chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The caller said experienced "the normal soreness" after the injection; she received the intramuscular injection in her "L side buttocks; This spontaneous report was received from a healthcare student who was also a consumer referring to herself, a currently 24-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unspecified date (also reported as "approximately 1-2 years ago"), the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (anatomical location: left side buttocks outer area; strength, lot#, and expiration date were not reported) via intramuscular administration for prophylaxis (product administered at inappropriate site).  On an unspecified date after the injection, the patient experienced "the normal soreness" (pain). The outcome of pain was not reported. The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and pain was unknown.
Parents stated that on 9/7/06 that they did not want may more pneumococcal shots because child had gotten very ill after first 2 injections.  After first injection within 12 hjours infant had tmep of 103-104 and was very lethargic.  After second injection temp didn't go up as quickly but went to 103-104 again and child became lethargic again.  The first time it lasted about a week.  The second time 3 to 4 days.  On the date of the sencond set of immunizations the parents told me he had had a high fever and that he had been seen in the E.R.  Dr. told them his illness had nothing to do with the immunizations.  I went ahead & gave the second prevnar on 5/2/06.  That is the only vaccine he received that day.  The parents did not notify me of any problem after that immunization until 9/7/06 when they brought him in for his MMR & Varicella vaccines and said they didn't want anymore pneumococcal vaccine.  Infant's grandmother is an R.N. and had observed behavior following both sets of immunizations and had advised them not to give him any more pneumococcal vaccine.  I do not believe they took him to Dr. following second dose.
headache midday Saturday 17Apr2021; "couldn't get back to sleep"; "flu like symptoms."; "Could feel aches coming on"; temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5."; "stayed in bed all day."; "waking up at 3am with a headache"; "Could feel chills coming on"; This spontaneous case was reported by a consumer and describes the occurrence of MIDDLE INSOMNIA ("couldn't get back to sleep"), INFLUENZA LIKE ILLNESS ("flu like symptoms."), PAIN ("Could feel aches coming on"), BODY TEMPERATURE INCREASED (temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5.") and BEDRIDDEN ("stayed in bed all day.") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced MIDDLE INSOMNIA ("couldn't get back to sleep"), INFLUENZA LIKE ILLNESS ("flu like symptoms."), PAIN ("Could feel aches coming on"), BODY TEMPERATURE INCREASED (temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5."), BEDRIDDEN ("stayed in bed all day."), HEADACHE ("waking up at 3am with a headache") and CHILLS ("Could feel chills coming on"). On 17-Apr-2021, the patient experienced HEADACHE (headache midday Saturday 17Apr2021). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN USA) at an unspecified dose and frequency. On 15-Apr-2021, MIDDLE INSOMNIA ("couldn't get back to sleep"), INFLUENZA LIKE ILLNESS ("flu like symptoms."), PAIN ("Could feel aches coming on"), BODY TEMPERATURE INCREASED (temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5."), BEDRIDDEN ("stayed in bed all day."), HEADACHE ("waking up at 3am with a headache") and CHILLS ("Could feel chills coming on") had resolved. On 18-Apr-2021, HEADACHE (headache midday Saturday 17Apr2021) had resolved.            There is no relevant treatment and concomitant medication provided.
Pt. stated her arm started to hurt around 6pm.  She thought nothing of it.  Wed AM her arm was red & swollen.  Pt was examined on 3-13-08 - 3pm.  Her Lt upper arm was red with severe swelling.  Area very warm, tender to touch.  Pt started on steroids therapy x several days.
