chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 52 year old male physician referring to himself. The patient had high cholesterol, depression and aspirin (multiple unspecified manufacturers) allergy (the patient developed hives 10-15 years ago after aspirin use, and he recovered on an unspecified date). In April 2013 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, lot# and dose were unknown). Concomitant therapies included atorvastatin and LEXAPRO. On approximately 21-APR-2015, about 2 weeks ago the patient developed shingles with a "V1 ophthalmic distribution on the right side of the nose and right eyelid and on the forehead. There were 5 scabbed vesicular spots on the forehead. The affected area had a burning feeling." The patient went to see a physician for medical attention. There were no lab diagnostics studies performed. The patient started valacyclovir therapy (manufacturer unspecified) for the shingles on 02-MAY-2015. The "burning feeling" was recovering. The shingles were recovering. The relationship of the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Onset 12/04/2004 of fever (100.4 degrees -> 101.4 degrees), swelling around injection site.  "Feels bad and weak" went to ER on 12/05/2004, was told it was a normal reaction.  Was taking Tylenol.  Called Health Department  on 12/06/2004 for a follow up appointment, until appointment was told to continue fever meds. and apply ice.  Kept appointment  - observed large area below and around TD site that was red, swollen and warm to touch.  Advised to take Ibuprofen every 6-8 hours, apply hydrocortizone to area, wrap with plastic wrap and leave on 30 minutes to help with pain and swelling.  To put MD if status worsens.  Call Health Department as needed.
weakness, numbness, tingling and pain of both legs, falling, progressive difficulty and inability to walk
Marked facial edema and rash on the head, neck, chest, upper back, and arms starting ~ 3 hours after vaccination and developing over the course of a week.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient continued suffer ongoing injuries including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries; significant medical and related expenses as medical losses and costs included care for hospitalization, physical care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of singles was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a physician refers to a 2 year old male patient with allergic rhinitis and no known drug reactions/allergies. On 29-MAY-2013 the patient was vaccinated with a dose of PROQUAD (merck) lot # H015638 (dose and route not reported). Concomitant therapies included TYLENOL and MOTRIN. On 07-JUN-2013, during his office visit 9 days after vaccination the patient stilled and had a fever of 103 degrees accompanied febrile seizure and generalized tonic-clonic movements and exudative pharyngitis with thick nasal yellow discharge and sinusitis. The paramedics were called, however the child did not require transport to the hospital. Treating physician marked the onset date of symptoms for this event as 06-JUN-2013, however no additional information was provided as to what the initial symptoms were other than the symptoms described that occurred on 07-JUN-2013 during the child's office visit. Upon internal review, the events of generalized tonic-clonic movements and febrile seizure were considered medically significant. The outcome of the events was reported as recovered/resolved on 08-JUN-2013. The causal relationship was not reported. Additional information has been requested.
Information has been received regarding a case in litigation concerning a patient on 24-JUN-1996 and 29-JUL-1995 was vaccinated with the first and second dose of Recombivax HB (thimerosal containing). On 30-JUL-1996, the day after he received his second dose, the patient reporting tingling, numbness in his feet, and stomach pains. On 31-JUL-1996, the tingling and numbness spread to his knees and his stomach pain continued. On 01-AUG-1996, this spread to his thighs. By the end of that week, tingling and numbness spread to his hips and stomach pain continued. On 20-AUG-1996, the patient was diagnosed with post-immunization neuropathy. On 25-OCT-1996, a magnetic resonance image found "multiple tiny thigh signal lesions in the periventricular white matter", which suggested multiple sclerosis. Upon internal review, multiple sclerosis was considered to be an other important medical event.
I started to get night sweats and then pain in my groin areas then the joint pain and muscles pain kind of went to my back. I went to the ER room and they ran test. CT scan and urine test.
