chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received possible expired dose  of vaccine with no reported adverse event; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional [ -00797024].  This case involves a female patient of unknown age who was vaccinated with expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Expired product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 mL (total) dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength: standard; lot QFAA2007 and expiry date 23-May-2021) via an unknown route at an unknown administration site prophylactic vaccination.  It was reported "Caller was given the Vaccine with expiration date of 05/19/2021. Caller wanted to see if someone could make sure this was the correct expiration date for the product. Outbound call placed to Pasteur CS on 04Oct2021. Verified with Pasteur CS the date of expiry date 23-Ma-2021 upon looking up the given".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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 third party has contributed to or is to be held liable for the occurrence of this medication error.
A report was received from a health care professional on 12/17/03 concerning a 22 month old female vaccinee who inadvertently received Fluvirin vaccine on 12/17/03. On 12/17/03 the vaccinee was administered 0.25ml Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient received the vaccination, then reported back in about 10 minutes that she was feeling tightness in her chest, I administered an oral dose of diphenhydramine (50mg) and strongly recommended that the patient follow up with the local emergency department. the patient left following the diphenhydramine dose and stated that she would probably go to the ED.  I followed up with the patient about a half hour later and she said she was feeling better and no longer was experiencing  any chest tightness and had decided not to go to the ED after she was feeling better.
36 hours later fog, headache, floaty. no fever. no gi issues. No cough
Information has been received from a health professional concerning a 4 year old male with no past medical history who on 26-Sep-2003 was vaccinated with SC 0.5 ml dose of MMR virus vaccine live (lot #644843/1229M). There was no concomitant medication. On 03-Oct-2003 the patient presented to the office with a classic measles rash on the trunk, face and neck. He had a low grade diffuse fever and Koplik's spots. No laboratory of diagnostic testing was done. Additional information has been requested.
Swelling of extremities and joints; numbness in fingers and toes. Symptoms began 11/6/02 when patient went to ER. Dx: Lyme disease, allergic reaction, arthritis or Lupis.
Pt with 3-4 day hx fever.  Got small pox shot 2 weeks ago and site is swollen and red. Pt c/o axillary swelling. Site has not scabbed over. Decreased appetite, headache and body aches. HEENT normal. Neck no Lymphadenopathy. Chest rhonchi bilaterally. Abd soft Skin: vaccine site approx 8mm yellow scab, no drainage large 5cm area erythema, tender to palpation, no fluctuance. Secondary infection. Augmentin 875mg twice daily x 10 days.
Area where Pnuemo, DTaP and IPV, administered -left deltoid is red, swollen, and hot to the touch. She is currently running fever. Mother states child is behaving normally, sleeping and eating well. Mom also says child is fine otherwise. Will follow up 02/14/2005,GT. 02/14/2005-came back swelling and pain gone, child is fine, GT.
SEVERE NERVE PAIN; BATCHES THAT LOOK LIKE BRUISES IN LEGS AND ARM; WORSENING BURNING SENSATION IN BODY; LEGS ARMS HANDS AND FINGERS PAIN WITH WORSENING RIGHT LEG AND LEFT HAND PAIN; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, non smoker, and drinks alcohol, and other pre-existing medical conditions included: The patient has no known allergies and no drug abuse or illicit drug usage. The patient was on unspecified inhaler for asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the patient experienced severe nerve pain. On 27-JUL-2021, the patient experienced batches that look like bruises in legs and arm. On 27-JUL-2021, the patient experienced worsening burning sensation in body. On 27-JUL-2021, the patient experienced legs arms hands and fingers pain with worsening right leg and left hand pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe nerve pain, batches that look like bruises in legs and arm, worsening burning sensation in body, and legs arms hands and fingers pain with worsening right leg and left hand pain. This report was non-serious.
Pain at shot sight.; Headache; Severe tinnitus in the left ear; Left-arm felt dead and less strong; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8732) via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced pain at shot sight, left-arm felt dead and less strong for 2-3 days, headache, severe tinnitus in the left ear, still there 1 week later. The patient was afraid to get the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events pain at shot sight and tinnitus in the left ear were not recovered while that of headache and left-arm felt dead and less strong were resolved on an unknown date in Mar2021.    No follow-up attempts are needed. No further information is expected.
