chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of migraine in a 39-year-old patient who received BEXSERO for prophylaxis. The patient's past medical history included splenectomy (spleen was removed in 1997 at the age of 17 years). On 14th February 2019, the patient received the 2nd dose of BEXSERO. On 17th February 2019, 3 days after receiving BEXSERO, the patient experienced migraine, nausea, bedridden and headache. The patient was treated with TYLENOL. On an unknown date, the outcome of the migraine, nausea and bedridden were unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the migraine, nausea, bedridden and headache to be related to BEXSERO. Additional details were provided as follows: On 17th February 2019, by the evening the patient experienced migraine. The patient never experienced migraine previously. The patient was nauseous and bedridden for half the following day and had a constant, debilitating headache that never seemed to go away. The patient reported that, TYLENOL helps but cannot eat them like candy for the rest of life. The patient asked how long would these side effect last and what else can be told about the patient's condition.
Received 1.0 ml flu vaccine IM. Complain of soreness at injection site for 2 days and took Ibuprofen.
Pt received PREVNAR, ROTAVIRUS, PENTACEL vaccines at 1:30 pm. At 4:30 pm, pt developed high pitched cry-not consolable. mom noticed redness around immun site on L thigh. Seen in clinic 2 hrs later. Crying resolved after pt given Tylenol, Sweet Ease, and warm compress.
This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (2nd vaccination mistakenly scheduled for the Pfizer shot) and product availability issue (2nd vaccination mistakenly scheduled for the Pfizer shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Apr 13, 2021, patient experienced inappropriate schedule of product administration (2nd vaccination mistakenly scheduled for the Pfizer shot) and product availability issue (2nd vaccination mistakenly scheduled for the Pfizer shot). At the time of the report, inappropriate schedule of product administration (2nd vaccination mistakenly scheduled for the Pfizer shot) and product availability issue (2nd vaccination mistakenly scheduled for the Pfizer shot) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use and treatment information not reported.
About one month after the vaccine I developed hives and they tested me for allergies and I test positive for every outdoor allergy. I even developed an allergy to cats that I never had before. In May I developed joint, nerve, and muscle pain. My ANA blood work is positive, seeing a rheumatologist. The rheumatologist is labeling it as loose ligaments. In January I developed a blood clot in my lungs that wasn't provoked. February was seen for swollen thyroid. In October 2021 completed breast exam in right breast a cyst turned into masses and have it removed.
Injection site reaction.  Oval, egg-sized, raised, red, itchy area around injection site.
Headache, Myalgia, Fever, Angioedema,  face and hand swelling, fatigue advised to take benadryl and see pcp - took days off from work
I had it three times after the shot/ suspected vaccination failure; had it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Shingles three times after the shot. The patient stated that even if you get the shot the Shingles will occur but not as bad as before getting it. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
The evening after receiving her vaccination on 7/6/21, patient experience soreness in her arm.  Starting 7/7/21, patient  experienced headache, body aches, sore throat, fatigue, chest pain on the right side,  and her tongue felt thick and was sore on both sides (not swollen).
8:30 PM SOB and chest pain. Midnight-lips swelling, throat swollen; eyes matted and red and severe chest pain-went to ER. 2:00 AM was given ROBITUSSIN DAC q 4-6 hours/TOBRA DEX tid. 3:00 AM improved/dismissed from ER.
Pt called stating she received her second covid shot and her arm is very swollen and and spreading. Pt have already took benadryl and wants to know what else should she take?  Pt requesting an call from the provider. Moderate injection site reaction/allergic response. Swelling
Client presented for vaccination at county jail and was vaccinated with J &J Covid vaccine at 11:00 am without incident.  At 11:05 am client appeared flushed and diaphoretic. C/O nausea and dizziness.  BP 165/121; HR 121. Client repositioned, offered cool water and cloth and removed mask. MD on site assessed lungs and heart. 8 mg Zofran administered subq at 11:15. Client continued to complain of nausea and at 11:20 am complained of chest pain 3-4/10 with no change with repositioning. Jail staff called for ambulance to take client to ED for further assessment.  Client was transported at 11:50 am.
