chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was mistakenly given Engerix-B adult dosage (1ml). It was discovered after patient had left the clinic. I called Mom to inform about 3 hours after the adverse event occurred and he was doing fine, denied any symptoms at the time. I advised mom monitor for adverse reaction and if any occur, contact our office ASAP or bring the ED for further evaluation. Mom verbalized understanding. I also let Mom know that I would be submitting an incident report regarding this Adverse Event.
Chills through the night of 12/26 - 12/27. Woke up with fever of 103.1f, headache, body aches. Felt better through the day of 12/28 with only low grade fever. Woke the morning of 12/29 with fever of 102.7f. Continued with waves of chills and fevers as high as 103.9fthrough the 29th and 30th. Messaged my PCP the morning. Message was forwarded to the on-call Dr with instructions to go to Care Clinic for evaluation. Covid and flu swabs and UA done, CBC, CMP and cytomegalovirus labs drawn.  FLU neg. Covid and cytomegalovirus results pending. CBC normal, CMP showed elevated liver enzymes. To follow up with PCP on 1/4/21. Cont with fever, chills, and headache. I was diagnosed with CLL in 2/2018 and treated with 5 months of chemo. Developed active cytomegalovirus. Currently in remission and virus undetected at this time. I am immunocompromised and did not respond to immunoglobulin  infusions.
1yr M presented for well child visit. MMR vaccination ordered without varicella vaccination. Patient was given ProQuad instead. Patient did not experience any adverse side effects from this.
I started getting a buzzing in both ears. It was getting worse and louder. It is constant but the loudness varies. I told my doctor and he did not have any suggestions for the tinnitus. I did try to plug my nose and blow and it seems to make it worse. It still continues to this day.
fighting a cold; feeling fatigued; This case was reported by a consumer via other manufacturer and described the occurrence of cold in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced cold and fatigue. On an unknown date, the outcome of the cold and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the cold and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated she was fighting a cold and reported feeling fatigued after her last Shingrix injection. Otherwise doing well.
PT IS UNDER AGE OF 18. PT IS 14 YEARS AND 11 MONTHS. PT AND FAMILY ARE AWARE AND THERE IS NO ADVERSE EVENTS OF THE VACCINE
12/28 upset stomach,  12/29  afternoon projectile vomiting , confusion 12/30-31 Continued confusion joint pain hips 1/1/21 began to feel better
Patient received the vaccine and apprx 5 minutes into waiting period she passed out and fell out of her chair. Patient hadn't reported any previous similar reactions on first ask. when the paramedics arrived to check her out, she state that she's been known to pass out while giving blood, admitted a fairly strong aversion to needles and when asked if she felt it was a reaction to the vaccine or anxiety she said anxiety quoting "as soon as I got the shot I started thinking about a chemical being in my body and my brain took it from there and the next thing I knew, I was on the ground"
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning an eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
I noticed swelling in my right armpit Saturday afternoon/evening. I asked my parents (both nurses) what to do the following morning and they advised me to take ibuprofen. I wanted to check with the pharmacy as well, so I called them once they opened several hours later and was told the same. I took two ibuprofen between about 1pm and 10pm on Sunday and then I think one or two Monday before noticing the swelling had nearly disappeared by the time I went to sleep Monday.
Malaise; ear pain and/or pressure; "Hot ears"/ felt like they had hot liquid in them; ear pain and/or pressure; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 21st May 2020, the patient received the 2nd dose of Shingrix (intramuscular). In May 2020, less than a day after receiving Shingrix, the patient experienced sensation of pressure in ear, ear pain and feeling hot. On an unknown date, the patient experienced malaise. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the malaise, sensation of pressure in ear, ear pain and feeling hot were recovered/resolved.   It was unknown if the reporter considered the malaise, sensation of pressure in ear, ear pain and feeling hot to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported but could be 50 or 51 years. On 21st March 2020, the patient received 1st dose of Shingrix and experienced malaise and tiredness, refer case US2020252546. On 21st May 2020 at around 2 to 3 pm, the patient received 2nd dose of Shingrix in left arm and experienced pain and/or pressure, as well as hot ears, a sensation she described as felt like they had hot liquid in them and later that night was when she felt the hot ears. The patient visited to the ENT physician. The patient stated that less than 9 months after 2nd dose, she might possibly had malaise with the 2nd dose but did not notice it due to the ear pain and/or pressure overpowering it. The patient stated that this sensation and/or pressure took 2 months to resolve and was on and off. The patient reported that everything had resolved. The patient reported that she getting the flu shot annually, with the most recent one given back on August 2020. The reporter provided limited information and requested to remain anonymous. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020252546:same reporter
pt recv vax 10JUL95 2PM & c/o dry cough, h/a, & runny nose; seen @ ER w/vomiting, h/a & c/o diff breathing;epi & DPH given;poss rxn to vax vs viral synd
No adverse event; Nurse is calling to report that a 7-month-old patient received First dose Bivalent Moderna COVID-19 vaccine 0.2 ml from a vial with Pink Cap (Lot no.215K22A & Exp. Date: 19AUG2023); This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Nurse is calling to report that a 7-month-old patient received First dose Bivalent Moderna COVID-19 vaccine 0.2 ml from a vial with Pink Cap (Lot no.215K22A & Exp. Date: 19AUG2023)) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 10-May-2023 at 11:56 AM, the patient experienced WRONG PRODUCT ADMINISTERED (Nurse is calling to report that a 7-month-old patient received First dose Bivalent Moderna COVID-19 vaccine 0.2 ml from a vial with Pink Cap (Lot no.215K22A & Exp. Date: 19AUG2023)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Nurse is calling to report that a 7-month-old patient received First dose Bivalent Moderna COVID-19 vaccine 0.2 ml from a vial with Pink Cap (Lot no.215K22A & Exp. Date: 19AUG2023)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Nurse is calling to report that a 7-month-old patient received First dose Bivalent Moderna COVID-19 vaccine 0.2 ml from a vial with Pink Cap (Lot no.215K22A & Exp. Date: 19AUG2023)).    No concomitant drug information was provided. The patient had not received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.
