chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her menstruation never came back; menstrual disturbances; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (COMIRNATY), administration date 10Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "tubal ligation" (unspecified if ongoing); "lot of stress" (ongoing), notes: lot of stress. Date of last menstrual period: 09Sep2021. Concomitant medication(s) included: APPLE CIDER VINEGAR.The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 2021, outcome "unknown", described as "her menstruation never came back"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "menstrual disturbances".  Additional information: Caller stated that she got the first dose of the Pfizer Biontech Covid-19 Vaccine on 10Sep2021 and a day before the vaccination was the last time that she had her menstruation and her menstruation never came back after. Caller also stated that her menstruation was regular before the shot and the only thing that she is taking in is apple cider vinegar and some other Vitamins. Caller also stated that she is not pregnant as she had ligations done. she is also under a lot of stress and has been under stress most of her life and has not missed a period and had a tubal ligation, so she is not pregnant; no further information provided by the caller. there is no information on dizziness and palpitation as an AE after getting the Pfizer BioNtech Covid-19 Vaccine. Spoke from reports of menstrual irregularities (US) Although not specific to Comirnaty or Pfizer-BioNTech COVID-19 Vaccine, withheld COVID-19 Vaccination Considerations for withheld that there have been anecdotal reports of temporary changes in menstruation patterns (e.g., heavier menses, early or late onset, and dysmenorrhea) in individuals who have recently been vaccinated for COVID-19. While environmental stresses can temporarily impact menses, vaccines have not been previously associated with menstrual disturbances. withheld will continue to monitor and evaluate available evidence on this issue. withheld has placed a special call for research focused on this issue. Also, an open survey to gather qualitative data on post-vaccination menstrual patterns has been initiated. Additionally, there is no reason for individuals to schedule their vaccinations based on their menstrual cycles; vaccines can be given to those currently menstruating. Yes is Pfizer COVID Vaccine a Pfizer product. Age was 43 Years Old. Patient medical history was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt had prolonged crying spells lasting 6hr starting 3 days p/vax lasting for 72hr
BP 180/100 , repeat 170/90  Pulse Ox 96  While sitting in observation pt reported having an itchy area on her left wrist. Pt reported a history of CT Scan Contrast Dye and seasonal allergies. Pt was evaluated by EMS paramedic. Pt declined transport to the ED despite recommendation and education on precursor to anaphylaxis. Pt signed refusal with EMS. Pt reported she often gets itchy for no apparent reason.  Pt stayed at clinic in observation for over 45 minutes with no progression of itchiness or other symptoms. . Pt was given ED precautions.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was unknown. On 10-SEP-2014 the patient was vaccinated with first dose of PNEUMOVAX 23 (lot number: unknown with expiry date 31-JUL-2014), 0.5 ml, intramuscular. On the same day, patient was vaccinated with second dose of PNEUMOVAX 23 (lot number and expiry date unknown), 0/5 ml subcutaneously. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 ws not reported. Product quality issue was not involved. Additional information has been requested.
I had a mild amount of discomfort, as expected, following the injection. The next day, I had quite a bit of aching and soreness at the injection site which seemed similar to previous flu shots I have received. This pain has not gone away since the injection date and has gotten worse.
Mild fever and trouble sleeping on first night, followed by horrible night of non-stop screaming for 3+ hours, called doctor, took to emergency room and was given Tylenol and ibuprofen and told to take them each every 4 and 6 hours, respectively.  Diagnosis was combo of teething and flu shot reaction.
ER 1 day later with high fever and febrile seizure. Negative for flu.
Mini-flu; Headache; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Mini-flu), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008B21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-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 INFLUENZA (Mini-flu), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, INFLUENZA (Mini-flu), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.      No concomitant medication were reported.  No treatment information was reported.
At off site flu shot clinic today, I inadvertently administered the FLUZONE Intradermal twice to this client. I observed no redness or "wheal" at all. So I though that the shot was invalid. When I reviewed the prescribing materials, it stated that redness and/or wheal might occur. It didn't say it must occur. I then administered a second dose to the opposite arm.
