chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed rash (hives) on trunk, arms, legs and face on morning of 10/21/09. Patient received prescription for Ibuprofen and Benadryl as needed.
Saturday Night, I felt nauseated and tried to eat a cracker.  I was dizzy and almost passed out.   Sunday and Monday, had no appetite, weak, No energy.   Tuesday, felt fine.
Within 3 hours after receiving the seasonal INFLUENZA vaccine, Pt came to the health unit stating she was light headed, short of breath, & nauseous. Her throat was "tingly". Vital signs stable, lungs were clear, respiration was normal. BENADRYL 50 mg PO and health teaching. She felt well enough to return to the office & was referred to ER if symptoms returned. She felt well the next day.
Pt was given the wrong shot on 2-20-18. The M.A that checked for the M.A administering the shot is no longer allowed to sign for her. Only senior M.A's are allowed to check for the M.A that administer shot. Both M.A's were written up.
Information has been received from a registered nurse concerning an 18 month old white female patient with reflux and no allergies who on 06/07/2004 at 10:30AM was vaccinated with a first dose of varicella virus vaccine live subcutaneously.  Concomitant vaccination included diphtheria toxoid, pertussis vaccine, tetanus toxoid given in the right arm.  On 06/07/2004, within 5 minutes of vaccination the patient developed a local reaction with 2 raised, swollen and reddened spots, size of little fingernail on upper left arm.  The patient also experienced slight redness in the right arm at the diphtheria toxoid, pertussis vaccine, tetanus toxoid injection site.  Medical attention was sought and the patient was administered diphenhydramine hcl.  No product quality complaint involved.  Follow up information indicated that on 06/07/2004 at 10:32am the patient developed 3 inch welts at the injection site.  The patient was given diphenhydramine hcl.  No hives or wheezing was noted.  Decreased redness was noted soon afterwards.  The patient recovered on 06/07/2004.  No further information is expected.
Immediately following vaccination, client appeared to have a vasovagal reaction. Client states she has had a similar reaction to vaccine in the past. She was immediately assessed by on-site medic unit. BP= 90/60, HR= 70, O2 = 98. Client was given recommendation to transport to hospital, but she declined. She was monitored for 30 minutes by EMS and was accompanied by mother. End vitals:  BP = 100/60, HR = 85, O2 = 95.
Narrative: Patient received one dose of covid vaccine. Patient was admitted at hospital 2/16-2/18 with AMS and possible seizure, concern for chronic subdural hematoma and possible disseminated Cryptococcosis; discharged with hospice services. Cause of death noted to be cirrhosis. Reporting per instruction.
At 10:45 pm on Oct. 1, 2019 I had severe chills and generalized skin sensitivity accompanied by 101 degree F temperature. At 4:45 am Oct. 2, 2019 I woke up with 102.47 degree F with a severe headache, extreme weakness, and generalized body aches.
Shingles type outbreak buttocks (no treatment) and herpes simplex right upper lip.  Treated the herpes simplex of the lip with Abreva with good result (gone in 3 days)
Treatment of COVID-19; Treatment of COVID-19; Dose Number: 3 Moderna Booster (first two vaccination doses were Pfizer); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "known allergies: Guava" (unspecified if ongoing), notes: known allergies: Guava (food); "smoking" (unspecified if ongoing), notes: quit smoking 5 yrs ago. Concomitant medication(s) included: BUPROPION HCL XL, start date: 01Sep2022. Past drug history included: Rocephin, reaction(s): "known allergies: Rocephin"; Clindamycin, reaction(s): "known allergies: Clindamycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Jun2022, outcome "unknown", described as "Dose Number: 3 Moderna Booster (first two vaccination doses were Pfizer)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: She began this medication at 11:30 pm on 03Dec. On 04Dec, she started tasting metal with every meal she ate. She could still taste the food itself but had an added metal taste. Today 06Dec at 2:21 was she was smelling cigarettes everywhere and could taste them as well. She quit smoking 5 yrs ago. She has never had any smell or taste issues when sick in past.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue swollen, slurred speech, dysphonia. Was given benadryl, epipen and decadron transferred to ER where she was given additional benadryl and solumedrol and observed. Pt discharged from ER after period of observation.
