chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID after fully vaccinated; Tested positive for COVID after fully vaccinated; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old (non-pregnant) female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: EP6955, expiration date: not reported), via intramuscular route, administered in right arm on 12Apr2021 as dose 2, single and patient had earlier received dose 1 of bnt162b2 (COMIRNATY, formulation: intramuscular, lot number was EP6955 expiration date was not reported), via intramuscular route administered in right arm on 22Mar2021 as dose 1, single for COVID-19 immunisation. Age at vaccination was 47 years. Medical history included dry eye, Chronic pain in hands from an unknown date and unknown if ongoing. Known allergies were none. Patient was not pregnant at time of Vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within 2 weeks of vaccination) included pregabalin (LYRICA) 25mg (2 per day), probiotics, colecalciferol (VITAMIN D [COLECALCIFEROL]), omega 3 (OMEGA 3 [FISH OIL]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. On 15Oct2021 at 20:00 the patient was tested positive for covid after fully vaccinated. The most recent COVID-19 vaccine was administered in workplace clinic. On 15Oct2021 the patient underwent lab tests and procedures which included PCR (polymerase chain reaction) with result positive and Covid test (SARS-CoV-2 test) with result positive (nasal Swab). No hospitalization. Therapeutic measures were not taken. The outcome of events was recovering.  Follow-up attempts completed. No further information is expected.
Soreness in arm starting the day of vaccination starting 6/28 eye twitching, 6/30 numb tongue followed by no taste, 7/2 facial paralysis
Experienced an electric shock; She thinks she has an allergy to the vaccine since she had three marks on her back like on the skin; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6208, Expiration date: Unknown) via an unspecified route of administration on 19Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she received the second dose on 07Apr2021; the lot number is EW0153, unknown NDC number and expiry. In 2021 the patient experienced an electric shock, and she thinks she has an allergy to the vaccine since she had three marks on her back like on the skin. Caller stated she got the vaccine the first and second dose and on the first dose, she had experienced an electric shock, but she thinks she has an allergy to the vaccine since she had three marks on her back like on the skin. Caller stated Pfizer should send her straight to the doctor since the marks happened after the second vaccine. There was no product complaint to this report. A medical information request was there. The clinical outcome of the events was unknown.  follow-up attempts are possible, additional information has been requested.
Received vaccine 10/24/07. Red swollen area started 10/25/07. To see MD 10/26/07-area approx 3" x 3" on left arm, red, swollen, warm. To use Benadryl as needed. Keflex if not improved in next 2-3 days
Patient was given a monovalent pfizer vaccine as a booster. Patient should have been given the bivalent pfizer vaccine. No adverse outcomes. PCP consulted. Per CDC, in general, do not repeat dose unless a provider indicates a need for repeat dose with bivalent. Per PCP, no additional dose needed.
pt reports residual pain - states shot high on arm - states immunizer changed needle sizes before giving prevnar in other arm - no issues with prevnar - only with hd flu - rec pt f/u w/dr as pain from flu shot should not be present 1mo later
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains age group added and narrative updated.
I gave Infanrix to a child over 7 years old instead of Adacel. No symptoms while in clinic.
Pt c/o generalized numbness/tingling in all extremities lasting 3 days & resolved. She then c/o generalized discomfort with both arthralgias & myalgias, shoulders, back, hip, along with muscle pain. Denies any fever, N/V/D, or site reaction. Symptoms improved with no medical attention or treatments.
On 7-4-2022, I started having a sore throat. The following day, I just generally did not feel well and had chest congestion. On 7-6, I ran a low grade temp of 100.1. On 7-7, I started having chills. body aches and fatigue. I took a home Covid 19 test with positive results. I called the doctor and they scheduled me a telehealth visit for 7-8. They wanted me to come in for a Covid test so we drove to the back of the clinic drive thru and they tested me for Covid. On 7-9, the doctors office called and told me the PCR was positive and told me just to stay hydrated and to rest. On 7-10, I noticed slight shortness of breath. On 7-11, I started having symptoms of a bladder infection and the doctors office wanted me to come to the office for a urine test which showed Ecoli infection. They prescribed Nitrofurantoin Mono-MCR. On 7-13, I started having abd discomfort/pain. This continued thru morning of 7-16 so I went to the local ER and the doctor gave me an injection of Toradol for the pain/inflammation and another medication that I am not sure of the name but it was for inflammation as well. He felt like it was Covid fatigue muscle spasms.  I am feeling a little better today but I still have lingering chest congestion and fatigue. I am reporting my breakthru case of Covid.
