chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Patient notes having rushed to the vaccination visit without eating/drinking or checking her blood sugar. After vaccination, she proceeded to go to her nephrology appointment and then to go shopping. On her way home driving (>4 hours after vaccinatino), she began to experience lightheadedness and then next remembers being surrounded by EMS and police and being told her blood pressure was low. At that time, she denies pruritus, flushing, angioedema, LOC, SOB, wheezing, palpitations, nausea or vomiting. Per chart review she was found to be driving erratically - with EMS reporting BP 60/30 initially and subsequent improvement to 80s/50s with administration of IVF. There was no LOC reported at/during the event, which was confirmed by Patient today. She notes having been observed o/n and then instructed to change some of her medications. Today, she states that she is feeling "ok". She again rushed to today's vaccination appointment, but had eaten toast and cocoa this morning. She has not yet checked her blood sugar. Discussed concerning adverse effects of vaccination, including anaphylaxis and immediate allergic reactions and ER precautions-for which she was able to state verbal understanding. She was provided with water and consumed a bag of trail mix while waiting for 30 minutes post vaccination. During the post vaccination period, she did not experience any side effects and was able to ambulate using walker out of clinic w/o difficulties.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first, second and the third dose of GARDASIL (Lot # unspecified) 0.5ml intramuscularly on 29-JUL-2009 and 01-AUG-2011. It was reported that the patient received the fourth dose of GARDASIL (Lot # unspecified) 0.5 intramuscularly on 01-AUG-2012 inadvertently. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
The patient said she felt light headed like she was about to pass out.  I asked her if she was nervous about the vaccine beforehand and she said yes she was.  After she sat around for about 30 minutes with me, she got to feeling back to normal.  She had 2 people with her to keep an eye on her, but she said she was fine by the time she left.
Information has been received from a physician concerning an adult female who in Nov 2005, was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. The physician reported that in Nov 2005, the pt developed injection site swelling and redness that extended onto her chest. The pt was seen in the ER, but was not admitted. In Nov 2005, the pts injection site swelling and redness resolved. Additional information has been requested.
DTAP was given when DTAP-HEPB-IPV was given. No adverse symptoms in the clinic. Tried to call pt to see how she was doing, no response. Left voicemail.
Pt had itching to back and arms post injection. No respiratory changes, no hives, no rash, no stridor or any other symptoms of an allergic reaction. Pt rested in chair for 45 min then felt better. Declined transport to the hospital.
I have a swollen armpit in the right arm in which I received the shot. It is sore but I have no other adverse symptoms at this point.
Swollen right arm, then left arm, lethargic , weaker, slow cognitive, more confusion. Right arm normal now, have left arm elevated request of hospice nurse. Thought it was Parkinson's but it came on all of a sudden, rather than a slower pace like Parkinson's would react?  Can't be sure, but thought it was best you have the report. More tremor in right hand but is slowing up.
