chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm soreness at injection site; left neck swollen lymph nodes; left arm hot at injection site; left arm swollen at injection site; left arm hard at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (left arm soreness at injection site), INJECTION SITE SWELLING (left arm swollen at injection site), INJECTION SITE INDURATION (left arm hard at injection site), SWELLING (left neck swollen lymph nodes) and INJECTION SITE WARMTH (left arm hot at injection site) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ISOSORBIDE MONONITRATE, CLOPIDOGREL, CARVEDILOL, GABAPENTIN, ROSUVASTATIN, RANOLAZINE (RANEXA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and SERTRALINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE SWELLING (left arm swollen at injection site), INJECTION SITE INDURATION (left arm hard at injection site) and INJECTION SITE WARMTH (left arm hot at injection site). On 05-Feb-2021, the patient experienced SWELLING (left neck swollen lymph nodes). On 26-Feb-2021, the patient experienced INJECTION SITE PAIN (left arm soreness at injection site). At the time of the report, INJECTION SITE PAIN (left arm soreness at injection site), INJECTION SITE SWELLING (left arm swollen at injection site), INJECTION SITE INDURATION (left arm hard at injection site), SWELLING (left neck swollen lymph nodes) and INJECTION SITE WARMTH (left arm hot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided
30 minutes after injection, throat felt scratchy.   45 minutes after injection, roof of mouth felt swollen.  Then lips were numb.  Felt it was allergic reaction and took Claritin which helped a bit.  Then took Benedryl 25 mg. which seems to help further.  Took at 5PM and 9PM. Saw the doctor the next  morning  (2/5) and he prescribed methylPrednisolone to take PRN.  That evening, throat and roof of mouth felt a bit swollen so I took both Benedryl and prednisone.   2/6 Felt fine all day until about 9:30pm, felt hot and a bit  of nausea.  Again took Benedryl and prednisone.  2/7, this morning, feeling very tired but no allergy symptoms.  All vitals were normal this whole time.
TOOK THIRD DOSE OF VIVOTIF 3 DAYS LATER; This spontaneous case report was received from a pharmacist (PVX2019-470) on 20-Feb-2019. The report describes an adult male consumer who "took third dose of Vivotif 3 days later". The consumer was receiving oral Vivotif capsule (one dose every other day) (lot number: 3003239) for typhoid prophylaxis.   It was reported that the consumer took Vivotif doses incorrectly. The doses were taken on 12-Feb-2019, 14-Feb-2019, 18-Feb-2019, and 20-Feb-2019, respectively.  The action taken with Vivotif with respect to the event "took third dose of Vivotif 3 days later" was not applicable.  The clinical outcome of the event "took third dose of Vivotif 3 days later" was unknown.  Company's Comment: The causality of the event "took third dose of Vivotif 3 days later" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose of Vivotif 3 days later" was considered as not applicable.
Client received the 1st Pfizer COVID vaccine  (lot # EW0162 and expiration date: 4/18/21) at 10:11am. Client reported numbness in left arm at 10:26am to EMT. Vitals were taken at 10:28am oxygen: 100%, Blood pressure:120/80 and pulse:58.  Both Nurses responded to find client alert and oriented x 4. Client reports numbness is localized from injection site to forearm of left arm where injection site is.  Client has full mobility and sensation in left arm. Client had already waited 15 minutes, so advised waiting another 15 minutes and since vitals are WNL will get another set of vitals after 15 minutes. At 10:43am retake vitals: pulse: 65, blood pressure: 120/80 and oxygen: 100% and client reports that all symptoms completely resolved. Provided client with ER precautions and do advise primary care provider. At 10:44am client left facility with a steady gait.
pt recv vax 20JAN97 & 3 days post vax pt exp inflammation of the brain & ataxia;
Pain at injection site, severe stomach pain and dieherria 12 hours after injection for about one hour
A report has been received from a Pharmacist concerning a 4 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter reported that patient received one half dose of FLUMIST which started on 15-Oct-2013. The outcome of the event of patient received one half dose of FLUMIST is unknown. The report was considered to be non-serious.
