chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching on his chest up to his hair and said it lasted for 20-25minutes.; sore arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on his chest up to his hair and said it lasted for 20-25minutes.) and PAIN IN EXTREMITY (sore arms) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (itching on his chest up to his hair and said it lasted for 20-25minutes.) and PAIN IN EXTREMITY (sore arms). On 28-Jan-2021, PRURITUS (itching on his chest up to his hair and said it lasted for 20-25minutes.) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. Treatment medications were not provided.
No additional AE or PQC reported.; Caller stated PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a licensed practical nurse (L.P.N.), referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 18-MAR-2022, the patient was administered with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), dose 0.5 mL, lot number U014483, expiration date was not provided but upon internal validation established as 15-SEP-2023 (route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) reported (no adverse event). No additional information was provided.  There were reported temperature excursions of the administered vaccine of 35.1 degrees Fahrenheit (F) for 4 hours 40 minutes, 35.2 F for 54 hours and 35.3 F for 30 minutes. There were no previous temperature excursions. It was not provided if digital data logger was involved.
Hard of hearing; Cold and shaky; Cold and shaky; I took my temperature, it was 99.9; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received 2nd dose of bnt162b2 (Pfizer COVID-19 Vaccine,Batch/Lot number was not reported),via an unspecified route of administration on 05Mar2021 as Dose 2,single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced hard of hearing, cold and shaky, temperature measured ,it was 99.9 on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: okay, body temperature: 99.9 on unspecified date. Consumer was unwilling to share further information, hence, product details  and other details were unknown. Limited information was available over the call. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A large 4 inch rash appeared after 9 days at the injection site of the right arm.
Sore throat, body ache, 99 temp highest, lost of taste and smell.  Was coughing sneezing and are still coughing. I tested positive on the 25 January.
Difficulty sleeping, general malaise, weak, disoriented, dizzy, fainted (8:30 AM), went to urgent care (3:00 PM), continued to feel ill and dizzy, nearly fainted again, tests ruled out UTI, heart, kidney and diabetes, discovered ear infection (hole in eardrum), prescribed antibiotic drops.
Patient  got first covid 19 pfizer adult vaccine on 11/5/21 and got another covid 19 adult pfizer vaccine and an influenze vaccine on 12/15/21, Patient didn't report any adverse events at time of administration
At injection site, normal administration pain and sensation of burning in arm. Within 24 hours of administration patient reached 101 fever and fatigue. Within 36 hours of administration, patient reached 103 fever and fell asleep. Upon waking the next day, patient had developed significant coughing and wheezing. On the second night, patient developed difficulty sleeping with continuous coughing and migraines hypothesized as aggravating factors. It is now ten 10 days after the vaccine administration and the patient still has significant coughing and a light fever which has been continuous since the 15th.
Left arm painful and inflamed since injection; could not lift arm above level of shoulder nor rotate arm; called PCP and was advised ice, ibuprofen and later added massage therapy.  Pain moved up arm and into shoulder by this time.  Massage therapy X 4-5 weeks with improvement but still having problems lifting arm or full range of motion.  Has improved but not returned to normal levels of activity at this time 1/15/2008.
Information has been received from a physician concerning a 6 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced mild breakthrough chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. The patient's sister (WAES 0603USA00508) had a similar experience after vaccination with varicella virus vaccine live (Oka/Merck). Additional information has been requested. Follow up information from the physician indicated that he did not remember the patient's name. He only knew that he had a kid who broke out wiht a few red bumps and might have had a mild case of breakthrough varicella. There were no cultures or blood tests done. The patient's sister (WAES 0603USA00508) had a similar experience after vaccination with VARIVAX (Merck). Additional information is not expected.
AE of muscle weakness and moderate discomfort (of arm) started 6/2/15 after injection with rash onset of 6/3/15 progressively worsening until today's visit with rash measuring 9.5 x 4.5 inches.
