chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ringing and pulsing in left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 14:45 (Lot number: ER8727) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "ringing and pulsing in left ear". The event "ringing and pulsing in left ear" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional Information: Patient did not receive other vaccine in four week. Patient took over the counter meds as treatment. Patient was not tested for Covid post vaccination. There are no known allergies or other medical history. Patient reported that after first dose, ringing and pulsing in left ear. After second dose, it got worse, hearing loss, muffled hearing and echoing in ear.   No follow-up attempts are possible. No further information is expected.
Inappropriate Schedule of Vaccine; Itching around injection site; Swelling aroun injection site; Hot to touch around injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, couple of hours after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site itching, injection site swelling, injection site warmth and incomplete course of vaccination. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site warmth were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site itching, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Caller reports receiving 1st dose Shingrix vaccine presumably in her left arm a little over 6 months ago and till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. A few hours following vaccination caller reports a little itching, swelling, and hot to touch around the injection site for approximately 24 to 48 hours. The reporter consented to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Menstrual period started a week early) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A or 037B2HA) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-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 POLYMENORRHOEA (Menstrual period started a week early). At the time of the report, POLYMENORRHOEA (Menstrual period started a week early) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.This case was linked to MOD-2021-114277 (Patient Link).
DVT in groin of right leg and DVT behind the left knee; swelling in the back of the knee; swelling in the groin; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (DVT in groin of right leg and DVT behind the left knee) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included DVT (because of chemotherapy but it was under control).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2012, the patient experienced SWELLING (swelling in the groin). In October 2021, the patient experienced DEEP VEIN THROMBOSIS (DVT in groin of right leg and DVT behind the left knee) (seriousness criterion medically significant) and JOINT SWELLING (swelling in the back of the knee). At the time of the report, DEEP VEIN THROMBOSIS (DVT in groin of right leg and DVT behind the left knee), SWELLING (swelling in the groin) and JOINT SWELLING (swelling in the back of the knee) outcome was unknown.     No concomitant medication details were provided.  It was reported that patient was on blood thinners for at least 7 years (Feb-2014).  Treatment included: Doubled blood thinners for two weeks and was given something for pain.  Company Comment - This case concerns a 76-year-old female patient with relevant medical history of DVT at least 7 years ago because of chemotherapy, who experienced the unexpected, serious event deep vein thrombosis (AESI) and non-serious unexpected events of swelling and joint swelling. The events occurred on an unknown date approximately 9 months after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events occurred after the second dose. The relevant medical history of DVT at least 7 years ago because of chemotherapy remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 76-year-old female patient with relevant medical history of DVT at least 7 years ago because of chemotherapy, who experienced the unexpected, serious event deep vein thrombosis (AESI) and non-serious unexpected events of swelling and joint swelling. The events occurred on an unknown date approximately 9 months after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events occurred after the second dose. The relevant medical history of DVT at least 7 years ago because of chemotherapy remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Pt reported feeling "super achy" Fri evening after shot through Sun afternoon. Arm still sore Mon, warm, a little swollen in area of shot. No fever.
Developed chest pain on 6/23 x 1 day, worse lying down/breathing in, relieved by being upright. Episodic in nature. no interventions done. Seen in primary care clinic on 6/24 - ECG should findings c/w pericarditis, so referred to cardiology for evaluation. Normal ECHO without pericardial effusion, good function. Labs notable for HS troponin of 3378 pg/mL. CRP and ESR mildly eleated (17.8 and 20 respectively). BNP normal. CBC w differential all WNL for age. COVID IgG negative.  Started on ibuprofen TID with close clinical follow-up planned.  no associated fever/chills/URI sx/GI sx/rash.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated subcutaneously with a dose of PNEUMOVAX23 (dose, frequency and lot # not reported) into the "back of the arm" not into the deltoid muscle. No adverse effects reported. Additional information has been requested.
