chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms - ?Patient reports around 04:00 while at work began with back pain, chills.  Patient reports she took Tylenol at 0400.  Patient reports after her shift went home and went to bed and when she woke up around 11:00 am took her temperature at fever Tmax 101.6 and took Tylenol at 11:00 am.  Patient reports + congestion but endorses she has hx of asthma and allergies and takes Zyrtec daily.  Patient denies COVID-19 exposure and travel.    Last day of work and shift - ?2/4/21  Home remedies? -   Tylenol at 11:00 and rest Any improvement? ? mild improvement Recommendation?  Patient educated to continue to monitor symptoms at home and to take Tylenol and motrin as directed in the Medical Directive and to increase fluid intake.  Patient educated to manage her symptoms and to adhere to the Workplace Policy.  Patient verbalized back understanding and denied further questions at this time.  Patient educated to contact vaccine support line if worsening of symptoms, Patient verbalized back understanding.
Immediately after getting the shot: the injection site slightly hurt for a hour or so after getting the shot.  My left bicep hurt for the next two days due to the shot.  It felt like someone punched my bicep a few times.   (see continuation page for more).
5 minutes after injection of the Pfizer vaccine I had a slight throat constriction and a tingling throat with  a touch of nausea. I recovered after about 15 minutes.
Numbness on the arm; dizziness; He was not feeling well; This is a spontaneous report from a contactable physician.  A 18-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported.  The patient developed numbness on the arm, dizziness and he was not feeling well in general after the administration of the vaccine, on an unspecified date. After one day the symptoms gave away and he recovered from the events on an unspecified date. Information on the batch number has been requested.
Headache , dizziness, severe body aches and cramping , fever , fatigue , arm pain and weakness
Received 1st dose 6 weeks prior and experienced deep pain in left leg hamstring area and sciatic pain the following day, also developed a rash on chest and nerve pain in the back of head. Visited Dr. following week and was told it was an inflammatory reaction and recommended waiting longer than 3 weeks before getting 2nd dose.    The symptoms subsided and received 2nd dose 6 weeks after 1st. Two days later, left leg began to hurt in the same hamstring area and also felt like a rope pulling sensation in lower leg as well as foot pain, which felt like a vein, that made it difficult to walk. Visited Dr again, a d-dimer was ran, and it was negative. Days later, experienced severe burning sensations on the backs of upper legs and also the upper fronts of both legs. Leg muscles became rigid. Went back to Dr, and they ran other blood work including rheumatoid tests and all came back normal. Because the leg pain continued and felt like veins, went to a vein specialist and had an ultrasound, and all was normal. Leg pain continued in the following weeks, some days unable to sit and others unable to walk due to extreme nerve pain in hamstring area of left leg as well as electric shock zaps. Three weeks after vaccine, legs began to fill with fluid. Spent evenings laying on stomach in bed with ice on the back of legs. Visited Dr.?s office again after 9 weeks of pain and several weeks of swelling. More blood work ran, and all normal. EMG scheduled. Currently deal with rubber band feeling around lower thighs, feeling of someone pinching legs in various areas, and pain in hamstring areas and directly under buttock area of both legs, more severe on left.   Other symptoms experienced included pain around sternum, burning pain both sides of neck, red spots on roof of mouth, and swollen lymph nodes.
This spontaneous report as received from a physician via company representative refers to a 2 female patients of 80 and 81 years of age. Medical history and drug reactions were unspecified. On an unknown date in 2008, the patients were vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and route were not reported), 0.65 milliliter (ml). Concomitant medication were unspecified. It was unspecified whether these patients received ZOSTAVAX from the same lot number. One of these patients developed shingles five years after receiving ZOSTAVAX on an unspecified date in 2012, and the other patient developed shingles five years after receiving ZOSTAVAX on an unspecified date in 2013 (reported as a month or so ago), but it was unspecified whether the 80-year-old or the 81-year-old developed the more recent shingles case a month or so ago. Laboratory studies were unspecified. The patient who developed shingles a month or so ago sought medical attention. The patient went to an unspecified emergency room for treating the shingles (treatment unspecified). Neither patient was hospitalized for the shingles. The patient with the more recent case of shingles had not followed up with the physician since notifying the physician of seeking treatment in the unspecified emergency room. Neither patient died, neither patient adverse reaction involved cancer or overdose, and neither patient had intervention to prevent serious criteria. The outcome of shingles for both the patient was unknown. The recovery status of both patients was unspecified. Additional information has been requested.