I received the shot at 9:00 AM and by 3:00 PM I felt hot and achy.  By 7:00 PM I had a fever of 102 and my joints were extremly sore.  I was shaking and could barely walk.  I had a terrible headache and was nauseous.  This was on Thursday.  The fever slowly dropped and abated by Saturday.  My normal teperature is about 96.  By Saturday I was back to 96 degrees and my joints were Ok by Monday.
pt recv vax;noted warmth induration and erythema over deltoid region of lt shoulder approx 10-12cm;
Information has been received from a  nurse concerning a patient (age and gender not reported) who was vaccinated (date of vaccination, site and route not reported) with PNEUMOVAX 23 (lot # not reported). The patient developed a fever, myalgia and redness at injection site post vaccination. It is unknown if the patient sought medical attention and if they recovered. Additional information is not expected.
Red itchy area around the injection site.  Area is larger than a quarter.  Patient visited PCP and they told her to ice.  Called pharmacy 9/21/2012 - patient told to use Tylenol for pain and Benadryl for itch. Cover the area.  Seek physician help in 48 hours if it is not better.  If it gets worse seek medical attention immediately.
Petechiae lesion developed on my wrist. It went away in about 3 days.
I had a bad reaction in my right arm.; On Saturday night , I noticed a swelling under my arm; On Friday I was on bed whole day / On Saturday I was on bed whole day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I had a bad reaction in my right arm.), ILLNESS (On Friday I was on bed whole day / On Saturday I was on bed whole day) and PERIPHERAL SWELLING (On Saturday night , I noticed a swelling under my arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced ILLNESS (On Friday I was on bed whole day / On Saturday I was on bed whole day). On 24-Apr-2021, the patient experienced PERIPHERAL SWELLING (On Saturday night , I noticed a swelling under my arm). On an unknown date, the patient experienced VACCINATION SITE REACTION (I had a bad reaction in my right arm.). The patient was treated with METHYLPREDNISOLONE ongoing since an unknown date for Swelling arm, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (I had a bad reaction in my right arm.) and ILLNESS (On Friday I was on bed whole day / On Saturday I was on bed whole day) outcome was unknown and PERIPHERAL SWELLING (On Saturday night , I noticed a swelling under my arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. treatment medicine include Methylprednisolone  Action taken with mRNA-1273 in response to the event was unknown
My son started having fever up to 38.5C and bad headache about 8-9 hours after he received the second dose of COVID vaccine; My son started having fever up to 38.5C and bad headache about 8-9 hours after he received the second dose of COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to shell fish" (unspecified if ongoing), notes: known allergies: allergic to shell fish. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious), PYREXIA (non-serious) all with onset May2021, outcome "recovered" (May2021) and all described as "My son started having fever up to 38.5C and bad headache about 8-9 hours after he received the second dose of COVID vaccine". The patient underwent the following laboratory tests and procedures: body temperature: (May2021) 38.5 c. Therapeutic measures were taken as a result of headache, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications in two weeks. The reporter said son started having fever up to 38.5C and bad headache about 8-9 hours after he received the second dose of COVID vaccine. He took Tylenol and slept about 12 hours. He felt better after the rest. Prior to vaccination, the patient was not diagnosed with COVID-19 Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received PREVNAR 13, via an unspecified route of administration in left arm on 18Sep2018 at single dose for immunization. Medical history was none. There were no concomitant medications. Tuesday on 18Sep2018, the patient received a dose in left arm and her left arm had been swollen, red, and hot to the touch ever since and the pain was deep in the muscle that hurts and bothers her when she was trying to sleep. Her heart rate was higher than usual, and her tummy was a bit off. She stated that when she went to pick up her kids from teen group someone noticed and said, wow do you have a bee sting your arm was red and swollen. She stated the warmth of her arm can still be felt through her shirt. The patient stated that her heart rate was higher than usual: Heart rate usually hovers around 61 maybe 62 and was pretty consistent. On Tuesday (18Sep2018) it went to 64, Wednesday (19Sep2018) it was 65, Thursday (20Sep2018) it was 66 and today still says 66 (21Sep2018), which was really odd. Stated that her heart rate might drop a little sometimes and it does go up when she was in the mountains but had not been to the mountains lately. No treatment was received for the events. The outcome of the event abdominal discomfort was unknown while the outcome of the other events was recovering.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of VAQTA 10 Pk 25 U/0.5 ml SD Llok w Cap Ped, which had the lot # L001445, with expiration date 15-FEB-2016 (dose, dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On an unspecified date the vaccine experienced a temperature excursions of 24 hours. The lowest recorded temperature was 34 F (1.1111111111 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
pt recv vax 22OCT98 & had elevated temp & became irritable w/periodic bouts of screaming;mom compared this as much worse than p/#1 vax;DT given on 29DEC98 7 mom reports no problems @ this time;
Vomiting x2 (at 12:10 on 1/9/2022 preceded by about 4 hrs. of upset stomach and continued upset stomach post vomiting.
