chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling at the injection site / MIinuscule swelling near what may have been the injection site; Itching; Pain; Pain at Injection Site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, 1 hr after receiving Shingrix, the patient experienced pain in arm. On 20th August 2019, the patient experienced injection site swelling, pruritus and pain. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the injection site swelling and pruritus were not recovered/not resolved and the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the injection site swelling, pruritus, pain in arm and pain to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. 1 to 2 hours following vaccination, the patient experienced pain. Approximately 3 to 4 hours following vaccination, the patient experienced swelling at the injection site which lasted approximately 3 to 4 days. 3 to 4 hours after receiving Shingrix, the patient had very minor itching when he had swelling. Several weeks later there was re-occurrence of itching and pain which he believed was near the injection site but was unsure. The caller reported that the itching that reoccurred was much more severe and itches various times of the day. The caller reported cortisone cream helped, but sometimes he may had minor itching in the morning and minor itching again the same evening. Lastly, the caller mentioned minuscule swelling near what may had been the injection site that had been ongoing for approximately 2 weeks. The reporter mentioned that this minuscule swelling may not be noticed by others, but he can tell.  The reporter did not consent to follow-up. The reporter did not consent to healthcare professional follow-up.
Patient has a greenish/yellow mark above where vaccine was administered. Mark appeared about 2 to 3 days after vaccine. Reports no pain, itching, irritation, or discomfort.
Initial report received on 19 March 2009 from a consumer who is the patient's aunt.  A female patient had received a DTP vaccine (manufacturer, lot number, route/site and date of administration not reported) and an unspecified amount of time later, she experienced a seizures.  The reporter's son had also experienced a seizure following DTP vaccination when he was an infant (captured in case 2009-01149).  No additional information was provided at the time of the report.  The reporter for this case is the same as for case numbers 2009-00841 and 2009-01149.
seizures; Muscle jerking; muscle twitching; pain; external & internal tremors; electric shock feeling; brain fog; cramps; stomach issues; blurry vision; fatigue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 02Mar2021 at 12:00 PM (at the age of 39 years old) as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021 at 21:00, patient experienced muscle jerking, seizures, muscle twitching, pain, external and internal tremors, electric shock feeling, brain fog, cramps, stomach issues, blurry vision, and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Therapeutic measures were taken as a result of seizures, muscle jerking, muscle twitching, pain, external and internal tremors, electric shock feeling, brain fog, cramps, stomach issues, blurry vision, and fatigue. The events treatment included numerous doctor's visits. The outcome of events was not recovered.  Information about lot/batch number has been requested.
10/14: Red, swollen, warm to touch left thigh; 10/15: Increased in size, warm, hard to touch.  Antibiotic -Duricef 250mg/5cc 3/4 tsp
Pain and redness in right eye. Diagnosed as uveitis. Prednisone eye drops 4 times a day. Cyclopentolate  ey drops in both eyes two times a day
I started with a cough and sore throat for 2 days. It got worse with a runny nose and congestion shortly after. The cough was persistent which caused a headache with it. A week later, I got an earache. I went to an urgent care and was given antibiotics to aid that. The cough continued days after that; I went to get a viral swab for RSV, pneumonia, and COVID-19 on 01/11/2023. It all came back negative thankfully; however, on 01/17/2023, I had another earache so I went to my doctor. My eardrum was red and swollen so I was given another set of antibiotics. As of now, I'm doing better with some slight ear discomfort sometimes.
Report received on 04.Jun.2012 from a nurse and forwarded by Crucell, ref. no. CVAE 022-2012. This case concerns an 18-year-old male patient who received the first dose of VIVOTIF (batch number 3000128) per oral on 02.Jun.2012. The patient's medical history and concomitant medications were not reported. On 02.Jun.2012 ie the same day as the first intake of VIVOTIF, the patient started feeling nausea and stomach ache. The reporter also specified that the patient participated in heavy physical activity. The patient took the second dose of VIVOTIF on 04.Jun.2012 and was still experiencing nausea and stomach ache. The outcome was reported as resolving. The event was considered non-serious.
