chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose was not administered; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (second dose was not administered) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (second dose was not administered). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (second dose was not administered) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: TCR form received in which gives information about second dose .
Patient had a mild seizure several hours after receiving the J&J vaccine. She is epileptic and generally has two seizures a year that would last 30 minutes or longer. The seizure she had after receiving the vaccine only lasted around 40 seconds. She had her last regular seizure in January so she stated she was not due to have a seizure anytime soon based on her previous medical history. Her father was present and able to keep her safe during seizure so no medical treatment was received.
Tinnitus in right ear noticed within 72 hours of first injection.  Ongoing, persistent high pitched ringing in right ear.  No prior history of tinnitus. It has not subsided after 17 weeks.
11/12/07-Blurred and double vision 11/13/07-worsening vision 11/17/07- muscle weakness, difficulty swallowing, dizzy, difficulty talking, hospitalized 12/17/07-records received for DOS 11/22-11/25/07-DC DX: Dizziness. Weakness of glossopharyngeal nerve with diminished cough and gag reflex. Dysarthria.  Neurology workup pending.Ten days prior to admission sudden onset of generalized weakness of upper arm and thigh region. No decrase in hand grip. Diplopia with blurred vision. Lightheadedness. Tongue felt thick and difficult to swallow. Six pound weight gain in 10 days. Increased fever blisters. Recent increase in dosage of Levoxyl.
injection site soreness, shoulder tightness increased to a shock along nerve to back of thumb within 24hrs. Arm began to pull up with pain through forearm and biceps increasing through 72 hrs. Began meloxicam again at 60 hrs. Woke up at 84hrs with severe arm pain, unable to move arm without pain. Cold sweat and nearly fainted. Pressure/pain in shoulder, biceps, elbow/forearm wrist. Called sibling who is physician and began treating shoulder with ice, tylenol and benedryl. Pain controlled to moderate through day 10 but lifting arm at shoulder or extending results in shock at back of thumb and pain through biceps and forearm. Back base of thumb completely numb. Went to urgent care facility 10 days after injection and
Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case was linked with 2018SA251660, 2018SA251703, 2018SA251366 and 2018SA251618 (Same reporter). This case involves a six-year-old patient (gender not reported) who received 0.5 ml of FLUZONE QUADRIVALENT batch number: UI997AA on 31-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is actual medication error case due to product storage error (received FLUZONE QUAD 0.5 mL and 0.25 mL syringes after the 48 hours shipping, MA said it was still cool). No other vaccine was given to patient. It was unknown whether the patient had any adverse event. 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. List of documents held by sender: none.
Headache commenced in early evening, about 30 hours after injection. About 35 hours after injection he had an explicable nosebleed that commenced while showering. He is not susceptible to nosebleeds in general also it seemed to be very high in the sinuses as it exited from bothering the nose and back of the throat. Nosebleed stopped after simple pressure to nose within 15 minutes.
pt has been crying, irritable all noc & inj site bright red w/swelling;sl fever;nurse spoke w/MD to give APAP/motrin rotating q 3hr, cool packs to legs;
This spontaneous report as received from a medical assistant refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosage regimen were not reported) for prophylaxis on an unspecified date when the unspecified patient was 13 years old. On an unknown date in August 2016, unspecified patient was 15 years old received GARDASIL 9 (dosage regimen were not reported) for prophylaxis. No adverse events  were reported. The outcome of interchange of vaccine products, no adverse event, incorrect drug administration duration and inappropriate schedule of drug administration were unknown. No further information was available. Additional information has been requested.
Primarily it was intense body aches and pains with headache. I also had nasal congestion and dry cough. I had intense fatigue. All of this came on within 24 hours. On the second day it was much worse. My symptoms peaked on the 3rd day and began to fade on day 4. By the end of the 6th day it was much better. I got the anti-viral on day 3. (Molnupiravir) I took this for 5 days beginning June 23rd.
Chills, shivering, headache, feverish (low), tiredness, muscle aches. The chills and shivering came on very suddenly about 12 hours after getting the vaccine. I also have arm soreness where the vaccine was administered.
