chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous report (USASP2021068522) was reported to Amgen on 03/MAY/2021 by a consumer and involves an approximately 57 year old female patient who had swollen lymph node for reported 'node on the right side under the chin/jaw is hurting and swollen [PT: lymph node pain], never knew to leave her sureclick out at room temperature before injecting has not been doing it previously patient states optumrx told her enbrel could be frozen for four days [PT: wrong technique in product usage process], she had been storing in the freezer instead of in the fridge [PT: product storage error] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date in the past that happened when she took something she had allergy. On 20/MAR/2021, the patient had COVID-19 vaccine and on an unknown date in 2021 the patient's lymph node on the right side under the chin/jaw was hurting and swollen. The patient wanted to know was her system building antibodies from the vaccine or could this happen from being off Enbrel because the patient had been off it a couple weeks. On 23/APR/2021, a few days ago, Friday or Saturday (30/APR/2021 or 01/MAY/2021) the patient stated that her son put her Enbrel in the freezer instead of in the fridge, which she just noticed after having attempted three doses. She stated they malfunctioned when she pulled the cap straight off and it looked like more came off than normal. When the patient pressed down the patient was not sure the needle was even going in. It stuck down but the color didn't change. Also the patient stated that she never knew to leave her Sureclick out at room temperature before injecting and had not been doing it previously. No treatment information was received. The outcome of the events lymph node pain, wrong technique in product usage process, product storage error was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the event lymph node pain. The causal relationship between the events lymph node pain, wrong technique in product usage process, product storage error and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.
Initial report received from a healthcare professional who is the patient's mother on 06 November 2013. A 13-year-old male patient received an intramuscular injection in the left arm of FLUZONE, lot number U2847AA, on 23 October 2008. The patient's chart states he received FLUVIRIN by Novartis but a lot number for FLUZONE was charted. On 09 November 2008, also reported as 09 November 2013, the patient developed muscle spasms, hiccup type movement in abdomen and neck jerking. The patient was evaluated by a physician when symptoms progressed per mother on 09 November 2008. Laboratory tests were negative for a Lyme blood test, no invasive tests for neurological, followup cardiac test for sinus arrhythmia an EKG, TSH and heart rate (HR) 40. The patient was referred to pediatric neurologists on an unreported date. The neurologists report states: Potential Tourettes, chronic motor tic, developmental condition he will outgrow. Possible onset dystonia. Possibly due to tick bite in 2006-07, possibly due to traumatic injury. Pediatrician health summary 20 November 2008: Cardiac arrhythmia, contusion chest wall, flu vaccination, dizziness, and twitch. Reporter states son is now 18 years old and in college and in her opinion still experiences motor tics but not overtly noticed by patient. The patient has no complaints about these or any symptoms to his mother at this time. Past medical history included being diagnosed with a cardiac arrhythmia in 2006, a contusion of the chest wall from people piling on top of him, a tick bite in 2006 or 2007, fatigue, iron deficiency anemia, an abnormal thyroid stimulating hormone (TSH) and bone fractures. The patient outcome is unknown. Documents held by sender: None.
Information has been received from a physician concerning a 5 year old patient who on 12/10/98 was vaccinated with a dose of varicella virus vaccine live. On 5/31/03, the patient experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no treatment and no hospitalization. The patient recovered. No product quality complaint was involved. This is one patient out of 40 reported. Thirty nine other cases (WAES0407USA01446, 0409USA01855 through 0409USA01862, 0409USA01863 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Nausea; Muscle ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of   in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-014103 (Patient Link).
dizziness, vertigo, nausea, blurred vision, agitation, sleepiness, hot flashes, sweats. Treatment: 1st day-emergency doctor prescribed Antivert. 3rd day-doctor prescribed Compazine and Zofran. 7th day-doctor prescribed Methylprednisolone.
Patient called on morning of 4/13/2021 with extreme headache starting evening of 4/6/2021 after receiving vaccine. Lasting until 4/15/2021. Was light sensitive and also had low grade temp. With release of findings of Janssen vaccine decided should call in.
presyncope, flushing, tachycardia with self resolution within 5 minutes.
Arrived with c/o encephalopathy 2/2 seizure d/o and UTI; found to be COVID + and dx w/ COVID pna. Given O2, steroids, zinc, singulair, lovenox. Advanced to vent support. Deterioriated and made comfort care.