Vaccine at lunch time.    Slight headache and tired within the hour.    Awful rash started At commute Home.   Welts. Hives swelling.  For days.
2 hrs p/inject numbness rt 2nd & 3rd fingers & poss rt forearm numbness; @ time of inject noted burning-pain which disappeared in 10 mins; day p/inject-lt leg twitching;
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL, injection (strength, route, lot number and exp.date not provided). The nurse stated that she had a couple of patients who experienced syncope after GARDASIL dose in the past on unspecified dates but could not provide any further adverse event information. This is one of two reports concerning the same reporter link (#1309USA003869; 1309USA003200). Additional information has been requested.
The patient received the vaccine and immediately after administration reported feeling lightheaded, dizzy, tingling in her left arm, nausea, neck sensation, minor throat constriction, and chest pain. We, myself and (the staff pharmacist), immediately offered to call 911 and offered an EPI PEN. The patient denied the EPI PEN and denied our offer to call an ambulance. We took the patient's blood pressure, and it was 116/82. She was conscious and responding to questions and denied once more the offer for us to call her ambulance. We had the patient sit in a chair with support and monitored her while she contacted a family member to take her to the ER. We took her blood pressure again and it came back at 108/82.  We insisted she seek immediate medical attention. She insisted her sister/friend, take her to the emergency room. She called friend and friend picked her up to take her immediately to the emergency room at our insistence. The patient departed our pharmacy at approximately 5PM stating she would have friend drive her to the ER.
BODY ACHES, VOMITTING, RED MACULAR RASH ON TORSO AND LOWER EXT.
I had the expected sore arm and body aches overnight the 1st night, then 18-20 hours later chills began, then 2 hours later nausea & vomiting for the next 15 hours, along with terrible headache overnight the 2nd night, by 3- 6 a.m. nausea & vomiting stopped, but my face was flushed all the next day with no fever which looked strange and I was fatigued, then  armpit soreness began which changed to armpit pain the 3rd night, I woke up midnight of this 3rd night drenched in sweat then went back to sleep and awoke 2 hours later drenched in sweat again. Now today is 4th day and Covid arm rash is beginning again as it did the first time, it's covers most of my upper arm and is more sore than it was a day ago. (The first Covid arm began 1 week later, this one began 3 days after the vaccine). I don't recall ever having such intractable nausea for so many hours and considered going to ER for fluids, but I felt to sick to consider doing that, after another 3 hours the nausea stopped thankfully.
36 y/o patient, admitted to ICU for skin rash and arthralgia 13 days after SPV. Patient was observed, treated, and discharged after a 2 day stay. Symptoms: Muscle Ache.
On day 6 after immunization, pt experienced swelling tenderness at site of injection. Day 7, pt had redness/swelling alongside length of arm and joint pain on same side elbow.
Aug 26,2008 Pediatric dose of Hep A was given instead  of Adult dose Hep A. Patient had no problems after receiving dose or other vaccines given at same time.  No treatment
After the vaccinations had been administered, the lady in the Immunizations department at the clinic who administered them, told me that if her fever went above 102 to take her in. By 6 pm that evening, I took her to the ER after rectally taking her temperature and it being 103.4. She was in and out of consciousness on our way and would not smile or react to me. They hooked her to a heart monitor machine and her HR reached as high as 212.
late period since 2nd dose; heavy period; affected ovulation; started to have cramps; a few days ago she had spotting; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (late period since 2nd dose), HEAVY MENSTRUAL BLEEDING (heavy period), OVULATION DISORDER (affected ovulation), MUSCLE SPASMS (started to have cramps) and INTERMENSTRUAL BLEEDING (a few days ago she had spotting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (Patient had planned both her pregnancies before and was unlikely that she miscalculated her ovulation) and Depression (Patient takes a newly FDA-approved medication for her severe depression.). Concomitant products included KETAMINE, ESCITALOPRAM OXALATE (LEXAPRO), ALPRAZOLAM (XANAX), GABAPENTIN, AMFETAMINE (AMPHETAMINE) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced OVULATION DISORDER (affected ovulation), MUSCLE SPASMS (started to have cramps) and INTERMENSTRUAL BLEEDING (a few days ago she had spotting). On an unknown date, the patient experienced MENSTRUATION DELAYED (late period since 2nd dose) and HEAVY MENSTRUAL BLEEDING (heavy period). At the time of the report, MENSTRUATION DELAYED (late period since 2nd dose), HEAVY MENSTRUAL BLEEDING (heavy period), OVULATION DISORDER (affected ovulation), MUSCLE SPASMS (started to have cramps) and INTERMENSTRUAL BLEEDING (a few days ago she had spotting) outcome was unknown.            No treatment medications were reported. The patient would be taking a pregnancy test soon.   This case was linked to MOD-2021-281053 (Patient Link).
