chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After waiting approximately 15  minutes after vaccination, the patient  explained that she experienced tingling of her right hand, five minutes after the vaccination.  Patient states it ended in 1  minute. Incident was reported to the supervisor who said to have a follow up call with the patient. Patient said after 10 minutes of leaving the clinic, she had tingling of the right hand intermittently. The patient was advised how manage the reaction and go to the ER if symptoms worsen. The patient was also advised to follow up with her primary care physician. The patient verbalized understanding that she understood the instructions.
Has a history of COPD but does not wear oxygen at home, lymphoma post chemotherapy in remission.  2 weeks prior to arrival patient started having worsening shortness of breath.  She has inhalers at home which were not relieving his symptoms.  Patient also had fevers, chills, cough, body aches that progressively got worse. Pt required oxygen at discharge. Fully Immunized and received booster.  Elevated procalcitonin.  Covid positive on 1/17. Sx started on 1/14.  Respiratory culture negative. Received remdesivire, decadron, and abx.
Information has been received from a physician concerning a 62 year old female who on 16-DEC-2010 was vaccinated with ZOSTAVAX (Merck). Then (on 16-DEC-2010) an injection site reaction occurred 24 hours after which was red and size of a baseball and lasted for 3 days. The patient was given ADVIL treatment. On 20-DEC-2010 the patient recovered. The patient did not seek medical attention. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9629), on 26Feb2021 as dose 2, single (Lot number: EN6200), on 25Sep2021 as dose 3 (booster), single (Lot number: FF2588), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Spinal stenosis" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. Concomitant medication(s) included: LISINOPRIL; GABAPENTIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included pf-07321332, ritonavir (PAXLOVID) with treatment start date: 30Jun2022 and treatment stop date: 04Jul2022.  No follow-up attempts are possible. No further information is expected.
apparently pt was found pale, limp & unresponsive 8 hrs post immun; episode resolved spontaneously
Patient was expecting to receive a Moderna Booster (.25ml) but received a full dose (.5ml) of Moderna. Patient is NOT immunocompromised.  Patient had completed pfizer series over 5 months prior.   Followed up with patient and he only reported a sore arm.
Within 1 minute of receiving injection, I immediately felt sweaty and hot. My hearting started to go and I became dizzy. I had to lay my head down and was about to faint but did not. Over the next 20 minutes, switched between hot flashes and cold chills.
abdominal pain; 104'F fever; diarrhea; bloodshot on eyes (patient usually wears contacts, but eyes are not clear); legs tight/crampy; tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain), PYREXIA (104'F fever), DIARRHOEA (diarrhea), OCULAR HYPERAEMIA (bloodshot on eyes (patient usually wears contacts, but eyes are not clear)) and MUSCLE SPASMS (legs tight/crampy) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced ABDOMINAL PAIN (abdominal pain), PYREXIA (104'F fever), DIARRHOEA (diarrhea), OCULAR HYPERAEMIA (bloodshot on eyes (patient usually wears contacts, but eyes are not clear)), MUSCLE SPASMS (legs tight/crampy) and FATIGUE (tired). At the time of the report, ABDOMINAL PAIN (abdominal pain), PYREXIA (104'F fever), DIARRHOEA (diarrhea), OCULAR HYPERAEMIA (bloodshot on eyes (patient usually wears contacts, but eyes are not clear)), MUSCLE SPASMS (legs tight/crampy) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported by the reporter  Treatment patients Wife was not sure but maybe the patient took Ibuprofen to treat symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2021-090599 (E2B Linked Report).
tested positive for COVID-19 after 1st Dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID-19 after 1st Dose) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19 after 1st Dose). At the time of the report, COVID-19 (tested positive for COVID-19 after 1st Dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
20cm erythema, pruritis and pain at site of VARICELLA injection within 24 hours vaccine. Seen at 48 hours.
nausea, dizzy, loss of balance ,small amount of vomiting: for most of the day (approximately 12 hours) no treatment: subsided the following day, 1/13/2021
Patient reported an episode of lightheadedness which subsided prior to leaving vaccination site. Her vital remained stable BP 110/70, HR 82, RESP 18, 02 SAT 99%. Patient left ambulatory accompanied by friend in stable condition.
Information has been received from a pharmacist referring to unknown number of patients of unknown ages and genders. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. On unknown dates, the patients experienced injection site rashes, all of which resolved (date unspecified). This is one of several reports received from the same source. Additional information has been requested.