Patient described redness of arm appearing off and on red ring where vaccine given, feeling sick off and on - on inspection 1 large bruise just above her elbow and diffuse redness. No red ring. Called drug co to report & risk management.
3-9-21 2:49PM 'TONGUE SWELLING'.  STATES SHE DID TAKE BENADRYL @ 1PM TODAY.  A/O, PINK, W/D, RESP WITHOUT ANY DISTRESS.  2:53PM TOOK BENADRYL 50MG PO (HER OWN).  3PM 'FEELS BETTER'.  3:14PM STATES SHE FEELS LIKE SHE CAN GO HOME-'FEELING BETTER'. 3:30PM HOME WITH HUSBAND PER S.C.A.T.
a very strong sensitivity to smells; This is a spontaneous report from a contactable consumer (patient herself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiry date: May2021) via unspecified route of administration, in left arm (left upper arm as reported) on 05Feb2021 09:40 (age at vaccination: 48-years) as dose 1, single for covid-19 immunisation. Medical history included high blood pressure (Why was the patient taking concomitant products Lisinopril HCTZ (Verbatim): high blood pressure) and sensitive to perfumes (Caller wanted to mention that there have been sometimes in her life that she has been a little sensitive to perfumes, but it has been 15 years since she has experienced that) from an unspecified date and unknown if ongoing. It didn't happen enough. She would get a headache from it if someone in the office would come in bathed in perfume. It would almost knock her out. The thing that caught her attention on Friday was because it was normal things in her home that she is accustomed to. There was nothing different about her environment. She couldn't tolerate it. Concomitant medication included ongoing Lisinopril HCTZ 20-12.5mg, 1x/day. There were no prior vaccinations (within 4 weeks). There was no AEs following prior vaccinations. She was calling the number on the COVID19 fact sheet to report side effects after the first dose. She had the first dose Friday last week. The same day as the dose, about 8 hours later, at 17: 40 she noticed a very strong sensitivity to smells. It was almost unbearable. They weren't smelly smells they were good smells like coffee and soap. Things that would not normally bother her at all. She hasn't called her primary care yet, but will do that next. She talked to her doctor before getting the vaccine and was told there was nothing contraindicated in her chart. She was going to call her primary care to get guidance because the second dose was coming up. The outcome of event was recovered on 06Feb2021.   Follow-up attempts completed. No further information expected.
Client is fully vaccinated for COVID-19. Client received Pfizer vaccine on 1/27/21 and 2/17/21. Client tested positive for COVID-19 on 4/12/21.
pt recvd vax & exp cold-type sx consisting of low grade fever, chills, sinus congestion, rhinitis, h/a, sneezing & rhinorrhea;
Bilateral Pulmonary Embolism  Unexplainable itchy hot rash on lower left leg
heartburn; didnt want to eat; nauseated/thought he might vomit; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heartburn), DECREASED APPETITE (didnt want to eat) and NAUSEA (nauseated/thought he might vomit) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPEPSIA (heartburn), DECREASED APPETITE (didnt want to eat) and NAUSEA (nauseated/thought he might vomit). At the time of the report, DYSPEPSIA (heartburn), DECREASED APPETITE (didnt want to eat) and NAUSEA (nauseated/thought he might vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Calluses on bottom of feet; Did not feel good; Bottom of legs got itchy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERKERATOSIS (Calluses on bottom of feet), MALAISE (Did not feel good) and PRURITUS (Bottom of legs got itchy) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In 2021, the patient experienced HYPERKERATOSIS (Calluses on bottom of feet), MALAISE (Did not feel good) and PRURITUS (Bottom of legs got itchy). At the time of the report, HYPERKERATOSIS (Calluses on bottom of feet), MALAISE (Did not feel good) and PRURITUS (Bottom of legs got itchy) was resolving.     Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of calluses on bottom of feet, did not feel good and bottom of legs got itchy with Humira (Adalimumab) was no reasonable possibility.  Treatment information was not provided.  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.
