chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The nurse reported that the unspecified patient received the 1st dose of MMR II (lot number, dose, route and strength were not reported) on 09-JUN-2014 and the 2nd dose of MMR II on 18-JUN-2014; the spacing between the vaccine doses was less than the recommended 28 day interval. No adverse effects reported. The outcome and action taken were not provided. It was not specified if the patient sought any medical attention. Additional information is not expected.
Had vaccine Saturday 3/18/06 at 1PM or so. By Sunday evening 3/19/06 arm, right arm, was very swollen (1 1/2 inches larger than left arm). Area red about 6" in diameter, area painful and red. No drainage from injection site. Fever of 101F. To MD 3/20/06 given Keflex. 1st dose at 14:00. 3/20/06 swelling improved 3/21/06 no fever, swelling, almost gone 3/23/06 asthma flared up 3/22/06 and 3/23/06.
Tinnitus and partial hearing loss (likely sensorineural) in the left ear. No significant symptoms otherwise. Symptoms have progressed gradually since onset, and are constant. I am a physician and have not yet started any treatment nor had a specialist evaluation yet.
The patient had pain upon injection of Prevnar. I advised to apply a cool compress if pain remains. Patient returned the next day saying that she had pain in arm and shoulder all night long and cannot lift arm. I told her to take Ibuprofen 800 mg 3 times daily and apply ice. Her doctor had me tell her to ice for 24 hour and then apply heat.
patient got the flu once, the year my doctor convinced me to get the flu shot; Initial information was received on 01-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got the flu once, the year patent's doctor convinced to get the flu shot (influenza), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient got the flu once, the year patent's doctor convinced to get the flu shot (influenza).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Very sore and painful for a few days; The last two doses she actually experienced a delay type of hypersensitive reaction; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Very sore and painful for a few days) and TYPE IV HYPERSENSITIVITY REACTION (The last two doses she actually experienced a delay type of hypersensitive reaction) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first 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 (Very sore and painful for a few days) and TYPE IV HYPERSENSITIVITY REACTION (The last two doses she actually experienced a delay type of hypersensitive reaction). At the time of the report, PAIN (Very sore and painful for a few days) and TYPE IV HYPERSENSITIVITY REACTION (The last two doses she actually experienced a delay type of hypersensitive reaction) had resolved.            No concomitant medications were reported. The patient reported that the last two doses the patient actually experience a delay type of hypersensitive reaction and just wanted to make Moderna aware as an adverse event. No seriousness to it, it resolved on its own and it was very sore and painful for a few days.  No treatment medications were reported.   This case was linked to MOD-2022-550462 (Patient Link).
patient received Daptacel vaccine that was expired, no adverse event; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 months old male patient received an expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C51718AA and Exp. Date 23-Mar-2019) via unknown route in unknown administration site, on 23-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Fever 95.7-99.5   Chills with repeated shaking  Hot flashes  Fatigue Diahrea Muscle and body aches Abdominal pain  All symptoms lasting 6 days
Developed hives over entire body - most concentrated over trunk.  She had receieved the seasonal influenza vaccine (single dose administration, thimerisol free) on 11/16/09 and developed hives on 11/17 -11/21.  Hives decreased during the precendent 5 days prior to H1N1 vaccine then increased significantly after H1N1 vaccination on 11/21/09. She was treated with 2.5mg po loratidine on 11/22/09 with subsequent resolution of hives.  No breathing difficulties, no wheezing, or other systemic reactions noted.  Pt had 2 seasonal influenza vaccines (primary and booster) 1 year prior without any reactions.
First 2 days after 2nd dose: severe fatigue and muscle pain Days 3-7 after 2nd dose- tingling in arms, severe fatigue, weakness, and brain fog Symptoms have not resolved as of the time of this submission
Once the second vaccine was administered in May of 2021 about a month after I started to have very dark urine.  The color of tea.  I was sent by my Rheumatologist who had me do a urine sample that sample showed large amounts of blood greater then 100.  Other samples I gave also has protein as well as large amounts of blood.  When I received the 3rd and 4th dose I developed a huge swollen armpit that lasted months along with the blood and protien in urine that would get worse and worse after each vaccine and.  Currently the large amounts of blood and protien is not going away.  I am being followed by nephrology now with doctor. They have mentioned that I do show signs of IgA nephropathy but a biopsy has not been done to confirm it at this time.  Unsure If it has to do with the vaccine or with my lupus.  But it did all start after the second dose of Moderna and has gotten worse and worse after the 3rd and 4th vaccine.  I was told I could get a 5th vaccine in August but a bit nervous too.  Each vaccine also causes terrible body aches, fatigue, and a low grade fever that lasts a couple days.