I experienced on 12/20/2021, I got a rash, rash on my scalp, shaft on my penis. It became scaly. I got topical hair shampoo. I also used topical in my genitalia, my skin was crackling and flares up. It has not gone away. I went to urgent care and saw a attending physician. I have not recovered yet from the rash in my scalp and my genitalia area.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: 3 minutes after admin patient was weak, light headed and confused, then became unresponsive. called 911. he sat forward and began vomiting on the floor. then slowly became more coherent - he said he felt like his blood pressure was very low. EMTs came, checked him out, and he refused treatment. after about 30 minutes he walked out on his own.
Booster dose. Vaccine administered on 11/01/21. Vial expired 10/11/21. Vial was kept in freezer until 10/30/2021 and removed to fridge on 10/30/2021 for administration on 11/01/2021. pt reports chills, body aches, fatigue, stuffy nose.
This spontaneous report as received from a medical assistant (who was also the administrator) 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 # M034799, expiration date 01-FEB-2018, oral (dose was not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccines experienced the temperature excursion of more than 8 but less than 25 degrees Celsius for 1 hour and 18 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA002338:
This spontaneous report as received from a pharmacist via a company representative refers to a 65 year old female patient. Medical history and drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot were not reported). Concomitant medication was not reported. On an unknown date, the patient experienced scarring and high fever after receiving ZOSTAVAX. The patient went to the emergency room but was not admitted to the hospital. The patient received an unspecified treatment. At the time of the report, the outcome of scarring and high fever was not reported. Additional information has been requested.
Shortly after receiving zoster vacc, pt experienced tightness in his chest, itching to back of his head, and elevated pulse (115 bpm)
COVID19 positive on 26thMay2021. Hospitalized for 7 days; Lack of drug ineffect; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID19 positive on 26thMay2021. Hospitalized for 7 days) in an 89-year-old male patient 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 Chronic leukemia (IVIG globulin treatment received on 2 sept2021).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced COVID-19 (COVID19 positive on 26thMay2021. Hospitalized for 7 days) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug ineffect). The patient was hospitalized for 7 days due to COVID-19. On 26-May-2021, DRUG INEFFECTIVE (Lack of drug ineffect) outcome was unknown. On 01-Jul-2021, COVID-19 (COVID19 positive on 26thMay2021. Hospitalized for 7 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 test: positive (Positive) COVID19 positive on 26thMay2021. Hospitalized for 7 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   IVIG globulin treatment received on 2 Sep 2021.  Concomitant product use was not provided by the reporter.  This case concerns a male patient of an unknown age who experienced Covid-19 infection approximately 3 months post second dose of vaccine. Based on the information provided including the established profile for mRNA-1273, and based on biological implausibility a causal association between the event of COVID-19 and the product administration is assessed as unlikely and thus assessed as not applicable.  Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of an unknown age who experienced Covid-19 infection approximately 3 months post second dose of vaccine. Based on the information provided including the established profile for mRNA-1273, and based on biological implausibility a causal association between the event of COVID-19 and the product administration is assessed as unlikely and thus assessed as not applicable.
Contracted COVID after receiving first dose of Pfizer Covid 19 vaccine; Contracted COVID; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient contracted COVID after receiving first dose of BNT162B2. Outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on the plausible temporal relation between vaccination with BNT162B2 and the onset of Covid 19 in the patient, the association between the two cannot be ruled out. However, Covid 19 mostly is an intercurrent illness.
Pt has redness, swelling, and softball size wheal that became hard, tender to touch, headache for 24 hours, soreness for 48 hours.
After receiving all ten shots - PENTACEL, ENGERIX and ROTATEQ. Pt noted to have significant erythematosis lower extremities that lasted few minutes then Pt completely recovered.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose; titer result was neg;
Like Toothache; Woke up During the Night; Left Jaw was sore; Sore Shoulder blade (Injected Arm); This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Like Toothache), SLEEP DISORDER (Woke up During the Night), PAIN IN JAW (Left Jaw was sore) and VACCINATION SITE PAIN (Sore Shoulder blade (Injected Arm)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.  On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced TOOTHACHE (Like Toothache), SLEEP DISORDER (Woke up During the Night), PAIN IN JAW (Left Jaw was sore) and VACCINATION SITE PAIN (Sore Shoulder blade (Injected Arm)).   On 09-Feb-2021, VACCINATION SITE PAIN (Sore Shoulder blade (Injected Arm)) had resolved.   At the time of the report, TOOTHACHE (Like Toothache) and PAIN IN JAW (Left Jaw was sore) had not resolved and SLEEP DISORDER (Woke up During the Night) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient is currently taking Blood Pressure Medication. No treatment information was provided.
