chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone quadrivalent dose was given a patient after not being viable/it was not supported by extended stability information post excursion and vaccine was given to patient with no adverse event; not supported by the extended stability information post excursion with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of an unknown age and gender and nurse reported that the Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] dose was given a patient after not being viable/it was not supported by extended stability information post excursion with no reported adverse event.  On an unknown date, the patient received a unknown (dose 1) dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization and dose was given a patient after not being viable/it was not supported by extended stability information post excursion with no adverse event (poor quality product administered) (same day latency); (product storage error) (unknown latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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 the Directive and Regulatory Authority 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.
unmonitored doses were administered; A spontaneous report was received from a Healthcare Professional concerning patients who received Moderna's COVID-19 vaccine (mRNA-1273) where unmonitored doses were administered to people (product storage error)  On an unknown date, the HCP reports about administering  mRNA-1273 (Lot number: 029L20A)  and mRNA-1273  (Lot number:007M20A) where unmonitored doses were administered to people.   The HCP reports that the Moderna vaccine shipment arrived at the pharmacy on 19Jan2021, and to her knowledge they were stored in the refrigerator. But the pharmacy staff did not take any temperature documentation prior to 27Jan2021. The fridge was observed at 49 degree F on 27Jan2021. She is contacting the manufacture (Moderna) and to see whether Moderna supports the continued use of these vaccine without prior temperature monitoring.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.; Reporter's Comments: This report refers to a case of product storage error (temperature excursion)  for mRNA-1273, lot # 029L20A and 007M20A with no associated AEs.
Patient received the shot and stood up. She exited the little room and said she didn't feel good- she had no color in her face. We sat her down and she passed out. While I was trying to get her to stay awake she looked like she was having a seizure (shaking did not last long). A lady nearby told me she was a nurse and asked me if she had histories of seizures. I said no. (At this time the pharmacy nurse was calling 911) the nurse said she was very pale and lips were blue. The pharmacy nurse then administered an EPIPEN because she felt she was having an allergic reaction. EMTs arrived. They took her blood pressure and checked her heart rate which was a little fast but not of a big concern being that she received the EPIPEN.
Information has been received from a registered nurse concerning a 4 year old male patient who on 4/2/01 was vaccinated SC in the left arm with a second 0.5cc dose of varicella virus vaccine (lot # 637668/1607K) (first dose given post 1 year of age). There was no concomitant therapy. On 6/21/04, the mother noticed the patient was very tired and was not playing much. On 7/22/04, the patient awoke with approximately ten small raised red spots. Some of the spots looked blister-like. Within about two hours, approximately five to ten more spots appeared, which were blister-like on a red base. Chicken pox was verified in the office. Symptomatic care was discussed and when to call the office back. On 7/4/04, the patient recovered. Additional information is not expected.
Adverse Events described to RN by pt's mother. 12/3/09 10 PM Pt. complains of Stomach ache. 12/4/09 7 AM Pt. complains of Stomach pain given Miralax for possible constipation and sent to school. In the PM decreased appetite. 12/5/09 3 AM pt. developed fever 101 F Treated with Tyenol. Temperature 104.4 at 9 PM. Treatment tepid bath. Temp down to 99.9 F. 12/6/09 Vomiting x 1 after eating at 8 AM. Increased abdominal pain. Refused PO fluids. Onset of rash at 6PM over entire body with exception of the face. 12/6/09 7:25 PM Taken to ER and admitted with diagnosis of Hepatitis R/O Rocky Mountain Spotted Fever. Liver enzymes elevated. Treatment was Protonix, Zofran, Zantac, Benadryl, and Motrin. 12/12/09 Discharged home from hospital. 12/14/09 Pt. to Hospital for liver biopsy.
