chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 4 year old patient. No medical history provided. On 28-OCT-2013 the patient was vaccinated with improperly stored VARIVAX lot # 671848/1797AA (expiration date: 15-NOV-2013), 0.5 ml once. No concomitant medications were provided. The VARIVAX had been stored in a freezer that had not maintained temperature since August 2013 and has had multiple excursions since then up to -10C maximum. No adverse events were reported. No outcome was reported. Additional information has been requested.
Flush face, blotchy skin, tingly fingers, rapid pulse  gave 50mg Benadryl
Bowel discomfort; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Bowel discomfort) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Bowel discomfort). At the time of the report, ABDOMINAL DISCOMFORT (Bowel discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by the reporter  No treatment medication reported by the reporter
Fever on the night of vaccination. Body aches that felt like every bone in my body hurt. Tylenol did not control the fever. Body aches lasted three weeks. Fever lasted about 4 days. No appetite, diarrhea. Sill lack of appetite and run down and nothing tastes good. The fatigue is lingering. The breathing and low oxygen levels are still causing problems since the first dose.
Note: Resumption of interrupted Anthrax reactions seem to be occurring more frequently. Erythema, edema, mild pain, fever, body ache, malaise.
approx 3 hr p/vax pt cried hard & persistently for 3-4 hr; father states could console pt & would stop crying-mom states cried almost all the time for 3 hr; took pt to ER t100.3 R given Pedialyte & APAP-no further problems;
I had pneumonia, I was short of breath, and they did a chest X-ray and said I had pneumonia. They gave me shots and some medication. After taking the medication I feel a bit better, but I still feel congested. I feel stable.
Dizziness, fatigue, blood in Urine, Chest and Stomach burning, joint pain, irregular heartbeat and numbness on both the hands  Blood test - Normal ECG - Normal Echo - Normal Cardio Monitor (72 Hrs) - Normal  Blood in Urine  - It was normal after 15 days.  Taking Meclizine 25 MG for dizziness.
Left deltoid area swollen, warm and had for three days following vaccine administration of DTaP x0771.
Patient received PNEUMOVAX and FLUVIRIN injection site was warm and red to touch had to go to ER next day after vaccine. (Arm was also swollen).
Information has been received from a physician concerning her physician colleague's son who was previously vaccinated with a 0.5ml single dose of varicella virus vaccine live. The physician noted that in February 2004, her colleague's son developed a breakthrough case of zoster. It was noted that he recovered completely from the breakthrough case of zoster. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Patient did well with actual shot, but after a few minutes began to turn very pale and slightly lost color in lips. Was not having trouble breathing but seemed very tired and almost as though he would pass out.  He did not pass out and patient actually had not eaten much that day. Once he was given some crackers and a soda, his color started coming back to his face and he appeared to have a bit more energy.
patient was administer rotarix via intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number x5z5z, expiry date 9th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th August 2021, the patient received the 1st dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 4th August 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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 nurse reported that the patient was administered with Rotarix intramuscularly, which led to inappropriate route of vaccination. The reporter consented to follow up.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the unspecified patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # L019996, expiration date 02-DEC-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effect was reported. This is one of several report from the same reporter. Additional information has been requested.
This spontaneous report was received from two pharmacists concerning an unspecified number of patients (demographics unknown). On unknown dates, the patients were possibly vaccinated with doses of improperly stored PNEUMOVAX23 (dose, route and lot# not provided). No adverse effects were reported. One of the pharmacist confirmed that no improperly stored PNEUMOVAX23 were given to patients since 11-AUG-2015. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. The pharmacist informed that on 13-AUG-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 (dosage and route were not reported) injection lot # J009827 and that had expired on 10-AUG-2014. Concomitant therapy was not reported. No adverse effects were reported. Additional information is not expected because the reporter refused additional contact.
Starting around 8 pm began experiencing fatigue, Chills, and nausea. By 10 pm began having headache and went to lay down. Woke up in middle of the night with high fever, cold sweats, and migraine. By morning migraine intensified, could not stand for more than a few minutes without feeling faint and waves of nausea, complete loss of appetite and felt extremely dehydrated and lethargic. Sore arm at injection site started second day and progressively got worse day 3 and 4. 36 hours after vaccine was when I felt more able to eat, walk around, migraine reduced to a dull headache. Fatigue lingered in day to day activities for about 1 week.
Patient received vaccines in office and was fine when left and went on to school. Mom called the office one and a half hours later and stated that he was in the school nurse office shaking uncontrollably and dizzy. Told mom to bring him by the office and we would check him out. When child got to the office he was light headed, dizzy, had a headache, shaking uncontrollable, had a blotchy rash and rigor. Patients blood pressure and pulse was elevated. Provider came into office and evaluated patient. We kept him in office for about 30 minutes after coming back to clinic, Provider advised mom to take him to the emergency room to continue to be evaluated to make sure no other symptoms occur, mom was in agreeance.
