chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme diarrhea still ongoing 1 week later. Full body rash. Half dollar size hard dark red lump where shot was administered.
Nasal irritation; Eye irritation; Feels weak; Nausea; Vomiting; Has chills; Fever; Headache; Spinal nerve pain; Muscle pain; Fatigue; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea) and VOMITING (Vomiting) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Chronic obstructive pulmonary disease and Nerve pain (Severe Nerve problem).    On 18-May-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 NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Has chills), PYREXIA (Fever), HEADACHE (Headache), NEURALGIA (Spinal nerve pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and DIARRHEA (Diarrhea). At the time of the report, NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Has chills), PYREXIA (Fever), HEADACHE (Headache), NEURALGIA (Spinal nerve pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and DIARRHEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that he takes many medications.
Started with a low grade fever (100.4) on 7/30. Fever subsided followed by a measles like rash over my son?s body. He is having trouble sleeping and cries inconsolably for hours which is not like him at all.
This case was reported by a physician (also the subject's husband) and described the occurrence of lymphoma in a 75-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included HCTZ, Naproxen and Vitamin D. On 13 October 2011 the subject received a dose of FLULAVAL (unknown route, left deltoid). In November 2011, 1 month after vaccination with FLULAVAL, the subject experienced lymphadenopathy and was diagnosed as having reactive lymphadenitis. Less than a year after vaccination with FLULAVAL, the subject experienced lymphoma. At the time the lymphadenopathy (enlarged lymph node) was discovered it was diagnosed as reactive lymphadenitis; however, once it was biopsied, it was lymphoma. This case was assessed as medically serious by GSK. Relevant test results included lymph node biopsy indicating lymphoma. At the time of reporting the outcome of the events was unspecified. According to the physician (also the subject's husband), the subject had received the flu vaccine for the past 10 years and may have had local pain as a side effect only in the past. See case A0960863B for details.
11-11-11 12cm x 9cm erythematous area with slight swelling and warmth and a 3cm x 2cm bullae in the center at left arm injection site. CBC, Blood culture, ESR and CRP done. Treated with Rocephin 1gm and Septra DS. F/u on 11-18-11 with marked improvement.
Patient had been more fussy than usual since immunizations.  No fever.  Went to hospital for scheduled heart catherterization on 1/5/05.  Baby fine when they left hotel, but when they arrived at hospital & uncovered his car seat, he wasn't breathing. CPR performed by staff at hospital but unable to revive. Death Certificate rec'd on 07/25/2005 adds term -- pulmonary thromboemboli & hypoplastic left heart syndrome.
Pt received scheduled vaccines for 2 mo WCV. Upon arrival home, child began to have high fever 102-103 degrees F. Taken to ED, follow-up with PCP, sent back to hosp.->admitted 8/3/10.
This spontaneous report as received from a registered nurse refers to a 4 months old female patient. The patient was vaccinated with the second dose of lot # (669072/1270Z expiration date 16-AUG-2012) ROTATEQ (dose and route not reported) on 20-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that they administered expirated ROTATEQ to child on 20-AUG-2012. No adverse effects were reported. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of serum sickness in a 16-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included MENVEO for prophylaxis. Previously administered products included MENVEO (1st dose received on an unknown date). On 3rd August 2018, the patient received the 1st dose of BEXSERO and the 2nd dose of MENVEO. In August 2018, less than a week after receiving BEXSERO and MENVEO, the patient experienced serum sickness, hand swelling, rash and fever. In August 2018, the outcome of the serum sickness, hand swelling, rash and fever were recovered/resolved. It was unknown if the reporter considered the serum sickness, hand swelling, rash and fever to be related to BEXSERO and MENVEO. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 15 or 16 years old. The reporting nurse was very experienced giving BEXSERO and MENVEO vaccines. The batch numbers for BEXSERO and MENVEO were unknown. The patient had both of BEXSERO and MENVEO vaccines administered on Friday and between Friday and Sunday, the patient experienced a fever, bilateral hand swelling and a rash on his arms and chest. The patient went to the emergency room on Sunday but was not admitted. The patient then saw an allergist who diagnosed him with possible serum sickness reaction. The nurse had a question whether the patient should be administered the 2nd dose of BEXSERO and was referred to medical information. The sales representative was concerned the nurse might also report the adverse event.
patient came into the pharmacy for the new moderna bivalent booster, she was accidently administered the moderna monovalent booster
Evening and night of injection - extreme soreness in left upper arm, unrelenting chills, excessively strong headaches. Headaches and general malaise continued through next day. Little to no interest in food through that day and next. Extreme lethargy for 2 days after the first night of chills and headaches; mild lethargy continues into today.
administered a vaccine post expiration with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] post expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Oct-2023, the patient was administered a dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (expiry date- 08-OCT-2023) (lot number, strength, dosage- not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) post expiration with no reported adverse event (expired product administered) (latency- same day). Information on the batch number was requested.  Reportedly, Caller would like to know the efficacy of the vaccine given to the patient.  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.
