chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 2019, 2nd Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   In October 2022, the patient received the 2nd dose of Shingrix. In October 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: 21-Dec-2022. Reporter's Comment: The reporter is the pharmacist. The patient was probably in his 50s who had his first Shingrix shot sometime in 2019 and his second Shingrix shot around the first week of October 2022 (She did not have the exact dates nor did she has his name or date of birth). The patient came in to the pharmacy seeking a third dose of Shingrix. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose late than recommended which led to lengthening of vaccination schedule.
Vomiting, chills, and nausea starting at 4 AM. Fever of 101 F starting at 8 AM lasting for the rest of the day with malaise, headache, and body aches, but no more vomiting. Fever broke in the middle of that night. That morning I noticed a swollen and painful axillary lymph node on the side of the injection site, (still present).
Fever, extreme chills, extreme muscle aches, sore arm, itchiness/redness/lump at site of injection and headache.
3 days of tenderness, erythema, swelling (mild) at injection site. Erythema/swelling measured 5x6 cm.
varicella infect approx 30 lesions on trunk, extremities, face;no fever all lesions crusted w/in 7-10 days;
Mom called on the 20th and said there was redness on his (L) thigh when he received his vaccine. "Red spot" she said she noticed it a week before and the spot is smaller. The area was erythematous and has associated pruritus, but no drainage from the site or swelling resolving with intervention. Expect to resolve in the next couple of days. Mom has not returned.
Had  swelling in my left arm that went from the top of my arm to the elbow, also had the red, itchy, rash that hurt at times. Had bad headache  for about two weeks after. I had called pharmacy, where I received the shot and they told me the rash and swelling was common, I also called my allergist, who told me to take Benadryl and put some cortisone cream on it, the swelling lasted for months, it has gone down, but I still have discomfort and the under arm area still hurts and feel swollen at times. I went for a Physical, told Dr and she sent me for a Mammogram and ultrasound of the lymph nodes under both arms. They both came back ok.
Patient complained of itching all over body. Patient denied trouble breathing and no hives present. Patient was given 50mg Diphenhydramine IM in left deltoid. Patient was observed for 30 minutes with regular vital signs. Epinephrine was by bedside in Ambulance Services where patient was being observed. 15 minutes post Benadryl, patient stated itching has gone away. Patient was told to call 911 if symptoms came back.
ED to Hosp-Admission Discharged  5/3/2021 - 5/5/2021 (2 days) Hospital  MD Last attending ? Treatment team COVID-19 virus infection Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine         HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient:                                                              Date: 5/5/2021 DOB:  Admission Date: 5/3/2021 MRN:         Length of stay: 2 Days PCP: MD Discharging provider:  MD    Admission diagnosis:     Primary Admission Diagnosis    Medical Problems     Hospital Problems        POA    * (Principal) COVID-19 virus infection Yes         Gout Yes         Hyperlipidemia Yes         Hypertension Yes         Transaminitis Yes         COVID-19 Yes       HPI: 67-year-old man admitted with COVID-19 pneumonia     Hospital Course: This patient was admitted for COVID-19 pneumonia.  He was treated with convalescent plasma and dexamethasone.  He was not given remdesivir because of elevated liver function tests.  On this regimen the patient did very well and by the day of discharge she was feeling much better.  He continued to be hypoxic and a home oxygen evaluation showed he required 1 L at rest and 4 with exertion.  We have set this up for him and will he will continue oxygen at home.  I will finish out his course of dexamethasone.  He should follow-up with his family doctor within the next week for an oxygen check and to be sure that he is getting better.  His family doctor can tell him when it is safe to discontinue his oxygen therapy.   I educated the patient on self isolation until he is no longer infectious.  He is in agreement with this plan.  He feels much better and is very eager to go home today.
833a c/o "headrush" Bp 132/87 P 63 837a "feels better" 842a Bp 128/84 P64 back to baseline ambulated to exit
cold, shivering as if with a fever yet no fever present along with sore leg muscles, a long hot shower relieved the symptoms temporarily but they lasted till approx. 3AM. Then waves of oversensitivity with knee and foot joints hurting as if arthritis, and this lasted most of the night. I also experienced strange hallucinations in the night as if I had a high fever but I don't believe I had a fever, and I also had a migraine and neck pain. The arm where the vaccine was applied is fine and not sore at all.  I also have a slight soreness in my stomach as if I had been coughing for a while, which was not the case.  It is now 11:34 AM the following day and I believe I'm getting back to my normal self but it sure was a rough night and I though you should be aware.
