  This was one of several reports from the same reporter.; Sender's Comments:  US-009507513-2304USA002815:
Patient  hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis: Atrial fibrillation with RVR
A half hour after receiving the vaccine, I couldn't move my neck. It was stiff, my glands in my neck and armpits were completely inflamed. I had flu-like symptoms that night around midnight. Nauseous, chills, fever, swollen glands, trouble breathing for the next 3 days. Immediate care- 11/25/16.
got the first dose on the 1Apr2021 and the second dose on the 21Apr2021; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on the 1Apr2021 and the second dose on the 21Apr2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on the 1Apr2021 and the second dose on the 21Apr2021). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on the 1Apr2021 and the second dose on the 21Apr2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  .   This case was linked to MOD-2021-404133 (Patient Link).
5/12/99 8PM eyelids became puffy itchy;5/13/99 830AM swollen face, puffy eyelids & 10AM hives-face & neck;11AM advised to go to ER by PCP;ER lethargy, h/a, hoarseness, face felt like leather;blister on face;has allergy sx;
A physician reported the occurrence of an injection site reaction in a 37-year-old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent medical conditions or concurrent medications were not provided. On 11/13/2002 an adult female was vaccinated with 2 pediatric doses of hepatitis B vaccine recombinant (Engerix-B) (ENG5356A2) rather than an adult injection. Two days later, on 11/15/2002, the pt experienced redness and burning distal to the injection site. This was the pt's 1st injection of hepatitis B vaccine recombinant.
Sore Arm, feeling weak & tired, extreme tooth ache #33 which to hot & cold, dissipated to zero pain after 3 months-gradual dissapation. Still weak & very tired after 5 months.
Chills non-stop since 0500 today. Elevated temp 102, fussy, vomiting and admitted to hospital for observation. Labs ordered; CBC with differential, Chem 7, Blood cultures, UA with UCX and S, CX rays AP & LAT. Tylenol, Motrin, Rocephin 500mg. IV Q 24 hours and IV fluids. The hospital discharge summary states influenza.
Hospitalization  Pt has been admitted, he has had several diagnostic/imaging tests including chest x-ray which revealed he has pneumonia in the left lung only. Pt. rep noted coughing up blood and phlegm prior to hospital admit date on 04/01/2021.
Top of arm, shoulder, neck then face went numb about 3:30 Friday 9-25-15 afternoon...had flu shot that morning. The numbness kept spreading around towards ear then around eye socket. Called doctors office and was told I could go ahead with an appointment but nothing could be done for me.
1 yr old boy (WM) seen 1/9/2009 for 1 yr old health steps exam. Mild rhinorrhea reported and nose congested. Exam otherwise normal. Afebrile. 1x 10 immunizations given. Evening on 1/19/2009 seemed ok at bedtime. mother heard noise child with fever and tonic seizure. Taken to local ER 103 degrees positive. Nose congested. Said to ? OM. Rechecked 1/20/09 in office- ?, ?. Rhinorrhea. No ear infection.
Arm pain, diarrhea, nausea, headache, chills, very tired
Patient requested Moderna vaccine.   Patient inadvertently received Pfizer vaccine.  Wrong vaccine administered.   Patient had received Moderna vaccine for 1st and 2nd doses.
Patient was given vaccine on 12/12/17 and had no reaction or problems on date given. Patient noticed soreness to right upper arm deltoid area at site where vaccine given sore and warm to touch. Patient reports warmth to area lasted about 2 days and soreness to area about 5 days.
Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 67 years old patient who experienced two vaccines were administered at the same time, while he/she received vaccines ADACEL and TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE HIGH DOSE for Immunisation. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6128AA via intramuscular route in the arm nos. On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6014AB via intramuscular route in the arm nos. It was a case of actual medication error due to extra dose administered. The patient outcome is reported as Not Applicable for two vaccines were administered at the same time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore arm at the injection site) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy (Allergy to shrimp).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (I had a sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (I had a sore arm at the injection site) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not provided.    This case was linked to MOD-2021-314922 (Patient Link).
Dizziness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Mar2021 at 15:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease and diabetes. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included metformin hydrochloride (GLUCOPHAGE), escitalopram (ESCITALOPRAM), acetylsalicylic acid (ASPIRIN) and clopidogrel bisulfate (PLAVIX) all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received carisoprodol (SOMA) and experienced drug allergy.  On 10Mar2021 at 23:00, the patient experienced dizziness and headache. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and headache were not recovered at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient c/o nausea, dizziness shortly after immunization administration Patient was assisted into a prone position (laying down) with ice pack applied to neck area.
possible UTI; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect (Patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced possible UTI (Urinary tract infection). The patient was prescribed an antibiotic for a possible UTI and wants to know if he can take the antibiotic or will it interfere with his second dose on Thursday. The outcome of the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
The night after the vaccine I had fever and sweats and in bed the room did spin out when I rolled over on my side. The next day,  I woke up with a constant sound in my head and everything is  very loud  in my head, every sound is amplified and now have hyperacusis and tinnitus. Making my daily leaving horrid. Also dizziness.
