chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bells Palsy; This case was reported by a other health professional via call center representative and described the occurrence of bell's palsy in a child male patient who received HAV (Havrix) (batch number 3TG52, expiry date 26th June 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix. On an unknown date, 3 days after receiving Havrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Havrix.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that the patient's mother, reported that the child developed Bells Palsy 3 to 5 days after receiving first dose of Havrix.  The reporter consented to follow up.
She has not received her second Shingrix vaccination; Rash / similar to poison oak, from her elbow to her shoulder; This case was reported by a consumer via call center representative and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 1st August 2020, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with prednisone. On 19th August 2020, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in her left arm at her physician's office and reported a rash, similar to poison oak, from her elbow to her shoulder on her left arm.  The patient was prescribed Prednisone on 11th August 2020 and took until 21st August 2020. Till the time of reporting, the patient had not received her 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The patient gives consent to follow up with her healthcare professional and also gives consent to email her Shingrix PI (package insert). The reporter consent to follow up. The age at vaccination was not applicable for 2nd dose of Shingrix.
Information has been received from a registered nurse concerning a 78 year old male, who, on an unspecified date, was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 12-FEB-2008, the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. On 12-FEB-2008, the patient experienced pain and developed swelling at the injection site. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare professional refers to a 18 year old male patient. On 05-MAY-2014, the patient was vaccinated by a medical assistant with GARDASIL in the right deltoid (dose, route of administration were not provided) (lot # was illegible, expiration date: 28-SEP-2014) that was out of range temperature. Additional information has been requested.
She had a rash on her head, neck, and back/broke out in a rash in her scalp, chest, and back; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had a rash on her head, neck, and back. She took Benadryl and it went away. She broke out in a rash in her scalp, chest, and back after the first dose she received of the Pfizer Covid 19 vaccine. She took Benadryl and symptoms went away and then nothing with the second dose. The outcome of the event was recovered.  Information about batch/lot number has been requested.
Shortly after I felt very dizzy, light headed and felt numb all over.  I developed heart palpatation.  I was laid down and was very nauseous, cold, had a headache and got cotton mouthed. I had an elevated HR and BP as well.  I laid there for about 30 minutes and finally the all symptoms except the headache subsided and it finally went away after day 3.
Slept a little; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Slept a little) and FATIGUE (Fatigued) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INSOMNIA (Slept a little) and FATIGUE (Fatigued). At the time of the report, INSOMNIA (Slept a little) and FATIGUE (Fatigued) had resolved.            No concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2022-455602, MOD-2022-455604, MOD-2022-455785 (Patient Link).
From the date of the injection, May 1, 2021 until Wednesday, May 5, 2021 (total of 5 days), I had experienced all of the following, (not always happening at the same time): Headache, fever anywhere from 101 to 104, severe chills that were painful, all over body aches that can only be described as a feeling of my nerve endings being on fire, nausea, muscle pain that made it difficult to walk, diarrhea, feeling of weakness and exhaustion.
I received the 2nd dose of the vaccine on 3/13/21 around 1pm. Later that evening I started having severe chills, fatigue, muscle aches, and headaches -to the point where I had to lay down and I slept for hours and woke up feeling even worse the next day.  The severe headaches felt like the worst migraine /tension headache ever-it was hard to lift my head. Chills, fatigue, headaches and body aches persisted from 3/13/21 until 3/15/21. My symptoms have improved today, 3/15/21, but I still have a slight headache and fatigue.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date in 2009, the patient was vaccinated with GARDASIL dose 1, for the prevention of HPV (dose, route and frequency were not reported). Concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with GARDASIL dose 2, for the prevention of HPV (dose, route and frequency were not reported). The patient did not follow the recommended dosing schedule. Treatment was not given. The representative could not confirm if the patient received a 3rd dose. No adverse effects were reported. Product quality complaint was not reported. Additional information has been requested.
At approx. 13 minutes after receiving the vaccine client was pasty, pale in color, and grabbing at left upper chest.. Pt taken to triage area, vital signs monitored,  Reports his heart was beating faster than normal as well as difficulty breathing. O2 administered.3:25pm he reports feeling better, less trouble breathing and heartrate not as fast. 3:33pm client reports improvement in symptoms. He refused EMSA, left ambulatory. I have attempted multiple phone calls, phone is not in service and I sent a letter on 1/19?21 with no response.
fever, chills, headache, swollen pectoral lymph nodes and fatigue. lasted three days.