No additional AE; VARlVAX was administered after the excursion; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant medications included sterile diluent (STERILE DILUENT).  On 18-JAN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 (units not provided) (lot #U020244, expiration date: 28-JUN-2023) (strength, frequency and route of administration were not provided) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was 30 degrees Fahrenheit for a time frame of 30 minutes on an unspecified date product storage error), without any previous temperature excursion.
Patient received vaccination on 03/22/22 in the morning .Mom reported end of day on 03/24/22 that the patient developped redness on injection site followed by rash 1-2 days after receiving the vaccines.  abd vomiting once. Denies fever  chest pain or Shortness of breath. Patient was seen in clinic on 03/25/22 by a provider and had patchy endurated erythema. Provider assessment points to likely due to 1st dose of HPV vaccine
VACCINE CAUSED HEART PROBLEMS  - Conclusion minimal ectopy. Symptoms correspond to sinus rhythm or sinus tachycardia or rare PVCs.  PCP - PRESCRIBED RX = PROPRANOLOL 20MG X 1 TABLET 2 TIMES A DAY TO CONTROL TACYCARDIA AND PALPITATIONS.
chills; low grade fever; headache; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 56-years-old non pregnant female patient received (not pregnant at the time of vaccination) bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 10Mar2021 11:00 (Batch/Lot Number: EN6206) as dose 2, single for covid-19 immunisation (at the age of 56-year-old). The patient medical history was reported as none. The concomitant medication(s) included vitamin d (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported and OTC seasonal allergy medications. The patient had known allergies for Levaquin. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 17Feb2021 09:30 AM (Batch/Lot Number: EL9266) as dose 1, single for covid-19 immunization. On 11Mar2021 07:00 AM, after 18 hours of post vaccination, the patient experienced chills, low grade fever and headache. The patient not received treatment. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Had severe headache, dizziness, numbness in his tongue, fingers and feet, was not able to communicate at all, he was nauseous,could not eat, had severe pain in the shot site, could not walk without assistance, hard to breathe, pressure in his chest, swollen face, muscles in the arm where he got the shot was sore for two weeks, felt extremely tired for about two weeks.
Information has been received from a consumer concerning a male who was vaccinated with MMR II.  The consumer stated that a friend of a friend's son became autistic after administration of "MMR".  The consumer could not provide further information.  Upon internal review, autism was determined to be an other important medical event.  Additional information has been requested.
the patient inadvertently received a dose of PROQUAD instead of a dose of MMR II; the patient inadvertently received a dose of PROQUAD instead of a dose of MMR II; This spontaneous report was received from a medical assistant and refers to a 2 year old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 30-JAN-2020, due to human error, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S002494 expiration date not reported, but upon internal validation established as 23-JUL-2020, for prophylaxis (dose, strength, and route of administration were not reported); instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
FLUVIRIN 0.5ml LA # 111787P1 administered I.M. 9-15-10. Pt developed swelling and black and blue on 9-22-10 or 9-23-10. He called CVS to tell us this 9-27-10. Itching started 9/27/10. He called his PCP- prescribed BENADRYL- swelling subsided black and blue cleared up.
She had Covid; I felt all weird; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Feb2021 (at the age of 73-year-old), as dose 1, single for COVID-19 immunization. The medical history was reported as none. The patient's concomitant medications were not reported. It was mentioned that patient had no other products, had no history and did not undergo investigation assessment. It was mentioned that not right after but shortly about 2-3 days after vaccination on an unknown date in 2021 the patient got real sick, she felt all weird, had headaches and could not breathe very well. She started coughing and everything. When probed for the treatment, consumer stated, that she got sick so bad that she had got to the hospital and they gave her a test and they confirmed that she had covid on 22nd, plus or minus. They gave her some treatment, but it was like some type of enzymes and then that she had to wait about 8 hours with them and then she started feeling better. They monitored her heart, her breathing, it was like for 3 weeks. There was a product complaint. The patient also mentioned that she was nearing the time when she was supposed to take the second shot and does not know if she should be taking the shot. She was thinking if she was supposed to get the 2nd shot or start it over. The lab test includes SARS-CoV-2 test on an unspecified date in 2021. The outcome of events was unknown.  No follow-up attempts were needed. Information about lot/batch number could not be obtained.
