chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme body pain/aches Chills, headache, nausea Severe stomach pains, especially at night- same symptoms as pancreatitis Fever of 102 for 24  hours then severe night sweats for 3 days Diahrea x1 day
Received pneumovax 01/10/2006 in left deltoid on 01/10/2006.  Developed redness, warmth, edema from site distally to hand.  Received Benadryl 25mg every 4 hours as needed and ice pack as desired.  Rash persisted thru 01/14/2006.
Sudden Sensorineural hearing loss Woke up one morning and no hearing in the right ear. Family physician treated for possible sinus infection. No results from treatment. Then referred to ENT and verified Sudden Sensorineural hearing loss.   Prednisone increased after hearing in the left ear also became diminished. After weeks of prednisone, left ear stabilized. No recovery of hearing in right ear,
pt devel weakness, nausea, & vomiting 3 wks p/flu vax; pt required 2 courses of ATB tx for this reaction;
Nausea, fever 100.4, HA, chills, racing heart rate, injection sites sore.
I would not loose things or be slow to remember them as I do now and when I get anxiety it is completely different it?s like my heart is trying to lose control
Patient had an anaphylactic reaction, her throat began to swell shut. She was given 3 doses of epinephrine 0.3mg SQ (left thigh, left thigh, and right thigh). 911 was called and EMS arrived in approximately 10 minutes, they proceeded to take her to the hospital. She was being monitored after the vaccine for 30 mins due to multiple allergies including anaphylactic reactions to bee stings and food allergies.
30APR92 pt fever greater than 103; APAP given by mom; fever dec; 1MAY92 began vomiting, hallucinations & staring spells; pt taken to MD & given Pedioprofen & fever dec;
This case involves a cluster of 4 patients (a mother and her 3 sons). This case represents one of the 4 patients (the 4-year-old son). The other 3 patients are captured in case numbers 2012-09093, 09094, and 09095. Initial report received from a company representative who provided a link to a non-scientific news report on 26 September 2012. On the same date, another company representative provided additional information obtained from an internet source that is maintained by the patient's parents. This case involves a 4-year-old male patient who had a pertussis vaccine (manufacturer, date, route, site of administration not reported) and later developed whooping cough. When the patient's mother first noticed that he had developed a cough, she took the patient and her other 2 sons away for a family vacation, to avoid the risk of her 2-year-old daughter getting sick as her daughter was undergoing chemotherapy. The mother and the patient's older brothers (ages 7 and 9) quickly came down with nagging cough that wouldn't go away and seemed to be getting worse. After approximately 2 weeks, the patient experienced episodes where he was gasping for breath during coughs and he would turn blue, vomit, and dry heave. The next day, the family presented to the pediatrician and asked for a Pertussis test (unspecified). The patient was diagnosed with pertussis and the whole family was treated with antibiotics (unspecified). According to the blog posting on 14 September 2012, the patient's mother and 9-year-old brother were reported to have a lesser, but still nasty, cough while his 7-year-old brother was doing great. The patient was reported to be lacking one dose of the pertussis vaccine series because of his age and the vaccine schedule. Outcome was not reported. Documents held by sender: None.
Experiencing the same random hives all over my body  after 13 days of taking Moderna booster shot.
Spontaneous, moving rash. Random hives breakout on body. Mainly concentrated in hands, back, neck and chest. Dermatographia seems to be occurring.
Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 15 years old patient (15 years four months old) who received a dose of MENACTRA (at the age of 11 years) and extra dose of the same vaccine (0.5 mL, lot number: U5839AA) in right deltoid on 10-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if the patient experienced any adverse event or not. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
messed with my menstruation cycle. Menstruated for about 3 week on and off.
This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. Additional information: Physician updated previous report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
really bad headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient experienced really bad headache on an unspecified date. Verbatim and event description: Swap from FC. It was reported that, patient has received second dose of covid vaccine and had adverse reactions. She was on hold for 2 hours company and was disconnected. She wanted to report these reactions still. Advised company would be the appropriate place for reporting AE. She wanted to speak to a manager about the hold times and disconnected from company. Transferred call to supervisor.  The outcome of the event was unknown.  Follow-up (03Mar2021): This is a follow-up spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported for herself that; It was reported that, the patient received her second dose of the vaccine and had been suffering side effects ever since. Has had a really bad headache and wanted to know how long it will last. Called over to rep (Name) Pharmacist who will give her a call back. Faxing AE to Pfizer from Support  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
19 days after vaccination, patient developed spontaneous conjunctival hemorrhage and widespread petechiae prompting visit to our primary care office.  He was cranky but otherwise well.  He had a CBC in the office with a platelet count of 8 and all other bloodlines were normal.  He was sent to the local hospital emergency room where he was diagnosed with ITP and placed under care of hematology.  He was not admitted.  His platelet count in the emergency room was repeated and was less than one.
