chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED FLU VACCINATION AND ON HER WAY OUT OF THE STORE SHE TOLD HER MOTHER SHE DIDN'T FEEL WELL AND FAINTED. EMS CALLED. THEY EVALUATED PATIENT AND AFTER A BRIEF REST, HER MOTHER TOOK HER HOME. PATIENT'S MOTHER SAID SHE WAS FEELING BETTER IN A FOLLOW UP PHONE CALL AT 7:30PM. SHE IS FOLLOWING UP PEDIATRICIAN IN THE MORNING
Facial swelling (eye, tongue, lip), high BP, high HR, shaking, lower O2 (95), monitored for over an hour while hooked up to BP machine and pulse oximeter, epi was brought out and kept nearby but not administered. Continued for several hours after I got home. Also had severe uterine cramping for about 12 hours even though I am in menopause.
numbness, pain, swelling, paresthesia, lower ROM lt foot;lt food became numb, painful & swollen w/in a few hr 91-2) p/vax;pt had to remove shoe @ homes 5PM;foot was too painful to walk on;tingling in foot;dark urine 10SEP96;
Achiness when walking up and down stairs; Chills; Lingering cough; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single, for covid-19 immunisation. The patient medical history included covid-19. The patient's concomitant medications were not reported. On an unspecified date the patient experienced achiness when walking up and down stairs, chills, and lingering cough. The patient's mother was calling on behalf of her son regarding the Covid 19 vaccine. She was checking for her son. She had some generic questions. Her son had the Covid 19 virus and before he returned to work, he had to get a negative Covid 19 virus test. Sixteen days after he was diagnosed with the Covid 19 virus he was able to get his first Covid 19 vaccine. She was asking if that was ok. He had his first dose and like everyone else getting the vaccine he had some side effects, normal side effects. That was about two weeks ago. He was not due for his second Covid 19 vaccine until next week. All of a sudden, he was getting his side effects again. He was having achiness when walking up and down steps. He had chills but no fever. And he had a lingering cough. These are the same side effects he had when he first got the vaccine. Is that possible. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX. On 18th January 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a year 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 reported as follows: The reporter stated that patient came in for second dose of SHINGRIX with a rash that appeared to be active shingles that stared in the week of reporting date. The patient received first dose of SHINGRIX at the same location he presented on the day of reporting for the second dose. The reporter agreed to follow up.
Arm is red , swollen and hot.  Still red, swollen and hot two days later.
Patient given expired vaccination. No known adverse s/s. No treatment required. Spoke with Nurse. Patient will need to be re-vaccinated. Should experience no adverse outcome.
Pt experiencing numbness and throbbing or pulsation at left thoracic region x 2 months since injection. Pt also experiencing bil feet swelling that may or may not be related, occurred x 3 days last week only.
He ate a light meal noodle soup then after an hour he started having diarrhoea; problem with swallowing; sore throat; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "He ate a light meal noodle soup then after an hour he started having diarrhoea"; DYSPHAGIA (non-serious) with onset Apr2021, outcome "unknown", described as "problem with swallowing"; OROPHARYNGEAL PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "sore throat". Additional information: He ate a light meal noodle soup then after an hour he started having diarrhoea, problem with swallowing and a sore throat.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upset stomach starting about 36 hours after injection. Stomach issues continued for 5 days; nausea; body shakes; weakness; fatigue; chills; This is a spontaneous report received from a non-contactable consumer reported for self. This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 24Mar2021 11:30 AM Left arm as single dose (lot: EP7533) for COVID-19 immunisation. No pregnant at the time of vaccination. Medical history included Eosinophilic Esophagitis. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. Concomitant medication included Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced Upset stomach on 26Mar2021 02:00 AM. Stomach issues continued for 5 days culminating in an episode of nausea, chills, body shakes, weakness, and fatigue. This episode passed fairly quickly in about an hour. Since the day after this episode have felt fine (approximately 48 hours). Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event Upset stomach was recovered on 31Mar2021 02:00. Outcome of the events nausea, chills, body shakes, weakness, and fatigue were recovered on 28Mar2021 02:00.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M004890, expiration date 10-NOV-2017, lot# M019691, expiration date 02-NOV-2017 and lot# M031802, expiration date 09-NOV-2017, orally (dose and site of administration were not reported). There was no adverse symptoms reported. Additional information has been requested.
Palpitation-pt verbalized heart beating fast. 11:32 BP 165/71 HR 70 96% saturation 11:40 BP  165/78 HR 72 97% saturation pt has instructed to follow up with PCP with me elvated BP verbalized understanding pt verbalized subsiding of the symptoms pt was driven home by family member in no distress.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated a dose of with GARDASIL (dose, route, lot# and expiration date unknown) for prophylaxis. On 20-JAN-2017, the patient received a dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) for prophylaxis as the next dose in the HPV vaccination series. No adverse effects were reported. The causal relationship between the event and suspect therapies was unknown. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001972:
The arm in which I received the first dose 2 weeks ago hurts more now than in the days immediately following the jab.  I'm concerned that this may portend a blood clot.
shingles; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a healthcare provider for shingles and post-herpetic neuralgia. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited  to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring, treatment, medications, and supplies: diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffered such losses, and damages in the future. The outcome of the event s was not provided. Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).