pt recv vax & exp a chickenpox like rash 18 days p/inj; no further details were provided;
The next day after receiving my first dose of the Pfizer covid vaccine I started feeling server joint and muscle pain throughout my legs and arms as well as my back. It has been difficult to sit or stand for periods of time due to the feeling of being uncomfortable. I have also been suffering from tingling in my hands and feet as well as facial twitching.  I also have started my menstrual cycle after just finishing it 3 days before my covid vaccine. I have been spot bleeding ever since getting the covid vaccine.
Not feeling 100%; Throat closing; BP 200/something; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat closing), BLOOD PRESSURE ABNORMAL (BP 200/something) and MALAISE (Not feeling 100%) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced THROAT TIGHTNESS (Throat closing) and BLOOD PRESSURE ABNORMAL (BP 200/something). On 16-Jan-2021, the patient experienced MALAISE (Not feeling 100%). At the time of the report, THROAT TIGHTNESS (Throat closing), BLOOD PRESSURE ABNORMAL (BP 200/something) and MALAISE (Not feeling 100%) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Blood pressure measurement: 200 mmHg. On 16-Jan-2021, Blood pressure measurement: high mmHg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
acute enlargement of thyroid 48 hrs p/recd #2 dose of Hep B vax; enlargement was significant enough to cause dysphagia & diffiuclty breathing when head was turned side to side; sx less pronounced when head was central-facing forward;
Injection site still throwing off heat and raised lesion around site approximately 3 inchX2 inch (covid arm). It has been more than 2 weeks since the injection. Information online gives time between 24hrs and a week for this "new" symptom to dissipate. I know the thread of advice states that this should not prevent getting the second shot. I am already immune compromised due to MS. I have lost muscular strength and use in the past due to antibiotic allergic reaction. Quite frankly I do not trust the current available info nor my body to this situation.
Pain in the arm; inflammation around the injection site; low grade headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2022 17:30 (Lot number: FJ5383) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Other medical history: Allergies; "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood, pressure; "Overweight" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Known allergies: mushrooms" (unspecified if ongoing), notes: Known allergies: mushrooms. Concomitant medication(s) included: LISINOPRIL; MONTELUKAST; ADVAIR; ALBUTEROL [SALBUTAMOL]. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Mar2022, outcome "recovered" (05Apr2022), described as "Pain in the arm"; VACCINATION SITE INFLAMMATION (non-serious) with onset 30Mar2022, outcome "recovered" (06Apr2022), described as "inflammation around the injection site"; HEADACHE (non-serious) with onset 30Mar2022, outcome "recovered" (01Apr2022), described as "low grade headache". Therapeutic measures were not taken as a result of pain in extremity, vaccination site inflammation, headache.  No follow-up attempts are possible. No further information is expected.
Patient's arm started to swell soon after the shotm and was described to be hard to the touch. The arm ws painful and hot. The event lasted for 8-9 days.
