chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes Zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or around 23-AUG-2012, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live(ZOSTAVAX) Plaintiff suffered severe pain and blisters and was diagnosed with Herpes Zoster. As a direct and proximate result  of defective zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff's symptoms had resulted in physical limitations not present prior to using the product. Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of  zoster vaccine live(ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The lawyer considered shingles, and other zoster-related conditions to be related to zoster vaccine live(ZOSTAVAX).  The lawyer considered the events to be disabling.
Patient experienced a "taste" in her mouth and a feeling of swelling at the back of her mouth/top of her throat.
No adverse event or signs symptoms at time of vaccination or after. Was given Flublok influenza vaccine prior to age 18.
Patient reported "severe hives" that came on several hours after the injection. They were on the backs of her thighs, on her stomach, and neck. She reported feeling dizzy, nauseated, and light headed. She took 50 mg of Benadryl and the hives went away but the feeling of dizziness and nausea persists even 24 hours later.
Patient complained on 4/9/2021: After getting 2nd dose she had normal rxn of fever and soreness at the site  and exhaustion.  After few days fever and soreness subsided but still feels exhausted and sleeps for long hours even in am and afternoon.  Her PCP asked her to get thyroid levels checked.  Patient thyroid levels had depleted significantly as if she had stopped taking her levothyroxine.
Patient experienced fever, diarrhea and dizziness later in the evening on the day of her vaccinations.  She visited an urgent care clinic on 9/1/2023 since her symptoms did not improve.  The nurse practitioner on duty told the patient she was having a reaction to the RSV vaccine.  She was treated and released and reported the incident to the pharmacy on 9/5/2023.
Janssen COVID-19 Vaccine EUA Shakiness, headache, muscle aches, fatigue. Started next morning and lasted 1.5  days. Nothing severe.
Patient called 11am next day after receiving vaccination, says fever of over 100, nausea, sore shoulder, body aches. Patient is taking tylenol right now. Also, this was his second Shingrix shot, first was in December 20, 2019, no reaction other than normal injection site pain.
seemed confused; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "seemed confused".  Additional information: The patient said that she had her 1st dose of the covid-19 vaccine the following week, and stated the she went to the vaccination site the on day of reporting morning to receive the second dose. The patient stated that no one was there and she was supposed to come back on the day of reporting for second vaccine and the patient seemed confused.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients received improperly stored doses of ROTATEQ oral liquid, orally, lot # L013206 with an expiration date of 29-JAN-2017 and lot # L033694 with an expiration date of 06-JUN-2017 (doses were not reported). No adverse effects were reported. Administered doses of vaccine underwent the temperature excursion of 9 degrees Celsius for 30 minutes which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014075: US-009507513-1701USA014062: US-009507513-1701USA003654.
Left arm was extremely painful; Pain on his left arm up and down and that is getting worse; A spontaneous report was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain on his left arm up and down and that is getting worse and left arm was extremely painful.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011A21A) in the left arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient experienced the events pain on left arm up and down and that was getting worse. On 04 Mar 2021, left arm was extremely painful. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events pain on his left arm up and down and that is getting worse and left arm was extremely painful was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I had a mild headache beginning in the forehead shortly after the injection and it increased in intensity radiating to the left temple, along with moderate fatigue.  The headache persisted daily and I treated it with Tylenol 625mg every 8 hours.  The Tylenol reduced the severity to some degree, but  did not reduce the pain measurably. I contacted my PCP and they prescribed Butalacetamin/CF 50-325-40 every 4 hours. As of today I still have the same headache symptoms and have scheduled an in office visit for Tuesday 6/1. I have no other symptoms and honestly would not have associated it with the vaccine had it not occurred immediately following the administration.
Patient called to report a rash on her hands, arms, and chest that is red and stings. Patient noticed the rash approximately 90 minutes after receiving her vaccination. Denies any shortness of breath or swelling in the face or neck. Writer instructed patient to take Benadryl after verifying no known drug allergies and to call a health care provider, especially if rash does not improve. Spoke to patient 1/15 AM, and she states that the rash is improving but still there after taking Benadryl.
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
EE states that soon after had his intradermal flu vaccine left arm at site began to swell about size of a marble, hot to touch red, and painful which is to be expected after this type of flu vaccine.  He also states that even a month out when moves arm in a certain position that his left arm at flu vaccine site still hurts that he describes as deep and aching pain around the entire deltoid muscle.
Patient mistakenly  received the Janssen vaccine after previously receiving 2 doses of the Pfizer vaccine.
Pt recvd 1st dose of Hep B vax w/no noted problem; Pt recvd 2nd dose of vax 18AUG92 & w/in an hr following vax pt exp sore arm w/pain @ inject site; sx resolved w/in 24 hrs; No further details were provided;
Varicella diagnosed clinically today in office. Dad with shingles earlier this month. Patient S/P varicella vaccine x 1 (1-25-16).
Prolonged fever, leukocytosis; Prolonged fever, leukocytosis; This is a spontaneous report from a contactable physician.   An adult male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced prolonged fever, leukocytosis on Feb2021 with outcome of unknown.  The patient was hospitalized for prolonged fever and, leukocytosis for 7 days.  Treatment was unknown.  It was unknown if patient had COVID prior vaccination or if patient was COVID tested post vaccination.   Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  fever and leukocytosis  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including blood cultures and chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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
Admitted to Hospital for IV Antibiotics for Cellulitis at Site of vaccine. 2/19/08-records received for DOS 11/8-11/9/07-DX DC: cellulitis left ar. Day after receiving vaccine developed itching, swelling, redness and burning at the injection site. Blister like lesion on arm with clear yellowish drainage. Fever, nausea nad malaise.
