chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported shaking arms after receiving COVID vaccine. Uncertain if vaccine was Pfizer.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "Patient reported shaking arms after receiving COVID vaccine. Uncertain if vaccine was Pfizer".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning a female patient who in approximately October 2002, was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M); additional therapy included a dose of influenza virus vaccine "flu vaccine", which was given in the opposite arm.  The reporter indicated the patient had a reaction to the pneumococcal vaccine 23 polyvalent.  In approximately October 2002, the patient developed soreness at the injection site.  The pain was described as a "4" on the pain scale and lasted 48-72 hours.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.
Headache experienced in the left top portion of the head and behind left eye. He felt a lot of pressure with pulsating feeling. Total of 3 episodes. 1st: around 7pm (same day of receiving vaccine 5/7/13), pain number of 7-8 out of 10. Took 2 tablets ibuprofen, no improvement, took another 2 tablets at 9am and headache went away. Was a gradual onset. 2nd: next morning (5/8/13). Sudden onset. Pain number 6 out of 10, took ibuprofen 2 tables, lasted 2 hours. 3rd: evening of 5/8/13, sudden onset. Pain number 2-3 out of 10, ate something and took ibuprofen 2 tablets, lasted about 30 minutes.
Iron deficiency anemia.  HGB dropped from 13.1 to 9.9  Ferritin level 5
2000 scratchy, full throat 2030 no voice, tightness in neck and throat took benedryl and zantac and relieved it
Patient administered HPV Gardasil at 11:00 a.m. and advised to wait in room to make sure no reactions to vaccine. Dad came out of room at  and stated that " she fell backwards in the bed and she looks very pale"
I was traveling  with my husband and four friends. We all developed cold symptoms (runny nose, sneezing, coughing, fatigue). My symptoms started on about May 10.   We didn't have many home covid tests with us, so not all of us tested. Those who tested all had positive results.   All of us had had two covid vaccines (Pfizer or Moderna) and two boosters (Pfizer or Moderna), for a total of four covid vaccines. We are all over 60 years of age. We were not sick enough to see a medical professional, although we were sick enough to have adverse effects on our activity level.   After my symptoms improved somewhat, I developed a cough. Over the course of a week it developed into bronchitis. I saw my family doctor, , on June 2. He prescribed antibiotics, prednisolone and an anti-inflammatory inhaler, albuterol sulfate. It is now June 10. My symptoms have improved somewhat, but I am still tired and still have a cough, especially at night. I am guessing that covid and travel wore me down, and the bronchitis  is a result of having covid.
Had high pitched unusual crying & unconsolable greater than 5 hrs; This started late afternoon p/immun;
I was woken up to inability to straightening my left leg and strong left leg pain around the knee. I  had trouble walking and pain while walking.  This lasted 12 hours and then stopped
Swollen lymph nodes, sore throat, nausea headache, fever, tachycardia.
I took the first dose of the vaccine at 4:30am on Friday, 2/22. I took it with cold water and did not eat for 2 hours. On Saturday, 2/23 I woke up vomiting several times. I also had a headache and was so tired and nauseous that I did not get out of bed all day. I had no appetite and ate very little that day. About noon I took a ZOFRAN to stop the vomiting. On Sunday, I still had mild headache and stomach discomfort, but felt much better. On Monday I was back to normal. I did not take a second dose.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; INTRACRANIAL ANEURYSM (medically significant), outcome "unknown", described as "Brain Aneurysm". Additional information: "I have questions about the COVID-19 Vaccine vaccination record cards (how to get, how to get a replacement if lost, etc.)". The caller stated that he and his wife both got vaccinated with the Pfizer COVID 19 Vaccine and he has his card but can not find hers and she is currently in a rest home due to a heart attack and Brain Aneurysm and they want to see her card. "How can I go about getting her another card"? No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE; Patient was administered expired ROTATEQ; This spontaneous report was received from a nurse practitioner referring to a 2 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.      On 19-MAY-2021, the patient was vaccinated with the expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose and strength were not reported, lot # 1660991, expiration date 27-APR-2021) orally for prophylaxis. No temperature excursion was reported for affected rotavirus vaccine, live, oral, pentavalent (ROTATEQ). No additional adverse event was reported. The reporter requested an evaluation for administered/expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
Significant swelling, extensive redness, pain, hot, headaches.  Symptoms increased first 24 hours and remained severe for first four days.  Symptoms improved on day five but pain, redness and swelling remained on day six
Seizures/Spells. Two days after the vaccine injection I started having seizures/spells. It started with 1 a day for 2 days then increased to multiple spells per day (up to 4-5) I was seen at clinic neurology on April 13th. While there they called Emergency Services and I was transported to Emergency Department for what they believed to be prolonged seizure activity. Dismissed from there with appointment with Dr. who is looking into adverse reactions to Covid vaccine and referral to clinic.  After 13 days recovered completely and back to normal activity and workouts.
