chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 72-year-old male with no known drug allergies, who has diabetes, high blood pressure, anemia, asthma, osteoarthritis, hyperlipidemia and cervical neuropathy, and a history of herpes zoster in July of 2005 (it was also reported that the patient had no prior history of shingles). On 09-JUL-2007 he was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 657767/0740U). Concomitant therapy included Glyburide, Gabapentin, montelukast sodium (MSD), hydrochlorothiazide (+) valsartan (Diovan HCT), niacin (Niaspan), fluticasone propionate (+) salmeterol xinafoate (Advair) and albuterol. On 06-Sep-2007 the patient received a dose of influenza virus vaccine (unspecified) (manufacturer unknown). On 10-SEP-2007 the patient came to see the doctor with shingles. The patient had a painful mouth lesions, burning of right face, vesicular lesions of right hand, pain in prepuce. The patient told the doctor that the symptoms appeared 3 days before the office visit. The patient was treated with acetaminophen (+) codeine phosphate (Tylenol with Codeine), acyclovir and tetracycline. On 14-Sep-2007 the patient saw a dentist who prescribed valacyclovir hydrochloride (Valtrex). It was unknown if valacyclovir hydrochloride (Valtrex) was taken along with acetaminophen (+) codeine phosphate (Tylenol with Codeine), acyclovir and tetracycline. On 15-Sep-2007 the patient was seen by a cardiologist, (which may have been for a regular follow up), it was unknown if it was shingles related. The cardiologist notified the primary physician that the shingles were spreading. The patient's lesions were located on the left nare, left upper lip, left mid chest, right inside of mouth, and genitalia. No laboratory or diagnostic tests were performed. The outcome was not reported. No product quality complaint was involved. The physician was not interested in the VZV ID program because the lesions had scabbed over and it had been 10 days. Follow-up information received concerning a 73-year-old (previously reported as a 72-year-old), retired male who on 09-Jul-2007 was vaccinated in the left deltoid with a 0.5 milliliter dose of Zostavax (Oka/Merck). At the time of vaccination the patient had muscle aches. It was reported that 60 days post vaccination, on 07-Sep-2007, the patient developed shingles with lesions on the mouth, right face, right hand, prepuce, nose, left upper lip, lower gum and upper chest. The lesions lasted 27 days and were not on a specific dermatome. The patient rated his pain as a 10 (0 being least and 10 being the most painful). There were no other systemic symptoms. The patient did not have a history of chickenpox, however he was seen in the emergency room on 27-Jun-2005 for herpes zoster. The patient's maximum temperature was 97.9 and had a HSV culture done which was negative, no isolated on 17-Sep-2007. There was no photo taken and a direct fluorescent antibody was not done. The patient recovered on 04-Oct-2007. Additional information is not expected.
After getting the vaccine I had a dry cough. It was hurting in the chest area just a little because of it being a dry cough but it wasn't painful.  I end up going to the doctor , and I had a X-RAY done and  I was diagnosed with bronchitis.
Case number PHEH2013US008349 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 11-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 04 Apr 2013. It was reported that the vaccine was at 33 to 36 F for 1 days and it was not frozen. No further information was provided.
Patient began with balance difficulty 3-4 weeks post-vaccination. Complained of "loss of feeling" in feet about 6 weeks post-vaccination. Difficulty walking followed by falls 8-10 weeks post-vaccination. Presumptive Dx Guillain Barre. Treated for Guillain Barre syndrome with 5 days of IV gamma globulin. Patient did not regain loss of feeling/nerve damage in feet and was bed/wheelchair bound. Rehabilitation and physical therapy for 8+ weeks with little/no improvement. Transferred to long-term care nursing home after no improvement in physical therapy. In addition to loss of feeling waist down, patient is now incontinent.
2/26 felt body aches and feverish for the next two days then felt very tired. 3/2 developed a cough with plugged ears and ringing 3/5 had a zoom call with dr office and they suggested Sudafed. Felt very sick 3/15 stopped Sudafed because I was feeling very dizzy 3/18 felt like I was going to faint or have a heart attack 3/19 went in person to dr office and they ordered EKG and said I was in Atrial Fibrillation. Prescribed blood thinners Cough lasted until April and once that went away I started feeling better. But I was still experiencing very hard heart palpitations and dizziness until end of July. It was enough to prevent me from doing normal activities like walking or driving alone. Today I still have
Narrative:  Patient developed lost of sense of taste (salty taste) after getting COVID-19 booster Mordena; patient previously received Moderna x 2 without incident / AEs. ID was e-consulted; suggested trialing time / conservative measures to see if symptoms improved.
Within 3 minutes of being administered the H1N1 FLUMIST, the child got a bloody nose. There was only a small amt of blood and the child was fine when she left. Follow-up calls to parent were not returned.
After two days I got the Vaccine, I notice I had a red irritation at the site I got the shot.
Large, red, hot knot to right arm where injection was give. Knot appeared within 12 hours of administration. Pain with use of arm.
