chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  Reporter stated that vial does not undergo any temperature excursions. The vial was initially stored in the refrigerator on 14Jan2022 The administration of vaccine was 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.
Both arms felt heavy and tingly. Started same day as vaccine and lasted for 7 days.
Information has been received from a registered nurse referring to multiple patients of unknown age and gender. On multiple unspecified dates the patients were vaccinated with improperly stored PROQUAD (Merck) (lot #: L019996, expiry date: 02-DEC-2016, lot #: L004007, expiry date: 15-APR-2016, lot#: L011079 (also reported as L0011079), expiry date: 01-OCT-2016) and VARIVAX (Merck) (lot # reported as L008273, expiry date: 11-MAR-2017, lot #: L001330, expiry date: 13-JAN-2017, lot #: L010146, expiry date; 24-MAR-2017, lot #: L000456, expiry date: 06-JAN-2017, lot #: L001330, expiry date: 13-JAN-2017). No adverse events were reported. Additional information has been requested.
PATIENT CAME IN ON 12/27/12 REPORTING THAT SHE HAD A FEVER ON 12/24/12 AND CONTINUE TO HAVE A RASH+SWELLING OF THE LEFT ARM NEAR INJECTION SITE.  RASH+SWELLING HAD SUBSIDED BUT STILL VISIBLE.
Odd vision in Right eye started 5 days after J & J booster.  2 days later vision became blurry.  Went to ophthalmology who urgently referred patient to retina specialist.  Specialist found blood clot in retinal vein of Right eye.  No increased eye pressure.  Platelet count normal.   Follow up on Jan 5 for pressure check with retina specialist.
Exactly 4 weeks after vaccination, I experienced severe enlarged hemorrhoids lasting  more than one week (8 days at the moment).  One of the hemorrhoids is bluish/blackish which I'm told indicates a thrombosed hemorrhoid.   I have never had series issues with hemorrhoids -- previous issues have been very minor and lasted only a matter of hours, perhaps only 2 or 3 times per year.  There have been no dietary changes, nor changes in work or leisure habits.
Fatigue and swelling (approximately 1 in in diameter), redness, muscle stiffness and pain at the injection site. Fatigue, stiffness and pain began approximately 8 hours after receiving the vaccination; swelling and redness found upon waking the following morning (approximately 22 hours after vaccination). All symptoms persisted through present (36 hours after receiving vaccination).
With in 10 min after shot I began to feel flush and my tee shirt became wet . Felt sweat heavily even wit car AC on. Felt out of sync. On-site nurse took me to emergency room and gave me a bed . Headaches starte. Nurse practice right stayed with me ,took vitals and said she heard heart murmer. Never been told I had a heart murmer by my heart doc. After an hour and a half  I felt a little better. Drove home went to bed early - stil had headache and felt week. Sept well. Woke up in am with headaches and physically weak.Waiting on my doctor to call.
Leg feels heavy; Knee has throbbing type pain that comes in and out/; Pain in her arm; Little bruises on legs, mostly on thighs; Numbness in cheek; Tongue was a little bit numb; Cheek and face were a little bit swollen; Upper body itching; Cheek was very hot; Very strong headache; Left side of neck is stiff; This is a spontaneous report from a non-contactable consumer or other non hcp. A 49-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:57 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has no known allergies. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with any event, prior vaccination. On 12Mar2021 the patient experienced pain in her, numbness in cheek on 11Mar2021, tongue was a little bit numb on 11Mar2021, cheek and face were a little bit swollen on 11Mar2021, little bruises on legs, mostly on thighs on 12Mar2021, leg feels heavy on 13Mar2021, knee has throbbing type pain that comes in and out on 13Mar2021, upper body itching on 11Mar2021, cheek was very hot on 11Mar2021, very strong headache on, left side of neck is stiff on 11Mar2021. The events little bruises on legs, mostly on thighs, leg feels heavy, knee has throbbing type pain that comes in and out, very strong headache were not recovered while all other events were recovered. No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a licensed practical nurse refers to a 20-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 06-AUG-2018, the patient was vaccinated with pediatric dose of VAQTA, intramuscularly (dose, units, frequency, lot# and expiration date unknown). The patient experienced no adverse event. There was no product quality compliant reported.