Information has been received from a laboratory technician concerning a 21 year old female patient who was vaccinated with her initial dose of GARDASIL in 2009 a few months ago (date unspecified). Subsequently the patient experienced a seizure of unknown etiology on 04-DEC-2009 "four days ago" (from time of reporting). She had an electroencephalography (EEG) and was awaiting the results. The patient had sought medical attention at office. The outcome of the event was unknown at the time of this report. Upon internal review, seizure of unknown etiology was determined to be an other important medical event. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
On Saturday, August 20, 2021, client received the COVID vaccine (Janssen, dose 1, lot# 205A21A, exp: 9/21/21) in to his left deltoid at approximately 1:40pm. After vaccine was administered, client was to wait in the Observation Area for 15 minutes. At 1:46pm, Vaccinator RN, noted that the patient dropped some forms on to the floor. Vaccinator, RN and Vaccine Monitor, RN, walked over to client who stated he was not feeling well. Vaccine Monitor, RN informed Co-Lead RN. Co-Lead RN responded. Client was assisted to sit in the anti-gravity chair. Upon assessment by Co-Lead RN, client's skin was diaphoretic, warm, and pink. Client reports he felt dizzy for about 10 seconds and then he felt sweaty. Client reports last meal was at 10:00am. At 1:49pm vitals were taken: BP: 118/62, HR: 58, RR: 16. Client denied shortness of breath, palpitations, chest pain, itchiness, rash, or throat swelling. At approximately 1:52pm , client stated his symptoms completely subsided. Patient was alert and oriented x4 during entire interaction. Client states he fainted one time x 10 years ago while receiving a blood draw.  At 1:59pm vitals were taken: BP: 122/78, HR: 55, RR: 16. The client skin was warm, dry and pink. Co-Lead RN educated client on ED precautions and advised to follow up with PCP. Client verbalized understanding. Client walked out of observation area with a steady gait at approximately at approximately 2:13pm.
Hypothyroidism; Palpitations; Anterior Wall chest Pain with respiration; Anterior Wall chest Pain with respiration; Chronic peripheral venous insufficiency; Metabolic syndrome; Pots; Late effect of infectious disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Lot number: EL9267) at the age of 53 years, in arm right for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: SERTRALINE; ZOLOFT. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. EL 9262, Location of injection: Arm Left), administration date: 26Jan2021, when the patient was 52-year-old, for Covid-19 immunization. The following information was reported: CHEST PAIN (disability), PAINFUL RESPIRATION (disability) all with onset 17Feb2021 at 20:00, outcome "not recovered" and all described as "Anterior Wall chest Pain with respiration"; PERIPHERAL VENOUS DISEASE (disability) with onset 17Feb2021 at 20:00, outcome "not recovered", described as "Chronic peripheral venous insufficiency"; HYPOTHYROIDISM (disability, medically significant) with onset 17Feb2021 at 20:00, outcome "not recovered"; INFECTION (disability) with onset 17Feb2021 at 20:00, outcome "not recovered", described as "Late effect of infectious disease"; METABOLIC SYNDROME (disability) with onset 17Feb2021 at 20:00, outcome "not recovered"; PALPITATIONS (disability) with onset 17Feb2021 at 20:00, outcome "not recovered"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset 17Feb2021 at 20:00, outcome "not recovered", described as "Pots". The events "hypothyroidism", "palpitations", "anterior wall chest pain with respiration", "chronic peripheral venous insufficiency", "metabolic syndrome", "pots" and "late effect of infectious disease" required physician office visit. It was reported that AE resulted in Doctor or Other healthcare professional office/clinic visit, Disability or permanent damage.  Therapeutic measures were not taken as a result of hypothyroidism, palpitations, chest pain, painful respiration, peripheral venous disease, metabolic syndrome, postural orthostatic tachycardia syndrome, infection.