Pt stated she felt dizzy less than a minute of when the vaccine (HPV #2) was administered. Pt also c/o having a stomach ache and feeling extremely hot and sweaty. Vitals were taken and were all normal BP: 93/60 P: 72.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer Inc.) concerned a 37 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa antibiotics allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 11-SEP-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 36 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-JUL-2022, the patient experienced confirmed covid-19 infection and had confirmed clinical vaccination failure.  The patient was treated with non company co-suspect Paxlovid (form of admin and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 03-JUL-2022 to 08-JUL-2022 for treatment of COVID-19.  On 13-JUL-2022, at 09:30, the patient had rebound covid-19 with sore throat and on 13-JUL-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000242966.; Sender's Comments: V0: 20220737095-Covid-19 vaccine ad26.cov2.s -Confirmed Clinical Vaccination Failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
48 yo male admitted for PNA and received the pnavax on 3/26. It was noted on 3/28 am that pt had developed a large painful injection site reaction that measured approx 8 inches in diameter per MD. Pnavax was manufactured by Merck, lot # 13124, exp 2/24/11. Pain managed with APAP, Ibuprofen, and morphine as well as cold compresses. No other s/sx of allergic reaction noted.
I have experienced on-and-off Pulsatile Tinnitus in right ear since the evening of 3/17/24.  I haven't seen my doctor yet about it... It's just been annoying.
This case was reported by a healthcare professional to a sales representative and described the occurrence of the redness and swelling at the injection site in a 4-year old subject (unknown gender) who receive diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On a unspecified date in either March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). The injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The outcome of the events was not reported. The nurse considered the events to be probably be related to vaccination with Infanrix.
Approximately 7 hours after vaccination, suffered an almost immediate nausea, weakness and dizziness which lead me to pass out for several minutes; these symptoms passed within 24 hours.   Had pain in the right lower jaw below a dental implant and pain below the hip in the right ischium (in the hip with an artificial hip replacement).  The jaw pain disappeared in 2 weeks, and the hip pain still evident after 3 weeks.  X-ray of right hip revealed no abnormalities.
patient was admitted on 7/22/2022 to the LTACH with covid pneumonia on 7/22/2022, tested positive for COVID 19 on 7/19/2022, 7/24/2022 pt was on 4L NC for o2 needs, during toileting patient began to show a decrease in oxygen levels and Heart rate, and became unresponsive. code blue initiated and patient expired.
A few hours after 12 diaphoresis X 15 took motrin.  This a.m. awoke with fatique, lethergy, muscle aches - moderate scale
This spontaneous report was received from a nurse practitioner and refers to a multiple unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB lot L042257 with an expiration date 17-AUG-2018, lot# M010440 with an expiration date 09-DEC-2018 for prophylaxis (doses, route of administration were not reported). No adverse effects were reported. Administered doses of LIQUID PEDVAXHIB experienced the the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 4 days. There was no previous temperature excursion. A digital data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004377: US-009507513-1706USA004376: US-009507513-1706USA002585: US-009507513-1706USA004379:
Donor states she was in the bathtub at home, when she began feeling chills and joint pain approximately 9/4/21 around 9:30pm. Donor got out of the bathtub and put on her heavy winter robe to try and warm herself. She then took 800mg of ibuprofen every 4 hours to help relieve her symptoms. A few hours later she developed a low grade fever. Symptoms subsided approximately 36 hours after onset.
Gave vaccine to 17 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave vaccine to 17 year old patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C27C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave vaccine to 17 year old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave vaccine to 17 year old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Non-significant Follow up Appended
injection site pain; arm soreness; headaches; dizziness; nausea; diarrheas; swelling; vomits; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unknown age and  unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 25May2021, as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 04May2021, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The clinical course was reported as follows: on an unknown date in May2021, the patient experienced injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swelling and vomits. The clinical outcome of the event injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swelling and vomits was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected
After receiving the 2nd shot of the Moderna Covid19 vaccine, I did not start my menstrual cycle on time. I have had a normal menstrual cycle for the past 19 years with no abnormalities. My menstrual cycle was supposed to start on April 14, but it did not start, and I had severe cramping and pain, bloating, and diarrhea for 14 days after April 14 when it should have started. During these two weeks I also gained 8 pounds, which is unusual for me. My menstrual cycle started 14 days late on April 28, and I continued to have severe cramping and also experienced heavy bleeding which is abnormal for me. My mentrual cycle is normally light and I don't usually have any cramps or pain.
inverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (inverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (inverse reaction). At the time of the report, VACCINATION COMPLICATION (inverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information provided. No treatment information provided.