Patient skin raised and red at injection site (left arm). Event started about 4 days after receiving vaccine. No fever or pain reported. Warm to the touch as per patient.
Pt reports 20 days later renewed soreness in left arm that pt got shot in, as well as itching all over and upset stomach. These resolved within the day.
This spontaneous report was received from a registered nurse and refers to a 14 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 25-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 14 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
After we left the vaccine site, I felt like my heart was racing and it continued for the rest of that night. I tried relaxing and laying down but the feeling wouldn?t go away. The next morning I woke up with a terrible headache and feeling nauseous. I had diarrhea, and I felt exhausted. I was on the couch most of the day. Later that day, I took my temperature and realized I had a fever. I took some Tylenol and felt fine when I woke up the following morning.  I was approximately 3 months pregnant at the time and f vaccination. My due date is September 17.
headache; Pimple on right breast; achiness; This is a spontaneous report from a contactable consumer (patient herself).  A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm on 04Feb2021 at 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021, at about 4PM, then that night in the evening the patient had a couple reactions from the first dose. The patient stated that she was achy and had a headache. The patient stated that her achiness was not bad at all, and she had gone through much worse and stated that achiness lasted for just one evening. The patient was not sure whether she had last effects of it or if she was just old. The patient also stated that she experienced her headache prior to the first dose and she actually has a light headache almost everyday. On 16Feb2021, the patient had a sort of broke out, like there was a pimple on the breast. The patient stated that it is just one pimple and it has the size of a nickel.  The patient stated that the pimple was on her right breast and she put some salve on it. She was scheduled to take the second shot on 25Feb2021 but she couldnot get through it and was supposed to get it next week. The patient wanted to know whether she was late in getting the second shot. The outcome of the events was resolved achiness, while the patient had not recovered from the events of for headache and pimple on right breast.  No follow-up attempts are possible. No further information is expected.
Symptoms from second vaccine lasting 24 hours: chills, fatigue, headache, muscle and joint pain Symptoms continuing to present: shortness of breath, dizziness, fatigue, hunger, shakiness, weakness
Severe malaise, fatigue, poor concentration, head and neck ache, myalgia, rhinorrhea, deep cough, chest pain, progressively worsening over a course of a week with development of burning nerve root pain to right upper chest, axilla, and right scapular region consistent with onset of shingles.
Urticaria.  Located at thorax , legs , axilla. Redness in face.   50mg shot of Benadryl  10 mg shot of dexamethazone Pepsin  Currently resolving
Severe hives all over her body, Lip and tongue swollen. Went to urgent care and pcp. They gave her 2 steroids injections and an epipen
pfizer sent out an email for a recall for this vaccine because it was short dated but did not know about it and it was administered to pt
I was diagnosed with left ventricular non compaction disease a month after vaccination. Doctors said at first could be virus that attacked the heart but I never had covid in the last year or the flu tested for covid multiple times for my job never was positive. Then after the mri they said it was a genetic disease but after genetic testing came back no results or proof it was from genetics . The Doctors have no answers and the only other thing it could be is the vaccine and the reaction I had to it attacked my heart.
