chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe migraine headache , started 18 hours after vaccine was given, and despite Imitrex, and propranolol, which usually abort migraine in this patient, it lasted for 36 hours, only subsiding after taking 5 doses of propranolol in that 36 hours (approx 2.5 times the normal dose) and 1 dose of imitrex 50mg .  Meclizine 25 mg and Benadryl 50 mg also had to be taken within that 36 hours span to control the nausea .    My concern and the reason for reporting this is : if I had not had my own prescriptions at home for imitrex, and propranolol , that headache might have lasted even longer than 36 hours , probably resulting in a visit to urgent care for the intractable migraine and associated nausea/vomiting.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer. This consumer reported same event for 2 patients. This is the second of 2 reports.  A patient of an unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced tested positive for COVID on 12Jan2021 with outcome of unknown. Event was assessed as non-serious by reporter.  Information on lot number/batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021028267 Same drug/event, different patient
Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 68.29 for dose administered on 27-Oct-2021.  No concomitant medications were reported. It was reported that for the vial Batch number of 035C21A, it was moved to fridge on 05-Oct-2021 that underwent temperature excursion on 27-Oct-2021 with temperature 32 degrees Fahrenheit at 10 AM and 29 degrees Fahrenheit at 9AM . The product was moved to clinic on 27-Oct-2021 and beyond use date for the vial was reported as 04-Nov-2021.  The vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. The vials were only punctured right before administration. The vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Approximately 11 days after receiving my first dose, I began feeling dull pain in my left calf. By Saturday, 4/17, the pain was severe enough to warrant a trip to the emergency room. After receiving an ultrasound of my leg, two blood clots were found in my left calf. One fully occluded a vein and another partially occluded a different vein.
Right after I got the shot which i got at 11am on Friday that evening i was fine. Next day I had 103.6 fever feeling chills and sweating a lot, pain at injection site with pain all over my body. Saturday evening the fever broke, the redness was 3" in diameter at that point and kept growing, fatigue, dizziness, and no appetite is still present. I still have nausea and no appetite. Since the red spot and not feeling better yesterday, I did a virtual visit with the clinic and was told to go to Urgent care. Urgent care said injection was done too low and that I could have gotten a bacterial infection or a bad batch, they gave me an antibiotic cream. And said my immune system is doing what it's suppose to do. I called my Immunologist and they called in an antibiotic pill for me as well. Today red spot is bigger at about 6" in diameter across my arm and I'm very tired, a little achy, no desire to eat, nauseous, and the cognitive fog I normally get is pretty worse right now.
Within 10 hours of second dose, chills, leg and ankle pain, fever (100+), malaise, nausea.
She felt she was drowning; Feels extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt she was drowning) and FATIGUE (Feels extremely tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Feels extremely tired). On an unknown date, the patient experienced FEELING ABNORMAL (She felt she was drowning). At the time of the report, FEELING ABNORMAL (She felt she was drowning) outcome was unknown and FATIGUE (Feels extremely tired) had resolved.            Concomitant medications were not reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: New event ( feeling abnormal ) was added.
Pain in left arm . Tension in arms and shoulders.  Shortness of breath.  On 3/19/2021 I was diagnosed with pulmonary embolisms in both lungs and right leg
Achiness; Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achiness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Achiness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            No concomitants were mentioned. No treatments were mentioned.
rash-(punctate lesions non-pruritic) scattered over face upper chest of extremities (measles-like) noted;1 day of low grade fever;arthralgia multiarticular;
two weeks post injection my right foot swelled up with extreme pain and I could not walk. This resolved in a week. Then four weeks after the injection my left hand at the carpus swelled up with pain  and I could not use my hand. On 12Dec 15-16 my left foot swelled up and was extremely painful and I could not walk . I obtained a MRI as I could not stand on the foot. I have tendinopathies and a bone contusion of my cuboid with an incomplete fracture.
A nurse reported the occurrence of an injection site reaction in a 15 month old female who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On 7/23/02, the subject received her fourth injection of Infanrix (566A2) into the right leg. On the same date, she received injections of Hib vaccine (manuf unk) and IPOL at unspecified injection sites. She was seen by the physician on 7/25/02 with an injection site reaction characterized by redness at the site of Infanrix administration and swelling of the right leg. As of 7/31/02, the injection site reaction had resolved. The reporting nurse stated that the injection site reaction was probably related to Infanrix administration.
Feeling like I had a mild flu: Fever, Body Aches and then started having burning sensation and pain in the armpit area that radiated under and above the breast and into the back.