Largest, most aggressive Herpes Simplex-2 I?ve ever had or seen on anyone. Moreover, last time I had a cold sore was over 30 years ago.  Also suffered headaches, fever & aches for most of the outbreak. Was completely fine before shot. FYI, I have had ocular herpes several times in adolescence & once after spending 5 days in ICU 14 years ago.  I was asked if I had ever had shingles before they gave the shot, so I assume it is well known that Herpes outbreak is a common side effect. If it is, it was extremely dangerous & reckless to risk my vision over this vaccine. I was extremely lucky this time. However, people should be informed Herpes outbreaks are a common side effect if this is the case and I certainly believe it is after what I went through.  Can send you a digital picture if you like.
Stated the shot hurt when the needle went in.  Stated that it felt like a pulled muscle with pain 7/10 with movement.  0/10 no movement.  Right upper arm swelling noted.  No edema or bruising noted at ER.  Went to ER 10/6/10 and told to take ibuprofen & F/U with MD if not better.  Went to Urgent Care 10/8/10 and told to hot pack injection site.  Return to full duty.  States it feels less painful as of 10/12.
Nurse stated the vaccine leaked out of the patient's left arm during ID administration; full dose not administered.  The same nurse repeated an ID dose on the same arm (left arm) successfully. No patient complications.
Arthralgia FATIGUE, PAIN/SWELL INJ SITE, RUNNY NOSE Narrative:
Injection #1:  Left Deltoid hard and swollen with pain on palpation for 3 weeks.  Heat and massage used to reduce.  Injection #2:  Headache for 5 days, fever, chills, body aches 3 days, nausea 3 days, vomiting 1 day, diarrhea 1 day.  Fatigue 7 days.  Self resolving.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 29-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K008409, with expiration date 04-MAR-2016 (dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced different temperature excursions of 88, 64, 264, 184, 152 and 320 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree), 33 F (0.555555556 Celsius degree), 32 F (0 Celsius degrees), 29 F (-1.66666667 Celsius degree), 30 F (-1.111111111 Celsius degree), 31 F (-0.555555556 Celsius degree) respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Vaccine was adminstered post expiration. A letter was sent to the patient's address on 2/17/2023 stating manufacturer's vaccine activity at the time of administration.   Manufacturer Statement: Moderna reviewed the stability of the vaccine you received and determined that it likely maintained the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you may have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.
shingrix vaccine administered and I had a terrible side effect, including, shaking, passing out, high fever 103.9. Face turned red and ears, sweating profusely. Five days later I was still feeing the effects, fatigue, no appetite, blury vision. Was sent to ER due to covid I was turned away. I reported to primary care doctor and basically no other instructions given. It has been 10 months since I had the vaccine and I had no idea this can be reported to the FDA. People need to know this, it has been 10 months and I am still not the same.
Within a few minutes (maybe 5 minutes?), the patient returned to the pharmacy after she threw up in her mask. Technician, gave her a bottled water, new mask, and plastic bag. She asked him if this was a normal reaction. He told her he was unsure. The vaccinating pharmacist was on the phone at the time of this event, but had verified with patient before administering the vaccine that it was preservative free. Patient also told rph that she was trying to get pregnant since she marked "yes" in the box "are you pregnant or is there a chance you could become pregnant in the next month?"
patient c/o dizziness and decides to lie down on the floor to avoid falling. Was placed on wheelchair and transfer to the observation room and was observed for 45 minutes. vital signs stable. bp= 110/70 HR =104, lung clear.  Patient reports this happens every time she goes to doctor or hospital; she gets very anxious and feels dizzy.  History of anxiety on medication.  Patient was feeling well and able to go home on her own, she had a friend accompanying her at the vaccine sight.
Vertigo  - onset 2 days after vaccine with inability to walk/stand; sudden onset
Information has been received from a certified medical assistant (C.M.A) concerning a female patient who in June 2008, was vaccinated with the first dose of GARDASIL (dose, route and lot # were not provided). In August 2008, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot # were not provided). On January 2009, the patient was vaccinated with the third dose of GARDASIL (dose and lot # were not provided). It was reported that on an unspecified the patient developed thrombocytopenia after receiving GARDASIL. On an unspecified date, there was given treatment of unknown nature for thrombocytopenia. The patient's outcome at the time of the report was unknown. The patient sought unspecified medical attention. Follow up information was received from licensed practical nurse (L.P.N) (also reported as certified medical assistant (C.M.A)) concerning a 16 year old female patient (currently 18 year old) who on 04-JUN-2008, was vaccinated IM with the first dose of GARDASIL (Lot #, and dose not provided). On 05-AUG-2008, the patient was vaccinated IM with the second dose of GARDASIL (Lot # 659439/1267U, dose nor provided). On 21-JAN-2011, the patient was vaccinated IM with the third dose of GARDASIL (Lot # 661703/0651X, dose not provided). It was reported that the patient was diagnosed with thrombocytopenia in March 2010 and was being treated by oncologist. At the time of the report, the patient had not recovered. Thrombocytopenia was considered to be life threatening by the licensed practical nurse (L.P.N). Additional information is expected. Lot check investigations were initiated for lot numbers 659439/1267U and 661703/0651X.