Initial report was received on 10 October 2011 from a consumer, who is also the patient. A female patient (age not reported) had received a TB tine test "years ago" (manufacturer unknown, route, site and date of administration not reported) and an unspecified amount of time later, she developed shortness of breath, difficulty breathing, feeling faint and her entire arm became swollen. Pre-existing medical conditions, past medical history, known allergies and concomitant medication usage at the time of testing were not reported. Outcome was not reported. Of note: the subject subsequently experienced injection site swelling and tenderness that was hot to touch after receiving FLUZONE on 08 October 2011. The reporter for this case is the same as for case number 2011-09800.
Got really sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient stated that, she received the 2nd dose of the shingrix vaccine in February 2021 and got really sick but did not wanted to provide additional details.  The reporter declined correspondence from safety team and declined to provide Healthcare professional information.  No further information was reported.  The reporter did not consent to follow up.
resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type two diabetes mellitus), CHF(congestive heart failure), open wound, wound infection, heart failure. Allergies to medications, food, or other products: none. Concomitant medications included unspecified products (List of any other medications the patient received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: Yes. Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender's Comments: The old patient had diabetes mellitus, congestive heart failure, open wound complicated by infection, all these pre-existing medical conditions contribute to the patient death.  More information including complete medical history, concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of the case.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired
Manifested from knee pain to serious neurological issues and degeneration, numbness and tingling in both legs. I was confined to a wheelchair about six weeks after the vaccine, Manifested into back pain after that. Pre clinical diagnosis was MS, but test have come back negative for MS.
Tested NAAT positive for COVID 10/15/21 after being fully vaccinated.
Fatigue, then chills, cough and headache, then nausea, called off work Wed 2/10 no appetite, Thursday 2/11 GI upset and urgency set in, R UE injections site sore to where I could not sleep on right side and firm slight bruising through Sunday 2/15
splenic artery thrombosis and splenic infarction  treated with anticoagulation unclear cause, not cardioembolic based on ECHO
No adverse event, vaccine given in error after 8/31/2022 as a booster dose.
Information has been received from a consumer's niece concerning her uncle whose age was undetermined. The consumer reported that her uncle was "older than me." The patient received a triple vaccine of MMR II. The patient became brain damaged. The patient had been hospitalized. The patient was reported to die from pneumonia "about 4 years ago" in approximately 2005. No further information is available.
12/27/2007  Telephone call from parent.  Slight redness and swelling.  Will monitor. 12/28/2007  Was seen in office.  Redness 6 inches of induration and erythema.  no discharge.  Has had similar reactions to other vaccines ie.  DTaP and Td
Chest tightness, SOB, dizziness. History of anaphylaxis for 1st vaccine. Gave 75 mg Pepcid and 75 mg Benadryl at 12:57. Transported to the ED.
Flulike symptoms from 4am - 8pm Nov 17. Symptoms included Headache, bodyaches and fever. Confined self to bed during time mentioned.
Shortly after vaccine developed hives and periorbital swelling and +/uninesa given Benadryl 12.5mg IM and Epi 1:1000 0.1 SQ.
On day 9 post vaccine (1/29): Injection site became a bit sore again, is now red, occasionally a bit itchy, firm and kind of warm.  Red has been growing these past couple day.  Seen at PCP office 2/1
28 or 29JUL92 pt recvd Engerix-B & 12AUG92 devel a rash on abdo & back; itching down arms & prickly feeling as opposed to itchy; MD visit was required to treat the events; blood was drawn to see if reaction was viral in nature;
Headache, Sedation, Myalgia, Arthralgia, Fever, chills and fatigue. pain and redness at the injection site Narrative:
gained weight; muscle and joint aches/ very sore muscles and joints; muscle and joint aches/ very sore muscles and joints; sore arm; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in arm, on 12Feb2021 (Batch/Lot Number: EM9809; Expiration Date: unspecified date in Jun2021) (at the age of 73 years old) as dose 1, single for COVID-19 immunisation in a clinic. Medical history included arthritis (diagnosed years ago). There were no concomitant medications. The patient reported that she has not had any other recent vaccinations or started any new medications. The patient experienced gained weight, muscle and joint aches/ very sore muscles and joints, and sore arm on an unspecified date. Clinical course was reported as follows. The patient reported that after she got her first shot, for two weeks there were no symptoms, but then her muscles were killing her. The patient reported that after she got her first dose, she started having muscle aches, almost the whole week. She said, when she first got the vaccine she had a sore arm, but other than that she was good. The patient also reported that her muscle and joint aches have got that much better that they are almost gone now, but it was almost a week. The patient reported that she has arthritis that was diagnosed years ago, but these pains were complete different. She experienced very sore muscles and joints, so she was wondering if symptoms can start that late from first shot, and if it was okay to get second shot. The patient used arthritis gel, exercised, and did hot showers as treatments for the muscle and joint aches/ very sore muscles and joints, and sore arm . The patient said that the aches were gone now, and she was like back to normal. The patient recovered from muscle and joint aches/ very sore muscles and joints, and sore arm on an unspecified date. The outcome for event gained weight was unknown.  No follow-up attempts are possible. No further information is expected.
