chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakout in fever blisters all over my mouth; usually happens when my body is under stress like that; local tenderness; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot EL3249), via an unspecified route of administration, on 12Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization.The facility where COVID-19 vaccine was administered was at a hospital.  Medical history included pain and anxiety depression from an unknown date and unknown if ongoing.  Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL]) for pain and desvenlafaxine succinate (PRISTIQ) for anxiety and depression.  On Jan2021, the patient experienced local tenderness and on 18Jan2021, the patient experienced breakout in fever blisters all over her mouth, stating this usually happens when her body is under stress like that. Therapeutic measures were taken as a result of local tenderness and breakout in fever blisters all over my mouth (anti-fever blister type medicine). The clinical outcome of the events fever blisters all over her mouth and local tenderness were unknown.  No follow-up attempts are possible. No further information is expected.
Vaccinated a pediatric patient; A spontaneous report was received from a healthcare professional concerning a 17 year old pediatric patient who received Moderna's COVID-19 vaccine (mRNA-1273) accidently.  No relevant medical history is provided. No relevant concomitant medications were provided.  On 19 Feb 2021, prior to the onset of the events, the patient received there first of two planned doses of mRNA-1273 (batch: unknown) for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event vaccinated to pediatric patient was resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration for mRNA-1273, lot # unknown, with no associated AEs.
During injection into upper left arm, I felt a twinge or two in my forearm. I waited for my boyfriend to finish his vaccination and then we walked around the Pharmacy to shop. After about 30 or 40 minutes I progressively got more and more shaky, and felt like I was going to pass out. My heart was racing, I felt very clammy, and my limbs and bottom half of my face felt numb/tingly almost as if they were vibrating. At the injection site on my arm, sharp hot stings pulsed on and off again for about an hour and I noticed the tiny pin prick that it left was gray/black in color. I had difficulty making sense of anything or focusing for the rest of the day. The vaccine went in my left arm but both my left AND right arms, specifically shoulders/upper, were incredibly sore to the point I couldn?t lift them without discomfort. I received the first dose at 12 noon on 8/3/21 and by 4:00 a.m. on 8/4, I was feeling a little better. I slept all day 8/4 (7am-6pm) and when I woke up I felt fine other than moderate all over body aches and soreness and some minimal swelling and tightness and localized pain around injection site.
No adverse event; Patient administered vaccine after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date).    This case contains information for the 2nd of 4 child patients described by the reporter.  No concomitant information was reported.  No symptoms reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704265 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704265:Master case - 1st child
Approx 1 hour after receiving first dose of Moderna patient reported itching and tingling at neck, scalp, eyebrows, and bilateral forearms. Reports right wrist swelling and and bilateral hand swelling.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-APR-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-SEP-2015, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX, prednisone, and ibuprofen for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
mom states pt was seen in ER 2nd day p/vax; had temp 104 R w/shaking & jerking of extremities; unsure if related to prev immun
Fever 101 for 24 hours Whole body aches 24 hours Headache 48 hours
Mild headache, muscle ache, joint ache,low grade fever 99.9 lasting as of now 2 days, chills.
tingling in her legs and arms/ tingling in the feet; severe burning in her legs and arms; arm pain; headache; myalgias; This is a spontaneous report from a contactable physician. A 64-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included mechanical valve, atrial fibrillation. No known allergies. There was concomitant medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On day 1-3 (13Jan2021), the patient had arm pain, headache, myalgias, then day 4 felt better and on day 5-7 (17Jan2021) developed tingling and severe burning in her legs and arms, that gradually improved to only included tingling in the feet at this date 7 day after injection. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.   Information on the lot/batch number has been requested.
No further information.; had a dose of MMR and 1stof VARIVAX on 20Jul2016; This spontaneous report was received from an other, referring to a 12-month-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 20-JUL-2016, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status of rHA (recombinant Human albumin), 0.5 ml 1 time, strength, vaccination scheme, route of administration, anatomical site of vaccination were not provided, lot # L041456) and first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml 1 time, strength, vaccination scheme, route of administration, anatomical site of vaccination were not provided, lot # M006726, expiration date was not reported, but upon internal validation established as 08-FEB-2018) for prophylaxis (inappropriate schedule of product administration). On 07-JUL-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) albumin status of rHA (recombinant Human albumin), 0.5 ml 1 time, strength, vaccination scheme, route of administration, anatomical site of vaccination were not provided, lot # S013713, expiration date 01-NOV-2020) for prophylaxis. On 09-JUN-2021, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml 1 time, strength, vaccination scheme, route of administration, anatomical site of vaccination were not provided, lot # T025945, expiration date 20-JUL-2022) for prophylaxis. No other adverse event as a result of the vaccine administrations.