My arm is always sore. My hands and fingers are really weak. I haven't been moving that much because my arms and legs are hurting so bad. Below the shoulders down, I have fiery nerve pain and a lot of weakness in my muscles. It started in my foot which was numb, and the nerve pain moved up my body. It has gotten worse about a week after receiving the shot. I was trying to push my walker but my biceps were so weak and so sore and have been this way since. I haven't been able to walk my dog anymore. I also have eye pain really bad with a headache. I also feel like my brain isn't functioning properly, but I think its from my medicine. When I stand up I feel like my legs aren't supporting me.
Patient came to pharmacy for his 9am covid vaccine appointment and attested to the fact that he never had a covid vaccine before. My CAIRs access needed to be renewed so while I was calling the HELP desk, I checked the patient's profile and mHealthKordinator - both of which has shown no records of him receiving the vaccine before. After being able to login to CAIRs to double check after giving the vaccine, it was shown that the patient had previously received the MRNA vaccine on  1/29/21, and 2/27/21 respectively.
Patient  had previous anaphylactic reaction to Moderna vaccine.  MD wanted patient to have 2nd dose.  Per patient, she was premedicated at home.  Approximately 5 minutes after receiving 2nd dose of vaccine, patient began to feel difficulty breathing, throat swallowing.  Husband gave epi-pen to left thigh.  Nurse called and patient taken to ED.
Vax administered 18DEC91 for routine PE 18 hrs p/fell down in preschool, devel tonic clonic activity less than 1 min & was post ictal; x-rays neg; transported to hosp for further eval;
swelling at injection site; rash; This case was reported by a physician and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site swelling and rash. On an unknown date, the outcome of the injection site swelling and rash were unknown.   It was unknown if the reporter considered the injection site swelling and rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had rash and swelling at injection site for two days.  No sure if the patient should be given second shot of shingrix.
5AM 24AUG95 pt awoke w/severe pain along spine from base of skull of coccyx,mod posterior h/a,muscle aching all parts of body;t99.8 po;denies sx,weakness in extremities;arm sore @ site of inj but denies redness
2/5/2023  I had some sinus congestion and sore throat. At home COVID test was negative. The next day I also took an at home COVID test which was negative.  On 2/7/23 I had a positive at home COVID test. That night I had a temperature of 100.4 which is as high as it got. I did not take a fever reducer. I called the doctor?s office on 2/7/23 to see if I could take Paxlovid.  I was given all  the information on Paxlovid and decided to think about it.  I started taking Andrographis Paniculata , for immune support; NAC and high doses of Vitamin C. I called my doctor back the next day and was given a prescription for Paxlovid, the kidney dose. I took the Paxlovid for 5 days, I had no side effects.  My symptoms were still there but were mild. I had a little bit of a cough. By 2/11/23 I had tested again with 2 negative tests.  On 2/14/23 and got a positive at home COVID test.  On 3/2/23 I tested again and it was negative.  And 2 days later I tested negative again.  I have recovered and feel fine now.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 22-SEP-2016, the patient was vaccinated with expired dose of ZOSTAVAX lot # L017165, expiration date: 13-AUG-2016, intramuscularly which was outside of prescribing information. No adverse effect was reported. Additional information has been requested.
Patient says that her arm was extremely sore following the shot. Within 48 hours she started to experience covid arm (redness, swelling, itchiness). Patient says that the reaction lasted 5 weeks. She says that she is just starting to feel better. Patient also expressed that this did not happen with her first 2 doses of the moderna series.
Information has been received from a registered pharmacist concerning an 11 year old female who, on an unspecified date, was vaccinated with a second dose of Gardasil. On 26-APR-2007, the patient was seen in the emergency room for hallucinations. The patient was discharged from the emergency room with instructions to follow-up with her pediatrician. The reporter stated that the patient was "fine" when she left the hospital. It was also noted by the reporter that the patient had reportedly experienced hallucinations after her first dose of Gardasil and was seen in the emergency room of another hospital. The reporter stated that the patient may have received other vaccinations with one or both of the Gardasil vaccine doses. No product quality complaint was involved. Additional information has been requested.
