chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got allergy symptoms within a few days - inflammation of sinuses, severe itching in nose and mouth, red eyes. Then they went away.  In October 2021, I started having 2 menstrual periods per month, bleeding heavily with extreme pain and night sweats. My menstrual periods last about 10 days each. The pain is so bad that I vomit. I vomit at work. I vomit at home.  Two periods per month every month since October so far. This has made my life so difficult. Before October, I only had one period per month.
Patient experienced an anaphylactic reaction. Follow up 8/13/04: He came in this morning. He was given Varivax 1, DTaP 4, HIB 4; 15 minutes later he started swelling, having difficulty breathing, and broke out in hives. They presented back to the clinic; he was given epinephrine 1:1000, .1ml SQ, 1.2 teaspoon Benadryl and nebulizer treatment of 083% Albuterol. Within 30 minutes he was breathing easier, swelling was going down, he had persistent hives. I kept him here two hours and had him come back at 1:00. He looks good. His breathing is relaxed, no hives or edema. I told them this is very rare and I will report it.
wheezing, body aches, swollen lymph nodes, fatigue, hard to sleep, body so painful it was hard to sit still, couldnt lift arm, liver swollen/painful
30OCT97 presented to hlth dept 10AM lt deltoid very edematous & hot to touch;pt states felt like had temp last PM; took APAP;
Pain in the arm; pain radiates down her arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 18th September 2019, the patient received Shingrix and FLUAD. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and radiating pain. On an unknown date, the outcome of the pain in arm and radiating pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and radiating pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient received Shingrix and Fluad in the same arm and developed pain in arm that radiated down her arm which she was still experiencing. All patient identifiers were provided. No data available for batch number or expiration date. It was unknown if the reporter considered the pain in arm and radiating pain to be related to FLUAD. The reporter consented to follow up.
Pt was given first dose of moderna series, and sat down in waiting room to be observed. Immediately after vaccination, pt reported nausea, dizziness, losing vision, and sweating. Pt was told to sit down to avoid falling. After 15 minutes, patient was feeling better and able to drive home. Pt was called the following day to check on health, pt reported feeling better and did not need to be hospitalized or need to take any medication.
Patient states that she began feeling like she had a sore throat.  On 05/27/2005 she could not swallow.  Patient went to the hospital.
Information has been received from a father concerning his 4 year old daughter with milk and casein allergies and no other medical history who on 15-NOV-2004 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number 647263/1136N), 0.5 ml in right arm.  Concomitant therapy included poliovirus vaccine (ELPV-3) on 15-NOV-2004.  The consumer mentioned his daughter received MMR (Enders-Edmonston) (MSD, HSA, lot number 648470/0317P) and VARIVAX (Oka/Merck) and at 18 or 20 months he noticed she stopped talking, regressed socially and was non-responsive.  The daughter was diagnosed with PDDNOS (Pervasive Developmental Disorder).  At the time of reporting, the patient was recovering.  On unknown date, the patient sought medical attention by the physician.  The daughter cannot get rid of metals that are in her body.  The daughter was also given 0.5 ml of MMR (Enders-Edmonston) (MSD, HSA) in left arm on 14-FEB-2005 concomitantly with Hib conj vaccine (OMPC) (manufacturer unknown).  The daughter is currently able to understand some of what is said and respond.  The daughter is also able to sign for what she wants to do but she is still not talking.  The consumer was not saying MMR (Enders-Edmonston) (MSD, HSA) or VARIVAX (Oka/Merck) caused the metals that have accumulated in his daughter's body, he was just trying to find out more information about the vaccines.  Upon internal review, it was determined that PDDNOS (Pervasive Developmental Disorder) was serious as other important medical event.  No further information is available.
Pt received three doses of varicella virus vaccine live; pt has not seroconverted.
