chrisvoncsefalvay/vaers-outcomes huggingface dataset:
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that the vaccine was stored in refrigerator on 26-Oct-2021, there was no temperature excursion and the patient did not experience any adverse event.  No treatment medications were provided.
Vaccine given 3-11-14. Mom noted redness, swelling, warmth, evening of 3-12-14. Child's arm sore. Child felt warm, but did not take temp. Subsided in 2 days.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: stated arm started to become red swollen and tender to tough on saturday. no urgent care, doctor's visit, or follow up. Also no breathing issues are serious events. To the eye looks like it could have been a bite of some sort because redness is lower part of upper arm where as you can see where shot was administed in deltoid muscle. Pt. believes its due to vaccine
Papules, vesicles, scabbed vesicles 50 on legs trunk and face. Dx: chicken pox post vaccination. Tx: Acyclovir.
Client reported to me on 5/4/11 that he was hypersomulent for 3 days after a Hepatitis A (Havrix) and Yellow Fever vaccine. Now he reports has had insomnia since 4 days after vaccines. No treatment.
Dizziness, blurred vision, fatigue, headaches, chills, low grade fever, muscle pain, joint pain, high blood pressure, and swelling of the throat.
Flu like symptoms; I am still sick and it is like the flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "Flu like symptoms"; ILLNESS (non-serious), outcome "not recovered", described as "I am still sick and it is like the flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
not feeling well; Sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Jan2022, outcome "unknown", described as "Sick"; MALAISE (non-serious), outcome "unknown", described as "not feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that has gotten sick (believe in the past week). He has gotten a Covid test, but we have not heard a result. - I am not sure what the resolution of "not feeling well" was, but I know the relative is high risk and that he must be well enough to see her without fret of getting her sick. I do not know the at-risk relative's vaccination status. They are elderly, female, likely white, and I think might have diabetes and has had trouble having discipline managing it (would need to confirm part about diabetes). If I learn vaccination status, will submit an AE report. She recently "is not doing well". I believe (withheld) is not in isolation - have not gotten direct report, but is likely feeling better. Believe (withheld), likely (withheld).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Pfizer 5-11 years dose instead of Pfizer 12 and up dose. No s/s of adverse reaction after waiting for 30  minutes.
I received my Moderna booster for COVID-19 on 4/25/2022. On 7/3/2022, I had a sore throat, a cough, and mild nausea. I took a home test for COVID-19 and got a positive result. I contacted my doctor on 7/5/2022 and told her about my COVID-positive status. She then prescribed me Paxlovid. Within 45 minutes of taking Paxlovid, I stopped feeling nauseous. On7/6/2022, the sore throat went away and the cough became much milder. My condition continued to improve, and I felt fine by 7/7/2022. However, I continued to test positive until about 7/13/2022. After that, everything was back to normal and there were no more symptoms.
Pt c/o numbness and tingling to throat and tongue after Td. Local swelling and redness to injection site noted. 25mg IM Benadryl given after Benadryl given denies s/s after 10 min. Pt feels fine s/s gone.
Patient is a former premature infant now 2 months of age receiving first series of vacinations.  Infant with a history of apnea/bradycardia requiring oxygen and Theophylline.  Theophylline was discontinued on 8/18/03 and resumed on 8/21/03 for increased episodes of apnea/bradycardia.  Theophylline was again discontinued on 8/25/03.  The infant had no episodes of apnea/bradycardia since 8/21/03.  At 0900 am on 8-24-03 the nasal cannula was discontinued with ocassional oxygen desaturations noted.  The Pediarix combination vacine was administered 8-26-03 at 1330 pm.  At 2330 pm on 8/26/03, the nasal cannula was restarted at 1/2 lpm for desaturations.  The infant continued to nipple feed all feedings.  On 8-27-03 at 0300 am, the physician was called to the bedside for apnea/bradycardic episodes.  A CBC was obtained with unremarkable findings.  The NC flow was increased to 1 lpm and a CRX/KUB was obtained.  On exam, upper airway congestion was noted.  The infant was reloaded with Theophylline in the am, but continued to have oxygen desaturations.  On 8-28-03, the nasal cannula was discontinued at 1100 am with one apneic epsisode ntoed that day.  The infant continued to nipple all feedings.  On 8-29-03 the infant continued to have ocassional desaturations with feeding.  On 9-1-03 Theophylline was discontinued. Discharge Summary received on 11/25/2003 states tachypnea.
Rec'd vaccination @ 1745 - No problems - Returned to clinic at 1900 with c/o itching that began @ 1830; Returned to clinic with hives on R arm only. BP 128/80 decrease 112/60 P 72. Examined by MD - given 50mg po BENADRYL.
patient got Adacel instead of Pentacel; they do not get a 4th dose of Pentacel at 18 months; Initial information received on 11-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 17.5 months old female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that patient got Adacel instead of Pentacel (wrong product administered) and they do not get a 4th dose of Pentacel at 18 months (product dose omission).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB).  On 06-Sep-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6213AA via intramuscular route in the right thigh. On 06-Jun-2018, 08-Aug-2018 and 09-Oct-2018, the patient received 1st, 2nd and 3rd dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Wrong vaccine administered and missed dose.  It was unknown if the patient had any adverse event.  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.  List of documents held by sender: none.
Overwhelming fatigue, nausea, headache, shivers, aching body which lasted for more than 3 days. I was unable to go to work and spent this time in bed.
Second Moderna vaccine was injected in wrong location; swollen arm; A spontaneous report was received from a nurse concerning a 50- year-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and was injected in wrong location (inappropriate route of vaccination) and developed swollen arm(peripheral swelling).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On an unknow date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 JAN 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route not in the deltoid muscle for prophylaxis of COVID-19 infection.  On 26 JAN 2021, it was reported that the patient received second Moderna vaccine in an area that may not have been injected in deltoid muscle (injected in wrong location) and developed swollen arm (far back of arm) on the same day.   On 28 JAN 2021, the patient consulted an HCP who advised patient to monitor the affected area and prescribed Benadryl, which was not applied.   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The event,  injected in wrong location (inappropriate route of vaccination)  was considered recovered/resolved and the outcome of swollen arm(peripheral swelling) was unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of peripheral swelling, a causal relationship cannot be excluded. Further information has been requested.
Felt like got punched in the arm and was eating dinner at 5pm and a blister inside my mouth appeared on left side bottom. Alergic reaction,  see if goes away in a 24Hrs?
25 year old female with prior history of syncope was at public vaccine clinic when she syncopated 9 minutes s/p receiving her 1-time IM dose of J&J COVID-19 vaccine in her L deltoid. When she syncopated, she fell forward while sitting in a chair and hit her head on concrete. She suffered a 1cm superficial laceration on her L frontal scalp.  There was a brief moment of generalized seizure-like activity that lasted for about 10 seconds. After this, she woke up and was able to sit up. Patient appeared anxious. She was alert and oriented x 3 once she was up with a GCS of 15.
patient vaccinated on 2/12, woke up dizzy on 2/13, taken by ambulance to hospital and remained overnight.  treated with IV fluids, meclizine and Ativan.  patient was on day 10 of antibiotics for ear infection
0945 Patient requested water, said throat is dry.  At 1000, patient reports throat tingling and asked for water. Stated that she had not had any water since 2am, uses CPAP, and often has dry throat. BP142/92 HR60.  On further assessment, patient clarified that throat is dry. No shortness of breath, no rash, no GI discomfort. Alert and oriented x3. Declined epinephrine. EMS for assessment and evaluation. o2 saturation 99-100% clear breath sounds.  Discharged at 1100.
I had Shingles on 14 Sep2021. Headache for 5-6 days and broke up into Shingles - bumps and pain with little fever was 24/7 and didn't go away. 5-6 weeks later, it was gone. Walk in clinic said it was Shingles and gave prescription.
