chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 2 vaccines Pfizer 4/6/21 lot# EW0153;  Pfizer 5/4/21 lot# Ew0171;
redness noted face, trunk & upper arms w/itching-alert & oriented;BP 110/70, P80, R16;DPH given;
Within 3 minutes of the vaccine, patient reported soreness and pain moving from the injection site up the neck.  Patient then called about a half an hour later to report the pain has turned into a numbness that moved across the chest and up the right side of the face. Patient has not yet been evaluated by a physician, but has been advised to seek additional medical advice. No other symptoms reported.
THROMBUS; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry Unknown) dose, start therapy date were not reported 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombus was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210848879.; Sender's Comments: V0:20210849013-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  thrombus- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient received a flu shot (?influenza? on her record) at her pediatrician?s office on Friday September 4, 2020. On Saturday morning, September 5, patient collapsed and started twisting on the floor. She started to cry and said that she didn?t remember what happened. We took her to the emergency room and the doctor did an EKG, urine sample, monitored her oxygen and took blood samples. He said the results of all came back clear and diagnosed her with syncope. He did not mention anything about VAERS or say he was going to report it even though I discussed the flu shot during the ER visit. I can ask which specific strain of the  vaccine was administered but it is the weekend so I am unable to call at the present.
Within 30 mins I started to experience high arm pain (not you normal sore arm) By evening the pain was becoming unbearable. I was unable to move it, without great pain. by bed time it was EXCRUCIATING. I was unable to sleep and was curled in a ball in great pain. The pain went from shoulder to fingers and was a throbbing, intense pain. I have never feel so much pain from anything before. I also had a swollen arm, mild rash and a bit itchy. By morning pain went from level 10 to 9 and continued all day from level 6-10. This continues that week again from level 5-8, so was a bit better. After approximately 10 days I was able to use the arm, it's now a month and still unable to sleep on it and still feels sore. The pain comes only if I put stress on it and the pain is manageable.  I took no OTC or prescription medications for this pain.
Dizziness, NauseaVomiting, mild dyspnea Narrative: Saw Provide  who offered Benadryl or Claritin for symptoms=>employee denied & eventually returned to work.
Information has been received from a health professional concerning a 7 year old Hispanic female who on 01/07/1999 was vaccinated with a dose of varicella virus vaccine live.  On 02/07/2005 the patient developed ten red papules on her trunk, arms, scalp.  It was reported that there were no vesicles yet.  Unspecified medical attention was sought.  Treatment included Tylenol, Benadryl, calamine camphor pramoxine, Aveeno.  At the time of the report the patient had recovered.
I received two shots on March 30, 2016 at the V.A. Clinic. One was TDAP and the other PREVNAR. I would also imply: I hadn't accepted but a few of these types of shots for years except for the PREVNAR. Yet when I arrived home I began to have increased pain in my back. As well I continually became increasingly nauseous. And during the course of time this pain became too intense and my ability to eat also diminished so much I presently can't eat. Yes the only differences regarding my everyday life and habits and my present condition had been after I received these two shots! And as of today (4/18/16 I've also lost at least 16 pounds! And if this can help anyone else who initially had Pancreatic Cancer along with all the residual occurring symptoms and effects then I'm certainly appreciative to provide this information has well.
Redness, induration anterior thigh with mild bruising at injection site. Given Keflex and Benadryl.
Body aches, chills, fever, headache, dry cough sometimes with mucous. Arm where shot was given , red, hot to touch, couldn't lift, very painful.
Moderna COVID-19 Vaccine EUA  Fever of 102.2 at 10 a.m. on the morning after the second dose
Feb. 25 - sore arm - pm through March 1 pm Feb. 28 - sore throat am, plus dry cough pm March 1 - sore throat, dry cough, went to work. By 4:00 pm chills and tiredness. Slept on couch under blanket. March 2 - Did not report to work. School nurse tested me for Covid on parking lot, rapid test, negative - Sore throat, runny nose, sore ears, bad dry cough, sneezing. Pharmacist suggested taking Delsym and Flonase. Took these at 8:00 pm. March 3 - Did not report to work. Took Delsym and Flonase at 8:00 am. Sore ribs (sides) from coughing so hard, Would lose my breath while coughing. Stayed in bed until 1:00 pm. Got up and took regular meds and ate a bowl of oatmeal and cup of orange juice. Went back to bed until 5:00 pm. Still NO fever, headache, nor loss of smell or taste. Took Delsym and Flonase at 8:00 pm. March 4 - Did not report to work.  Still sore throat, cough, runny nose. Did get a shower. Will get another Covid rapid test today at 3:00 by school nurse.