COVID Pfizer Vaccine Breakthrough Case  Pfizer Dose 1 1/8/2021 (EL1284) Pfizer Dose 2 1/30/2021 (EL1283) COVID Positive 9/6/21  9/5/21: Patient is a 56-year-old female who presents due to the above concerns, reports her symptoms have been ongoing for the last 10 days and not been getting better.  Patient was seen in the walk-in clinic yesterday; she was given a prescription for Zofran. Also has been having subjective fevers and chills and a dry cough as well.  The patient's fever was 102 as reported by her.  She has also been having a dry cough. Patient also reports some loss of appetite as well as a marginal loss of taste.  She is not vaccinated against COVID.  Initially patient refused a COVID test, but after further discussion with me in the emergency department, she is agreeable.  Patient is being admitted as she had become hypoxic in the emergency department.  CT abdomen/pelvis shows incidental bibasilar infiltrates in the lungs.  CT abdomen was otherwise unremarkable.  Chest x-ray was done which shows bibasilar infiltrates.  D-dimer was ordered and is currently pending, as well as a COVID screen.  9/10/21: Patient was admitted on September 5, 2021 for evaluation of COVID pneumonia.  Patient was treated with Levaquin, Decadron, remdesivir and required supplemental oxygenation throughout the hospital stay.  Patient had progressive subjective and objective improvement throughout the hospitalization.  Patient will require home oxygen supplementation.  Patient is to complete a course of Levaquin after discharge.  Patient was consult on Home Health however patient has refused.
Patient has red and swollen lower arm, well below the injection site and on the inside of the upper arm.
Monday, February 1st at apx. 5:30 pm. I began experiencing dirrreaha, nausea, and headaches. These symptoms come and go And last for periods of 30 min. to 3 hrs.
Patient contracted COVID after being fully vaccinated - Cough, Headache, Fever, and Chills
This spontaneous report as received from a nurse who refers to multiple unspecified patients of unknown age and gender. The multiple patient's medical history and concurrent conditions were not reported. On an unspecified date in January 2016, multiple patients were vaccinated with improperly stored doses of VAQTA lot # L045713 expiration date 14-JAN-2017, lot # L023936 expiration date 15-MAR-2017, lot # M009377 expiration date 17-JUN-2017, lot # L015460 expiration date 20-JUL-2017, lot # M017982 expiration date 13-SEP-2017. Dose, route and anatomical location were not provided. No other concomitant medications were reported. Excursion details: The vaccine was exposed to 9 degrees F for 9 hours, as well as to 0.3 degrees F for 837 hours and as to 30 degrees F for 542 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received flu shot around 4:30 PM.  By 6:30 PM had a dry persistent cough and large amounts of phlegm.  Driving home, individual could not seem to swallow the phlegm fast enough and was starting to gag.  By the time individual got home (15 minutes drive time), was wheezing so took 50mg Benadryl by mouth.  Within 40 minutes, the wheezing was starting to subside, but continued to have a lot of hlegm.  at 9:00 PM, took another 50mg of Benadryl by mouth and wheezing has resolved by 11:00 PM.  Phlegm was pretty much resolved by then as well.  The morning of 10/15/2009, individual reported eyes were swollen and had crusted secretions on lashes, eyes hurt and would go blurry at times.  Swelling in the eyes was gone by the next day.
When he inject I fill pain "like Bee-sting" hurt so much and not going away "the pain". I went home "I" fill not good, "then fill cold" when I go to bed "I'm so cold like I have a high-fever" in early-morn. Head ache "Too much" dizzy if I get up. 2-days fever and I see my arm "so red" and hot. "I fill aching" in my arm. For my knowing "I" went to pharmacy to get a flu-shot and I ask if it's okay to take the pneumonia vaccine. "I" said it's back more than 10 yr's. This is my second "vaccine" the first one I got like flu "But nothing" happen to my arm "only now!" and it's so different feelings "the pain" like, Bee-sting". And I feel this pain "like something in my arm "crawling feeling" w/pain, itching. And, the red "is like, tomato" and big, spreading "going-down" to my hand. It's pass my elbow I went to emergency hospital twice case "I'm so worried". The redness, is so fast "swollen itchy". First went to ER "the medicine" is cephalexin 500 mg. capsules/4 x daily for 10 days. Second, went to ER "the medicine" is AMOX-CLAV 875 mg. tablets/take 1-tab. by mouth 12 hours for 10 days. I received shots Penicillin injection at E.R. and it "help so much".