Noted redness, itching at site of Pneumovax injection after 1 week. Seen by nurse practitioner in office. Diagnosed local allergic reaction. Prescribed Medrol dose pack and to pick up Cortaid. Erythema had increased the following day. Zyrtec added.
Tinnitus( Buzzing and ringing in  left) constant day and night. Worse in evening. Hearing loss in left in. Beginning to have ringing in my right. Very difficult to deal with this constant noise. Also, have dizziness as well.
Diarrhea 02/04/21;Headaches 02/04/22;Headaches  02/05/21;Headaches  02/06/21
CHILD STARTED TO SNEEZE, RUB NOSE, WHEEZE & COUGH. DR ADMINISTERED .15 MG WITHIN 5 MINUTES OF RETURNING TO THE EXAM ROOM, THE REACTION WAS ALMOST IMMEDIATELY.  EMS WAS CALLED AT 1137, ARR. 1143. 110/70, P 170'S, O2 SAT INITIALLY WAS 83 - AFTER NEB TX 2.5MG/3ML SAT INCREASED TO 96 PERCENT. SENT VIA EMS. APPEARED TO BE SOMEWHAT RECOVERED.
Patient got H1N1 shot 12/10/09 around 2pm. On 12/1109 pt woke up and could not breath, chest was heavy, very weak. Continued through Sat. Sunday pt went to hospital, admitted to ER, Complaining of weakness. Weakness, pain in throat and ears, sore all over body.
Moderna injection given 01/15/2021 reaction began after 11 hours. Eye, face swelling. Went to see physician on 01/17/2021 was given steroid shot and placed on steroid pack. Swelling went down but redness and irritation continued on eyes and inside eyes. Swelling began 01/23 again returned to physician on 01/24/21 per physician cellulitis beginning on eyes. Started on antibiotics and eye drops. 01/25 eyes began to swell again.
Pt came into office 12/4 with her mother on 11/30 pt. had two vaccines administered PENTACEL and PCV13 in her right thigh. Mother states pt. had fevers on/off from 11/30-12/2 TMAX 102 rectal. Friday (11/30) Pt leg had red spots all over. On 12/4 Pts leg was still swollen.
Pt called in on 4-6-21 stating her L arm was red and warm to the touch. She stated the redness was about 2 in around the inj site. Pt denied any swelling no SOB, no fever and no rash. She did state her arm itched a little. Pt was seen in the office by Dr. on 4-7-21 and was started on Bactrim DS 800-160 mg BID for 7 days. Pt was told to take Zyrtec if Symptoms come back. Pt reported on 4-11-21 that her symptoms are better.
Fever, headache, chills, cough, congestion, lower oxygen levels, fatigue
elevated heart rate, difficulty breathing, lung infection, insomnia, night sweats  Musculoskeletal:  fatigue, weakness, joint pains, inability to exercise, post-exertional malaise, inability to perform normal activities of daily life (ADL?s), muscle spasms  7. Mucus membranes: Running nose, sneezing, Burning and itchy eyes.   8. HIGH BLOOD PRESSURE -- diagnosed at the Hospital visit on 12/14/2021          nebulizer, prescribed prednisone, ZPak
I experienced abnormal vagina bleeding outside of my regular monthly menstrual cycle following the vaccination for 4 days from 5/20-5/23.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 42 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2021 at 15:00 as dose 1, single (Lot number: ER8731), in right arm, on 03May2021 at 12:00 as dose 2, single (Lot number: EW0175), in right arm and on 02Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FF2598), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Myacin Family" (unspecified if ongoing), notes: Known allergies: Myacin Family. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Flu vaccine high in Deltoid area Nov 6, 2019. Persistent pain with arm elevation. Treatment: Moist heat, range of motion exercises, NSAIDS.