This case was reported by a consumer and described the occurrence of sniffles in a 14-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included sinus problems intermittent. On 15 January 2013 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm) and experienced inappropriate age at vaccine administration. The subject was younger than the indicated age for FLULAVAL. On 15 January 2013, 1 day after vaccination with FLULAVAL, the subject experienced sniffles. At the time of reporting the events were unresolved.
Initial and follow-up information has been received from an office manager concerning a 15 year old female, with no known medical history who on 06-JUN-2008 was vaccinated IM with her first dose of GARDASIL vaccine (yeast) (lot#660553/0070X) which had been improperly stored. The nurse reported that the vaccine was stored in a refrigerator that had gone below an acceptable range. No adverse events reported. It is unknown if the patient sought medical attention. This is one of many reports from the same source. Additional information is not expected.
pain at the shot side, gotten worst since first noticed; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, between 1 and 2 months after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-JUL-2022. Reporter's Comments: The case was reported by the consumer via interactive digital media. The patient had first shot about 2 months ago.  The patient was currently in traveling and was started to had pain at the shot side. It had gotten worst since patient first noticed few days ago. Patient wanted to know was it normal. The follow-up could not be possible as no contact details were available
Headache, facial and (R) ipsilateral extremity weakness, short-course. Symptoms consistent with neuro-encephalitis with (-) MRI, LP c/w pleocytosis of CSF. All cultures and tests viral illness negative. Self resolved and no residual. Possible HaNDL syndrome.
Pts inject site became red, hot & sore p/receiving an inject of Td; In addition, pt had a fever of 101;
received 2nd dose at 2pm- at 7 pm had slight arm pain.  at 0530 am had severe chills- at 0600 had fever 101- at 1130 fever of 103.5 at 3pm had Fever 104.2- only going down to 102 after taking Tylenol and advil ALL DAY----SEVERE body aches in all joints, headache. Fever blister. fever broke 12 hours later (6pm) - body aches calmed down to tolerable level.  For  24 -48 hours  tolerable aching in neck persisted.  after 1st dose of vaccine- developed clavicle pain x2 weeks. Resolved & returned 12 hours after 2nd Dose.
Pruritic erythema with very little induration. Sites did not appear to be tender. The reactions were not contiguous with the actual injection site.
Twelve days after 1st covid vaccine dose profuse sweating and increased heart rate 148. Two days later no energy or appetite and decreased exercise intolerance
Initial report received on 03 April 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 20-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance database. The subject had received 3 doses of PENTACEL; lot number C3670AA received on 05 August 2010, lot number C36585AA received on 04 October 2010 and lot number C3685AA received on 16 December 2010 and 1 dose of DAPTACEL; lot number C3957AA received on 29 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 13 February 2012, approximately four months after the last dose. On 21 February 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 24 February 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 February 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 07 March 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Starting the day after I received these vaccines, I began to suffer from extreme body aches, fatigue, chills, ringing in my ears and general misery. The arm with the injection sites continues to be painful three days later, but the worst of the other symptoms seems to have subsided. I cannot say which vaccine caused these adverse effects, or whether it might have been the combination of the two. I missed two half-days of work and am now reluctant to have the Shingrix booster when the recommended time for that comes.
soreness lt arm;no noted edema;T97.8;BP 122/60;APAP given;referred to PMD tomorrow;
whole body pain; weakness; headache; left arm aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body pain), ASTHENIA (weakness), HEADACHE (headache) and VACCINATION SITE PAIN (left arm aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21E) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (whole body pain), ASTHENIA (weakness), HEADACHE (headache) and VACCINATION SITE PAIN (left arm aches). At the time of the report, PAIN (whole body pain), ASTHENIA (weakness), HEADACHE (headache) and VACCINATION SITE PAIN (left arm aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Large, red, hot, itchy welt. Started 6 days after vaccination. COVID arm.
Received the DTaP vaccine and within 10 days awoke with most severe croup cough he ever had. Croup cough then turned into whooping type cough after 2 weeks then turned into chronic asthma cough as confirmed by allergy MD.
