chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling on RD, 10.2 cm width, 9 cm length. Warm to the touch underneath site vaccine was given. Dtap was administered.
Continuous pain and numbness in my left arm. I have developed a growth on my left hand about 2 weeks after the injection
groaning; terrible pain; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. This consumer reported for an unspecified age of female patient that received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient at hair salon was experiencing terrible pain after receiving Pfizer COVID vaccine. Unclear If it was his employee or clientf but said she was groaning because she was in such pain. Patient described it as pregnancy contractions. Outcome of the events moaning and terrible pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within weeks of receiving the vaccine, Patient lost the ability to stand, walk, move unassisted. He DIED august 2, 2021.  Prior to receiving the vaccine he was able to ambulate to bathroom unassisted, to the kitchen, to the patio. After the vaccine he was bedridden and unable to stand without the assistance of 2 people.
Patient received first dose of Pfizer BioNTech Covid 19 vaccine EUA. Patient reported to nurse that she felt lightheaded, nausea, and dizzy. Vitals taken every 5 minutes. Monitored patient for 1 hour. Patient left clinic after observation period.
Patient was injected with 0.3mL of undiluted 5-11year-old bivalent vaccine instead of adult dose. Patient was contacted and informed. Endorses feeling well and will return to be seen if concerns emerge. Message was left for Pfizer requesting guidance.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 08-OCT-2013 the patient was vaccinated with the first dose of PNEUMOVAX23 (0.5 ml, intramuscularly, lot # not reported) and subsequently inadvertently received another (second) dose of PNEUMOVAX23 (0.5 ml, intramuscularly, lot # not reported) on 08-OCT-2014 (also reported as a year later). No symptoms were reported. Additional information has been requested.
Covid-19; Covid-19/ Fatigue and sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4210732-00 (Agency).  A 57-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), since 01May2021 (ongoing) (Lot number: 1163675), subcutaneous for psoriasis. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "recovered", described as "Covid-19"; SUSPECTED COVID-19 (medically significant) with onset Jun2022, outcome "recovered", described as "Covid-19/ Fatigue and sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. The action taken for risankizumab was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Muscle weakness, body weakness, fatigue, headaches, sharp shooting pain in left arm between bicep muscles.
No other AE; Caller is a nurse who reports a dose of PROQUAD was given to a patient following temperature excursion.; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions or allergies were not provided.   On 22-MAR-2022 the patient was vaccinated with an improperly stored  dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin rHA) (PROQUAD) 0.5 ml once, administered as prophylaxis, lot number U029319 was verified to be a valid lot number, expiration date: 19-MAR-2023 (route of administration and anatomical location were not reported), the vial was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, lot number and expiry date were not reported) (product storage error).  The measles, mumps, rubella and varicella (oka merck) virus vaccine live (PROQUAD) was stored at a temperature of -11.7 Celsius (C) for the time frame of 49 minutes. There was no previous temperature excursion.  No further adverse event (AE) was reported.
Woke up this morning weak, fatigue, aches and too weak to walk. Stated headache from 11/1/22 increased on 11/2/22. Pt was so weak she fell and had to call the ambulance to "get me up". Pt stated she refused to have EMS take her to  the  hospital. Pt called to report symptoms. Pt encouraged to call her primary provider or EMS if she is unable to walk or symptoms have increased.
Soreness persisted in my left shoulder, and then spread to other large muscles/ Wrists and shoulders became so painful/ arthritic joint pain; Tight muscles made tendons sore.; The large muscle pain and cramps; The large muscle pain and cramps; Arthritic joint pain perhaps tendonitis.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 12:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and very mild arthritis. The patient had no known allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 11:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17Apr2021, the patient experienced soreness persisted in the left shoulder and then spread to other large muscles, tight muscles made tendons sore, wrists and shoulders became so painful that the patient had difficulty pulling covers up at night, and buttoning shirts, the large muscle pain and cramps were currently getting better, but still had what could best be described as arthritic joint pain and perhaps tendonitis. The patient had made an appointment to discuss these issues with his doctor. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcomes of the events soreness persisted in the left shoulder and then spread to other large muscles, tight muscles made tendons sore, wrists and shoulders became so painful that the patient had difficulty pulling covers up at night, and buttoning shirts, the large muscle pain and cramps were currently getting better, but still had what could best be described as arthritic joint pain and perhaps tendonitis were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever; Malaise; Fatigue; This is a spontaneous report from a contactable nurse (reported for himself). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 08Jan2021 at 16:00 (lot number: EL1284) and first dose on an unspecified date (lot number: EJ1685); both via an unspecified route of administration on his left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No vaccines received within 4 weeks prior to COVID vaccine. On 09Jan2021 at 13:00, the patient experienced fever, malaise and fatigue. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included ibuprofen 800 mg and cooling measures. Outcome of the events was unknown.