This spontaneous prospective pregnancy report as received from a consumer refers to herself, a female patient of unknown age with 19 weeks of gestation. On 08-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported), and found out she was pregnant "a few weeks later. No concomitant medications were not reported. She has not continued the regimen. Consumer said she did not experience any side effects. The patient became pregnant with estimated Last Menstrual Period (LMP) of 21-JAN-2013 and Estimated Date of Delivery (EDD) of 28-OCT-2013. Initial exposure to GARDASIL was at approximately 2 week. The outcome of the patient at the moment of the report was unknown. Additional information has been requested.
A 11 year old boy received Tdap, MCV4 and HPV on Wednesday 2/12/20. Tdap and MCV4 were in the left deltoid. HPV in the right deltoid. Mom called Thursday 2/13/20 afternoon to report his arm was red and swollen and hard, 3 fingers wide, the length of her fingers. He also did not feel well. I told her warm compresses and NSAIDs. Take to care if not better. In a follow-up call to mother Tuesday 2-18-20 she reported that later on Thursday 2/13/20, the arm, shoulder to elbow, and starting up his neck, and around under his arm and into the arm pit was red, and hard. He did not feel well, and temp 99 to 101. 2/14/20 he was seen in clinic, via telemed, and was told to go to an ER. They went to Hospital ER. Diagnosis reportedly was allergic reaction and cellulitis. The skin had blistered. He was given Keflex and Bactrim. Tuesday 2/18/20, mom reports the arm was back to normal, except scabs where the blisters were, the skin is soft, and just looks like he had been sunburnt. He is a sensitive kid and reacts to many things.
Fatigue, headache, loss of appetite, runny nose Medication - Tylenol, Benadryl Next day no symptoms
Information had been received on 10-MAY-2017 from a physician who reported that an unspecified patient (age and gender not reported) was inadvertently administered a "single dose" of M-M-R II (lot# M004899, expiration 27-JAN-2018) on an unspecified date, that had been improperly stored. Temperature was 59F for a time frame of 20 hours (unsupported). There was no previous temperature excursion. Call was because of a data logger. The physician could not provide the lot# and the expiration date for the properly stored sterile water diluent used to reconstitute the dose of M-M-R II. No adverse effects reported. No further information provided. Additional information has been requested.
transaminitis; This is a spontaneous report from a contactable consumer reporting for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The Reporter stated that they received a patient with transaminitis three days after receiving the vaccine on an unspecified date. The reporter asked, are there more reports about this? The patient underwent lab tests and procedures which included transaminitis (transaminases increased): increased on an unspecified date. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
I (MA-C) gave a DTap Vaccine after getting verbal orders to give to a patient even outside of age ranges per my provided. I gave the vaccine in the left deltoid and the patient did not have any complications. VIS sheet was given to the parent in office.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 6-month-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included PENTACEL (Sanofi Pasteur), influenza vaccine unspecified (Sanofi Pasteur), PREVNAR (Wyeth Labs) and rotavirus vaccine (Merck) all given on 21 March 2012. There were no concurrent medications. On 21 March 2012 at 11:29 the subject received 3rd dose of ENGERIX B at 0.5 ml in the left thigh. On 21 March 2012, less than one day after vaccination with ENGERIX B, the subject experienced swelling injection site. The child was taken to the emergency room by her mother because of the injection site swelling, but the child was not admitted. It was additionally reported that the child kicked during the ENGERIX B injection and the complete contents did not get administered. This was a vaccine underdose. At the time of reporting the outcome of injection site swelling was unspecified. The healthcare professional considered the injection site swelling possibly related to vaccination with ENGERIX B. Follow-up information was received on 24 April 2012 via healthcare professional. The subject was given the injection on 21 March 2012 and was seen in the emergency room for a fall on 24 March 2012. The mother had "noted the swelling at the injection site was on 22 March 2012 (previously reported 21 March 2012) and was concerned that it may have somehow caused the fall. The ER physician reassured the parents that the mild 'lump' at the site was normal and not related to the fall". The event of swelling at injection site was resolved at the time of the report. The reporting healthcare professional considered that event possibly related to vaccination with ENGERIX B.