Rash x 1 day on 9/20/02-had received MMR and varicella on 6/14/02 and on 9/3/02. Received DTaP/Hib/IPV.
Potentially received only the diluent portion; Potentially received only the diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number P2J7E, expiry date 10th October 2022) for prophylaxis.   On 16th August 2021, the patient received the 1st dose of Shingrix. On 16th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received of only the diluent portion of Shingrix 1st dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist reported the potential of administering 3 doses of Shingrix dose due to the potential of the administration of only the diluent portion at month 0. The patient returned for 2nd dose on 21st October 2021, but it was suspected that the patient only received diluent portion on 16th August 2021. At the time of the reporting, it was unknown if 2nd dose of Shingrix vaccine was administered at time of call on 21st October 2021. The reporter consented to follow up.
Patient said she got COVID arm about 8 days after the vaccine. She described it about the size of  a quarter and it did resolve. She asked to have her 2nd dose in the opposite arm.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was intended to receive vaccinated ZOSTAVAX was inadvertently administered with 0.5 ml of VARIVAX (merck) (Lot# unspecified) on 11-OCT-2012. No adverse effects reported. The outcome was unknown unknown. Additional information is not expected.
Patient received vaccine on 2/8/19. She reports that on 2/9/19 in the afternoon, she noticed her hands were red and itchy. The itchiness then spread to arms and entire body. She took 2 OTC Benadryl and was directed by a physician friend to take another 1 Benadryl an hour later. The symptoms all resolved by three hours and patient reports no long lasting effects.
area of lt deltoid turned red below & above inj site;pt afeb;c/o pain to lt arm;advised to take APAP for pain &/or fever PRN;
Pt returned to the clinic 6 hours after injection with severe hives. 911 was called; pt taken to the hospital.
Minutes after second injection, pt began to experience tingling in tongue and throat with visible hand tremors. Pharmacist was called to assess, at which time pt was having difficulty breathing. Due to previous anaphylaxis to shingles vaccine and presentation of current reaction, decision was made to administer epinephrine 0.3 mg autoinjector into patient's left thigh. Within 15 seconds, pt relayed breathing improved, in 4 minutes she was able to take a deep breath, and within 10 minutes, tingling in throat was completely gone.  All symptoms subsided after 30 minutes when patient's daughter arrived to take her home. Pt was beginning to feel shakiness and fatigue from epipen after-effects but was otherwise back to normal with no vaccination-related symptoms remaining.
Booster; chills (shaking uncontrollably); chills; body aches all night; 104 fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44 year-old male patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Note: Takes Lipitor. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Booster"; TREMOR (non-serious) with onset 17Dec2021, outcome "unknown", described as "chills (shaking uncontrollably)"; CHILLS (non-serious) with onset 17Dec2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "body aches all night"; PYREXIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "104 fever". Relevant laboratory tests and procedures are available in the appropriate section included body temperature: 104 fever.   Additional Information; The patient got Pfizer booster shot Friday 17Dec2021. Friday night had chills (shaking uncontrollably) and body aches all night with 104 fever. Optional Information: Patient has high cholesterol and takes Lipitor. Tylenol was received as treatment drug.  The lot number for bnt162b2 was not provided and will be requested during follow up.
5 weeks and 6 days later I suffered a PE with Infarct. was hospitalized 6 days. anticoagulants, IV antibiotics, s/s pain, fever,shortness of breath.
Severe pain in shoulder and upper arm persisted for 48 hours, with arm almost immobile due to pain, gradually tapering off.  On second night after receiving the vaccine, I had severe headaches and alternating chills/sweats.   72hrs after the vaccine,  pain continues, although it has subsided to the point where almost full motion is possible.  Periodic severe headaches continue, although these existed before receiving the vaccine and are linked to positive COVID in Nov 2020.
numbness and heaviness in back. severe dizziness, blurry vision and diaphetic, coe med called due to dizziness, pt was transferred to ED
has had fever x 6 days w/no other sx x/sleepy all the time;
left arm has been in pretty serious pain ever since; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm has been in pretty serious pain ever since) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (left arm has been in pretty serious pain ever since) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE PAIN (left arm has been in pretty serious pain ever since) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment for the event included 10 mg for one week of an unspecified medication.  Based on the 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.; Sender's Comments: Based on the 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.