Bad flare up on toe; mainly a blister; it just is ongoing and getting worse and worse; she has pernio toes; like Raynaud's disease in toes; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6205) at single dose for COVID-19 immunisation on 05Mar2021 at 16:45. Relevant history included ongoing Pernio and ongoing Menopause. Relevant concomitant drug included ibuprofen (ADVIL) for menopause headache, she stopped taking this medication a week before as she was told not to take a thing and stopped everything. Caller stated she does not take it regularly would say been taking 3-4 years.  Past drug included vitamin D. The patient had flu vaccine in Jan2021 and experienced sore arm. No vaccinations within 4 weeks. The patient stated she had pernio toes, like Raynaud's disease in toes which flared up after the vaccine. She had a blister on it that was not healing. The patient was going to see her doctor and may delay her second dose until her blister heals. The patient had blood work with unknown result. The patient stated she had Pernio which was an autoimmune in her toes and it was not a new thing as she had it for years but she had a bad flare up in one of her toes since she received the first dose of the vaccine. It could also be due to the cold weather since that triggers it, and it had been snowing, so the vaccine may not have anything to do with it.  She knew her doctor would say she would need to hold off and not get the second dose. The patient had bad flare up in toes mainly a blister. She stated it was hard to say when it started since she had this condition for a number of years and this one was mainly a blister, but she got the vaccine on 05Mar2021 so she probably first noticed it on Wednesday 10Mar2021 or Thursday 11Mar2021. She did not know exactly when it started because it was on the bottom of her toe, but probably it had been getting worse and worse, so it's not healing. Caller stated this coincides with cold spells which also trigger this, but it had not been this bad before it just is ongoing and getting worse and worse and she was actually seeing her doctor this afternoon for it. Neosporin and a cream that they have given me before named Triamcinolone which is a cream. Caller stated she has taken Advil for pain and that is about it. Caller stated she was going this afternoon to see if the doctor needs to clean the toe since blister was not healing or to see if she could get a topical cream for the toe. Caller stated she kept thinking it was a blister and it would get better and it's not and her doctor said to get in there because if it got infected in the bone in could be a whole other thing, but nobody has seen it yet. The patient stated she did not have any COVID vaccine side effects other than the one and it was great but she does not want to loose her toe. The outcome of event blister flare up/getting worse and worse was not resolved. Outcome of other events was unknown.
Increase in PAC's, arrthymias, chest pain, and shortness of breath within 2 hours after administration. symptoms lasted approx 2-3 post vaccination. upon completion of scheduled ECHO and EKG 3 weeks ago, symptoms all subsided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PCP appointment 9/10 and received the SHINGRIX vaccine for the first time around 2 PM. He was feeling well until 9/11 around 7:30 AM when he developed itching on his palms and soles associated with redness of these areas. Also noted hives on his thighs and trunk. He has a past history of anaphylaxis so checked his blood pressure which was in the 120s systolics and took a BENADRYL. Later that morning he continued to have some itching and noticed his tongue felt "thick".  Felt somewhat similar to a past history of angioedema. He took another BENADRYL and had his blood pressure taken which was in the 90s systolics. Came to ER for evaluation. At ER triage, BP 112/68, pulse 68, RR 18, O2 93%. Received NS x 1 liter, methylprednisolone 125mg IV,  epinephrine 0.3 mg IM, ranitidine 50 mg IV, and diphenhydramine 12.5 mg IV.  After those treatments, he is feeling better with minimal itching and no skin findings. BP after treatment was 106/53. Patient was admitted for observation.
I got my third dose of the vaccine in Pfizer. When I got the first two doses of Moderna I had Migraines and chest pain as well as shortness of breath. I waited for 60 minutes after my shot. Within two hours I had a headache. I tried some Tylenol but within 3 hours the whole left side of my head hurt. I took 25mg of Tramadol and had to take more and then the headache was better. My lymph nodes were very swollen underneath my arm and in my neck. I was still getting ear pain and my lymph nodes were swollen and tender on the left side. It was the same side as I got the vaccine. They were still swollen when I got the second dose and stayed enlarged for about six months. The headaches persisted for as long as the Lymph Nodes were very swollen during the first month. If I stayed ahead of the pain with Tylenol and Motrin the pain stayed under control. I was also fatigued for a long time. After getting the third dose of the vaccine I experienced the chest pain and pressure on my chest. I was short of breath also. It was the same kind of pain I had gotten with the first dose but the shortness of breath and chest pain were much worse. I had taken Tylenol and Motrin this time but the headache stayed under control. All Cardiac testing was negative at the ER. My lymph nodes are so swollen it feels like my throat is a little constricted.