Booster dose 4 adminstered; Booster dose 4 adminstered; Flat on his back; sleepy; tiredness; woozy; he has pain in his shoulder around the site of injection/ pain in arm and shoulder around site of injection; he has pain in his shoulder around the site of injection/ pain in arm and shoulder around site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2, on the 2nd and both boosters he is flat on his back and sleepy with no pain), for COVID-19 immunization, reaction(s): "on the 2nd and both boosters he is flat on his back and sleepy with no pain", "on the 2nd and both boosters he is flat on his back and sleepy with no pain"; Bnt162b2 (DOSE: 3, on the 2nd and both boosters he is flat on his back and sleepy with no pain), for COVID-19 immunization, reaction(s): "on the 2nd and both boosters he is flat on his back and sleepy with no pain"; Bnt162b2 (DOSE:3, on the 2nd and both boosters he is flat on his back and sleepy with no pain), for COVID-19 immunization, reaction(s): "on the 2nd and both boosters he is flat on his back and sleepy with no pain". The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "Booster dose 4 adminstered"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "not recovered", described as "Flat on his back"; SOMNOLENCE (non-serious), outcome "not recovered", described as "sleepy"; FATIGUE (non-serious), outcome "not recovered", described as "tiredness"; DIZZINESS (non-serious), outcome "not recovered", described as "woozy"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "he has pain in his shoulder around the site of injection/ pain in arm and shoulder around site of injection".  Additional information: The patient received the 2nd booster last night at 5 pm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pregnant; sore arm; body aches; chills; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and CHILLS (chills) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since January 2018. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], FAMOTIDINE (PEPCID) and PARACETAMOL (TYLENOL) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Jun-2020 and the estimated date of delivery was 19-Mar-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and CHILLS (chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 15-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 16-Jan-2021, PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, Pregnancy test: positive Positive.     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 treatment information was provided.
NASAL CONGESTION, COUGH, FATIGUED, WEAK, NO APPETITE, DEATH Narrative: 02/02-VACCINE GIVEN 02/22-pt not feeling well, dry cough, nasal congestion, weakness, loss of appetite, fatigued and weak; pt was exposed to "non-covid" virus through caregiver 02/23-caregiver called telecare to report pt with 3 days fatigue, admitted to hospital 02/25-alerted that pt passed away; they thought he might have been having a mild MI and later placed him on a ventilator and was told he had Pneumonia. He passed away on 2/24/21 at 1030AM confirmed by Daughter; no record of autopsy or death note no documentation of prior covid infection, acute adr to covid vaccine, teste negative to covid on 12/28 (exposed to daughter who have covid) hospitalized 09/23-09/29/2020 due to vomiting and diarrhea, found to have elevated troponins and abnormal kidney function, discharged home; was result of working in the sun and getting dehydrated not likely that covid vaccine contributed to patient's death, but death d/t advanced age and potential exposure to non-COVID virus shortly prior to death
Patient reported nausea and hot sensations within minutes following his immunizations - Pallor in color for several minutes.
This spontaneous report as received from a 66 year old female consumer with no pertinent medical history and no drug reaction or allergies. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot# and route not reported) on 09-JUL-2012. No other co-suspects were reported. Concomitant medications included metoprolol and XANAX. Within hours of getting the shot, on 09-JUL-2012 the patient experienced swelling in the joint of shoulder in the right arm. She had no redness at the injection site but had been unable to move her right arm for the last 3 days. She said her "arm was locked up." She had talked to her physician twice and was told to take some ibuprofen and soak her arm in magnesium sulfate and apply ice to the area. No lab diagnostics studies were performed. At the time of this report the patient had not recovered. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT, UNSPECIFIED VEIN
Nausea; Loss of appetite; Lethargic; Weak; Severe chills; Muscle aches; Sweats; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 20Aug2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney and pancreas transplant on 10Jan2007, allergy to lactose and COVID-19. Prior to the vaccination the patient was diagnosed with COVID-19. The patient received unspecified concomitant medications in two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 21Aug2021 at 16:00, the evening after the injection, the patient experienced severe chills, muscle aches, sweats, vomiting, and diarrhea. On 08Sep2021, the day of the report, the patient experienced muscle ache, nausea, loss of appetite, weak and lethargic. The events did not result in a doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe chills, muscle aches, sweats, vomiting, diarrhea, nausea, loss of appetite, weak and lethargic was resolved with sequelae on an unknown date in 2021.
Pt recvd sseries of 3 Engerix-B vax on 0,1,6 mo schedule.  Pt devel antibody titers 2-3 mo p/ last dose but subsequent tests antibody negative.
