chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low estrogen; can't concentrate/can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer reported same events under same the suspect product for 10 patients. This is 1st out of 10 reports.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on 30Apr2021 as dose 2, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on unspecified date as dose 1, single dose for covid-19 immunization. On unspecified date in Apr2021, the patient experienced low estrogen, can't sleep, can't focus, depressed, has anxiety and can't concentrate. Call received from patient who believe that she received the modern vaccine stating that since receiving her 2nd dose in April she has low estrogen cannot sleep, focus, depressed has anxiety and cannot concentrate she was tested and test prove that she has low estrogen she wanted to make sure to notify because this could impact people who want to have babies. her two nieces are waiting because they are young. Patient stated that she is thankful that she no longer wants to have children she went on to state that she is aware of 10 people who experienced the similar reaction and did not mention the nationality of other 5 upon request of the date of vaccination and lot number expiration date for the moderna vaccine patient realized that she called the wrong number because she received both losses of Pfizer vaccine first dose on 07Oct2021 and 2nd dose on 30Apr2021. Patient also stated that she called, because doctor does not believe her. Reported seriousness of the events was not life threatening, no intervention or medically important, not resulted in death, hospitalization prolonged, disabling or incapacitating, congenital anomaly or birth defect and no hospitalization required and also no other. The patient underwent lab tests and procedures which included estrogen results low on unspecified date in Apr2021. There is no product complaint associated with this case. The outcome of the events was unknown.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) :-PFIZER_INC-202101533632.
Redness and swelling at injection site and down arm to mid forearm. Patient had malaise and suspected fever although temp was not taken or recorded. At time of reporting, redness and swelling had receded to just past elbow. Patient reported feeling better.
Pt developed malaise, nausea, light headed, persisted till next day-  similar to reaction to first HPV vaccine in August.
On exam, on 9/22/00, arm was found to be red, swollen and warm to touch with some bumps. Child was playing as normal with no fever. Taken to PMD, who states child had scratched injection site and made it infected, no sign of general involvement.
About five minutes after vaccine administration, patient's mother noticed patient's left leg was noted red. Mother informed nurse and provider. Provider assessed patient and advised nurse to five 4 ml of benadryl. Nurse administered 4 ml of benadryl orally. Pt was kept in clinic for further observation. Patient's left leg redness subsided after benadryl administration and patient was discharge home with no other apparent distress.
Localized swelling and erythema, about 5-8 cm diameter, onset about 18 hours after injection. Seen in the office he following day. Acting normal, no systemic signs of illness such as fever, no signs of anaphylaxis or allergic reaction
weakness; feeling out of balance; missed second dose (88 days since first one); This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (weakness), BALANCE DISORDER (feeling out of balance) and PRODUCT DOSE OMISSION ISSUE (missed second dose (88 days since first one)) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), BALANCE DISORDER (feeling out of balance) and PRODUCT DOSE OMISSION ISSUE (missed second dose (88 days since first one)). At the time of the report, ASTHENIA (weakness), BALANCE DISORDER (feeling out of balance) and PRODUCT DOSE OMISSION ISSUE (missed second dose (88 days since first one)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
chills; Headache; Body Aches; Joint pain; Had to miss work; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (Had to miss work), CHILLS (chills), HEADACHE (Headache), MYALGIA (Body Aches) and ARTHRALGIA (Joint pain) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced CHILLS (chills), HEADACHE (Headache), MYALGIA (Body Aches) and ARTHRALGIA (Joint pain). In May 2021, the patient experienced IMPAIRED WORK ABILITY (Had to miss work). In May 2021, IMPAIRED WORK ABILITY (Had to miss work), CHILLS (chills), HEADACHE (Headache), MYALGIA (Body Aches) and ARTHRALGIA (Joint pain) had resolved.            Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable.
10-11 days post vax the pt experienced a fever for 2 days, and then severe body rash with several vesicles and extreme lethargy with anorexia for 3 days. Treated with Advil and monitoring.