Redness on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness on injection arm) in an 87-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 INJECTION SITE ERYTHEMA (Redness on injection arm). At the time of the report, INJECTION SITE ERYTHEMA (Redness on injection arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness on injection arm) in an 87-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 INJECTION SITE ERYTHEMA (Redness on injection arm). At the time of the report, INJECTION SITE ERYTHEMA (Redness on injection arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
No adverse reaction noted at this time. Pt received flu vaccine on 2/26 with another flu vaccine given again on 3/6.
Symptoms included swelling of both right and left ankles, pain in right leg, shortness of breath 5 days after receiving the vaccine. They put me on oxygen and started administering Lovenox twice a day.
Fever, chills, sweats, general malaise, headache, soreness at site of injection
started 1pm on 4/7 patient experienced dizziness, shortness of breath, tightness of chest and throat,  lethargic, and sweat profusely. PT woke up and bed was soaked. Anxiety and confusion lingers to today 4/8 - today patient still feel lethargic but not nearly as bad - Recommended patient to keep monitoring and proceed to ER if needed
Muscle ache, stuffy nose, coughing/sneezing watery eyes, headache. Lasted 3 days. Felt miserable. Day after the shot I reacted to it. As of 10-4-2010, I am back to work; stuffy nose and coughing other than that, feeling much better.
Redness swelling, pain, hot to touch, 2 days H.A, 33mm induration area 2 red raised papules, aching joints (L) arm, malaise.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since 08-JAN-2015, doses of VARIVAX (Merck) which were exposed to a supported temperature excursion, had been administered to an unspecified number of patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified) on unspecified dates. No adverse effects were reported. No concomitant therapies were reported. Additional information has been requested.
mom reports p/vax pt broke out w/rash on face, arms, neck & hand & stated it itched bad;mom took child to ER & placed on pediapred, phenergan & motrin;7/8/99 feeling worse & itched worse;told to return to MD for eval;
Terrible headache in lower back of head.; Extreme fatigue which has continued from first vaccine.; Terrible joint pain but feels like rheumatory arthritis after the second shot./my right hip is sore; debilitating; My lymph nodes in my right groin; my rib cage feels like it is broken; pain I am experiencing is debilitating; This is a spontaneous report from a contactable consumer (patient).  A 63-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration in Arm Left on 03Sep2021 16:00 (at the age of 63-year-old), as single for COVID-19 immunization. The patient's medical history included mastectomy from Dec2017, DBL Mastectomy No Cancer BRCA 2 Gene, hysterectomy from Dec2016 Complete Hysterectomy No Cancer BRCA 2 Gene. There were no concomitant medications. The patient's historic vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, lot no: unknown), dose1 on 02Aug202103:45pm at arm left for COVID-19 immunization and she experienced terrible headache in lower back of head and extreme fatigue. The patient was not diagnosed with COVID-19, Prior to vaccination. No known allergies and no Prior vaccine in four weeks. On 11Sep2021, The patient experienced terrible headache in lower back of head and extreme fatigue which has continued from first vaccine. She had Terrible joint pain which felt like rheumatory arthritis after the second shot. She never had any such symptoms before and the pain was debilitating. They were affecting her right side of body. Her lymph nodes in right groin, rib cage felt like it was broken, her right hip was sore. The pains came and went but her ribs and lymph glands hurt continuously. She was very active person who was always on the move and exercising, but not anymore. She regrets taking the vaccine as she goes nowhere unless necessary and use all precautions. The treatment was not provided for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Aug2021 Nasal Swab , sars-cov-2 test: negative on 27Aug2021 Employeed family came down with Covid sowe tested to be sure did not get covid , sars-cov-2 test: negative on 30Aug2021 Employed family came down with Covid sowe tested to be sure did not get covid. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is scheduled to receive her second dose on 1 March 2021, after the 42 days mark; A spontaneous report was received from a consumer concerning herself as, 59-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and  scheduled to receive her second dose on 1 March 2021, after the 42 days mark.  The patient's medical history was not provided. Concomitant medications are not reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   Patient was scheduled to receive the second dose on February 17, 20, and 23 but all appointments were cancelled due to winter storm. Patient is scheduled to receive her second dose on 1 March 2021, after the 42 days mark.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was considered as unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.