This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (blood pressure dropped so low last night) and DIARRHOEA (diarrhea, it's been 8 times) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 24-Feb-2021, the patient experienced BLOOD PRESSURE DECREASED (blood pressure dropped so low last night). On an unknown date, the patient experienced DIARRHOEA (diarrhea, it's been 8 times). At the time of the report, BLOOD PRESSURE DECREASED (blood pressure dropped so low last night) and DIARRHOEA (diarrhea, it's been 8 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (abnormal) Abnormal, blood pressure's like 90 over 60.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided
increase shortness of breath; increase shortness of breath; This non-serious case was reported by a physician via sales rep and described the occurrence of increased shortness of breath in a 71-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included shortness of breath. Concomitant products included prednisone.   On 03-SEP-2023, the patient received Arexvy. On 03-SEP-2023, immediately after receiving Arexvy, the patient experienced increased shortness of breath (Verbatim: increase shortness of breath) and condition aggravated (Verbatim: increase shortness of breath).The outcome of the increased shortness of breath and condition aggravated were not reported.   It was unknown if the reporter considered the increased shortness of breath and condition aggravated to be related to Arexvy.  It was unknown if the company considered the increased shortness of breath and condition aggravated to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-SEP-2023 The patient was administered the Arexvy vaccine (one injection). Shortly after receiving the Arexvy vaccine the patient complained of increase shortness of breath.  The patient was usually on a routine daily dose of 20mg of prednisone and due to his increase in shortness of breath he was increased to 100mg of Prednisone daily.  The doctor was not sure if it was directly related to the Arexvy vaccine but he thought it was a significant change in his health status that he thought it was worth reporting. The reporter agreed to follow up from GlaxoSmithKline.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4301543-00 (AbbVie), US-PFIZER INC-202200403588 (RA). A 41-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single, intramuscular, administration date 19Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 18Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1158187) at citrate free for crohn's disease. Relevant medical history included: "Moderate to severe adult crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: CROHN'S DISEASE (medically significant), outcome "recovered", described as "more crohn's pain"; ABDOMINAL DISTENSION (medically significant), outcome "recovering", described as "Bloating"; DIARRHOEA (medically significant), outcome "recovering", described as "Diarrhea". The action taken for adalimumab was unknown. Additional information: The reporter's causality for the event(s) of bloating, diarrhea and crohn's pain with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of more crohn's pain after Covid-19 vaccine with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's assessment of the causal relationship of the bloating, diarrhea and crohn's pain with the suspect product Pfizer BioNTech Covid-19 Vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for the event(s) of more crohn's pain after Covid-19 vaccine with Pfizer BioNTech Covid-19 Vaccine was a reasonable possibility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information provided in the narrative, a possible contributory role of the suspect vaccine BNT162B2 to reported event of  abdominal distention, diarrhea and crohn's disease aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Swollen lymph node; Not feeling well; Feeling tired; achy; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Not feeling well), FATIGUE (Feeling tired), MYALGIA (achy) and LYMPHADENOPATHY (Swollen lymph node) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced MALAISE (Not feeling well), FATIGUE (Feeling tired) and MYALGIA (achy). On 06-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MALAISE (Not feeling well), FATIGUE (Feeling tired) and MYALGIA (achy) outcome was unknown and LYMPHADENOPATHY (Swollen lymph node) had not resolved.
Pain in both knees was minor with the first dose and got worse with the second dose. Patient given 500mg Naproxen BOD, ice bilateral. Dx: Patellofemoral pain syndrome.
The injection site is fevered, swollen and hard about 6 inches long and 3 inches wide. The second day after the vaccine the actual puncture mark swelled and you can tell exactly where the needle was stuck.  It is hot to the touch. I've been experiencing Very super severe fatigue. I mean tiredness I've never felt nor ever been (and I do have 3 children.) The day after ( on the 21st)  I was very very queasy and anything I ate made my stomach hurt and I couldn't eat much. Thankfully that passed as of the 22nd but the swelling, heat and pain is still present as of this report as well as the fatigue.  I have a fever tonight and the symptoms (besides the stomach ) have worsened progressively!
Red swollen patch on arm at injection site, delayed reaction. Covers top of left arm, itchy and hot to the touch.