Cellulitis left thigh treated with nafcillin 400mg IV in hospital. Rx'd dicloxacillin susp. 62.5mg for 10 days.
After virus, we waited for no symptoms to get second vaccine. Are now miserable with symptoms exactly like we have virus again; shortness of breath; cough; Diarrhea; chills; Muscle ache; Headache; Fever; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (After virus, we waited for no symptoms to get second vaccine. Are now miserable with symptoms exactly like we have virus again), DYSPNOEA (shortness of breath), COUGH (cough), DIARRHOEA (Diarrhea) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (After virus, we waited for no symptoms to get second vaccine. Are now miserable with symptoms exactly like we have virus again), DYSPNOEA (shortness of breath), COUGH (cough), DIARRHOEA (Diarrhea), CHILLS (chills), MYALGIA (Muscle ache), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, SUSPECTED COVID-19 (After virus, we waited for no symptoms to get second vaccine. Are now miserable with symptoms exactly like we have virus again), DYSPNOEA (shortness of breath), COUGH (cough), DIARRHOEA (Diarrhea), CHILLS (chills), MYALGIA (Muscle ache), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, SARS-CoV-2 test: positive (Positive) Type of test- Not rapid Sample- Nasal.         No concomitant medication information provided by the reporter. No treatment information provided. Patients was also having abdominal pain.   This case was linked to MOD-2021-315854 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Significant Follow up received on 14 sep 2021 contains new events: fever, chills, shortness of breath, cough, muscle ache, headache, diarrhea.
Information has been received from a registered nurse concerning a 67 year old female who in 2005 was vaccinated with Pneumovax. On an unspecified date, the patient developed cellulitis. the patient saw a dermatologist afterwards. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 08:00 as dose 1, single (Lot number: EL9265), in right arm, on 25Feb2021 at 08:00 as dose 2, single (Lot number: EN6203), in left arm and on 10Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FJ8762) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "HBP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish. The patient took concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Rebound Covid" starting 8 days after paxlovid treatment began (day 10 after initial Covid symptoms initially appeared). Tested positive again and symptoms recurred after having felt better, tested negative after completion of paxlovid treatment.
Fever, Body Ache, Head Ache, Nausea, Fatique (like Bad Flu)
Pt presented to clinic with 5 cm x 4 cm  reddened, warm, hard area at site where MMRV given 2 days prior to visit. Non-pruritic.
Patient developed ARDS with ICU admission (initial presentation at outside hospital and then transferred to another medical facility
Numb arm and face. 8 days later patient feels like fire is going through her body and brain. Feels like her brain is numb.
Patient's Moderna Booster administered at a 3 month interval instead of a 5 month interval.
This spontaneous report was received from a 67 year old female patient reporting on herself during an interview as part of a marketing research program for ZOSTAVAX. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, strength and lot number not provided). Co-suspect or concomitant therapies were not provided. On an unknown date, according to reporter, patient had the ZOSTAVAX and then ended up in the ER (emergency room) (no hospitalization reported). At the time of the report, the outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was unknown. Additional information is not expected since no consent for follow up was given.
PATIENT CAME IN FOR 2ND DOSE OF PFIZER VACCINE ON 7/23/21. PATIENT STATED THAT AFTER RECEIVING THE FIRST DOSE OF PFIZER SHE STARTED HAVING CHEST PAIN AND THE CHEST PAIN LASTED 1-2 WEEKS. SHE DID NOT VISIT HER PCP.
FATIGUE; FEVER; This spontaneous report received from a patient concerned multiple patients. 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 not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced fatigue. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and fatigue was not reported. This report was non-serious.
Chills, muscle aches, fatigue, dizziness,  swollen lymphnodes and headache
Pt vaccinated with MMR experienced nausea/diaphoretic, collapsed in bathroom 10 mins after injection no loc - vasovagal response.
Itching and large red rash at the injection site that has been ongoing for several days (COVID-19 arm).
Information has been received from a health professional concerning a 4 month old male who on 18-SEP-2006 was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 veassortant vaccine live (human bovine). No problems with the administration were noted. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Pt Chief Complaint is body aches, nausea, fever, chills, and other flu like symptoms.