dizziness; This is a spontaneous report received from a 58-years-old female contactable consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced dizziness on an unspecified date. Caller stated she had dizziness two days after the first dose that went away and she told her primary care doctor and they told her it was okay and she received her second dose yesterday. Caller stated if she had known there was a possibility of unknown side effects she would not have gotten the vaccine. The outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
After I got my first Vaccine I started to have a few Leg and hand cramps after the second one it was much worse almost every night I can go to sleep however before I have slept an hour of less The cramps wake me up and I have done everything I know to do for them I only get 4 to 5 hours of sleep.I have taken Potassium  and I have drank so much pickle juice When they first got real bad I miss a couple of Days off due to no sleep.When they hit my Husband was in the floor rubbing Theraworx cramp foam.Iwake up every night and my  Doctor Doesn't offer any releif.I am so  tired of this
vaccination site warmth; red, itchy, warm spot; red, itchy, warm spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (red, itchy, warm spot) and VACCINATION SITE ERYTHEMA (red, itchy, warm spot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (red, itchy, warm spot) and VACCINATION SITE ERYTHEMA (red, itchy, warm spot). At the time of the report, VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (red, itchy, warm spot) and VACCINATION SITE ERYTHEMA (red, itchy, warm spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment information was provided.
Per patient, her left arm from her shoulder to about 5 inches below shoulder is hot, red, and has a burning feeling. She is not reporting any signs of anaphylaxis (trouble breathing, wheezing, swelling of tongue/lips). She reports having prior flu vaccinations without complications. I referred her to her physician for further evaluation.
I had the 2nd dose of shingrix last October. I just got back from my primary doctor. I have shingles; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis, systemic lupus erythematosus and raynauds.   On an unknown date, the patient received the 1st dose of Shingrix. In October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and less than 6 months after receiving Shingrix, 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 Shingrix and Shingrix.  Additional details were provide as follows: The age at vaccination was not reported. The patient just got back from his primary physician and the patient had shingles. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
16m.o. with large local inflammatory reaction in right upper arm 24 hrs s/p Pentacel vaccination. Area is pink, warm + measures 3.25 in x 2.75in
losing taste and smell for two days; losing taste and smell for two days; This is a spontaneous report from a contactable pharmacist. A 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on her left arm on 19Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included known allergy to Sulfa. The patient's concomitant medications were not reported. The reaction with the first dose was losing taste and smell for two days (unknown date). The reaction with the 2nd dose was three nights of very vivid nightmares to the point of waking up with panics with worm head. This is not usual and happened the night of the vaccination (11Jan2021) and subsequent two nights. The patient did not receive treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
I experienced breakthrough bleeding/additional period with painful cramps during the month of September after my regular period, which is not typical to me. I did not have a period at all in October, which is very unusual. I am not pregnant nor trying to become pregnant. In the month of November, I had a normal period but it has since been followed by additional breakthrough bleeding, breast soreness/tenderness, and now the need for an additional mammogram screening after something possibly asymmetrical was highlighted by the radiologist in my left breast. The breakthrough bleeding/hormonal issues are not typical for me at all, and the need for additional breast images is alarming considering I'm always up to date on my tests and now need additional testing to rule things out.  All of these side effects began a few weeks after receiving my second shot.
Swollen at injection site ( huge circle ring/ rash around injection site ) hot  to the  touch for 3 days  6 hrs after severe arm soreness for about 24hrs.  Slight fever of 100.5
This spontaneous report as received from an actually 60 years old female consumer reporting on herself with an allergy to REMICADE who on 17-JUL-2012, was vaccinated subcutaneously on her left arm with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that on 19-JUL-2012, it was not a rash but was red about 3 inches around the injection site. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for red about 3 inches around the injection site was unknown for ZOSTAVAX. Additional information is not available.
4 Hours After: Severe Headache 6 Hours After: Fatigue 8 Hours After: Fever, Chills  24 Hours After: Severe Lower Back / Kidney Pain Right Side 48 Hours After: Severe Lower Back / Kidney Pain Right Side, Swollen Lymph-nodes  72 Hours After: Lower Back / Kidney Pain Right Side, Swollen Lymph-nodes
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 8/21/2022 &  8/29/2022 -- RECURRENCE OF SAME SYMPTOMS
Severe abdominal pain and cramping, diarrhea, constipation, dizziness, vaginal spotting.
