chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid vaccine administered on 5/20.   1704 - in observation room pt complained of feeling warm and a sore throat.   1706 - 50 mg Benadryl PO given, VS HR 93, POX 99, BP 128/68   1710 - VS HR 97, POX 98   1712 - pt states throat feels better.   1715 - pt states throat feels okay.   1720 - pt states she feels fine. No dizziness, throat all better.   1723 - VS HR 97, POX 99   1725 - VS HR 93, POX 98   Pt monitored by 2 RNs for 30 minutes throughout this encounter prior to leaving observation.
Patient came to get her second dose of Pfizer Covid Vaccine,  after receiving the vaccine,  patient reports that she had tightness in her throat after the first dose, but her VAR did not reflect  reaction to any previous vaccine. While waiting after the second vaccine,  she reports having tightness in her throat and this time it is worse than the first incident . We gave her 50 mg benadryl liquid, then epipen then called 911
MODERATE TO SEVERE SORNESS IN AFFECTED ARM FOR A 3 DAYS , FOLLOWED BY ONSET OF ERYTHEMA AND SWELLING (NOT EXCEEDING NEAREST JOINT) ON DAY 4.
During preparation of this dose, the GARDASIL 9 pre-filled syringe was not shaken at all; she developed flu like symptoms; muscle cramps ("which felt like pinching") throughout the body; a fever (temperature unknown); burning at the injection site; This spontaneous report was received from a pharmacist referring to a 32-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On unknown date in June 2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R025725, 25-MAY-2021); intramuscularly to prevent human papillomavirus (HPV) infection (prophylaxis). Immediately after this dose, the patient had burning at the injection site which recovered on unknown date (approximately in 2019).  On 19-AUG-2019, the patient was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R025725, 25-MAY-2021); intramuscularly to prevent HPV infection (prophylaxis). It was reported that the during preparation of this dose, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe was not shaken at all (product administration error). After that on unknown date in (approximately in August 2019), the patient developed flu-like symptoms, a fever (temperature unknown) and muscle camps (which felt like pinching) throughout the body. The patient was recovering from the events. No treatment was given for adverse events. No laboratory diagnostics/ studies were performed. The patient did not sought medical attention. No PQC (product quality complaint) present. The reporter's causality assessment was not provided.
Narrative:  Headache, Myalgia, Arthralgia, Nausea Vomiting, Fatigue, Chills, Flu-like symptoms.
I developed cold urticaria the day following receiving the second dose of the COVID vaccine, I know develop hives when outside in temperatures <37 degrees Fahrenheit and swelling and hives when touching cold objects. I was seen by a doctor who diagnosed this condition, and he believes it is directly related to the COVID vaccine.
Unexpected bleeding in menstrual cycle. After the unexpected bleeding, menstrual cycle started early after first Covid 19 shot when my menstrual cycle had been consistent for years.
The patient received the first dose of Jynneos intramuscularly instead of subcutaneously; Case reference number US-BN-2022-002270 is a spontaneous case report initially received on 06-Sep-2022 from a consumer via Communication (reference number: USBAV22-1289) and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at an unknown dose, administered intramuscularly, at an unknown site, for monkeypox prophylaxis (explicitly coded as 'inappropriate route of vaccination').  On an unspecified date, after unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: unknown) at an unknown dose, administered subcutaneously at an unknown site, for monkeypox prophylaxis.  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 06-Sep-2022 included local BN case ID.; Reporter's Comments: A male patient of unknown age received the first dose of Jynneos vaccine at an unknown dose, administered intramuscularly at an unknown site, for monkeypox prophylaxis (which is considered inappropriate route of vaccination). An unknown amount of time following the first dose, the patient received the second dose of Jynneos vaccine, at an unknown dose, administered subcutaneously at an unknown site, for monkeypox prophylaxis. Inappropriate route of vaccination is considered listed per company convention. The patient's relevant medical history and concomitant medications were not reported. Inappropriate route of vaccination is considered not related to the suspect product, but to human factor. No associated adverse events have been reported with the reported medication error.; Sender's Comments: A male patient of unknown age received the first dose of Jynneos vaccine at an unknown dose, administered intramuscularly at an unknown site, for monkeypox prophylaxis (which is considered inappropriate route of vaccination). An unknown amount of time following the first dose, the patient received the second dose of Jynneos vaccine, at an unknown dose, administered subcutaneously at an unknown site, for monkeypox prophylaxis. Inappropriate route of vaccination is considered listed per company convention. The patient's relevant medical history and concomitant medications were not reported. Inappropriate route of vaccination is considered not related to the suspect product, but to human factor. No associated adverse events have been reported with the reported medication error.