She received the vaccine, and within 4 minutes she got a tingling feeling that swept through her whole body from her head to her toes.  They called a doctor to stand by her, and spoke with her, and she was explaining what she had with reactions had a very warm sensation through her body.  They have a medic station at the event center, and started taking her VS which her BP was high, and kept an eye on her, and kept talking to her.  She still had the tingling feeling through her.  She had this similar sensation from bee stings in the past.  She then got very cold and started shaking all over and her went to 175/101.  At that point she had probably been there for about 2 hours and she was then taken to Hospital.  She was monitored at the hospital for her BP and did oxygen levels which were fine, and her heart rate was elevated, but then dropped down to 98-99.  She asked for something to drink and something to eat, and they gave that to her, and was only at the hospital for about an hour.  They told her that she was okay, and they did not give her any medications as the reaction had passed and her BP was down to 149/87, pulse rate 102, and her respiratory rate was good and they dismissed her.  She did have fatigue since coming home from the hospital but is otherwise okay.  She is scheduled to see her PCP on Monday, 3/22/21.
Pt received smallpox vaccine on 15Jan by medic. Pt noticed chest pain 23Jan and was flown to facility 26Jan. Labs were drawn and they showed that his troponin was elevated: .56ng/ml.
Chills and muscle aches, fatigue 12 hours after receiving the second dose of Moderna vaccine
No AE. This is a vaccination error. It was discovered after the fact that patient had never received the initial series of COVID vaccines. He should not have received a booster dose.
Occlusive superficial thrombus developed to lesser saphenous vein extending toward popliteal vein within 2 cm, developed ~2 weeks after vaccination.
Feels bad; Feeling unwell; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Feels bad), MALAISE (Feeling unwell) and FATIGUE (Tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 24-Apr-2021, the patient experienced MALAISE (Feeling unwell) and FATIGUE (Tiredness). On 26-Apr-2021, the patient experienced FEELING ABNORMAL (Feels bad). At the time of the report, FEELING ABNORMAL (Feels bad) had not resolved, MALAISE (Feeling unwell) outcome was unknown and FATIGUE (Tiredness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was reported.
4/30/21 weakness and tremors in all 4 extremities, febrile 39.8*C, observation hospitalization 4/30/5/1/2021
As pt was checking out, after she received vaccinations, she fainted and hit her head on the wall, leaving a small punched out area on the sheet rock. She responded to stimulation and awoke after 15 s. Her pulse was steady in the 70s and pulse ox 99%. During that time, there was questionable stiffening and tremor of arms, and eyes seemed to be rolling. Then she awoke. She recognized her grandmother, responded to questions, and then sat up. EMS was called and she was transported to the ER for further evaluation.
Immunizations given 05/13/2003. Mom states fever 102 in middle of night with hallucinations "mice biting butt and running out of PJ's". Mom presented to family practice and saw MD with c/o hallucinations continued even after fever gone with Tylenol. PCP to flu with pt.
Arthralgias, myalgias, chills from 4:00 - 10:30. At this time I went to sleep. In the middle of the night I broke into a cold sweat.
pt devel bruising, that became worse;devel ITP& is receiving immune globulin;MD is treating pt;
When pt was a little over 1yr old he received 4 shots- one in each extremity. He stopped saying "MD" and "DA" did it and saying words again until 3 yrs old. He cont'd to babble. Mom contacted doctor due to event.
patient called to the pharmacy and stated that after 5 days she is still having the soreness in the arm and redness is there around the area where she got the vaccine
Soreness and swelling at injection site(beginning overnight) lightheadedness/dizziness, slight shortness of breath(just before noon the following day)
Diagnosed with pneumonia having a cough, Covid 19 positive; Has been over 42 days since she received first dose; A spontaneous report was received from a consumer concerning a 66-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed with pneumonia (COVID-19 pneumonia), was tested positive for COVID (COVID-19 ) and it was over 42 days since the patient received first dose (product dose omission issue).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: U10M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient had cough and was diagnosed with pneumonia. On 17 Feb 2021, the patient was tested positive for Covid and was quarantined for 10 days. It has been over 42 days since the patient received first dose of the Moderna COVID-19 vaccine   Treatment information for the events was not reported.  Laboratory information included COVID-19 positive.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, diagnosed with pneumonia, was unknown. The outcome of the events, tested positive for COVID, was resolved and it was over 42 days since the patient received first dose, was considered as resolved on 03 Feb 2021.; Reporter's Comments: Based on MAH causality and It has been over 42 days since the patient received  her first dose of the Moderna COVID-19 vaccine the event is assessed as unlikely related to mRNA-1273.
Swelling, tenderness and erythema of the injection site extending throughout the entire thigh up to the groin and extending down toward and including the level of the calf. This lasted for 7 days.
The left side of my tongue has a tingling sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "The left side of my tongue has a tingling sensation". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Became very anxious wanting to pace all the time, loss of appetite, constipation and a rash on back, arms, and legs. Doctors don't know what is wrong or what to do. Was given Benadryl, and a cream for the itch and an antianxiety medicine. Nothing is working. Now my dad is weak and falling.