chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT STATED SHE HAD PNEUMONIA; BAD REACTION TO THE COVID VACCINE THAT CAUSED BLOOD CLOTS; This spontaneous case was reported by a consumer and describes the occurrence of pneumonia (PT STATED SHE HAD PNEUMONIA) and thrombosis (BAD REACTION TO THE COVID VACCINE THAT CAUSED BLOOD CLOTS) in 53-year-old female patient who received apixaban (ELIQUIS) tablet for an unknown indication. Co-suspect products included Covid-19 Vaccine for an unknown indication. On an unknown date, the patient started ELIQUIS (oral), 5 milligram twice a day and Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced pneumonia (seriousness criterion medically significant) and thrombosis (seriousness criterion medically significant). The action taken with ELIQUIS (oral) was unknown. At the time of the report, pneumonia and thrombosis outcome was unknown. Patient stated she had pneumonia and a bad reaction to the COVID vaccine that caused blood clots. The strength of apixaban was 5 mg. For ELIQUIS (oral), the reporter did not provide any causality assessments.  Apixaban (ELIQUIS) is under agreement with Bristol-Myers Squibb.; Sender's Comments: BMS medical evaluation comment: This patient had pneumonia and thrombosis after apixaban therapy and COVID-19 vaccination. Based on the nature of the disease and its etiopathogenesis, the event pneumonia is considered not related to apixaban. Based on the limited information regarding the site of thrombosis and therapy details, it cannot be ascertained with the reasonable possibility that the apixaban could have caused the event.
Breakthrough case after Covid vaccination. Dose #1 1/21/2021 Dose #2 2/19/2021. C/O runny nose, sore throat, cough, and nausea/vomiting. Onset 8/18/2021
Pain in arm with itching. Headache    Fever.   Cold that my teeth clattered. Pain in arm with itch for 7 days
After patient fainted following the first dose of the Pfizer COVID-19 vaccine, 9-1-1 was called immediately and the paramedics came. Patient woke up and felt better.
Patient presented with a rash on his left forearm. He said he had taken antihistamines and it was resolving. He was instructed to go to the ER if it got worse of his breathing became affected.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patients concurrent conditions, medical histories and concomitant therapies were not provided. On 30-AUG_2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot # M018593, expiration date 28-JUN-2017; strength , dose, frequency and route were unknown). No adverse reactions were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient received varivax 11/24/1995.  Patient has never had wild chicken post.  Patient presented to clinic 10/15/2003 with diagnosis of herpes zoster.  Patient was seen at clinic on 10/15/2003.  Follow up on 10/28/2003: "This immunization was not done at our office.  The fax we received did not have info on it.  Immunization was done at another clinic, who is no longer in practice."
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 03-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Chills, fever, nausea, severe fatigue, cotton mouth,   Onset 16-17 hours after injection
Shot given 5pm. Pt experience rxn at night with hives and leg edema. Pt put HC 1% on rash & elevate legs.
Onset of  epileptic seizures  two months after vaccine in previously completely healthy person. No family history or risk factors for epilepsy. No childhood seizures.  Obviously unclear if due to vaccine but given onset of epilepsy in someone in their 30s is rarer and it was only two months after vaccine, I think it should be reported as possibly related.
symptoms include severe back pain, fever and headache after vaccine 01/19/2021. Patient had COVID-less than three months ago. Advised to see Family doctor
Adverse event for first vaccine:  Arm sore at injection site; fatigue Adverse events for second vaccine:  Within 8 hours of vaccine, fever of 101.8 lasting for 24 hours, headache, nausea, joint and muscle pain, loss of appetite, extreme fatigue, chills.  Fever, chills resolved in 24 hours; headache, nausea, joint and muscle pain, loss of appetite and fatigue still persist but better in the last 8 hours.  Took Tylenol every four hours, which helped.
