chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt yuck/like how she felt when she gets her flu shot every year/didn't have this much of bad feelings; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt yuck/like how she felt when she gets her flu shot every year/didn't have this much of bad feelings) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Previously administered products included for Flu: flu shot (she gets her flu shot every year.). Concurrent medical conditions included Hypertension (She takes her daily dose for blood pressure and has been taking that for a long time.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and GABAPENTIN (NEURONTIN) for an unknown indication.    On 25-Jan-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 FEELING ABNORMAL (felt yuck/like how she felt when she gets her flu shot every year/didn't have this much of bad feelings). At the time of the report, FEELING ABNORMAL (felt yuck/like how she felt when she gets her flu shot every year/didn't have this much of bad feelings) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she had been taking blood pressure and female hormone medicine which were considered as concomitant drugs.  No treatment medication was reported by patient. Patient reported she was not immunocompromised.   This case was linked to MOD-2021-306735, MOD-2021-306741 (Patient Link).
6/25/2021 Produced 32 oz of breastmilk, received vaccine at 10:00 that am.   6/28/2021 Mild production had decreased to 11 oz and by 7/2/2021 decreased to 1-2 oz./day. 7/9/2021 Had MD appt, and MD suggested that significant decrease in milk supply after vaccine was a concern and requested that it be reported.
After my second dose vaccine,  experienced arm soreness but no pain.  I also realized I had been taking a cortisone medication before my vaccine. I had trouble remembering things as well. I have been out of work for two months.  I do not know if maybe the cortisone medication I took counter-reacted with the vaccine.  I will be returning to work in few days.
c/o feeling bad, red patch 2.5 inches below site and small reddened area at site. No fever, site warm but not hot, fatigue.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. This report is regarding a 19-24 year old Male patient who was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (ORAL) batch: 34600017, on 26-Mar-2012. From 27-Mar-2012 to 06-Apr-2012, the patient was administered SULFAMETHOXAZOLE W/TRIMETHOPRIM 800/160 mg per tablet for a urinary tract infection. On 28-Mar-2012, the patient experienced OTHER ANAPHYLACTIC SHOCK, NEC and was hospitalized the same day. The patient was administered intravenous medications as treatment in the hospital. Lab tests: 27-Mar-2012, WBC: 14.5 mmol/L; 27-Mar-2012, Neutrophils: 85.8%; 27-Mar-2012, Absolute neutrophil count: 12.4 mmol/L; 27-Mar-2012, Monocytes: 0.9 mmol/L; 27-Mar-2012, Creatinine kinase: 378 IU/L; 27-Mar-2012, C-reactive protein: 4.30 mg/dL; 29-Mar-2012, C-reactive protein: 5.30 mg/dL; 29-Mar-2012, Neutrophils: 84.0%; 29-Mar-2012, Absolute neutrophil count: 8.9 mmol/L; 29-Mar-2012, ESR: 18 mm/hr. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: Unknown. Action taken with suspect drugs: ADENOVIRUS VACCINE - Not applicable; SULFAMETHOXAZOLE W/TRIMETHOPRIM - Dosage maintained. The patient's medical history was not reported. The patient's concomitant medication included INFLUENZA VACCINE (since 26-Mar-2012); DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS (since 26-Mar-2012); MENINGOCOCCAL POLYSACCHARIDE (since 26-Mar-2012); HEPATITIS A VACCINE (since 26-Mar-2012); POLIOMYELITIS VACCINE INACTIVATED (since 26-Mar-2012). The patient's past medication were unspecified. This case was considered serious based on the following criteria: (Hospitalization Required, Other Serious (Important Medical Events)). The Medical Monitor Assessment of Events: Causality of event OTHER ANAPHYLACTIC SHOCK, NEC in relation to Adenovirus is "No Reasonable Possibility". Event in relation to SULFAMETHOXAZOLE W/TRIMETHOPRIM is Probable. "Severity not assessed. Likely reaction to Sulfamethoxazole or Trimethoprim." ICD-9 code is confirmed.
Two days subsequent to receiving one dose of varicella virus vaccine live the pt developed a headache and fever of 101F.  The next day the pt developed a sore throat. Six days post vax the pt developed a pin prick rash which lasted 5 days. Medical attention was sought and the pt recovered.
Chills; Shoulder pain; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), ARTHRALGIA (Shoulder pain) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021 at 8:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (Chills), ARTHRALGIA (Shoulder pain) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) on 25-Jan-2021 for Chills, Shoulder pain and Myalgia, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), ARTHRALGIA (Shoulder pain) and MYALGIA (Body aches) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.
Site reaction red, tender to touch, burning sensation, 3x3 margins, hard, warm to touch in right arm.