Pfizer COVID vaccine vials had a thawed BUD of 1/13/20 at 08:00. Pharmacy made up #38 vaccine doses at around 12:00. The error discovered in the middle of clinic around 13:30. Remaining doses sequestered. Reviewed clinic schedule to identify 18 patients that received the doses. Recommendation from Advisory Committee on Immunization Practices/CDC was to repeat the dose. Patient was contacted to repeat her second dose. Patient received her Pfizer COVID vaccine doses in the following sequence: first dose  12/23/2020, second dose (of expired vaccine) 1/13/2021, and repeated second dose on 1/13/2021.
C/O:  DIZZINESS.   1140:  VS:  184/98, P: 92; 02 SAT:  RA:  98%; 1152:  VS:  167/88, P:  70; 02 SAT:  RA:  98%
fever, sick all week, vomiting, fever 103.0;mom requested pertussis be discontinued;MD requested DTAP;neighbor child died d/t pertussis vax;pt recovered fully given ped DT on 22APR96
Within 15-minutes of vaccination, the patient reported feeling lightheaded. EMS managed patient's care on-site.
Minor sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles in May 2022). Concurrent medical conditions included pain and scar.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that, It was now December and he/she still had pain as well as scarring.  The doctor said that, he/she could get shingles again and to get the shingles shots.  There was no way in hell that he/she was going through this again.  The patient got shot one with minor sore arm.  The second shot was due in 4-6 months. The reporter stated that, did not be stupid and had the shingles shots.
Bell's Palsy; This is a spontaneous report from a contactable Physician and a consumer. A 72-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Left arm on 05Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. Concomitant medication included ASA, levothyroxine sodium (SYNTHYROID), telmisartan and simvastatin (ZOCOR). There was no other vaccine in four weeks. The patient previously took lisinopril and experienced allergy. The patient experienced bell's palsy on 20Feb2021 and treated with prednisone. Event resulted in Doctor or other healthcare professional office/clinic visit. Covid did not test post vaccination. The outcome was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered the reported serious event as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Tinnitus- started 2 days or so after vaccine; Sleeplessness; Fatigue; Muscle pain throughout body; Fever; Injection site pain; Painful left tonsil for a few days; Bad taste in mouth; Extreme back ache; Tightness in chest; Sinus pain; Swollen left tonsil for a few days; Hot and sweat flashes; This is a spontaneous report from a contactable consumer, the patient. A 48-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 left arm on 27Sep2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history includes COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Sep2021, at 17:00, the patient experienced bad taste in mouth, fatigue, extreme back ache and muscle pain throughout body, sleeplessness, fever, tightness in chest, sinus pain, injection site pain, swollen painful left tonsil for a few days, hot and sweat flashes and on 29Sep2021, the patient experienced tinnitus which started 2 days or so after vaccine and still had it. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of bad taste in mouth, fatigue, extreme back ache and muscle pain throughout body, sleeplessness, fever, tightness in chest, sinus pain, injection site pain, swollen painful left tonsil, hot and sweat flashes, tinnitus was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Felt fine after the shot but 11 hours after the shot I developed a high fever ( 102-103 Temp )  I was sweating through my clothes and aches/fatigue through the night.  The next day I still felt weak but my temperature by 9PM the following night was down to 100.00.  The following few days I still had a headache but other symptoms went away.
24 hours after the shot; speech was affected.  Could not speak plainly.  Tongue had tingly feeling and felt like it was swollen, but it was not.  Regular speech would come back for a few minutes, but then it would be impaired again.  This went on for about ten (10) hours before the regular speech returned.