Patient reported the injection site was red and swollen, about 2 inches around. Patient also reported having severe itching (a 6 on a scale of 1 to 10) at the injection site.  Patient treated site with Benadryl topical cream covered by a gauze and Advil.
Very unsteady when the patient looked down to the point of falling; feeling very dizzy/lightheaded; nauseous; This spontaneous case was reported by an other health care professional and describes the occurrence of GAIT DISTURBANCE (Very unsteady when the patient looked down to the point of falling), DIZZINESS (feeling very dizzy/lightheaded) and NAUSEA (nauseous) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced GAIT DISTURBANCE (Very unsteady when the patient looked down to the point of falling), DIZZINESS (feeling very dizzy/lightheaded) and NAUSEA (nauseous). At the time of the report, GAIT DISTURBANCE (Very unsteady when the patient looked down to the point of falling), DIZZINESS (feeling very dizzy/lightheaded) and NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
The day after the vaccine was given I began experiencing the worst pain I'd ever experienced. On a scale of 1-10 it was easily between 18-20 from that day until the week point following the date of receiving the vaccine. I'm used to pain, being someone with more than one chronic pain condition but this was just off the scale. Then on the 8th day following the injection I woke up screaming, my scale doesn't go that high. However, I think it was a turning point, as my pain began improving from that point on. I'll admit I'm dreading the 2nd shot, but I will go through with it, otherwise what I suffered from the 1st shot was wasted effort.
pt recvd vax & immed p/vax exp burning on inj: it hurt when vaccine went into the muscle;sx subsided;
10 minutes after her first dose, pt described that she couldn't feel her "legs," had a "hard time breathing" and likened to a minor version of any dystonic and catatonic reactions she has had in the past.
Patient was leaving the health center after receiving his shots and fainted.  aroused when shook.  BP low.  Left in recumbant position until BP stabilized.  Had Orthostatic hypotension when attempting to sit up.  Took 45 minutes to regain normal BP and vision.
Pain from lower foot to up right side to shoulder; stiff neck 3 days;  extreme sore throat to present.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for few seconds after receiving flu and moderna vaccine. Patient woke up after few seconds. We are not sure if the patient fainted due to the vaccine as she mentioned this happens frequently in her normal actvities
Patient with history of asthma and diabetes type II was seen in the ED on 12/18/22 for evaluation of difficulty breathing, shortness of breath, cough, and chest pain. She was found to be hypoxic at 86% and required oxygen supplementation. COVID-19 PCR test performed in the ED returned positive. She was admitted 12/18/22 - 12/22/22 for acute respiratory failure with hypoxia, COVID-19, and acute exacerbation of COPD and asthma, among other diagnoses. The provider suspects the COVID-19 infection triggered a COPD exacerbation which caused her acute respiratory failure. Patient was able to be weaned to room air prior to discharge. She is fully vaccinated.
pt recvd vax;5 mins later exp ha & quizzy;that noc (3am) n,v,d,felt feverish; in am facial swelling & redness at inject site;
Body aches (arms, shoulders, armpits, hands, neck, back, butt, calves, feet), headache, brain fog, fatigue, skin sensitivity. Lasted through the evening and the full next day. Fine on 3rd day.
loss of taste; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccination (mRNA-1273) and who experienced loss of taste.  The patient's medical history was not provided. No concomitant medications were reported.  On 28-Dec-2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 28-Dec-2020, the patient experienced loss of taste.  No treatment information was provided.  Action taken with mRNA-1273 vaccine was not provided.  The outcome of the event, loss of taste, was considered unknown.; Reporter's Comments: This case concerns a female of unknown age who had a NS event of unexpected ageusia.  Event onset occurred the same day as the first dose of mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the ageusia, a causal relationship cannot be excluded.
Patient tolerated vaccines without difficulty. Approx 3-4 minutes after vaccines, fainted while walking around on floor. No injuries. Came to immediately (witness by nanny only). Oriented to place and person with a minute. Normal vitals and BP. Slightly shaky. Given lollipop and rested for 15 minutes. Discussed with father (on phone) and nanny. It took patient approx 30 minutes to feel back to normal. Walking well (running) and playful when left.