This spontaneous report as received from a registered nurse refers to a 65 year old female patient. On 28-MAY-2013 the patient was vaccinated with PNEUMOVAX23 (0.5 ml / once only, lot # H017759, expiration date 04-JUL-2014) subcutaneous. There was no concomitant medication reported. The patient called the physician's office to report having a high fever and redness and swelling at the injection site on 30-MAY-2013. No treatment was given for the events. The outcomes of the events were unknown. Additional information has been requested.
I had a fever, chills and abdominal pain that caused me to go to the doctor.
This case was reported by a physician via sales rep and described the occurrence of allergic reaction in a 11-year-old female patient who received MENVEO. On 17th November 2015, the patient received the 1st dose of MENVEO. On 17th November 2015, less than a day after receiving MENVEO, the patient experienced allergic reaction and swelling arm. The patient was treated with antihistamine. On an unknown date, the outcome of the allergic reaction and swelling arm were unknown. It was unknown if the reporter considered the allergic reaction and swelling arm to be related to MENVEO. Additional details were provided as follows: The patient experienced swelling of entire forearm after receiving the MENVEO vaccine. It was reported that it is not believed to be cellulitis but just an allergic reaction to the vaccine. On Wednesday, 18th November 2015, the patient was treated with an antihistamine. This was the first dose in series for the patient and at this time further information regarding patient condition is unknown. The patient's date of birth, lot number and expiry date of the vaccine were unknown. No further information was reported regarding the event.
shivering/cannot seem to get warm; red spot / at injection site; lump at injection site; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site lump. On 29th December 2020, the patient experienced shivering. On an unknown date, the outcome of the injection site erythema, injection site lump and shivering were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site lump and shivering to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced large red spot and lump at injection site, approximately 2 across and also shivering and he/she could not seem to get warm on the night of 29th December 2020. The follow-up would not possible as no contact details were available.
Pt bumped small, hot site that evening large vesicle that popped later. When seen in time vesicle with clear-fluid about 4cm with erythema about 3-4cm behind. Indurated tx for cellulitis.
I had the worst chills I have ever had in my life. I was tired and extremely achy. I had a fever and three days later am still very tired. I also have a rash on my arm with a raised swollen bump that is itchy and painful.
Patient complains of extreme pain and swelling. She also states that the area is red and warm to the touch and has spread and she has red discoloration all down her arm.
COVID-19 PCR test positive; COVID-19 PCR test positive; This is a spontaneous report from a Pfizer Sponsored Program Covax US Support. A contactable consumer (patient) reported that a 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection) (age at the time of vaccination was 68-year-old), on 08Jan2021 15:00 (Lot Number: EL3248) as dose 2, single and on 18Dec2020 15:00 (Lot Number: EK5730) as dose 1, single, both via an unspecified route of administration, administered in Arm for covid-19 immunization. Medical history included and concomitant medications were reported as none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine: None. It was reported that the patient COVID-19 PCR test was positive on 14Aug2021 and was treated with Regeneron antibody treatment via Subcutaneous injections. One injection in back of each arm, two injections in abdomen. All injections administered at one time. She was told that if she needs to get a 3rd/booster dose she would need to wait 90 days after the Regeneron treatment before doing so. She asked do we have information on this. It was unknown whether culture performed. There were predisposing factors (eg. immunosuppression, contact with other infected persons). Then patient went to an urgent care (Physician Office) for follow-up to see if she was progressing as expected). The outcome of event COVID-19 was unknown.  Follow-up attempts are completed. No further information is expected.
PT was walking, began to feel lightheaded and fell to the floor. Did not hit her heard. Remained conscious and orientated x 4.  Episode began at 10:05AM. Repaid response was called by fellow staff at her workplace in the clinic. Patient complained of dizziness with positional changes and nausea. Legs were elevated. Vitals signs taken. Initial bp elevated, retaken 10 minutes later and WNL. provided orange juice and water. Patient  reported dizziness felt better, denied need for ambulance. Assisted to front door in w/c and left in private vehicle with her spouse. Instructed to go home, put legs up, rest and drink plenty of fluids.
chills, dry heaves, nausea, vomiting, uncontrollable body shaking while heaving.  Hard to describe feeling in head of being not in control of my body while heaving. Never experienced this feeling before.  Severe lethargy. Two days after vaccination I got  itchy rash under both upper arms. Worse on left than right side.  As I slowly recovered, brain fog set in at different times making it difficult to "think straight".