Pt Reports numbness in right hand radiating up to elbow and Armpit numbness. No reduction in mobility, just "numb, lack of feeling entirely in fingers"
lt upper arm 4-5" circular area of erythema, swelling, pain 24hr p/vax;lateral triceps area induration 4cm x 2cm;+heat;r/o possible cellulitis vs allergic reaction;prescribed keflex;warm compress;
No Adverse event; first dose of the Moderna COVID-19 vaccines at 7:00 AM on 23FEB2023 after the published expiration date. Lot number 015B22A, published expiration date 12FEB2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (first dose of the Moderna COVID-19 vaccines at 7:00 AM on 23FEB2023 after the published expiration date. Lot number 015B22A, published expiration date 12FEB2023.) and NO ADVERSE EVENT (No Adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023 at 7:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2023 at 7:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose of the Moderna COVID-19 vaccines at 7:00 AM on 23FEB2023 after the published expiration date. Lot number 015B22A, published expiration date 12FEB2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (first dose of the Moderna COVID-19 vaccines at 7:00 AM on 23FEB2023 after the published expiration date. Lot number 015B22A, published expiration date 12FEB2023.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (first dose of the Moderna COVID-19 vaccines at 7:00 AM on 23FEB2023 after the published expiration date. Lot number 015B22A, published expiration date 12FEB2023.).    No concomitant medications were reported.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. There was no reported symptoms. the patient had no additional doses, medications or treatments.
On 9/7/05, 12 month old received MMR, Varicella, HIB, PCV7. Grandmother states on 9/9/05, AM, noticed rash on trunk of body; has spread throughout the day. Upon evaluation to HD, rash (red0 noted from head to toe, mostly concentrated on trunk area. No fever noted. Some spots beginning to look slightly fluid filled. Rash light on legs, arms, and face. No signs or symptoms of difficulty breathing noted. Child not experiencing any discomfort at this time. Advised to go to clinic.
Per mom, child had elevated temp with swollen area on leg at either 2 or 3rd dose. 4th dose given 7/7/03, per mom entire right thigh is warm, red and swollen, noticed on 7/8/03. No elevation of temp. Advise warm compresses to area.
Started with Bad chills, freezing cold, hip/back joint pain more severe then normal, legs felt heavier to move/lift, fatigue, bad sinus headache, chills returned for hrs turned back to hot, clammy with sweating for 30 min. Then freezing cold came back for several hrs once hot again I broken my 101.6 temp finally about 6pm.
Patient is a 72 yr/o male with PMH significant for COPD, OSA (non-compliant with CPAP), DM2, HTN, HLD, CAD s/p CABG, AFIb (on Xarelto), and chronic diastolic CHF who presented to the ED by EMS due to respiratory failure. Per family- pt had been feeling unwell overnight and the checked on him several times and noted some "gurgling" respirations.  EMS was called this morning as patient was found unresponsive.  Upon EMS arrival they noted he was completely unresponsive with apneic respirations.  He did have a palpable pulse.  He was hypoxic to the 50s and cyanotic.  He was nasally intubated without complication.  During transport his mental status did improve.  Patient unable to provide additional history at this time. On arrival to the ED, pt was placed on CPAP however TVs noted in the 200s and tachypneic therefore he was placed back on VC mode. Pt will be admitted to the ICU for further management
Case number PHEH2014US021072 is an initial spontaneous report from the nurse received on 17 OCT 2014. This report refers to a 59-year-old female patient. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) on 17 OCT 2014. It was reported that FLUVIRIN was administered via subcutaneous route into her arm by the pharmacist. Nurse believed that the pharmacist inserted the one inch needle only a quarter of an inch into  her arm which did not penetrate the muscle. The pharmacist stated to the nurse the "needle inserted partially into her arms because she was too thin". No adverse event reported following this medication error (inappropriate route of vaccination).