Fatigue; Headache; fever (~100F); joint pain; chills; facial rash (flat, bright red rash on both cheeks and chin); This is a spontaneous report from a contactable consumer (patient).  A 32-years-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL8982), via an unspecified route of administration on 24Jan2021 at 12:15 at single dose in left arm for COVID-19 immunisation. Medical history included depression and anxiety. Concomitant medication included sertraline and buspirone, both from unknown date for unknown indication. The patient experienced fatigue, headache, fever (~100f), joint pain, chills, facial rash (flat, bright red rash on both cheeks and chin), all on 24Jan2021 18:30 with outcome of recovering. No treatment was received. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. This case was reported as non-serious.
On 12/23/09 receive phone call from the client complaining of reaction after receiving H1N1 vaccine. Client stated that she and her boyfriend received H1N1 vaccines at the same time on 12/17/09. Two days later she and her boyfriend had developed rash on the face "measles like" and painful and swollen lymph nodes under the arm on the side of the shot. Client stated that her boyfriend and she received preventive course of Tamiflu for five days prior to the vaccination because her daughter was diagnose with Swine flu.
Papular rash arranged in a circular fashion at the site of administration of the vaccines (VZV, MMR, PCV 13). She also developed rash on the posterior neck, face, buttocks and upper extremities. She also had URI symptoms and a fever to 101F at the time of onset of the illness.
pt recvd vax 17JAN95 & 2AM on 27JAN95 devel elevated temp 103 R; shortly thereafter pt had a tonic clonic convuls lasting 2 mins; pt was taken to ER; erythamatous eruption;
Muscle aches; Fatigue; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced muscle pain and fatigue. On an unknown date, the outcome of the muscle pain and fatigue were unknown.   It was unknown if the reporter considered the muscle pain and fatigue to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The patient experienced muscle aches and fatigue with 2nd dose. The reporter asked if anyone could have muscle aches and fatigue two weeks after the 2nd dose of shingle shot. Follow-up would not be possible as no contact details available.
Person c/o lightheadedness, "red sensation" after about 5 minutes post shot.  B/P 130/90. P 60, no c/o shortness of breath.  States did not eat this AM ad did take pain meds (not disclosed).  Continued to c/o lightheadedness, B/P 15 min after first: 138/92 P 60.  Person requested transport. Follow-up:  Person reports that he has a seizure disorder from a prior brain trauma.  He indicated that the ER Md gave him medication to "counteract the reaction to the shot".  He stated that several blood tests were done along with a CAT Scan.  Discharge Dx was "mild allergic reaction".
Suffered from a severe migraine for three days starting on the day of the 2nd dose. Had a low fever for the first two days. The following week, another 3 day migraine came back. Felt very fatigued for 3 weeks following the 2nd dose. On the 2nd week, my left arm broke out in purple bumps all around the injection site which lasted 2 weeks. Finally, on Thursday, 05/20/21, the left side of my face went numb. I went to an walk in clinic and was diagnosed with Bell's Palsy which I continue to suffer from today.
3b kidney failure; hands were swollen; numb (hands); not eating because she gets kidney pains; lost 10 pounds; essential tremor got much worse; cannot work a 5 day week; This spontaneous case was reported by a health care professional and describes the occurrence of RENAL FAILURE (3b kidney failure) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038k20a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis. Concomitant products included HYDROXYZINE, TOLTERODINE, URO MP, MELOXICAM and CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRIN) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL FAILURE (3b kidney failure) (seriousness criterion medically significant), PERIPHERAL SWELLING (hands were swollen), HYPOAESTHESIA (numb (hands)), RENAL PAIN (not eating because she gets kidney pains), WEIGHT DECREASED (lost 10 pounds), TREMOR (essential tremor got much worse) and IMPAIRED WORK ABILITY (cannot work a 5 day week). At the time of the report, RENAL FAILURE (3b kidney failure), PERIPHERAL SWELLING (hands were swollen), HYPOAESTHESIA (numb (hands)), RENAL PAIN (not eating because she gets kidney pains), WEIGHT DECREASED (lost 10 pounds), TREMOR (essential tremor got much worse) and IMPAIRED WORK ABILITY (cannot work a 5 day week) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included hydrochlorothiazide and propranolol.  Reporter states has current medical condition autoimmune issues, Interstitial cystitis, essential tremor, spastic pelvic floor, arthritis.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's current medical condition of autoimmune issues, interstitial cystitis, essential tremor, spastic pelvic floor, arthritis and product usage of NSAIDS remains confounders.