Patient didn't feel well after receiving  the vaccine. We gave her Benadryl; however, her condition was getting worse. She complained her throat is closing, so we gave her Epipen and called 911.
weight loss; loss of taste smell probably; loss of taste smell probably; This is a spontaneous report from a contactable consumer reporting on behalf of the patients. This consumer reported same events under the same suspect product for two patients. This is second of 2 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single  for covid-19 immunisation.  Medical history included exposure to sars-cov-2. The patient's concomitant medications were not reported. The patient experienced weight loss, loss of taste smell probably, loss of taste smell probably, all on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included CPVID test: negative on an unknown date. Clinical course: In reporter's circle, 5 people including her and her doctor had been experiencing the same side effect, that were life threatening. 2 friends the reporter only found today in at withheld was also sick. A friend she met 4-5 months ago had the same problem and same long experience. All tested for COVID many many times. All of them had worked with COVID patients for a long time. Her friend had each experience in a hospital. They had symptom including weight loss, loss of taste smell probably but all of their tested result were negative. All of the symptoms are escalating and getting worse. Her friends and doctors symptoms were also getting worse.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383019 same reporter, product, event; different patient
On February 20, 2021 in the early evening my husband began to experience chest pain and pressure, took Tylenol, however did not relay the symptoms to me. About 6:50 AM on February 21, 2021 told me that he did not feel well, had chest pain and pressure in his chest. An ambulance was called and my husband was transported to the Hospital. I was contacted by the treating physician and was told that my husband suffered with a Pulmonary Embolysm (sp?). He was started on Heparin and admitted to the hospital. Later that evening his medication was changed to Eloquis. He was released from hospital the following evening. He has since followed up with his primary care.
pt developed b/l LE edema 1+ pitting edema roughly 2-3 weeks after getting covid vaccine cbc, cmp, trop, bnp were normal during ER visit 4/30 pt complained of "red dots" like rash at first but no petichial rash noted on exam
Headache, dizziness, blurred vision, paralysis, weakness, fatigue, seizures, joint pain, lower back pain, pulling in neck, and spinal cord, weight loss, fever, tremors, Has seen multiple specialist over the last 2 years.
Pt. developed pain with vesicular lesions on her right lower extremity.  Pt. was started on acyclovir & LORTAB.
The following morning after the shot she had a seizure followed by diarrhea.  Called 911 since she had the Moderna vaccine  the previous afternoon.   I knew she was allergic to MiraLax but had no clue that a similar product (PEG) was also in the Moderna vaccine.   The fact that she had diarrhea let me to do extensive research on line regarding contents of MiraLax .  After extensive research I concluded that she had the seizure  because of the PEG in the Moderna.  It had been over six years since she had had a seizure.  After eliminating MiraLax the seizures stopped.
Patient states that she developed 3 cold sores on the right side of her mouth that started 1 to 2 days after 1st covid shot.
felt like having aurora borealis in his peripheral side of both eyes; headache; chills; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL FIELD DEFECT (felt like having aurora borealis in his peripheral side of both eyes), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VISUAL FIELD DEFECT (felt like having aurora borealis in his peripheral side of both eyes), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired). At the time of the report, VISUAL FIELD DEFECT (felt like having aurora borealis in his peripheral side of both eyes), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired) outcome was unknown.