I have experienced regular, persistent and disturbing hiccuping  since shortly after receiving this second dose of COVID19 Moderna vaccine. This continues to this day.
diarrhea; after both vaccines she experienced a sore arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE PAIN (after both vaccines she experienced a sore arm) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q29K20A) for COVID-19 vaccination.     Concomitant products included DOFETILIDE (TIKOSYN), METFORMIN, INSULIN GLARGINE (LANTUS), METOPROLOL SUCCINATE and APIXABAN (ELIQUIS) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE PAIN (after both vaccines she experienced a sore arm) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), VACCINATION SITE PAIN (after both vaccines she experienced a sore arm) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-231100 (Patient Link).
pt has local reaction very big  indurated area very tender initially ice applied but no improvement.  Next day given warm moist compressions which made comfort improved. Also given benadryl.
Friday - 05/14/2021    - I took the second dose of the vaccine at 4:30 pm   Saturday - 05/15/2021  - I woke up at 9 am with the vaccine side effects (Fever, headache, weakness and pain in the arm where the vaccine was applied) and took 2 Advil 200mg (Equate brand).  - 3 pm, the effect of the pill has passed and the reactions of the vaccine have not..I took 1 more Advil 200mg tablet.  - 9 pm I took 1 more Advil 200mg tablet.  Sunday - 05/16/2021 I woke up without reactions.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Fainting / Unresponsive-Medium
Pt ran high fever of 103 for 3 days following influenza injection (1st dose received, fever started following day).
severe local react rt arm secondary to pneumovax; systemic react w/hypotension, dizziness, nausea;
Weakness, syncope, increased nervousness (Has hx of syncope since child, has gotten worse since receiving GARDASIL).
flu shot given 27OCT92; noticed rt eye tearing & some swelling of lids that noc; rt eye only; still some mild swelling of medial aspect of upper lower rt lid the next day;
Sore and itchy at site of vaccination; Redness 1" diameter around site of vaccination.
pt recv vax 18OCT95 & 2wk post vax pt devel irritation of eyes;29NOV95 pt presented to ophthalmologist who dx episcleritis of the eye w/hematoma;
This infant was seen in the clinic on 03/28/01, diagnosed with bilateral  otitis media. He was also given DTaP #4, IPV #3, Hib #4, Varivax, and PCV #1. Seen on 04/13/01 with petechiae, platelet count <1, diagnosed with Idiopathic Thrombocytopenic Purpura, hospitalized for 3 days, IVIG Win-Rho. Also diagnosed with anemia. Mom states on 05/09/2001 that child is recovered from her point of view, scratches are healing okay
interstitial cystitis; after this latest booster, it has been very uncomfortable/had to add other forms of therapy to try to control the pain & spasms; uncomfortable; spasms; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "interstitial cystitis" (unspecified if ongoing), notes: had been well under control for years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Primary Immunization series completed., I received all of the Pfizer COVID vaccines.), for COVID-19 Immunization, reaction(s): "I did not have with the previous doses"; Bnt162b2 (DOSE 2, Primary Immunization series completed., I received all of the Pfizer COVID vaccines.), for COVID-19 Immunization, reaction(s): "I did not have with the previous doses". The following information was reported: CYSTITIS INTERSTITIAL (non-serious), outcome "unknown", described as "interstitial cystitis"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "after this latest booster, it has been very uncomfortable/had to add other forms of therapy to try to control the pain & spasms"; DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortable"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "spasms"; PAIN (non-serious), outcome "unknown". Therapeutic measures were taken as a result of cystitis interstitial, condition aggravated, discomfort, muscle spasms, pain. Additional information: Patient received all of the Pfizer COVID vaccines, including the most recent booster shot. Patient had a reaction to this booster that did not have with the previous doses. Patient has interstitial cystitis that had been well under control for years, but after this latest booster, it has been very uncomfortable. Patient had to add other forms of therapy to try to control the pain & spasms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5 cm x 6cm, erythematous lesion, blanching, slighlty warm, nontender.