This spontaneous report as received from a doctor of pharmacy concerning his approximately 52 year old mother with no pertinent medical history and no drug reaction or allergies. On 19-May-2011 (also reported as back in 2011), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). There were no concomitant medications. On an unknown date in August 2012, the patient experienced shingles episode. The patient sought an unspecified medical attention. The patient was treated with VALTREX. No lab tests were performed. The outcome of shingles episode was unknown. The relatedness for shingles episode was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information has been requested.
I experienced the following symptoms and was out of work for 3 days. Lightheaded/Dizzy, diarrhea, nausea, increased resting heart rate, felt like my heart was pounding, weakness, arm pain, armpit pain, ear on the same side as the vaccine felt stopped up, fever, muscle and joint pain, red hot lump at the injection site, abdominal pain, leg pain on the same side as the injection, rash on chest, facial swelling on the same side as the injection, fatigue, hot flashes, and heart palpitations. All symptoms resolved within 4 days. I contacted my doctor who recommend Tylenol/ibuprofen, rest, and drinking plenty of fluids. I considered going to the ED for my heart related symptoms but they got better in a few days.
This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported for a female patient of an unspecified age started to receive Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) Formulation: Solution for injection in pre-filled syringe and IODINE, both via an unknown route of administration from an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient had drug allergy to Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) and Iodine on an unspecified date. The action taken in response to the event for Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) and iodine was unknown. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected. Follow-up (23Nov2016): New information received from same contactable physician includes: New suspect drug (Pneumococcal vaccine) was provided. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported Information: Suspect Pneumococcal vaccine was re-coded.
hives that come and go; started to have hives that is itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives that come and go) and PRURITUS (started to have hives that is itchy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced URTICARIA (hives that come and go) and PRURITUS (started to have hives that is itchy). At the time of the report, URTICARIA (hives that come and go) and PRURITUS (started to have hives that is itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Soon after vaccination experienced numbness developing on tongue.  Then progressed from tip of tongue to back of tongue.  She felt a  little bit of numbness around her lips as well and feels subjectively swollen but no difficulty swallowing or breathing. Employee took Benadryl prior to arriving to the ER due to having numbness on the tip of tongue after 1st COVID vaccination. Received IM Epinephrine, Benadryl 25 mg and Prednisone (Deltasone) 60mg once in ER.
CLIENT CAME IN WITH HIS PARENT TO GET BOTH VACCINES. WHILE SITTING IN WAITING ROOM, HE STARTED PASSING OUT, MOTHER LOWERED HIM TO THE FLOOR, HE WAS COMPLAINING OF BEING DIZZY AND "TINGLY," HE WAS PALE AND CLAMMY, BUT CONSCIOUS WHEN I CAME OUT TO SEE HIM , BP WAS 120/80. EMT CAME IN A FEW MINUTES LATER, AT THAT TIME HE RECOVERED AND REFUSED TO GO TO ER AND LEFT WITH HIS MOTHER.
Extreme joint pain-advancement of arthritis to all joints. 2/2021 Referred to rheumatologist (appointment 9/20/2021) Severe gastritis-emergent EGD 3/5/2021  Extreme allergies-referral to ENT. Underwent allergy testing and started in immunotherapy 5/2021. Underwent sinus surgery for extreme congestion 6/18/2021
Information has been received from a physician concerning a 77 year old female who on 12-FEB-2009 was vaccinated SQ with ZOSTAVAX (Oka/Merck) in the left arm (Lot # not reported). After receiving the ZOSTAVAX (Oka/Merck), on 13-FEB-2009, the patient had an injection site reaction. The patient had soft tissue swelling, allergic reaction, fever and pruritis. The patient was being treated with a steroid dose pack, heat and elevation. The patient was not recovered from adverse events. It was reported that the patient sought medical attention: seen in office. Additional information has been requested. 06/24/09 This is in follow-up to report(s) previously submitted on 3/27/2009. Additional information has been received from the physician who reported that the patient with no illness at time of vaccination experienced allergic reaction-erythema, soft tissue swelling, and pruritis. No further information is available.
