chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild case of shingles" on her back; experiencing a rash/ after receiving the 1st dose.; This case was reported by a consumer and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the dose of Shingrix about 6 week ago and experienced rash and for the past two weeks. Patient had experienced a "mild case of shingles" on her back. Consumer gave no further details, and ended the call precipitously. No further information available. The reporter was referred to the health care professional. The reporter did not consented to follow up
Developed hives on chest and arm of vaccine administration. Developed difficulty breathing approximately 2 hours after receiving vaccine. Received BENADRYL, prednisone & epi.
Pt has diffuse erythematous maculopapular rash with fever, all over body, pale, extremities including palms and soles, after took 6/16/06 ///.
Child developed fever (102) approximately 2 days after vaccine. Kept fever for 25 days per mom. Vaccine site was hard (swollen), red and warm to touch. Other thigh (RT) with "chicken pox like" mark. Called to private MD. No Rx given.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs was not provided. Concomitant therapies included properly stored sterile diluent. On an unknown date, the patient was vaccinated with a improperly stored M-M-R II (rHA) lot # N023146, expiration date 24-AUG-2019 (route and dose were not provided) for prophylaxis. The vaccines were exposed to a temperature of 47°F to 77°F during 33 minutes. No adverse effects were reported. It was reported that data logger was involved.
No additional AE; reconstituted the MMR II vaccine with normal saline instead of the supplied STERILE DILUENT; This spontaneous report was received from a pharmacist, referring to a 23-year-old male, at the time of the report. The patient concurrent conditions,relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On 14-APR-2021, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneously (lot number T006166 has been verified to be valid, expiration date 19-FEB-2022)  (anatomical site of vaccination was not reported), as prophylaxis. This vaccine was administered with normal saline (dose, frequency, lot number, expiration date were not reported) instead of  sterile diluent (manufacturer unknown) (Product preparation error).  No additional adverse event reported. It was reported that the patient would repeat dose in 4 weeks (28 days).   Moreover, the dose was single use vaccine, operator of device was an healthcare professional. There was no product quality complaint and no excursion ocurred, the vaccine was not available for return/evaluation. The operator was trained and vaccine was purchased with funds.
Second dose inadvertently given early (3 weeks instead of 4 weeks).  More tired than usual for 2 days.
This case was reported by a nurse and described the occurrence of itchy rash in a 57-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 7th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 8th January 2019, 1 days after receiving SHINGRIX, the patient experienced itchy rash and papular rash. The patient was treated with Triamcinolone Cream and CERAVE Moisturizer. On an unknown date, the outcome of the itchy rash and papular rash were recovering/resolving. It was unknown if the reporter considered the itchy rash and papular rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient never smoke had and no known allergies. The reporter stated that 2 days after receiving SHINGRIX vaccine the patient developed an itchy rash on the opposite arm on left deltoid and upper back. Symptoms persists now after 2 weeks. The patient had the picture on his phone and dermatology physician looked at the pictures. Dermatology physician advised to continue triamcinolone cream 1 percent and monitor. The patient used dove soap or body wash for now, moisturizer CERAVE. The patient was to contact dermatology if rash get worse.
- The day after the vaccine I had joint pain and extreme exhaustion. I also remember having a strong headache. -End of Jan I had Covid. Extreme back pain - continually vomited for 12 hours and then went to the hospital for fluids, help me stop vomiting and  pain management. I was prescribed medication to help me continue to not vomit.
MOBILITY AND AGILITY NEGATIVELY IMPACTED; ARTHRITIC CONTORTED HANDS; NEEDLES AND PINS IN EXTREMITIES; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 167 pounds, and height was 64 inches. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have any allergies or allergy to vaccine, food, drug. The patient did not have any history of drug abuse or any history of relevant pre-existing conditions. The patient was not on any other medication at the time the event started. She did not have any illness at the time of vaccination or any past medical history of similar event. She did not have any past adverse events after previous vaccinations. She did not have any history pre-existing acute illness 30 days prior to vaccination or history of hospitalization in last 30 days, with cause. She did not have any family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 and expiry: UNKNOWN) dose was not reported, administered on 12-SEP-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritic pain, and ascorbic acid for drug used for unknown indication On 14-SEP-2021, the patient experienced needles and pins in extremities and arthritic contorted hands. On an unspecified date, the patient experienced mobility and agility negatively impacted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mobility and agility negatively impacted, needles and pins in extremities, and arthritic contorted hands. This report was non-serious.