NEUROPATHY; LONG TERM SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. Initial information was processed along with the additional information received on 01-DEC-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient had long term side effects with JNJ Covid-19 vaccine. On an unspecified date, the patient experienced neuropathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neuropathy and long term side effects was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221206568- Neuropathy- The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
3/28/21 was a Moderna vaccine second dose clinic day. There was one cancellation during the day, so to avoid wasting a vaccine a patient that was scheduled for an appointment on 3/29/21 was called to come in one day early to receive the second dose. The pt was willing and able to come in and so was given the Moderna vaccine. Without realizing that he was to recieve the Pfizer vaccine before the administration.
Client pulled her arm away on 1st attempt for vaccination, no vaccine was injected. Dose discarded, On 2nd successful attempt,  vaccine administered on same side (parent insisted on getting the injection on same side), different location (Left deltoid) with mom's assistance in restraining the client.
PATIENT STARTED FEELING TIRED AND ACHY ON THE DAY FOLLOWING THE VACCINATION (9/23). THIS RESOLVED THE NEXT DAY (9/24) BUT HER CHEEKS BECAME RED AND SWOLLEN. THIS HAS NOT RESOLVED AS OF 15:20 ON 9/25 AND ADDITIONALLY, SHE HAS BROKEN OUT IN A RASH.
I received in October of '19 still hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced pain after vaccination. For tolerance to 2nd dose, refer case US2020AMR021465.
Pt presented to clinic on 06/15/2021 c/o chest pain, Ha, sore throat starting two days after receiving second dose Pfizer COVID19 vaccine. Chest Xray normal. Labs: Sed Rate, Troponin, C-Ractive Protein, CBC, CMP. EKG, two leads with elevated T. Awaiting Troponin.
This spontaneous report was received from a health professional refers to a 12 month old female patient. No pertinent medical history or any known allergies were reported. On 17-MAR-2015 the patient was inadvertently vaccinated with PROQUAD (Merck), IPV (unspecified) and M-M-R II. Patient's parent stated that the patient was fussy before nap time. Patient sought medical attention and nurse was called. No lab diagnostic studies were performed. No treatment was given for the adverse events. Outcome of the events were unknown. No product quality complaint (PQC) was involved. Causality assessment was not provided. Additional information has been requested.
severe dizziness, lethargy, extreme nausea and difficulty seeing. Reported about 3 days after vaccination.  WEnt to see Dr. and got ondansetron. Followed up 10/23 , pt seems to be doing better per wife.
Says no lot number on his vaccine card.  Pain in left arm  where shot administered for months. Just stopped within last 2 weeks.  Around the same time felt dizzy and tired. Could have been his diabetes.
liver lymphoma; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHOMA (medically significant), outcome "unknown", described as "liver lymphoma".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous retrospective pregnancy report as received from a registered nurse refers to a 26 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient had no drug reactions/allergies. On 20-JUL-2018, the patient was vaccinated with GARDASIL 9 (Strength, dose and anatomical location were not reported) of lot # N022952 with an expiry date of 14-JUN-2020, intramuscularly for prophylaxis. It was mentioned that the pregnant patient was inadvertently administered with the vaccine. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not known. It was reported that it could not be further clarified if the patient terminated her pregnancy prior to or after the appointment. It was unknown if treatment was provided to the patient. It was unknown if lab diagnostics/studies were performed. The patient did not seek any medical attention. There was no product quality complaint involved. The outcome of the event of abortion was considered to be recovered on an unknown date in 2018. The causality assessment was not provided. Upon internal review, the event of abortion was determined to be medically significant.
Received 1st dose approx 6 weeks gestation.  Fetal development stopped later same week.  Missed miscarriage discovered at 8 week 3 days.  Complete miscarriage at 8 weeks 5 days.
My arm usually gets sore within a few hours of getting a flu shot, but after this one, the left side of my face from my lower cheek to my eyebrow became slightly numb at the same time. Within five days, slight numbness/tingling began to gradually spread to other parts of my body, particularly the left arm, left leg from the knee down, and eventually forehead, around my lips/mouth/eye sockets, and right forearm/hand, right ankle/top of foot, along with sporadic feelings in other places. Also experienced some lightheadness/vision feeling slightly off first few weeks of October.
Advrs effect of pertuss vaccine inc combin w pertuss, subs on 2018-03-16.
2 days after shot, began with erratic muscle pain, after tingling chest, shoulder, arms and thighs. Initially treated with Advil x 2 weeks and partial relief of symptoms, got worse and visits to ER x 2 (times) within next week. Then my PCP and finally rheumatologist. All testing has been negative so far.
pain; tenderness at the injection site; general fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain), VACCINATION SITE PAIN (tenderness at the injection site) and FATIGUE (general fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017S21A, 036B21A and 007B21A) for COVID-19 vaccination.     The patient has not ever tested or diagnosed with COVID.  Medical history relating to mentioned event and both acute and chronic illnesses at the time of vaccination were none.  Patient did not take other vaccines within 1 month prior to moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Ceftin).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain), VACCINATION SITE PAIN (tenderness at the injection site) and FATIGUE (general fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pain), VACCINATION SITE PAIN (tenderness at the injection site) and FATIGUE (general fatigue) had resolved.            No concomitant medication was provided.  patient did not seek medical care  It was reported that the patient experienced similar event in past ( last vaccination).   It was reported that the symptoms were improved.   This case was linked to MOD-2022-643547 (Patient Link).