Slight tingling and numbing feeling on side of face; numbing feeling on side of face; Face burning; This is a spontaneous report from a contactable consumer (who is also the Patient, reported for self).  A 38-years-old (non-pregnant) female patient received first dose of BNT162B2(Formulation: Solution for injection; Batch/Lot Number: EN6200; Expiration date: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 13:15 (at 38-years-old) as single dose for COVID-19 immunisation. Medical history included MTHFR (Methylenetetrahydrofolate reductase deficiency) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks. No known allergies. No covid prior vaccination.  On 05Mar2021 12:15 PM patient experienced Slight tingling and numbing feeling on side of face. Face burning. The patient did not receive any treatment. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
started vomiting; Massive headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 01Apr2021 at 15:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had known allergy to sulfa drug. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 02Apr2021 at 02:30 about 36 hours after the vaccine, the patient started vomiting and had a massive headache. The vomiting lasted for about 7 hours and the headache had not left as of 04Apr2021 09:00. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vomiting was recovered with sequelae on 03Apr2021. The clinical outcome of the event massive headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This study case was received from the investigator (MILVAX) on 23 January 2012. A 20-year-old male subject received ACAM2000 (lot number not reported) on 07 November 2011. The subject had no significant medical history. On 21 November 2011, the subject had an abnormal troponin I of 1.74, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 21 November 2011, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
pt had syncopal episode of 5 seconds followed by 1-2 seconds jerking motion of upper extremities;no post-ictal period;no incontinence;
As of Monday 23Mar I tested positive for exposure to Covid-19. I am asymptomatic; As of Monday 23Mar I tested positive for exposure to Covid-19. I am asymptomatic; This is a spontaneous report received from a contactable consumer (patient herself) of an age 40-years-old female non pregnant received Second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration on 24Feb2021 12:45 Pm in Arm left and first dose (Lot number: EM9810) on 03Feb2021 01:00pm in Arm right both as SINGLE DOSE for covid-19 immunization. The patient medical history was reported as none. Patient had known allergies with azithromycin and experienced drug hypersensitivity. No medication was taken within four weeks prior to vaccination. No covid test was done prior to vaccination. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken within two weeks prior to vaccination. On 23Mar2021 Monday, the patient tested positive for exposure to covid-19 and patient said that she was asymptomatic and not appeared to have infected anyone in family and contacts were also asymptomatic. No therapeutic measures were taken. On 22Mar2021 post vaccination, the patient underwent lab tests and procedures which included sars-cov-2 test, results positive as of Monday 23Mar2021 and informed to get re-tested on 26Mar2021. The outcome of the event was unknown.
Myalgia Narrative:  Employee reports all over muscle soreness and almost immediate onset s/p injection. Symptoms resolved within 36 hours.
Fatigue, headache, slight nausea, and moderate pain in arm at injection site.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# L039660, expiration date 04-FEB-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 32 and 35 Fahrenheit degrees (also reported as 34.2 F) for a time frame of 4 hours and 45 minutes; digital data logger was involved. There was not previous temperature excursion for the vaccine. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003209: US-009507513-1704USA003208:
Site: Pain at Injection Site-Mild, Additional Details: according to pt the pain on her right arm started about 2 days after injection. she had mentioned this to someone at one point. She complained about pain/tenderness, shooting pain sometimes from the inner side of her elbow going upwards, also had neck stiffness. A knot formed on the inside part of her elbow and it was tender for awhile and still is.
12JUN96 irritable Wednesday afternoon-1230AM 13JUN fever 103 ax for 2-3 hrs APAP & sponging;temp down to 101;14JUN t105 R saw MD-felt rxn to vax;fever down Saturday, irritable thru Sunday OK today 18JUN96;
Information has been received from a vaccine specialist concerning a 35 year old female with genital herpes who on 09-FEB-2007 was vaccinated with a single dose vial of Zostavax (Oka/Merck) (lot #656606/0033U), SQ.  Concomitant medication was not reported.  On 11-FEB-2007, the patient experienced a genital herpes outbreak about two days after being vaccinated with Zostavax (Oka/Merck).  It was reported that the patient had been previously diagnosed with genital herpes prior to the vaccination.  The patient sought unspecified medical attention.  At the time of reporting, the patient was recovering from the event.  There was no product quality complaint.  Follow up information indicated that the patient had recovered.  No further information is expected.