Two patients were administered expired COVID-19 vaccine (5-11 year Pfizer formulation). 8/31/22 expiration date assigned. The items were not properly quarantined in the Outpatient Pharmacy refrigerator storage unit & were dispensed to nursing staff. Doses were administered to two patients, one an 11 year-old female receiving their first booster vaccine after completing the 2-dose primary series. The second patient a 9 year-old male, also receiving his booster after completing the 2-dose primary series. After the vaccines were administered, the nurse attempted to document the vaccines. The expiration was noted when the vaccine lot number was not available since the vaccine was expired.  Pharmacy was notified as well as Dr.. Pfizer was contacted regarding available in-house viability data beyond the 12-month viability post-manufacture date. Per Private from the Medical Information Department, no viability data is available beyond current expiration date recommendations. Also, no further information is available regarding re-vaccination of the two patients. Another Pfizer Help Desk Representative took the patients' information for further follow up. Pfizer states the information will be forwarded to their Safety Team to see if there is any physical stability testing on further viability beyond 12 months after manufacture. If viability information exists, then the CDC can be contacted for further clinical guidance. Response from the Safety Team may take 2-3 days. Since no further recommendations on revaccination received, Dr. recommended not revaccinating the patients at this time.
On 03/08/2002 patchy redness, itching on lower extremities, swelling lower extremity, joints, neck, elbows, wrists, headache, nausea, diarrhea, problem urinating. Seen in ER on 03/10/2002 and given Benadryl. Had flu one week ago.
Within a week of my 1st dose, I was experiencing brain fog so intense that I could barely function at work.  The brain fog did not go away until December.   A few days after my 2nd dose, my speech began slurring off and on, and I found myself unable to think of words. (It was not a stroke, I have had 1 in the past and it's different from that).  I had to drop out of the college I had transferred to because I did not have the ability to think.  My brain was not working.  I had to quit my job because my inability to form words was humiliating and my fatigue was so bad.   Also I was too fatigued to exercise for several months following this.  To be clear, the symptoms did not subside until December (my doses were in July and August).
patient experienced dizziness immediately after receiving vaccine, patient was given an ice packed and was told to sit down. dizziness subsided within 3-5 mins and was monitored for 15 mins, once 15 mins were up patient  left with spouse.
Received meningitis vaccine (MENVEO). Woke up next day with severe headache, stiff neck, fever, malaise (101 degrees). Rash on face and neck on 3rd day, this rash persisted for 5 days.
rash on face; presure in eyes dangerously high; change in her vision in her left eye; itching and burning of the eyes; eyes were red; eyes were red and inflamed; Corneas split; eye swollen shut; eye symptoms; itching and burning of the eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OCULAR HYPERAEMIA (eyes were red), EYE INFLAMMATION (eyes were red and inflamed), CORNEAL DISORDER (Corneas split), EYE SWELLING (eye swollen shut) and RASH (rash on face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry eye, Allergy NOS, Penicillin allergy and Drug allergy (Prednisone). Concomitant products included LIFITEGRAST (XIIDRA) for Eye allergy.    On 02-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced EYE SYMPTOM (eye symptoms). In May 2021, the patient experienced EYE IRRITATION (itching and burning of the eyes). On an unknown date, the patient experienced OCULAR HYPERAEMIA (eyes were red), EYE INFLAMMATION (eyes were red and inflamed), CORNEAL DISORDER (Corneas split), EYE SWELLING (eye swollen shut), RASH (rash on face), INTRAOCULAR PRESSURE INCREASED (presure in eyes dangerously high), VISUAL IMPAIRMENT (change in her vision in her left eye) and EYE PRURITUS (itching and burning of the eyes). The patient was treated with ANTIBIOTICS for Eye symptom, at an unspecified dose and frequency; PREDNISONE (conjunctival) in May 2021 for Eye redness, at a dose of 1 UNK; LOTEPREDNOL ETABONATE (LOTEMAX) at an unspecified dose and frequency; PROPYLENE GLYCOL (SYSTANE BALANCE) ongoing since an unknown date at an unspecified dose and frequency; MUPIROCIN (BACTROBAN [MUPIROCIN]) at an unspecified dose and frequency; TRAVOPROST (TRAVATAN) (intraocular) on 31-May-2021 for Intraocular pressure increased, at an unspecified dose and frequency; ERYTHROMYCIN in May 2021 for Eye symptom, at an unspecified dose and frequency; NEPAFENAC (ILEVRO) ongoing since an unknown date for Eye symptom, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Eye pruritus and Eye irritation, at a dose of 1 dosage form and ANTIBIOTICS (oral) from May 2021 to June 2021 for Eye symptom, at a dose of 1 dosage form. At the time of the report, OCULAR HYPERAEMIA (eyes were red), EYE INFLAMMATION (eyes were red and inflamed), CORNEAL DISORDER (Corneas split), EYE SWELLING (eye swollen shut), RASH (rash on face), INTRAOCULAR PRESSURE INCREASED (presure in eyes dangerously high), EYE PRURITUS (itching and burning of the eyes), EYE IRRITATION (itching and burning of the eyes) and EYE SYMPTOM (eye symptoms) outcome was unknown and VISUAL IMPAIRMENT (change in her vision in her left eye) had not resolved.            Treatment also included a mild moisturizer cold packs on eyes and contact patches over the eyes.