Seriousness criteria other medically significant (OMIC). This case involves a cluster of five female (no specific identification provided). The patients had all received vaccinations with Fluzone SV 2005-2005 USP on unspecified dates. The vaccines were received at the local health department and were from three different lots. No information on the specific lot numbers was provided. An unspecified amount of time following vaccination, the five women experienced intra-uterine fetal death. Two of the patients were sisters. Of the five total patients, two of the fetuses were at 37 to 40 weeks gestation at the time of fetal death, and three were 20 to 36 weeks. There was no available information on the causes of deaths in the fetuses or if autopsies are planned. It was not reported whether any of the five female patients recovered from the events.
AUTOIMMUNE DISORDER; CRYING NON-STOP; FELT VERY COLD AND HOT; NOT BEEN FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after vaccination, the patient had been crying non-stop, was having bowel issues, was experiencing pain in stomach under ribs, and felt very cold and hot. The patient had generally not been feeling well. It was reported that the patient had an appointment with her doctor and was told that the results of her fecal sample showed that she had an autoimmune disorder. Laboratory data (dates unspecified) included: Stool analysis (NR: not provided) autoimmune disorder (unspecified). It was reported that the patient was feeling progressively unwell during the time of this report and stated that she needed to lie down and could not provide any further information at this time. The patient had a colonoscopy scheduled on Wednesday, 18-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not been feeling well, and the outcome of crying non-stop, felt very cold and hot and autoimmune disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210832464--Autoimmune disorder. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recv vax & devel body rash, fever, headache,"lost the ability to speak the 6-10 words she knew, severe hypersensitivity & sensitive to touch & sound;
Shot was in right arm, when I woke up at 4:00 am I was shivering and very tired.  Both of my shoulders hurt, after 24 hours my left shoulder and arm (which 5 years ago underwent a shoulder repair) continued to hurt and continues to hurt to date.  Constant throbbing, burning going down my arm into my elbow that also hurts which also had surgery repair about 6-7 years ago.  Icing helps briefly but the pain is immense.
Patient received Moderna Covid 19 EUA vaccine at 5:05pm and reported feeling nauseous and anxious at 5:21pm. Vitals: 5:25 135/92, HR 103, O297% 5:30pm 126/90 HR112 O2 96% 5:35 128/83 HR100 O296%, 5:40pm 129/89, HR101 O297% 5:45pm 134/89 HR98 O2 97%.  Patient reported nausea came and went and he was given water.  By 5:45 patient reported feeling better and was released with instructions to call MD or go to ER if symptoms recur.  Patient has history of taking flax seed daily to lower heart rate, which he stated often ran high.  Patient also has history of prostate issues
30 minutes after shot I had chills. At home my temp was 101. Chills all day & night day of shot. Next day 4/20/2021- I still had a fever of 99-100, headache, body aches and tiredness. Day 3-4/21/2021- headache & body aches but no fever. Diarrhea showed up today as well. Day4-4/22/2021- diarrhea & tiredness; Day 5-4/23/2021- back to normal
I have been getting hives on my stomach, lower back ,armpit and above eyebrows every night. This has been happening for five days straight. I had to take Benadryl and put Cortizone on rash. When i wake up in the morning I am fine. My hives seem to only appear at night .
4/5 Night sweats; 4/9 dizziness at work.  Admitted to the hospital on 4/20/21 with fever, dry cough, difficulty sleeping, shortness of breath, headaches and muscle aches and pains
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of Gardasil. Subsequently the patient developed a small itchy rash, pain. Subsequently, the patient recovered from small itchy rash and pain that lasted 2 days. On an unspecified date the patient was vaccinated with a second dose of Gardasil. Subsequently the patient developed a large itchy painful rash that lasted 2 weeks. Medical attention was sought. Additional information has been requested.
Patient experienced dizziness within 5 minutes that lasted intermittently for 30 minutes.
menstrual cycle 1 week early on 11/8/21 then again on 11/27/21.  Only change was getting the booster.  Menstrual cycle normal and regular prior to this.
shortness of breath, difficulty swallowing, headache, chest pain, anxiety, and tremor
fever-cleared w/in 24hr;t100.8ax;vomited x 2;
Patient received expired dose of Moderna COVID-19 Vaccine; Patient received 0.5 ml 4th dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 Vaccine) and ACCIDENTAL OVERDOSE (Patient received 0.5 ml 4th dose of Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     The patient had no known allergies and was not diagnosed/tested positive for COVID-19. The patient had no chronic conditions or long lasting heath conditions and not had acute illness at the time of vaccination and up to one month before.     On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 Vaccine) and ACCIDENTAL OVERDOSE (Patient received 0.5 ml 4th dose of Moderna COVID-19 Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 Vaccine) and ACCIDENTAL OVERDOSE (Patient received 0.5 ml 4th dose of Moderna COVID-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The number of doses/vials was 28. The date of the vials initially stored in the refrigerator was unknown. The vials did not undergo any temperature excursions. The frequency was reported as times per. The patient had not experienced any adverse event.  No treatment medications were reported.
