chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weird side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Weird side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Weird side effects). At the time of the report, ADVERSE EVENT (Weird side effects) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.  Treatment: Not reported.
2 year old female was fine prior to immunization, she was eating dinner and slumped over. Mom thought she was choking. Patient was clearing her throat and mom states she felt warm. Mom gave MOTRIN, then she began to shivering. Mom put her into the car and mom states she began to seizing.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 17:15 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Covid rebound. I test positive and felt covid symptoms 4 days; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Known allergies was none. The patient received antiviral treatment from 13Nov2022 to 17Nov2022 for COVID 19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Eight days after getting vaccine developed itchy rash in region of right upper side area, under arm pit.  This was diagnosed as shingles on 5-31-2021.  Acyclovir and Lidocaine cream prescribed to use for 7 days.  Second dosage of vaccine rescheduled.
pt recvd vax 27JUN95 & on 10JUL95 pt devel three lesions on leg, one lesion on tongue & was irritable;no further details were provided;
Sudden Hearing Loss in Left Ear & Tinnitus- On April 26, 2021, 12 days after my second Moderna vaccine. I woke up with no hearing in my left ear. I had my ear checked and there it was not infected, my primary care physician suspected it could be Allergies to pollen and said to take Fluticoasoe Propionate Nasal spray twice a day and one tab 24 Hr. Claritin D one time a day. After 4 days with no improvement to the hearing in my left ear, I decided to see an ENT. My first appointment was Friday, April 30, 2021, my Audiological Evaluation was 30 (mild) range in right ear and below 96 (profound) in my ear. The doctor prescribed an MRI (which came out normal), and put me on Prednisone 10mg for 12 days. I completed my oral Prednisone 20 mg 12 Day pack as prescribed, on my third visit (05/14/21) to ENT (slight improvement to hearing) he began Steroid injections into my left ear. Thus far I have had four steroid shots 05-18-21, 05-21-21, 05-25-21, each Audiological Evaluation since receiving the steroid injections show steady improvement and my hearing range is mild to moderate to severe. I am scheduled for another steroid injection and hearing test on 06-01-21. ENT also started me on Lipo Flavonoid for Tinnitus 6 pills a day (which has not improved). Last appointment on June 8/2021.
Headache LIGHTHEADED, CHILLS, FATIGUE, LEFT ARM PAIN Narrative:  Other Relevant History:
Pt received 4th Anthrax and noted joint pain (excessive) in hips, knees and right wrist, 48 hours, post vax. He did not associate pain with the injection. Pt thought he had injured himself. Symptoms subsided slightly. Post vax of 5th Anthrax, he noted same symptoms, 48 hours after injection. Symptoms, all persist. Difficult for pt to jog. Complaining of fussiness.
second dose, labs drawn, PSA elevated; This case was reported by a consumer via call center representative and described the occurrence of prostate specific antigen increased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2022, the patient received the 2nd dose of Shingrix. On 12th May 2022, 2 days after receiving Shingrix, the patient experienced prostate specific antigen increased. On an unknown date, the outcome of the prostate specific antigen increased was unknown.   It was unknown if the reporter considered the prostate specific antigen increased to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-May-2022 Reporter's Comment: This case was reported by the patient's wife. The patient received dose of Shingrix vaccine and when the patient went get his labs drawn for PSA (Prostate specific antigen) it was elevated. The reporter did not consent to follow-up.
Swelling in armpit of arm which received shot. Minor swelling in neck lymph node on the same side. No swelling in either area on the other side of the body
Pt presents to ER via EMS with c/o dizziness 2/16. Pt admitted from ed, pt vital signs stable, pt oriented to room and unit, pt received dinner, tele monitor in place pt in SR, pt denies pain. COVID positive 2/16. Pt is aox4, on RA not in acute distress, c/o headache, with ongoing IV fluid infusing well, external cath in placed 2/19. Patient is A&O x 4. Able to sit up in a chair with two person assist. On room air. No complications 2/21.  5/23 pt denies any new c/o., denies any SOB, CP, N/V/D or abdominal pain. Discharged on 2/23.
Fever 101.8 Chills headache nausea red rash on injection arm for 72 hours
Arm was red, warm, swollen, hurt. No SOB/wheezing/systemic rash.
Initial: fever, severe headache, lethargy, malaise, body aches, joint pain, left arm pain (next day unable to use arm, by day 2 painful but useable).   Day 7: Stabbing Left medial Chest pain especially with activity, shortness of breath with exertion and while lying supine, audible wheeze when lying supine, generalized non-pitting edema, 1+ pitting edema in hands,  3+ pitting edema in ankles and feet (tops of feet swelled to overlap medial toes and unable to wear my shoes).   Current: dyspneic with exertion, fatigue, chronic cough and audible wheeze when supine, dependent edema in ankles, feet and hands, decreased lung capacity. Unable to breathe deeply without need to cough and unable to hold notes while singing compared to pre vaccination. My air just cuts off much quicker
"I started to have muscle weakness and spasms. The area (vaccination site) is tender to the touch".