Patient presented to the Health Department both on 09/07/2023 and 10/06/2023 with a I.D showing the birthdate of patient and without a shot record from out of the country. With this in mind, clerical staff did not find a IR for this information and treated the patient as having no shots. Patient presented and received shots on both dates before it was recognized there was another IR with the same birthdate which he indicated was correct. With this also in mind, he had presented a foreign shot record to "Global Health Department" that was not provided to our Health Department. With all of this said, patient received in total 2 MMR's, one IPV, and one hepatitis B that he did not need.
No adverse event; Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021); Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021); 2nd dose was Moderna Covid-19 booster (monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), COVID-19 IMMUNISATION (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), WRONG PRODUCT ADMINISTERED (2nd dose was Moderna Covid-19 booster (monovalent)) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (1st dose) on 05-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 02-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), COVID-19 IMMUNISATION (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)) and WRONG PRODUCT ADMINISTERED (2nd dose was Moderna Covid-19 booster (monovalent)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), COVID-19 IMMUNISATION (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), WRONG PRODUCT ADMINISTERED (2nd dose was Moderna Covid-19 booster (monovalent)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), COVID-19 IMMUNISATION (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)) and WRONG PRODUCT ADMINISTERED (2nd dose was Moderna Covid-19 booster (monovalent)).    No concomitant medications were reported.  No treatment medications were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm and on 13Apr2021 as dose 2, single (Lot number: ER8731) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Nov2021 as dose 3 (booster), single (Lot number: 035C2114), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported to be non serious, Seriousness criteria-Resulted in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. Reported about COVID treatment: Yes, No other medication were received in 2 weeks anti viral details: product=COVID 19 Treatment, It was reported that patient had Covid rebound 3 days after finishing Paxlovid. No treatment for adverse event recieved. Had no known allergies. Had no other medical history.  No follow-up attempts are possible. No further information is expected.
Reported "bug bites" to her left mid-axillary chest. The next day reported more bug bites in the same area. Looked like a line of bites. I became suspicious of shingles. The next day she complained that her shirt hurt her bug bites when it touched them. I called the doctor and scheduled an office visit.
On 5/18/07 was given vaccine at health center that evening mom states She was bathing baby & suddenly baby passed out, limped over, threw up mom states that baby turned blue and immediately called 911, when arrived baby was back and just fine is what paramedics stated so she did nothing else until she she came on 7/18/07 to see doctor
deep pain under her right breast as if she had received a blow there,which goes down to her stomach and passes to her back; pain at the injection site; right hand felt stiff in the mornings, she cannot open it well and it increased after the second dose; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (right hand felt stiff in the mornings, she cannot open it well and it increased after the second dose), MYALGIA (deep pain under her right breast as if she had received a blow there,which goes down to her stomach and passes to her back) and VACCINATION SITE PAIN (pain at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (right hand felt stiff in the mornings, she cannot open it well and it increased after the second dose) and VACCINATION SITE PAIN (pain at the injection site). On 14-Apr-2021, the patient experienced MYALGIA (deep pain under her right breast as if she had received a blow there,which goes down to her stomach and passes to her back). At the time of the report, MUSCULOSKELETAL STIFFNESS (right hand felt stiff in the mornings, she cannot open it well and it increased after the second dose), MYALGIA (deep pain under her right breast as if she had received a blow there,which goes down to her stomach and passes to her back) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicine included Arnica   This case was linked to MOD-2021-080150 (E2B Linked Report).; Sender's Comments:  MOD-2021-080150:1 st dose of vaccine
2/5/2023 In the morning I had a fever of 102.5, had body aches and just felt like Flu.  2/6 At Home COVID-19 test, positive.  After about 4 days, I woke up feeling much better.
Fast Heart Beat; Hot Sweats/Cold Sweats; Hands were shaking; allergic reaction; Did not feel like she could drive for 45 minutes post vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast Heart Beat), HYPERHIDROSIS (Hot Sweats/Cold Sweats), TREMOR (Hands were shaking), HYPERSENSITIVITY (allergic reaction) and FEELING ABNORMAL (Did not feel like she could drive for 45 minutes post vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEART RATE INCREASED (Fast Heart Beat), HYPERHIDROSIS (Hot Sweats/Cold Sweats), TREMOR (Hands were shaking), HYPERSENSITIVITY (allergic reaction) and FEELING ABNORMAL (Did not feel like she could drive for 45 minutes post vaccine). On 27-Mar-2021, HEART RATE INCREASED (Fast Heart Beat), HYPERHIDROSIS (Hot Sweats/Cold Sweats), TREMOR (Hands were shaking), HYPERSENSITIVITY (allergic reaction) and FEELING ABNORMAL (Did not feel like she could drive for 45 minutes post vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
rash  in dermatome T 7 , difficult to distinguish between contact dermatitis and Shingle at the time of presentation
Extreme fatigue Dizziness Whole body aches Chills Soreness on injection site all the way through arm
Rash appeared and was hot to the touch for a few hours, but has now disappeared. I have images for your records. I did not initially have a rash for either dose of the vaccine before this.
This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number LN9539, expiry date 7th December 2021) for prophylaxis. Previously administered products included Engerix B (received 1st dose on an unknown date).  On 16th August 2021, the patient received the 2nd dose of Engerix B adult 20 ug. On 16th August 2021, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown. Additional details were provided as follows: Pharmacist Manager called to report that a 19 year-old patient received Engerix-B 20 ug on his left arm, which led to overdose and inappropriate age at vaccine administration. The reporter consented to follow up.
The patient states after 15 minute wait time she felt like her heart was jumping out of her chest. She waited an extra 15 minutes before alerting stand-by EMS. The patient kept having what she described as palpitations for approximately 5 minutes. The patient requested transport to the ED for further evaluation.