90% blockage of her heart; shortness of breath; tired when she walks; A spontaneous report was received on 2 Feb 2021, from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 90% blockage of her heart, tired when she walks, and shortness of breath.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient is scheduled for second dose.  On an unknown date, the patient experienced events, 90% blockage of her heart, tired when she walks, and shortness of breath.  Treatment details not provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include 90% blockage of her heart, tired when she walks, and shortness of breath were 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 the events, a causal relationship cannot be excluded
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received SHINGRIX. On 18th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fever, joint pain and nausea. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the fever, joint pain and nausea were recovered/resolved. It was unknown if the reporter considered the pain in arm, fever, joint pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The batch number and expiry date were not reported. Within one day after receiving SHINGRIX, the patient experienced soreness in arm, nausea, joint aches, joint pain and a low grade fever. In September 2018, nausea, joint aches, joint pain and a low grade fever were resolved. Health care professional was not able to provide any further details on the SHINGRIX product administered. Event onset date of low grade fever, joint ache/joint pain and nausea were reported as 19th September 2018 (with latency of 1 day), clarification has been raised for the confirmation of latency.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 33-year-old female patient who received Rabies Vaccine for prophylaxis. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced injection site pain, joint pain and migraine. On an unknown date, the outcome of the injection site pain, joint pain and migraine were unknown. It was unknown if the reporter considered the injection site pain, joint pain and migraine to be related to Rabies Vaccine. Additional details were provided as follows: The reporter reported this case for someone she knew. The age at vaccination was not reported. The reporter was not sure of the brand of the rabies vaccine that the patient received, so she was not sure whether it was definitely GlaxoSmithKline's vaccine.
Burning at injection site/Burning on injected arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Burning at injection site/Burning on injected arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Burning at injection site/Burning on injected arm). At the time of the report, VACCINATION SITE PAIN (Burning at injection site/Burning on injected arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient received 2nd Moderna Vaccine ~28 days from 1st Vaccination and 2nd Vaccine did not hurt, had no symptoms.
I got headache, fever, vomitting , rash all over body. got symptoms after taking the covid-19 vaccine.
Initial unsolicited report received from a non-health care professional on 03 Nov 2016. This case involve three patients (gender and age not reported) who were vaccinated with a dose of Fluzone ID QIV (Batch number: UT5572BA, expiration date: 30 Jun 2017, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Illness at the time of vaccination was also not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified timeframe following the vaccination, the patients had developed red, inflammed, itchy, painful, area at injection site with lump noted at injection site. Laboratory investigations and corrective treatment were not reported. The outcome of events was recovering (reported as after 4 days symptoms began to resolve). List of documents held by sender: none.
Systemic: Had behind the arm, through the armpit and side. and throughout arm. thinking maybe the radial nerve was hit-Medium
chills & uncontrollable shivering for a few hours beginning 9:15am, headache (still feeling it next day at lunchtime), joint pain (every joint in my body aches), shortness of breath, fatigue,
Diagnosed with Bullous Pemphigoid; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGOID (Diagnosed with Bullous Pemphigoid) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Autoimmune disease).    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced PEMPHIGOID (Diagnosed with Bullous Pemphigoid) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (Diagnosed with Bullous Pemphigoid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2022, Biopsy: abnormal (abnormal) A biopsy done and patient was diagnosed with Bullous Pemphigoid.     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.   No concomitant medications were reported.  Patient had tried Steroids and Antirejection medications. Now they were thinking of giving patient a chemo. Patient does not have cancer but an autoimmune disease.  Company comment: This case concerns a 84-year-old male patient with concurrent medical condition of autoimmune disease, who experienced the serious (seriousness medically significant) unexpected event of Pemphigoid. The event occurred 1 year 1 month 2 days after the dose of mRNA-1273 vaccine. At the time of the report, outcome of the event was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-390433.; Sender's Comments: This case concerns a 84-year-old male patient with concurrent medical condition of autoimmune disease, who experienced the serious (seriousness medically significant) unexpected event of Pemphigoid. The event occurred 1 year 1 month 2 days after the dose of mRNA-1273 vaccine. At the time of the report, outcome of the event was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
5mo old child experienced fever of 104-105 p/HIB-TITER was administered;
This case was reported by a consumer and described the occurrence of autism in a child male subject who was vaccinated with Dtpa (manufacturer unspecified).  A physician or other health care professional has not verified this report.  The subject received concurrent vaccinations that were not specified.  On an unspecified date the subject received unspecified dose of Dtpa (unknown).  At an unspecified time after vaccination with Dtpa, the subject was diagnosed with autism.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the event was unspecified.  It was reported that this event occurred in five of the consumers children, three boys and two girls.  This case A0725679A serves as the master case and the other case numbers are A0725685A, A0725686A, A0725687A and A0725688A.