Patient presented to the ER with chest pain, found to have Covid-19. Patient is not experiencing any respiratory symptoms but chest pain is thought to be from Covid-19. Patient experiencing hemopytsis as well, which is thought to be secondary to Covid-19 and taking ASA/Plavix. Discharged home.
09/21/22 presents to EC ED for "fall". PMHx of "HTN, hypothyroidism, OA, afib (no longer on Eliquis), HLD, remote b/l TKA, left THA, orthostatic hypotension"
Large reddened area - warm to touch at site of injection, swelling, tenderness, fever.
Ringing in ears started about 1 week after 1st shot.  Has not gone away...fairly consistent on a daily basis...really no better/worse times...just constant and consistent
Sore/tenderness at site. Red and swollen. Very sore and discomfort when left arm.
Flush, sweaty, fast heart beat, extreme nausea and abdominal discomfort, light headed and weak feeling. This lasted for an hour, went back to bed, and woke up at 6 AM feeling a little weak in the legs. As the day progress, I felted better.
1/17/21 Received dose at 0800. Fever started at 2330.  Fever started at 100 then progressed to 103. Also had muscle aches, joint pain, feeling chilled, and severe headache. Took ibuprofen at 0300 1/18/21. Followed by Tylenol and Motrin (alternating). Headache still ongoing. Aches and chills subsiding as of 1500 1/18/21. Temperature still 100.
rash or rash-like lesions on various parts of body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash or rash-like lesions on various parts of body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash or rash-like lesions on various parts of body). At the time of the report, RASH (rash or rash-like lesions on various parts of body) outcome was unknown.            No concomitant medication reported. No treatment was provided. The action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up received on 27-JUN-2021 contains No New Information
PER PATIENT RECEIVED 1ST DOSE AT 12PM AND WAS OK UNTIL 1AM. PATIENT GOT A SEVERLY ITCHY THROAT AND EARS, HAD TROUBLE SWALLOWING. ATE ICE CHIPS AND TOOK TYLENOL. OK AFTER ABOUT 2 DAYS OR SO.
1 of 2 adult pts who exp inj site rxns following immun w/Tetanus Toxoid control# 352982; No further info available @ this time
Vaccine administration error: Pfizer monovalent was administered erroneously when Pfizer Bivalent Omicron booster was indicated, intended, and agreed upon between client and healthcare professional.
Patient felt a sudden severe headache around her forehead, around her eye sockets. When she stood up, the pain worsened. She also felt very weak, but not dizzy or feeling like she was going to pass out.
Vomiting, headache, fever, 102.7 1 day after vaccine given.
I noticed some vision changes October 28, 2021  which became obvious November 2, 2021 while I experienced binocular double vision while driving. On November 22, 2021 I was examined by Dr. who diagnosed me with right sixth nerve palsy. I researched online November 29, 2021 and discovered there were other instances of sixth nerve palsy in otherwise healthy people after the Pfizer Covid vaccine.
Information has been received from a registered nurse concerning an 85 year old female with hypertension, osteoporosis and no known drug reactions or allergies who on 23-MAR-2007 was vaccinated subcutaneously with 0.65 mL of zoster vaccine live (Oka/Merck) (Lot # 656607/0163U). Concomitant therapy included hydrochlorothiazide, losartan potassium (MSD), CRESTOR, amlodipine besylate, aspirin and omeprazole. On 28-FEB-2008, the patient sought medical treatment for left hip pain that was described as a mild eruption of a shingles rash at the L1 dermatome. The patient was prescribed FAMVIR, VICODIN, and LYRICA. At the time of the reporting the patient had not yet recovered. The physician was not interested in VZV Analysis by PCR. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
extremely heated arm at the injection site; A spontaneous report was received from consumer concerning a 81 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site warmth.   The patient's medical history was not provided. No relevant concomitant medications were reported.      On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.    On 15 Jan 2021, The patient experienced extremely heated arm on the injection site.   Laboratory details are not provided.    The patient was treated with Benadryl.     Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was unknown.; Reporter's Comments: This case concerns an 81-year-old female who experienced a nonserious unexpected event of vaccination site warmth.  The events occurred the same day as the first dose of mRNA-1273 (lot # 041L20A). The patient was treated with Benadryl.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
My arm was achy afterwards, but the next day I woke up feeling very sick to my stomach and wiped out. I was running a low grade fever and took some Tylenol and laid down. Later on in the day I continued to feel bad. Everything in my body aches and was super sore. I had a headache off and on all day. I didn't have much of an appetite. It is now two days since I for my second shot and I'm still feeling feverish one minute and sweaty the next. I still have no energy or very little.