Patient woke up and noticed swelling, tenderness, redness and site being itchy. Patient reported to medical and was evaluated by staff at 0651 am. Patient then returned to medical at 0800 am and was re-evaluated by staff. Patient was diagnosed with localized cellulitis to the area of vaccination. Patient treated with Naproxen 500 mg Take 1 tab PO Q12, Benadryl 25mg Take 1 Cap PO Q6, Bactrim DS Take 1 Tab PO Q12, and Tylenol #3 Take 1-2 tabs PO Q6 PRN pain.
diarrhea, fall due to loss of consciousness, closed head injury, tachycardia, hypotension, leg cramps, low potassium
After the second vaccine I have an increased frequency in my headaches and an increase in intensity. My menstrual cycle has gotten even heavier I have to use a super plus tampon and an overnight pad and my menstrual cycle is full of blood clots like never before. My menstrual cycle went from being exactly 7 days to 9 days and even heavier flow. My nervous tics have increased in intensity when I am anxious, sometimes I look like I have Tourette?s syndrome.  I have lost some of my short term memory. It seems to get worst everyday. I forget simple words and medical terms (I am a healthcare worker) I forget what I?m saying mid sentence and feel like a dementia patient.
Patient developed nickel sized redness on his right arm at the injection site 5 days affter vaccination. Mom reported the redness started after patient took a bath. Redness subsided after 48 hours without treatment. No reported swelling or pain at the site.
Left arm red, swollen, no fever. Advised by doc to observe and if more tender, painful to be seen at urgent care
Severe pain in knee joints.  So painful it was very hard to walk up and down stairs.  Starting taking  Glucosamine to ease pain.  Over the next week pain eased.  However a tightness and discomfort in knee joints has continued.
Information has been received from a healthcare worker concerning a 17 year old female who on 20-NOV-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 660612/0229X).  Concomitant therapy included ADACEL, ALEVE and Multi-Vitamin.  The patient developed hives on the left side of her face and neck after receiving her first dose of GARDASIL.  The dose of GARDASIL was administered in the patient's left arm.  At the time of reporting the patient was recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
POXX CELLULITUS. TREATED WITH CEPHALEXIC 250 MG PO #40
I95.9 HYPOTENSION 1/31/2022 ACUTE ON CHRONIC RESPIRATORY FAILURE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 1/29/2022 ACUTE ON CHRONIC RESPIRATORY FAILURE I95.9 HYPOTENSION 1/31/2022 ATHEROSCLEROSIS J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 1/29/2022 ATHEROSCLEROSIS
At around 10:00pm person stated that he began with swelling in mouth, "delirious", slurring of speech, right arm pain, trouble breathing. These symptoms continued until 8:00am on 3/27/2021. No meds were taken at this time. Person did not go to ER for a visit and did not phone Dr.
J96.00 ACUTE RESPIRATORY FAILURE 2/15/2021 ASTHMA, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 2/15/2021 ATRIAL FIBRILLATION, PAROXYSMAL J96.00 ACUTE RESPIRATORY FAILURE 2/15/2021 DYSPHAGIA J96.00 ACUTE RESPIRATORY FAILURE 2/15/2021 MITRAL VALVE PROLAPSE
Bump on the back, possible shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Bump on the back, possible shingles) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Bump on the back, possible shingles). At the time of the report, HERPES ZOSTER (Bump on the back, possible shingles) outcome was unknown.            No treatment medication reported. No concomitant medication was reported. AE submitted via ChatBot.  Consent for follow up denied.