Hard swelling at injection site; tenderness; bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above); bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Hard swelling at injection site), TENDERNESS (tenderness), CONTUSION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)) and SKIN DISCOLOURATION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 19-Oct-2023, the patient experienced INJECTION SITE SWELLING (Hard swelling at injection site), TENDERNESS (tenderness), CONTUSION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)) and SKIN DISCOLOURATION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)). At the time of the report, INJECTION SITE SWELLING (Hard swelling at injection site), TENDERNESS (tenderness), CONTUSION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)) and SKIN DISCOLOURATION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were provided.   Reporter did not allow further contact
2 hours post vax, the mother called to report that the child looked pale and not very active. She was advised to take child to ER; in the ER the child was reported to be having a fever. She got better and was discharged home.
Tiredness; Chills; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 11Apr2021 at 12:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included type II diabetes, factor 5 leiden and COVID-19. The patient did not have any allergies to medications, food or other products. Concomitant medications included metformin (METFORMIN), vitamin d nos (VITAMIN D) and sitagliptin phosphate (JANUVIA); all from unknown dates for unspecified indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced tiredness and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On an unknown date, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The clinical outcome of the events tiredness and chills were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
Woke up morning after the injection with pain in the generalized area of the injection site. As the day progressed the pain spread throughout my body and by 2 PM I took one extra strength TYLENOL and one regular strength Ibuprofen, wrapped up in a heavy blanket and wondered how bad to allow it to get before I went to the hospital. I slept for about 2 hours and woke up with noticeable improvement. As of today 3/10/19 my left arm muscle has bouts of pain handled with TYLENOL.
Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 4 year old female patient. On 18-APR-2017, she was vaccinated with VARIVAX lot # M039615, expiration date 20-SEP-2018 which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received.; Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008916: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008921: US-009507513-1706USA008922:
FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. o The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced  fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some fatigue the following day on MAR-2021. This report was non-serious.
Around 8 pm (about 6 hours after receiving the vaccine) I started to feel typical flu symptoms such as chills and aches, and I had some body shaking as well. I was in bed that night and the symptoms kept getting stronger, and around 11 pm I started to feel tingling throughout my body, mostly in my hands and feet. It was very uncomfortable to lay still and I felt I'd never be able to fall asleep if I couldn't lay still. I took 10mg of Z-Quil around 11:30 pm. My body and skin was also starting to get very hot, I never took my  body temperature but I probably had a fever. I put a cold compress on my forehead. I also took 1000 mg acetaminophen and 400 mg Advil. I got up to use the bathroom and I could walk but my balance was off and I felt tingling up my legs. I laid back in bed with the cold compress again and the tingling in my hands and feet increased. I tried walking around again and again felt tingling up my legs. I sat on the edge of my bed moving my feet around which helped the tingling, but when I laid down again the tingling kept coming back. I took another 10mg of Z-Quil and 0.25mg xanax (prescription for anxiety). I finally decided to move to a chair with lots of pillows so I could sit upright since that helped reduce the tingling. I finally fell asleep sometime after 12:30 am. I woke up in the chair around 2 am and was feeling better - no tingling, no body shaking, chills and aches were reduced and body temperature didn't feel as high. I was then able to sleep in bed for the rest of the night. The next day I still had aches and chills and a fever but it was manageable with Advil or acetaminophen, and by Monday (March 8) I was able to go to work.
Two weeks after the  first vaccine was administered the patient experience fetal death intrauterine. Pt was 18 weeks and 5 days. G4P3  EDD 10/3/21
injection site RXN - 8-8.5 annular, raised erythematous lesion, painful, pruritic to R arm systemic RX - lower limb weakness, dizziness, loss of appetite, fever.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient did not have any anaphylaxis, main complaint was mild tightness under chin between jaw and lymph nodes 20 minutes post immunization lasting for a max of 30 minutes. Also mild tingling in forearm a few minutes after injection.
April 15 - chills, body aches, head cold/pressure, headaches, extreme fatigue; April 16 - body aches, head cold/pressure, headaches, extreme fatigue, April 17 -  head cold/pressure, headaches, fatigue; April 18 -  head cold/pressure, headaches, fatigue; April 19 -  head pressure, headaches, fatigue; April  20 -  head cold/pressure, headaches, fatigue (taking Dayquil, Ibuprofen, acetaminophen without much relief)