Tongue swelled, couldn't breath, weakness, extreme dizziness, incontinence. Called 911 for help - couldn't stay awake. Paramedics took me by Ambulance to ER - I vomited in ambulance and fainted. Blood pressure fell very low.
Pt had imm on 12/4/07.  On 12/6/07 R knee swelled, parent said R leg was red and very tender to the touch.  He was taken to ER, they were told be ER dr. to give him Motrin.  The child had not had Motrin before.  The following day child had broken out in whelps all over his body.  Had a temperature of approx 100 degrees.  Took back to ER, given steroid pack.
For thirty-six hours after the vaccine. I had body aches and chills and my eye sockets were sore and it hurt to look up. Ten days after the vaccine I was in the shower and a large blood clot came out of my nose. It was a large clot about the size of a quarter and there was no other blood with it. The clot came out of my left nostril but it was not like a nose bleed. I went to the Urgent Care but they did not do tests.
Improperly stored administered PROQUAD vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 01-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T029103, expiration date 23-FEB-2022 for prophylaxis (dose, anatomical location and route of administration were not reported).  The vaccine was stored at the temperature that was reported as 9.6 degrees of Celsius for 80 minutes. There was no previous temperature excursion reported.  No additional adverse event reported.  This is one of several reports received from the same reporter.
That particular day I had more than usual heart palpitations. I let it pass because of my anxiety disorder. Later that afternoon it was still there. I don't have high blood pressure, but it's been a little spiky. My doctor put me on hawthorn berry. I took my blood pressure, and it was 159/80. That was when I started looking for a walk-in clinic. I didn't connect it to the vaccine at the time. When I went, they took my blood pressure and it was 180 over something, my pulse was around 112. I took a XANAX and water while I was there. The doctor thought it was my anxiety. He told me to keep an eye on it and he didn't think I needed high blood pressure medication. I went to my PCP today and my blood pressure was back to normal. I also had fatigue for several days after the vaccine as well.
patient that received Menactra a day after it had been expired; Headaches; left arm is hard; Initial information received on 10-Oct-2019, 11-Oct-2019, 14-Oct-2019 and 15-Oct-2019 were processed together regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced headaches (headache) and left arm is hard (limb discomfort), while she received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HPV VACCINE VLP RL1 9V (YEAST) [GARDASIL 9].  The patient's past medical history included Headache and Visual impairment. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and HPV VACCINE (HPV VACCINE) for Immunisation.  On 07-Oct-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA, Exp. Date 06-Oct-2019 via intramuscular route in the left deltoid. On 07-Oct-2019, the patient received a dose of suspect GARDASIL 9 not produced by Sanofi Pasteur lot number not reported via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious headaches (headache) and left arm is hard (limb discomfort) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and GARDASIL 9.  It was also a case of expired vaccine used.  It was reported that RA's doctor has deduced it is not the expired Menactra that caused the Headaches and the left arm that is hard. It is the Guardasil 9.  Other relevant tests not reported.   Final diagnosis was headaches and left arm is hard.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for headaches and left arm is hard.  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.
Pt states after vacs pt waited in store approx. 20 min and walked around store and felt muscles in leg cramped and couldn't walk for a few seconds.
Fever, chills, headache, photophobia, severe nausea, anorexia, watery diarrhea x 6-12/day with 10 lb at loss. Severe malaise and myalgia.
