chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearbeat faint; Vaccine exposure during pregnancy; This is a spontaneous prospective case, initially received from other non- health professional on 08-Aug-2019, concerning a 27-year-old female patient.   The patient's obstetrical history included two previous pregnancies with no stillbirth or miscarriage. Birth defect or congenital anomaly in any previous pregnancy was not reported. The patient's maternal or paternal medical history relevant to pregnancy was not reported.  The patient's medical history included amenorrhea and the patient was Rh negative.The patient's historical drug included oral contraceptives.   The patient's last menstrual period was not reported.  On 08-Aug-2019, the patient was administered intramuscular Afluria Quadrivalent [influenza Vaccine, batch number: not reported, dose: 0.5 ml, expiry date: not reported and anatomical location: deltoid] (explicitly coded as vaccine exposure during pregnancy) for influenza prophylaxis.   On unknown date, the patient experienced heartbeat faint and as reported not growing, but details were not specified.  The outcome of the event of faint was not reported.  The patient's expected date of delivery was reported as 21-Oct-2019.  Company Comment: The patient experienced syncope after vaccination with the suspect product Afluria Quadrivalent (influenza Vaccine). Reportedly, vaccination occurred during pregnancy. There is a lack of information regarding therapy dates and reaction onset dates, however the occurrence of adverse reaction was reported after exposure to the suspect product, making chronology unclear but plausible. Medical history of pregnant state may have contributed to development of the event. No diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal relationship between the suspect product and the event syncope is assessed as related and as not related per company conventions for exposure during pregnancy.; Reporter's Comments: The patient experienced syncope after vaccination with the suspect product Afluria Quadrivalent (influenza Vaccine). Reportedly, vaccination occurred during pregnancy. There is a lack of information regarding therapy dates and reaction onset dates, however the occurrence of adverse reaction was reported after exposure to the suspect product, making chronology unclear but plausible. Medical history of pregnant state may have contributed to development of the event. No diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal relationship between the suspect product and the event syncope is assessed as related and as not related per company conventions for exposure during pregnancy.
One day post vax, pt developed severe swelling, heat, and redness of the left thigh extending to the mid calf. Cellulitis of the leg was diagnosed. Pt was treated with Cephalexin for 7 days.
Information has been received from a physician via a newsletter. It was reported that male college roommates, aged 18 and 19 years, on unknown dates, had received 2 documented doses of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). They had fever, chills, and myalgia on 09-SEP-2007 and 10-SEP-2007, respectively; one had conjunctivitis. Both had a rash on 11-Sep-2007, detectable measles IgM antibodies in serum, and measles virus RNA by RT-PCT in throat swab specimens. No further information is available.  This is in follow-up to report (s) previously submitted on 5/30/2008.  Information has been received from a physician via a newsletter.  It was reported that male college roommates, aged 18 and 19 years, on unknown dates, had received 2 documented doses of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3).  They had fever, chills, and myalgia on 09-SEP-2007 and 10-SEP-2007, respectively, one had conjuntivitis.  Both had a rash on 11-SEP-2007, detectable measles IgM antibodies in serum, and measles virus RNA by RT-PCT in throat swab specimens.  No further information is available.
Fever; Arm pain; Fatigue; This is a spontaneous report from a non-contactable consumer.  A non-pregnant 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 21Jan2021, at 16:45 as single dose for covid-19 immunization.  The patient's medical history was not reported. There were unspecified concomitant medications; this was reported as antibiotics within two weeks of vaccination. No other vaccines were received within four weeks prior to the COVID vaccine.  On 22Jan2021, at 07:00, the patient experienced fever, arm pain and fatigue, which were non-serious. No treatment as received  for the events. Prior to vaccination, the patient  was not diagnosed with COVID-19, nor has the patient been tested for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of experienced fever, arm pain and fatigue was not recovered.
Large red warm to touch Lt. deltoid. Advised cool compress. Call in 24 hrs if not improved.
I have received the first (and only) dose of the Johnson and Johnson COVID-19 vaccine as of 6pm, July 7th 2021 and starting noticeably bleeding (menstruating) approximately 4 hours after I received the vaccine (10pm 7/7/2021).  It has been 23 days of continuous bleeding since I have received the vaccine (today?s date is 7/30/21).