The patient was seated and given a dose of the covid 19 vaccine from jansen. About 10 seconds after administration the patient stated he was feeling light headed then passed out cold. He was supported in the chair for approximately 45 seconds until he regained consciousness . He was very weak and was then placed on the floor and 911 was called. After their evaluation he was determined to be ok. His father picked him up for transport home.
Localized rashes at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date unknown) for prophylaxis.   On 2nd August 2019, the patient received Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional information received were as follows: The patient experienced localized rashes at injection site and when she reported it was 4 by 4 inches.
Pain; Swelling; Fatigue; Vaccination site pain/Tender arm and pain/sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/Tender arm and pain/sore) in an adult 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 Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain), SWELLING (Swelling), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/Tender arm and pain/sore). At the time of the report, PAIN (Pain), SWELLING (Swelling), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/Tender arm and pain/sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Initial unsolicited report received from a physician on 20 May 2015. A 59-year-old female patient, whose medical history was reported as none and whose concomitant medication were not reported had received an intramuscular first dose of IMOVAX (batch number, expiration date, dose and site of administration were not reported), dose of TYPHIM VI (batch number, expiration date, dose, dose cycle and site of administration were not reported), intramuscular first dose of IPOL (batch number, expiration date, dose and site of administration were not reported) and dose of ADACEL (batch number, expiration date, dose, dose cycle and site of administration were not reported) on an unspecified date. The patient had received first dose of Yellow Fever vaccine (batch number, expiration date, dose and site of administration were not reported) intramuscularly seven to ten days ago on an unspecified date. Patient had also received Hep A (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) within four weeks timeframe, on an unspecified date. Patient's any pre-existing physician diagnosed allergies, birth defects and medical conditions, illness at the time of vaccination were reported as none. Patient had not received any previous dose of Yellow Fever, IMOVAX and IPOL vaccines. Two weeks ago on an unspecified date, patient had a cut to her leg and it became cellulitis. Patient required treatment in the emergency room where she had a shot of Clindamycin and was given 7 days of oral pills. Reporter saw the patient about 4 days ago and noted a rash which he felt might be due to an allergy to clindamycin and not taking the last few pills. After 4 days the rash did not improve and patient was referred to a Dermatologist who diagnosed her with psoriasiform rash and wanted to start her on STELERA and was not sure if it was due to stress but could not rule out all the vaccines. Laboratory investigation was reported as none provided. At the time of this report, outcome of the event was not resolved. Upon medical review, company assessed the event of had a cut to her leg and it became a cellulitis as serious and important medical event. List of the documents held by sender: none.
This spontaneous report as received from a physician via company representative refers to a 71 year old female patient. In approximately Jun 2007 ("in mid 2007"), the patient was vaccinated with ZOSTAVAX (lot number was not reported), single dose 0.65 ml, once subcutaneous injection. Concomitant therapies included VALTREX. In approximately Jun 2007 ("in mid 2007"), the patient experienced lower trunk pain and "shingle like symptoms" since her ZOSTAVAX injection in mid-2007. The patient stated that the pain was not as bad in the past two days. No treatment was received for the events. On 28-MAY-2013 (two days ago), the patient was diagnosed with colon cancer and was receiving chemotherapy. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered from the events. Upon internal review colon cancer was considered to be medically significant. Additional information has been requested.