Area of warmth and induration on left arm 6 cm x 4 cm where vaccine was administered 2 days earlier.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 2 (initial pfizer dose), single (Lot number: GH9702) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14May2022 as dose 1, single (Lot number: 043B21A), in left arm and on 27Oct2023 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Inflammation caused muscle pain" (unspecified if ongoing); "Inflammation caused muscle pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Oct2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, 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 drug ineffective, covid-19. Clinical course: Patient took Paxlovid for treatment of COVID-19 from 31Oct2023 to 06Nov2023. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367608 Same patient, different product/events;
Roughly 5mins after vaccine administration, patient reported feeling more anxious, with SOB, left sided chest pain described as pressure.  Epi-Pen brought to bedside but was not administered.  VSS, 100% on RA, HR=89, normal BP,  no visible rashes, lungs clear, no wheezing, RRR, no OP edema.  Pt transferred to emergency room for further workup.
Patient returned to clinic on 12/01/06 with a red raised area on right arm with yellow drainage. Rocephin 1 gram IM given. Wound care supplies, Bacitracin ointment and instructions for wound care given also cephalaxin 500 mg 1 BID for 14 days.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 30-year-old female patient received BNT162b2 (BNT162B2), on 01Dec2022 as dose 1, single (Lot number: FJ6369) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfadiazine, reaction(s): "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". 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 drug ineffective, covid-19. Clinical course: No other Medication in 2weeks. COVID 19 Treatment, Treatment start date: 29Mar2023, Treatment stop date: 30Mar2023, Administrator route: Oral; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events COVID-19, drug ineffective and the suspect  product BNT162b2.,Linked Report(s) : US-PFIZER INC-202300139940 same reporter/patient, different AE;
Developed fever/chills next day and following day which resolved but also began having having purple/blue fingertips - both pads and nails - when my hands are cold.  This began on day after vaccine and continues to date.
couldn't breathe; had a high fever of 101° F; passed out at work; got really sick; irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out at work), ILLNESS (got really sick), HEART RATE IRREGULAR (irregular heartbeat), DYSPNOEA (couldn't breathe) and PYREXIA (had a high fever of 101° F) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E_IA) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out at work), ILLNESS (got really sick), HEART RATE IRREGULAR (irregular heartbeat) and PYREXIA (had a high fever of 101° F). On an unknown date, the patient experienced DYSPNOEA (couldn't breathe). At the time of the report, LOSS OF CONSCIOUSNESS (passed out at work), ILLNESS (got really sick), HEART RATE IRREGULAR (irregular heartbeat), DYSPNOEA (couldn't breathe) and PYREXIA (had a high fever of 101° F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: 101° f (High) had a high fever of 101° F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment information was not provided.  The symptoms started on 20-Aug-2021 at about 11 am. the patient "got really sick" and passed out at work, had a high fever of 101° F and started noticing an irregular heartbeat. The patient went to the doctor and they put him on a heart monitor for 48 hours. The patient also stated that he couldn't breathe.; Sender's Comments: This case concerns a 53 year old male with no medical history who experienced the unexpected events of Illness, Loss of consciousness, Heart rate irregular and Dyspnoea and the expected event of Pyrexia 1 day after the first dose of Moderna COVID-19 vaccine. No re-chalenge has been note and no causality reported.  The benefit-risk relationship of Moderna COVID-19 is not affected by this report. The event Loss of consciousness was automatically upgraded to serious as per IME; however, based on medical judgement and the information available the event is assessed as non-serious.
Vasovagal syncope- dilated pupils, sweating, passed out, tonic posturing, lasted about 1 minute. Felt weak and nauseous afterword and didn?t feel strong enough to walk out of clinic (took wheelchair). Vomited about 45 mins later. Did not eat dinner. Fell asleep at 8:00, which is unusual for my 16yo.
States on 9/28/11 she was home and at 1615 felt her throat getting tight and closing up. Called a friend to take her to the hospital. States she got there about 1650. States she received epinephrine about 2200. Received a breathing treatment. Received Morphine, TORDAL and ZOFRAN since her left arm was sore from the vaccine also. Stayed overnight in the hospital. Left the next morning with Epi Pen and oral DECADRON. Returned to hospital 9/30. Stayed overnight until 10/1. 9/28 ER visit. Had stridor and resp. distress. C/O shortness of breath. CXR and labs were negative. Received VISTARIL 50mg and PREDNISONE 40mg with minimal relief. CT of neck showed severe narrowing at the level of the oropharynx. No masses. ENT specialist was called and given DECADRON 16mg twice daily. Sent to ICU with continuous pulse ox. Also got PEPCID in ER and ICU. 9/29 AM Swelling resolved. No stridor or resp. distress. F/U CAT Scan - soft tissue swelling at level of oropharynx markedly improved compared to 9/28. Home on Epipen, Dexamethasone, Hydroxyzine. F/U with physician and an allergist. Discharged in afternoon. 9/30/11 Stated she had been feeling better, then got so SOB "couldn't walk across room". States she began having more and more increased swelling and difficulty getting air into her lungs through the night. Returned to the ER 9/30 in the AM. Given IV DECADRON and nebulizer with relief of symptoms and readmitted for observation. 10/2 Discharged with extended Dexamethasone taper and Albuterol inhaler. To follow up with physician and allergist. D/C 1100 on 10/2. Symptoms resolved.