Approximately 5 minutes after injection patient briefly lost consciousness. He became pale and started sweating. He appeared confused and his eyes had rolled back in his head. We attempted to move him to the floor as he appeared to be fainting but he then came out of it. He was confused and thought he had fallen asleep. He remained nauseous, pale and sweaty. 911 was called at the time of occurrence and EMTs came to assess the patient and took him to the hospital.
Edema & discoloration 20 hrs post vax; erythema present also was approx 115 x 60 cm yesterday night, presently 60 x 50 cm, red, hot, painful to touch;  To be seen by MD;
This patient received a Covid-19 vaccination on 1/28 at his post-acute skilled nursing facility. He began having fevers and low oxygenation the next day. He was brought to Hospital ED, tested positive for coronavirus, and was admitted to the hospital with Covid-19.  I do not know what brand or lot vaccine the patient received. The SNF should have those records.
Ten hours after receiving vaccination, I began to feel ill. Chills, low grade fever 96.4. Elevated blood pressure. Extreme body and joint aches that prevented me from sleeping.  Headache. Sore arm. Hip pains.
Initial and follow up information has been received from a physician, nurse and a 35 year old female with a shell fish allergy, and a history of abnormal PAP test (February 2008), colposcopy (April 2003), biopsy (April 2003), and low grade CIN 1, who on 01-MAY-2008 was vaccinated intramuscularly in the lateral part of the thigh (unspecified which thigh) with her first dose of GARDASIL vaccine (yeast) (Lot # 660387/1967U). On 01-MAY-2008 the patient experienced injection site pain. On approximately 03-MAY-2008, also reported as "a couple of days later", the patient experienced leg muscle pain, muscle pain in the hands, knees and ankles, joint pain in the hands, knees and ankles and general tiredness. On 08-MAY-2008, the patient called the doctor's office and was treated with over the counter ibuprofen. The patient was to call the office if symptoms did not improve. At the time of the report, the patient had not contacted the doctor's office again. Subsequently on an unspecified date, the patient recovered from the injection site pain, arthralgia, fatigue, leg muscle pain, and muscle pain in the hands, knees and ankles. No further information was provided. Additional information has been requested.
injection site hardness; injection site redness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site hardness), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (injection site redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced VACCINATION SITE REACTION (injection site hardness) and VACCINATION SITE ERYTHEMA (injection site redness). At the time of the report, VACCINATION SITE REACTION (injection site hardness), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
My 17 yo teen son was given his meningitis booster (in arm) vaccine on 11/11/20 & by 11/12/20 he had significant soreness & swelling.  As of today, 11/16/20, swelling/tenderness are still present.  I attempted today, 11/16/20, to contact Doctor's office on several occasions but the number is ringing busy, failing or not going through as they are clearly experiencing phone problems.  ***** I AM GUESSING AT THE EXACT TYPE OF VACCINE.  THIS WAS HIS MENINGITIS BOOSTER.
At roughly 4pm the day of vaccine I started to feel generally sore in my muscles. At around 7pm I started to become light headed, had a headache, and bad muscle pain. My fever at this point measured 102f. These negative effects increased over the next few hours until I fell on the floor and couldn't get up without help from my wife. I felt like I was going to pass out every five seconds, threw up twice, my muscles kept contracting and relaxing and were intensely painful. Around 12:30am Saturday morning we went to the emergency department. I needed a wheelchair to get around. The wait at emergency was too long, and by 3am we went back home. I was feeling slightly better, but still not great, and my fever had reduced. I rested on Saturday with less severe but still considerable symptoms, and took paracetamol. Now on Sunday I feel sick and a little sore and very tired, but mostly better.
Erythema, Induration, swelling 15.5 x 17.5 cm.  Treatment cold compression.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient has pain redness and tenderness around site of injection can not lift arm above her head
Started with right ear pain, which became within several days severe Bell?s palsy.  I had complete right sided facial paralysis, including the right side of my mouth, throat and eye not closing. I had extreme fatigue, facial pain, ear pain, throat pain, difficulty swallowing. This took 1 month to have improvement. Also had some elevated heart rate.