stomach sick; Left arm hurting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach sick) and PAIN IN EXTREMITY (Left arm hurting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L2OA) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cardiac arrest.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm hurting). On 17-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach sick). On 18-Jan-2021, ABDOMINAL DISCOMFORT (stomach sick) and PAIN IN EXTREMITY (Left arm hurting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Blood pressure medication, cardiac medication. Treatment details were not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Chills; He also received a positive; This is a spontaneous report received from a contactable consumer, for her husband. A 60-year-old male patient received first dose of (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Lot number: not provided, Expiry Date: Not Provided) via an unspecified route of administration on 26Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Report is not related to a study or program. The caller was calling about the Pfizer, clarified the vaccine for COVID. She said she and her husband received their first shot on 26Mar2021 and the next day her husband had the side effect of chills for a couple of days. She said on monday she still did not feel well, he went to work, someone at his work tested positive for COVID and he also received a positive. She reported that his quarantine is up, he is feeling better, and his second shot is on saturday 17Apr2021. She had heard you should wait, and you shouldn't wait. She asked should he get this shot on saturday or should he wait. She said she was at work and had been on hold and did not have time to file a report. Outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Tingling down legs and arms immediately after 1st shot.  Felt sensation up spine and around skull too.  Heart sensations.  Tingling in all limbs lasted for several weeks.  Heart sensations on and off.  Extremely tender breast for two weeks on top of fatigue.  Sat at clinic longer hoping symptoms would go away, never did.  EMT wasn't helpful (she didn't take my name, just said she needed to make sure I didn't get palsy of the face) so I left.  Made an appointment with my primary doctor and he didn't know how to advise since data not out.
Nausea, fatigue, and extremely sore arm started approximately 6 hours after injection. On 6/19 I woke up extremely tired and elevated heart rate of 100bpm, chest tightness,  fatigue, joint pain, headache, nausea. At this time I felt the worst but I did not check my temperature until later in the day. At around 4 pm my temp was 100 and my bpm went down to 90. I felt sick all day until it was time for bed again. On 6/20 symptoms seemed to have subsided. The injection site is still sore but has gotten better.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015 09:38, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date; 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.5 and 2.9 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
serious reaction to MMR; This literature marketed report was received from the authors of the published article as stated below, concerning a child (gender and age were not provided).  The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On unspecified date, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) for prophylaxis.   It was reported that after immunization, the patient experienced a serious reaction to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). At the time of the report, the patient's outcome was not provided. According to the reporter, the event of reaction to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) was considered medically significant (serious). The authors considered the event to be related to suspect therapy.  Literature article:
Awoke with 3 pustules on right side of face associated with right sided facial swelling. (pustules remain today, this RN questions whether bug bite or adverse reaction). Left arm painful, red & swollen.
sudden onset bilat arthralgia; PE-neg labs-decreased platelet; refer hematologist decreased C3-C4-prednisone therapy increased DS DNA; refer rheumatologist  8/15/08 Reviewed PCP medical records which consisted of consultant records & labs. FINAL DX: ITP & probable drug induced lupus Heme/onc records reveal patient experienced joint aching & bruising.  Tx w/steroids.  Rheumatology records reveal patient evaluated for possible lupus erythematosus. Patient experienced extreme joint pain & fatigue that started several weeks after vaccinations.  Then developed petechia on hands & feet which resolved w/steroids.  ALso w/mild dyspnea. Follow-up Information 26-JUL-2008: This is a follow up on our mutual patient. She was referred to me by your nurse practitioner for thrombocytopenia. Her platelet was running in the range of 30,000. She also had ecchymosis and arthralgia. I have ordered workup. At the time when I did the CBC it showed her platelet acount was 31,000. I have reviewed her peripheral smear which showed she had giant platelet. Her thyroid function test was normal. Her C3 was low at 57, normal is 90-207. C4 level was less than 5.0, normal is 17-52. B12 level was low-normal 230. Folic acid was 16. ANA was negative, but initially her ANA was positive which was ordered by nurse practitioner. H. pylori was negative. Hepatitis profile was neagative. Immunoelectrophoresis was normal. Anticardiolipin antibody was 6, IgG and IgM, but anticardiolipin IgA level was less than 6. Double-stranded DNA was high at 294. Lyme titer was negative. Anti Smith antibody was 2. I have started her on prednisone 60 mg daily. Her platelet count today is 266,000. She is accompanied by her mother. I actually also referred her to another doctor for evaluation of lupus. SHe had seen the doctor this morning. Her mother was also with her. Patient is my office nurse. Doctor thinks that it is due to Gardasil. We have reviewed the literature. Seems to be Gardasil can cause drug-induced lupus. On today's examination, her blood pressure is 98/70 which according to her mother is normal for her. She has no oral thrush. She has no petachiae. Her arthralgia has significantly improved. She has no pedal edema. Drug-induced lupus, possibly from Gardasil. Will taper off prednisone 10 mg each week. Will follow up lab work in about five weeks. I have discussed with her mother that if she develops thrush, she should call us. Otherwise, I will see her back in about five weeks. She will be having a weekly CBC to monitor her blood sugar, as well as her platelet count.
