chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain in the neck), MUSCULOSKELETAL STIFFNESS (stiff shoulder plates) and ARTHRALGIA (pain in shoulder plates) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol and Blood pressure. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain in the neck), MUSCULOSKELETAL STIFFNESS (stiff shoulder plates) and ARTHRALGIA (pain in shoulder plates). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 24-Jan-2021 at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain in the neck), MUSCULOSKELETAL STIFFNESS (stiff shoulder plates) and ARTHRALGIA (pain in shoulder plates) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact.
It was reported that a 29 year old female patient received a Fluzone SV '01-'02 vaccination, lot UO601AA administered IM in the deltoid on 10/01/01 at 1:00 pm. Reportedly on 10/02/01 at 10:00 am, the patient experienced pain, redness, heat, swelling and a delayed rash at the injection site. Reportedly, the patient recovered from this experienced.
Patient received second dose. After about 5-6 hours started getting headache and blurred vision with black dots. patient then reported to ER. Last BP in the ED was 201/198
Excessively heavy menstrual cycle/off normal menstrual cycle/My menstrual cycle has been tapering off as; Now I'm having heavier flow an more intense cramping than anyother time in my life; Now I'm having heavier flow an more intense cramping than anyother time in my life; Information has been received from the patient via the FDA under the Freedom of Information Act (FOI Service Control# 6241256) on 19-DEC-2022.  This spontaneous report referred to a 49-year-old non-pregnant female patient (ethnicity). Prescriptions, over-the counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination was reported as ibuprofen (ADVIL) and multivitamins. Allergies to medications, food, or other products was reported as mild seasonal allergies. Other illnesses at the time of vaccination and up to one month prior was reported as none. Chronic or longstanding health conditions was reported as insomnia.  On 08-APR-2021 10:00, the patient was vaccinated with zaire ebolavirus (kikwit) glycoprotein recombinant vector vaccine (vesicular stomatitis virus) (ERVEBO) injection, Lot# ER8737, has been verified to be invalid (strength, expiry date and route of administration were not provided) for prophylaxis.  On an unknown date, the patient experienced excessively heavy menstrual cycle within a couple days of second dose, off normal menstrual cycle as well as the following (normal time) 3 cycles. Her menstrual cycle had been tapering off as 50. She was having heavier flow and more intense cramping than anyother time in her life. The patient had not recovered from the adverse events. Medical tests and laboratory results related to the adverse events was reported as none. The patient had no ever had an adverse event following any previous vaccine.  The causal relationship between all the events and zaire ebolavirus (kikwit) glycoprotein recombinant vector vaccine (vesicular stomatitis virus) (ERVEBO) was not provided.  Follow-up information has been received from a healthcare worker regarding the 49 year old female patient. The healthcare worker was unable to locate any information about this patient.  Furthermore, she said they had never administered zaire ebolavirus (kikwit) glycoprotein recombinant vector vaccine (vesicular stomatitis virus) (ERVEBO) at their facility, so they did not have a patient who received that vaccine.