With in few minutes of having the injections administered  my face started getting numbed. I notify one of the workers from the park. Medic came to check me out to my blood pressure everything; This is a spontaneous report from a contactable other HCP, the patient. A 42-year-old female (unknown if pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EL9267) via an unspecified route of administration (Age at vaccination 42-year) in Right Arm on 02Mar2021 at 09:00 AM as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Thyroidectomy of the right side, bilateral hernia, right humerus metal rod surgeries; all from an unknown date and unknown if ongoing. Concomitant medications included thyroid NP 30 mg; ethinylestradiol, levonorgestrel (SEASONIQUE); both taken for an unspecified indication, start and stop date were not reported. No COVID prior vaccination was reported. The patient has not been tested for COVID, post vaccination. The patient has not received any other vaccine in four weeks. On 02Mar2021 at 09:00 AM, within few minutes of having the injection administered patient's face started getting numbed. Patient notified one of the workers from the park. Medic came to check patient's blood pressure, and everything seemed ok. Patient just could feel the face. Now almost 24 hours later patient still feel some parts of the face numbed. No treatment was received for the adverse event. The clinical outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
I experienced double vision and difficulty in focusing.  This is not a symptom I've ever experienced before.  I was outside walking around when it began.  I also had a mild headache.  The vision problems ended after around two hours.
fever & coughing, then started to cough up blood, went to ER; pneumococcal pneumonia;
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not provided. it was reported that since 17-JAN-2017, the patient have been administered doses of improperly stored GARDASIL 9 injection (lot # reported as M037770, expiration date 01-JUN-2019) for prophylaxis (strength, dose and route were unknown). On an unknown date, the vaccine was stored to a temperature excursion between 0 Celsius degrees and 2 celsius degrees for 48 hours. There was no previous temperature excursion. The call was made because of a digital data logger. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA013818: US-009507513-1701USA013819: US-009507513-1701USA013820: US-009507513-1701USA013631:
itchy throat. chest tightness, patient report of tongue swelling 22 minutes after vaccine
10 cm area of erythema, warmth at injection site on left arm with pain in left jaw, decreased range of motion in jaw, swollen cervical glands.  Treated with NSAID and Bactrim DS. Jaw pain persisted for 6 weeks. Skelaxin was prescribed after 6 weeks.
CHILLS; FEVER; BODY ACHES; HIVES ON FACE AND NECK; FATIGUE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's thyroiditis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced fatigue. On 07-APR-2021 12:45, the subject experienced hives on face and neck. On 07-APR-2021 20:00, the subject experienced body aches. On 07-APR-2021 20:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 07-APR-2021 22:00, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 101.6 F.  Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hives on face and neck, and the outcome of body aches, chills, fever and fatigue was not reported. This report was non-serious.
8/7/21 PMH most significant for Afib, CKD, HTN  presents with chief complaint of shortness of breath
Received Fluzone Vaccine on 12-18-07. Developed fever 101 12-19-07, with left arm hard, red, warm from shoulder to anticub area. Fever continues today, Ice applied, motrin given. Red area measures 12.5 cms X 17 cms diameter 19.5 cms. Right arm diameter is 16.5cms. To F/up with phone call to Dr.