Body aches, fatigue, chills, fever began approximately 18 hours after second dose; these symptoms (except for fatigue) eventually resolved.  Have had a high pitched ringing or hissing in ears since receiving the vaccine; did not make the connection to the vaccine because tinnitus was not disclosed as a side effect, and no questions about this side effect were raised in follow up surveys. Yesterday, while reading an article about someone, committing suicide, I saw a reference to tinnitus.  Only now do I see many reports online of this side effect.
Chills within moments after injection. Sore throat within one hour. Headache within three hours. Sinus congestion within six hours.
swollen; warm to touch; area was red; itching on injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PRURITUS (itching on injection site), VACCINATION SITE ERYTHEMA (area was red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to touch) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Cefzil).    On 07-Jan-2021 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching on injection site). On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (area was red). On 19-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to touch). At the time of the report, VACCINATION SITE PRURITUS (itching on injection site), VACCINATION SITE ERYTHEMA (area was red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to touch) outcome was unknown.        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 medications were reported.   The patient was using Benadryl cream as treatment for the events.
Myalgia, Fever, Fatigue, SOB w/exertion Narrative:
Moderate pain around injection site lasting 2 days. Episode of nausea 20-30 minutes after administration of shot.
Itching in the back and hands for a couple days. Symptoms improved after taking Benadryl.
Patient received Moderna 2nd dose (0.50mL) 1 week early (21 days). Patient made aware, asymptomatic. All questions and concerns addressed.
This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of injection site pruritus in a 33-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. On 27 October 2011 at 12:00 the subject received a dose of BOOSTRIX (unknown route, left arm) and experienced experienced vaccine exposure during pregnancy during the third trimester of her pregnancy. On 27 October 2011, less than one day after vaccination with BOOSTRIX, the subject experienced swelling injection site, injection site redness and injection site tenderness. On 31 October 2011, approximately 4 days after vaccination with BOOSTRIX, the subject experienced injection site pruritus. The gestational age at the time of the vaccination was not specified. Date of last menstrual period was not provided. Estimated date of delivery was 17 November 2011. At the time of reporting the events were unresolved and the pregnancy was ongoing.
prescribed paxlovid after vaccination; prescribed paxlovid after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 21Jul2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 19Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient did not have any Known allergies. Concomitant medication(s) included: ROSUVASTATIN, start date: 20Nov2012, stop date: 16May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "prescribed paxlovid after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.. Antiviral details product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 16May2022, Treatment stop date: 20May2022 Lot number: N/A, Indication: Treatment of COVID-19. Adverse event: 5days following completion of Paxlovid I started experiencing extreme dry and sore throat, cough, chest and nasal congestion, exhaustion, loss of taste, inability to speak without "tired" throat, very low voice, inability to speak loudly enough to be heard properly. Adverse events start date: 25May2022, Adverse event start time: 04:00 AM, If patient recovered: Not recovered, If treatment ae: Yes, Ae treatment: (1) Tylenol PM at night to sleep  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I experienced: fatigue for two days; intermittent nausea for about 12 hours; rapid heart rate beginning at about 6pm (4 hours post vaccine) until the next morning. My HR was about 100 BPM while at rest and trying to sleep; arm soreness for 48 hours.   I felt fine, back to normal by the beginning of the third day post-vaccine dose #2.
I was sick for four days with: fever, headache, body aches, sweating, nauseous, in so much pain and no energy I could barely move. Lastly, was clear odorless liquid coming out of my vagina.  The last symptom lasted for a full week.
Pt had been advised to stay in observation room for 30 mins following vaccination due to allergies.  Pt called into Health Dept call center 8/26/21 and reported that after 5 minutes in observation room, she had been coughing, and proceeded to leave observation room and leave building without alerting anyone that she needed assistance; she reportedly went to parking lot and vomited and collapsed (per pt report).  She drove home with her children (age 6, 6, and 11), reported not driving well, reported incomplete memory of events of evening after arriving home.  Reported that she later went to ER  where she was treated and later released.