tightening of throat and tongue within approximately 45 minutes  pt took benadryl and had epipen on hand if needed
Severe stomach cramps; diarrhea; This is a spontaneous report from a contactable other hcp (patient herself). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203, expiration date not reported), intramuscularly, administered in the left arm on 06Mar2021 12:30 (at the age of 31-years-old), as first dose, single dose for COVID-19 immunisation. Patient 's medical history was not reported and there were no concomitant medications. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced severe stomach cramps and diarrhea on 08Mar2021 00:00. No treatment was received as a result of the events. Patient did not seek consult to physician or urgent care. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Pt received the 2nd moderna shot and sat in the post vaccination waiting area for approximately 15 minutes. Pt  did not appear to have any problems prior to leaving  the area and did not mention anything to pharmacy staff prior to leaving the pharmacy area.  Pt was paged back to the pharmacy to retrieve her vaccination record card at which time she informed pharmacy staff that she was feeling dizzy. I went to speak with her she said she was feeling dizzy, said that her blood pressure was high and requested we call an ambulance for her.  She sat with her head on her arms on the steering wheel of the scooter she was driving . We provided her a bottle of water and she remained seated until EMS arrived.  EMS personnel asked her some questions, had her raise her arms up and down and then she climbed on to stretcher and they took her to the emergency room
Temp 100.8. Three days after receiving DTPA shot my child had 2 small petit mal seizures. I reported them to my doctor. A week later he again experienced seizures and passed out 2 times. An EEG or cardiac work up and CT was done - all normal. We were sent home. He had a petit mal seizure 6/7 and then 2 grand mal seizures 6/8. Started on Trileptal 6/10.  Medical recors state irritable, droopy, diarrhea, vomiting, cough.msv
Intense, shooting, intermittent pain in/below left inner ear/jaw area that came and went for about 3 days along with a mild sore throat Acetaminophen 500mg seemed to help eliminate for about 2 hours after taking, then didn't help My left inner ear would pop every once in awhile on its own and a dull pain persisted for a couple more days in my inner ear and back of my neck area. Seemed to go away for a couple days, then the right side of my head felt swollen and stuffed--but no mucous or anything. No intense shooting pain, just a constant dull ache in my inner ear that also could be felt on the right side of my face and back of my head/neck area. Lasted for close to a week. Doctor ended up prescribing antibiotics and diagnosed me with sinusitis. All symptoms went away after about 2 days of antibiotics.
Pt had eaten 1 hour prior to Vaccine. Pt received Vaccine w/o incident, Pt left clinic 25 min after receiving vaccine, pt ate 2 bites of a donut and slumped to the ground then went rigid for about 20 sec but was unconscious for 2 min. Pt was confused after the event and vomited twice on the way to the ED. Pt has had no problems reoccurring since the incident.
24 hours after getting vaccine, she noticed her arm was red, round, firm, hot to touch at injection site. No radiation, all local. She went to ER where she was treated with 10 days of BACTRIM DS and 3 days of prednisone 20mg bid. At follow up 4/15/14 - area is scabbed over.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions: one for 712 hours with lowest recorded temperature of 33 F (0.555555556 Celsius) and other one for 216 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
10 days after my 1st dose, I got a lump underMy armpit. It started throbbing and pain growing towards my shoulder blade. Pain worse; It started throbbing and pain growing towards my shoulder blade. I then noticed a big red spot on my back that also started to hurt. Pain worse/he stated I could have long term effects including pain; My armpit. It started throbbing and pain growing towards my shoulder blade. I then noticed a big red spot on my back that also started to hurt. Pain worse; I then noticed a big red spot on my back that also started to hurt. Pain worse; I went to my dr and he said I got shingles; he stated I could have long term effects including pain or nerve damage; This is a spontaneous report from a contactable consumer. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 04Aug2021 14:00 (age at vaccination 31 years) as dose 1, single for covid-19 immunisation. Medical history Known allergies to Penicillin. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient visited doctor or other healthcare professional office/clinic visit. On 15Aug2021 14:00 the patient experienced 10 days after her 1st dose, she got a lump under her armpit. it started throbbing and pain growing towards my shoulder blade. she then noticed a big red spot on her back that also started to hurt. pain worse, she went to her dr and he said she got shingles, he stated she could have long term effects including pain or nerve damage, he stated she could have long term effects including pain or nerve damage. Reporter stated, Pain worsened so she went to her doctor said it was probably a reaction to the vaccine given she had no other conditions to cause this and she Otherwise healthy. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 16Aug2021 Nasal Swab. Patient received treatment for reported events. she now have a 7 day medication and pain meds to manage this. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
At 10:20 student came to the health room. c/o chest pressure and pain in mid-chest color pink. No sob, no difficulty breathing, red blotches on face and nose, red and hard ear lobes, temp=98.6 HR=92, resp=20 BP=88/62.
Patient states that she had a quick onset headache, "pins and needles" type pain, and numbness of the face.