Information has been received from a physician concerning a 23 year old female who was "very nervous and anxious upon receiving" the first dose of GARDASIL (lot # not reported). The physician reported that he administered the first dose of GARDASIL to the patient who fainted after receiving the vaccine. The patient was given some juice and sat in a chair for 15 minutes after the first episode and then fainted again. She fell to the floor and hit her head. She did not have to go to the hospital, but the doctor reported that he felt there might be some underlying cardiac issue. The patient was referred to a cardiologist. The physician did not feel this was directly caused by GARDASIL because the patient shared that she had this same experience when receiving other vaccines. Patient outcome was not reported. Additional information has been requested.
Since 2nd vaccine my BP has been up.  Prior to vaccine it would range 107/75 to 138/85.  After vaccine it would range 135/80 to 170/90 on same dosage of medication.  I've had to double my medication to be able to keep it at a range of 128/80 to 155/85 for the past month.  I thought it might be in my mind at first, but when my Mom recently got her 2nd injection, she had a stroke within 24 hrs.  Her BP was very well controlled, but within 24 hrs after vaccine it was 180/110.  I understand she was older etc, but I'm thinking certain genotypes may be more predispositioned for this kind of reaction and that doctors/caregivers may want to be more aware and prepare their patients for this.
Patient hospitalized for cellulitis of toe of right foot within 6 weeks of receiving COVID vaccination.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old male patient who received Shingles vaccine. Concomitant products included SHINGRIX, folic acid, gabapentin, omeprazole, Rosuvastatin, ZETIA, KLONIPIN, doxepin and PROTONIX. On 2nd April 2018 15:00, the patient received the 2nd dose of Shingles vaccine. In April 2018, 16 hrs 30 min after receiving Shingles vaccine and an unknown time after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, chills, fever and appetite absent. The patient was treated with Pain Medication. On an unknown date, the outcome of the influenza-like symptoms, headache, chills and fever were recovering/resolving and the outcome of the appetite absent was unknown. The reporter considered the influenza-like symptoms, headache, chills and fever to be almost certainly related to Shingles vaccine. It was unknown if the reporter considered the appetite absent to be related to Shingles vaccine. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on right arm and 2nd dose on left arm. The reporter was the patient calling to report his experience on SHINGRIX and stated that this was the second dose in the series and was experiencing same flu like symptoms that he experienced after the first dose in the series. At 7:30 am, on 3rd April 2018, 16 hours and 30 minutes post vaccination the patient experienced flu like symptoms with headache, fever and chills. The patient stated that, less than a day after vaccination, he did not feel like eating in the morning, on the day of reporting and took pain medications to help relieve the symptoms. The patient had started to feel normal. The reporter had denied permission to contact their physician and could not provide any extra information. This case was linked with US2018GSK063519, reported by the same reporter for same patient.
Just muscle soreness for first day or two then on the 8th day after vaccination redness, heat, swelling, and itching at injection site. I did not go to clinic but instead treated at night with benedryl and tylenol so that sleeping was easier. During the day no treatment was really needed. So far reaction has lasted three full days though symptoms are lessoning.
Pharmacist reported 38 yr old hospitalized post partum pt was vax /w Rubella vax on 1Sep90, following vax pt experianced deafness in rt ear, vertigo, rash & malaise. Pt treated /w Fiorinal & Valium
Extreme Chills/Shaking, extreme tiredness and fatigue,  bilateral leg cramping, intermittent & random sharp pain in upper abdomen, dehydration and gaunt appearance. excessively runny nose.