angioedema; hives/chronic urticaria; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 31 years of age), via an unspecified route of administration on 13Jan2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included anaemia, type 1 diabetes mellitus (IDDM), hypothyroid, lymphocytic colitis, hyperlipidemia, known environmental allergies, and COVID-19 prior vaccination. Concomitant medications included insulin and levothyroxine sodium (SYNTHROID), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 dose 1 on 22Dec2020 07:00 AM (at 31 years of age) (Batch/Lot number: EK5730) in the right arm for COVID-19 immunisation. The patient was not pregnant. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. About 2 weeks after receiving second dose on 13Jan2021, the patient developed hives and angioedema. She had now been diagnosed with chronic urticaria. The hives have been present everyday since. They are not responsive to antihistamines, steroids, or Montelukast. The patient stated that she had been waiting for insurance approval to try XOLAIR. The adverse event start date was 27Jan2021 07:15, which resulted to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient has not recovered from the events. Therapeutic measures were taken as a result of the events with antihistamines, steroids (po and topical), and Montelukast.  Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspectt drug BNT162B2 Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Dizzy. Short of breathe, muscle soreness, weakness, diarrhea, muscle pain and decreased appetite
Information has been received from a nurse concerning a 64 year old male patient with no pertinent medical history, drug reaction or allergies. On 12-NOV-2012, the patient was vaccinated with single dose of 0.65 ml ZOSTAVAX subcutaneously injection. No other co-suspects were reported. No concomitant medications were reported. On 12-NOV-2012, the patient complains of a 2.5 inch barely noticeable area of redness at the injection site that appeared shortly after the vaccination and persists through the time of informed the event. No treatment information was reported. Labs diagnostic or studies were not performed. The patient seeks medical attention. At the time of the report, the outcome of 2.5 inch barely noticeable area of redness at the injection site was not recovered. The relatedness for 2.5 inch barely noticeable area of redness at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
A few hours after the vaccine, I started having pain in the lymph nodes under my left arm. The pain was intense for 3 days and just started to lessen. After the 1st dose on 4/19/2021, I started having worsening tinnitus in my right ear. I had it years ago, but was reduced to nothing with acupuncture. The noise in my right ear has gotten worse. It escalated after this second dose of the COVID vaccine. I now have constant tinnitus in my right ear. The sounds range from a siren to a microwave being constantly on.
I developed ?COVID arm? about 12 days after the injection. I already take loratadine (Claritan) 10mg twice daily but it still came up. It seems to be spreading further along my arm.
I missed my period the week after the vaccine, then came the following week after that. It was heavier than normal. I had it in the normally scheduled week of June, but my period was very heavier with lots of blood clots.  It lasted seven days, but my periods usually last around four days and my periods are usually very light. I also had lots of spotting . I went to the OBGYN and they prescribed me a hormone to try to restart my cycle and get it back to normal.
This is a spontaneous report from a doctor via a Pfizer Sales Representative with follow-up from the contactable physician. A 2-month-old female patient was administered a dose of PREVNAR intramuscularly and a dose of PENTACEL (not SYNTHASIL as previously reported) intramuscularly, on 02May2011. No relevant past medical history, nor other illnesses were reported. Concomitant medications of the patient were non-applicable. On an unknown date, after the vaccinations, the patient experienced hives all over the body and the patient had an unspecified reaction. The relevant laboratory data was unknown. Status of both the therapies was unknown at the time of report. Therapeutic measures taken, if any, were unknown. Clinical outcome of the reported event was unknown at the time of report. Follow-up (14Jun2011): New information received from a contactable physician included: patient demographics, date of administration of PREVNAR and PENTACEL on 02May2011, route of administration, indication, description of event as hives all over body, concomitant medications are non-applicable, no other illness/relevant history were reported.
Patient states severe pain in shoulder joint.  States she saw doctor for symptoms and diagnosed with Serva.  Received a steroid injection in shoulder after 5 weeks of pain.  Since steroid injection, states that it seems to be helping.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
extreme pain in face, jaw, neck, head; fever, chills, cough, swollen glands, sinus congestion, nausea;stiffness in jaw & neck, backache
Left upper arm injection site. Left upper arm surrounded by 16cm x 16cm erythema, mild swelling.
Ringing in ears/low-frequency sound; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced ringing in ears/low-frequency sound/ Low grade hum on an unspecified date. The patient received the shot (Unspecified Medication) on Thursday afternoon. And starting Friday evening had started with a ringing in ear and it's a low grade hum and it's ringing on ever since and had it before and I got the Pfizer shot. The patient talked to doctor she had no answer, she had suggested that maybe call and report it as possible side effect. She hasn't heard of anything. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Flushing of the face; Sudden racing heart; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8731) via an unspecified route of administration in the left arm on 13Apr2021 at 17:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19.Concomitant medications included xantofyl, zeaxanthin (AREDS 2), vitamin d nos (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid(ASPIRIN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 18:00 the patient experienced flushing of the face and sudden racing heart. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event flushing of the face and sudden racing heart was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Rash involving the leg and trunk. On lower extremities, from ankle to the inferior thigh, she has pink plaques, well-circumscribed in some areas, confluent in others. They are firm but flat. The biopsy site on the posterior right calf is healing well without erythema or exudate.
Had a horrible reaction / Admitted to the hospital 3 times with tachycardia; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tachycardia (serious criteria hospitalization). On an unknown date, the outcome of the tachycardia was recovered/resolved.   It was unknown if the reporter considered the tachycardia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient took the two vaccine series a year ago from date of reporting and had a horrible reaction. She was admitted to the hospital 3 times with tachycardia.  Emergency room visit required. The reporter did not consent to follow up.
Severe pain in entire arm that received vaccines. Lasted 7 days. Extreme difficulty moving/using left arm. Development of fibromyalgia and chronic fatigue sydrome within one month of recieving vaccines.