Swollen tongue, swollen throat, faint, face paralysis,  dizzyness, swollen eyes.
C/O sight pain shortly after receiving shot and awoke around 2AM with Temp of 103.1.
Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Additional Details: at 4:08pm 5 mins after giving shot, pt and mom complained of sweating and headache, put fan on pt while sitting and was fine after few minutes pt left with mom 4:18pm no issues
About 2 days after my third Covid booster shot, I started having episodes of racing heart rate and shortness of breath. This occurred at night when I was laying down, but came back periodically over the day. The episodes lasted about 10-15 minutes, and occurred about every few hours for the first 2 weeks. At one point, I felt so lightheaded, that I used my portable monitor, and it said my HR was 155 and my oxygen was 87%.  It is now 2 months after my COVID booster and I am still having episodes of high heart rate and feeling lightheaded, although the frequency is reducing to about twice a day, and almost always at night when I lay down.
I received my first dose of the moderna vaccine. About 10 minutes after the 15 minute observation period, I began to feel tingling and  pins and needle like sensation throughout my bilateral arms to hands. Also an itchy throat for 5-10 mins that resolved. Throughout the day the pins and needles seemed to be more generalized from my head,  torso to legs and feet. I continued to feel this through the night. I again continue to feel the generalized pins and needles the next day after my injection.  I didn?t think much of it until researching  that this may be considered a ?serious adverse effect?. I would like further direction if it is safe to go ahead with my second dose next month.
Red, raised rash on right arm 4 days after vaccine with burning and itching. Rash still faintly evident 2 weeks later despite antihistamines and hydrocortisone cream. At same time rash started, upper jaw pain extending to back of ear. Ear canal pain with ear fullness, and sensation swirling in ear moving outward. Noise sensitivity in ear as well.  All on right side. Had ears examined at clinic, there is no evidence of ear infection.
Vaccination failure; Sore throat; Body aches; Strain A on the flu; Flu/had strain A on the flu; This is a spontaneous case, initially received from other health professional (nurse) on 11-Mar-2019, concerning a 14-year-old, adolescent female patient.  The patient had no medical history. The patient had not received any concomitant medications.  On 25-Oct-2018, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) for active immunization against influenza.  On 09-Mar-2019 (Saturday), 4 months and 12 days after vaccination, the patient experienced a sore throat and body aches. On the same day, the patient consulted the doctor who confirmed that the patient had strain A on the flu (influenza A virus test positive) (considered as vaccination failure). On the same day, the patient started the treatment with Tamiflu (oseltamivir phosphate). It was reported that, the patient was not hospitalized.   The outcome of the events was not recovered.  This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QAI reference number was 1039510 for batch number 252664. Based on the investigation performed, it was concluded that Flucelvax 252664 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the Fill Finish or Bulk manufacturing process at the facility and no trend was identified for the batch. Therefore, no internal root cause could be confirmed.  The reporter assessed the case as serious (medically significant).  Follow up report received from Quality assurance department on 28-Mar-2019: Based on the investigation performed, it was concluded that Flucelvax 252664 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. The narrative was amended accordingly.  Non-significant follow up received from the reporter on 15-Apr-2019: It was reported that they had tried to reach the reporter on 18-Mar-2019, 25-Mar-2019 and 04-Apr-2019 but were unable to obtain the information requested. No additional information was received hence, no changes were made in narrative.; Reporter's Comments: A 14-year-old female patient experienced influenza infection (considered as vaccination failure), more than 4 months after receipt of Flucelvax QIVc. Time to onset is plausible following vaccination with the reported Influenza and vaccination failure events. Hence, company assesses the events as possibly related to suspect vaccine.
Sore arm after both vaccines; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose, dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. he patient medical history and concomitant medications were not reported. Patient mentions that she had a sore arm after both doses of the COVID 19 vaccine. Outcome of the event was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Approx. 36 hrs after receiving injection of Flu vaccine developed headache and body aches. R4lieved with Advil. Denied fever or cough. Headache persists to present (aa/14/05).