Client in clinic 4/10/07, for travel immunizations, received Adacel and Hep A #1, awoke at 4AM 4/11/07 with numb and stiff arm, N&V, fever 102.6, headache, muscle aches, swollen lymph nodes and facial swelling. Went to ER for eval of severe reaction. Was there for 5-6 hours, given IV with Benadryl    stenosis. F/U PCP. Discharged on Prednisone. Dx: severe reaction to immunizations.
This spontaneous report as received from a nurse via company representative refers to a 57 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (1 shot, dose unspecified, lot# and expiration date were not reported) for prevention of shingles. On an unknown date, 2 days after vaccination the patient's left side of body had lots of achiness, her arm hurt and she had a slight vertigo. The patient sought medical attention. No treatment was given for the events. The patient recovered from the events (date unspecified). Relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sore arm, hot, red, lump for 5 days, then it cleared up 3 days later became sore and itchy and red again (same size redness) cleared in 3 days (11 total)
Mother is here in our clinic and reported this reaction.  She has child here to receive her scheduled vaccines.  Mother states Approx. 2 hours after last vaccines administered, the child had pruritis at the site of injection.  In 2 more hours Mother noticed swelling and redness at injection site.  No treatment at that time.  The following morning of 11/8/2011 Mother noted "severe" swelling, approx size 3in x 2in.  Child also c/o tingling in mouth.  Mother stated that speech was altered.  She immediately gave Benadryl.  She stated that she gave 3 times before child's speech was back to normal.  Symptoms were all resolved 3 days post vaccination.  She did not seek treatment or advice from MD or ED.
I went to the agency and got the SHINGRIX vaccine shot for shingles. Within 2 hours I started to experience dizziness, swollen face, double vision, hallucinations, and red blotches all over my body. After two days of complete and total bed rest, I still felt really lethargic and exhausted. I couldn't do anything without having to lay down. I felt terrible. Somethings not right. I called the agency nurse and tried to explain my situation. I was told that it sounded like a reaction of some kind that they have not heard of anything like this before. Well as days passed, I was not feeling much better. After approximately 12 days I had an unrelated appointment with the agency. The first thing I said to the team of doctors (the pain clinic) I was told to see my primary. Well 11 vials of blood later, and then 2 days later another 9 vials of blood, I was at the agency and was told by one of the doctors that he believed that the shot da.aged my liver and that was the reason I was feeling so bad. I looked on the agency health website at my blood work results myself and sure enough my levels in quite a few areas were outside the normal limits indicating liver problems. (This is 3 weeks now). Coincidentally the next day my primary calls me and says that my results indicate I "may" have a hep c problem and was to come in for more blood work. Well 6 years earlier the agency cured me of hep c and I was verified cured by the agency and by a private doctor. This is available on my health website. I don't have this information on hand
This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with ZOSTAVAX (lot number, expiration date, dose, route and anatomical location were not provided). There was not concomitant medication reported. On unknown dates, the patients developed nodules at the injection site on an unspecified time after they received ZOSTAVAX. At the time of the report, the outcome of injection site nodule was unknown. The reporter did not assess the causal relationship between the adverse events and the vaccination with ZOSTAVAX. This is one of several cases received from the same source. Additional information has been requested.
On the day of the vaccination, my arm hurt pretty badly. It lasted about 3 days. I pretty much had the same symptoms as the first dose: chills, body aches. headache, pain at the injection site, fatigue. It lasted for about 3-4 days. Now, I stared with bloody stools with my first dose and it never really resolved before I got the second dose. I noticed it increased the frequency, made it a little worse after the second dose. They were not so frequent anymore. I still have blood in my stool at least 2 times a week.
