chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at injection site; swelling at injection site; fever; nausea; weakness; pain at injection site; difficulty breathing; balance feels off; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received in February 2019, refer linked case US2019075925).   On 25th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever, nausea, weakness, injection site pain, difficulty breathing and balance disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, nausea, weakness, injection site pain, difficulty breathing and balance disorder were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, nausea, weakness, injection site pain, difficulty breathing and balance disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A day before reporting, the patient received 2nd dose on left arm and experienced fever of 100.3 degrees F, nausea, weakness, pain, swelling and redness at injection site, difficulty breathing and balance feels off. The patient's date of birth was not obtained during the call. The reporter consented to follow up.
Itchiness and rash on legs, thighs, butt, back, under arms
Severe headache for 21 days and counting. Vaginal bleeding and infection.  Doctor prescribed medication.
First vomiting, then severe chills, severe headache . Chills and headache lasted 42 hours. Did get out of bed for that duration except to go to bathroom. Vomiting never returned after first occurrence. On 3-2-2021, 48hours post injection. My right arm from bicep to shoulder was swollen and red, Stiffness also associated with slight rash on pectoral area and under arm. As of 3-5-2021 swelling and redness have disappeared, however there is occasional itching in the overall area. No other systems currently.
On 4/5/2010, I received a phone call from the mom stating that her baby had to have surgery and it was because of the "shots he was given" and she had paper work from her doctor stating that the baby had a "knot on his leg caused by the shots". I suggested that she bring it for me to review. A short time later the grandmother came in with the baby and said, "He had to have surgery on his right leg because of the shots that he was given, because he had allergic reaction to the shots". The grandmother further stated that she brought the baby in for immunizations on 9/11/09. Later that night he broke out with "red whelps and rash all over from head to toes". He was taken to Family practice and treated. After the rash and whelps cleared up, he had a lump in his thigh. On 10/14/09, the grandmother brought the baby in for his 3rd set of immunizations. She states that she spoke to the nurse about the previous shots and symptoms. The nurse, RN, gave her reassurance and she allowed the 3 set of immunizations to be given. The next morning she stated he had a rash with blisters "like chicken pox" all over him and again he was taken to the doctor and treated with antibiotics. After the rash went away he had a bigger "Knot" in is right thigh and a smaller one in the left. On 3/24/10, because the baby was behind on immunizations as part of her routine immunization follow-up LPN, called the grandmother to schedule and appointment for immunizations. The grandmother stated that the child "has an allergy to the shots" and that she was going to Family Practice for shots. LPN asked her to bring us a note from the doctor verifying the shot. On 4/1/10 the grandmother took the baby to Family Practice because the "knot was bigger and hard". The doctor did a needle aspiration and gave some antibiotics. He was told to come back to the doctor on 4/2/10 for follow-up. On 4-2-10, the "knot" was "cut opened and packed", and he had to return to the doctor on 4/5/10 for repacking and dressing change. After visiting the doctor on 4/5/10, the grandmother came to see me. Grandmother stated that she asked for a referral to hospital for evaluation of both his thighs. A dressing was noted on the right thigh and on palpation of his left thigh, there appeared to be a raised area about 1x1 cm in diameter and a core of about 1/2 inch in depth. I asked the grandmother to call me with the results of the referral. I notified Communicable Disease Nurse Specialist. She attempted to contact grandmother, but there was no answer and no return call from the mother or grandmother. On 4/15/10 and 4/20/10, I made attempts to contact the grandmother and received no response.
vaccine didn't work for me/ suspected vaccination failure; vaccine didn't work for me; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she shingles vaccine did not work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Congestion and loss of smell day 6 from first COVID vaccine dose.  Tested positive (PCR) for COVID 1/19/2021
temperature excursion due to Adacel vaccine was exposed to 27F for more than 3 hours/No AE; Initial information was received on 01-Jul-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174910, 2020SA174906, 2020SA174941, 2020SA174940, 2020SA174932 and 2020SA173110. (same reporter)  This case involves a 11-year-old male patient who was received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed it (product storage error).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On 18-May-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6378AA, expiry date: 04-Jul-2021] via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a medical assistant referring to a unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. From 18-SEP-2017 to 20-SEP-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M042324 and expiration date on 10-JUN-2018, (dose and route of administration were not provided) for prophylaxis. The doses of PNEUMOVAX 23 were exposed to a temperature excursion of 32 degrees Fahrenheit (°F) to 35°F during a time frame of 2 hours 45 minutes which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1709USA010663.