Both arms red, swollen, hematoma, hives from site of vaccine down arms.  No resp. issues.  Advised BENADRYL q 6 hours - call if no improvement.
This spontaneous report was received from a physician (also reported as "registered nurse (RN)") and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in July 2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date not reported). The second dose was administered on an unknown date in September 2016. On 19-OCT-2016, earlier than recommended, the patient was given the third dose of GARDASIL 9. No adverse effect reported. Additional information has been requested.
Hypersensitivity reaction - rash around injection site. Rash seen outlining bandaid. Injection given 8-12-10 at 3:40pm; upper left deltoid. Rash observed at 2pm 8-13-10. BENADRYL given.
Change in menstrual cycle. I've only had 1 period in 5+ months of having the vaccine. I was regular before the vaccine. No other changes in medication or major life events have happened at this time.
For the first 12 hours I got injection site pain and hot flashes. After 12hrs I started having severe muscle /skin pain, hot flashes, low grade fever (99.8 oral), burning and pain on my eyes, and joint pains (big and small) especially in my hands and feet.
Receive his MMR vaccination about 2 weeks prior and developed diffuse rash over chest about 10 days after vaccination.
This was my 2nd Shingrix vaccine so I was prepared, because the same thing happened on my 1st dose. After 4 hours, the 1st day, I started to feel achy.  That got to be so bad it was like I had the flu. That got worse through the 1st night. By the 2nd day I checked my temperature and it was 99.4. It fluctuated between 97 and 99.4. I was sweating a lot and trying to just keep as comfortable as possible, taking Ibuprofen. The 3rd day I began to feel better with less aches, and no fever. By the 4th day, good as new!
This literature report (initial receipt 18-Nov-2011) concerns a healthy patient aged in the mid 40's. The patient received trivalent inactivated influenza vaccine and developed neuromuscular weakness one day later. The event outcome was not reported.
Vaccine administered within 1-2min pt. start to wretch/no vomit, became clammy, pale, dizzy, eyes glazed, HR 82-96, RR 16-22, afebrile. Loss of tone, slight delay in response to questions. No loss of consciousness. Given juice, milk. Pediatrician called; instructed to monitor and attempt to feed patient. If no return to baseline within 30 min to call 911. Pt returned to baseline with improved tone and dizziness subsided = 1/2 hour. Color improved. Fully back to baseline within 2 1/2 hours.
8/02 Pt woke in a.m. with 3" - dia red rash and pain at injection site. 8/03 Rash expanded to 4" diameter with pain/itch. MD dx cellulitis & Rx KEFLEX 500 mg. 8/04 Rash expanded about 8" dia; ER MD ordered to continue BENADRYL, KEFLEX & ice. 8/05 Rash size stable, color fading, pain & itch persist, swelling visible.
Headache, Arthralgia, CoughWheeze, NauseaVomiting, Stomach pain, chest tightness, fatigue, chills Narrative:
Patient received 1st Moderna COVID vaccination, and had been sitting in the post-vaccine waiting area. He walked up to the consultation window and asked for a place to lay down because he wasn't feeling well. Person 1 asked the patient to be seated and told the patient she would come out and help him put his feet in a chair for elevation. The patient then began to kneel on the floor. Person 2 ran out to the patient, Person 1 retrieved the emergency supplies, and Person 3 called 911. Patient ended up laying flat on the ground, experiencing syncope, but did not lose consciousness. A cloth was placed under the patient's head, a cold pack was applied to his forehead, and his blood pressure and heart rate was checked. His first reading at 11:30am was 129/72 and HR was 53. Patient was pale and sweaty, but could answer questions. Before a next reading could be taken at 11:35, EMT's arrived and begun their care. They repeated his blood pressure check and checked his blood glucose. All readings were WNL. Patient did say that he had not eaten since early morning (eggs) and his just come from working out. Patient declined to seek further medical treatment and was released on his own recognizance.
This spontaneous report was received from a registered nurse refers to a 5 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with improperly stored doses of PROQUAD lot # M032497 22-JAN-2018. No adverse effects were reported. Additional information has been requested.