Started with left wrist, then left knee pain. Shooting pains in knee. Then the next day went to my right hip and down leg into foot. Continued to get worse until I couldn?t longer walk on it. After second shot it was again worse but is now continuing to get better. I?m walking with a limp but not using crutches any longer. Attending physical therapy. Pain is much better but still there.
Patient complained of chest pain , vitals signs taken at 1109 and medical emergency response team called at 1109.   3-81mg Baby ASA given at 11:10.  Transported to ER 1120
Patient received first dose of COVID vaccine on 2/10/21 On 2/12/21 she developed redness and itching at the injection site, approx 2 inches in diameter SHe was advised to outline the red area and call if it increased or she developed swelling and warmth or fever
second Shingrix shot too soon; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received second Shingrix shot too soon, only about a month later, which led to drug dose administration interval too short. The patient asked that was he/she covered, or did he/she need to do the process again. The patient stated that he/she had side effects with the second shot and would prefer not to go back. The patient also stated that his/her pharmacist hasn't been able to give him/her an answer. The follow-up would not possible as no contact details were available.
Severe headache for 6 days with first injection.  Second injections started with vestibular migraines 6 weeks after.  Same type of headache I had with first covid injection. I have had vestibular migraines for a year now.  Little to no relief.
No additional AE reported; Accidentaly an expired dose of PNEUMOVAX 23 (SYRINGE) was administered on 03-MAR-2022; This spontaneous report has been received from a medical assistant, concerning an 81-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, current conditions, concomitant medications, previous drug reactions, or allergies.  On 03-MAR-2022, the patient was accidentaly vaccinated with an expired Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) syringe administered once as prophylaxis (lot number T016160 has been verified to be a valid lot number, expiration date reported and established as 13-FEB-2022) (dose, route and anatomical location of administration were not reported) (expired product administered). No other adverse events (AE) reported (no adverse event), no temperature excursion.
Left thigh started getting red/warm/swollen on 6/24/15. Seems like it was spreading. No fever.
Swelling / redness at injection site. Fever, chills, fatigue. Cellulitis at and around injection site. "Chest tightness".
Has started having tremors in both hands since 3rd dose of Moderna, which was given due to immunocompromised condition. Is also having vertigo now. Seen at dr office and nurse said to let the health department know. Instructed to let Dr know at next appointment on October 5, 2021.
numbness in feet and legs; nerve problem; burning in legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in feet and legs), NEURALGIA (nerve problem) and BURNING SENSATION (burning in legs and feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced HYPOAESTHESIA (numbness in feet and legs), NEURALGIA (nerve problem) and BURNING SENSATION (burning in legs and feet). At the time of the report, HYPOAESTHESIA (numbness in feet and legs), NEURALGIA (nerve problem) and BURNING SENSATION (burning in legs and feet) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
No adverse events reported by parent. Notified parent of incident and they will return in 4 weeks to have vaccine re-administered.
From initial info received on 3/12/03 from a registered nurse regarding an adverse event, it was reported that a 53 year old female pt received a second dose of Imovax Rabies vaccine, lot U0595, a dose of YF-Vax vaccine, lot unknown, and the third dose of hep B vaccine, manuf. unknown on 3/10/03. A few hours later, the pt experienced fever and chills lasting until noon the next day. THe pt's recovery status was not reported.
Getting a tingling sensation in the vagina after vaccination shots; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Getting a tingling sensation in the vagina after vaccination shots) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Getting a tingling sensation in the vagina after vaccination shots). At the time of the report, PARAESTHESIA (Getting a tingling sensation in the vagina after vaccination shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was not provided.
Child received 0.2ml of the adult Pfizer Covid vaccine formulation.  No adverse effects noted at this time.
Started feeling that my heart was racing (palpitations), dizziness around 4 days after vaccine. Went to ER 10 days after vaccine due to heart palpitations and was sent home as all tests and EKG came back normal. I followed up with PCP and Cardiologist - recommended Holter monitor for 48 hours. nothing  showed up on the results and all was normal. Still to this day I get palpitations occasionally and am prescribed Metoprolol to help control as needed. Before getting the shot I was healthy and had no issues with palpitations.