Was here for a nursing visit for her HPV. Did fine, although does not like shots. While in waiting room after shot started to feel wierd, lump on the left iof her throat feels funny when she swallows but is able to swallow.  Also brought to exam room, supne with head elevated. Had water , had juice. Benadryl given.ADVERSE REACTION TO HUMAN PAPILLOMAVIRUS VACCINE.  vs anxiety/ nervous about vaccine. Pt examined 3 times- at no time in distress, breathing fine, speaking fine, no rash or cough, exam normal. Mom comfortable. Pt given benadryl and eventually lump felt a little better. Pt still feeling dizzy and sl wierd. Upon standing stable but reported wierd feeling. MOm comfortble going home- good car and cell phone. ? now some fatigue and dizzy from the Benadryl. Discussed with mom no outward sign or anaphylaxsis. Second dose due in 6 months and has well visit at that time with Dr. We will check on her tonight and am, second dose depends on how she does but I feel safe to go home at this point. Observed and re examoned over at least 1/2 hour.
AFIB; really tired; chest pain; A spontaneous report was received from a consumer concerning a himself, a 75-year-old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation, chest pain and really tired.   The patient's medical history included atrial fibrillation with ablation 3 years ago. No relevant concomitant medications were reported.   On 01 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lo038A20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Feb 2021, the patient woke up at 2:30 a.m. with chest pain, which "has" subsided (date not reported).  On 03 Feb 2021, the patient was really tired.   On 04 Feb 2021, the patient felt great.  On 05 Feb 2021, at 6:30 a.m., the patient went into atrial fibrillation.   Action taken with mRNA-1273 in response to the events was not reported.   The event of chest pain was recovered/resolved. The event of really tired was recovered/resolved on 04 Feb 2021. The outcome of the event of atrial fibrillation was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's age and history of atrial fibrillation with ablation are risk factors and confounds causality assessment.
I woke up at 4 am covered in sweat with a splitting headache. For the next four hours, or so my body felt like it was on fire. I kept waking up covered in sweat. The headache improved with drinking water but it's been consistent for about 4-5 hours.
fever; headache; achy arm/sore arm; felt tired /felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm/sore arm), FATIGUE (felt tired /felt really tired), PYREXIA (fever) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (achy arm/sore arm) and FATIGUE (felt tired /felt really tired). On 29-Mar-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (achy arm/sore arm), FATIGUE (felt tired /felt really tired), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-356645, MOD-2021-356492, MOD-2021-356505 (Patient Link).
Pt came to my clinic today 6/24/10 and showed me rash on rt ant chest and thoracic area, his pcp re ordered acyclovir per phone prior to this visit. Pt wanted confirmation if this was shingles like "worse than when I had shingles".
Diagnosed with herpes zoster in right axilla on 2/14/2021,  never had chickenpox (Varicella) before. Was told was probably due to the Varicella vaccine.
Per pt's mother, pt was given vaccine in outpatient clinic where given vaccine. By 5 PM 1/14/11 presented to ED w/ 1 day of emesis, fever to 103 degrees F on 1/13/11 at home, decreased O2 sats, increased resp rate, poor PO intake. Observed in ER. Labs done (CBC, BMP, CRP). CXR done. D/C'd home in stable condition that night.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (2 years ago from the reporting). On 3rd January 2019, the patient received the 1st dose of SHINGRIX. On 4th January 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain. In January 2019, the patient experienced injection site swelling, injection site erythema and injection site discoloration. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site swelling, injection site erythema and injection site discoloration were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site discoloration to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine last Thursday in left arm. About 24 hours after vaccination, the patient noticed pain at the site. She also noted redness from the site down to elbow, but she was unsure when this started and might had slight swelling at the site. At the time of reporting the site slight pink but no pain and just a small bump about the size of a pencil eraser if that at the site. The patient went to show these side effects to the pharmacist. No medications or advice gave by the pharmacist to the patient. The pharmacist only noted the day when the patient received SHINGRIX. The pharmacist commented that he wished they would have changed the needle after drawing the vaccine up before he gave it. No healthcare professional information asked.
Started period 2 days after shot and stayed on it until my following expected period, 3 weeks later.
patient was given adacel instead of daptacel with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 4-year-old female patient was given adacel instead of daptacel with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 04-Aug-2023, the patient received a dose 5 of 0.5 ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: unknown) (lot: U7837AA, expiry date: 07-Jul-2025) via intramuscular route in the right thigh for Immunization.  On 04-Aug-2023 the patient was given adacel instead of daptacel with no reported adverse event (wrong product administered) (latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was unknown if any lab data/test results available.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  Outcome: Unknown.    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 guidelines. 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.
Patient was erroneously given Pfizer instead of Moderna for dose 2. Patient was contacted to notify patient of error and to follow-up if patient had any side effects. No side effects noted by patient during call.
Patient had a vasovagal response while being observed for the 15 minutes following vaccination.  Rapid Response was called, vitals taken.  Patient recovered with juice, crackers, and water.
Information has been received from a RN concerning a 29 month old female with no past medical history and no known drug allergies who on 19Mar2003 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live.  There was no concomitant medication. On 08Nov2003 the mother noticed a few lesions on her daughter. No treatment was required. The outcome was reported as recovered. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. There reporter also reporter one other pt who experienced an adverse event. Additional information has been requested.