10:45 vaccine given. 11:15 reported redness, itching at site. 11:25 1 Benadryl po administered. 12:05 re-eval. 13:05 re-eval.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild
Getting scratches and not healed up; Getting scratches and not healed up; Some blood coming in urine; This is a spontaneous report from a contactable consumer (reporting for husband). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 10Apr2021 (Lot Number: EW0150; Expiration Date: Jul2021) as single dose for covid-19 immunisation. Patient History and Investigation Assessment were reported as none. Concomitant medications were not reported. The patient got his first Pfizer dose for Covid on 10Apr2021 which was on Saturday and after that like another 24 hours after his first dose. He had some blood coming in his urine. It was not too much; it was less but it was there. At least for 24 hours or may be 26 hours. It was 10Apr2021 only. Like he got his vaccine in the afternoon and towards the evening he noticed that. He had beet root also that afternoon like it might and also not sure if that was the thing. But he saw that in the evening and approximately in the night and then next morning it was fine. After that he did not had any issues but he was getting a lot of scratches even if his daughter scratches him he was getting a scratch and that was not getting healed up. It had been like two days he had got a scratch and that was not getting healed up that was they got a little worried. No treatment was received for events. They were wondering if they need to go and get any blood work done before the second dose because he would have his second Pfizer dose on 28th. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Everyday for the following 8 days after the vaccine I had a severe migraine with visual aura. 2 days after the shot I had 4-5 aura migraines.  I also experienced a flare up of eczema on my right pointer finger knuckle on the back of my hand.  The flare up lasted the same amount of time.
Headache, Fever, Body Aches, Drainage from eyes, dry cough, hard to lift left arm where shot was given. These symptoms went away the next day (Friday 11/12/2010), but a lymph node has now swelled in my neck on the left side, same side the shot was given on.  Also, had strange hiccups, like no other, wake me during the night Friday 11/12/2010.
After 6 days second vaccine shot, my heart rate was not normal, it was skipped.  I felt very tired.  It happened suddenly at anytime, such as early morning, or driving a car?? I visited my doctor on 4/13.  He monitored my heart,  but he didn?t find this problem. This problem continued about two months.  I am ok now. In that time, I didn?t think about that it might relate to vaccine.  Until now, we may have third shot, I am scared if it will happen again after third shot.
Left upper arm local reaction to either flu or pneumonia vaccine. 19 cm x 11 cm reaction area.
Vaccine #2 of Hep B series given 6/16/11 positive cutaneous reaction began 6/20/11 positive hard, swollen area in site of injection, no fever, no rash.
puffy face; swollen lip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (swollen lip) and SWELLING FACE (puffy face) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced LIP SWELLING (swollen lip). On 20-Apr-2021, the patient experienced SWELLING FACE (puffy face). At the time of the report, LIP SWELLING (swollen lip) had resolved and SWELLING FACE (puffy face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Treatment information included cetirizine for swollen lip and diphenhydramine for puffy face.
I experienced after my 3rd dose, rashes on my legs. I still have a little bit of rashes on my legs. I was given cortisone cream to apply by a dermatology center. I also had eczema on my hands also but do not know if it related to the vaccine or it coincidental.
Chronic right shoulder pain, reduced range of motion Intermittent pain in right hand Intermittent shortness of breath Increased fatigue
FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Pfizer (BNT 162) form of admin, route of admin, batch number and expiry date not reported) dose was not reported for prophylactic vaccination (dose number series 1). The patient had serious anaphylaxis with previous covid-19 Pfizer (BNT 162) vaccine (dose number series 1). The patient received booster with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date not reported) dose, 1 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination (dose number series 2). 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 an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s the patient had fever (dose number series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Temp. 102 degrees started April 17th in the pm.  Fever went to 103.7 on April 18th in pm.  Used Tylenol to help reduce fever, also used ice pack on groin area and under arms.  Had a few red dots on body and progressively got more as the days went on.  Fever lasted until April 21st, which was a low grade 99.7.
only the diluent of the Pentacel was delivered to the patient / no AE; Initial information received on 02-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received only diluent from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] batch number U6257AA (expiry date 27-Oct-2020) via intramuscular route in the left vastus lateralis for Prophylactic vaccination And Box Lot UJ056AA (expiry date 27-Oct-2020) (PT inappropriate reconstitution technique).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCIN).  It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that only the diluent of the Pentacel was delivered to the patient)  At a time of reporting no adverse events reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any thirdparty has contributed to or is to be held liable for the occurrence of this medication error.