ActHIB is given with sterile water/no AE; Initial information received on 02-Apr-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years old male patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] with sterile water (Inappropriate reconstitution technique, PT- Product preparation issue).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 09-Mar-2020, the patient received a fourth 0.5mL dose of suspect HIB (PRP/T) VACCINE lot UJ116AAA expiry date 24-Aug-2020 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to product preparation error.  At the time of this report, no adverse event was 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 and Module VI of the 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.
Muscular/Shoulder pain on administered arm, lack of strength and flexibility resulting in tendonitis/bursitis. Physical therapy prescribed by physician.
On November 29, 2022, I experienced flashes and floaters in my right eye. I called my eye doctor. They referred me to a Retina Specialist. The following day, the Retina Specialist diagnosed me with Posterior Vitreous Separation. I'm still experiencing the same symptoms. They are being monitored. I have a follow up in January.
60 hours--fever-chills-sweats-vomiting(first night only)-migraine-muscle aches-joint pain-dizziness  I took Tylenol every 6 hours=-felt back to normal after 60 hours
heart rate elevated; body temp elevated; can't sleep well; tired; felt hot all the time; 1st herpes outbreak in 9 months; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN0171) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 41-year-old), as dose 2, single for COVID-19 immunisation. Medical history included chronic constipation, herpes, allergic to contrast dye, red dyes, milk products and penicillin. Concomitant medications included linaclotide (LINZESS), lysine (MANUFACTURER UNKNOWN) and linum usitatissimum seed oil (FLAX OIL), all for unknown indication from unknown date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 41-year-old), as dose 1, single for COVID-19 immunisation and experienced constipation and bad menstrual cycle. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced heart rate elevated, body temp elevated, could not sleep well, felt tired, felt hot all the time and experienced 1st herpes outbreak in 9 months. No therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included: heart rate elevated, result: elevated and body temp elevated, result: elevated on 21Apr2021. The clinical outcome of the event heart rate elevated, body temp elevated, could not sleep well, tired, hot all the time and 1st herpes outbreak in 9 months was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Agitation, Confusion, Headache, Sedation, Myalgia, Fever, RespDepression, Diarrhea, NauseaVomiting, Angina AWOKEN WITH FEET " LIKE ICE, NEVER HAD HAPPENED BEFORE" ORAL 102.0F Narrative: N/A
Information has been received from a Licensed Practical Nurse concerning a female patient with allergic reaction to antibiotics cefaclor who was vaccinated with a dose of HIB (date not reported). The nurse reported that the patient had an allergic reaction to HIB. This incident occurred years ago (date, year not specified). The patient recovered. No other information was available. Additional information has been requested.
Livedo reticularis reaction immediately after getting injection but faded well enough after 30 minutes. Sore arm with large lump, head ache, joint aches for several days following. Lump pain faded but lump area skin turned red and the itching began the second week following.  Should like to  note here that I don't recall getting an alcohol swab prior to injection, no band-aid afterward, protocol for people on blood thinners was not followed and no choice of arm offered.
Information has been received from a physician concerning a 20 month old patient with no drug reaction, no allergies, and no pertinent medical history who on 09-APR-2012 was vaccinated subcutaneously with a 5.0ml dose of VARIVAX (Merck) (LOT# 671126/1062AA, exp. date 05-Jul-2013). There was no concomitant medication. The physician mentioned on 21-APR-2012 the patient developed chicken pox. The child had 10 lesions and no fever. The patient had visited office to sought medical attention. At the time of this report, the patient had not recovered. Follow up information has been received from a physician who reported that the 20 month child female patient with no illness at the time of vaccination, no pre-existing allergies, birth defects and medical conditions was vaccinated with a first dose of VARIVAX (Merck) (671126/1062AA), IM, (previously reported as SQ) at 18:00. The physician described that on 24-APR-2012 at 18:00 (previously reported as 21-APR-2012) the patient experienced chickenpox, rash that had grown from leg to "over all body", decreased appetite and activity. There were no labs performed. At the time of reporting, the patient's outcome from rash that had grown from leg to "over all body", decreased appetite and activity was unknown. Additional information has been requested.