Patient reported that approximately 1 week after 2nd vaccine she had red itchy rash appear on left arm that spread to hand, other arm, and also feet.  Rash goes away and then repeatedly comes back.  Patient reported adverse event to Pharmacist on 9/9/2021 after it had been occurring for 2 weeks.  She had looked up side effect online and read that it was common with the Moderna vaccine and her rash was similar to pictures she saw.  Pharmacist advised patient to seek medical treatment for rash and she was making Dr. appointment for later that day.
Patient could not move arm and had swelling and warm the next day. After 2 days she could move the arm but was still swollen and painful. She went to er and was given Keflex for cellulitis.
10/11/21 7pm -Chill nausea joint pains headache started   10/12    12pm approx. -nausea resolved 10/13  still with  joint pains
localized inflammation @ site of inj w/appearance of cellulitis w/in 48hr of the inj;
high readings in blood pressure on Monday, Tuesday, and Wednesday-  4 readings taken each day- 178/100 , 174/103, 175/106, 163/93, 175/101, 162/103, 185/105, 177/103, 171/98  starting thursday morning, all subsequent readings back to normal-  124/78, 113/78,  etc. everything fine now There had been no change in daily diet nor medication to cause the high readings, all started a couple of days after 1st dose of vaccine
1 of 3 pts vaxed from the same vial who exp a localized, erythematous rash @ inject site w/in 24-48 hrs p/vax; size of react approx 7-8CM; treated w/DPH;
Pt recieved dose and after sitting for a few minutes started to sweat and convulse pt regained awareness shortly paramedics called and patient was transported to receive care
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted and was passed out for ~30 seconds but resumed consciousness soon after. 911 was called and firefighters arrived to the scene and assessed patient. His vitals were normal. Patient declined further medical attention.
12 days after inoculation I had a severe allergy, accelerated pulse, high pressure, panic attacks, heat sensitivity.
Information has been received from a physician concerning a patient who was vaccinated with PROQUAD developed severe swelling at the injection site. No other information was available. Additional information has been requested.
Right after the shot the client started having heavy , red, clots, and menstrual bleeding like a very heavy perios which was unlike anything she had experienced.  Heavy bleeding for 5-6 days, severe bruising on arm where vaccine was given, fatigued, very painful for the duration of the bleeding, Had a CAT scan a couple weeks later for a head injury, in the hospital for a week for observation, had multiple blood draws for tests, had ultrasound and eventually MRI.  Has been seeing doctor monthly for follow-ups.  Doctor would like her to receive the 2nd shot but she is hesitant for fear of more bleeding side effects.  Since the shot her menstrual bleeding is not the samt as before.
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Patient reported that after using shingles vaccine patient experienced headache.
It was like a cold, I had congestion, coughing, no shortness of breath. I used a home COVID-19 test that came back positive. I called my oncologist to consult with him about my positive test result. He called me in a prescription of the PAXLOVID, I started taking it immediately, within three days I was feeling better.
Ulcers on tongue; Swollen lymphnodes; Armpit pain, left; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 (Lot number: 33130BA/3313OBA) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , NDC/expiration: Jun2021, Lot: EP6955, Site: left arm), administration date: 27Mar2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, NDC/expiration: Jul2021, Lot: EW0153, Site: left arm), administration date: 17Apr2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Swollen lymphnodes"; AXILLARY PAIN (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Armpit pain, left"; TONGUE ULCERATION (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Ulcers on tongue".  Additional information: Patient did not have any additional vaccines administered on same date of the Pfizer suspect. Patient did not require visit to emergency room or physician office. Patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Patient did not have AE(s) following prior vaccinations.