Patient given a booster dose of Moderna vaccine on 07/15/2022. The last extended expiration date: 07/13/2022. Patient has not reported any adverse events since vaccine was administered.
Child seen 38 hours following a well child care visit, in which he received his 5th DTaP vaccine. He developed swelling and redness to right upper arm within 24 hours of vaccine administration. Examination shows a 9.5 cm x 9.5 cm erythematous/warm/cellulitis right upper arm. Pt not requiring antibiotics. Tx: Benadryl and compresses, Tylenol PRN.
a patient received her first dose of Shingrix about 4 years ago and never got a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a patient received her first dose of Shingrix about 4 years ago and never got a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-MAY-2023 The pharmacy technician reported that a patient never got a second dose. The reporter did not ask about follow-up - pharmacy address is above in HCP details. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Headache within 1 hour, nausea after 6 hours, insomnia, body aches, swollen lymph nodes in armpit on the same side as the vaccine was received.
Pt recvd 2 doses of Hep B vax on 30APr92 & 28MAY92 & on 29MAY92 pt devel lemon size swelling w/discharge @ the inject site; Tx w/meds; pt exp residual probs of swollen fingers & hands; pt may have an allergy to thimerosal;
I have had nausea and severe diarrhea since receiving the shot almost a week ago, resulting in stomach pain and weight loss.
Both ActHiB and Pentacel were given in one round of shots. No symptoms have been reported.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unkonwn gender. The patient's drug allergies and pertinent medical history was not reported. On 11-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012984, 1407USA012985, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
Information has been received from a nurse practitioner concerning a female who on 27-DEC-2007 was vaccinated with GARDASIL. Subsequently the patient developed a sub curvecular node on the left hand where the shot was given. As of 11-JAN-2008 the patient had not recovered. Additional information has been requested. This is in follow up to reorts previously submitted on 2/14/2008 Initial and follow up information has been received from a nurse practioner concerning a 14 year old female who on 27-DEC-2007 was vaccinated IM with a first 0.5ml dose of GARDASIL in the left arm. As of 11-Jan-2008 the patient had not recovered. On 11-JAN-2008 the patient developed subclavicular lymphadenopathy. The patient was seen and treated with AUGMENTIN and the  subclavicular lymphadenopathy "cleared". The patient recovered 18-AUG-2008. Additional information is not expected.
Pt presents to ED 2/3 c/o weakness, worsening over the last week. Pt is A&Ox3-4 upon arrival, reports hx of CVA (in 1980s) with R sided weakness. Pt COVID positive 2/3, tolerated well. 2 L nc O2 albeit unsure of baseline.  Bradycardia noted. On 2/7 pt A&Ox4, denies pain, reports generalized weakness and fatigue. SpO2 97% on 5L O2 nasal cannula. On 2/9 pt remains alert and oriented to 4 on 4 liters of oxygen, heart monitor on, IV saline. 2/11 pt remains bradycardic so remdesivir not started. 2/14 pt complains of some shortness of breath and nonproductive cough. BP stable, no temp spikes HR NSR, no bradycardia. Pt discharged 2/14.
Within the first few minutes experienced palpatations, increased heart rate, and dizziness. Palpations were frequent. This continued for several days. I have a history of SVT's - but after vaccine the palpations felt with SVT's increased in frequency and lengthy. Heart rate was in the 90's- 110's at rest most of the time.  Had chest discomfort by day 3 post vaccine. On Feb 8th- late night began to have left chest pain, left arm/jam tingeling, and shortness of breath.   In addition to this had weakness, fatigue, muscle aches, pain at injection site, headache- started on January 30th 2021 and worsened over the next several days.  ** Immediate symtoms not reported at the vaccine site as I thought they would go away on own.