pt recvd vax 9MAY95 & 23MAY95 pt began to digress;had trouble eating, swallowing, choked on liquids & threw up;pt's mom felt that vax may have precipitated the digression;
Initial unsolicited report received from pharmacist on 13-Oct-2017. This case involves a 40 year old female patient who was vaccinated with 0.5 ml dose once of FLUBLOK QUADRIVALENT (Batch number: UI829AA, expiration date: 30 Jun 2018, dose, route was not reported) in left deltoid on 10 Mar 2017. The patient's medical history was not reported. It was reported that, the patient had no known drug allergies. Concomitant medications was not reported. It was also reported that no other vaccines given was given today. On 10 Mar 2017, 10 minutes following the vaccination, the patient experienced anaphylactic reaction, which consist of hot flash, nausea and left facial numbness. On an unspecified date, post vaccination, the patient experienced left arm heaviness, chest heaviness, and a burning sensation in her tongue. On an unspecified date, post vaccination, the patient experienced that right side of her lip was numb. The patient was sent to the emergency department for evaluation. Lab data included blood pressure was 142/93 and a CT scan was performed. Corrective treatment was not reported. The patient had not recovered from event symptoms Left facial numbness, left arm heaviness and Right side of her lip is numb. Outcome of other symptoms was not reported. Upon internal review, the company decided to consider the event serious due to important medical event anaphylactic reaction. List of documents held by sender: none.; Sender's Comments: Patient experienced anaphylaxis within ten mins of vaccination. Reported symptoms of hot flash, numbness in face and lips, heaviness in limbs and chest and burning sensation in tongue are consistent with anaphylaxis. Time to onset is compatible with the role of vaccine. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Information has been received from a female consumer with sulfonamide allergy who on 01-MAY-2006 was vaccinated with a dose of VAQTA (lot# 652507/0886R). The patient also noted that she may have received HAVRIX. On approximately 15-MAY-2006 two to four weeks after vaccination, the patient's liver swelled nd she experienced hepatitis symptoms. The patient also experienced exhaustion, pain and severe food sensitivity. The patient sought medical attention through a physician. Lab diagnostic studies performed included a blood test and hepatitis tests. The patient was not recovered at the time of this report. There was no product quality complaint. Follow-up information on 24-MAR-2008: The consumer reported she was told by the health department that she received HAVRIX (lot # "0886R"). Additional information has been requested.
(R) chest wall/back paresthesias/pain -> severe spinal pain, (R) leg and foot numbness. MRI showed demyelination T4->T11. Sxs started 4 days following Tdap vaccine. So far labs and lumbar puncture CSF results negative for other causes. Brain MRI negative for multiple sclerosis.
Patient fully vaccinated (Janssen), but not boosted, and admitted to the hospital with COVID-19 and associated hypoxia. Patient was discharged on 1/13/22.
Back pain; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), 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, lidocaine (ZTLIDO), topical from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for back pain. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced back pain (non-serious). The action taken in response to the events, for lidocaine was unknown. Outcome of the event was unknown.    This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 23-SEP-2016, the patient was vaccinated with GARDASIL 9 (dose, lot# and expiration date unknown) intramuscularly. On 28-OCT-2016, the patient was vaccinated with GARDASIL 9 (dose, lot# and expiration date unknown) intramuscularly. On 23-NOV-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose unknown, lot # M028323, expiration date: 26-SEP-2018) intramuscularly. No adverse effects were reported. Additional information has been requested.
The day the patient went in to get the shot she passed out in the floor and died; The day the patient went in to get the shot she passed out in the floor and died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient in her 20's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown" and all described as "The day the patient went in to get the shot she passed out in the floor and died". The patient date of death was unknown. The reported cause of death was "The day the patient went in to get the shot she passed out in the floor and died". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: The day the patient went in to get the shot she passed out in the floor and died
Aching discomfort per RUE s/p flu vaccination progressing to guarded ROM from date of vaccination, resolving as of 1/6/15.
Shortly after receiving vaccine, while sitting on table she became ashes in color, used ammonia inhaler but she passed out to lying down position on table. Ice was applied to neck and forehead. Mother was present. I was forewarned as pt. fainted with 1st HPV vaccine. About 20 minutes later pt. stated she was ok, left with family to go eat.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients might have been vaccinated with improperly stored doses of GARDASIL (lot # K011562 with expired date 08-APR-2017; dose and route were unknown). No concomitant medications were provided. No adverse effects were reported. This was one of two reports received from the same reporter (1510USA002079). Additional information has been requested.
PATIENT RECEIVED TWO DOSES OF PFIZER COVID VACCINE (2-19-21 AND 3-12-21). WE WERE NOTIFIED TODAY 7-22-21. I CALLED PATIENT TO DISCUSS ANY POTENTIAL ADVERSE EFFECTS BUT NO ANSWER/NO RESPONSE.
Excruciating pain in upper left arm; shoulder, radiating down to elbow. Headaches. Can't sleep. Can't lift arm or exert any pressure using arm. Originally thought was part of normal pain associated with shot but never got better.
Last night (L) arm went numb, tingling, & swollen. Difficulty lifting arm.