Thought she was going to faint; Took Tylenol felt "really bad"/Still a little bad; could not do anything that day; Headache; Body aches; Stomach ache; she was sick with a fever; Skin was warm/Fever; skin was warm; She felt chilly; Body weakness/ little weak; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for product used for unknown indication.   The patient's past medical history included shingles (shingles outbreak in (around August 2021)- painful rash) and painful rash. Concurrent medical conditions included post herpetic neuralgia (post-herpetic neuralgia (PHN)- intermittent).   On 13th April 2022 15:00, the patient received the 1st dose of Shingrix. In April 2022, the patient started Tylenol at an unknown dose and frequency. On 14th April 2022, 1 days after receiving Shingrix, the patient experienced activities of daily living impaired and feeling bad. In April 2022, the patient experienced sickness, fever, skin warm, chilliness, weakness generalized, headache, general body pain and stomach pain. On 15th April 2022, the patient experienced felt faint. The action taken with Tylenol was unknown. On an unknown date, the outcome of the sickness, chilliness, weakness generalized, general body pain and stomach pain were recovered/resolved and the outcome of the fever, skin warm, activities of daily living impaired, headache, feeling bad and felt faint were unknown.   It was unknown if the reporter considered the sickness, headache and feeling bad to be related to Shingrix. The reporter considered the fever, skin warm, chilliness, weakness generalized, activities of daily living impaired, general body pain, stomach pain and felt faint to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's Comment: The case was reported by the patient.  The patient did not have the lot number or expiration date of the injection but did provide the contact information for the pharmacy where she received the shot. The patient had the shot around 3:00 in the afternoon and felt fine until around midnight/early in the morning and then she thought that, something was wrong with her.  The patient did not take her temperature but felt like she was sick with a fever, her skin was warm and she felt chilly.  She had to use an electric blanket (to keep warm). She also experienced body weakness, headache, body aches and stomach ache. She took Tylenol.  She felt really bad on 14th April 2022 and could not do anything that day.  On 15th April 2022, she felt better but she was still a little weak, still a little bad. She felt like she thought that, she was going to faint.  After receiving Tylenol, the patient experienced activities of daily living impaired, feeling bad and felt faint. It was unknown if the reporter considered the activities of daily living impaired, feeling bad and felt faint to be related to Tylenol. The reporter consented to follow up.
Patient presented to the pharmacy 2 days post vaccination with a ~6cm (diameter) round raised welt on vaccination arm in a location around where vaccination was given. Patient stated she started to notice it the afternoon after the vaccine. She reported that it had not worsened over the last 48 hours but did not seem to be getting any smaller/better either. She reported pain in her back and arm in the first 24 hours which has now subsided. Patient did not report any itching associated with the "welt". She did mention that it was hot to the touch and painful when palpated. The patient is monitoring her symptoms and will be contacted in 24h to see if they have worsened/subsided.
Pt rec'd 1st @ 2nd MMR vax w/o adverse rxn; On 28JUL71 rec'd MMR experienced an unspecified "severe rxn" w/in 1 day following vax; shortly afterward, pt began to lose hearing; On 29JAN73 child noted to have hearing loss during PE;
client presented with Covid card and flu consent - Covid booster given before realized consent was for flu vaccine - once realized client only wanted flu vaccine was given that vaccine - client had already had bivalent booster in November
Nausea and dizziness. Persisted overnight and went to emergency room at major hospital to rule out stroke or heart attack.
Deep severe shoulder pain within 12 hours of injection and lasted for 3 days. Limited range of motion in all directions. Injection noted to be at the site of the Acromioclavicular Joint (superior to the belly of the deltoid muscle). Pain spread to shoulder girdle.
Patient developed redness/itchiness on 2/14/19 on left and right upper arms at sites of immunizations. Mom reports he was scratching a lot and his upper two arms became swollen, painful, and warm over the next 2 days. He developed a fever, and given the redness/swelling at the site, Mom brought him to Emergency Department on 2/15/19. He had no cough, difficulty breathing, vomiting, diarrhea, or rash on other parts of his body. In the ER, he had about a 10cm area of warmth, erythema, and swelling extending from shoulder to upper triceps on left upper extremity and a 4-5cm area of erythema and swelling on right upper extremity, consistent with cellulitis. An ultrasound of the area of erythema/induration on his arms showed no fluid collection. Due to the rapid progression of the erythema and fever, he was admitted for IV antibiotic therapy. IV clindamycin was continued throughout his admission and switched to PO once he showed signs of clinical improvement. He was discharged with improved symptoms on 2/17/19 to complete a 7 day course of PO clindamycin. He followed up in clinic on 2/28/19 and swelling/erythema had completely resolved.