PARALYSIS; This spontaneous report received from a consumer via social media via a company representative concerned 4 patients of unspecified age, sex, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced paralysis. The reporter stated that "I personally know of 7 cases of paralysis of which one is my neighbor's daughter in law and know of 2 kids paralyzed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralysis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220548194 and 20220547591.; Sender's Comments: V0-20220548149-covid-19 vaccine ad26.cov2.s-Paralysis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Headache, Arthralgia, UrticariaPruritus, Diarrhea, Fatigue; pain, discomfort, redness, swelling, mild itch, and warmth at inj site Narrative:  Other Relevant History:
MTR called clinic 1155AM reported that pt was up all noc crying & unable to move the arm had been given the DTP; reported swelling is the size of an orange & redness; denies any breathing problems; giving APAP;
Within 10 of receiving vaccine, tingling, numbness down left arm to fingertips. Waited 30 minutes, then returned to work. Within 45 minutes of return to work, tingling throughout my body. felt nauseous. Supervisor checked BP 144/88, P 98, temp 96.8. Medical Director advised go to ER. By the time I arrived at ER, cold feel my throat closing, tongue felt thick,swollen. Not clear about all that occured in ER. I recall a shot and pill. Rested for a couple hours. Felt better to go home.
Erroneously administered. approx. 7-8 weeks gestation, outcome unclear.
Approx 24 hours after my second COVID vaccination, I can only describe it as the skin on my entire body became intensely painfully, to the point where it made me cry until I passed out from exhaustion. This went on for about 24 hours. My arm around the vaccine site was also burning hot and extremely sensitive. On 01/12/2022, four days after the vaccine, I woke up with horrible hives that started around the vaccine site on my left arm, and eventually covered both arms and both legs. The hives were swollen and very itchy. I self- treated with benedryl tablets (oral) and hydrocortisone cream (topical), because I do not have medical insurance or money for a doctor. The hives lasted approximately one week.
Third day after booster  shot was administered had severe migraine headache for 5 consecutive days with last 2 days eyes watering and wearing sock tied across forehead to attempt to reduce pain. Reported earlier to VAERS FND experience after receiving second Moderna dose 749230 Temporary VAERS E-report#.
3" Injection Site Rash; Injection site itchiness; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (3" Injection Site Rash), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE PAIN (Injection site pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-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 VACCINATION SITE RASH (3" Injection Site Rash), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE RASH (3" Injection Site Rash), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported
Convulsive syncope. After vaccine was given patient became pallor in color, diaphoretic, face twisted, hands clenched, urinated on herself and then passed out on the examination table.  LOC for less than 1 minute.  Was able to respond to questions.  Vital signs stable. Cold packs placed on her forehead and back of neck.  Child was AAOX3 at time of discharge from office with no residual affects.
Developed pain at the injection site; Small rash at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain and injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient received the first dose of the shingrix vaccine and developed pain at the injection site accompanied with a small rash at the injection site. Those reactions were resolved.  The patient could not find Healthcare professional's contact information during call, it was not obtained for that reason. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2021AMR032873. Discrepancy: Patient's DOB was not captured even though it was not reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR032873:Same reporter.
No known adverse effects; An adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant and refers to an adult patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported.  On 29-APR-2019, the patient received a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) (incorrect dose administered) intramuscularly for prophylaxis (strength, dose number, anatomical site of injection, lot number and expiration date were not reported). No adverse effects or product quality complaints were reported.
On 05/14/2003, patient developed fever of 101 degrees; Temperature of 104 degrees on 05/16/2003, decreased appetite and irritable.  Infant was brought to office on 05/16/2003 per evaluation.  Fever 103 degrees on 05/17/2003; no fever 05/18/2003.
Information was received on 14-JUL-2017 from a medical assistant regarding an unspecified patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient may have received an improperly stored dose of one of the following vaccines, but she is not sure which of the vaccines the unspecified patient received. The names of the vaccines involved included GARDASIL 9 (lot # M028323, exp 26-SEP-2018); PEDVAXHIB (lot # N000236, exp 24-OCT-2019); PNEUMOVAX 23 (lot # N005096, exp 22-OCT-2018); RECOMBIVAX HB (lot # M029233, exp 09-AUG-2018); ROTATEQ (lot # M016918, exp 15-FEB-2018); or VAQTA (lot # M021124, exp 02-FEB-2018) (dose, route, and site of administration not reported). Temperature: In the range (9 degrees Celsius to 25 degrees Celsius). Time frame: 5 hours and 23 minutes. Previous temperature excursion? No. Was call because of a data logger? (Y/N). No adverse effect reported. No additional information was provided. Additional information has been requested.