On 9AUG91 pt devel fever of 102-105; On 10AUG91 pt devel diarrhea; on 12AUG91 devel rash & runny nose; Taken to MD 12AUG91 afternon & dx w/heat rash & tonsilitis; Pt put on amoxicillin & rash got worse;  dx w/PCN allergy;
1) Inconsolable fussiness lasting greater than or equal to 3 hours within 48 hours of DTaP. 2) Fever to 103 degrees within 24 hours of DTaP. No treatment necessary.
a few minutes after receiving her vaccine the patient complained of feeling flushed, lightheaded, mild headache.  she had no rashes or shortness of breath.  It was a few minutes before the patient reported to the observation nurse that she was having these symptoms.  By the time I was called over, the patient stated she was already feeling better.  Her vital signs were recorded and her case was discussed with the doctor on duty.  The patient was kept for an additional 10 minutes of observation.  Her symptoms completely resolved and she was discharged to home after the doctor saw her per the doctor's instructions.  The patient left the clinic ambulatory with out any further complaints.
This is a spontaneous report received from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced behind the arm it was red swollen and in pain. It lasted about a week.
Patient reported itchiness on her neck, leg . Pt has a history of anaphylaxis. MD administered Zyrtec PO
little flare up of her asthma; get sicker; respiratory illness; This is a spontaneous report from a non-contactable consumer or other non hcp. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced little flare up of her asthma, get sicker and respiratory illness. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash to Face, neck, ears, chest & forearms.   Swelling to lips, nose and eyes.
still foggy; some short term memory issues; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the right arm on 24Mar2021 at 17:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure and allergy. Concomitant medications included unspecified medications for blood pressure and allergy, taken from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 18:45, the patient experienced foggy which was still present at the time of this report and had some short-term memory issues. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events foggy and short-term memory issues were resolved with sequelae on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Pain in vaccinated area for three day.  Felt freezing cold for two day.  Had to take Tylenol.
getting uncomfortable pain in shoulder; getting uncomfortable pain in shoulder; not able to sleep at night; throbbing pain in his shoulder; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that, he took first vaccine Pfizer two and half weeks ago and now started getting uncomfortable pain in shoulder not able to sleep at night it didn't happen right away, couple of weeks afterwards. Put a heat and cold pack and kind of relived the pain but came back and throbbing pain in his shoulder on an unspecified date. Patient wants to know why it took so long to cause a side effect and how long this will continue. Scheduled for the 2nd dose next week and do not want to take it on the same arm. If I refuse to take the shot this week how long can I wait to take the 2nd dose. Outcome of event was Unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained. No further information expected.
He doesn't recall any new symptoms until almost exactly 24 hours after receiving his Pfizer COVID-19 booster (3rd dose) when he developed 5-6 days high grade fevers to 102 range, with fatigue, dizziness, headache. He had some improvement in symptoms but had ongoing lower grade fevers regularly from 100-101.5 degrees F range thereafter then with ongoing fatigue, some dizziness/unsteadiness, headaches that worsen with fever. He developed non painful, non-pruritic rash on his back 9/14.21 which subsequently spread diffusely all over his body and face and he developed about 9/18/21 dry non-productive cough. Skin rash became diffuse over most of his body with erythematous nodules and plaques. He acutely developed dizziness/fatigue on the day of admission and was found to have atrial fibrillation with rapid ventricular rate and hemoglobin 6.6. He was admitted to hospital 10/3-10/15/21. He did require blood transfusion for anemia and atrial flutter ablation. Fevers and cough eventually resolved while in the hospital with treatment with ceftriaxone and doxycycline for treatment of potential atypical bacterial pneumonia however extensive work-up with serologies, antigens and bronschopy were negative for pathogens. His rash also gradually resolved on this treatment and typical steroid creams.  It was unclear if his illness was due to an atypical pneumonia or a hypersensitivity reaction with organizing pneumonia related to his vaccine. His symptoms had resolved at follow-up visit 10/28/21.
PCP notified health department his ct reported when receiving her 2nd vaccine on 3/6/21, she did not feel vaccine liquid going into her arm, asked the vaccinator if that was normal, told yes.  PCP responded, not normal, called ?Moderna manufacturer (Pfizer was given per ct consent form), was told ct should have received another dose right at that time. 3/18/2021 a third dose of Pfizer vaccine was administered to the client as lead vaccine RN felt possible loss of too much vaccine when 2nd dose given, discussing with client she may have a strong reaction following this dose. 03/21/21- f/u phone call-ct very happy to have had a reaction! Sore, red, itchy arm and a bit of a headache after the third dose.
presented with increased confusion, cough, shortness of breath, hypoxia. Medical history is significant for chronic A-fib (on warfarin), CHF (unclear of type from documentation), HTN, hypothyroidism, hypocalcemia, neuropathy, insomnia, chronic pain, "edema". She resides at a skilled nursing facility and tested positive for COVID-19 on the morning of 11/5.  Vaccine given at an outside facility. No Lot# noted
Patient developed a frontal headache, tachycardia and shortness of breath about 6 hours after receiving the vaccine.  She was evaluated in the emergency room where her labs including platelets and complete blood count, EKG and vitals were normal.