I received a positive pregnancy test 3/22/22. The same day, my arm began to hurt at my injection site and the pain has increased such that I can no longer pick up my toddler and hold him. It doesn?t feel like a pulled muscle; it?s a sharp acute pain centered where I got my three injections on my left arm (which I can pinpoint because they hit a certain area of a tattoo I have.)
A spontaneous report was received on 11-JUL-2016, from a male registered nurse concerning an unknown patient (gender not specified, but the doctor's office was an OBGYN office) who on 22-JUN-2016 (was the first of three patients) who was vaccinated with a dose of expired PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The NDC number reported was 0006-4837-03. The second unknown patient (gender not specified) (Reference MARRS # WAES1607USA010414) was vaccinated on 06-JUL-2016 with a dose of expired PNEUMOVAX 23 (lot # K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The third unknown patient (gender not specified) Reference MARRS # WAES1608USA010415) was vaccinated on 11-JUL-2016 with a dose of PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The reporting nurse stated that the office staff just realized after the third injection that the vaccine was expired. The nurse had concerns on how to proceed and questioned if the injections should be readministered. The reporting nurse stated there have ben no known complaints from any of the patients (3) that were vaccinated, an no treatment has been given thus far. No further information has been provided. Additional information has been requested. This is one of three reports received from the same reporter.
Patient stated hard Knot on arm at injection site, that is uncomfortable. Patient stated that she has tried pain relievers, but still swollen and hard at injection site.
COULD NOT LIFT ARM; PAIN IN INJECTION SITE; LYMPH NODES IN THE UNDERNEATH OF RIGHT ARM AND BREATH; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced could not lift arm, pain in injection site, and lymph nodes in the underneath of right arm and breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not lift arm, pain in injection site, and lymph nodes in the underneath of right arm and breath. This report was non-serious.
Site: Bruising at Injection Site-Mild, Systemic: Other- cyst-like bumps at injection site-Mild
This is a prospective pregnancy case. This female subject was enrolled in a study. The subject received BOOSTRIX (unknown) on an unknown date. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included incorrect storage of drug. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included incorrect storage of drug (unknown). The pregnancy was ongoing.
Fell asleep p/vax, slept x 2 hrs; upon waking sat up on couch shorly p/fell backwards onto couch, stiffened w/clenched fists, eyes opened face turned blue, began breathing again, became limp, nl color returned; disoriented 2-3min; to ER;
Hives and rash across body started 09/4.  Swelling of hands, arms & lips; difficulty swallowing 9/6.  Treatment and observation overnight at ER on 9/6-9/7.  Home care with Rx steroid and antihistamines since 9/7.  Swelling has subsided, rash persists but has improved slowly.
5/14/03: pt developed a red rash on his scalp and came into clinic with dad. Diagnosed with contact dermatitis, treated with prelone 10 mg po qid for 5 days and triamcinolone ointment 0.025% bid for 7 days.
pain in arm; muscle pain; This case was reported by a consumer and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and muscle pain. On an unknown date, the outcome of the pain in arm and muscle pain were unknown.   It was unknown if the reporter considered the pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st shot of Shingrix in arm. The patient experienced pain in arm and muscle pain. The patient asked to have to take ibuprofen for the shot muscle pain. The Agency recommends if localized reaction occurs, such as soreness, redness, itching, or swelling at the injection site, apply a cold compress to the injection site. Consider giving an analgesic (pain reliever) or antipruritic (anti-itch) medication. It was important to note that these were general recommendations from Agency and had not been evaluated with Shingrix. The pharmacist checked for interaction between Shingrix and ibuprofen and no known drug interactions between Shingrix and ibuprofen. The pharmacist suggested to follow-up with doctor.