J18.9 - Left lower lobe pneumonia I48.91 - Atrial fibrillation with RVR (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC) N30.01 - Acute cystitis with hematuria
Received the first dose of the Pfizer Covid 19 vaccine on a Monday and was diagnosed with Covid 19 the following Friday; This is a spontaneous report received from a contactable consumer (patient's girlfriend). A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiry was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received the first dose of the Pfizer covid 19 vaccine on a Monday and was diagnosed with covid 19 the following Friday with the lab test of SARS-COV-2 test. He was due to get the second dose of the vaccine today (19Apr2021) and was wondering how long he has to wait to get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Mother brought child patient back in 2 days after immunizations were given. Mom stated right thigh was red, swollen. Mother stated child patient was in pain, crying, didn't want to walk. Mother stated no medication was given to child patient for symptomatic treatment.
Fever, aches, severe headache approximately 15 hrs in duration.  Fever range: 99.2 to 202.6 F.  Onset of signs/symptoms approx. 15 hrs after Phizer vaccine dose #2.
Information has been received from a physician and the office manager concerning an 8 month old male patient who on 30-MAR-2009, was vaccinated with PNEUMOVAX instead of PREVNAR by mistake due to an office error.  It is unknown if the patient sought medical attention.  Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot 661934/1441X).  There was no illness at the time of vaccination.  No reactions or adverse events were reported.  The patient did not seek medical attention. This is one of several reports from the same source.  Additional information is not expected.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine and  advised lot 007B21A maintained activity needed to protect against covid 19 0n the date vaccine was administered. Also patient did not call in to complain of adverse event. This is administrative error without adverse event.
Patient received Janssen vaccine on 5/11/21 @  Pharmacy, noted 12 hours after the vaccine had headache, body aches, and chills.  The on 5/17/21 woke with a head to tow rash.  Went to ED and was treated with Prednisone and antihistamines.  5/19/21 noted chest and head congestion, shortness of breath and return of rash on his back only. Patient referred to see provider 5/19/21 to rule out covid infection and discuss the treatment of symptoms.
Body aches, chills, cough, headache, stomach ache, loud of appetite, fatigue
Apr 15 :Vaccine administered in left arm Apr 16-17: sore arm & fatigue Apr  21-30:  swollen & painful lymph nodes on left side of neck, Neck & shoulder pain Apr 24:  Rash appeared on left arm that was very hot  Apr 25: Rash has faded to an outline
throat swelled hard to breathe,I was rushed  to the hospital and on route to the hospital I was given a shot and in the hospital I was given another shot to stop and prevent any further swelling of my throat
pt recvd flu vax & 48 hrs later devel a severe h/a which lasted 24 hrs then went away on its own;
Patient developed chills, body aches, loss of appetite, and general "weak" feeling hours after receiving the vaccinations. Patient later began vomiting a few hours later. All symptoms lasted almost two days. Patient's spouse suggested visiting a physician or the hospital but patient stopped vomiting and felt better late Wednesday morning and decided not to seek medical care. Patient's spouse came to the pharmacy to report adverse event and stated that patient was at home and still had chills, body aches, loss of appetite and nausea.
Bells Palsey - June 19th - Lasted 3 weeks. Vestibular Neuritis (possibly) - Suggested by Doctor, not officially diagnosed. Severe Dizziness lasted 4 days. Lingering Dizziness still ongoing. July 26th
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored ROTATEQ injection, route of administration not reported, defaulted to oral (strength, dose, lot # and expiry date were unspecified). No concomitant medications were reported. No adverse effect were reported. This is one of several reports from the same source. Additional information has been requested.