Infant was seen 11/12/08 for pulling ears x 1 week.  He had no URI Sx or fever but mom reported one slightly loose stool that am, sl. decreased appetite and waking during naps and @ pm suddenly crying.  On exam, he had a right otitis media, was started on AMOXIL and given routine  4 mo old vaccines.  Within 24 hrs he ran a fever and 102.5 degrees (Ax).  They went to the ER the next day 2 degree fever and decreased appetite.  He had 1 loose stool on 11/12/08 then developed more watery stools the next day. No additional Rx was added at the ER.  The child was seen in our office again 11/21/08 with c/o watery diarrhea x 9 days at that point about every 2 hrs.  Fever had resolved 2 days prior.  The infant did vomit that day.  He was drinking PEDIALYTE well.  The vomiting was reported as nonbilious and the diarrhea was reported as nonbloody.  A stool Cx and stool rotavirus Ag were ordered (results never received).  Mom states the infant started having blood in the stool that pm.  The diarrhea was heavy (2-3 times an hour) for 3 to 4 more days then gradually cleared over the next week.  He did develop a bright red diaper rash during the heavy diarrhea stage.  Mom also states the baby "looked like a Downs Syndrome kid" while he was running the fever.
The evening of 6/18/14 the patients right upper lateral arm began to show redness, warmth , and swelling. Patient brought to clinic by father at 0800 6/19/14. Vitals WNL, with exception of 99.3 oral temperature. Patient examined by FNP, Benadryl 25mg every 6 hours ordered and follow up in clinic in am. Patient returned to clinic 6/20/14 No erythema or warmth noted, with decrease in swelling. Pt seen by FNP, instructed to continue Benadryl for 2 additional days and then discontinue.
infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (infection). At the time of the report, INFECTION (infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Redness, swelling, itching, inflammation. Visited Dr. MD prescribed KEFLEX 500mg three times daily #21 (per patient infection).
Patient was administered expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021 at 11:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 11:55 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine). On 16-Mar-2021 at 11:55 AM, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) to be not related.    No concomitant medications were reported  The patient has no known allergies.  No treatment medications were reported   This case was linked to MOD-2021-396123 (Patient Link).; Sender's Comments: This is a case of expired product administered for this 37-year-old male patient with no medical history reported. No adverse events were reported in association with expired product administered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
have had 5 of my wife's friends who had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2, Solution for injection), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "have had 5 of my wife's friends who had miscarriages".  Clinical course: Caller started referring to a document that was regarding breast feeding and pregnant women. Caller spoke for a while and then summarize by asking about information regarding breastfeeding and pregnancy with the Pfizer COVID19 vaccine. He mentioned both he and his wife were not vaccinated. The reporter had 5 of his friends' wife who had miscarriages.They had the COVID vaccine. All of our friends who had no COVID vaccine had a normal, healthy baby. So 5 out of 5 that were vaccinated had miscarriages in their third trimester and then one had a still born birth so he guessed that was 4 out of 5. No doctor linked any of that to the COVID vaccine and all those doctors- all those women were told, cause we actually they were in the same church and they were obviously were very mentally upset, but all their doctors, OBGYN, all of them recommended that they get the COVID vaccine because they said their baby was gonna get COVID or they could get COVID during it and their baby would die. They didn't give any data and that scared those women into getting the shot. They didn't provide anything.   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-202200677408 mother/baby case
This 57 year old  female received the Covid shot on  12/30/20    and went to the ED on 1/14/21     and was admitted  on /21 with the following diagnoses listed below. U07.1 - COVID-19 J12.82 - Pneumonia due to Coronavirus disease 2019
moderate pain that basically encircled my body just above the hips; back pain; abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 25Feb2021 at 12:00 PM (at the age of 69-year-old) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included allergies: yes, antibiotics. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 25Feb2021 17:00, the patient stated that, he didn't know if it's related or not, but later on the day of the first vaccine shot he started to experience moderate pain that basically encircled his body just above the hips. After 3 or 4 days the back pain lessened somewhat. Today, 10 days after the vaccine the patient still had some back and abdominal pain in that area. The patient was concerned that the second shot would have the same effect. Has pain in the area above the hips been reported by others or not. Treatment was not received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
her father who ise 93 years of age received the Penumovax 23 and then developed a COVID pneumonia; This spontaneous report was received from the patient's daughter and refers to a 93-year-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), administered for prophylaxis (strength, dose, route of administration, anatomical location, lot #, and expiry date were not provided).  On an unknown date, the patient experienced COVID pneumonia. It was unknown if the patient received treatment. At the time of reporting, the outcome of the event was not known.   The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.   Upon internal review, the event of COVID-19 pneumonia was determined to be medically significant.