Pt vaccinated with DTP/OPV/HIB became restless for 36 hrs after vaccine given. Then had 2 1/2 hr of almost continuous screaming, some high - pitched. No fever. Treated w/Tylenol40 mg for discomfort.
Very hot extremely large swollen thigh each day for 4 days-bigger - then discolored-about 14 long by 12 wide.
p/vax pt devel scattered papules on arms & legs approx 5 papules on each limb;MD felt papules were bug bites;
It started about 11 hours after the shot:  malaise, then severe shivering (almost locking my jaw).  Fever got to 101.8 after a few hours and would not go down with ibuprofen or aspirin.  It got down to 100 by morning.  Then it hovered around 99 the next day after taking Aleve.
Pt was a resident at a nursing home.  She tested positive for Covid at that facility on 4/26/22 and subsequently died on 5/9/22.
This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. On 25-APR-2013 the patient was vaccinated with PROQUAD (Lot # not provided) (dose and route not reported). Other suspect therapies included VARIVAX (Merck) (Lot # not reported) (dose and route not reported). No concomitant therapy was reported. On 25-APR-2013, the patient was vaccinated with PROQUAD (Merck) and VARIVAX (Merck): no adverse effects reported at this time. Additional information is not expected.
a feverish area on my arm about 2 inches below the injection site; 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 (a feverish area on my arm about 2 inches below the injection site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (a feverish area on my arm about 2 inches below the injection site). At the time of the report, PYREXIA (a feverish area on my arm about 2 inches below the injection site) had not resolved.
Breakthrough case admission after 4 vaccines Moderna 7/2/21 lot# 049C21A;  Moderna 7/30/21 lot# 049C;  Moderna 2/9/22 lot# 042J21A;  Moderna 8/2/22 Lot# 037A22B
Case number PHEH2014US018299 is an initial spontaneous report received from consumer (who is the patient) on 10 Sep 2014, with a follow up consumer on 30 Oct 2014. This report refers to a 38 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 01 Sep 2014. On the same day 04 hours after vaccination, he experienced flu like symptoms for 10 days. The symptoms were described as tiredness, weakness, tired muscle feeling, runny nose and cough. The first two days of the event were worst and after that he was a little better. The final outcome was reported as unknown. The seriousness and causality were not reported. Non-significant follow up received from consumer on 30 Oct 2014: updated nurse contact information only.
Myalgia, UrticariaPruritus, fatigue Narrative:  Left bandaid over injection site on until evening. On removal, noticed that skin partially under adhesive was removed as this was taken off. No prior reaction to adhesives, bandages, or similar bandaids. This area became pruritic on day three and lasted for over a week. She applied Neosporin and took acetaminophen. She also experienced about 1.5 weeks of myalgia and fatigue. She called her PCP, who did not make any further recommendations. The area now appears to have post-inflammatory hyperpigmentation.
Patient states began having "racing heartbeat, feeling of anxiety, sweating from scalp, cold feet, temperature of 100.1" at 4:30pm on 3/10/21, patient states took Ibuprofen 800mg and began to feel better. Patient states on 3/11/21 at about 4:30pm began having "racing heartbeat, feelings of anxiety" again, denies having temperature at that time, patient states "went away on its own", did not take medication. Patient states had "rapid heartbeat and feeling anxious" at 5am, no fever, no medication taken.
one large hive, redness, area hot to the touch, itching , swelling, pain
Mother called at 11(08/03/2007) am to say her son woke up today with complaints of right upper arm pain and itching.  Told not to let him itch it and to give him Benadryl and apply ice to site.  If it becomes worse to go see doctor.
In the few hours following receipt of the Anthrax vaccine, the injection site was very achy and tender. By the evening of May 6, 2017, the pain increased with the slightest movement of my arm (where the injection site was), to the point that I lost full mobility of my arm without unbearable pain. Additionally, any pressure on the arm, (i.e. laying down), was borderline excruciating. The following morning, approximately 5:00am, I woke in considerable pain, radiating from the injection site to my neck and upper back. Also, there is a firm lump at the injection site, and it appears that the muscle itself is raised, as the lump sort of wraps around the top of my arm where the muscle is. Also, throughout the morning, felt extremely fatigued, and generally sick. It felt as if I could fall asleep at any moment if I just closed my eyes. This is my fifth Anthrax vaccination over the course of 7 years, and each time presented similar side effects, albeit the effects were somewhat worse the past two times (6 May 2017 and 11 Jan 2015). It is currently 9:00 AM on 7 May 2017, and I am still experiencing the radiating pain from my arm, up my neck, and across my upper back; I still have very limited mobility of my arm without extreme discomfort, and am still very fatigued with general feelings of malaise.
chills; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (really bad headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A or O15M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (really bad headache). At the time of the report, CHILLS (chills) and HEADACHE (really bad headache) outcome was unknown.            Treatment details included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Tinnitus began after the first series of two shots and worsened after the booster third dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus began after the first series of two shots and worsened after the booster third dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed Rash on Lower Back,  on 2/23 since rash is still on back.