Pt reported he was "aware of his heart" and that it "felt like when adrenaline is running through his body" that began approximately 24 hours after vaccination, and resolved 48  hours after starting. He reported this information at his second dose appointment 21 days after vaccination. He says his symptoms were hard to describe, but he overall felt poorly and says he could feel his heart beating more than normal. He denied chest pain, racing heart, excessing sweating, headache, agitation. Patient has no history of cardiac issues. After 48 hours his symptoms resolved with no intervention.
Chills, fever, headache, fatigue, painful, sore, red, hot to touch.
no adverse effects; An improperly stored dose was administered to a patient; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 18-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S007069 (albumin status: rHA), expiration date 06-SEP-2020, which was reconstituted with an improperly stored dose of sterile diluent (manufacturer unknown) (lot# and expiration date were unknown), both administered subcutaneously for prophylaxis (strength, dose, frequency and anatomical site were unknown for both products); the products had a temperature excursion of -11.5 Celsius degrees for 76 hours, which was detected by a data logger. The vaccines had no previous temperature excursions and no adverse effects were reported.
severe pain in arm; Headache; low grade Fever; Shivers; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (4 years later after receiving original shingles shot (Zostavax)). Previously administered products included zostavax (dose received on uknown date).   On 3rd December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd December 2020, less than an hour after receiving Shingrix, the patient experienced pain in arm. In December 2020, the patient experienced headache, fever and shivers. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the pain in arm, headache, fever and shivers were recovered/resolved.   It was unknown if the reporter considered the pain in arm, headache, fever and shivers to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix and within 15-20 minutes after vaccination patient developed severe pain in arm. During the middle of the night of vaccination patient had shivers, a low-grade fever and a headache.  The patient reported that all symptoms had resolved due to relief provided from 2 Aspirins. The reporter did not consent to follow up.
This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from a mother regarding her 29 month old son who experienced autism. At 4 month of age, the patient received the second dose on 10/30/02. The patient also received the second dose of Prevnar on 10/30/02. The indication for Hib-Titer Vaccine was immunization. The product was administered on 10/30/02. The dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included Prevnar.  Concomitant medications were not reported. The mother reported that her son was diagnosed with autism in November 2004. No addition information was available at the time of this report. This is one of two reports from the same source where a patient developed autism following receipt of Prevnar and Hib-Titer vaccines. See related case: HQWYE830710AUG05.
Approximately 12 hours after vaccination, awoke with severe trembling and nausea. Fainted twice. Fever of 100F. Nausea lasted approximately 30 minutes, trembling lasted about 45 minutes.  Important to note that I previously had COVID-19 60-70 days prior to vaccination. The symptoms from the vaccine were significantly worse; however, they appear to have lasted for a much shorter period.
Information has been received from a consumer concerning his 6 year old son who on 23-JUL-2009 was vaccinated with VAQTA (manufacturer unknown). Within 24 hours of receiving the patient had a welt the size of a bee sting. The following day the welt grew to the size of a baseball and it looked like it was spreading to the patient's lymph nodes and groin area. The patient was then admitted to the hospital and was given antibiotics (name and manufacturer unspecified) and BENADRYL (manufacturer unspecified). The consumer did not mention how long his son was in the hospital. At the time of report the patient's status was recovered. Additional information has been requested.
Initial report received on 02 April 2009 from a physician.  A 16 year old female patient, with no medical history, received the following vaccines in the left deltoid on 06 March 2009;  an intramuscular injection of MENACTRA (lot number U2730AA), a subcutaneous injection of VARIVAX (Merck, lot number 1143X), and an intramuscular injection of BOOSTRIX (GSK, lot number AC52B030AA).  The patient had received no other vaccines within the four weeks prior.  On 08 March 2009, two days after vaccination, the patient developed a fever (101.3 oral), body aches, a severe headache, malaise, anorexia, and a rash on the upper extremities.  The rash was lacy in appearance and her face was flushed.  The patient was seen in the ER and received a prescription for AMOXICILLIN.  She was seen again in the ER, on an unspecified date; AMOXICILLIN was stopped and ZITHROMAX was prescribed.  On unspecified dates, the patient had the following tests:  viral and throat cultures, which were negative and blood work-up which was within normal limits.  The patient was reported to have recovered on an unspecified date.
Metallic taste in mouth on day of vaccination, resolved then recurred 6 days later.
I received my Covid-19 vaccine on 11/02/2022. On 01/19/2023 I came down with chills, fever, cough and sinus congestion. The next day I contacted my doctor and was prescribed PAXLOVID. Took medication for 5 days however on the 3rd day I rapidly improved. Symptoms gradually went away however I still have a slight cough.
No side effects; incorrect product storage; This spontaneous report has been received from a vaccine provider referring to a 1 month-old female infant.  Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.  On 17-NOV-2020 , haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB)(lot #T001206 with expiration date: 03-JUN-2022, dose details and frequency were unknown)  was administered to the patient intramuscularly in left thigh for prophylaxis, after a temperature excursion (product storage error). No side effects was reported. The vaccine was stored at maximum 50 degrees Farenheit (F), but they were moved to transport containers in frozen packs at 47.2 degrees Farenheit (F) for a time frame of 30 minutes. Then they were moves to another fridge. Malfunction was identified, fixed and the vaccines were moved back to original fridge, where the temperature was appropriate. There was digital data logger involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA007335: US-009507513-2011USA013815:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, he noticed when a patient received a shot from the box with 10 vials, the patient does not complain about the pain during injection, but when he used an injection from the single box, every patient had complained about the injection hurting.