This spontaneous report was received from a nurse referring to 10 unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.    From 24-JAN-2017 to 16-FEB-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis (dose, route, lot # and expiration date were not reported). It was stated that the vaccine was exposed to a temperature between > 46 Fahrenheit degrees but < 77 Fahrenheit degrees. The time frame was 149 hours. A data logger was used to log temperature. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Patient, a minor inadventently vaccinated with Moderna on 03/24/21 in community clinic. DOB incorrect - corrected is 2/24/2004. Pt. presented with Father  to receive second dose of Moderna vaccine.  RN Verified ID, ENA FDA explained, all questions answered, off label consent form signed by Father . Proper authority notified, Verified first appointment , and site managers are aware of situation.
This spontaneous report as received from a licensed practical nurse (vaccine coordinator) refers to a 12-month-old patient of unknown gender. No medical history or concurrent conditions were reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (lot #  L000456, an expire date 06-JAN-2017) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever, lethargy, extreme headache, nausea, weakness, crying, emotional, agitated.
Inappropriate route of vaccination; Swelling at injection site; This is a spontaneous report from a contactable consumer reporting for himself   A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 25Feb2021 at 15:00 PM,  on Left leg an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization .Relevant medical history included Type 2 diabetes and high blood pressure. Concomitant medications were not reported. On 25Feb2021 at 16:00 1 hour after vaccination the patient experienced swelling at injection site. At the time of the reporting the patient was recovering from the events.   Follow-up attempts completed. No further information expected.
Onset of hives about 4 hours after IZ's. Mom reports hives on head, body (Front and back) and under arm pits, but not on extremities. Advised by MD to given BENADRYL when triaged, but mom opted not give and says hives resolved on own. Little "Flushed" on 4/9, but no fever or other concerns. F/U phone call 4/10/14 all WNL, except little "bruise" at injection site.
Patient presented to the Emergency Room with acute onset of unilateral vision loss. Exam notable for absent pupillary reflex. Was transferred to an eye specialist. Dilated eye exam was suspicious for thrombosis of retinal artery.
5 weeks after the booster of J&J I have been really SOB, can?t get a good breathe and feels like someone is sitting on my chest. I took a Covid test it?s negative and don?t feel sick.
Patient received Pfizer booster at age 15 by nurse on duty. Patient reports having mildly sore arm day after administration of vaccine. No other adverse effects.
Itches so bad; red lump spot in the middle where the vaccine was given; red lump spot in the middle where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itches so bad), VACCINATION SITE INDURATION (red lump spot in the middle where the vaccine was given) and VACCINATION SITE ERYTHEMA (red lump spot in the middle where the vaccine was given) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itches so bad), VACCINATION SITE INDURATION (red lump spot in the middle where the vaccine was given) and VACCINATION SITE ERYTHEMA (red lump spot in the middle where the vaccine was given). At the time of the report, VACCINATION SITE PRURITUS (Itches so bad), VACCINATION SITE INDURATION (red lump spot in the middle where the vaccine was given) and VACCINATION SITE ERYTHEMA (red lump spot in the middle where the vaccine was given) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient does not take any concomitant medications.  Treatment was reported as none.
3.31.97 & 5.2.97 rec'vd 1st & 2nd hep b vac recomb in L & R deltoid respectively. After 2nd, pt developed severe arm pain inject site. 3rd on 10.6.97 in L deltoid -- severe & shoulder pain, gen. malaise, memory loss, chronic fatigue symps.
At 2:00 in the a.m. after getting the second COVID shot I awoke with very bad burning under my armpits, feeling unwell, and very fatigued.  The burning spread throughout my lymph system it seemed and lasted for about three days, and very slowly dissipated.  I was also fatigued and had slight headache for three days.  I did not take my temperature.  I noticed also that the lymph glands under both arms were very swollen for several days.  I WILL NEVER GET THIS SHOT AGAIN!!!!!!