Pt is four years old and was given GARDASIL 9, MENACTRA, and BOOSTRIX. Pt reported no issues.
Vax was injected into pt's arm & when syringe/needle was removed, liquid ran out of pt's arm;
Pt received PNEUMOVAX 23 in upper left arm. After working outside all day doing yardwork, he woke up the next morning with a swollen and warm lower/upper arm. We referred him to his PCP who could not determine if it was an allergic rxn or a possible bug bite. Pt received a steroid from PCP.
Patient received his 1st dose and now wants to take his 2nd dose 90 days later; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received his 1st dose and now wants to take his 2nd dose 90 days later) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received his 1st dose and now wants to take his 2nd dose 90 days later). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received his 1st dose and now wants to take his 2nd dose 90 days later) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient wanted to take his 2nd Moderna vaccine 90 days later.  No concomitant and treatment medication was reported by the reporter.
Onset of pain injection, limited range of motion in right shoulder, pain when doing any movement. MRI results show two tears in my roator cuff resulting from the flu shot. Did cortisone shot and still doing 2-3 times a week of Physical therapy.
Overall body chills started about 10 hours after vaccine.  Raspy voice.  Coughed about 5 times (dry/throaty cough).  Headache and nausea started approximately 14 hours after vaccine.  Drooling during the night after vaccine (approx 11 hours after vacccine).  Bi-lateral hip pain throughout the night (approx 11 hours after vaccine).  Light headed the next morning (approx 20 hours after vaccine).
Vomiting started at 0130 am 11/29/21.  She continued with vomiting 6 times until around 0800 am 11/29/21. She was able to eat and drink a little with one last episode of vomiting at 2:30 pm on 11/29/21.
Increased swelling, erythema about 24 hours after with erythematous patch 12 3/4 cm. No fever.
Pruritic rash on hands, legs, groin and stomach <24 hours following vaccination that persists for 1 week.
A physician reported that a 22 month old male received a dose of Prevnar and within 12 to 18 hours following immunization, developed fever, vomiting and diarrhea. The pt recovered after 3 to 4 days. As of the date of this report, no further information was available. This is 1 of 2 reports from this facility of adverse events following receipt of Prevnar. See HQ0814314MAY2001.
6DEC95 presented @ ER w/szs--treated w/Valium & Phenobarb--venilator assisted-transferred to another hosp by air ambulance for adm to PICU;12DEC final dx sz d/t dehydration; diarrhea;
The patient initially had a large area of erythema and swelling the day following the vaccine which improved but did not fully resolve. Then 7 days after the vaccine, she experienced severe pruritis that actually woke her from sleep and had been scratching the area. It has now on day 8 become much more indurated and has grown in size, even during today.
Shortness of breath, low tolerance for physical activity (winded walking up & down stairs or talking for periods of time) fatigue has improved, nausea is improving but worsens with exertion. Reaction to first dose was similar, took about a month to feel completely better. First dose lot #032H20A Left arm, IM, 1/21/21.
I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fever.   On Saturday I was better but still weak and that is when cellulitis started in my left leg.  On March 7, 2021, I was seen in the ER.  I was given a shot and antibiotics and told to return if not better.  So on Monday, March 8, I returned to ER and then was admitted to the hospital.  I was allowed to go home on Saturday, March 13.  Since then I had two sores to develop on my left leg.  I had to have wound surgery on them on March 25.  I am a lot better but still not completely well.
