chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccines on Friday AM; ran 103 degree fever Friday PM. Went to ER after hours.  Diagnosed with allergic reaction.  Told to give Benadryl and ice packs.  Continued to run fever through Sunday.  Patient also had swelling to left arm at vaccine site.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/17/2023 ASTHMA, UNSPECIFIED R09.02 HYPOXIA 4/17/2023 ASTHMA, UNSPECIFIED
Injection date was too soon. Patient received first dose of Moderna on 6/14/2021, and second dose was 2 days too soon from the 4 days time-frame of early injection. Notified Moderna, who indicates that the date of early injection is ok at 7 days prior. Patient did not have a reaction or any signs of adverse event prior to exiting the clinic after the 15 minute wait time. She was notified of what happened and of response from Moderna already.
This spontaneous report was received from a Registered nurse regarding an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
got colitis; high infections; severe stomach pains; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 54-years-old via an unspecified route of administration, administered in arm left on 03Mar2021 11:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included dry eye and dry mouth from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient reported that they got colitis, and continue to have high infections, and severe stomach pains on 06Mar2021 12:00 for almost 2 months now since the time of the vaccine. The patient was hospitalized due to the events for 6 days. The patient's hospitalization was prolonged as a result of the events. The patient underwent lab tests and procedures which included Covid 19 testing PCR (Nasal Swab): negative on 23Mar2021. Therapeutic measures were taken as a result of the events which included treatment with IV and antibiotics. The patient did not recover from the events.  Information on lot number/batch number was requested.
Information has been received from a health professional concerning a 25 year old female who on 06-SEP-2007 was vaccinated with Gardasil (yeast, lot # 658556/1060U) in her right deltoid. Concomitant therapy included oral contraceptive (therapy unspecified). When the patient received her first dose of Gardasil, she experienced a rash. The rash was described as a red, blotchy area on her chest that covered an area of approximately 3-5 inches. The rash did not itch or spread. Medical attention was sought, the patient called the office. As of 27-SEP-2007 the outcome was unknown. Additional information has been requested.
Fever, headache, tiredness lasted more than 24 hours. Took ibuprofen.
I got chills and shivers, was feverish, weak, tired and hard to walk or stand, headache and my whole body hurt inside, very painful on the area where I got the shot and swelling there too.
pt recv vax 17OCT95 & that evening pt devel an inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who experienced above rxn p/vax
Two minutes after administration, patient passed out. She lost consciousness and fell from a chair straight forward onto the floor, hitting her head as I (the pharmacist) caught her from the righthand side. When she came to we administered Tylenol with water. Patient does have a history of fainting with vaccines, but reported it had not happened in years.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 25-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # L040458, expiration date 04-FEB-2018), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a RN concerning a 12  yr old Caucasian female student with no known allergies or medical history who on 05Sep96 at 17:50 was vaccinated SC in the left arm with her first dose of varicella virus vaccine live (lot 617224/0252D). On 08May05 at 09:00 the pt became febrile with fevers of 102-103F and developed a pruritic, pustular rash. The pt was seen by a physician on 09May05, the rash was on her face and scattered on her body and her temp at the time was 98.2F. A CBC was performed and she was given diphenhydramine hydrochloride (BENADRYL), after which she slept. It was also reported that the pt had received ibuprofen (Advil) at 2AM and 10AM on 09May05. At the time of the report there was no information on the pt's recovery status. Additional information has been received form a RN indicating that as of 14Jun05 the pt has not been seen in her office since the last correspondence. Therefore, recovery status is unk. No further information is available.
12 hours after vaccination developed headache, low grade fever (100.5), chills and nausea. Duration of symptoms was 3 days. Self limited.
Within twelve hours patient reported excessive "burning" pain (9 out of 10) at site of injection radiating to neck and below elbow associated with inability to move arm, denied redness and swelling, within eighteen hours patient reported transient "fever" but did not report recorded temperature, symptoms improved but not resolved within twenty-four hours such that pain reported as 7 out of 10 and some recovery of range of motion
2 1/2 days after vaccination baby presented with vomiting. Then next day vomiting with low grade fever. Then next day cough with rash on trunk 1st, head, extremities. Baby received double -dose H1N1 vaccine.