Gave her chills; Gave her / fever; Made her weak; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2021AMR064841).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever and weakness. On an unknown date, the outcome of the chills, fever and weakness were unknown.   It was unknown if the reporter considered the chills, fever and weakness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported The patient received 2nd dose of Shingrix and experienced chills, fever and made her weak For tolerance for Flu Shot refer US2021AMR064858. The reporter and healthcare professional consents to follow up was reported as not applicable.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064841:Same reporter. US-GLAXOSMITHKLINE-US2021AMR064858:Same reporter
like the ringing is causing pain.; tinnitus; she could not sleep; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Jan2021 (Lot number: EL3249) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (ongoing), notes: Additional Information for Other Conditions: diagnosed about 10 years ago. Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for autoimmune thyroiditis (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EK9231, Expiration: unknown), administration date: 07Jan2021, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 28Jan2021, outcome "not recovered", described as "tinnitus"; INSOMNIA (non-serious) with onset 28Jan2021, outcome "unknown", described as "she could not sleep"; EAR PAIN (non-serious), outcome "unknown", described as "like the ringing is causing pain.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of tinnitus, insomnia, ear pain.  Follow-up (17Jan2022): This is a spontaneous follow-up report received from a contactable nurse. This 54-year-old female nurse (patient) reported that: Updated Information included: Slider#02 in reporter section, Concomitant drug. Suspect vaccine information, new event Batch/lot number, intramuscular injection in left arm  Additional Context: She just got the Pfizer covid booster on Thursday. When she got the second vaccine in Feb2021,she developed tinnitus. Clarified she got the second vaccine on 28Jan2021, not in Feb2021. The tinnitus is ten times worse within a day of getting the booster. She can still hear the ringing even if she has the TV on. With the second dose she could only hear the ringing in her ear if the room was silent.  States she she does not get sick and she is not on any medication. Asking what should she do. It is to the point that she has to go to the doctor but they will not know what to do.   Follow-up (26Jan2022): Follow-up attempts are completed. No further information is expected.
He felt dizzy 3-4 minutes after he received the shot. He vomited 7 minutes after receiving the injection. At 4 minutes after vomiting he felt better. He drank water and had  cool wet clothes on his forehead and neck. He remained seated at our pharmacy department until he felt completely better. He left accompanied by his mother.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Vomiting and diarrhea and listlessness. Diagnosed with Rotavirus. 4/27/07 Received medical records from hospital which reveal patient experienced diarrhea, vomiting, dehydration, irritability, decreased activity & poor appetite for 1 day prior to admit 2/13/07-2/15/07.  Treated w/IVF, no further vomiting/diarrhea & progressed well w/diet.  D/C to home. FINAL DX: Viral gastroenteritis, rotavirus.
Swollen huge lymph nodes in arm pit and all around reaching to breast, neck and upper back of injection arm. Lymphadema in arm. Some pain and swell on other arm pit.
3SEP96 (12hr post vax) felt tired & achy all over & had malaise;felt as if had the flu w/resp sx;temp was 99.8 since 4SEP96;7SEP96 devel UTI w/burning on urination;11SEP96 devel rash;itched;achy joints;serum sickness;
8/7/15 at well child visit received MMR, VARIVAX and Hep A, after shots small amount of redness and swelling at (R) thigh injection site. 2 days ago (8/15/15) developed new redness (R) thigh, pink dots, papules. 8/16/15 hives off and on arms and legs. Went to ER for eval, fever to 102. Hives resolved. Question virus vs. vaccine reaction.
Erythema and warmth (L) upper arm dx: cellulitis. KEFLEX 500mg 1 PO TID x 7 days.
Redness; Itching; Swelling; Tenderness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itching), SWELLING (Swelling) and TENDERNESS (Tenderness of the arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and METFORMIN for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (Itching), SWELLING (Swelling) and TENDERNESS (Tenderness of the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching), SWELLING (Swelling) and TENDERNESS (Tenderness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that her reaction spread but not through the whole body and she was very uncomfortable with the allergic reaction. And by the time she got her second shot, it had  almost gone away  Other treatment included warm and cold compress.   This case was linked to MOD-2021-207872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 3-Jun-2021, spreading of adverse events reported.