Bad headache; Not feeling very well; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) and MALAISE (Not feeling very well) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Bad headache) and MALAISE (Not feeling very well). At the time of the report, HEADACHE (Bad headache) and MALAISE (Not feeling very well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
She developed itching of her hands at approx 4 pm which progressed to itching of the sides of her abdomen and sides of her face.  Her face became slightly swollen.  Eyes were burning .  She had one whelp on the left outer hand.  No trouble breathing or itching of her throat.   She took Benadryl and within 30 minutes all symptoms resolved.
pruritis, 4cm x 7cm wheal adjacent to injection site approx 4 hours after immunization.
Headache, redness and itchiness at  injection site, nausea; patient says side effects started immediately and lasted for 1 week
Complained of arm hurting all along-sterile abscess at injection site with mild erythema.
marked elevation of Antinuclear antibody; severe bilateral upper extremity pain at both shoulders and deltoid muscles; This is a spontaneous report received from a contactable physician (patient) .   A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) intramuscularly in the left arm on 09Apr2021 as a single dose for COVID-19 immunization, when the patient was 64-years-old.  Medical history included hypertension and migraine from an unknown date and unknown if ongoing. The patient had allergies to medications, food, or other products was reported, which was not specified. The patient receive other vaccines within 4 weeks prior to the COVID vaccine.  The patient had received other unspecified medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 17Mar2021, as a single dose for COVID-19 immunization.  The patient experienced severe bilateral upper extremity pain at both shoulders and deltoid muscles on in Apr2021 (reported as 08Apr2021, at 06:00) with outcome of recovering and marked elevation of antinuclear antibody on an unspecified date with outcome of unknown.  Details were as follows: severe bilateral upper extremity pain at both shoulders and deltoid muscles was noted. Patent labs included marked elevation of ANA 1:1280 - nuclear, fine speckled pattern, mild elevation of C-reactive protein (C-RP) 14, normal White blood cell count (WBC), Red blood cell sedimentation rate (ESR) 11, Rheum Factor was within normal limits. Reported event included severe bilateral upper extremity pain at both shoulders and deltoid muscles. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of severe bilateral upper extremity pain at both shoulders and deltoid muscles in form of treatment with tramadol (MANUFACTURER UNKNOWN). The outcome of severe bilateral upper extremity pain at both shoulders and deltoid muscles was recovering; the outcome of marked elevation of Antinuclear antibody was unknown.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-FEB-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L014458, expiry date 16-FEB-2015, 0.5 ml given intramuscularly. On 08-MAR-2016, the patient received another dose of PNEUMOVAX 23 lot # L014458, expiry date 17-FEB-2017, 0.5 ml given intramuscularly for the same indication. No adverse effects were reported. Additional information has been requested.
About 27 hours after vaccine, my husband?s arm hurt.  He also experienced the inability to get up easily off the couch and walk down the hall.  He was taking small steps and could barely walk and control his movements.  I held on to him as he tried to get to the bathroom.  All evening he had trouble walking and was unable to control his urination.  He could not hold it and peed down his pant legs.  This incontinence continued all evening and into the night.  He got up three times to use the bathroom that night while sleeping and could not hold his urination.  The next morning these reactions passed and he was able to walk and urinate normally.  He experienced fatigue over the next few days.  I would say he felt normal by Friday of that week.
sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Sep2021 (Lot number: EN3592) as dose 3 (booster), single and intramuscular, administered in arm left, administration date 25Feb2021 (Lot number: EN6200) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Polio", start date: 1950, stop date: 1951, notes: Pertinent details: Chemo & Radiation; "Rectal cancer", start date: 1998 (unspecified if ongoing), notes: Pertinent details: Chemo & Radiation; "Surgery", start date: 2008 (unspecified if ongoing); "Beneign neurofibroma neck", start date: 2008, stop date: 2008; "Right Bundle Branch Block", start date: 2017, stop date: Dec2017. Concomitant medication(s) included: TIMOLOL MALEATE; DILTIAZEM; METOPROLOLSUCCINAAT; DRONEDARONE; ATORVASTATIN; LEVOTHYROXINE; ASPIRINE; ALPRAZOLAM; OMEPRAZOLE; FLUTICASONE PROPIONATE; CIALIS; MAGNESIUM OXIDE; MULTIVITAMIN & MINERAL; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAMIN B COMPLEX; MELATONIN; DIPHENHYDRAMINE HCL. Vaccination history included: Bnt162b2 (Pfizer/BioNTech covid-19 vaccine details:, Dose: 1st, Date: 04Feb2021, Site and route of injection:, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: Lot EN5318), administration date: 04Feb2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "Sore arm to the touch". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Feb2021, outcome "recovered" (11Sep2021), described as "sore arm at injection site".  Additional information: The patient did not taken any other vaccine prior or within four weeks. She took concomitant as Vitamins/Supplements Medication: Fish Flaxseed, Borage oil-omega 3,6,9 Dosage: Omega 3 800mg, Omega 6 380mg, Omega 9 300mg with frequency Two daily am. On 26Feb2021 7AM and 10Sep2021 he had experienced sore arm at injection site for 1 day which was recovered.  He did not taken the event initiation of new medication/other treatment/procedure.  No follow-up attempts are possible. No further information is expected.