I lost the vision of the bottom half of my right eye, about 44%. I see darker and blurry.  Due to this lost vision I get dizzy and get headaches if I am in front of the laptop too long, or anything that I need to focus on for a prolonged time.
dizzy/Dizziness; nausea; This is a spontaneous report from a contactable Other Health Care Professional, the patient.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), via an unspecified route of administration on 02Feb2021 at 07:00 (at the age of 55-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included COVID-19 infection on an unspecified date. The patient was not pregnant at the time of vaccination. Concomitant medications were reported as "No." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021 at 06:00, the patient experienced dizziness and nausea. The reporter commented that she did not think these were side effects from the vaccine because she got it on Tuesday but her husband  pointed out that she normally does not have these side effects, so it has to be from the vaccine. The clinical outcomes of the events dizziness and nausea were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Injection site arm pain; Headache; Fever; This case was reported by a consumer and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th December 2020, immediately after receiving Shingrix, the patient experienced injection site pain, headache and fever. On an unknown date, the outcome of the injection site pain, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had injection site arm pain almost immediately. The patient developed headache and fever as well and that these symptoms persist. The reporter did not consent to follow up. The reporter did not had vaccine information for this AE and declines follow up. This case linked with US2020243291, reporter by same reporter for patient husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020243291:Same Reporter
Information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history who on 15-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot #657617/0384U). Concomitant therapy included MENACTRA, hepatitis A virus vaccine (manufacturer unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (manufacturer unspecified) (+) tetanus toxoid. On 15-AUG-2007 10 minutes after vaccination the patient fainted. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. On 15-AUG-2007 the patient recovered. Additional information has been requested.
About 24 hours after having flu vaccine administered in (R) deltoid, developed localized pain/pruritus.
Generalized body rash started ~24 hours later; still has 4 days later.
Routine well child check for a 1 year old appointment. Wednesday, October 27th, 2021; appointment time: 3:30pm.  time of vaccination 4:20pm; Two nurses administered vaccines- 1 in each thigh. (1 single dose of Varicella/ 1 dose of Varicella/MMR mix); Child was administered a single varicella dose IN ADDITION TO a varicella/MMR mix. Child was given an overdose or EXTRA unnecesary dose of Varicella at this appointment. I was notified of the incorrect dosage 7 days later.
Next morning after receving Tdap employee developed chills, felt feverish, muscle aches and fatigue. Felt "Heavy" all over. Had diarreah and lack of appetite. Felt better by that night. Did not miss work. Took ibuprofen twice (am and pm).
arm a bit tender at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 2nd dose of Shingrix. In March 2022, less than a day after receiving Shingrix, the patient experienced injection site tenderness. In March 2022, the outcome of the injection site tenderness was recovered/resolved.   It was unknown if the reporter considered the injection site tenderness to be related to Shingrix.  Additional details were reported as follows: The case was self-reported by the patient. The age at vaccination was not reported. After receiving 2nd dose Shingrix, the patient's arm was a bit tender at injection site. 20 hours after receiving Shingrix, the patient was feeling fine at the time of reporting. The patient enquired if it was okay to exercise 30 hours after receiving Shingrix.
Initial unsolicited report received from a physician on 16 October 2015. This case involves a 64-year-old female patient who was vaccinated with a second dose of FLUZONE (batch number UI493AA, expiry date and route of administration were not reported) in left deltoid on 15 October 2015. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was no known allergy (NKA). Patient had no vaccinations within 4 weeks of vaccinations. On 15 October 2015, few seconds "immediately" following the vaccination patient experienced redness and induration at the site of a few inches. Patient had no laboratory investigation. Corrective treatment was ice. The outcome of event was recovered. List of documents held by sender: none.
pt had itchy throat and cough, she assumed it was her nasal allergies , had taken a walk outside, also heart started to race and she attributed it to nerves. went home and felt sweats and flush and thought it was probably the  imz making her feel bad. took a nap, then woke up with ring around mouth and red chest , called her dr and went to er
1st dose years ago, wants 2nd dose today; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml 1st dose in October 2020 into unknown arm intramuscularly).   On 2nd December 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd December 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's comment: The pharmacist reported that the patient got the first dose of Shingrix vaccine two years ago and was getting the second dose of Shingrix today (on the day of reporting). The patient did not have any further information about the first or second vaccine. The reporter did not consent to follow up. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
I've never had hemorrhoids before in my life. However, beginning March 31st (about 6 days after my first COVID vaccine shot), I begin having symptoms of hemorrhoids. I have not been able to find this as a common vaccine side effect. However, (as mentioned), I've never before had it and I experienced the same (but on a smaller scale) after my 2nd dose. For treatment, I used over the counter medicine (Tucks). The issue cleared after a couple of days.
This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 23-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
7 cm red raised lump. Treatment with ice, children's Advil, Benadryl.
Pt recvd 3 doses of Engerix B according to 0, 1, 6mos schedule. 6Dec91 it was determined that pt did not respond.
pt exp severe pain, rt shoulder & rt collar bone drove to hosp, 8:30PM fainted, during evening fainted two more times;in bed every since;now has transitory pain in abd, rib cage;eating less, lost 4lbs;red cheeks & ears;
Local reaction.  Erythema, Swelling at injection site.  Patient described having a headache and some systemic itching.