Swelling and redness at injections site. Nausea, low-grade fever (99.9 orally), chills, generalized body aches. These symptoms lasted for 24 hours. Localized redness and swelling has continued.
Information has been received from a registered nurse concerning a 13 year old female with no pre-existing drug allergies and medical conditions who on 10-APR-1996 was vaccinated with a dose of VARIVAX (Oka/Merck). There was no illness at time of vaccination. On 27-JUN-2008 the patient began to breakout on her back, head, arms labia and buttocks. The patient also had crusting which was painful and she could not sleep. The patient was using calamine, BENADRYL and MOTRIN. On 29-JUN-2008, ATARAX was added. On 02-JUL-2008, there was no new breakout. The patient was doing better. It was unspecified if the patient sought medical attention. Additional information has been requested.
Pt developed Guillian Barre syndrome after receiving the Shingrix vaccine. She was hospitalized 5/7/21 to 5/8/21
I had severe vomiting and diarrhea that started around three in the morning. I went into an emergency clinic to find out what this could possibly be and get something to help me stop vomiting and going to the backroom. The only explanation or diagnosis I received was that there was some kind of virus going around. I was given a prescription for ondansetron to help control the vomiting. I did take a home COVID-19 test the next day that came back negative.
A spontaneous non-serious report of burning the nostril, hurting and administered of half dose has been received from a nurse practitioner concerning a 10 year old female patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 19-Nov-2008, the patient received one-half dose of FLUMIST in one nostril. During the administration of FLUMIST, the patient complained of the vaccine burning the nostril and burning. The patient was not able to tolerate administration in the other nostril; therefore, the patient only received a half dose of FLUMIST. At the time of the report, the patient had no symptoms. The events of burning the nostril and hurting were recovered/resolved on an unspecified date in Nov-2008.
Hives, nausea/vomiting, local muscle induration w/ in 24 hours. Fevers approximately 8 hours after vaccines.
The patient is a 46 yo F who has a history of pemphigus vulgarisms in 2019 s/p one cycle of Rituxan completed in August 2019.  She had significant improvement and was last seen in my dermatology clinic 11/2019.  She had not followed up until this current visit.  Patient then again presented to me on 6/14/2021.  On this date she presented with a severe flare of her pemphigus vulgaris affecting her scalp, trunk, extremities, mouth.  The patient reports that she had essentially been in remission from the pemphigus from when I last saw her in 2019.  However, she says she received the first dose of the Moderna vaccine on May 23, 2021 and then approximately 1 week later (aprox June 3) she developed this acute flare of her pemphigus.  I have asked her several times if she had any blisters or erosions prior to the Moderna vaccine.  She states that she had zero blisters prior to the Moderna vaccine.
Within hours post 2nd vax, pt developed bloody drainage out of Left ear and clear/yellow fluid from right ear. He lost hearing in his left ear one day post vax which lasted approximately 1 month. It began to improve in February but has not returned to normal as of 03/16/00. Pt has been seen by ENT, neurologist, primary physician, and neurosurgeon. Has been treated with Augmentin, ciprofloxacin and another unspecified antibiotic. Has symptoms of carpal tunnel syndrome in wrists. Had reported intermittent blurry vision lasting 2-3 minutes affecting primarily close vision starting in approximately late February, 2000 and is ongoing. Has received steroid injections in wrists as of March. Took ibuprofen 1200 mg/day when symptoms were very bad. This report is considered to be medically serious. Medical confirmation is being sought. Most recent information received 03/16 reports that pt still had cough, sinus problems, wrist pain and decreased hearing in left ear. It is still unknown if he still has pain in hands, fingers, or numbness in his hands and fingers. Flu-like symptoms, fever and swelling at injection site resolved. Blurry vision is ongoing.   Follow-up information received on 8/7/00 states that the pt had right ear cerumen, left ear otitis media and slightly decreased hearing, left hand severe pain and numbness, righ thand minimal pain, toes occasional numbness, and some orthostatic symptoms.
HYPERgylcemia SCRATCHY THROAT, ELEVATED BLOOD GLUCOSE BY 50
2 red bumps (1/2") appeared on thigh near injection site. No fluid filled blisters. Mom states she left the bandaid on "a long time".