It was reported post vaccine pt developed a generalized maculopapular rash all over his body. The rash was slightly elevated, red, and pruritic.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Small side effects), FATIGUE (Tiredness), VACCINATION SITE PAIN (Injection site hurt), MYALGIA (Aches) and PYREXIA (Fever for a day) 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 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Small side effects), FATIGUE (Tiredness), VACCINATION SITE PAIN (Injection site hurt), MYALGIA (Aches) and PYREXIA (Fever for a day). At the time of the report, VACCINATION COMPLICATION (Small side effects), FATIGUE (Tiredness), VACCINATION SITE PAIN (Injection site hurt) and MYALGIA (Aches) outcome was unknown and PYREXIA (Fever for a day) had resolved. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.
Fever, extreme body aches, pain and swelling in left arm, inability to move left arm past 90 degrees, exhaustion.
Arm sore night of injection. Then 2 days later hives over body. Patient had previous Tetanus without reaction.
heart and chest pain, tinnitus, severe oressure in sinus area, headaches,  back/spinal problems, decreased mobility, brain fog, fatigue, emergency room visits,
Patient report that she has burst blood vessels in her feet and ankle area...both feet are having issues.. goes away and comes back
Dark pink, itchy, raised rash around neck, chest, and groin, trunk on front of body developed at 6pm the day following vaccine administration. Patient took benadryl 25mg at 09/05/2020 at 10pm and 2am and topical benadryl. Patient states rash is subsiding. 3:14pm rash still exists on groin.
This case was reported by a pharmacist and described the occurrence of injection site soreness in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine for prophylaxis. On an unspecified date on or before 10/18/05 and on or before 10/28/05 the subject received a dose of Fluarix. The site of injection of the Fluarix was not provided. On an unspecified date in 10/05, less than one month after vaccination with Fluarix, the subject experienced injection site soreness. The injection site soreness resolved on an unspecified date on or before 11/28/05.
This spontaneous report as received from a registered nurse refers to an unspecified patient. The patient received 3 doses of an unspecified Hepatitis B vaccine ((manufacturer unknown, RECOMBIVAX could not be ruled out) dose, route and lot# not reported) in approximately 1995 (reported as "about 20 years ago"). It was reported that the patient was recently administered 3 more doses of an unspecified Hepatitis B vaccine (manufacturer unknown, RECOMBIVAX HB could not be ruled out) on unspecified dates. No adverse effect was reported for this patient. This is one of the several reports from the same reporter (linked to 1501USA001237). Additional information has been requested.
The patient has a rash and inflammation at the site of injection that has swollen to encompass most of the patient's bicep and tricep.
Reporting fever and body aches for 2 weeks since 2nd dose Pfizer on 5/8. Pt reports difficulty breathing with chest congestion and some "swelling under tongue."Advised to seek emergency care or call 911. Pt and son verbalized understanding. Son stated he will drive his mother to the emergency department now
Within 2 days, the lymph nodes at my collar bone/neck on the left side began to swell. By the following Tuesday, I went to the ER for the enlargement. Routine blood tests showed nothing unusual (lymphoma). Was sent home to see my doctor if the swelling doesn't subside.  Scheduled an appointment with my PCM on 23 Apr 2021 (virtual - they are not seeing in-person patients yet). By this point, the swelling had not subsided and there was new pain in my left elbow shooting dow nto my hand.  The doctor prescribed Naprosyn, lidocaine patches, and a wrist brace to keep the nerves stable. Was told it was "pain management" until the swelling from the lymph nodes go down. It is now 6 weeks post-vaccine and the pain and swelling is still the same. I have been unable to secure an appointment with my PCM. For the past 6 weeks, my pain level has been at a steady 8 out 10.