Patient received Moderna COVID vaccine on 2/10/21 and 3/11/21. On 11/12/21, patient admitted to our inpatient facility for acute hypoxemic respiratory failure due to COVID-19. Patient discharged home on 11/15/21 without any home oxygen needed.
cold; weak; flu-like symptoms; body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (body aches) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (body aches). At the time of the report, NASOPHARYNGITIS (cold), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (body aches) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (body aches). At the time of the report, NASOPHARYNGITIS (cold), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), CLONAZEPAM (KLONOPIN) for Seizures, CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) 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.   Treatment information was not provided.   This case was linked to MOD-2021-217052 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up received on 21-JUN-2021. Consent for FU denied.
Patient developed a fever of 103 and swollen, red, cracked lips that developed an infection. The patient recovered completely.
Rashes, itching and swelling welks on thighs and arms. Rashes covered most of the front of my thigh and caused some muscles soreness and pain
Day after I got the shot, I went into a huge exhaustion. I was falling asleep at work at my desk, I would have to stop on my drive home. I couldn't mow the lawn. I could work for 5 to 10 minutes and walking upstairs I would be exhausted. This went on and I finally went to doctors in August. All my tests for my heart and lungs came back normal.
Fever, chills, myalgia, rash and dry mouth, post vax. Temperature was elevated to 103F-104F X 4 days, beginning 1 day, post vax.
Told her no more treatment for Leukemia; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Told her no more treatment for Leukemia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Told her no more treatment for Leukemia). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Told her no more treatment for Leukemia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Approximately 5 minutes after the vaccine, I broke out in cold sweats all over my body. Subsided about 5 mins later.
3 weeks after third shot (booster)   Continuing ever since the first day Severe rash and hives all over body Painful, red skin crawling, all over body Hives are growing progressively larger after each flare-up Comes and goes Dry eyes Headache Nausea
This spontaneous case, initially received on 16-Feb-2017, was reported by a health professional and concerns a(n) unk patient. Weight: not provided; Height: not provided. The patient had no other known allergies. Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) from 2015 to 2015. Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 2015, the patient experienced an anaphylactic reaction (Medically Significant, outcome: Not Reported).
Reconstituted with an MMR vaccine diluent; Reconstituted with an MMR vaccine diluent and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 6-month-old male patient who received Hib (Hiberix) (batch number D5B5G, expiry date 24-FEB-2024) for prophylaxis.   On 24-MAR-2023, the patient received Hiberix. On 24-MAR-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with an MMR vaccine diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with an MMR vaccine diluent and administered to patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAY-2023 The reporter reported that the patient received Hiberix vaccine which was reconstituted with an MMR vaccine diluent. The vaccine administration facility was the same as primary reporter. At the time of reporting no more information was provided about the diluent used in reconstitution of vaccine. The reporter did consent to follow up via email. The reporter gave Hiberix vaccine with an MMR vaccine diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered This case had been linked with US2023063928 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023063928:Same reporter/Other patient
received first dose of moderna vaccine; approximately 3 mins later feet became numb. Hands became numb. felt flushed. progressed into vago-vagal reaction; was instructed to lie down in bed provided in clinic. patient felt better after lying for 40 minutes and left clinic. Proceeded to work from home the rest of the day. Approxmiately two hours later felt throat tightening/swelling. resolved with benedryl..   Patient has had previous vaso-vagal reaction to all three doses of HPV vaccine series.
leg and foot cramps; skin itching all over/itchy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (leg and foot cramps) and PRURITUS (skin itching all over/itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for Asthma.    Concurrent medical conditions included Asthma.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) 1 day. On an unknown date, the patient experienced MUSCLE SPASMS (leg and foot cramps) and PRURITUS (skin itching all over/itchy). At the time of the report, MUSCLE SPASMS (leg and foot cramps) and PRURITUS (skin itching all over/itchy) was resolving.            Concomitant products were not provided. Treatment medication were not reported. Consumer reports leg cramps and foot cramps, skin itching all over after starting Dupixent. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.