Case number PHEH2012US021245 is an initial spontaneous report received from a medical assistant on 10 Oct 2012. This case refers to multiple patients (3 patients). There were total five patients who were vaccinated with MENVEO (batch number: not reported) on unspecified dates. Three out of these five patients received only the lyophilize powder A with a sterile diluent. It was not known which of these five patients received only the lyophilized powder component of MENVEO. No other information was available.
a patient received their first dose of Twinrix in December; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received 13th December 2021).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-Jun-2022 Reporter's Comments: Pharmacist stated that a patient received their first dose of Twinrix in December. The reporter consented to follow up via postal. Additional Supportive: Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
pt recv vax 15AUG97 or 16UAG97 & 1997 pt devel varicella w/many lesions although less than 50 on the upper trunk, face & arms;
Initial report received on 22 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3954AB received on 14 July 2011, lot number C3953AA received on 16 September 2011 and lot number C3953AA received on 17 November 2011 (routes and sites of administration not reported). The subject developed a cough on 15 May 2012 and paroxysmal cough (without whoop) on 18 May 2012, approximately six months after the last dose. Laboratory testing included positive PCR on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 12 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Ache and muscle pain in shoulder and right leg, between thigh and knee, after the second vaccine; Ache and muscle pain in shoulder and right leg, between thigh and knee, after the second vaccine; Ache and muscle pain in shoulder and right leg, between thigh and knee, after the second vaccine; Red bump at injection site, right arm, after second vaccine; Red bump at injection site, right arm, after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Thought he had Covid, loss of some taste, test was not positive or negative, never confirmed, after first vaccine, ), administration date: 09Aug2021, when the patient was 67 years old, for Covid-19 immunization, reaction(s): "loss of some taste", "Thought he had Covid". The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 31Aug2021 02:00, outcome "recovered" (01Sep2021) and all described as "Ache and muscle pain in shoulder and right leg, between thigh and knee, after the second vaccine"; VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Red bump at injection site, right arm, after second vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states he is feeling good right now, and he didn't go to a hospital or a doctor. Red bump at injection site, right arm, after second vaccine: Multiple reclarifications with Caller, Caller states after the second vaccine, 2 or 3 days after. Time: morning. End: within 24 hours of when the bump first appeared.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
R thigh swelling, redness and serious fluid discharge from injection site (Bio-Jet). Black circles also present.
patient stopped getting them when they made me sick; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (consumer) on 08-Dec-2020.  This case involved patient with unknown demographic, who experienced patient stopped getting them when they made me sick (Illness), while patient received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On unknown date, the patient developed a non-serious patient stopped getting them when they made me sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.  There will be no information available on the batch number for this case.
Pt fainted after 2nd Pfizer injection.  Pt fell from chair, resulting in a minor injury to his right knee. BP was taken and found to be low (96/54). He was given ice packs until symptoms resolved.
Allodynia of right side of face and neck Trigemminal distribution in addition to neck and back of head and ear lobe
Painful sores (Psoriasis like) inside mouth; Painful sores (Psoriasis like) inside mouth; Painful sores (Psoriasis like) on tongue.; Painful sores (Psoriasis like) on tongue.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) in the right arm on 21Mar2021 at 18:00 (at the age of 61-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) in the left arm on 11Apr2021 at 18:00 (at the age of 61-years-old); both as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) , ezetimibe (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient experienced painful sores (Psoriasis like) inside mouth and on tongue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event painful sores (Psoriasis like) inside mouth and on tongue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
On 12/18/00, pt received TD vaccine and on 12/19/00 he started having migraines, dizziness, sides of head to back of neck, after sneezing.
Fluzone High-Dose was given to a 28 year old that was 22 weeks pregnant/ No AE; Fluzone High-Dose was given to a 28 year old that was 22 weeks pregnant/ No AE; Fluzone High-Dose was given to a 28 year old that was 22 weeks pregnant/ No AE; Fluzone High-Dose was given to a 28 year old that was 22 weeks pregnant/ No AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 28 years old female patient who received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ238AB, Expiry date-14-Apr-2020 via intramuscular route in the left arm, while she was 22 weeks pregnant on 06-Sep-2019.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine exposure during pregnancy. The patient was 22 weeks pregnant when she received vaccine.  It was also the case of actual medication error due to inappropriate age at vaccine administration, product use in unapproved population and overdose.  At the time of report, no adverse event was reported.  Pregnancy outcome was unknown at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Left arm is swollen, irritated and there is a large red spot several inches in diameter.  This happened about a week after initial dose. Have had this irritation for about 2 days.
Three weeks post vax the patient developed an acne-like breakout on her face and neck. The lesions were described as small, vesicular and initially pruritic but quickly healed over and ceased to itch. They appeared in blotchy patches and she has had a total of about 25 to 30 lesions which appeared in clusters of ten about once a week starting three weeks post vax. They appear and resolve within a few days. The patient has no other complaints or discomfort. Additional information has been requested.
Administered H1N1 Flu Mist at 10 am - developed wheeze after  administration.