chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sx started as aching pains in the right toes and then right calf, by the month's end he experienced weakness of right leg. When taking stairs, patient is unable to support weight on right leg. Physical therapy ordered and attended.
Sore Arm; Early menstruation; fatigue; chills; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have allergy to any medications, food, or other products. Concomitant medications included vitamin (MANUFACTURER UNKNOWN), valaciclovir hydrochloride (VALTREX) and birth control all used for an unknown indication and from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 08:00 the patient experienced sore arm, early menstruation, fatigue and chills. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The patient did not receive any treatment for the events. The clinical outcome of sore arm, early menstruation, fatigue and chills were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
headache with pain in the eyebrow and temple area upper facial area; headache with pain in the eyebrow and temple area upper facial area; sore arm; pain in her hands to the point she could not hold a phone; pain in feet; tingling; fibromyalgia symptoms flared up; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache with pain in the eyebrow and temple area upper facial area), FACIAL PAIN (headache with pain in the eyebrow and temple area upper facial area), PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain in her hands to the point she could not hold a phone) and PAIN IN EXTREMITY (pain in feet) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027a21a and 002b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia. Concomitant products included DULOXETINE, ROSUVASTATIN and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (headache with pain in the eyebrow and temple area upper facial area) and FACIAL PAIN (headache with pain in the eyebrow and temple area upper facial area). In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain in her hands to the point she could not hold a phone), PAIN IN EXTREMITY (pain in feet), PARAESTHESIA (tingling) and FIBROMYALGIA (fibromyalgia symptoms flared up). At the time of the report, HEADACHE (headache with pain in the eyebrow and temple area upper facial area), FACIAL PAIN (headache with pain in the eyebrow and temple area upper facial area), PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain in her hands to the point she could not hold a phone), PAIN IN EXTREMITY (pain in feet), PARAESTHESIA (tingling) and FIBROMYALGIA (fibromyalgia symptoms flared up) outcome was unknown. Not Provided      Treatment information was provided i.e., acetaminophen, ibuprofen, vitamin C, butalbital/acetaminophen/caffeine  Action taken with mRNA-1273in response to the events was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098290 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098290:
She had a little pain, but that was nothing; This is a spontaneous report from a contactable consumer (reporting for herself).  A 75 year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, at age 75 years, on 07Apr2021 (Batch/Lot Number: EP7533) as 1ST DOSE,SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing slow thyroid  and high blood pressure. She has never been in the hospital. She has never had surgeries. She doesn't have diabetes. She is a healthy woman. She is a hiker, and usually hikes 4-5 miles a day,  She tries to make sure her heart goes to 128. She didn't have any problems getting there. Concomitant medication included levothyroxine 75 ug taken for slow thyroid, start and stop date were not reported; valsartan (DIOVAN) 160-12.5 mg taken for high blood pressure, start and stop date were not reported. The patient previously took Centrum but usually stops it a month before her blood test to see how normal her blood test is. So she hasn't taken the Centrum since Mar2021. The first dose was given on 07Apr2021, with lot number EP7533 in her left arm. She had a little pain, but that was nothing on an unspecified date in 2021. She had no reaction on her arm. She was so happy not to have side effects. She had no rash or shortness of breath. She was so happy. Last year (2020), she had an electrocardiogram done, and everything was normal with no problems. She doesn't have diabetes or any illness. ECG done everything normal no problems. She gets a blood test every year to see if everything is normal. The outcome of the event was recovered. Patient had her second dose was on 28Apr2021.   Information on lot/batch number has been requested.
Client became ill approximately one hour after COVID immunization. Symptoms include weakness, light headed, general malaise. Client refused wife's offer for medical assistance.
The next day I had a sensitive skin sensation in my upper back. I am not sure if it resolved or just decreased over the weekend but by the next week it would not go away and it was in my upper back and upper anterolateral thighs. That sensation did NOT leave for 3 weeks.   When it finally resolved from that area it went to a small area in my right hand and right wrist and a small area at the bottom of my right scalp. That sensation was present for 2 weeks and then again resolved.  Then most of Sept I was fine.  October the sensation returned to my upper back in the beginning of the month for a few days and again resolved.  Then it returned in the middle of October in my upper back again and last 2 weeks and still is slightly present and not fully gone.