Patient fainted shortly after vaccination while walking to waiting room. Patient was treated by pharmacist until paramedics arrived. Patient was released by paramedics after assessing patient for low blood sugar.
Narrative:  Admission 10/9/2021 Discharge 10/15/2021. 58y M with history of beta-thalassemia trait, atrial fib/flutter (not on oral anticoagulation), OSA, COPD, COVID-19 Pneumonia in 12/2020 complicated by cryptogenic organizing pneumonia and presumed COVID related auto-immune hemolytic anemia presenting to the Emergency  Department for worsening cough, dyspnea, and hypoxia in setting of active COVID infection. He tested positive for COVID despite being vaccinated three times: 3/17/21, 4/8/21, 8/31/21 with negative antibody response perhaps not surprising in the setting of weekly Rituximab x 4 in July 2021. CT imaging with worsening diffuse bilateral interstitial and groundglass opacities worse than previous. Negative for PE. Admitted to ICU for AHRF and Afib w/ RVR. He received remdesivir, high dose prednisone and enoxparin as described above. He was ultimately discharged on 10/15/2021 with home O2 - 4L oxygen.  Symptoms:  & HOSPITALIZATION FOR COVID DESPITE FULL VACCINATION AND BOOSTER
I have had a temperature for 5 days and chest and back pain. Chills and dizziness.
Information was received on 10-MAY-2017 from a lawyer regarding a case in litigation regarding a female of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 12-AUG-2011 at the Health Department, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-JAN-2016, the patient was treated at a medical center for a painful vesicular eruption that was diagnosed as shingles. The patient has been prescribed acyclovir (manufacturer unknown), oxycodone/acetaminophen (PERCOCET), and  acyclovir(ZORIVAX) to manage persistent symptoms. As a direct and proximate result of these malfunctions, 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.
Several hours after the shot my upper arm swelled up and became red and hard.  From the shot site down to my finger tips was continuously tingling like it had "fallen asleep" and like that pins and needles feeling after that occurs. I took some advil. By the next morning the tingling spread up through my shoulder neck jaw and temple intermittently and my face on that side was  swollen.  I took advil again.  The tingling subsided slowly over the next few days but the swelling remained until 6 days later when it slowly cleared from my cheeckbones down to my jaw.
Severe Throbbing and stabbing pain and major joints including wrists, elbows, and knees. Severe sharp and burning pain from the scalp of the head all the way down to the ankles. Limited ability to walk and support self. Began at approximately 5 PM on the day of vaccine and continued in severity through approximately 12 noon the following day. Symptoms were treated with Motrin and heat. Please note that I received the Moderna series 1st with the last injection in January 2021. I opted to try the Pfizer vaccine for the booster because I had the same reaction with Moderna back in January. I was hoping to have a lesser reaction with the Pfizer
99.3 fahrenheit  temperature; Pentacel was ordered, but a dose of ActHib was inadvertently given; Pentacel was ordered, but a dose of ActHib was inadvertently given; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months old male patient who experienced 99.3 fahrenheit temperature, while he received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 08-Apr-2019, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UJ072AAA via intramuscular route in the right deltoid.  On 08-Apr-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious 99.3 fahrenheit temperature (body temperature increased) following the administration of HIB (PRP/T) VACCINE and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was also the case of actual medication error due to wrong vaccine administered and Extra dose administered. It was reported that the patient received an extra dose of the Hib, on 08 Apr 2019. Pentacel was ordered, but a dose of ActHib was inadvertently given   (Other relevant tests included no lab data.)  Final diagnosis was 99.3 fahrenheit temperature.   It was not reported if the patient received a corrective treatment.  The outcome of the event body temperature increased was not reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.