Patient received shot and made her way from the clinical room to the observation area for the required observation period she walked back to the clinical room while another patient was being placed in the room and said she felt light headed, nauseated and dizzy . We had her sit back down and and elevate her feet in the waiting area while we moved the next patient out.  She was coherent and talking and said she felt nauseated and we moved her back to the clinic room and had her lie down on the carpet with her feet elevated. A few minutes went by and she reported that she felt her skin was hot and tingly.  We called for emergency services and began to attempt to take her bp. Pt appeared normal and reported no issues with her airway. She was speaking normally and answering question  appropriately.  The paramedics arrived and monitored her bp while lying down, sitting and standing. Her bp presented as elevated with tachycardia. Paramedics performed a blood glucose test which showed a low reading within normal limits. Patient reported not having eaten since breakfast. Pt's o2 saturation was "excellent" and she declined transport to hospital when offered by paramedics. No drugs were administered by pharmacy nor paramedics.
Patient reported feeling dizzy. Rph advised patient to put her head between her knees. When asked if pt was experiencing difficutly breathing, or swelling of lips, throat, or tongue, pt reported tingling in her lips.  Rph called 911. Patient's care was transitioned to EMS. Patient was transported to Medical Center
Body aches, Fever 100 -100.5, headache, chills.  Resting at home.  If symptoms worsen will contact PCP.
Fever over 100; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever over 100) 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 PYREXIA (Fever over 100). At the time of the report, PYREXIA (Fever over 100) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took medication for fever.  Concomitant medications were not reported.
pt exp tenderness & inflammation @ inject site (deltoid) for 1 month; pt hands & arms had a cold sensation, treated w/Amoxicillin x 10 days w/no improvement; arm became more painful; dx muscle inflammation;
Right away I went back to bed, dizzy, no appitite, feeling really bad. 101 fever.
COVID arm,  soreness after first few hours and swelling.  Redness after 48 hours
Information has been received from a physician concerning a 62 year old female who on 04-JUN-2007 was vaccinated with Zostavax (Oka/Merck) (lot# 657675/0618U).  Concomitant therapy included EVISTA and omega-3 marine triglycerides.  On 04-JUN-2007 the patient's balance was off when walking after the vaccination.  As of 08-JUN-2007 the outcome was unknown.  Additional information has been requested.
Redness, hot/warm to touch, inflammation 50mm x 42mm dk red inner, 60mm x 60mm pink, outer. 10/03/18-only pinkness remains-smaller 40x50mm negative pain.
Experienced swelling in the neck, lymph nodes and under her arms; Experienced swelling in the neck, lymph nodes and under her arms; Experienced swelling in the neck, lymph nodes and under her arms; This is a spontaneous report received from a contactable pharmacist. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 03Jun2021 (age at vaccination 32 year) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling in the neck, lymph nodes and under her arms on an unspecified date. Outcome of the events was unknown. PQC Details: Request Name: REQ- Product: PFIZER-BIONTECH COVID-19 VACCINE. Question: Callback attempt #1 performed on 24Jun2021 at 05:32 PM because caller preferred a callback than to be placed on hold for the information. Caller warm transferred to (withheld) of DSU with NTID and reportum #. Upon warm transfer, caller got disconnected from the call. DSU agent mentioned "she'll take care of it." E-transmitting AE report for review. Potential AE duplicate. (32 years old, female). Caller has a 32-year-old female patient who had the first dose of the Pfizer BioNTech COVID-19 vaccine last 03Jun2021 and experienced swelling in the neck, lymph nodes and under her arms which was reported. Caller asked if it was appropriate for the patient to get the second shot of the vaccine. Proposed response: Provide disclaimer. Speak from attached document and mention Interim Clinical Considerations for the Use of COVID-19 Vaccines from ACIP. Response: Provide disclaimers. Spoke from attached document and mentioned "Interim Clinical Considerations for the Use of COVID-19 Vaccines from ACIP". PSCC Communication: After MI provided information, MI agent attempted to bring caller onto the line. MI agent returned to call handler and stated that the caller had remotely disconnected the call. All information provided is as reported by the MI agent. No additional details provided.  Follow up activities closed: No follow up activities are required for non-serious AEs reported in spontaneous/other solicited sources, no follow-up assessment to be made by DSU at initial case entry per EXCEPTION ICSRs FOLLOW-UP PROCESS DURING PANDEMIC.
Lower Abdominal Pain (stabbing pain that radiates)Happened sporadically for a month. Client took herself off gluten products and pain went away. Pain returned one month later. Client stopped dairy products and pain went away. Client has seen Gastroenterologist who wanted to test for celiac disease. Client also seen by Ob Gyn and Nutritionist.
6x6 cm local rxn; awoke 2MAY92 w/shivers, sl fever;
swollen tetramune site, all ant w/firm induration yesterday about 37sec duration of grand mal sz @ home;recovered w/o problem
07/30/05 Child developed 10-20 lesions over trunk by 8/1/05 has 40 chicken pox lesions. No fever, no other symptoms.
Headache, Myalgia, UrticariaPruritus,  NauseaVomiting, lethargic, swollen lymph nodes Narrative:
Received first covid shot on Sunday 8 Aug. While lifting weights on Monday 9 Aug, suffered hearing loss and tinnitus in right ear.