Patient developed shortness of breath on 9/25, went to the ED the next day and was diagnosed with a saddle submassive bilateral pulmonary emboli as well as bilateral lower extremity DVT's and is receiving treatment with heparin in the hospital. Interventional Radiology refused intervention due to patient's advanced age and CT surgery is consulting to see what they will do.
Administration PNEUMOVAX into right upper arm and patient developed a 4-5 cm raised erythematous patch which decreased over 24 hours rt 02/21/2012 Fluticasone nasal spray 2 sprays into each nostril daily - start 02/21/2012 Aspirin 81 mg by mouth daily - start 02/21/2012 Atenolol 25 mg by mouth daily - start 02/21/2012 Enoxaparin sodium 40 mg subcutaneously daily - start 02/21/2012 Acetaminophen 650 mg by mouth every 4 hours as needed - start 02/20/2012.
3 days after getting vaccination I was fatigued and not able to complete all of my things, took vitamin C and rested, day 4 woke up in sweat, today day 5 red itchy hives on palms but no other symptoms
nauseous/felt like throwing up again; slight temperature which was about 100degF; not feeling good; threw up everything; still felt sick in my stomach; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (threw up everything), ABDOMINAL DISCOMFORT (still felt sick in my stomach), NAUSEA (nauseous/felt like throwing up again), PYREXIA (slight temperature which was about 100degF) and FEELING ABNORMAL (not feeling good) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VOMITING (threw up everything), ABDOMINAL DISCOMFORT (still felt sick in my stomach), PYREXIA (slight temperature which was about 100degF) and FEELING ABNORMAL (not feeling good). On 07-Mar-2021, the patient experienced NAUSEA (nauseous/felt like throwing up again). At the time of the report, VOMITING (threw up everything) outcome was unknown and ABDOMINAL DISCOMFORT (still felt sick in my stomach), NAUSEA (nauseous/felt like throwing up again), PYREXIA (slight temperature which was about 100degF) and FEELING ABNORMAL (not feeling good) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-037195 (Patient Link).
Patient received the second Moderna vaccine shot on 041021.Wednesday morning at 6:15am , May 19 she felt bad that morning, She received a 4mm stent for the 100% blockage in the left anterior descending artery. She had a massive heart attck. She remained in the hospital for 3 days. She has 0 Risk factors for heart disease. Hospital. 3 day Stay May 19 before noon, released May 22 2021
This spontaneous case reported by a consumer, describes the occurrence of erythema (red), vaccination site warmth (warm), peripheral swelling (swollen) and pruritus (itchy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 046A21A) for COVID-19 immunization. Concomitant products included rosuvastatin and melatonin. On Mar 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 26, 2021, patient experienced erythema (red), vaccination site warmth (warm), peripheral swelling (swollen) and pruritus (itchy). At the time of the report, erythema (red), vaccination site warmth (warm), peripheral swelling (swollen) and pruritus (itchy) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments.
Per Client received second dose of Moderna COVID 19 vaccine in right arm on 3/29/31 at around 2:00pm. Client expressed on 3/29/2021 at 4:00 pm having nausea, emesis and sore arm. Client on next day, 3/30/2021 experienced increase pain in right arm and now left arm. Client also experienced soreness, tightness, swelling an arm pit swelling. Client applied ice pack to right arm, rested arm and followed up with PCP. Client stated that arm is improving. Provided education on Moderna COVID 19 vaccine to Client. Client also informed to continuing following up with PCP.
Woke up 11-5-08 with pain in (R) arm. (R) deltoid tender to touch. Arm from shoulder to elbow warm, red. Used warm, moist compresses to remove medicine from muscle. 11-6-08. (R) arm not as swelled, still hurts, and is red. Has used Aleve for pain.
Tachycardia, swollen red painful deltoid that began 8 days after injection. patient felt fine in 8 days prior to that injection. patient to take Benadryl and return to urgent care or er if worsening or change in condition.