woke up a couple of nights with perspirations soaked undershirt, but no fever and nothing; woke up a couple of nights; bilateral ears are ringing/ had tinnitus in the past, it was stabilized and realized, this caused it to be aggravated / mild humming; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 27Feb2021, outcome "unknown", described as "bilateral ears are ringing/ had tinnitus in the past, it was stabilized and realized, this caused it to be aggravated / mild humming"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "woke up a couple of nights with perspirations soaked undershirt, but no fever and nothing"; MIDDLE INSOMNIA (non-serious), outcome "unknown", described as "woke up a couple of nights". Additional information: The age of the patient was reported as: Age:71, Unit: Unknown. The patient wanted to know if event ears were ringing was a normal side effect and if he should get the second dose. It was reported that the first dose caused mild humming and patient was worried the second dose may cause a worsened effect. Event was also described as: the tinnitus came from sound, the patient used to work with sheet metal, even noise can cause it to become aggravated. The patient stated that he doesn't know how Pfizer could have overlooked this, nothing mentioned in the data that this was something to consider. He wouldn't have taken Pfizer; he would have taken this can qualify for long term disability. People need to be told about this. He can tell right away that the vaccine caused it, it had to be the vaccine. Tinnitus was disabling, he may have to pursue disability. The patient was querying on how long it was going last and said that he has read online or maybe in the news that 40% of people who had the vaccine it created it or made it worse. Patient also said that he has read that Moderna, it does not do that; and said that the problem was, you don't have all of the data, you need to have some idea of what to take or what to do.  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 lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 09-OCT-2012, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 15-DEC-2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 18 hrs after receiving SHINGRIX, the patient experienced pruritus. On 20th August 2018, the patient experienced pain in arm and influenza like illness. The patient was treated with paracetamol (Tylenol) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus and pain in arm were not recovered/not resolved and the outcome of the influenza like illness was unknown. It was unknown if the reporter considered the pruritus, pain in arm and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: In the morning, around 10:30 AM, the patient received SHINGRIX on left arm. Less than a day after receiving SHINGRIX, the patient arm hurt the first day and then got bad and her arm was still sore to the touch. Less than a week after receiving SHINGRIX, the patient felt like flu and received Tylenol. Around 6:00 pm on Tuesday, the patient experienced itching. Two days later, the patient had an incredible itch on the palms of her hands and the soles of her feet. The patient was still taking Benadryl and the itching had not resolved. This is 1 of the 4 linked cases reported by the same reporter.
hard knot @ inj site onset 2 days p/vax;blotchy rash located around rt leg where inj given-spreading to belly button & onto back & abd-3 days p/vax;tx w/DPH elixir;
temp to 104 w/in 24hr to DTP;moaning, irritable;
Here for Kindergarten Immunizations. Approximately 5 minutes after immunization received patient stood up and fell to the ground. Patient landed anterior and made an arch position was some eye fluttering noted briefly and while holding shoulders no seizure like activity noted. Lasted about 30 sec. then patient started to answer question but still extremely confused. Mom picked child up. Mom was obviously very nervous and scared. Patients Pupils Equal and reactive to light right after incident. Had patient squeeze my hands, push feet against my hands then pull feet towards my hands. Patients strength equal bilaterally in all extremities. After mom and patient calmed down patient was able to tell us where he was "Doctors Office", Asked who was holding him he said "My Mom", Asked him what sport we were talking about before the incident and he said baseball which was correct. Patient denies any pain anywhere at this time besides where he received his shots. Head palpated no bumps or lacerations noted to head. While assessing patient head he denies any painful areas. Explained to mom that things like this occasionally happen. Mom still extremely nervous. Told her if it would make her feel better to take him to a doctor to have him checked out I think that would ease her mind a little. Pupils checked prior to leaving and remain equal and reactive to light. Patient did not want to walk so mom carried him out of the office. Advised mom to keep us updated on patient and that if the doctor had any questions about the incident to give me a call. All of mom's questions answered as best as they could be. Assessment and Plan. Create Assessment Group.
Pt received 1st dose of Moderna at community pharmacy, within 7 minutes developed dyspnea with stridor.  Received epinephrine, methylprednisolone, and diphenhydramine by EMS then transported to MMC emergency department for additional treatment.
COVID-19 Vaccine (Pfizer)  EL3302  Exo 05/21.  Itching and redness (flushing) on chest, stomach, legs occurring 10 minutes after receiving vaccine.  Face was flushed red no itching. Initial BP 152/99  HR 84.  Benadryl 50 mg PO and famotidine 20 mg PO administered.  Patient reports similar reaction following the first dose of the vaccine - COVID-19 Vaccine (Pfizer)  EL0140 Exp 03/21; itching resolved without medication the first time.  Patient reports that this reaction is slightly worse than previous reaction to the first dose.  At 3:48pm, BP 151/87  HR 82  O2=96%.    Patient itching and redness on chest and flushing of face dissipating by 3:45pm.  Patient clinically stable.  Patient dismissed from clinic at 3:54pm.