Administered on 10-25-05 3pm, 101.6 temp 10-26-05 6pm. 10-27-05 2 inch red spot right arm and 101 temp 6 am. 10-27-05 reddened area doubled in size by 11 am.  Physician (allergist) notified. Seen by physician at 4pm, size increasing, moving around arm. Tx with augmentin.  Received 2 doses by 10-28-05(16th birthday), fever continues as well as growth of area.  By 10 am 10-28-05 fever 104, arm very hot to touch.  Returned to pediatrician due to close proximity to home as instructed by allergist.  Decision by both physicians to admitto hospital to treat for sever case of cellulitis.  Admitted to hospital. Blood culture , cbc, creatine protein, etc drawn.  Iv clindamycin Q 8hours started at 6 pm x 48 hours.  Discharged 10-30-05 on po clindamycin x 10 days.  The area ended up extending from below the shoulder to just below the elbow and almost encirling the upper arm. Discharge summary states cellulitis. msv
Last night (around 9:00 pm) I became very nauseous and had a severe headache, chills and nausea. I took 2 Tylenol pills and went to bed. At 11:00pm I became extremely ill with a fever of 103 F and vomited 4 times consecutively.  I went back to bed, still with a fever and chills. At 12:30 am (April 9th) I again started vomiting again (around 3 times).  I then went back to bed and fell asleep. I woke up around 8am (April 9th) still feeling feverish, with chills and a severe headache. I have no appetite and no energy to get out of bed as of right now (11:00am).
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Feb2021 as dose 1, single (Lot number: 025A21A), in left arm, on 26Mar2021 as dose 2, single (Lot number: 028A21A), in left arm, on 05Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm and on 09Sep2022 at 12:15 as dose 5 (booster), single (Lot number: AS 7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN, start date: Jun2015; EZETIMIBE, start date: Jun2015; GABAPENTIN, start date: Jun2015; ZOLPIDEM, start date: Jun2015. Past drug history included: Cyclobenzaprine, start date: Jun2015, stop date: Jun2015. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Oct2021, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive, notes: positive PCR test; (19Dec2022) Positive, notes: rapid at home test. Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 07Dec2022 to 11Dec2022 for COVID-19 treatment. The patient developed covid symptoms 06Dec2022; positive PCR test 24 hours later (07Dec2022), got RX for Paxlovid immediately and took Paxlovid pills for 5 days, final pill on 11Dec2022. All covid symptoms gone by 11Dec2022. Then, the patient stayed home for 5 more days, until 16Dec2022. Felt fine. On 16Dec2022, she had a doctor appointment. The doctor kept her waiting for an hour in a horribly crowded waiting room in which several people were coughing loudly. All wearing masks, but not every minute. Two days later (18Dec2022) she had symptoms; on 19Dec2022 she tested positive (rapid at home test). She did not know if this was covid rebound or if the recurrence of covid was due to her exposure to coughing people in docs waiting room on 16Dec2022.
Sévère arthralgia, not able to walk. Facial paresthésie.  Extreme fatigue, chills and fever
6/20/18 1515 Mom phoned today stating patient starting vomiting yesterday afternoon. Mom states she had just given a small amount of applesauce prior to the vomiting. No fever, no rash. Acting normally between episodes of vomiting. Having normal wet diapers. Mom will offer PEDIALYTE, monitor wet diapers, and have patient seen for any worsening.
8 days after receiving vaccine, I had urticarial plaques at the injection site with mild pain and stiffness. Treatment has included icing, topical TAC, and oral Zyrtec.
my ear and eye got really hot; running low grade fever; body aches; very fatigued; really swollen lymph nodes; throat hurts; extreme pain in my arm, neck, ear, and eye; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (really swollen lymph nodes), OROPHARYNGEAL PAIN (throat hurts), PAIN (extreme pain in my arm, neck, ear, and eye), ABNORMAL SENSATION IN EYE (my ear and eye got really hot) and PYREXIA (running low grade fever) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN (extreme pain in my arm, neck, ear, and eye). On an unknown date, the patient experienced LYMPHADENOPATHY (really swollen lymph nodes), OROPHARYNGEAL PAIN (throat hurts), ABNORMAL SENSATION IN EYE (my ear and eye got really hot), PYREXIA (running low grade fever), MYALGIA (body aches) and FATIGUE (very fatigued). At the time of the report, LYMPHADENOPATHY (really swollen lymph nodes), OROPHARYNGEAL PAIN (throat hurts), PAIN (extreme pain in my arm, neck, ear, and eye), ABNORMAL SENSATION IN EYE (my ear and eye got really hot), PYREXIA (running low grade fever), MYALGIA (body aches) and FATIGUE (very fatigued) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The treatment reported was Tylenol which helped with the pain, sore throat, and fever.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.