This spontaneous report as received from a consumer (mother of the patient) via employee refers to a 11 year old female patient. On 11-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 (also reported as adult pneumonia vaccination) (lot # and expiry date were unknown) for prophylaxis (Drug administered to patient of inappropriate age). It was reported that the mother of the patient wanted to know what was the name of the adult pneumonia vaccine manufactured by Merck, as she is trying to gather her daughter's immunization records. The reporter also mentioned that they have moved a few times in the past couple of years, and her daughter was seen at a medical practice group, where she was given an unspecified adult pneumonia vaccination on 11-SEP-2014 in error. Mother of patient stated a couple of days later her daughter was seen at the physician's office again, where she was given the correct (unspecified name) vaccination. No adverse reactions were reported. No product quality complaint was involved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies- Tree nuts" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.   Clinical information: Patient had no other medication in 2 weeks.The patient received treatment with Paxlovid from 06Jul2022 to 10Jul2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I got COVID after the first; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got COVID after the first) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I got COVID after the first). At the time of the report, COVID-19 (I got COVID after the first) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
nausea for 2+ days, temperature 101.7, dizziness, muscle aches
12/17/2009 11:10 AM- Patient called health dept clinic c/o generalized itching, hives. Denied breathing problems or tongue or facial swelling at this time.  States had Benadryl 25mg tablets in her house and was instructed to take 50mg-2 tabs.  Benadryl was taken while still on the phone.  Instructed to go directly to the ER if any problems breathing, if tongue or face or throat swells or if symptoms persisted. @11:15 AM (5 minutes after phone call ended) the patient stated that she had problems breathing and that her tongue started to feel swollen so she went directly to the local ER for treatment.
Information has been received from a consumer concerning her 14 year old daughter with seasonal allergies and a history of concussion (January 2007) who on 11-JUL-2007 was vaccinated with the first 0.5 mL dose of Gardasil. There was no concomitant medication. On approximately 11-JUL-2007, "soon after beginning therapy," the patient experienced migraines and developed a low grade fever. On 28-AUG-2007 and 01-SEP-2007, the patient went to an emergency room. On 12-SEP-2007, the patient was vaccinated with the second 0.5 mL dose of Gardasil. The patient continued to experience migraines and a low grade fever. On 04-SEP-2007, the patient was hospitalized. On an unspecified date, magnetic resonance imaging (MRI) and unspecified blood work were performed on the patient. It was reported that the patient was hospitalized for a total of five days. At the time of this report, the patient's migraines and low grade fever persisted. Additional information has been requested. 9/05/08-records received-routine office visit 7/11/07-C/O irregular periods, premenstrual symptoms and menstrual discomforts. Right and left hip pain.Moody. 8/8/07-C/O migraine headaches for 1-2 weeks. 8/07-continues to C/O bilateral hip pain for over a year intermittent in nature with clicking and popping. PE normal. 11/02/07-allergic rhinitis, headaches, asthma. 1/3/08-C/O abdominal pain. Headaches improved. 2/20/08-ovarian cyst, prescribed birth control pills. 4/5/08-C/O back pain.
The patient initially came into the clinic with complaints of bug bites on both her arms. She was unsure where she received the bug bites.  I asked if she had any allergies and she stated her allergies were almonds and walnuts but no known drug allergies. Patient stated that she had allergy testing a few years ago and was given an EPI-pen, but was never shown how to use the device. She states that she has been diagnosed with asthma. I provided her 1 tab Loratadine and the Td immunization because she stated that she doesn't remember how long it has been since she received any immunizations. Approximately 1 hour later, I Spoke with patient while on a floor warehouse walk. She reports c/o itching and burning of skin all over. She c/o throat itching as well. She states that, "It feels like I drank an energy drink." TM states that she did not bring her EPI- pen with her.  She asked if she should bring her EPI- pen to work with her everyday and I confirmed, yes. I escorted her to the clinic for further evaluation. Vital Signs stable  B/P: 124/70, P: 94, T: 98.4, Respiration 24, No SOB, no audible wheezing, no hives.  TM A&O x4, Skin throughout extremities appeared flushed. No hives present around immunization area of her right deltoid or any where else on the skin. Lung sounds clear bilat at bases and apices, no obvious use of accessory muscles.  I recommended that she goes to the ED via ambulance - Emergent 911 Referral - TM declined the use of the ambulance 911 transport and signed an AMA for transport for emergency care. She stated after her shift she will have her friend drive her. I directed her to go to the closest ED and to go straight there when she is done with her shift. She states that she is familiar with where it is located as she is a resident of city. I asked again if I could call an ambulance to come and bring her to the hospital. She declined again. She requested an antihistamine and I provided her loratadine as requested. I asked her again if I can call the ambulance and the TM declined again. She then left to go and speak to her manager (OM) to notify of her whereabouts and to gather her personal things because it was 10 minutes to the end of her shift (1600). I waited for TM to return through the lobby and provided TM with paperwork for authorization for treatment prior to her walking out of the warehouse.
Fever, right knee swollen, limping-on Augmentin already for URI, watch, finish antibotics. Sx persisted referred to Dr.-said rx'n to MMR, rest and Motrin.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 09:00 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL3302), on 07Feb2021 as dose 2, single (Lot number: EL9261), on 20Sep2021 as dose 3 (booster), single (Lot number: FF8829), in left arm and on 16Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid; lot number: 00069-1085-30) were taken as a result of vaccination failure, covid-19 from 01Sep2023 to 06Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300301020 same patient, different drug, different event;
Per employee, red, swollen arm from shoulder to elbow.  Diarrhea, pain at site.  Described as cellulitis.
Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went away about 12 hours after the vaccine. Ten days after I developed a slight pain in right lateral side that progresses to constant pain in 2 places on right side including under right clavicle. I had pain upon taking in a deep breath. Saw MD after 4 days of these SXS. Performed labs, Chest x-ray and EKG. All were essentially normal except elevated WBC count. Have 2 COVID test which were both normal. Md said possibly some sort of inflammation and suggested taking anti-inflammatories which did not help much at all with SXS. After a few more days the SXS changed to constant chest pain(pressure), SOB upon exertion and pain behind knee. F/U with MD again and it was decided to wait a few more days. Upon suggestion from friend asked MD to perform D-Dimer lab test. The result was 4,400. My normal value should have been 550. Sent to ER. CT of chest, EKG and more labs performed. CT revealed large bilateral pulmonary embolisms in pulmonary arteries. Started on blood thinners. Ultrasound of left leg revealed large DVT. Sent home after 2 days on blood thinners. SXS stopped after a few days.
This case was reported by a consumer (the mother of vaccinated patient) and described the occurrence of explosive diarrhea in an adult female subject (grandmother of the vaccinated patient) who was exposed to ROTARIX (GlaxoSmithKline) given to her two month old granddaughter. A physician or other health care professional has not verified this report. Concurrent vaccination received by the vaccinated child included HIB (manufacturer unspecified), DTaP (manufacturer unspecified), poliomyelitis vaccine (manufacturer unspecified) and pneumococcal vaccine (manufacturer unspecified) all given to the patient on 10 June 2011, same day as ROTARIX vaccination. There were no concurrent medications taken by the vaccinated child. On 10 June 2011 at 09:30 the vaccinated child received 1st dose of ROTARIX (oral). On 13 June 2011, 3 days after vaccination with ROTARIX, the grandmother of the vaccinated child experienced explosive diarrhea and nausea. The reporter suspected that the live oral ROTARIX vaccine given to her child infected the "entire household" (infection via vaccinated person). At the time of reporting the events were unresolved. The vaccinated child did not experience any symptoms from vaccination with ROTARIX.
Symptoms occurred almost immediately- aching joints, fever, chills, soreness at injection site - last for 3 days
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Second dose was improperly stored and administered) and PRODUCT ADMINISTRATION ERROR (Improperly administered) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced PRODUCT STORAGE ERROR (Second dose was improperly stored and administered) and PRODUCT ADMINISTRATION ERROR (Improperly administered). At the time of the report, PRODUCT STORAGE ERROR (Second dose was improperly stored and administered) and PRODUCT ADMINISTRATION ERROR (Improperly administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-163779 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-163779:Same reporter
Exactly three (3) weeks after the first vaccine, I developed COVID-like symptoms. I lost my taste and smell and started a low-fever (100.0).   I postponed my second vaccine for a week.  I got the second vaccine after I received four (4) negative COVID tests.  I had violent shaking chills, a fever off 104.6 (could have been higher), severe nausea without vomiting, and an intense headache that was as bad as a migraine.  This all lasted for 24 hours.  The fever was reduced to 102.5 with fever-reducers.  That lasted 48 hours.  The fever then went down to 100.5. I had extreme fatigue and severe headaches for six (6) weeks (unable to perform daily routine) and the fever never went away.  The fatigue and headaches are no longer severe but still impact my daily routine.  The fever has not gone away.  Never one. I have had a fever of 100.5 since April 6th.  Sometimes the fever goes as high as 101.5.  Headaches and fatigue are also constant. There has been no diagnosis.  Treatment with indomethacin was attempted. It did not work.  "Waiting longer" was also a treatment suggestion. It has not worked.  Outcome is I still have a fever, headache and fatigue and am beginning to suffer from depression.
Had only a sore arm after 1st Moderna shot.  Received 2nd Moderna shot on 3/21/21 AM.  Sore arm began at ~8h, chills began ~11 h, achiness & headache ~14 h, shooting pains (mostly to head) began ~17 h ... these side effects continued through the day after vaccination.  After 48 h, the chills/fever were gone, but the head & muscle aches continued (tho diminished), so I took 1 Advil and felt much better that night.  But on both 3/24 and 3/26, I experienced severe vertigo/dizziness/room spinning on awakening and for a couple hours longer; this was accompanied by nausea, headache, some hot flashes and mild chills.  In both instances, the vertigo gradually eased during the day and I felt considerably better by evening.  The dizziness is very unpleasant and disruptive, so I'm hoping it doesn't return; it?s too soon to know if it will, but I will see my PCP if the problem persists.  Of course, I can?t be sure the dizziness was caused by the vaccine, but it seems likely.    I?ve had many vaccines and tolerated almost all of them very well.  But I had a strong reaction to Shingrix in August, 2019 ? had a huge, red, hot swelling of my arm around the injection site, and very bad chills, fever, muscle aches, head ache (but no vertigo).  Spent ~2.5 days in bed.