This is a not serious spontaneous case from a pharmacist of headache. The reporter causality is not provided to FluMist. A health professional reported headache, runny nose, nasal and head congestion after receiving her first dose of FluMist on 28Oct04. On the morning of 29Oct04 the reporter stated she had a headache, runny nose, and congestion. The reporter took ibuprofen for treatment and had some relief. The symptoms continue. No further information is available.
Patient under the age of 65 receive a dose of the FLUZONE HD QIV with no adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Regulatory Authority (under the reference 00838659).  This case involves Adult patient (unknown gender) who was under the age of 65 receive a dose of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to Inappropriate age at vaccine administration (same day latency).  It was reported "Pharmacy manager states they had a patient under the age of 65 receive a dose of the FLUZONE HD QIV. The pharmacy manager states that she thinks the patient was between 23-26 years of age but she does not have any additional information handy."  At time of reporting, the outcome was unknown for the event.  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. 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.  There would be no information on the batch number for this case.
1/29/21 Develop rash around injection site - itchy, red, raised, warm to touch 1/31/21 Develop random pinpoint rash over entire body - red, itchy, raised. Rash area around injection site worsened. Red, itchy, raised. Took 25mg Benadryl OTC at bedtime 2/1/21 Took 25mg OTC Benadryl in am. Rash very faint and itching diminished greatly. (8.9cm x 11.4cm) 2/2/21 Pinpoint rash still in random area, itchy
she had a welt the size of her finger on the site of the injection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE URTICARIA (she had a welt the size of her finger on the site of the injection) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (she had a welt the size of her finger on the site of the injection). At the time of the report, VACCINATION SITE URTICARIA (she had a welt the size of her finger on the site of the injection) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746010 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746010:Reporter's case
Red patch around vaccine site. Hardness and sensitivity around vaccine site. Noticed 24 hours after vaccine.  From vaccination site to elbow slightly swollen.  Ice applied. No other symptoms.
I woke up the next morning feeling achy in all my muscles and joints, dizzy and feverish. While sitting at the table, I abruptly felt tingling and numbness in my hands, similar to when they fall asleep, but much stronger. It was very difficult to move them. My vision dimmed. The vision dimness and trouble with my hands lasted for a few minutes and started to dissipate after I stood up and walked a little. The aches, fever, and dizziness persisted for the rest of the day.
Information has been received from a health professional concerning a 38 year old female who on 9/28/01 was vaccinated with 1 dose of MMRII (lot 633815/0893L). Concomitant therapy included hormonal contraceptives (unspecified). The pt has not had a menstrual period since. The pt's last menstrual period date was 9/3/01. The pt had urine pregnancy tests on 10/8/01 and 11/27/01 which were negative. The pt sought medical attention. Follow-up information from the health professional noted that the pt was not willing to sign a consent form to release information. No further information is available.
rash (red bumps, itching) covering body-arms, legs, trunk-mother states child also has ringworm.
She had a fever and runny nose with a cough the next morning and then the following Saturday 02/11/2017 she developed a rash over her entire body.
Muscle spasm of left deltoid at site of pneumovax MSD 0930Z administration.  Treated w/ NSAID, Ice, Massage.
# hrs post getting 2nd vaccine patient developed a rash.  Benadryl 100mg given.  Pt did not need to go to the ER nor was she hospitalized.
Medical diagnosis cellulitis because of vaccine. Symptoms constant burning in whole arm, including veins, numbness of fingers, swelling in arm, induration at vaccination site, reddish discoloration, fever, chills, dizziness, lethargy.
Initial misuse report received from a healthcare professional (pharmacist) on 24 June 2014. A patient had received a dose of PENTACEL and Dtap on an unspecified date. It was reported that patients received PENTACEL and Dtap at the same time resulting in over dose. No adverse event was reported. List of documents held by sender: none.
Rash on forearms and backs of hands, started about 1 hour after receiving the vaccine.  Was seen 4/23 in clinic, no obvious distress aside from mildly itchy rash which was still present. Was given antihistamine medication for itching.
3-4 hrs post/vax, was playing on floor with brother & suddenly stiff, mouth clenched & grey around the lips. Lasted approx 25 sec, then pale and sleepy, but aroused & is fine now.
This spontaneous report as received from a consumer via Market research agency, refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. No other concomitant medications were reported. On 04-SEP-2013 the patient experienced tender rash on back. The outcome of tender rash on back is unknown. The causality of tender rash on back is not reported. Additional information is not expected.
Patient with polymorph ic papular eschar like rash 10 days post vaccine with lesions in different stages consistent with varicella.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 09-AUG-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
Red rash over entire body.   Not raised but itchy.  Mottled appearance.  Started on arm of injection site then spread to both arms, both legs and torso.  Approximately 45 minutes after reaction started took diphenhydramine 25 mg x 1 dose.  Reaction started to ease off within 1 hour but did not completely resolve until the next morning.
serum sickness - like illness: urticarial  rash, vascular, fever = 103 F 2/24/2020  7 days following above vaccines