Breakthrough COVID-19 case with symptom onset 8/24/2021: Shortness of breath/difficulty breathing. Hospitalized 8/27/2021 for unknown duration. Death 9/19/2021. From Vital Records = COVID-19. Per vital records, Not yet coded ; Other Significant Conditions include: None listed. lace of death: HOSPITAL-INPATIENT, certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: MECHANIC, SALES
This patient was scheduled to receive the second dose of their primary series of Pfizer COVID-19 vaccine. At the time of the first and second doses, the patient was 11 years of age. For the second dose, administered on 12/14/2021, the patient received Pfizer 12+ COVID-19 Vaccine and should have received a Pfizer 5-11 COVID-19 Vaccine.
My wife started menstrual cycle after second shot. She had been in menopause for over a year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 12:30 (Lot number: EW0162) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: ER8727, Administration time:10:00, Dose number 1, Vaccine location: Left arm), administration date: 22Mar2021, for Covid-19 immunisation. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 18Apr2021, outcome "unknown", described as "My wife started menstrual cycle after second shot. She had been in menopause for over a year". Therapeutic measures were not taken as a result of postmenopausal haemorrhage. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient was not tested for COVID.  No follow-up attempts are possible. No further information is expected.
15AUG96 mom reports p/vax 8AUG96 pt broke out w/whelps & later had chills;pt taken to ER & recv meds;
body ache; headache; swollen lip(filler in lip); sensitivity (hurts) where has derma filler; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), HEADACHE (headache), LIP SWELLING (swollen lip(filler in lip)) and DEPILATION (sensitivity (hurts) where has derma filler) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body ache), HEADACHE (headache), LIP SWELLING (swollen lip(filler in lip)) and DEPILATION (sensitivity (hurts) where has derma filler). At the time of the report, MYALGIA (body ache), HEADACHE (headache), LIP SWELLING (swollen lip(filler in lip)) and DEPILATION (sensitivity (hurts) where has derma filler) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medication was not given.
Patient received moderna vaccine on 4/13/21 and 5/11/21. Presented to ER on 5/7/22. COVID19 on 5/7/22. admitted on 5/7/22 with acute hypoxic respiratory failure secondary to COVID -19 pneumonia.  COVID test positive on 5/7/22.   Pt Initially required BiPAP and then high-flow oxygen.  CT chest with contrast done and show right-sided pulmonary emboli in addition to COVID pneumonia.  Pt continued on warfarin; will need follow up of labs as outpatient.  She completed treatment for COVID Pneumonia with antibiotics, remdesivir, Decadron and bronchodilator therapy.  She was followed by Infectious Disease and Pulmonary Services.  Overall she has done well and has shown improvement and pt states that she feels much better.  Pt with SpO2 in the 90s on RA today.  She can be taken off of isolation.  Pt has been accepted to an assisted living facility and is stable for discharge.  Pt to continue with Rehab and f/u with PCP as OP.  Discharged on 5/18/22
2 pts (husband & wife), both vaxed from the same vial exp inject site reacts; wife, who had reaction, entire arm was swollen & red; afebrile; no known allergies;
Headache, Arthralgia, PAIN/SWELL INJ SITE Narrative:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The treatment information was not given.   This case was linked to MOD-2021-008744 (Patient Link).
Pain between the spine and shoulder muscle stiffness on left side - neck down to the shoulder. From rate 1-10 (Pt says 8-9) experienced pain after 30 minute of vaccination, last about 48 hours.
Weakness, fatigue, mono-like symptoms X 7 days, following each vaccine. Pt recovered.
Covid 19 positive on 28Mar2021; This is a spontaneous report received from a Pfizer- sponsored program Covax US Support. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 23Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for covid 19 on 28Mar2021. The second dose is scheduled on 13Apr2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021360084
Given Shingrix & Pneumo 23 on 1/29/2020 (L) deltoid reddened area below injections approx. 3"x3"
Red stripe, almost like cellulitis, fever of 100.4, doesn't want to put pressure on her legs, tired, lethargic, acting like she feels achy.
79 yr. old female presents with concerns over recent vaccination with PREVNAR 13, was itchy and painful at time of injection and scratched periodically and noted expanding redness, warmth, around the site. No dyspnea, wheezing, or swelling of the mouth or tongue. Blood pressure is elevated today and is intermittently but prior significantly higher. She is on lisinopril and normally takes as prescribed. She does have a bruise near the region but husband notes was there prior to vaccination reaction, not applying any over the counter meds. A dog caused the bruise, she does take AKA daily.