Patient had moderna covid vaccines on 2/25/2021 and 3/26/2021.  He had a breakthrough case of covid diagnosed on 12/7/2021
Friday 6/3/16 arm started to feel hot, red, itchy, started to swell, became painful and pt had difficulty lifting overhead, no difficulty breathing. Pt. applied cold compresses and took ALEVE.
Administered vaccine that had been stored in the refrigerator for more than 30 days; Administered vaccine that had been stored in the refrigerator for more than 30 days and administered to 81 patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that had been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Administered vaccine that had been stored in the refrigerator for more than 30 days and administered to 81 patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that had been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Administered vaccine that had been stored in the refrigerator for more than 30 days and administered to 81 patient). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that had been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Administered vaccine that had been stored in the refrigerator for more than 30 days and administered to 81 patient) had resolved.        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 reported. No treatment medications reported.
Rash appeared under left side of chin and upper part of neck within 3 hours of the vaccine shot. Continued to itch and feel hot to touch where rash was.  Before bed, abdomen felt very itchy. Next day.left side of chin and upper neck continued to be very itchy and both ears became itchy and burn. Then mid morning, rash spread to left side of face. Continued to be itchy and burn. Around 3pm, the rash spread to right side of face near jawline. I called my internal medicine doctor, sent photos of the rash.  They advised me to go to the nearest Urgent Care Center immediately for a steroid injection. I went to Fast Med, was seen around 5pm. I was given a steroid injection on left hip and a Benadryl pill to help with itching.  The rash looked like mosquito bites. I have photos I can share.
This spontaneous report as received from a registered nurse refers to a 49 years old female patient with penicillin allergy and no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) on 09-SEP-2011. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 18-JUN-2012, "about 2 weeks ago", the patient developed shingles described as a painful bilateral rash that occurred on the patient's back. The patient was treated with unspecified painkillers. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Myopericarditis; This is a literature report for the following literature source(s):  A male patient in his 20's received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: MYOPERICARDITIS (medically significant), 3 days after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Echocardiogram: depressed EF; Electrocardiogram: PR tract sloping and ST elevation in V1-V3; Magnetic resonance imaging heart: unknown results; Troponin: Increased.; Sender's Comments: Based on the information available, the causal relationship between the reported event and suspect 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.
L upper 2 length area of redness + local temp - started ? 2cm x  2 in and elevated to 5cm X 5cm overnight. Fever > 99.8 (A)
From shoulder to mid forearm broke out in a full red rash that was warm to the touch.
Diarrhoea; Rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhoea) and RASH (Rash) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    Concurrent medical conditions included Drug allergy (Sulfa allergies associated manifestation for the hives). Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (OCELLA) and ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhoea) and RASH (Rash). At the time of the report, DIARRHOEA (Diarrhoea) was resolving and RASH (Rash) had resolved.        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.
Moderna COVID-19 Vaccine EUA Nausea, vomiting, and a headache for hours
Information has been received from a licensed practical nurse (LPN) concerning a 2 month old patient with no medical history or allergies who on 16-OCT-2006 was vaccinated PO with the first dose of rotavirus reassortant vaccine live (human-bovine). There was no concomitant therapy. The LPN reported that on 16-OCT-2006, the patient vomited in the office after rotavirus reassortant vaccine live (human-bovine) was administered. The LPN indicated that the vaccine was vomited as well as the contents of the patient's stomach. It was unknown if medical attention was sought. No laboratory/diagnostic tests were performed. On that same day, the patient recovered. The LPN noted that there have been no residual effects since the vomiting. Additional information has been requested.
Developed a red spot on her left side; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MACULE (non-serious) with onset 03Jun2022, outcome "unknown", described as "Developed a red spot on her left side".  Additional information: It was reported that the caller stated that she took her daughter to get the Pfizer COVID-19 vaccine first dose on Friday but didn't mention the specific date. She stated that overnight right above her temple, she developed a red spot on her left side. She asked if she needed to be worried and she was afraid that she might die in front of her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
allergic rxn w/in 5min post vax became lightheaded, fainted, felt surge of med, fell on ceramic potted plant, numbness, swelling-broke rt orbital bone-nerve damage, BP dec 90/60, entire body locked body partially paralyzed, teeth chattering
Itchy red spot, Flu symptoms, fever of 101.9, chills, body ache fatigue, diarrhea, migrane for over 2 days.
administered patient under age of 18; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered patient under age of 18) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered patient under age of 18). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered patient under age of 18) 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.