Headache, sweats began 06/22/2012.  Symptoms increased over two weeks, and then included nausea, shortness of breath, right upper quadrant pain.  Diagnosed with leukemia (AML) on July 9, 2012.  First Hep A injection given 11/18/2011, booster given 06/05/2012.
Chills, fever, body/muscle aches, headache, nausea, vomiting, exhaustion, loss of appetite. Symptoms started at 10:30pm the night of the vaccination and were severe until the following day around 5:30pm- for about 19 hours. Symptoms then began to subside. Now, about 54 hours after vaccination I still have a headache and mild fatigue. Symptoms are still subsiding/improving slowly.
Sensation of having a lightly burned tongue, mid tongue to tip; Sensitive tastebuds; the feeling that the tongue is slightly swollen; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown as did not look) via an unspecified route of administration, first dose administered in Left arm on 31Mar2021 at 10:30 (at the age of 26-year-old) at single dose, second dose administered in Left arm on 28Apr2021 at 10:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication included progesterone (PROGESTIN) and birth control. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sensation of having a lightly burned tongue, mid tongue to tip. Sensitive tastebuds, sometimes the feeling that the tongue is slightly swollen. No loss of taste. Happened several days after first vaccine in Apr2021 and lasted about a week. Happens again, 2-3 days after the second on 30Apr2021. No hospitalization prolonged involved. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Apr2021 for about a week, then reoccurred on 30Apr2021 with outcome of recovering.  Information on the lot/batch number has been requested.
At approximately 9:30 AM of 10/23/2020, I started to feel nauseous and light-headed.   Notes from Nurse Manager: At around 10 AM, I was notified of the employee's condition. Went to see her at the clinic, she was in the room with the provider and patient. She came out and she advised me that she drank water and feels a little better. At around 11 AM, she verbalized that she's no longer lightheaded since she's sitting. Employee declined the other supervisor's offer to seek medical consult. I advised the employee to call me ASAP if symptoms persist or worsen. She verbalized understanding and that she had my direct number.
Patient presented to clinic with red blotchy rash area over the right upper thigh. This rash was warm to the touch. Mom stated that baby seemed to be itching the rash area. Baby was recommended to be treat with BENADRYL per weight dosing by provider. Mom is to watch for worsening symptoms and notify clinic if needed.
I started my period very late that night into early the next morning and bled more than I have ever in my life and then it went to clots. Normally my cycle is like clockwork and never has anything like this happened to me in my life. I should have gotten my second shot today but won?t until I can have some explanation. I started my cycle again a few days ago. It isn?t as bad as the last but it?s not the same.
excessive crying; pain/burning with injection; This spontaneous report was received from a medical assistant and refers to a 2-month-old patient of unknown gender, whose medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for prophylaxis (strength, dose, frequency, anatomical vaccination site, lot number, expiration date, and route of administration were not provided).  On an unknown date, the patient experienced excessive crying and pain/burning with injection. At the time of reporting, the outcome of the events was not provided. The  The causal relationship between the events and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2303USA002529:same reporter link
Physician called Nursing service reporting a generalized rash with 1 or 2 vesicles. Rash was macula papular.
Case number PHEH2012US023870 is an initial spontaneous report received from a pharmacy student on 28 Nov 2012: This report refers to a female patient of unknown age group. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown)on an undetermined date five years ago. After vaccination she experienced swelling, warmth and pain in her upper arm. No further information was available.