12/17/2022 - 3 or 4 hours prior to my booster, my eyes were swollen, blood shot, and they were lacrimation. My eyes tear from the moment I open my eyes till the end of the day. I have used steroid drops, moisturizing drops to no avail. I need to have a stint, plugs, in my to help open the tear drops to keep the tears from coming out. The steroid decrease the inflammation in my eye itself. My eyes are tearing profusely everyday.
breathing harder; limitation of daily activities; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing harder) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (limitation of daily activities) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, CLONAZEPAM (KLONOPIN), PAROXETINE HYDROCHLORIDE (PAROXETIN +PHARMA) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced DYSPNOEA (breathing harder) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (limitation of daily activities). At the time of the report, DYSPNOEA (breathing harder) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (limitation of daily activities) outcome was unknown. Not Provided          Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-092161 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092161:Dose1
I began having severe shaking chills on 01/19/2021 in the evening. I kept being awakened by chilling and covered up on 3 blankets. I took my temperature at 11:00pm and it was 100.3 degrees. My normal is 97.3degrees. Around 1:00 am I was awake with nausea and stomach pain. I did doze off and on all night. I woke at 8:00 and my temperature had gone down to99.4. The nausea eased off. I rested all day. My arm was very sore and in the evening it was red. The next day I had no fever, but my arm was a little swollen and sore. The redness had increased and it felt warm to the touch. This began to subside on Friday and is now still a little red, but not painful. I had suffered with COVID in July. I assume this is why I had a reaction. It was much less severe that the infection.
Initial unsolicited report received from a non-health care professional on 12 September 2016. This case involves an 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, route, dose not reported) on an unspecified date. Patient's medical history includes diabetes. Illness at time of vaccination was not reported. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not provided. On an unspecified date, following the vaccination, the patient cannot move arm or hand (in frozen state) and experienced nausea. Lab data and corrective treatment was not reported. It was unknown that patient was recovered or not. List of documents held by sender: none.
Headache, Chills, Low Grade Fever, knee pain, collarbone pain Left arm swelling, burning, painful to touch all the way to fingers
First 24-48 hrs arm was sore and felt sleet but over all fine. 7 days later strong fatigue, muscle soreness, swollen glands. The. Injection site became itchy and hot and swollen and hard and raised. The next day the are covered grew. I used ice and Tylenol to mitigate symptoms but the injection site was not really affected. It remained raise, hot red etc.  Ibuprofen seems to have been more effective I  took it last night and this morning and the are was less hot and smaller. I went to my regular doctor he did not know about this condition but suggested I have ?covid arm.? He suggested I take Zyrtec and Benedryl to help everything calm down.
Child reported feeling sick 10 minutes after H1N1 vaccine administered, nausea, no vomiting, diaphoretic, pale, no loss of conciousness, low BP, EMS called, responded with in 5 minutes, cchild was monitored by EMS for 20 minutes, discharged to parents care and sent to War Memorial Hospital for evaluation.  Child did not require medication, was only monitored for one hour with out further incident and discharged.  Mother reports "child was OK 20 minutes after the incident".
Second day post 3rd booster - developed fever and severe sepsis due to left lower extremity cellulitis - he is being admitted to hospital for IVF and IV ABX.
Sharp, throbbing pain in the muscle, hurt really bad, and the pain spreading down to the elbow/arm. Patient put on ice pack, take ibuprofen to help with the pain. She said it helps a little bit.
I had significant pain (that impacted my ability to move my right arm) in my right armpit, back and breast in what felt like swollen lymph nodes. The entire region was very tender to the touch and hurt even when held completely still. The pain lasted for approximately one week .
I feel my arm sore at the injection site start the night after receiving the vaccine. The next morning around 11am (~20 hours after injection), I start to develop symptoms including chills, low-temp fever (99~99.8F), sore joints around the hip and the spine, increase in heart rate (~70~80bpm at rest) during the day. . I took 2 doses of NyQuil (Acetaminophen) that evening but the symptoms persist and start to get worse, especially with the soreness at the injection site.  The symptoms last until 48 hours after injection and were relieved after taking Advil (200mg, Ibuprofen). Despite most of my symptoms are relieved, the soreness at the injected arm lingers. I still have to take Advil occasionally.
Temperature up to 102.1; body aches; headaches; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on from 17Jan2021 10:15 at a single dose for COVID-19 immunization. The first dose was received on 27Dec2020 10:00 on the left arm (lot number: EK5730). Medical history included SVT, celiac gluten allergy. Patient was not pregnant at time of vaccination.  Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient experienced temperature up to 102.1, body aches, and headaches. Events started 10 hours after vaccine on 17Jan2021 20:30. Outcome of the event was recovering. No treatment was received. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Information about lot/batch number has been requested.
Throat swollen and inside cheeks swollen, no taste tongue and cheeks feel burning sensation when eat or drink.