chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin rash that's spreading. The rash started on the right thigh and has been spreading to the entire body. She had a fever after getting immunizations. Her appetite has decreased. She had two watery stools after immunizations.
syringes stored at room temperature all day; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (syringes stored at room temperature all day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (syringes stored at room temperature all day). At the time of the report, PRODUCT STORAGE ERROR (syringes stored at room temperature all day) had resolved.            No concomitant medication was reported. No treatment medication was reported.
after a full week and got a circle on the injection site, it was itchy; It was coming out but it was not really a vomit.; couldn't get the head out of the pillow and that have not really eaten; very frequent shiver, really shivering. Feels like a bad flu and just don't feel well; fever of 100.3°F and when drink goes to 99; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (couldn't get the head out of the pillow and that have not really eaten), INFLUENZA LIKE ILLNESS (very frequent shiver, really shivering. Feels like a bad flu and just don't feel well), PYREXIA (fever of 100.3°F and when drink goes to 99), INJECTION SITE PRURITUS (after a full week and got a circle on the injection site, it was itchy) and NAUSEA (It was coming out but it was not really a vomit.) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DECREASED APPETITE (couldn't get the head out of the pillow and that have not really eaten), INFLUENZA LIKE ILLNESS (very frequent shiver, really shivering. Feels like a bad flu and just don't feel well), PYREXIA (fever of 100.3°F and when drink goes to 99) and NAUSEA (It was coming out but it was not really a vomit.). On an unknown date, the patient experienced INJECTION SITE PRURITUS (after a full week and got a circle on the injection site, it was itchy). At the time of the report, DECREASED APPETITE (couldn't get the head out of the pillow and that have not really eaten), INFLUENZA LIKE ILLNESS (very frequent shiver, really shivering. Feels like a bad flu and just don't feel well), PYREXIA (fever of 100.3°F and when drink goes to 99), INJECTION SITE PRURITUS (after a full week and got a circle on the injection site, it was itchy) and NAUSEA (It was coming out but it was not really a vomit.) outcome was unknown.            Treatment drugs include:  Cold pack after second dose Concomitant medications were not reported   This case was linked to MOD-2021-015899 (Patient Link).
After a few hours, I began to have horrible chills, so bad, like I've never had chills before.  I couldn't hold a water glass.  This was very unusual, as I normally get little to no reaction to the flu shot which I have every single year for many years.  I fell asleep and awoke about 1 am feeling very hot.  I took my temperature and my digital thermometer said 107.9 deg F.  I couldn't believe it!  I grabbed a 2nd thermometer and it said 108.0 deg F.  I immediately started to take Tylenol, 2 tablets.  The temp started to come down to 106 in an hour.  I took 2 more Tylenol and it came down to 104 in another couple of hours.  I remained a temperature between 101 and 103 deg F for the next 7 days, then my temperature st I called my doctor who suggested that I was having a reaction to the vaccine and told me to continue Tylenol, stay warm and rest.  I did that.  When the temperature was very high I also used ice and cold compresses to bring my temperature down.  My doctor told me to go to ER if my temperature rose higher than 104 deg F again.  It did not after I continued Tylenol for the next 7 days.  In addition to the high temperature, my body went through other weird symptoms.  The first two days, I felt sick to my stomach, couldn't hold food down, threw up as soon after I ate.  After that settled down, then day 3 I got a very sore throat.  A couple days later, I felt like I had a sinus infection with bad headache and sinus pressure.  I again talked with my doctor who told me to just stay the course.  I took a Covid test (at home test) and that was negative.  I had muscle aches and hurt all over the remaining days.  This was a reaction that I have never seen myself before!  I also spoke with our Emergency Care office over that first weekend.  They said they had heard of some bad reactions to the flu shot this year and told me to keep taking Tylenol and resting with lots of fluids.
This spontaneous report was received from a Licensed Practical Nurse (L.P.N), refers to a female patient of unknown age, with unspecified seasonal allergies. The patient did not have a pertinent medical history. It was reported that in August 2010, reported as 3 years ago, the patient received the first dose of GARDASIL (lot # not reported) (dose and route not reported). Also, the patient received the second dose of GARDASIL (Lot # not reported) (dose and route not reported) in 2013, reported as on an unspecified date last week. There was no concomitant therapy. The reporter stated that after receiving the first dose of GARDASIL, the patient experienced unspecified pain (approximately in 2012). The patient did not receive a treatment for the adverse event and therapy with GARDASIL continued. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
2mo infant suffered brain damage as a result of trauma; Apparently DTP had also been given; MD feels strongly that trauma caused the problem & that DTP did not;
Rash-morbiliform rash.  Atarax 1 tsp per mouth every day.