Systemic: Fainting / Unresponsive-Medium, Systemic: pt became unresponsive and had seizure-like movement-Mild, Additional Details: administered moderna booster and then gave flu shot and before apply band-aid, pt lost conciousness and had seizure like movement. pt regained conciousness within 30 seconds
Headaches, extreme body ache (shoulders, back, legs, abdomen), mobility is difficult, including moving to a sitting or standing position. I experienced these same symptoms when I had covid last January-March along with double pneumonia.  I experienced the same extreme aches and pains after each vaccine shot. The pattern has been extreme pain for 2-3 days after which I begin to get relief. I am hopeful this time will follow the same pattern.
Was down for two weeks; Could have been allergic to the egg in the vaccine; Diarrhea; Vomiting; Fever 105.7; Felt horrible; This is a spontaneous case, initially received from other health professional via Med Communication (reference number: SEQ20-00490) on 03-Feb-2020, concerning a 18-year old female patient. The patient was 63-year-old at the time of this report.  The patient's relevant medical history and concomitant medications were not provided.  On an unspecified date in 1975, the patient was administered unspecified flu vaccine [influenza vaccine, dose, route of administration, batch number, expiration date and anatomical location: not reported] for an unknown indication.   On the same day, minutes after vaccination, the patient experienced a horrible reaction to the flu vaccine and was sent to the emergency room (ER). The patient described that she experienced a fever 105.7 F, vomiting, diarrhea and felt horrible. She was discharged home, where she was down for two weeks.  It was reported that ER doctor thought the patient was possibly allergic to the egg in the vaccine, the patient reported that they really did not know what the patient had reaction to.  On an unspecified date, the patient was recovered from the events.  The reporter assessed case as serious.  The reporter stated that a horrible reaction, which she experienced was due to the flu shot.  The reporter did not grant the permission for follow up.  Company comment: The patient experienced depressed mood, food allergy, diarrhoea, vomiting, pyrexia and feeling abnormal after vaccination with the suspect product, unspecified flu vaccine. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Reporter's Comments: The reporter stated that a horrible reaction, which she experienced was due  to the flu shot.; Sender's Comments: The patient experienced depressed mood, food allergy, diarrhoea, vomiting, pyrexia and feeling abnormal after vaccination with the suspect product, unspecified flu vaccine. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.
This spontaneous report as received from a health professional refers to a 15 year old patient of unknown gender. On 11-JAN-2016, the patient was vaccinated with a second dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the left arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of data logger. Concomitant therapies included influenza virus vaccine (unspecified). Additional information is not expected, as all required correspondence was received.
itch in the arm i got the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch in the arm i got the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itch in the arm i got the vaccine). At the time of the report, PRURITUS (itch in the arm i got the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
She woke up on the morning of 2/14/21, was not feeling real good, but noticed a tightness in her mouth.  Her cheeks were swollen, she felt that maybe her tongue was as well.  She got the liquid Benadryl and let it stay there and it helps that feeling.  She had taken the Zyrtec and Singulair the night before.  She did the inhaler puff in the morning, the feeling did not go away.  She then took the Ventolin and it seemed to calm down.   The symptoms then went away and didn't come back, and thought that she was ok.   She felt bad for about a week and a half like she wanted to sleep all the time, but did what she had to do.  She is fine now.