After the vaccine. I felt tired and slept , just low energy for one day.  My covid symptoms started on 11Oct2021 with post nasal drip, mild cold like symptoms, sinus congestion and coughing went on Monday- Friday fairly mild - 11 to 15 Oct2021. then I had more coughing sat evening strongly until 19-20Oct. 21Oct feeling a lot better. 17Oct had 103 fever and some chills. Did not see doctor and called them on 14Oct2021
Received 2nd dose of Pfizer vaccine on 1/8  around 12:40pm. Only had a sore arm yesterday. The next morning, woke up with mild abd cramping that resolved over about 1 hour. Throughout the day, had 2 episodes of NB diarrhea. At night, she noticed diffuse body hives and b/l upper and lower eyelid swelling. +accompanying mild SOB with audible wheezing. Pt took benadryl, zyrtec, and pepcid just before arrival to ED and reports feeling better. SOB/wheezing has resolved. Hives are mostly resolved. Only has residual eyelid swelling, Ice applied to eyelid and sent home for observation along with epinephrine pen.
The patient per Mom gets flu shot each year. This year also the flu shot was given, right after injection to upper per pt and mom. Next day per pt and Mom, sais some pain on left arm and then pain in right arm with tingling and after that pt became better with the arm and then started having pain discomfort on ankle/feet on both sides, event to Pediatrics and was told might have Guillain Barre syndrome. Mom brought child for follow up and said having pain in both feet. At that pint as precaution ASAP referred Pt to ER, pt stable at that time, vitals stable, referred to ER for further evaluation. No swelling at injection site.
Information has been received from a registered nurse a female patient who on approximately 01-NOV-2005 (three weeks ago) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient experienced an injection site reaction.  The patient's outcome was unknown.  Additional information has been requested.
second vaccination 2 days ago, tender w/100mm x 75mm erythema, 20x20 induration, generalized myalgia/h/a mild for 3 days;
High fever - 103 degrees, body aches, headache, nausea and vomiting within 24 hours of administration.
1 wk following vax pt woke in middle of noc; had fever 104.5; had a convuls was hospitalized for 7 days; there was never any other signs of sickness only fever that lasted 6 days;
This case was reported by a nurse via call center representative and described the occurrence of injection site mass in a adult female patient who received SHINGRIX. On 6th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site mass, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site mass and injection site erythema were unknown and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site mass, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The reporter was an occupational health nurse at GSK and reported the case on behalf of the patient. The age at vaccination was not reported. At 14:00, the patient received SHINGRIX on left arm. The patient experienced a bump at injection site. The reporter stated that the bump was now a 3 inch rounded red circle around the injection site. The patient reported (1/10) pain at the injection site that seemed to be improving. The patient reported this event to reporter on the day of reporting.
Received Moderna 2nd dose on 5/19/2021 and on 5/20/2021 I had an adverse drug reaction and was taken by ambulance to the Hospital.  Dr. noted that I had a vasovagal response reaction.   What happened:  I had extreme pain in my arm, neck and abdominal core area and was light headed and began to sweat.  I laid on the floor to try to calm things down and my spouse said I was unresponsive at times and shaking, he called 911 for assistance.
Information has been received from a pharmacist concerning a patient of unknown age and gender, who on 23-AUG-2012 was inadvertently administered with a dose of GARDASIL 0.5 ml IM (lot # 666121/0597Z) that had expired on 19-AUG-2012. No adverse effect reported. Additional information is not expected.
Headache, Myalgia, Arthralgia, chills and soreness at injection site Narrative:
arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful; pain radiated down to her fingers; tingled; sluggish; fatigued; rash on arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (sluggish), FATIGUE (fatigued), INJECTION SITE RASH (rash on arm at injection site), PAIN IN EXTREMITY (arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful) and PAIN (pain radiated down to her fingers) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (sluggish), FATIGUE (fatigued), INJECTION SITE RASH (rash on arm at injection site), PAIN IN EXTREMITY (arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful), PAIN (pain radiated down to her fingers) and PARAESTHESIA (tingled). At the time of the report, SLUGGISHNESS (sluggish), FATIGUE (fatigued), INJECTION SITE RASH (rash on arm at injection site), PAIN IN EXTREMITY (arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful), PAIN (pain radiated down to her fingers) and PARAESTHESIA (tingled) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. Concomitant product use was not provided.    This case was linked to MOD-2021-213373 (Patient Link).
Fever and headache for about 12-14 hours; remedied with rest and Tylenol
My husband got the flu shot the very next day he was in the hospital, made him so sick; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case received from a non-health care professional (patient's wife) via social media.  This case involves a male patient of unknown age who was so sick (illness), while he received Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after administration of suspect vaccine, reporter reported that her husband got the flu shot the very next day he was in the hospital (seriousness criteria), made him so sick (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.; Sender's Comments: Sanofi company comment dated 08-Dec-2020: This case concerns a male patient who was hospitalized with sickness after vaccination with Influenza Vaccine. The time to onset was unknown. However, patient's medical condition, concomitant medication, laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.