Break-through vaginal bleeding- I didn't have this the first 4 times. Friday I had the flu vaccine and the Moderna Bivalent covid vaccine. I have had an IUD for excessive menstrual bleeding since 2020 which has been effective. Today I started excessive menstruation of Biblical proportions. No idea if it is related to the booster but damn it is weird. And a bit scary.
This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 54-year-old male patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. Concomitant products included PREVNAR. On 18th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 2 days after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant and other: as per reporter), fever (serious criteria other: as per reporter), erythema of extremities, swelling arm and pain in arm. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the cellulitis and fever were recovered/resolved and the outcome of the erythema of extremities, swelling arm and pain in arm were unknown. It was unknown if the reporter considered the cellulitis, fever, erythema of extremities, swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: On 18th May 2018, the patient received 1st dose of PREVENAR vaccine on an unknown arm intramuscularly (batch number S43277, expiry date 1st September 2018). The patient received a dose of SHINGRIX vaccine on an unknown arm and 48 hours later receiving dose of SHINGRIX, the patient experienced a fever. The patient also experienced redness, swelling and soreness in the arm in which he received the SHINGRIX vaccine. The patient had to visit the doctor and was diagnosed with cellulitis and received antibiotics for the cellulitis.
Resident had one emesis and fever. Reported complaints of nausea, decreased appetite, weak, and unwell.
Pt received Flu vaccine and PREVNAR on 09/10/2018 at flu clinic. At home same day, pt started having swollen arm, tender to touch and redness on injection site. Pt came to clinic and Dr seen pt and diagnosed allergic reaction to vaccines.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
According to records obtained from clients PMD: Clent presented to the office the day after receiving vaccine with redness, and swelling at injection site.  No fever. No dyspnea.  Client was Rx: Duricef.
No adverse events; pt was given Pfizer BioNTech instead of Pfizer BioNTech Bivalent
Mom states, while walking to exit, pt fell to ground, face fluctuated, eyes rolled back for a few seconds and then awoke and stood up and stated she felt nauseous. Questionable seizure; probably vasovagal episode.
I became seiously Ill; pain and hurt; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005498). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I became seiously Ill"; PAIN (non-serious), outcome "unknown", described as "pain and hurt".  Additional information: Patient became seriously III after my second shot. I haven't caught Covid and it has given me nothing good except pain and hurt.  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 consumer refers to a female patient of unknown age. The patient's pertinent medical history was not reported. Approximately on an unknown date and month in 2013 (reported as about a year ago) the patient was vaccinated with ZOSTAVAX (strength, dose and frequency not reported). Other co-suspects and concomitant medication were not reported. On an unknown date the patient experienced sharp stabbing pain on her right side of her body and abdomen. The outcome of experiencing sharp stabbing pain on her right side of her body and abdomen is unknown. Causality was unspecified by the reporter. Additional information has been requested.
On 12/2/22 I woke up not feeling well, I felt lethargic, absolutely no energy, coughing sore throat. I took a home COVID-19 test that came back positive. I called my doctor's office as I waited on them to call me back, I called my pharmacy. They did say that they could legally have the medication prepared and waiting on me if I could show them the positive test result. Once my doctor's office called me back and we discussed my symptoms the prescription I was able to start the Paxlovid that afternoon. I took a home COVID-19 test on 12/10/22 that came positive, but I was feeling much better. I am now feeling more like myself.
cannot walk; blurred vision; numbness in one leg below the knee; Initial information was regarding an unsolicited valid serious case was received from a consumer/non-healthcare professional via Medical Information (MI) (Reference number- 00841577) and transmitted to Sanofi on 03-Nov-2021.  This case involves an 83-year-old female patient who experienced cannot walk (gait inability), blurred vision (vision blurred) and numbness in one leg below the knee (hypoaesthesia), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious cannot walk (gait inability) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was leading to disability.  On an unknown date, the patient developed a non-serious blurred vision (vision blurred) and numbness in one leg below the knee (hypoaesthesia) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient was admitted to the hospital yesterday and has had "a lot of tests" and they all came back normal.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an 83-year-old female who had gait inability, vision blurred and hypoaesthesia after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown. Furthermore, information regarding medical history, past medical treatment, vaccinations, concomitant medication, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
This case was reported by a nurse and described the occurrence of adverse drug reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had possible side effect of SHINGRIX.
