chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered 0.25 ml Fluzone Quadrivalent to 4 year old, No AE; Initial information was received on 28-Feb-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a four year old female patient who was vaccinated with 0.25 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date: not reported) via intramuscular route in the left thigh on 28-Feb-2020 for prophylactic vaccination (PT: underodse).   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error due to vaccine underodse.  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 holders 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.  Information on the batch number was requested.
This case was reported by a healthcare professional via sales representative and described the occurrence of muscle wasting in an adult female subject who was vaccinated with TWINRIX, GlaxoSmithKline. Previous and/or concurrent vaccination included TWINRIX; GlaxoSmithKline given on an unspecified date. In July 2008, the subject received 2nd dose of TWINRIX (1 ml, unknown, left arm). At an unspecified time after vaccination with TWINRIX, the subject experienced muscle wasting, indentation at injection site and injection site pain. The subject is a nurse at this office who is experiencing pain and an indentation at the injection site which has been diagnosed by her physician as muscle wasting. She was seen by specialists and a physician in her practice. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
Information has been received through the manufacturer pregnancy registry from a physician concerning a 30 year old female who on 9/3/04 at 8 weeks and 1 days pregnant, was vaccinated with a dose of varicella virus vaccine live (lot number not known). No symptoms were noted. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 9/13/04 the patient experienced a spontaneous abortion. Post miscarriage, instead of a D&C procedure, the patient was given misoporstol, unknown if oral or vaginal suppository. The reporter was unsure, but believed that the client came to the ER on 9/13/04, and she was not hospitalized, but sent to the on-site clinic. Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: the only rxn was swelling at injection site and bruising no other symptoms
This spontaneous report was received from a nurse refers to a 15 month old male patient. Medical history was not reported. The nurse informed that on 29-AUG-2014 the patient received a fourth dose of ROTATEQ oral, (dosage, lot number and expiration date were not reported). The patient had received the first dose of ROTATEQ approximately in July 2013 at 2 months of age, the second dose approximately in September 2013 at 4 months of age and the third dose approximately in November 2013 at 6 months of age. Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Four and a half months after the second dose of the vaccine, I went camping and I got a rash with swelling and pain in my left arm. My doctor thought it might be vaccine related because I got my shots in that arm. I was prescribed Ivermectin, but it did not help. My whole arm was swollen and painful. I have Lupus and I thought it was a flare up of my condition. I saw another doctor and I had an Ultrasound, and I was Diagnosed with Lymphedema. He prescribed Hydroxychloroquine 200mg twice daily. I also used Clobetasol Propionate cream. Neither of those things seem to help. The swelling has gone down but my arm is still very painful after four months.
fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, back of the neck/headaches and pain, disoriented, injection site swelling, tenderness, and hot to the touch,  fever, sinus infection like symptoms ( stuffiness, difficulty breathing, ear pain, sinus/facial pain )
DISCOVERED SWOLLEN LYMPH NODES IN RIGHT NECK; PAIN AND DISCOMFORT BELOW AND ABOVE COLLAR BONE ON RIGHT SIDE; EXTREME FATIGUE. SAW NP AT PCP OFFICE ON  APRIL 9, 2021.  STILL EXPERIENCING DISCOMFORT IN ABOVE STATED AREA. FATIGUE, UNBEARABLE AT TIMES, COMES AND GOES.
swelling of face/throat; tightness of heart; fever; muscle ache; nausea; pulse was 122; This is a spontaneous report from a contactable other hcp. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 29Jan2021 16:30 (Batch/Lot number UNKNOWN) as single dose for covid-19 immunisation. Medical history included, food allergy. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 29Jan2021 16:30 (Batch/Lot number UNKNOWN) as a single dose for COVID-19 immunization. The patient's concomitant medications were not reported. The patient previously took doxycycline and experienced drug hypersensitivity, caffeine and experienced drug hypersensitivity. The patient stated she had a slight tightness of heart and nausea after 1st dose. They were resolved after 48 hrs. She informed the several nurses about my tightness of heart but they said it's ok if they were gone after 48 hrs. After 2nd dose, she had fever, muscle ache, swelling of face/throat, nausea, and tightness of heart. Again, they were gone after 48 hrs. And then they came back after a week later(6Feb). She had muscle ache and stronger nausea and a racing heart. She called vaccine adverse hotline on 10Feb2021 and was told to go to a urgent care which helped me schedule with respiratory clinic. Her pulse was 122 when she was sitting down. The fast heartbeat lasted for 5-6 days until completely gone. The patient did not take any other vaccine in four weeks or any other medications in two weeks. The patient was not covid vaccinated priorly. The patient was tested covid post vaccination. The patient underwent lab tests and procedures which included heart rate: pulse was 122 on 6Feb2021, sars-cov-2 test (Covid PCR): negative on 10Feb2021, sars-cov-2 test (nasal swab): negative on 10Feb2021. The outcome of the events was recovered on an unspecified date 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On morning of 9/6/08 pt crying with different cry "painful". On way to office pt noted to be pale. In office HR 110-increased to 190 in 10 mins, Hgb 10.6, Glu 320. Ambulance called. En route to ER had asystole. Code X 30 min but no HR. Autopsy showed entire bowel ischemia and true knot in small intestine.
tightness and pain in the center of my chest; tightness and pain in the center of my hest; My heart is beating more rapidly as well.; This case was reported by a consumer via interactive digital media and described the occurrence of chest tightness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2021, the patient received the 2nd dose of Shingrix. On 14th June 2021, less than a day after receiving Shingrix, the patient experienced chest tightness, chest pain and heartbeats increased. On an unknown date, the outcome of the chest tightness, chest pain and heartbeats increased were unknown.   It was unknown if the reporter considered the chest tightness, chest pain and heartbeats increased to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported. All the evening the patient had a tightness and pain in the center of  chest. The heart was beating more rapidly as well. The reporter thought was he/she having heart attack.
Patient had warm to touch injection site and experienced headache. Gave water. Patient felt better but still symptomatic.
to ED c/o back pain, myalgias, fever, tachycardia, no hypoxia, does not meet criteria for steroids or remdesivir; TX: Zosyn, zinc.  D/C'd home
covid vaccine breakthrough case dose 1 12/28/20 Pfizer EL0140 dose 2 1/19/21 Pfizer EL3248
ADMITTED: 10/20/2021: 94 y/o female with history of dementia, HTN, hypothyroidism who p/w increased sob. The patient is unable to give history due to her dementia. She was having some respiratory distress with tachypnea and hypoxia at facility per report, and so was sent to our facility. Known covid positive test there, tested today, they note when she didn't come to breakfast they came to check on her. Due to symptoms she was tested. Cough started last night at dinner, patient coughs quite frequently during our interview. They deny the patient has been febrile.  Her husband is in the same room with her. Patient here arrived on 4L, ABG on room air however was 7.42/31/60. She currently is on 2L, remains tachypneic Per Nursing at facility, fully vaccinated early this year, but has not yet had her booster. Her husband is currently now in quarantine.   PT IS CURRENTLY IN-PATIENT.
Patient came by 7 days post vaccination, mentioning soreness/redness at injection site. On 3/15/16, patient had a softball size blister on her (L) deltoid that PM. Recommended OTC for relief and to monitor.
Approximately 32 hours after vaccination a rash (purpura) with Urticaria appeared on upper side of left forearm to wrist.  Took Benadryl, used Hydrocortisone cream and Calamine lotion.  At the time of this report (5th day after vaccine) the rise and itch have substantially subsided for the 1st time. The purpura is starting to burst and leak clear fluid. Estimate 50% improvement from 12 hours ago.
patient stated on 3rd day had to go to er had trouble breathing, all her organs hurt and had white spots/ lesions on feet. Received ketorolac, methocarbamol, and prochlorperazine from the er
Full body Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Full body Rash) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history reported by the reporter.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced RASH (Full body Rash). At the time of the report, RASH (Full body Rash) outcome was unknown. Not Provided          Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Non-significant follow-up received on 20-Apr-2021, appended in the case on 27-Apr-2021.
Patient recieved a flu shot on Thursday (10/15/09) and 4 h later he had rash on  both arms and legs and intense itching . he took benadryl . it started to get better.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported   This case was linked to MOD-2021-395985.
ABOUT 2 WEEKS AFTER VACCINATION, Patient started with GI symptoms-constipation, diarrhea.  The lower GI bleeding started.  He was hospitalized twice-sepsis and GI bleeding requiring transfusion and Remicade. Patient had had a colonoscopy in May of 2020 and he was fine-no problems.  Not sure if any of this was related but it won't be known until we investigate.  No one can say why he was so acute
I don't know if the pneumonia shot gave me the pneumonia or reaction to shot. I hurt all over my body and could hardly walk. My feet felt like I was walking on pins and needles. I could not close my hands they still hurt till this day 10/23/18. At ER they gave me this Etodolac 200mg, 2 times per day by Dr. I guess this medication is helping. I thought I was gona die that's how bad it was.
The next day arm was reddened up to neck and around it It had red streaking, Sat and Sun sore throat and bad headache, achy Metallic taste and different smell to urine.
Presented with fever X 4 days, fully vaccinated in March. Covid +, recevied bamlamlivimab, etesevimab and steroids.  Pt reported feeling better and wanted to go home
Red lesion at site of injection.   Slightly painful,  slightly itchy.   Only appeared after 4 days
shortness of breath,short of breath when he is walking around today; trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath,short of breath when he is walking around today) and INSOMNIA (trouble sleeping) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, INSULIN, PANTOPRAZOLE, ENALAPRIL, FAMOTIDINE, DILTIAZEM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DYSPNOEA (shortness of breath,short of breath when he is walking around today) and INSOMNIA (trouble sleeping). At the time of the report, DYSPNOEA (shortness of breath,short of breath when he is walking around today) and INSOMNIA (trouble sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided.
HPI: She got a flu shot, high dose. This was 10/14/20. The injection site was hard and swollen and red. This resolved for the most part at this time )11/4/20). Hurt for 2.5 weeks and in the last day or 1 it's stopped hurting at the injection site but her whole upper arm is "a little bit more than an ache" and she can't "exactly use her arm" from the shoulder to the elbow but not involving the shoulder. The most difficult is "holding something" and trying to reach out and set it down. If there is any kind of weight in her arm, she can't extend it well. If she uses it a lot (like today picking up great grand baby), and she's using it a lot, now it hurts a lot without doing anything.  Will attempt treatment with Medrol dose pack for inflammation.  Treatment outcome pending
can barely lift up, it was bothersome, affected patient this pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) via an unspecified route of administration on 08Jan2021 02:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included flu shot for immunisation. The patient got the vaccine (COVID-19 Vaccine) yesterday (08Jan2021) about 2 O'clock and this morning (09Jan2021) patient was having trouble with the right arm. Patient can barely lift up, it was bothersome, affected patient this pain. The patient had flu shot before and it never affect patient like this. The patient meant Flu shot (Unspecified Medication) affected patient but not severe. Patient asked if there is anything the patient can do to make this pain go away. The outcome of event was unknown.
on Jun 18th 2021 / received Pediarix /with expiration date on Jun 14th 20; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the Pediarix vaccine after its expiry date which led to the event expired vaccine used. The reporter consented to contact via email. The batch number was updated from D93BA to D93B4 as per sales data sheet. The case is linked to case US2021134507 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134507:same reporter
Severe weakness, could not stand, would slip to floor, vomiting, had no sensation to coordinate his gait.
-Severe chills -High Fever (Did not measure) -Trouble breathing -Neck pain/facial pain -Arm soreness -Weakness and SOB -Tachycardia - (Peak 132 BPM)
HIB was give to patient mixed with the sterile water diluent not the diluent provided with the HIB. Age of patient at time of event: 2 years 2 months 15 days.
I felt light headed for 3 hours post injection. 11 hours post injection I had cramping, diarrhea, and nausea. The diarrhea and nausea lasted for four days post injection. I had a temperature of 100 degrees on and off, with a headache for 1 week post injection. I took Tylenol the first few days and then switched to advil. I week post injection I had severe pain in my right ovary that lasted for 2 days. I took advil, but it didn't really help. I got the HPV vaccine April 1st and felt very fatigued and brain fogged the entire month. I have also have what feels like menstrual cramps on and off the entire month, and I don't have a period due to my birth control.
Started with a bad headache that wouldn't go away. Then heavy pressure over my eyes, and feeling very tired. Symptoms went away for a few days, then returned. Got tested for COVID-19, with a PCR lab test, and the results were positive.
Case number PHEH2014US013337 is an initial spontaneous report from the nurse received on 19 Jun 2014. This report refers to a 17-19-years-old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. This patient was vaccinated with an intramuscular dose of MENVEO, (batch number: M13030, expiry date: Sep 2014) on an unknown date in Jun 2014. The nurse reported that the patient experienced a fainting episode, described as an in and out feeling after receiving MENVEO and had to lie down for 15 minutes before being able to leave the facility. Patient completely recovered after episode. The seriousness and causality of the events were not reported.
First day after vaccine (4/30/21): 102 fever, chills, severe nausea, vomiting, aches, migraine-like headache pain, malaise, and fatigue (took Tylenol with minimal effect).  Second day after vaccine (5/1/21): aches, shakiness, fatigue, mild nausea, medium-intensity headache, diarrhea, malaise (took Tylenol, which helped with headache pain). Third day after vaccine (5/2/21): aches, mild nausea, shakiness, mild fatigue, mild headache, and mild malaise. Fourth day after vaccine (5/3/21): mild nausea, shakiness, mild headache, and mild fatigue. Fifth day after vaccine (5/4/21): mild nausea, mild headache. Sixth day after vaccine (today 5/5/21): mild nausea, mild headache.
Injection has caused severe intermittent pain in the left shoulder where the vaccine was administered.  I thought the nurse had stuck me a little high, only about an inch below the top corner of my shoulder, (where the corner of your shirts are measured), but I was in pain from my original injury, and did not really care at that time.  I thought it should have been closer to the middle of my upper arm.  The pain did not begin until somewhere between 24 and 48 hours after I was discharged, but that was expected.  When it had been a week, and the pain was not only not gone, but at times was a stabbing pain, I thought something was wrong.  My mother is a Ph.D. prepared nursing professor, (and my first call for all medical questions), but she told me that my fibromyalgia could have contributed to a longer recovery time, since it was administered so close to my shoulder, and fibro is manifested by joint pain, even if it is truly a muscle disorder.  But now, over three weeks later, the pain has not only caused the stabbing pains, but now often renders my shoulder useless, even if only for a short time, there are shooting pains to my elbow, the shoulder pain is more constant, and the sharp stabbing pains are more frequent and are not the least bit affected by pain medication I already take for my fibromyalgia and a permanent back injury, and these medications are very strong - 10mg. Percocet and 20-30mg. of Valium 1-3 times a day.  Nothing has helped, not cold, not heat, and as I mentioned, not pain medication.
Extreme irritability. At site of injection of right thigh, with tenderness and swelling (severely tender), lasting 2-3 days.
Acute psychosis. No history on either family. No mental issues prior. Perfectly fine straight A student. All testing done in hospital give him a clean bill of physical health.
When vaccine was administered, 4/6/21 - I passed out.  Within 24 hours - i was vomiting  and had severe nausea.  I had extremely bad headaches that went away for 2 days then started up again extremely bad the Monday (4/12/21) after my vaccine.   Visited my primary care doctor on Wednesday (4/14) as they wouldnt go away. advised to take motrin.  On friday (4/17) they still had not gone away and went to Urgent care due to fear since the vaccine had been pulled for preventative measures. they did blood work and advised to take some decongestants as the weather had been strange (Snow and 80degrees in the same week) that helped.
Woke with body aches and fever at about 3am.  Husband gave her 3 Advil and symptoms resolved. No recurrance of symptoms.