Vaccine-9AM 6 PM back hurt I am collapse to floor - wheelchair 24 hrs. Walker 6 days - walk with difficulty thru 10-1-16 today 10-7-16 not 100% maybe 75% (chiropractor and family Dr.) (back X-ray) nothing unusual.
pt recv vax 230PM 8OCT98 by 10OCT98 rash appeared on back of hand & arm of vax in morning;by afternoon;rash appeared on chest, abd, back of legs;
Aches and sore all over; Headaches/ developed headaches; Fever; Very tired/ extremely tired; Increased indigestion; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732/ER8729) via an unspecified route of administration in the arm left on 13Apr2021 at 10:00(at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient did not receive any other medications within 2 weeks of vaccination. Past drug history included hazelnut. 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 13Apr2021 at 18:45 the patient was extremely tired and on 14Apr2021 patient experienced aches and sore all over, headaches and fever. On an unknown date in Apr2021 (over the next two weeks) the patient experienced increased indigestion, nausea and diarrhea. The clinical outcome of the events extremely tired, aches and sore all over, headaches, fever, increased indigestion, nausea and diarrhea were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Patient was vaccinated with Pfizer on 3/18/21 and 4/8/21. Patient has been admitted to hospital for COVID since 1/19/22 after presenting with lethargy and weakness
12 months old with pink confluent macular rash. Afebrile, exam otherwise WNL>
prednisone x 5 days unable to lift arm (shoulder to hand) L L hand tingles/numb at times left deltoid
This is a  18 Years old  Female  presenting with chest pain for [a couple hours last night]. Pain started [gradually]. It is described as [dull and aching], radiating into [nowhere]. Pain is described as [moderate] upon onset and is currently [mild]. [No] history of the same. Pain [is not] worse with exercise. Patient [has no] decrease in exercise tolerance recently.  Patient states that she received her second dose of her Pfizer vaccination 3 days ago, and last night she started to experience chest pain, headache, palpitations, and shortness of breath, and feeling dehydrated.
INCAPACITATED; FATIGUE; VOMITED; FAINTED; FLUSHING FROM ARMS UP TO THE NECK AND THEN INTO THE FACE; BED RIDDEN; This spontaneous report received from a patient concerned a 69 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802070 expiry: 23-AUG-2021) dose was not reported,1 total, administered on 10-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient within twenty minutes of receiving the shot experienced flushing from arms, up to the neck and then into the face, fainted, after being revived patient vomited. On 11-MAR-2021, the patient experienced fatigue and incapacitated. On an unspecified date in MAR-2021, the patient experienced bed ridden for three days and no change in patient lifestyle. The action taken with covid-19 vaccine was not applicable. The patient recovered from fainted, flushing from arms up to the neck and then into the face, and vomited on 11-MAR-2021, incapacitated, and fatigue on 18-MAR-2021, and bed ridden. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210944286 -JANSSEN COVID-19 VACCINE fainted -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Warm to the touch IS; Redness IS; Swollen IS; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch IS), INJECTION SITE ERYTHEMA (Redness IS) and INJECTION SITE SWELLING (Swollen IS) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch IS), INJECTION SITE ERYTHEMA (Redness IS) and INJECTION SITE SWELLING (Swollen IS). At the time of the report, INJECTION SITE WARMTH (Warm to the touch IS), INJECTION SITE ERYTHEMA (Redness IS) and INJECTION SITE SWELLING (Swollen IS) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR added. Reporter said it's been a while those reactions happened. She doesn't want to do any follow up as she is fine.
6:59P right intestinal movement 7:01P left upper thigh ache 702P feet tingly 10-11P absent minded  Friday and Saturday night, body temp was warmer than usual but no head fever Missed menstrual cycle date
First shot received on 4/3/21, and second received on 4/24/21. Symptoms of cold, tingling, and numb left toes and left foot noticed about 2 weeks after 2nd Pfizer dose. Went to ER and blood clots were found in arteries in left knee and ankle, and clots in the vein in left calf.  Four procedures performed by Intervention Radiology (IR) at Hospital on 5/25/21, and was treated with Heparin and TPA. Released from hospital with clot remaining in left calf vein and is taking Eliquis. Continuing treatment with hematologist post release from hospital.
STARTED FEELING WEAK ABOUT 10 MINUTES AFTER SHOT; FELT WARM; HAD A DULL ACHE IN HER HEAD; WAS SHAKY WHEN SHE WALKED AND SHE WAS TAKEN TO THE EMERGENCY ROOM. B/P WAS 140/82 SITTING AND 173/92 WHEN STANDING