Pericarditis, treated with several weeks of rest (no exercise), ibuprofen. Signs and symptoms include chest pain (especially when lying down), dry cough, fatigue, shortness of breath, slow recovery from activity, and high heart rate. I can share data from my wearable device if needed.
Information has been received from a physician concerning a 20 year old female who was vaccinated with three doses of GARDASIL.  There was no concomitant medication.  Only after the third dose, the patient broke out in hives on her face, arms and legs.  Subsequently, patient recovered.  No further information is available.
Mother presented to health department the day after immunizations and patient's right upper arm had  a localized reaction consisting of redness, warmth, and patient reported "it hurts a little".  Mother reports the redness started last night but the swelling has gotten worse.  She states she will take patient to the doctor if no improvement by this afternoon.
This case was reported by a physician via a sales representative and described the occurrence of rash in a 4-month-old male subject who was vaccinated with ROTARIX, PREVNAR and PENTACEL. There were no concurrent medications. On the afternoon of 1 April 2009 the subject received 2nd dose of ROTARIX at 1.0 ml, 2nd dose of PREVNAR and 2nd dose of PENTACEL. On 1 April 2009, at an unspecified time after vaccination with ROTARIX, PENTACEL and PREVNAR, the subject experienced a severe rash and was seen in the emergency room. At the time of reporting the event was unresolved.
This case was reported by a physician and described the occurrence of injection site pain in a 42 year old female pt who receiving hep B vaccine recombinant (Engerix B) for prophylaxis. On 8/13/03, the pt received an injection of Engerix B (5386A2). Immediately post-immunization, she experienced "severe stinging and pain" at the injection site which resolved after two minutes. The reporting physician suspected an "unusual or abnormal vaccine lot"; however, the physician also reported that patients who previously received this lot of vaccine did not experience pain.
cellulitis like swelling at elbow and forearm with no pain but intense itching. relieved by Benadryl
trouble with the Moderna vaccine because it's the worst of all for the side effects; affections in blood pressure and menstrual cycle; affections in blood pressure and menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (trouble with the Moderna vaccine because it's the worst of all for the side effects), BLOOD PRESSURE ABNORMAL (affections in blood pressure and menstrual cycle) and MENSTRUAL DISORDER (affections in blood pressure and menstrual cycle) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (trouble with the Moderna vaccine because it's the worst of all for the side effects), BLOOD PRESSURE ABNORMAL (affections in blood pressure and menstrual cycle) and MENSTRUAL DISORDER (affections in blood pressure and menstrual cycle). At the time of the report, IMMUNISATION REACTION (trouble with the Moderna vaccine because it's the worst of all for the side effects), BLOOD PRESSURE ABNORMAL (affections in blood pressure and menstrual cycle) and MENSTRUAL DISORDER (affections in blood pressure and menstrual cycle) outcome was unknown.        mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Patient had some trouble with the Moderna vaccine because it was the worst of all for the side effects. Patient mentioned there were affections in blood pressure and menstrual cycle, these injections should be studied more. Patient would not be getting any more injections and just use the COVID-19 pills. No treatment information was provided.
Extremely high blood pressure. On 2/5 started 192/82 at 6 PM , first time I checked it on 2/5.  Continued up to 216/84 at 11 PM. Called 911.. EMT did EKG which looked OK.  Pressure dropped 20 points in 30 minutes. No other symptoms , no pain , no nausea , no fever. Did not go to hospital. 2/6 , had 3 readings , 174/79 , 150/75 and last one at 9 PM , 165/73 . On 2/7 , 1 reading at 2 PM , 142/74.  No other symptoms.
3 days after injection, severe myalgias and arthralgias in bilateral joints. Headache on and off. Excessive fatigue. Lasting weeks. His CRP was extremely elevated. Prednisone dose pack given and symptoms improved after 1 dose but then recurred when dose pack was completely. CRP came down after dose oack done, but symptoms recurred in full. Another dose pack given and symptoms resolved after 1 dose again. Concern for PMR.
Mom states child developed rash day after flu vaccine. Pt developed hives on the back & body along w/redness around the eyes. However dates mom states symptoms began and when pt presented to clinic are 10 days apart.
Patient went to his primary care md because he was having an ocular disturbance. The md described it as a ocular migraine but voiced his concern that it could be a TIA. The patient experienced this 3 days after receiving shot. The patient did follow up with an eye doctor where they were told everything looked normal. patient concerned this was unnecessary and then question consequence of receiving second dose.