Major headache, swollen lymph nodes, head sinus congestion, I sounded like I had a bronchitis - my voice was affected.  Unable to sleep at night. Called Dr on 17th and requested paxclovid and was prescribed and took it for the 5 days. Today I am feeling just about normal and have tested negative for Covid.
Information has been received from a registered nurse concerning a female "between 70 to 80 years of age", who on 11-OCt-2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23. Subsequently, the patient developed redness at the injection site. The patient sought unspecified medical attention. No laboratory diagnostic were performed. At the time of the report, the patient was recovering. No product quality complaint was involved. This report is one of three from the same source. Additional information has been requested.
she had a reaction on her face. She described it as her cheeks turning red, rashy, and itchy; my eyes were just little bit itchy; This is a spontaneous report from a contactable nurse reporting for self. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), intramuscular on 22Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included letrozole (FEMARA), Antioxidants and Vitamins. The patient had a reaction on her face. She described it as her cheeks turning red, rashy, and itchy. Within 24 hours, it went away. She mentioned that she used a different face mask yesterday and wasn't sure if it is a reaction from the vaccine or from her face mask. Her eyes were just little bit itchy. It started about an hour and a half and within three hours it was gone. Outcome of events was recovered.
She had fever; Severe fatigue; Malaise; Felt terrible; Redness at the injection site; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, 1 days after receiving Shingrix, the patient experienced fever. In October 2020, the patient experienced injection site erythema, injection site pain, fatigue, malaise and feeling bad. On an unknown date, the outcome of the injection site erythema, injection site pain, fever, fatigue, malaise and feeling bad were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, fever, fatigue, malaise and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had redness and pain at the injection site.  The patient had Fever and reported severe fatigue and malaise and felt terrible. The reporter did not consent to follow up. All information was not available.
The restless feeling in my legs got worse. It started early in the evening before I went to bed, which usually does not happen. It would prevent me from sleeping because I still had the feeling, so I would have to get up at night and walk around. I went to the doctor on 09/08/2021 and he increased my dose of ropinirole, and it seems like the symptoms are much better now.
Information has been received from a healthcare worker referring to a 48 year old female patient. The patient had no pertinent medical history. The patient had no pertinent medical history. The patient had doxycycline and codeine allergy. On 01-DEC-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L033707 with expiration date of 18-MAY-2017, 0.5 ml, intramuscular). Concomitant therapies included albuterol, ESTRACE, amlodipine, omeprazole, levothyroxine sodium, clobetasol propionate and cholecalciferol. 8 hours after receiving PNEUMOVAX 23, the patient developed redness and swelling on the arm. The redness had spread to chest and upper shoulder. The red area was sensitive to touch. Her whole body was also achy. The patient sought medical attention by seeing the physician. No treatment was given for the events. No lab diagnostics study performed. The patient was not recovered from the events. Causality was not reported. Additional information has been requested.
This spontaneous report was received from a healthcare provider, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 (lot # M016193, expiration date 24-APR-2017) that were improperly stored (Temperature/Time frame: 49F for 1 hour and 48F for 1 hour). The vaccines did not experienced previous temperature excursions. The data logger was reported as Yes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Warm to the touch Injection Site after 3rd shot; Itching from Head to toe after 3rd shot; Itchy Injection Site after 3rd shot; Swollen Injection Site after 3rd shot; Histamine reaction after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), INJECTION SITE PRURITUS (Itchy Injection Site after 3rd shot), INJECTION SITE SWELLING (Swollen Injection Site after 3rd shot) and ALLERGY TO VACCINE (Histamine reaction after 3rd shot) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulfa).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), INJECTION SITE PRURITUS (Itchy Injection Site after 3rd shot), INJECTION SITE SWELLING (Swollen Injection Site after 3rd shot) and ALLERGY TO VACCINE (Histamine reaction after 3rd shot). At the time of the report, INJECTION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), INJECTION SITE PRURITUS (Itchy Injection Site after 3rd shot), INJECTION SITE SWELLING (Swollen Injection Site after 3rd shot) and ALLERGY TO VACCINE (Histamine reaction after 3rd shot) outcome was unknown.            No relevant concomitant medication was reported. Treatment information were not provided.
PATIENT FELT LIGHTHEADED AND THEN FAINTED.  WOKE UP, SEEMED DISORIENTED, CLAMMY.  CALLED EMS WHO CHECKED HER BLOOD PRESSURE, BLOOD SUGAR, TEMPERATURE, AND PULSE.  PATIENT REFUSED ANY OTHER SERVICE FROM EMS.  LEFT AFTER ABOUT 30 MINUTES