1250 Called for nurse to observation area. Pt said, "my throat is scratchy" Pt ambulated to office area behind waiting area. Husband with pt. 1249 Activate EMS asked of staff, Dr. notified. 1253 Benadryl 50 mil/IM , left deltoid 1254 Epi .5mil /SQ, left deltoid "my throat feels tight"; pt appears dusky, responsive to questions, sitting in chair, coughing 1256 Vitals 98%, HR 90, 142/86 Lungs clear, breath sounds strong in all lobes, throat congestion, Pt remains communicative, husband in room 1255 EMS Called 1300 Lungs remain clear 1303 97%, HR 84, 134/76 1305 EPI .5mil/SQ left deltoid 1309 97%, HR 78, 140/82 - Diminished breath sounds. Pt remains sitting in chair. States she doesn't feel any better. Still coughing-unproductive 1310 EMS arrives 1320 Transport pt to hospital. Pt walks out to ambulance with cane. Husband remains with pt., MD notified. RN, MSN, CNS Pt has history of Sjogren's disease, Lupus and Fibromyalgia
Information has been received from a nurse concerning an 8 month old patient who was vaccinated po on 04-DEC-2007, 25-JAN-2008 and 09-APR-2008 with the first, second, and third doses of ROTATEQ  (first dose lot # 657606/1391U and third dose lot # 660550/0616X). The nurse reported that the patient developed rotavirus, confirmed by the office lab technician. It was reported that the patient sought medical attention, unspecified. The outcome was not reported.  Follow-up information was received from a nurse concerning a 9 month old (previously reported as an 8 month old) patient. On 03-JUN-2008 the patient experienced vomiting for 3 to 4 days and diarrhea for 2 to 3 days. On 04-JUN-2008 a stool test was done which was positive for Rotozyme, negative hematest and no fecal white blood cells seen. The patient was seen for a doctor  visit. It was reported that the patient recovered.  This is one of several reports from the same source. Additional information has been requested.  No further information is expected.
gave her Tylenol after the shot but low grade fever started  about 12 hrs after the shot.   then  the fever spiked to 102.6 about 6 hrs. later.   gave her  Tylenol and fever stayed high.   as she is non verbal, she could not tell us how she felt, but  we observed her to be lethargic.  she kept putting her hand on her forehead  indicating headache. 24 hours after shot low grade fever remained.
2nd Moderna bivalent vaccine booster was administered on 8/1/23. Moderna vial was moved to fridge on 6/28/23 and labeled with a 30 day expiration on 7/28/23. Technician removed vial from fridge for administration and expiration date was not checked.
This case was reported by a nurse via other manufacturer and described the occurrence of vaccination failure in a male patient who received ROTARIX for prophylaxis. On an unknown date, the patient received ROTARIX (oral). On an unknown date, unknown after receiving ROTARIX, the patient experienced vaccination failure (serious criteria GSK medically significant), hemolytic uremic syndrome (serious criteria hospitalization and GSK medically significant), viral infection and rotavirus infection. On an unknown date, the outcome of the vaccination failure, hemolytic uremic syndrome, viral infection and rotavirus infection were unknown. It was unknown if the reporter considered the vaccination failure, hemolytic uremic syndrome, viral infection and rotavirus infection to be related to ROTARIX. Additional details were provided as follows: The case was reported by nurse practitioner who reported the case to other manufacturer. The age at the vaccination was not reported. The patient was previously vaccinated with ROTARIX on an unspecified date. The Lot number and expiration date was reported. The nurse practitioner reported to the employee that her son suffered a viral bout that caused hemolytic uremia in which her son was taken to a hospital. Months later the patient contracted rotavirus which was very concerning as the previous event with hemolytic uremia was a taxing event on his kidneys. On an unknown date, PCR testing (Polymerase chain reaction) was being conducted to determine the strain. Employee confirmed that he heard of this event on 17th July 2018. No further information was provided. This case was considered as the suspected vaccination failure case since the exact time to onset for the event and vaccination schedule were not reported. Lab Comments: Lab test performed on an unknown date.
she was really confused; "shh" noise in her ears; eyes drop burn more; dizziness when she moves or bends down; Brain fog; fear that symptoms won't go away; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (she was really confused), TINNITUS ("shh" noise in her ears), EYE IRRITATION (eyes drop burn more), DIZZINESS (dizziness when she moves or bends down) and BRADYPHRENIA (Brain fog) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VALSARTAN, AMLODIPINE, ATENOLOL and OMEPRAZOLE for an unknown indication.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (she was really confused), TINNITUS ("shh" noise in her ears), EYE IRRITATION (eyes drop burn more), DIZZINESS (dizziness when she moves or bends down), BRADYPHRENIA (Brain fog) and FEAR (fear that symptoms won't go away). At the time of the report, CONFUSIONAL STATE (she was really confused), TINNITUS ("shh" noise in her ears), EYE IRRITATION (eyes drop burn more), DIZZINESS (dizziness when she moves or bends down), BRADYPHRENIA (Brain fog) and FEAR (fear that symptoms won't go away) had not resolved.            Concomitant medications also included Vitamins and eye drops. Concomitant product were used for high blood pressure in the morning, bone, heartburn acid indications. No treatment was given.   This case was linked to MOD-2021-248210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up received. New events were added. On 06-Aug-2021: Follow-up received and contains no new information.