Arm began aching after yoga the evening of the injection. Pain occurring when lifting left arm continued down middle of front of arms for two weeks until reported to home health. Referral to MD. Patient saw MD on Friday 11/12/10. Patient states doctor said "immune response"; patient thinks possible "strain". MD prescribed heat and ALEVE according to patient. Patient conversation at approximately 3:00 PM 11/16/10.
Moderna on 2/25 and 3/25. Positive on 10/1
Severe Diarrhea (3days), Bloody stool (1 event in the 3 day period). Resolved after about 3 days.
1/17/2023 I had a cold with coughing and postnatal drip. I felt pretty decent. I did a home COVID test that was negative. I also had a COVID PCR test was negative. That evening I was achy, coughing and felt worse. By early morning, I began having trouble breathing. I called an ambulance; they gave me oxygen and took me to the hospital. My pulse ox was in the 80?s when I got to the hospital. I was given a breathing treatment and oxygen. I had a complete viral panel which was negative; Chest x-ray showed no pneumonia; CT of lungs, no blood clot; Echocardiogram, within normal limits. I had bloodwork and my WBC was within normal limits and my potassium was a little low. I was treated with albuterol, oxygen and a steroid shot. I was also prescribed antibiotics in case there was a bacterial infection, a Z PAK. I stayed overnight to be monitored. I was released to home on 1/19/23. My pulse ox stayed in the low 90-s for a week to two weeks and I had a cough that lasted at least six weeks. I have recovered.
severe softball swelling over the left deltoid along with mouth rash, followed by scaling and blistering of the skin and spreading erythema/  Treated with oral antibiotics with concerns for cellulitis after severe localized swelling and possible allergic reaction.
received the first dose of the vaccine/have pre-existing conditions having floaters and headaches. but there's an increase in frequency.; received the first dose of the vaccine/have pre-existing conditions having floaters and headaches. but there's an increase in frequency.; received the first dose of the vaccine/have pre-existing conditions having floaters and headaches. but there's an increase in frequency.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 67; Unit: Unknown) received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 (on the 07 or 08 of this month) at single dose for covid-19 immunisation.  Medical history included she had pre-existing conditions having floaters and headaches.  The patient's concomitant medications were not reported.  The patient received the first dose of the vaccine on the 07 or 08 of this month. She stated she had pre-existing conditions having floaters and headaches. This could be coincidental, but there was an increase in frequency. She asked if it was ok to get the second vaccine. She asked if there was any information on floater or blindness. She wanted to know if it was okay to take Benadryl. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult female patient who experienced flu like symptoms, nausea, vomiting, diarrhea, joint pain, left shoulder upper arm pain, heaviness and left neck swelling of lymph node, while she received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Aug-2018, the patient received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5882AA via intramuscular route in the left deltoid. The patient developed a non-serious flu like symptoms <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious nausea <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious vomiting <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious diarrhea <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious joint pain <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious left shoulder upper arm pain <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious heaviness <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious left neck swelling of lymph node <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Final diagnosis was left neck swelling of lymph node, heaviness, left shoulder upper arm pain, joint pain, diarrhea, vomiting, nausea and flu like symptoms. No corrective treatment was received. The patient outcome is reported as Recovering / Resolving for flu like symptoms, as Recovering / Resolving for nausea, as Recovering / Resolving for vomiting, as Recovering / Resolving for diarrhea, as Recovering / Resolving for joint pain, as Recovering / Resolving for left shoulder upper arm pain, as Recovering / Resolving for heaviness and as Recovering / Resolving for left neck swelling of lymph node.