Nerve its pinched; I cannot perform some movements with my left arm; Pain in my left arm/pain in fingers; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in left arm on 19Mar2021 at 08:15 (at the age of 34 years) as single dose for COVID-19 immunisation. Medical history included thoracic-lumbar scoliosis. The patient had known allergies to lactose intolerant. Concomitant medication included cholecalciferol (Vitamin D3) (MANUFACTURER UNKNOWN), Probiotic 10 Nature Bounty (MANUFACTURER UNKNOWN) all from an unknown date, for unknown indication received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 08:15, patient experienced pain in left arm (pain in the whole arm) although it had been 17 days since the day of the vaccine, patient cannot perform some movements with left arm (for instance rotating the arm towards as if patient want to check the time on her watch), feels like nerve is pinched and even pain in fingers. No therapeutic measures were taken as a result of reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event patient experienced pain in left arm/ pain in fingers, cannot perform movements with left arm, nerve was pinched were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
ATRIAL FIBRILLATION; VASOVAGAL EPISODE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 14:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced a very adverse reaction. According to the physicians at the site, it was a vasovagal episode. Ultimately, the patient had to go to the ER because of atrial fibrillation. If interested, the patient would be happy to speak about it, and share the experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vasovagal episode and atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).  Version (1) created to amend previously reported information on 10-Mar-2021. Upon review the following information was amended: Reporter causality statement was removed from narrative, vaccine type and vaccination site were removed.; Sender's Comments: V1: Covid-19 vaccine ad26.cov2.s-Atrial fibrillation, vasovagal episode. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
the BIVALENT 5 year to 11 year Pfizer covid vaccine was given instead of the monovalent. It was the first covid vaccine this child had received
All she had was swollen lymph nodes under the arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "interchange of vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (COVID-19 Vaccine: Dose 1, Manufacturer: Moderna, Date: 04Mar2021, LOT: 026A21A, NDC/EXP: unknown, All were done at Withheld.), administration date: 04Mar2021, when the patient was 64-year-old, for COVID-19 Immunization; moderna (COVID-19 Vaccine: Dose 2, Manufacturer: Moderna, Date: 06Apr2021, NDC/EXP: unknown, LOT: 028A21A, All were done at Withheld.), administration date: 06Apr2021, when the patient was 64-year-old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered", described as "All she had was swollen lymph nodes under the arm.".  Additional information: She had two Moderna COVID-19 Vaccines since last Mar and then two Pfizer COVI-19 Vaccines. All were done at withheld Her most recent Pfizer COVID-19 Vaccine has sent her reeling. She called on Saturday, spoke with a representative who took down a lot of information and was then advised to call this number today. Caller doesn't know what's going to come of this today. Had first Pfizer COVID-19 Vaccine in Dec, doesn't specify year. All she had was swollen lymph nodes under the arm. For dose 3 vaccine, she only had swollen lymph nodes that resolved. It was under the left arm, not both arms, only the left arm. She had the shot on the left arm.
9AUG91 pt recvd MMR & 23AUG91 pt seen in ER c/o red swollen mass 1 day p/shot & by 1 wk down @ arm into 3-4th fingers w/swelling of these fingers & top of hand w/dec sensation esp in 4th finger;
Having really bad headaches; I have had the headache all week; My blood pressure was high all day; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265; Expiration Date: unknown), dose 1 via an unspecified route of administration on 31Jan2021 as UNK, single for an COVID-19 immunization. Medical history included diabetes mellitus (from an unknown date). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced having really bad headaches; have had the headache all week, blood pressure was high all day. patient took Lisinopril for blood pressure. The patient underwent lab tests and procedures which included blood pressure abnormal: high, cardiac stress test: it was fine, echocardiogram: it was fine, laboratory test: last lab work everything was great. Therapeutic measures were taken with Tylenol. The clinical outcome of the events was unknown.   Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
mild pins and needles; dizziness; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021395390 (Pfizer).  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Lot number: ER8735) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (ongoing); "Asthma" (ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN taken for blood cholesterol; CALCIUM; MAGNESIUM; ZINC; ALEVE; FAMOTIDINE; VITAMIN A [RETINOL]; VITAMIN C [ASCORBIC ACID]; VITAMIN D3. The following information was reported: PARAESTHESIA (non-serious) with onset 29Mar2021, outcome "recovered" (2021), described as "mild pins and needles"; DIZZINESS (non-serious) with onset 29Mar2021, outcome "recovered" (2021), described as "dizziness"; NAUSEA (non-serious) with onset 29Mar2021, outcome "recovered" (2021), described as "nausea".  Additional information: Patient reported she took levothyroxine 2 dose, micrograms. Consumer said events were Immediately following the shot and not experiencing this any longer.The consumer was concern if second dose should be taken or not and, and is pins and needles and feeling dizzy and nauseated were a severe reaction or not. Patient experienced events that the day of vaccine. It happened the first day. This is not ongoing. This is still not happening. The patient reported for concomitant medication yes she was that day or daily medicine. For Laboratory test the patient stated, she go to lab every 6 months, not till have she took the vaccine.  No follow-up attempts are possible. No further information is expected.