On 10/29/98, the pt developed a widespread urticarial rash. There are no itchiness or fever. The pt sought unspecified medical attention and was treated with Zyrtec. Subsequently, she recovered from her experience.
Swollen and tender lymph node underarm where vaccine given, large tender red circular area at injection site, larger than a quarter, body aches. Tylenol and ice therapy without relief. 3 days since vaccine so far.
10/15/03 9:05 left arm 3" redness/swelling. 10/15/03 2:55 left arm 4" redness/swelling. 10/16/03 9:20 left arm 5-6" redness/swelling. Mother taking child to ER. Had steroid injection and placed on Augmentin in ER-swelling gone, redness gone.
2 weeks  ago on April 17th,  I woke up feeling very dizzy and nauseous. The room was spinning. My left ear was ringing, My balance was off.  Every time I bent over it was worse. I vomited after I ate.  Spent the day and the next day in bed. On Monday I called my doctors office and explained how I was feeling  and a tele visit was scheduled later in the day. During the tele visit,  the doctor diagnosed my symptoms as vertigo. I never had vertigo in the past. She couldn't tell me if it was from the vaccine or not. She did mention she had patients complaining of vertigo after getting the covid vaccine. Medication and exercises were given to me.  A few days later, my big toe on my right foot was aching terribly.  Each day it seems to be worse and I am at the point where I can barely walk.  Today I did some research online and saw that it could be gout. I never had gout n the past. I read vaccines can cause gout.  So here I am 2 weeks since my symptoms began and I am still dizzy and have the toe pain. Exercises and medication is not helping.
Upset, nauseas stomach after the first vaccine; Upset, nauseas stomach after the first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female 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: ABDOMINAL DISCOMFORT (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "Upset, nauseas stomach after the first vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain, headache, dizziness, vomiting and chills. Possible myocarditis
Situation: The patient is in the covid vacciantion clinic today for her second Pfizer vaccination. Background: Hx of allergies to Shellfish. Assessment: Patient states during observation post injection she feels a little itchy and has some redness on both posterior arms, and on the jaw line present. Face looks flushed. She is in no acute distress. Patient transferred with gurney in supine position, head 70% elevated to private observation/assessment room. Dr. informed. Dr. in the room to examine patient. Order from Dr. for Benadryl 25 mg po given at 1207 pm.  Vital signs at 1210: 123/72, Hr 76, O2 Sat 98% on RA. Patient states she is feeling better, itching is improving. Patient is resting in the exam, treatment area. At 1220 the patient states the itching is worsening. Per Dr. Benadryl 25 mg po given. Vital signs at 1225: 117/71, HR 66, O2 Sat 97%. Patient states she is feeling better and the itching is lessening. Vital signs at 1235: 121/69, HR 73, 98% on RA. The patient states the itching in her arms has subsided. No redness noted. The patient states she still has a little itchiness in her jaw line. The patient tolerated the Benadryl well. Informed Dr Recommendation: 1240, the patient was discharged into her husband's care, per Dr.
2 days p/administration of MMR vax pt devel orchitis of lt testicle;
soreness in the arm after all 3 shots; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm after all 3 shots) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arm after all 3 shots). At the time of the report, PAIN IN EXTREMITY (soreness in the arm after all 3 shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not on any concomitant medications. Treatment include over the counter painkiller medications    This case was linked to MOD-2021-409787, MOD-2021-409788 (Patient Link).
Partial temporary blindness in peripheral field of view in right or left  eye that last about 45 minutes, experienced 4 different times over a period of 4 months.
About 5 min after administering the vaccinations, I noticed that both legs were red in an area covering most of the tops of the legs. Dr. looked at the affected areas and said that it was was a localized reaction. When the patient left, the redness was starting to fade.
Rash at vaccine site x 2 weeks. With recurrence of rash at vaccine site after 2nd dose lasted 2 weeks. Currently with recurring diffuse macular papular rash to body which began on May 27th and is ongoing.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old male patient who had FLUZONE HD given to 61yo male patient, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Oct-2018, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ036AA via intramuscular route in the right arm. It was a case of actual medication error due to Inappropriate age at vaccine administration. The patient outcome is reported as Not Applicable for fluzone hd given to 61 yo male patient. 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 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.
Low fever, muscle aches, headache. Starting around 10pm on 4/7, I noticed muscle aches, followed by a low fever by 4am on 4/8; woke up in the afternoon with a headache.
Pt. transferred to reporting hospital received second dose of Moderna COVID-19 on 4/14/21. Pt was admitted to reporting hospital on 8/22/21 with an admitting diagnosis of Worsening ARDS 2/2 COVID. Pt arrived intubated and sedated. Patient has been in outside hospital ICU since 8/13/21 with COVID pneumonia and has been intubated since 8/15/21.
Pt developed rash, heat, pain & itching on (L) upper arm the day after she received ADACEL shot 3/30.
Swelling of left arm lymph glands, muscle cramp left leg calf, sore throat, running nose and headaches.
Electroshocks in my hands spiking from my shoulder blades down to the finger tips.  It was more than a tingly feeling; felt like needles pinching my nerves and feeling pain at the tip of my hands.  The strongest pain was on the left, on the side of the vaccine.  I also had a large bump under my left armpit which I read is a normal thing from my lymph nodes reacting. However, the electroshock feeling was very new and uncomfortable.  It would happen sporadically throughout the day.
This spontaneous report as received from a patient's mother, consumer refers to her son of unknown age. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot number, route, site not reported) on 23-JUL-2012. He received his second dose at nearly 6 weeks after first dose, approximately on 03-SEP-2012, instead of 2 months. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Fevers up to 103, chills, headaches,  fatigue,  nausea
PT WAS FINE IMMEDIATELY FOLLOWING VACCINE. ABOUT 5 MINUTES LATER, STATED HE WAS FEELING A BIT LIGHT HEADED.  WE HAD HIM LIE DOWN FOR A FEW MINUTES. HE STATED THAT HE DOES GET NERVOUS/ ANXIOUS WITH SHOTS AND THIS HAS HAPPENED TO HIM BEFORE FOLLOWING HIS FLU SHOTS. HE REPORTED NO TACHYCARDIA, SWEATING, SWELLING OF THROAT/MOUTH, ETC. HE ALSO STATED HE DID NOT EAT YET TODAY. HE DRANK SOME WATER AND HAD A PIECE OF CANDY. WE CHECKED HIS BLOOD PRESSURE WHICH WAS NORMAL AT 121/79. HEART RATE WAS ALSO NORMAL AT 68. HE SAT IN VIEW OF THE PHARMACY FOR ABOUT 10 MORE MINUTES AND STATED HE FELT FINE AT THAT POINT. I DID CALL HIM ABOUT 45 MINUTES LATER. HIS MOTHER SAID HE WAS GETTING SOMETHING TO EAT AND THAT HE FELT FINE. NO FURTHER FOLLOW UP NEEDED.
Case number PHEH2014US025126, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 51-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
Pediarix accidentally given instead of Bexsero, no immediate adverse effect. Bexsero administered 30 minutes after per parent request.
Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: AFTER RECEIVING THE VACCINE, AROUND 3PM, PT SEEMED AOX3, AFTER ABOUT 5 MINUTES, PATIENT BECAME EXTREMELY PALE AND BECAME EXTREMELY FLUSHED, AND WAS PERSPIRING.  PATIENT CONCOMITTANTLY BECAME NAUSEOUS WITH ABDOMINAL PAIN, AND HEADACHE, AFTER WHICH (~5MIN) PROCEEDED TO VOMIT.  PATIENT LEFT STORE AFTER ABOUT 30 MINUTES AFTER HE BEGAN TO FEEL BETTER.  SPOKE WITH PT BRIEFLY THIS MORNING (5/24/2021) AND PT STATED HE IS FEELING MUCH BETTER, AND HAD NO ADDITIONAL S/Sx OF VACCINE REACTION.
24 hours, nausea, chills, aches, headache, weakness, exhaustion, lethargic.