COVID-19 Vaccine Reaction   Vaccine administered: Pfizer 1of2  1631, doing 30 minute observation for hx of reaction to abx  Patient reaction: Pt came to observation area requesting benadryl for c/o tongue and facial swelling reported by pt.   Action taken: 50 mg benadryl given PO at1700  Outcome:1706-VS stable, Pt hypertensive 158/86, pt reports Hx of hypertension, HR initially elevated in 90's, but decreased to 70-75 after 15-20 minutes, no stridor or respiratory distress observed.   1725- HR 73, BP 139/96 1727 - pt released to contact a ride home, pt reporting feels good to leave observation area. .  Doctor present and at bedside
Patient checked into vaccination clinic to receive 2nd dose of Moderna. RN vaccinator obtained Moderna vaccine and entered into her device all of the information. Then vaccinator reached into her Pfizer box and administered a Pfizer vaccine instead. Vaccinator immediately disclosed to patient what had occurred and reported to myself as the vaccine clinic supervisor.  Phone call to provider, who advised that they are both mRNA vaccines and patient should experience no issues. Patient should also obtain full 90%+ effectiveness. He advises patient to enter her information into the online information and that handout was provided to patient. Moderna dose was deleted from record and a new retroactive administration was entered into the system with the correct vaccine
Quadriceps reaction secondary to injection in the left thigh. Pt had limping for approx. 1 1/2-2 weeks. She was seen by orthopedist and told to follow-up in 2 weeks if symptoms persisted. Limping resolved.
I became pregnant around the time of administration of the third booster. Unknown if vaccine was given before or after conception. I was diagnosed with a blighted ovum at roughly 8-10 weeks of gestation and subsequently had a D&C. I have been unsuccessful at getting pregnant again.
I was diagnosed by Dermatologist with Pityriasis Rosea yesterday.  Onset of initial herald spot was about a week or 2 after second dose.
Upper lt arm very red, swollen, warm to touch; 4 days p/inject of TD;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications.   On an unknown date, the patients were vaccinated with improperly stored M-M-R II lot # M029230 with expiration date of 08-JUN-2018, lot# M037096 with expiration date of 23-AUG-2018, lot# M040624 with expiration date of 03-OCT-2018(rHA), lot# M029919 with expiration date of 13-JUN-2018 and lot# M035388 with expiration date of 02-AUG-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 3 hours. There were not previous excursions. Data logger was involved.  No adverse symptoms were reported. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001009: US-009507513-1705USA001228: US-009507513-1705USA001229: US-009507513-1705USA001231: US-009507513-1705USA001232:
JIA flare-up  (inflammation in jaw, knees, ankles) H. Sup flare-up (inflammation if skin, increase in active spots)
Headache,  fatigue,  chills,  fever,  horrible body aches.  2 days later arm extremely painful.  Red, warm, itchy,  swollen at injection site
Left hand will clinch but cannot open on command.  I have to drop my arm to hang and then the hand will open.   Hand will not stay open, fingers bend without prompting them to.  Grip is strong but fingers will not open.  No pain or tingling at this time.
getting an abnormal amount of HSV outbreaks, like almost daily; breakthrough infections; I'm miserable; This is a spontaneous report from a contactable consumer (patient). A 66 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, 66-year-old at vaccination) via an unspecified route, administered in Left arm on 24Feb2021 at 11:15 (Lot Number: EL9264) as Dose 1, Single and via an unspecified route, administered in Left arm on 24Mar2021 at 15:30 (Lot Number: E6955) as Dose 2, Single, both doses for COVID-19 immunization. The patient was non-pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. The patient's medical history included HSV (herpes simplex infection ailment for 40 years. No known allergies reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for Covid post vaccination. Since getting the Pfizer-BioNtech COVID-19 vaccine she had been getting an abnormal amount of HSV outbreaks, like almost daily.  She used to only get them about 3 times a year.  Normally she could manage it with a lot of L-Lysine.  But that doesn't even work anymore, relentless.  She had to get a prescription for acyclovir which she have to take daily.  Even with taking that, she would had breakthrough infections.  She didn't have any of these long term infections before she took the vaccine.  She had both doses; last one was in March 2021.  She have had this HSV ailment for 40 years and it had never been as active as it was now.  Ever since getting your vaccine.  It was the only new thing that she got that could be the reason for the numerous outbreaks. She was miserable. These Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received Acyclovir, 400 mg daily as treatment medication for the resulted events. These adverse events resulted doctor or other healthcare professional office/clinic visit. Device date was mentioned as 23Aug2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information was expected.
This spontaneous report as received from a other health professional refers to a 3 year old patient. On 05-AUG-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reprots received from the same source. Additional information has been requested.