HYPOTENSION 5/5/2021 CEREBROVASCULAR DISEASE  HYPOXIA 10/7/2021 CEREBROVASCULAR DISEASE  HYPOTENSION 5/5/2021 METABOLIC ENCEPHALOPATHY  HYPOXIA 10/7/2021 METABOLIC ENCEPHALOPATHY  HYPOTENSION 5/5/2021 ATYPICAL CHEST PAIN  HYPOXIA 10/7/2021 ATYPICAL CHEST PAIN
This is a spontaneous report from a contactable 75-year-old female consumer reporting for herself. A 75-year-old female patient received PREVNAR 13, via an unspecified route of administration on 26Jan2017 11:00 at 0.5 ml, single in left arm for routine immunisation.  The patient's concomitant medications were not reported.  The patient previously took influenza vaccine, pneumococcal vaccine.  The patient experienced shingles on her face and head and shingles affected her eye on 30Jan2017 with outcome of recovering. She also experienced nerve pain and numbness since unknown date with outcome of not recovered.  The patient underwent blood tests resulted good.  She has had both primary care and eye doctor visits.  She was seen first on 30Jan2017, then was seen again when her eye closed shut as it was all on the right side.  Her physician  prescribed acyclovir at 5 times a day for 7 days and prednisone. She also was prescribed gabapentin for the nerve pain, strength of 100mg.  She started taking 1 a day for 3 days, then 2 a day for 3 days, then 3 a day for 3 days. It helped, but she still had the pain and numbness.   Another doctor had said since caller's daughter was going through a breast biopsy that the stress the caller was experiencing may have triggered it.  She has never had a problem with stress before going through a divorce and other breast biopsies her daughter has had.  She attributed the events to the vaccine.
Patient received 2nd Moderna vaccine Thursday Jan 21st at 1610. Patient checked injection site and arm Friday Jan 22nd with no issues. On Sun Jan 24th, patient noticed redness of arm below injection site and warm to touch. Per patient, the area of redness was very large, achy to touch, and very itchy.
Got the vaccine and about 30 minutes later started having rapid heart rate and shortness of breath.  She was tired.  She called her doctor and told them about her reaction, and called and asked about the 2nd vaccine, and informed her not to take it or what to do.   She did take her evening heart medicine to try to reduce it, Metoprolol.  The reaction lasted about 6-8 hours.  It was doing it when she went to bed and when she woke up the next morning it was better.  The reaction has now totally resolved.
This spontaneous report was received from a consumer, concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot # K020215 expiration date: 15-MAY-2016) (dose, route and anatomical location of administration were not reported). On an unknown date, the patient experienced pain at the injection site. The outcome of the injection site pain was unknown. Additional information has been requested.
This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 05-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date of 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. The vials were placed in refrigerator on 6-Dec-2021. The vaccine was used past 30-day use by date. It was reported that patient took booster dose.
16 YEAR OLD PATIENT WAS INADVERTANLY GIVEN THE MODERNA VACCINE
Three days after the first shot I intermittently started seeing double. Brier 1 x episode lasted about 1/2hr. 2nd dose 1 month later same place also Moderna, started to see double more often late in the day. I thought I was tired. I got the booster while visiting at a pharmacy and the next day woke up seeing double. That lasted until Dec 26th when I woke up and everything was back to normal. I was evaluated for stroke, saw a neuropathologist, had MRI, CAT san and many lab tests all were negative. The Dr. does not know what was wrong and I am seeing a neurologist in Jan to rule out myasthenia gravis, although my blood work is neg for it. I was given prism glasses to wear, which helped. I am keeping them close.
Pt recvd MMR on 02JUL90; Eight days later pt devel maculopapular rash, fever & irritability;
mom states about 5 hrs p/vax began shaking & crying loudly; took to ER was given med for cramps & shaking; no elevated temp was given APAP p/vax given;
fatigue, malaise, abd discomfort;no vomiting or diarrhea;no fever;tx w/supportive care only;