KILLED; This spontaneous report received from a consumer via a company representative from social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the reporter mentioned  to sue for killing the reporter's dad after vaccine. On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220254949-COVID-19 VACCINE AD26.COV2.S-Killed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
T78.40XA ALLERGIC REACTION, INIT 12/24/2022 NONPROGRESSIVE RELAPSING MULTIPLE SCLEROSIS
Constipation, vomiting, headache, dizziness, fever of 100F.
she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; This is a spontaneous report from a contactable consumer (patient). The 54-years-old female patient (weight: 150lb-160lb) received first dose of bnt162b2 (BNT162B2, lot number: EL0142), via an unspecified route of administration in left arm on 14Jan2021 15:40 at SINGLE DOSE for covid-19 immunisation. Medical history included none. No Prior Vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID), omeprazole, calcium. On 20Jan2021 weds: "bad diarrhea", vomiting, low grade fever, sore arm (only the day after) and bad stomach cramps. Caller says, "if that's going to happen after 2nd dose- I wont take it". Caller referred to HCP for treatment of post vaccination side effects. She notes that at work on Wednesday she didn't feel good  on 20Jan2021 and yesterday she was useless on 21Jan2021. She does feel better today thank goodness. No AE(s) require a visit to Emergency Room or Physician Office. The outcome of the events didn't feel good, she was useless, sore arm was unknown and  was recovering for the rest events.  No follow-up attempts possible. No further information expected.
Headache, fatigue, rhinorrhea, sneezing Narrative: Extreme fatigue, headache, rhinorrhea, sneezing within
Patient hospitalized for nonrheumatic aortic valve stenosis on 4/28/2021. Patient hospitalized for TAVR on 5/17/2021. These visits are within 6 weeks of receiving COVID vaccination.
No additional AEs reported; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 13-month-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 15-DEC-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot number U024221, expiration date 04-OCT-2023 (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 39.55 degrees Fahrenheit for 10 hours. No previous temperature excursions were detected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID 19 treatment starting from 23Sep2022 to 28Sep2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5 people she knew were vaccinated and died; This is a spontaneous report received from Pfizer sponsored program. A Non-contactable consumer reporting same event under the same suspect product for 5 patients. This is 4 of 5 reports.  A patient of unspecified age and gender received bnt162b2 (COMIRNATY) on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated that she had J & J vaccine in March. She wanted to start over with the Pfizer Covid vaccines but her Provider was saying she could only have Pfizer Covid Booster. Wondering if there are any clinical trials she could get in to. Also wondering if steroids affect the Pfizer Covid vaccine. She would call back the day after reporting to speak with them. She also stated during conversation that 5 people she knew were vaccinated and died. It was unknown if Autopsy Done. The outcome of the event was fatal.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101451919 same reporter/drug/event, different patient.; Reported Cause(s) of Death: 5 people she knew were vaccinated and died
Initial misuse report received from a healthcare professional  on 08 January 2014. This case is invalid as invalid as individual patient identifiers were not reported. Some patients had received ACTHIB on an unspecified date. The ACTHIB was reconstituted with sterile water instead of the diluent. The patient did not experienced any adverse event. Documents held by sender: none.
Unconsolable crying 24 hrs after DTP. Cont crying for over 24 hrs. Supportive treatment given: Tylenol, Motrin, reassurance to Mom. Seen by physician-letter to health dept stating Halley had reaction to DTaP and series should discontinue.
first evening--sore arm (still sore today); during the first night, low-grade fever (100.5); yesterday and today, dizziness and body aches (including headache); no appetite even yet
Patient reports fatigue and arm soreness that started immediately after second Moderna shot and have not improved (currently > 7 weeks post-vaccination).  Additionally, she experienced a fever for about 2 days, as well as "terrible" fatigue and "odd thoughts" for about 24 hours,.
Arm pain and Migraine .. Took Migraine medication and that's when I had a  anaphylaxis reaction . I  have an appointment to see a specialist to verify  if the  reaction was caused by the COVID  vaccine or the medication I took that day
After having been given FLUZONE HD I became very ill. Like the worse case of flu ever. This lasted over 24 hours. I was throwing up all night long could not eat or drink.
Diaphoretic, felt like she was going to pass out. Lost pulse momentarily, stopped breathing momentarily. Spontaneously recovered.
had a mild case of COVID-19; had a mild case of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had a mild case of COVID-19".  Clinical course: Patient received a COVID-19 monovalent booster (manufacturer not specified) and had a mild case of COVID-19 "sometime afterwards". Also reported a heart attack following their second Pfizer vaccine shot (Reporter was unsure if this was referring to primary series or booster).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Description of Event Patient received pfizer vaccine on left arm at 1549. Complained of dizziness and ringing in left ear at 1615.  Interventions:Instructed patient to lie down, given apple juice and water, observed for 45 mins.
Pt was given Zostavax on 3/5/14. On 3/7/14 she returned and the site was somewhat swollen and red. Informed pt to call me or MD if it gets any worse or more painful. Also told her she could ice it if she wanted.