Three weeks post 3rd dose of vax, the pt experienced an itching red rash which started on the insides of his thighs and progressed to his chest and arms. A doctor visit was required. He was treated with hydroxyzine. The vaccinee is allergic to silicone, poison ivy, doxycycline, pollen and sumac. He has a history of arthritis (bilateral knee and cervical spine)for "many years." In 1997 he had a tick bite and developed a bull's eye rash. He was treated with antibiotics and events resolved without sequelae. The vaccinee was not sure whether he was tested for Lyme disease. Concomitant medications included Claritin and Allegra. The vaccinee felt that he experienced as allergic reaction to the silicon based additive to Lymeri. The vaccinee received his first and second IM doses of Lymerix for prevention of Lyme disease on 3/10/99 and 4/12/00, respectively. After the first and second dose of Lymerix, he experienced having more stiffness in his knees and neck. Symptoms resolved without treatment. The vaccinee received his third IM left deltoid dose of Lymerix on 3/13/00. Three weeks later, on 4/1/00 he experienced an itching red rash which started on the insides of his thighs and progressed to his chest and arms. A doctor visit was required. He was treated with hydroxyzine 25mg qid prn. The dermatologist stated that the rash and aching had nothing at all to do with the Lymerix and that the vaccinee had something more consistent with eczema. He did not feel that the rash was either allergic, immunologic or exanthematous in nature. The most recent info, received on 8/31/00, reports the condition of the vaccinee is unknown. The event of "stiffness" does not meet serious criteria but is being submitted expeditiously per FDA request.
SEVERE HEADACHE; DID NOT CLARIFY SYMPTOM HAD LAST NIGHT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-JUN-2021, the subject experienced did not clarify symptom had last night. On 16-JUN-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and the outcome of did not clarify symptom had last night was not reported. This report was non-serious.
Initial unsolicited report received from a consumer (patient) on 26 May 2016. This case involves a male patient (age was not reported) who was vaccinated with a first dose of Adacel (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date (reported as two weeks ago). It was reported that patients neurologists and a pharmacist advised him to get the vaccine. Patient's illness at time of vaccination was reported as CIVP (not specified) since 2000 and the symptoms stopped in 2005. Patient had a brief relapse in 2010. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergy and no other medical conditions. Concomitant medications were reported as none. On an unspecified date, 12 hours post vaccination, the patient had experienced tingling in feet which stops for 2-3 hours and then returns. On an unspecified date, post vaccination, the patient had experienced balance issues and calf muscles felt weak while walking and had overpronation. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none.
DYSPNEA 3/7/2021, CONFIRMED BREAKTHROUGH  WITHA POSITIVE COVID-19 RESULTING IN DEATH
Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were provided.   This case was linked to MOD-2021-131302 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received contains no new information regarding dose 1 of mRNA-1273.
This spontaneous report as received from a physician refers to a female patient of unknown age. On 16-MAY-2014, the patient was vaccinated with her first dose of VAQTA (route, dose, lot # and expiration date were not provided). Then on 13-JAN-2016, the patient was in the office to receive her second dose (Inappropriate schedule of drug administration). No adverse symptoms were reported. Additional information has been requested.
Sore arm lasting at least 2 days, headache lasting 2 days.  Chills, fever, body aches lasting 1 day; treated with 500 mcg acetaminophen in the morning and night.
Extreme chills and body aches. Could find no comfortable position. Also soreness at injection site.
Rash on face Extreme body aches High fever, 103+ Weakness Knot at injection set
Per note from ER physician: 10/20/2018. HPI: 57 y/o M c/o 2 d hx of diffuse pruritic rash without any clear exposure or trigger. No outdoor exposure, no STD exposure. No environmental/chemical exposure, no Rheum Hx. No fever, mucous membrane involvement, no arthralgia, no sore throat. No IV drug use. Pt does suffer from alcoholism. Next Day ER 10/21/2018. Note from physician: Chief Complaint: My rash is getting worse. History of Present Illness: 57 y/o male presents to ED with c/o red and itchy rash that started at the palm of both hands 3 days ago. From there the rash has spread to his torso, groin, and extremities. I haven't been able to sleep at night because of the itching. Reports recent exposure to a new detergent. He lives in the woods and gets tick bites occasionally and becomes exposed to poison oak and poison ivy as well. No recent exposure to those lately. Denies pain to this rash. Denies swelling of the lips of tongue. No difficulty breathing and no difficulty swallowing. Denies any other C/O at this time. Skin rash. Famotidine 20 mg once, Methylprednisolone 125 mg once, Diphenhydramine 25 mg once.
Scalp numbness after the 96 hours of injection. The numbness takes place 5-6 times per day.
redness/pain/swelling at injection site 2 d after; fever/myalgia/arthralgia night of shot admin;