Fever of 101 deg post injection. Left arm at injection site sore, red and swollen and hot to touch.
Pt did not know she was pregnant. Received FLUMIST at school where she works. Pt was 3 weeks pregnant. No adverse reaction. Was told to report. Was reported to CDNS/FDA and MedImmune.
severe headache, muscle aches, fatigue, sore arm,  lack of appetite, weight loss, trouble focusing
A couple days post vaccine, red rash appeared intermittently,  Used Benadryl which resolved.  Nine days post vaccine, a larger spot appeared.  Called the Covid line at employer and advised to take Benadryl.  Cleared in approximately 3 days.  On day 14, rash returned bright red and larger (approximately 6 inches long and about 3/4 around my arm).  I called the Covid line through Employer and was advised to be seen at the Emergency Room.  I was diagnosed with  Cellulitis. and a Doxycycline Hyclate , twice daily.  It cleared in approximately 10 days.
Pt c/o "very" sore arm after receiving the flu shot. Sometimes he could not lift arm. States it's lasted for 2 weeks. Did not have any bruising of swelling. Will see personal physician on 11/26/03.
lymph node under armpit is swollen; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101689622 (Pfizer).  A male patient received bnt162b2 (BNT162B2), administration date 27Nov2021 19:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 19:00, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 29Nov2021, outcome "unknown", described as "lymph node under armpit is swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning her husband, an approximately 35 years old male with a history of smoking, and no drug reactions/allergies who on 23-OCT-2004 was vaccinated intramuscular with the first dose of RECOMBIVAX HB (lot number 647274/0426P). Concomitant therapy included NEUROTIN, CYMBALTA and EXELON. On 24-MAR-2005, the patient received a second dose of RECOMBIVAX HB (lot number "0325P"). On 31-OCT-2006 was vaccinated with a third dose of RECOMBIVAX HB (lot number 653363/1063R). Six months after the completion of series, a test showed that her husband did not seroconvert. NO other symptoms have been reported. No further information is information is available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 08-Apr-2022; 21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 08-Apr-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No adverse events were reported.  Vial was stored in refrigerator on 17-Feb-2022 at 10.00 am.  The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-536013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received includes no new information.
BlurredVision, Headache, Myalgia, Fever, SkinRash, Rash, UrticariaPruritus, Palpitations, HYPERtension Day 1 - Fever 103.6/bilateral neck pain; Day 2 - HA, R eye blurry/white lines, heart fluttering/chest tightness, R arm numb/tingly; Day 3 - chest pain/shortness of breath with exertion, palpitations; Day 4 - cont'd Narrative:  Day 4 (cont'd) - "woke up with full rash and hives to neck back, itching, swelling of neck, increased SOB worse than day prior. Rash went up to face with swelling within hours and heart palpitations were worse, so went to urgent care at shopping center. BP 140/92 hr 123. Normal is 109/60 hr usually in 70. Explained adverse effects over days prior and that things have gotten way worse since. Dr. placed me on prednisone for swelling 20mg once a day to see if it would help with chest tightening and SOB. Day 5 - no change, followed orders Day 6 - rash persisted with itching, heart fluttering, SOB with deep breath, Rt arm still numb. Went to primary care and asked for EKG and chest x ray. I was only given the EKG which was normal sinus rhythm. Run down and so fatigued. Day 7 - headache with blurred vision in Rt eye getting worse. Pain in back of calf. Fatigued and feeling that head is about to explode. Will reach out to ophthalmology as recommended by occupational health."
Had this symptom everyday  starting June18, 2021 to June 29, 2021 my heart was fluttering/ irregular heartbeats on and off all morning and lessened by noon. Was always worse in the morning accompanied a few times by pressure on my sternum area.
Information has been received from a physician concerning a 15 month old white male with a history of no known drug allergies, possible allergy to milk, and a prior history of having a rash and urticaria for more than a month (cause unspecified) who on 17 SEP 2001 was vaccinated SC (SQ) in his left arm with his first dose of MMR. Concomitant therapy included a fourth dose of streptococcus pneumoniae vaccine which was administered IM in his left leg. On 27 SEP 2001, 10 days after his vaccination, the patient developed a temperature of 99.8 degrees F to 102.6 degrees F. After ibuprofen, his temperature was 99.8 degrees F in the physician's office. In addition, the patient had developed a maculopapular rash/sandpaper rash on his extremities, axilla, abdomen and back. Lab evaluation revealed streptococcus test negative. The patient was diagnosed with rash from the vaccine. Treat prescribed was ibuprofen as necessary. On 29 SEP 2001 after 48 hours, the patient recovered from his fever and maculopapular rash. No further information is available.
Lethargic, headache, muscle weakness,  chills, low grade fever, nausea but no vomiting