3/2/21 shoulder soreness at inj. site 3/3/21 1pm Heat - Discomfort skin legs Wed 3/3/21 Rash legs  backs of Knees and hips Thurs 3/4/21 shins & Thighs at 2:00 Thurs 3/4/21 arms rash consulted Dr to have #2 dose as Dr felt would be ok
Local reaction at injection site with red, hot, swollen and very tender left deltoid. About 3cm swelling. Lasted about 1 week.
I received a flu vaccination and the first dose of the Moderna vaccine on 9/21/2021 at about 5:30 PM. When I awoke on 9/22/2021 at about 5:30 AM, I had a headache, which I treated with Ibuprofen. The headache lasted for about 2 weeks, and during this time, I was able to treat it with Ibuprofen in order to take the edge off and so that I could function well at work.  On 10/5/2021, I woke up at about 5:30 AM with pain behind my right eye, a headache, and cloudy vision in the right eye with flashes of light. I continued working and going about my normal activities, but I saw doctor on 10/12/2021, and he diagnosed me with a retinal tear. He then referred me to the eye surgeon doctor, whom I saw on 10/13/2021. Doctor performed laser surgery to correct the retinal tear. As of the present, I continue to have cloudy vision in the right eye, but I am able to work and function normally.
I had nausea, vomiting, chills, cough, fever, and body aches.  These lasted for about 5 days.  I got tested for Covid-19 at a facility, positive results.
Information has been received from a physician and an employee in a physician's office concerning a 71 year old female who within the last two weeks, in October 2002, was vaccinated with a dose of penumococcal vaccine 23 polyvalent (lot # 640981/1050L). Subsequently in October 2002, the patient developed swelling and cellulitis of the arm that was vaccinated. The patient was treated with oral antihistamine (therapy unspecified) and antibiotics (therapy unspecified) however, on 10/25/02, the patient was hospitalized with cellulitis for three days. The patient was released from the hospital on 10/28/02. As of 10/29/02, the patient's symptoms were resolving. The physician requested that a lot check be initiated. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. The physician also provided information concerning another patient's experience (WAES0211USA00098). Additional information has been requested.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL3247) as dose 1, single via an unspecified route of administration administered in left arm (at the age of 54 years old) on 25Feb2021 at 13:45 for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Atorvastatin calcium (LIPITOR), Sertraline (SERTRALINE). On 25Feb2021 at 13:00, the patient experienced diarrhea. The outcome of the event was reported as  recovering.
FEVER,FAINTED,COUGH,RUNNY NOSE FOR 5 DAYS
Pt began to feel dizzy, warm and faint within 10 minutes of her second pfizer vaccine.  Pt did not lose consciousness but was dizzy, clammy, sweaty, pale, faint feeling.  Pt responded to commands but felt faint.
sore bones in arms & legs; achy sore; Weak; nausea; swollen lymph glands in right breast; "baseball"  swollen right arm pit; Tired; Headache; Shot sight large red inflamed lump; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 66-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24Sep2021 11:00 (Age at vaccination: 66-years-old) as dose number unknown, single for covid-19 immunization. (Vaccination facility: Pharmacy or Drug Store). Medical history included diabetes, high blood pressure, allergies all from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (BAYER ASPIRIN), mometasone furoate (FLONASE [MOMETASONE FUROATE]), atenolol (ATENOLOL), famotidine (FAMO) all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included Flu shot in Left arm on 21Sep2021 (Age at vaccination: 66-years-old) for immunization. Patient not had covid prior vaccination. On 25Sep2021 04:00 Headache, sore bones in arms & legs, nausea, achy sore, swollen lymph glands in right breast and baseball swollen right arm pit, Tired. Weak. Shot sight large red inflamed lump. Patient was not tested for covid post vaccination. The outcome for the events was reported as resolving at the time of this report.   The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.