0.5ml H1N1 vaccine was administered to a 12 month old instead of 0.25ml
it felt like a really bad flu; feeling icky and chilly and cold and hot; sweating; Feeling cold and then hot; high blood pressure/Blood pressure was crazy; nausea; dizziness; chills; she woke up so sick.; Headache; Aches; sore arm/Soreness of arm; This is a spontaneous report from a contactable consumer (patient herself).  A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534, Expiry date: Unknown) via an unspecified route of administration in Left arm on 25Mar2021 at the age of 67-years-old as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior Vaccinations within 4 weeks were none. Adverse events following prior vaccinations were none. Family medical history relevant to adverse events were none. Relevant tests were none. On 25Mar2021, the patient experienced soreness of her arm, on 28Mar2021, experienced blood pressure was crazy, nauseous, dizziness, headache, aches, feeling cold and then hot, she woke up so sick and chills, on an unspecified date experienced it felt like a really bad flu, feeling icky and chilly and cold and hot and sweating. Caller reported that yesterday, 28Mar2021, her blood pressure went way high.  Caller reported that yesterday, 28Mar2021, she tried to get up to go to the bathroom and was dizzy and nauseous. Caller reported that her blood pressure this morning, 29Mar2021 her blood pressure was still elevated. Caller reported that she got dizzy and nauseous again today, 29Mar2021, but that her blood pressure was ok when a second reading was taken. Caller reported that yesterday her headache was extreme and felt like her brain was going to blow off. Caller reported that one minute she would be feeling cold and the next minute she would be sweating. She reported that the day before on 28Mar2021, her blood pressure was crazy, she was nauseous, dizzy, and she thought her head was going to blow off. She reported that she stayed in bed and took aspirin the previous day on 28Mar2021. Caller reported that when she woke up this morning, 29Mar2021, she thought her headache was gone.  Caller reported that she got up to go to yoga and thought she couldn't even get in the car to drive. The patient underwent lab tests and procedures which included Blood pressure: 172/106 on 28Mar2021 and 154/92 on 29Mar2021. The outcome of event, Soreness of arm was recovered on 27Mar2021 and for high blood pressure/Blood pressure was crazy, chills, sick, feeling icky and chilly and cold and hot, sweating was unknown and for other events was recovering.  Batch/lot number was obtained. Further information has been requested.
Pain at injection site, knot at injection site, muscle and joint pain, slight fever, no apetite, no strength, fatigue.
Started with muscle aches and fatigue 5-6 hours after injection. Fever and chills started 10-12 hours after and continued for 36 hours. Experienced headaches and nausea the morning after as well.
instant headache; dizziness; fatigue; chills; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 65-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number and expiration date were unknown), dose 2 via an unspecified route of administration on 06Apr2021 as 2nd DOSE, SINGLE for covid-19 immunization. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number and expiration date were unspecified), dose 1 via an unspecified route of administration for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Apr2021, the patient experienced instant headache after the vaccine was administered and dizziness. The patient also reported the dizziness has resolved but she now has fatigue and chills. The patient also shows concern about if this is all normal and how long could it last. The outcome of the events headache, dizziness and chills were reported as unknown, whereas for dizziness it was recovered.  No follow up attempts are needed. No Information on lot/batch number cannot be obtained.
1/6/21 starting feeling itchy and geting worse, hard, red,warm,size of softball in diameter Narrative:
24hr p/vax fever 102, redness, swelling @ site of inj;tx Levloz, Ibuprofen;rxn resolved;
Not feel so well; Nausea; Vomiting; Fatigue; stomach not feeling well like she wants to vomit; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 72-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), via an unspecified route on unspecified date of Feb2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date in Feb2021, after 4 days the patient experienced not feel so well. Since Monday (unspecified date in Feb2021) having nausea, vomiting and fatigue and stomach not feeling well like she wants to vomit. The patient queried that was this normal, can she take something and can she take second dose. The outcome of events was unknown. Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Tachycardia Narrative:  Reports HR up to 140 in the 30 minute period following vaccine. Will be evaluated in the ER.
Started feeling ill around 7 p.m.  Overnight was running a temperature up to almost 103.  Felt sick to stomach but did not vomit.  Achy all over, just felt generally bad all over.  Symptoms started subsiding by morning and was pretty much back to normal by the next evening.