1:00 p.m. on September 12th, 2009 onset of fever continued until 4:10 a.m. September 13th when child became unresponsive and stiff with shaking (seizure) that lasted until 5:15+- a.m. Child was taken by ambulance to medical center and given ativan to stop the seizure Child was still unresponsive for several hours and came out of this state at aprox. 7:15 a.m. Child was admitted and still somewhat sleepy and weak through September 14th  Child was released on 14th at 1:00 p.m. with a follow up visit in 1 week for results from EEG.  12/30/09 DC summary and H&P received for DOS 09/13/09-09/14/09. DX: febrile seizures, fever possibly secondary to MMR vaccine. Pt c/o fever, SOB, cough, generalized seizures for 20 mins, jerking spells when stimulated, vomiting. Tx: Ativan. Pt improved.  01/05/2010 Duplicate DC summary received for DOS 09/13/09-09/14/09./rem  01/05/2010 Newborn Discharge summary and clinic records received for DOS 08/31/2008-09/06/2008 and Hospital test records, Duplicate H&P received for 09/13/09-09/14/09.
Patient woke up the next morning after vaccines with - soreness/pain at site of injections, as well as itching rash to legs, abdomen, chest, arms and back - hives. Seen in the ED and treated with Benadryl.
Dizziness, lightheadedness, elevated temperature. (R) right arm redness, swelling, pain within a day of injections, lasted 6 days. Elevated arm, cool compresses used. VICODIN used.
Nurse pulled up dose of Pfizer bivalent vaccine at 0.1 mL and gave to client intradermally instead of MPX vaccine. Client was informed, and brought back in to received does of MPX vaccine 0.5 mL subcutaneously. Incident report filed, and double check on all medication reinforced to staff.
9/26/07 Fever 100 F. 9/28/07 Red, blotchy rash covering face and small area chest and back.
Weight gain; Muscle cramps; Tiredness; Arthritic pains; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), MUSCLE SPASMS (Muscle cramps), FATIGUE (Tiredness) and ARTHRALGIA (Arthritic pains) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) unknown. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), MUSCLE SPASMS (Muscle cramps), FATIGUE (Tiredness) and ARTHRALGIA (Arthritic pains). At the time of the report, WEIGHT INCREASED (Weight gain), MUSCLE SPASMS (Muscle cramps) and FATIGUE (Tiredness) had not resolved and ARTHRALGIA (Arthritic pains) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: Three. On an unknown date, Weight: gain 25 Pounds.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No information on concomitant medication were reported. The patient had experienced weight gain 25 pound since beginning Rinvoq. She had felt tired most of the time and also having muscle cramps since beginning Rinvoq. But it had been able to manage them by taking an over the counter magnesium product. Her rheumatoid arthritis pain had primarily subsided but has occasional pain. She rated this pain at a three. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of WEIGHT GAIN, TIRED and MUSCLE CRAMPS with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporter's causality for the event(s) of OCCASIONAL RHEUMATOID ARTHRITIS PAIN with RINVOQ(UPADACITINIB) was no reasonable possibility.  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
after 2nd, and persistent joint pain in shoulders and elbows through present; after 2nd, and persistent joint pain in shoulders and elbows through present; after 2nd, and persistent joint pain in shoulders and elbows through present; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 17:00 (Lot number: EW0158) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR; LEXAPRO; WELLBUTRIN. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: ER8731, Lot unknown: False, Administration date: 14Apr2021, Administration time: 05:00 PM, Dose number: 1, Vaccine location: Left arm), administration date: 14Apr2021, when the patient was 38 years old, for COVID-19 immunisation, reaction(s): "Pain", "Joint pain", "Muscle pain". The following information was reported: ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 08May2021, outcome "recovered" (2021) and all described as "after 2nd, and persistent joint pain in shoulders and elbows through present". Therapeutic measures were not taken as a result of arthralgia, arthralgia, arthralgia.  Additional Information: Patient had not taken other vaccine in four weeks. Clinical course: It was reported that adverse event were severe joint and muscle pain in upper body. 8 days after first shot, 3 days after second, and persistent joint pain in shoulders and elbows through present and Recovered with lasting effects. After the first dose, Adverse event start date was 14Apr2021 and Adverse event start time was 08:00 PM. Patient had no Covid prior vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Arm really red, swollen went to Dr's office on Monday 8-6-12 got an Rx for antibiotic (sulfamethoxazole-TMP DS).
diffuse macular rash (large lesions) w/ low grade fever beginning 2 days p/vax;dx urticaria;erythema mult;
Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Apr2021 09:20 (Lot number: EW0167) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin for Allergy; Sulfa drugs for Allergy. Vaccination history included: Covid-19 vaccine (lot number: EW0158, dose number: 1, vaccine location: Left arm, Time: 9:30 am, route of administration: intramuscular), administration date: 07Apr2021, when the patient was 40 years old, for COVID-19 Immunization, reaction(s): "diarrhea"; Covid-19 vaccine, for COVID-19 Immunization, reaction(s): "joint pain".  The following information was reported: DIARRHOEA (non-serious) with onset 28Apr2021, outcome "recovering", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: Following the first covid vaccine patient developed diarrhea that did not go away. she assumed it was a bug and it would go away after her second vaccine, the diarrhea had continued with no other symptoms. she noticed it was worse after certain foods. she cut out dairy and gluten and only have diarrhea when she eat those things. Previously, she was diagnosed with IBS 10 years ago, but it caused nausea and vomiting and dairy\gluten were not triggers. Patient had no COVID prior vaccination. Patient had not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.