Two weeks after the first dose I had swollen lymph nodes on the left side of my neck. Two days after receiving the second dose I started experiencing very itchy blisters on big toes of both feet, as well as itchy hives on cheeks of my face. Symptoms are ongoing. I took a Benadryl.
-Trembling/felt cold -Extremely fatigued - exhausted, tired -Severe headache -Queasy - not vomit -Injection site very sore & red for 5 days (symptoms finally subsided by 3rd day) -Call CDC - asked if I could take Tylenol for pain
Patient received the vaccine on 4-9-2021, on 4-10-21 patient felt "blah," on 4-11-21 patient got up and around and was ok, on 4-13-21 patient was not feeling real great, but was tolerable, on 4-14-21, patient was feeling worse with blurred vision, throwing up, aches, doesn't want to eat, dizziness.  Recommended that patient contact their primary care doctor for further treatment.  On 4-13-21 pt went to ER and was admitted for one night, on 4-14-21 pt was dismissed from hospital, and is feeling improved.
During day after shot, some stiffness in arm (nothing unexpected). Leaving work about 5:30 pm, felt general muscle stiffness in neck/shoulder area, that was indicative to me of starting to feel an illness coming on. I then realized it was probably an effect of vaccine. Ate dinner and was starting to feel better. Went for walk and still had some right shoulder/upper arm stiffness, but otherwise felt good. Got home around 9pm and started to read. Stayed in about same position in chair for about an hour, and started feeling tired. I stood up and felt muscle and joint pain throughout my body. Felt feverish. Took Advil (2) but was feeling very uncomfortable, shaky, and joint and muscle pain all over. Went to bed and had difficulty getting comfortable. Slept on and off until about 4 am. Felt like muscle and joint pain were easing but by no means gone. Woke up a little after 7 am and emailed work saying I would try to be in by 11. Felt like fever had broke, but still had some lingering muscle and joint pain, but not as bad as earlier. Slept for two hours until 9:30 am. Woke up but still didn?t feel well enough to go into work. Most muscle and joint pain has resolved, but still feeling tired (possibly from poor sleep over night). Checked Unknown as to recovery as I still feel some negative impact and am hopeful that the bad feelings won?t return.
Light headed; Bodyache; Sweats; throwing up; Headache /extreme headache at night; Fever 101F; chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), PAIN (Bodyache), HYPERHIDROSIS (Sweats), NAUSEA (Nauseous) and VOMITING (throwing up) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), LAMOTRIGINE (LAMICTAL) and Breo inhaler for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced DIZZINESS (Light headed), PAIN (Bodyache), HYPERHIDROSIS (Sweats), VOMITING (throwing up), HEADACHE (Headache /extreme headache at night), PYREXIA (Fever 101F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headed), PAIN (Bodyache), HYPERHIDROSIS (Sweats), NAUSEA (Nauseous), VOMITING (throwing up), HEADACHE (Headache /extreme headache at night), PYREXIA (Fever 101F) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Woke up the next day with nausea, headache, dizziness, fatigue that lasted a full day. She also had irritation at injection site that continued to get worse throughout for the next 3 days.
Became gray with lips blue. Acted lethargic but not sloppy. Episode lasted about 5 minutes.
Began with rash on torso that still keeps spreading to more spots. Within 2-3 days of rash beginning, started with a stiff neck. Within 24 hours stiff neck became extremely painful. Swelling of neck on right side.
Flu-like symptoms (sore throat, sneezing, big area of redness/purple color at injection site.
Information has been received from a registered nurse concerning a teenaged female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Two or three months ago, the patient experienced syncopal episode. The patient fell and the reporter believed it was her head she hit on the table and the patient needed stitches. At the time of the report, the patient fully recovered. This is an amended report. The AE term of "head banging" was delete and the reporter term of "hit her head on table" was added to map to AE term of "head injury". Additional information has been requested.