This report describes headaches in a female vaccinee of unspecified age who received Lyme disease vaccine recombinant OspA (Lymerix). It was received from the vaccinee's husband and has not verified by a physician or other healthcare professional.  Medical history, concurrent conditions and concurrent medications were not specified. In October, 1999, the vaccinee received her second injection of Lymerix. Subsequently, she experienced headaches and neck stiffness which persisted as of 04/02/02. The adverse event 'headache' does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
At 1230 am I awoke with a  fever of102 and chills which lasted for 3 hours.  Both times I got the vaccine I felt extreme pain at the injection site for several days and a rash below.
overnight he gained over 25 pounds; lot of pain on his body and problems; his hair hurts; swelled up; This is a spontaneous report from a contactable consumer or other non HCP. A 84-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: not reported), via an unspecified route of administration on 09Mar2021 (at the age of 84-Years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported and concomitant medications were not reported. The patient experienced overnight he gained over 25 pounds, lot of pain and problems on his body, his hair hurts and swelled up on an unspecified date. Adverse event gained over 25 pounds was considered as serious with seriousness criteria of medically significant and remaining event were considered as non-serious. Adverse events was resulted in emergency room visit. The patient underwent lab tests and procedures which included weight: 25 lbs. on an unspecified date. Therapeutic measures were taken as a result of overnight he gained over 25 pounds, lot of pain on his body, his hair hurts and swelled up included IV fluids. The outcome of the events were reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Shortly after going to bed I felt a discomfort in the upper right side of the ribs. During the night and into Sunday the discomfort became more acute and spread to under the rib cage on the right side. I tried lemon water as a way of detoxing. I tried ice on the area to decrease inflamation as it felt like my liver/gall bladder area was swollen. When that failed I contacted my doctor who order blood work and a sonogram. To this point the tests are OK.
My face became swollen 10days after the shot. I couldn't recognize my features. It look like a red burn. It swell every month. My face became very hot. I started taking hydroxyzine cream and prednisone.
Information has been received from a physician concerning a 57 year old female with a history of metastatic colo-rectal carcinoma and no drug allergies, who on 05-FEB-2008 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). Within 24 hours post vaccination the patient experienced a 103 degree fever. The patient developed an area of 3cm of swelling at the injection site and a "non-purpuric macular papular" rash all over her body except the face. The patient was seen by the physician. No laboratory diagnostics were performed. It was reported by the physician that the patient started to feel better. The fever was slowly fading, the rash was improving, and the injection site swelling was coming down. No therapeutic treatment was given to the patient. The physician reported that this was a severe reaction and that he was going to contact the patient later that day to see how she was doing. At the time of the report, the patient was recovering. No product quality complaint was involved. The physician believed the high fever, rash, and injection site swelling to be related to the vaccination with pneumococcal 23v polysaccharide vaccine. The physician considered the high fever and rash to be disabling. Additional information has been requested.
started with a mild headache on 10/7/07 around noon and progressively getting worse toward the end of the day. At around 6:30 PM, headache is worse (splitting/throbbing) and had 2 episodes of vomiting. Have to get home early and not finish work that day. Took ZOFRAN ODT at 7PM vomiting / Took Advil migraine at 7:30 p.m - Headache better at around 12 p.m.
A non-serious spontaneous report of GENERLIZED RASH as been received from a nurse concerning a 13-year-old male subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. The patient received FLUMIST vaccine on 21-Aug-2008. Two and a half hours after receiving FLUMIST vaccine, the patient developed rash described as covering the entire body except the hands and soles of the feet. The rash was aggravated by heat and is relieved by BENADRYL. At the time of the report, the event has not resolved and the rash was reported to be "still waxing and waning".
Two weeks after receiving the vaccine, I started noticing nerve pain in my left arm. The next day I had a few red blisters on my arm, which began to spread along my arm over the next couple of days. I then went to the doctor on a Friday (18 days after receiving the vaccine), and he diagnosed me with Shingles and I was started on Valtrex and gabapentin.