It started with a sinus condition where they were draining. The next day I had a sore throat and was tired. The third day I started the coughing and that led me to test on the 29th. I took a nap that day I was so tired. Since then it's been like a head cold and I continue to cough and have sinus problems. Cough seems to come from my sinus and not the lungs. I spoke to the nurse on July 1st and it was too lake for the antiviral and she advised I take CLARITIN.
1-2 hrs following vaccination noticed red bumps, face itchy - transient and periodic itching scalp, scratchy throat. BENADRYL 25 at 3 PM.
Information has been received from a registered nurse concerning her 11 year old daughter with no pertinent medical history who on 13-SEP-2007 was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL. There was no concomitant medication. On 14-SEP-2007 within 24 hours the patient developed an injection site reaction. The site was swollen, painful, warm to the touch, and red. The area was about 4" x 2" in size. There were no laboratory or diagnostic tests performed. A call was made to the office. At the time of the report the patient had recovered fully. Additional information has been requested.
Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, trouble swallowing, difficulty breathing, confusion, chills, difficulty speaking.
Numbness in left hand; sensation like her hand was getting bit or swollen; Face numbness; tingling sensation in her tongue; Headache; A spontaneous report was received from a consumer concerning a 24-year old, female patient who received Moderna's COVID-19 vaccine and experienced headache, numbness in the left hand, sensation of swelling, facial numbness, and tongue tingling.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the evening of 06 Jan 2021, the patient began to experience a headache, numbness in the left hand and face. She also reported having a sensation like her hand was getting big or swelling and tongue tingling. Treatment for the event included diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the events was not reported.   The events, headache, numbness in the left hand, sensation of swelling, and tongue tingling, were considered resolved on 06 Jan 2021.  The event, facial numbness, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 01-DEC-2017 and 01-FEB-2018, the patient was vaccinated with improperly stored ROTATEQ (strength were unknown) (lot # M042169 and expiration date 22-JUN-2018; lot # N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for maximize 15 hours. And on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
The adverse reaction lasted for about a month and started with my elbow and joints hurting. Then a day or two after my shot I was having weird out-of-body experiences, heart palpitations, and rapid heart rate. The scariest moment I remember was on 03/27/21, as I was taking my brother-in-law out to eat and my heart was racing (while sitting not provoked), and felt like I was on the verge of losing consciousness. For the rest of that day and the following day, if I stood up (not walking or moving just standing up) my heart rate would increase to 115-120, my resting heart rate at the time was 65-70bpm,. I wear a watch so I was able to see all of this in real-time and was able to monitor it. After a few days passed, my heart rate seemed to go back to a normal resting rate but was still fluctuated more than normal. For example, if I walked up the stairs in my apartment or did any sudden moments I would feel like my heartbeat abnormally, race up to a number that was scary high in my opinion (shown on my watch), and then slowly come back down after a few minutes.   Meanwhile, during these random out-of-body experiences and racing heart rates, my chest hurt. My entire chest, lack for a better description, felt like I got hit by a truck. After 7-10 days of feeling this way I contacted my doctor, and over the next few weeks I did blood work, chest x-ray, checked my blood pressure frequently, and finally at the end an EKG. Which all came back normal, but my chest pain still continued. My doctor thinks the joints in my chest were inflamed, which all began when I got my shot. He prescribed me an anti-inflammatory booster pill pack, which really helped.
Information has been received from a physician assistant concerning a patient who "5 years ago" approximately in October 2004, was vaccinated with the first dose of PNEUMOVAX 23. Patient did not have any reactions after the first dose. In middle of October 2009 patient was vaccinated with the second dose of PNEUMOVAX 23 (lot # 664000/0621Y). Subsequently the patient experienced injection site reaction as bright red, swelling, painful that went from the top of the shoulder area almost to the top of the elbow all the way around the arm. At the time of reporting, the outcome of the events were unknown. This is one of several reports received from the same source. Additional information has been requested.
Left upper thigh developed an erythemic, warm to touch swelling on 2/16/2013. Was treated for cellulitis with an antibiotic. Mom also gave BENADRYL. Left upper thigh mostly clear 2/18/13.
started as round, red area around injection site and two weeks later it's 8.5 cm wide.  No systemic symptoms
CONTINUOUS SNEEZE, SHORTNESS OF BREATH, CONGESTION, RASH, ITCHY ALL OVER BODY.