Patient has had muscle pain at injection site since getting injected.  Describes it as a dull pain
Started with itching the following day the warm, red and swelling currently hard at injection site; reported by patient spouse.
PT recd series of 3 Engerix-B vaxs (20mcg) on 15AUG90, 16SEP90, & 15FEB91; 18APR91 test indicated PT was a low responder;
Hives for seven subsequent days.  Woke with hives and after taking Benadryl hives disappeared until next morning.
Heavy menstrual bleeding day after period was over/day after vaccine. Bleeding began on May 4 at 9 am. Migraine headache.
1. Five minutes after administration of the phizer vaccine on May 22, 2021 I experienced a movement sensation in my chest. The sensation lasted for approximately a minute and then subsided.  2. Over the course of the next few weeks I experienced headaches, chest pain, chest pulsations and sensations (to the point of waking me up from sleep), tightness and cramping feeling in both calves (mostly in the right calf), tingling sensations in my fingers, and feet, muscle aching throughout my body, heavier breathing than normal, my legs felt heavier than normal, swelling in fingers (mostly right hand) and joint pain in my left knuckle (between pointer finger and middle finger). I went to urgent care on 5/27/21 and to the ER on 5/30/21.  3. On June 27, 2021 cardiology physican assistant ordered a Holter/Event Monitor for my heart to be monitored for a week; results showing pulmonary hypertension and/or premature ventricular contractions less than 1%. To my understanding I did not have this condition before administration of the vaccine.  4. Lab results ordered by rheumatologist on July 8, 2021 showed that I had positive RNP, SSA, SSB and Nuclear Antibodies. To my understanding these autoimmune antibodies were not positive anytime close to the administration of the 1st shot of the pfizer vaccine on May 22, 2021. I believe the pfizer vaccine triggered the positive antibodies.  5. On August 9, 2021 cardiology physician assistant ordered an echocardiogram for the heart. Results of the test showed mild right atrial dilation and mild right ventricular function while the left was normal. cardiology physician assistant also mentioned to me the terms premature ventricular contractions less than 1% and pulmonary hypotension.  To my understanding I did not have these conditions before administration of the pfizer vaccine.  6. The following symptoms are still ongoing: daily chest discomfort (including heartburn feeling, slight pain in chest, heavy/fast heartbeat on and off), out of breath feeling with exertion, slightly heavier breathing, pain in knuckle and finger swelling.  I am currently undecided of the following: whether I should take a 2nd shot of pfizer, whether I should take a J&J shot or not to continue with a 2nd dose of covid vaccines at all.   Immunologist suggested for me to take J&J because it may not have the adverse effects like pfizer did; while Infectious Disease doctor understands and respects my hesitancy to take another covid vaccine shot but mentioned if I do take a 2nd shot he believes I should take the 2nd shot of pfizer and not J&J. He mentioned because of my age and gender I fall very close within the category of those who have had blood clots with J&J.
Patient received the vaccination per protocol in the pharmacy. After approximately 15 minutes she approached the pharmacist indicating she felt a little dizzy and scratchy in her throat. I asked some follow-up questions to assess possible causes for the dizziness. I then provided 25 mg liquid diphenhydramine for the patient, which she promptly took. After about 10 minutes I reassessed the patient and she said that the scratchiness was persisting and I provided another 25 mg of liquid diphenhydramine. The patient rested in the pharmacy waiting area while waiting for the medication to take effect. She was reassessed every 5 minutes to determine  how she was progressing. At first she started to feel better, but subsequently after about 25 minutes she indicated that she felt some swelling in her face and throat. I further examined her and didn't notice any frank swelling of the tongue. I advised them they could proceed to emergency to be treated for an allergy there or they could go to urgent care for treatment with possible steroids or other medication. The patient and her husband then left the pharmacy and headed for more medical attention.
mom states pt became limp & couldn't move most of noc; mom had to move pt when wanted to change position, OK in morning;
Patient has a hard, warm, red circle around the injection site and a small brown scab in the middle. Patient's parents were advised to use warm compress on the site and start antibiotics for infection.
She woke up with a 103 fever followed by a red rash on her face later in the day. Over the next day the rash spread to cover her whole face, back, abdomen, some on her arms and eventually down her legs and even the bottoms of her feet. On the second day, her eyes swelled and were bloodshot (resembling a severe case of pinkeye). She started coughing, had a runny nose, and continued with diarrhea (7-8 times a day) for approximately five days. A few of the rash lesions scabbed from her scratching but most faded away over time.  One seems to have left a scar, and another is still healing but looks likely to leave a bit of a scar on her thigh as it is fairly large.  She was extremely irritable, awakening during the night many time screaming and crying for an hour or more at a time, for about 5 nights. Today is day 8, and she has now spiked a 104 temp again, but as the rash has faded, I am unsure if she has a secondary infection or if she is simply coming down with some other viral illness. Her twin brother had a similar course of illness with immunization on the same day with a slighly less severe rash.