10 hours after vaccine woke with moderate body aches and chills.  Tylenol and Motrin take every 3 hours alternating x 48 hours.  Symptoms completely resolved after 4 days.
Red swollen knot came up where injection was given larger than a 50 cent piece. It was hard, swollen and itches like crazy.  It is warm to the touch.
Fever, Chills, Weak, Extreme Fatigue, Dizziness Resolved on own after 24 hours
I received my Moderna Covid-19 series on February 20 an March 20 of 2021. I experienced moderate expected adverse effects immediately following each vaccine dose. In June 2021, I experienced the onset of L shoulder pain (the side of vaccine administration) which felt like a rotator cuff injury. but I had no history of trauma or overuse. I used a combination of rest and NSAIDs but pain continued. limiting my use of that arm. My PCP ordered an MRI which showed microtears of the subscapularis muscle (note: the contralateral (R) side was normal for comparison). I am a 56 year old, R-handed woman. I decided to report this event since it didn't make sense that I would have "wear-and-tear" injury to my non-dominant shoulder. I have a referral to an orthopedist for an evaluation, for an evaluation, but have not yet seen them.
pt recvd vax;six wks later tested neg for antibody;following 2nd dose varicella antibody IGG was 0.21;
Patient came to vaccine clinic day for 2nd Pfizer dose. Had first dose on 9/22/21. 2 nurses were working together. Nurse 1 grabbed a Pfizer vaccine that was on a different table than the Moderna vaccines next to the administrating nurse, nurse 2. Nurse 1 asked the patient's name and birthday, scanned the Pfizer syringe, asked the appropriate screening questions and set the Pfizer vaccine on the table for Nurse 2 to administer. Nurse 2 inadvertently grabbed a Moderna vaccine 0.25ml syringe from the basket on the table next to the Pfizer syringe that Nurse 1 set down. Nurse 2 administered the Moderna 0.25ml vaccine to the patient's left deltoid. The patient waited the appropriate 15 minutes and was monitored, no adverse symptoms noted. Mother was called and notified of error. Educated mother to call with any adverse symptoms. Patient left the building at approximately 4:35 PM.
dizzy; Fever of 102.6; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PYREXIA (Fever of 102.6), HEADACHE (Headache) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizzy), PYREXIA (Fever of 102.6), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (dizzy), PYREXIA (Fever of 102.6), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: high (High) 102.6  High..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  No treatment information was reported. Patient wants to know why she cant take Tylenol for her symptoms.
Parent transferred care. Pt received 0.5ml of Fluzone instead of 0.25ml. No adverse events were known to occur.
Body ache; Chills; Fever; Nasal congestion; Itching and rash on my arms and legs, left side; swelling and redness of my face; swelling and redness of my face; Tingling of my face and lip; Itching and rash on my arms and legs, left sid; Mild allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8731) via unknown route of administration on 12Apr2021 at single dose in left arm for COVID-19 immunization. Medical history included ongoing high cholesterol in 2017, high blood pressure in 2010 and ongoing, ongoing prediabetes in 2013, overweight was maybe 25 years in 1996, and scoliosis was discovered when I was age 12 around 1970 (patient was taking pills for all the other things except for overweight), ongoing acid reflux. Concomitant medications included atorvastatin 10 mg, once a day for blood cholesterol increased, amlodipine 10 mg, once a day for high blood pressure, metformin 750 mg, once a day for glucose tolerance impaired, omeprazole at 40 mg, twice a day for acid reflux, solifenacin succinate (VESICARE) single for bladder control. Patient stated, "I got the first dose of the Pfizer vaccine yesterday and I just want to report that I had the mild allergic reaction to the vaccine on 12Apr2021", patient stated, "she got fever, chills and body ache on 13Apr2021 in the middle of the night." patient stated, "when I woke up I had nasal congestion too but that was very mild on 13Apr2021. patient further stated, "The allergic reaction it was mild, it was swelling and redness of my face and also tinging of my face and lips on 12Apr2021. And itching and rash on my arms and legs and my, my side, left side on 12Apr2021". Patient was feeling somewhat better because was taking Tylenol 500mg 2 pill 3 times a day just started today for all events. No hospitalization because of any of the events. The outcome of events pain and nasal congestion was unknown, while for other events was recovering.  No follow-up attempts are possible. No further information is expected.
Administered the Moderna COVID-19 vaccine today by IM injection to Left delt. Pt became diaphoretic, pale, dilated pupils, nauseated, feeling 'unable to focus' at 10 minutes with VS: BP 90/59, HR 40 bpm, resp 22, SpO2 95%. Cool cloth applied. Pt remained in chair with eyes closed until nausea passed within 2 min. Diaphoresis, palor, pupil dilation passed by 30  min but pt cont to feel 'shakey' so staff member was called to evaluate pt. Pt was advised not to have a second Moderna vaccine and was allowed to leave ambulatory at 35 min with BP of 159/96, HR 59. Pt was asked to call office this afternoon with update.
Extreme fatigue, brain fog, confusion for up to 1 week following  vaccination. Soreness/pain in arm up to 3 weeks following vaccination.