I had developed all over my body, from my scalp to my ankles and large white welts had started to form on my body. It was insane itching. I took Benadryl and took a steroid prednisone to help begin clearing the bright red rash. I saw my PCP and he informed me this was a reaction to the vaccine. I also went to the ER prior to visiting my PCP where they performed blood work, vaccine allergy test, and CT scans on my chest due to mild chest pain and history of blood clots. That's where I was given the prednisone to reduce the rash.
arm was very very sore - left arm; rash at the vaccination site - left arm; middle of it is hard kind of like a mosquito bite - at the vaccination site - left arm; COVID arm; warm to the touch - at the vaccination site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (arm was very very sore - left arm), INJECTION SITE RASH (rash at the vaccination site - left arm), INJECTION SITE INDURATION (middle of it is hard kind of like a mosquito bite - at the vaccination site - left arm), VACCINATION SITE HYPERSENSITIVITY (COVID arm) and VACCINATION SITE WARMTH (warm to the touch - at the vaccination site - left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE RASH (rash at the vaccination site - left arm), INJECTION SITE INDURATION (middle of it is hard kind of like a mosquito bite - at the vaccination site - left arm), VACCINATION SITE HYPERSENSITIVITY (COVID arm) and VACCINATION SITE WARMTH (warm to the touch - at the vaccination site - left arm). On an unknown date, the patient experienced PAIN (arm was very very sore - left arm). At the time of the report, PAIN (arm was very very sore - left arm), INJECTION SITE RASH (rash at the vaccination site - left arm), INJECTION SITE INDURATION (middle of it is hard kind of like a mosquito bite - at the vaccination site - left arm), VACCINATION SITE HYPERSENSITIVITY (COVID arm) and VACCINATION SITE WARMTH (warm to the touch - at the vaccination site - left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 63 degrees Fahrenheit for 564 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician via company representative refers to an unknown age and gender patient. The reporter reported that the patient received three doses of VARIVAX (Merck) (lot # unspecified) route and location unspecified. The patient received the three doses of VARIVAX (Merck) as followed: first dose on 26-JUL-2011, second dose on 06-AUG-2012, and third dose 31-JUL-2013. No adverse effect reported. Additional information was received from the physician. This report concerns a 3 year old, male patient with no pre-existing allergies, birth defects or medical conditions. The patient had no adverse events following prior vaccination. Patient's weight was reported as 35-units not provided). On 31-JUL-2013 at 4:00 PM the patient was vaccinated subcutaneously in left arm with the third dose of VARIVAX (Merck) lot number reported as J001176 (expiration date not provided). On 03-AUG-2013 the patient experienced fever which started at 5:30 PM. There were not relevant diagnostic tests and laboratory data performed. He did not require the doctor visit or emergency room. The outcome of fever was unknown. The patient was healthy at the time of vaccination, there were the relatedness between the patient's adverse events and the vaccination with VARIVAX (Merck) was not provided. Additional information is not expected.
This is an initial spontaneous report from Pfizer Medical Information for a contactable pharmacy technician who reported for an unknown consumer. This consumer (age, race and gender unknown) might have started receiving PREVNAR 13 since an unknown date at an unknown dose and frequency for an unknown indication. Relevant medical history and concomitant medication was unknown. Since an unknown date, the consumer was ill after administering with PREVNAR 13 [elaborated that the consumer was possibly on a series of PREVNAR 13 and missed dose of PREVNAR 13 on an unknown date [elaborated that the consumer was possibly on a series on PREVNAR 13 and this might be second or third dose in the series, which could not be given as the consumer was ill]. Relevant laboratory data was unknown. Last action taken with PREVNAR 13 was unknown at the time of report. Therapeutic measures taken in response to the reported events were not provided. Clinical outcome of the reported events was unknown at the time of report.