Hot; Rash on arm; Swollen; Red; Rash; Tongue is swollen/Tongue swelled a week after vaccination; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue is swollen/Tongue swelled a week after vaccination), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot), RASH (Rash) and VACCINATION SITE RASH (Rash on arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Loss of memory (bad memory and is getting worse).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced SWOLLEN TONGUE (Tongue is swollen/Tongue swelled a week after vaccination), VACCINATION SITE REACTION (Covid arm) and RASH (Rash). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE RASH (Rash on arm), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Tongue is swollen/Tongue swelled a week after vaccination) was resolving, VACCINATION SITE REACTION (Covid arm) and RASH (Rash) had resolved and VACCINATION SITE WARMTH (Hot), VACCINATION SITE RASH (Rash on arm), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant medication provided. Treatment medication includes Benadryl and  Arnica.  The patient lost 10 pounds and stated that her tongue was so big that it hurt to talk. The patient discovered Arnica later which was a homeopathic medicine that worked within 15 minutes after taking it.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow up information received included ne events and treatment information.
I experienced chills, which intensified in the evening into full body shudders before finally calming. Alongside this, I felt extremely sore, especially in the joints and feet, like they had or were being pressed or squeezed. This made it hard to move around or get out of bed. I also experienced a headache, and likely a fever.  I had similar symptoms after my first shot, but while those symptoms were still noticeable and took me out of work, I had a much stronger reaction this time around. I have been experiencing a sore neck and shoulders due to tension even until today.
Severe fatigue, chills, fever, inability to remain upright, headache, sore throat, sinus pain and  coughing. Severe fatigue for 7 days. Lingering cold-like symptoms for 10 days and counting.
is pregnant: yes; Extremely sore arm; body aches; headache; This is a spontaneous report from a contactable other health professional (patient). This reporter reported information for both mother and fetus/baby. This is a maternal report. A 36-year-old female patient (pregnant) receive first dose of BNT162B2, via an unspecified route of administration on 04Jan2021 16:45 in right arm at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient experienced extremely sore arm, body aches, headache on 04Jan2021. The adverse event was not resulted in emergency room visit and physician office visit. The events were reported as non-serious. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. Last menstrual date was 12Jun2020. The mother was 29 weeks pregnant at the onset of the event. The mother was due to deliver on 19Mar2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks: Prenatal vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Allergies to medications, food, or other products was no. The outcome of events was resolving.  Information on the Lot/batch number has been requested.
I noticed in March 2021 that I started having an irregular heart beat. It's more noticeable at night. I contacted my doctor. I had tests did. The doctor found no abnormalities. I had an at home heart monitor in December 2021. The doctor said I had frequent PACs and rare PVCs. I have never had an irregular heartbeat before. It happens a lot but more noticeable at night. I still have the PACs. As of now its on going still.
This spontaneous report as received from a healthcare worker refers to 2 patients of unknown age and gender. No medical history and concurrent conditions were reported. On 10-MAY-2016 the patients were vaccinated with an improperly stored dose of ZOSTAVAX (incorrect product storage) (lot #L048452, expiry date 01-MAR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
suspected vaccination failure; Shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. In spring at the time of reporting after receiving both the doses of Shingles vaccine, the patient broke out in shingles across right chest under arm and a tiny bit on the back.  Nothing was foolproof, they definitely made him/her notice them, but sure they were not as severe as if he/she had never gotten the shots. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
pt recvd vax & exp arthralgia sx in both hands, hips, arms & neck; sx have persisted for almost 6 months since 2nd vax; seen by MD for lyme disease & arthritis testing;
This spontaneous report was received from a medical assistant refers to unspecified number of unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with doses of improperly stored GARDASIL lot # K011325, expiry date 08-APR-2017 (dose and frequency not reported). No adverse experiences reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
March 6, 2021 Saturday ? J&J Vaccine 3:30 PM ?  3/6/21 10:30 PM ? Nausea, vomiting, chills, violently shaking, fever.  1 bout.  Slept the rest of the night. 3/7/21 Sunday ? Exhausted, tired, slept most of the day.  Thought I would call off work on Monday. 3/8/21 Monday ? 100% recovered.  Went to work.
(R) thigh 3x4 in erythema, tender, warm. (L) (-), A/P (R) thigh cellulitis vs reaction, PCN allergy, Zithromax rx started heat recent.
little sore on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 54-year-old female patient received bnt162b2 (Pfizer Covid-19 Vaccine), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "little sore on the injection site". Additional information: The patient wanted to reschedule her second dose. She had her first dose last 04Mar. She had a little sore on the injection site after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt states she woke up w/ flu like symptoms.  Fatigue, chills, achy, loss of appetite arm left arm is sore.  Pt urinated more than usual and had a bad headache.  Pt took Tylenol for her symptoms and is slowly feeling better.