Sore arm for a few days that got better. On day 7, I woke up with my arm sore again. It was swollen with a large red patch that is warm/feverish to touch. The rash grew throughout the day and was larger on day 8, which is today.
dose #2 25-August-2022, dose #1 late December 2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in late December 2021).   On 25th August 2022, the patient received the 2nd dose of Shingrix .5 ml. On 25th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received second dose of Shingrix vaccine 8 months after first dose in the left arm. The reporter stated that the patient does not remember the exact date of first dose but it was late December 2021. The reporter did not consent to follow up.  Additional supportive information: The patient received 2nd dose of Shingrix later than recommended time frame, which led to lengthening of vaccination schedule.
Within an hour started getting heated and tired. 1:00 am started shacking uncontrollably  bone pain sever headache hurt to breathe. Could not stay awake.  Finally started coming around at 5. 04/07 still had  soreness in lungs. Dr. advised me not to get second vaccine.
rt arm from shoulder to wrist pt c/o pain; mom states pt wakes up @ noc crying because of pain; c/o sl swelling in rt upper arm; no c/o swelling or fever;
Patient is out of range to receive a booster vaccine. Attestation was signed stating eligible and age verification was not verified until after administration of vaccine.
Foggy mind ever since first shot, alone with aches and weakness, followed by scull and scalp pain on my right side, and then terrible vertigo and light sensitiv on 5/18/21
03/09/22 presents to Triage for "scheduled IOL". PMHx of "Asthma".
Patient had a lot of anxiety about shot.  After shot she still felt anxious and not feeling well.  After sitting and resting for 30 minutes she started to feel chest tightness, hot and started to get splotchy or her chest.  We called emergency and EMS took her in.
Fever of 104.8 for 2 days. Painful left armpit with cellulitis and abscess. Start Keflex Capsule, 500 mg, Orally, 20, 1 capsule, every 6 hrs, 5 day(s), Refills 0 Start Benadryl Capsule, 25 MG, Orally, 1 capsule, tidm PRN until symptoms resolve
starting a little over a month after the 2nd shot, I started having severe pain in my elbows.  I went to my Doctor who referred to me to an orthopedist.  He sent me to a physical therapist. But he asked me if I had any other joint pain because fibromyalgia can present like tennis elbow.  At the time I did not but by July both my  hips were aching and I couldn't run any more.  This prompted another trip to my Doctor who tested me for Lyme and autoimmune markers and C Reactive Protein, RA and also Epstein Barr IgG-- results below.  As of this date, I am still trying  to recover.  I am not the person I was prior to being vaccinated.  I am continuing to struggle with my health.
Developed transverse myelitis and right optic neuritis, symptoms included - leg weakness, back weakness, numbness of lower extremities & torso, urinary retention and blurred vision right eye. Admitted to hospital - MRI (brain & spinal cord), bladder catheter, lumbar puncture. Treatment with steroids.
weakness in arm, cannot grasp thing-cont for a couple of wks w/grasping problems;
Large red welts around my trunk (under breasts) some on breast. Small spots on back and abdomen. All itching and burning.
Headache, Diarrhea, NauseaVomiting, Acid reflux, pain in upper abdomen Narrative: