chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fluzone Quad was delayed in transit with no AE.; fluzone Quad was delayed in transit with no AE.; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 85 patients of unknown demographics who were received quadrivalent influenza vaccine (Fluzone Quadrivalent), that was delayed in transit (Incorrect product storage and Product distribution issue).  The medical history, medical treatments, vaccinations and family history were not provided.  On unknown date, the patient received a 0.5 mL dose of suspect quadrivalent influenza vaccine [lot UT6695JA Expiry Date: 30-JUN-2020] via unknown route for Prophylactic vaccination.  It was a case of Incorrect product storage and Product distribution issue.  At the time of report no adverse event was 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 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.
The first 10 minutes everything was fine then started sweating uncontrollably, vision went very white and hearing felt like I was in a tunnel. Felt some pressure in my heart and my heart still feels different, best way to describe it is I feel my heart beating which is something I never had before.
Information has been received from a physician concerning a 13 year old female with an allergy to Amoxil, who was vaccinated intramuscularly in the right arm on 18-Oct-2007 with Gardasil (lot# 658556/1060U).  Concomitant medication included the influenza virus vaccine (unspecified) which was administered in her left arm on 18-Oct-2007 (lot Number U2443AA).  Subsequently the patient experienced numbness in her arm for one to three months post vaccination.  The patient sought unspecified medical attention.  Follow up information revealed the pain is still lingering at the time of second dose, which is 2 months later.  Additional information has been requested.
Headache, chills, body/joint aches, fever up to 103.8, nausea, extremely tired
Approximately 10 min after getting her vaccine she reported some mild blurry vision. She put her (fairly new) glasses on and had no further complaints. She waited at least 15 min and then left. Several minutes later she returned saying she started to feel dizzy as she drove off so she came back. We brought her directly to an exam room. BP 160/100, O2 100%, HR 82. Exam was unremarkable and patient was in NAD. She reported some sinus pressure between/above her eyes. No other sx reported including no SOB, hives, itching, swelling. She was given Zyrtec 10 mg and observed for around 25 minutes. BP improved: 150/90 then 140/88. Symptoms improved and she had no complaints including with standing & walking. She returned home safely and after that developed generalized itching without any rash/hives. Continued to deny SOB, swelling.  We will check on her again tomorrow and she has agreed to keep us updated as well.
1o minutes after receiving the vaccine client started c/o feeling her heartbeat in her head. This lasted for a few minutes. Information was obtained by a neighbor that lives 4 doors down from her. She has had no other problems.
7/25/22 Pt. came in for a shot only appointment and received 2 vaccines DTP on the left thigh and HIB on the right thigh  .  7/27/22 Pt. came in for sick visit, Left thigh was hard and inflamed Diagnosis: Reaction to vaccine  Medication: Clindamycin 75mg/5ml (10.5 ml TID x 10 days)  Follow up phones calls by office
About 9pm on 3/26/2021 I started feeling a slight fever come on, so I tried to drink a bunch of water and rest and go to bed. I had a very stressful night with no sleep because my fever kept peaking at 102. I kept drinking water and checking my blood sugar and felt bad so I couldn't sleep much. I think I had the night sweats as well, but achy all over and the fever. So by 5am, I was feeling very beat up and decided to test my ketones in my urine like my doctor instructed incase I was feeling ill. I had large evidence of large ketones so I decided since I'm diabetic, I drove myself to the local ER. And got there around 6am. I explained immediately that I had the vaccine the previous day and they did an EKG and a heart work up on me because they said I was having tachycardia and my heart rate was at a steady 125. I hadn't noticed with the fever but they told me the high heart rate was more concerning for them. The EKG was fine and everything they ran was fine. I did also experience nausea and my stomach pain as well. And they did a CT scan. One of the medications they put me on was prescription Advil and 3-4 liters of saline and gave me an injection for anti-nausea. I also probably left with some medication for that. I'm not usually a nauseous person but with each injection, I get sea sickness. So I took the fluids and I was having fevers for the next 4 of those hours. I probably had the last fever at 4pm on 3/27/2021 and they asked me if I was comfortable being released. The ER did also test me for COVID right before they released me, and it came back negative. They did write me a note and said not to go to work for about 4 days. I took their advice and felt really run down and tired for that entire next week. I probably had a headache too but the fevers and nausea were more prominent. I did rest and my blood sugars were high but not dangerously high. I would say I'd have to watch my blood sugar for the next 3 weeks after that. It took a while to recover fully.
BEAN SEEING FLASHES OF LIGHT LIKE SOMEONE TOOK A PICTURE USING AN OLD FLASH CAMERA. THEN SAW A FEW VEIN OR TREE BRANCH LOOKING FLOATERS ON SAT AS WELL. SAW OPTHOMOLOGIST WHO SAW HEMMORHANGES  AND 1 TEAR ON MONDAY,3/22/2021. RETINA DOCTOR SAW 2 HORSESHOE TEARS AND HEMMORHAGES RESULTING IN LASER SURGERY WED  3/24/2021.
"can't lift my left arm where vaccine was injected".; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 09:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy, hay fever and medical tape allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications were not reported. On 13Apr2021 at 13:30, the patient reported that can't lift her left arm where vaccine was injected. The adverse events resulted in the doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of the events. It was reported that the patient was scheduled for doctor visit on 14Apr at 14:00 for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event, can't lift her left arm where vaccine was injected was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Severe muscle pain at site at 48hrs, soreness about 4" below injection site, eased by day 7; Severe muscle pain at site at 48hrs, soreness about 4" below injection site, eased by day 7; Couldn't lift arm from shoulder, but could from elbow; Fever - low grade (99-100°F) - 7days; Chills; Body Aches - even when fever gone; Severe fatigue even after full nites sleep; Tinnitus - this continued full 3wks; Had to force myself to eat, Bfast & Dinner at least, every day; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 63-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at 09:00 (at the age of 63-years-old) as dose 1, single for covid-19 immunization. Medical history included Chronic migraines. Concomitant medication(s) included paraffin (MINERAL), start and stop date were not reported. Patient received other medications in two weeks was Mineral and Vitamins supplements. The patient previously took tylenol and experienced drug allergies. On 04Mar2021 at 14:00, patient experienced severe muscle pain at site at 48hrs, soreness about 4" below injection site, eased by day 7, couldn't lift arm from shoulder, but could from elbow, fever - low grade (99-100°f) - 7days, chills, body aches - even when fever gone, severe fatigue even after full nites sleep, tinnitus - this continued full 3wks, Had to force myself to eat, Bfast & Dinner at least, every day. Patient did not received any treatment. On 04Mar2021, patient underwent lab tests and procedures which included body temperature: low grade (99-100°f) fahrenheit. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all events was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
I felt terrible. I was achy, coughing and my sinuses were running. My coughing was so severe that I could hardly get a word out. My teeth were hurting, my left side of my neck and my ear were hurting. The doctor prescribed Benzonatate to help with the cough. She also advised me to go get the infusion which I did. The next day I felt much better than I was in the beginning. By day 2, I felt almost back to normal. I waited for about a week to test and it was negative.
Palpitations ( and fever) began about 24 hours after vaccine, lasted 8 hours, had another 4 hour episode the next day, gradually went away.  No other cardiac related symptoms. Of note, 2 weeks later I had a flu vaccine and the palpitations returned,  Gradually they subsided over the next few days.  Exact arrhythmia unknown. THIS VACCINE WAS A COVID BOOSTER.
Severe Cellulitis on left arm, 40 degree fever for 3 days. Body muscular pain, nausea, diarrhea, head pain, tiredness, difficult respiration. I started with Antibiotics, Levaquin 750mg ever 12 hours, Flovent HFA 110mcg twice per day, Albuterol 90mcg twice per day, Symbicort once per day. Severe Cellulites left arm, fever, muscular pain, head pain, nausea, diarrhea, difficult respiration, cough. 47 year female patient receives MODERNA 3rd dose October 10 2021.
After H1N1 vaccine was administered, pt had a seizure.  It lasted for approx. 3 mins.  After wards he was incoherent & confused until paramedics showed up.  He was taken to medical center -   DILANTIN level was normal, EKG & CT were o.k. 12/3/09 ER records received for date 11/19/09. DX: seizure Presented to ER via EMS. Seizure resolved, no post-ictal noted. Injury to tongue(+), witnessed seizure w/ LOC, generalized motor activity, post-ictal confusion. Pt states received H1N1 vax same day. Assessment: tongue abrasion on both L and R side.
Metallic taste developed in mouth about 3 - 5 minutes after injection.  After about another couple of minutes, mouth began to feel numb.  Also started to tingle.  Sensation/response lasted for about 2 hours.  No other side effects.
Red swollen arm.  Temperature up to 101-8 Terible headache. Today is the third day of not feeling well.
Symptom onset 12 hours after injection. Rapid growing headache to migraine + status Inability to leave bed for next (11/12/2021 1:30 AM - 11/12/2021 5:30 PM except 1 assisted trip to the bathroom) due to intense head pain, weakness and nausea. Attempted 2 Tylenol caplets at 11/12/2021 at 5:45 PM Nausea persisted most of the day resulting in vomiting at 11/12/2021 6:00 PM Headache started to abate around 11/12/2021 7:30 PM  Weakness and continued headache pain (though much milder that previous day ) encouraged bedrest until 11/13/2021 at 11:00 AM. Continued weakness until this present time (11/13/2021 3:35 PM) however able to walk safely through my home.  I do not feel it would be safe to drive (for myself and others) or be alone at this time due to the weakness.
PATIENT COMPLAINED OF NAUSEA, VOMITING, FEVER. LEFT ARM WAS RED, SWOLLEN AND HAS A KNOT.
The patient was set to receive the second dose of the series on 1/26/21 and instead received it on 1/20/21. The patient experienced nausea/vomiting, sweating, body aches, loss of appetite, and headaches intermittently for about 24 hours following the vaccination.
This spontaneous report was received from a pharmacist refers to a 61 year old female patient. Concurrent conditions included unspecified reaction to Talwin generic, morphine, cephalosporins, quinolines, iodides and phenothiazines and shingles. On 12-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J006156, expiration date 30-AUG-2014 and route not reported). Concomitant therapies included KCl. Patient reported on an unknown date after 12-OCT-2013 she was experiencing a "shingles outbreak" on her hand described as red bumps on her hand. Pharmacist could not clarify if the red bumps on the patient's hand began before ZOSTAVAX was administered on 12-OCT-2013. The patient was being treated for shingles and prescribed valacyclovir and hydrocodone on 01-OCT-2013. The event was reported to be resolving. No laboratory diagnostic studies were performed. Patient did not seek medical attention for the event. Causality was not reported. Additional information has been requested.
First came the shingles.  They appeared on my left side just below the breast... From spine to sternum. Just as they were starting to clear up, I was hit with a severe case of Bell's palsy... Also on my left side. The ear on my left side has the effect of me standing in a steel drum. Even though I have taken precautions, my left eye may be permanently damaged due to my inability to close it  (because of the palsy).  I now have no confidence in my government or the "Big Pharm" companies.  Because of this horrible experience, I will NOT be getting my booster shot, nor will I recommend anybody do so.
Flu like symptoms ( body aches, low grade fever), and lymph nodes swelled under left arm
could not walk; could not urinate on his own; Transverse Myelitis; weakness in his legs; numbness in his legs; This case was reported by a lawyer and described the occurrence of myelitis transverse in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). As per the medical records plaintiff had received Shingrix on 16 February 2020 for Prophylaxis. Around 18 March 2020 he was started feeling weakness and numbness in his legs progressing over several days to the point that he could not walk or urinate on his own. he started to experienced further progression of LE weakness with further difficulty ambulating. Then was diagnosed with Traverse Myelitis, cannot walk and was on wheelchair.
malaise; fever; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 21-Nov-2023, the patient experienced MALAISE (malaise), PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, MALAISE (malaise), PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2023, Body temperature: 101.8 Farad.         Concomitant product use was not provided by the reporter. Treatment information was not provided.
vital signs were unremarkable, with the exception of intermittent tachypnea and mild hypertension COVID-19 swab was positive.  dose #3 given 3/2/2021
My Wife appears to have developed SICCA(HCC) AKA: Sjogren's syndrome with the following symptoms: Rapid weight loss, Dry Mouth, Dry Eyes, Abdominal Pain, Interstitial Cystitis, Skin Lesions,  and Irregular heartbeat.
Tested positive to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive to COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (Tested positive to COVID-19). At the time of the report, COVID-19 (Tested positive to COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Fainting; Back Ache; Fever; A Spontaneous report was received from Consumer concerning 65-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting, fever, and back ache.  The patient's medical history and concomitant medication was not reported.  On 03 Feb 2021, 1 day prior to the onset of the events, the patient received their second dose of mRNA-1273 (Lot number: 029L20A, Expiration date: not provided) via intramuscular route in the in the deltoid muscle arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, after administration of vaccine, the patient experienced fever, back ache and fainting. The fainting was considered as medically significant.  Treatment information was not provided.  Action taken with the mRNA-1273 in response to the events was not applicable.   The outcome for all events was considered recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age. The last menstrual period (LMP) and estimate date of delivery (EDD) were not known. The patient's pertinent medical history included psychosis. The patient did not have drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (route, dosage information and lot number were not informed) for Prevention of HPV. Concomitant medication included "mood stabilizers". The physician reported that the patient "may be pregnant". The patient who was presently in the hospital for "psychosis", was "being tested to determine if she was pregnant". However, it was also reported that no adverse effect were reported. Treatment was not given for the adverse event. Laboratory diagnostics studies were not performed. There was no product quality complaint involved. At the time of reporting, the pregnancy outcome was pending as well as the outcome of psychosis. The causality assessment between psychosis and therapy with GARDASIL 9 was not provided. Additional information has been requested.
Drug dose administration interval too short; fever; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (For tolerance of 1st dose refer linked case US2019099058).   On 30th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced fever and injection site pain. On 30th May 2019, the patient experienced drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the fever and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient stated he received 2 doses of Shingrix vaccine 3 weeks 2 days apart, which led to shortening of vaccination schedule. In May 2019, less than a week after receiving Shingrix, the patient experienced fever and it was stronger than 1st dose which had at the time of reporting recovered.  In May 2019, less than a week after receiving Shingrix, the patient also experienced pain at injection site which was less than the 1st dose and it was still present. The reporter did not consent to follow-up. No further details were provided.
This spontaneous report was received from a healthcare worker concerning an adult patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated a dose of MMR II (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. On 14-MAY-2014, an adult patient was administered MMR II for the first time. No adverse effects reported. Additional information is not expected.
All the fingers felt numb at the left hand the first day. Three fingers still felt numb after 2 days. Right now, still two fingers fell numb. Event can't sleep.
Starting at 10:00 a.m. this morning I started feeling fatigued by 2:00 p.m. I was feeling chills and shaky. I also started feeling nauseous around noon. I got in bed under the covers and continued to feel very shaky and chills. Around 2:30 p.m. my all of my fingers went numb as well as my toes. I took ibuprofen early this morning around 8:00 a.m. and again around 1:00 p.m. I also took 20 mg of prednisone at 3:00 p.m. I now I'm starting to feel better I did of note feel poorly after the first two vaccines this was my booster and it seems to be worse than the previous two.
Case number PHEH2013US013238, is an initial spontaneous report received from a nurse on 14 Jun 2013. This case refers to an 11-year-old female patient. her medical history and concomitant medication were not provided. She was vaccinated with MENVEO, batch number: M11082 and expiry date: 31 May 2014), at a dose of 0.5 ml intramuscularly in between 07 Jun 2013 to 14 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached-1 degree Celsius for atleast 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error.
FLUZONE HIGH DOSE administered to patient under 65 years of age->incorrect vaccine administered.
Mother noticed patient's face swollen 24-30 hours after receiving vaccine.  Patient also experienced extreme fatigue and nausea, and swelling of arm.
Fever, shortness of breath, muscle aches, malaise, subsequent respiratory failure, renal failure. Began on 04/02/2002. Hospitalized on 04/05/2002 and is still hospitalized. Received on 06/16/2003: "Annual follow up, patient recovered, but still has slight heart problem, mild chest discomfort occasionally."
Vomiting, poor oral intake, and mild dehydration within 24 hours. Vomiting continued x 3 days total, few loose diarrheal stools for 2 days after onset of diarrhea. Seen in ER after patient failed outpatient oral Pedialyte challenge. Repeated Pedialyte challenge and patient tolerated oral intake well. Sent home and improved over next 2 days. Seen back in PCP office 4 days after vaccines with weight gain of 7 oz in 4 days.