chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The back pain was constant. If he is sitting, it's bearable, but moving makes it worse; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (The back pain was constant. If he is sitting, it's bearable, but moving makes it worse) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced BACK PAIN (The back pain was constant. If he is sitting, it's bearable, but moving makes it worse). At the time of the report, BACK PAIN (The back pain was constant. If he is sitting, it's bearable, but moving makes it worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 17-AUG-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot# N027781; expiration date: 08-AUG-2019 (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Burning Lip Sensation for 7 days Scratchy throat for 2 days oral thrush for 7-10 days with medication took nyastatin, difluocam and chlorhexidine
This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 11-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot # K006805 and expiry date:24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
the day after the vaccine I got a headache that became a terrible Migraine that lasted for 4 day, subsided and then  returned. It was bad and I did call  and spoke to the nurse and doctor. I vomited for 4 days. I am a little better but this is day 6 and I am still dizzy and have a slight headache
This case was reported by a nurse via call center representative and described the occurrence of chest heaviness in a 16-year-old female patient who received BOOSTRIX (batch number AH4LF, expiry date 8th July 2018). Co-suspect products included CERVARIX (batch number BF7A2, expiry date 28th May 2016) and MENVEO (batch number M15099, expiry date 30th March 2017). On 18th April 2016, the patient received BOOSTRIX, CERVARIX .5 ml and MENVEO. On 18th April 2016, several hours after receiving BOOSTRIX, CERVARIX and MENVEO, the patient experienced chest heaviness (serious criteria other: As per reporter), headache and stomach cramps. On an unknown date, the outcome of the chest heaviness, headache and stomach cramps were unknown. It was unknown if the reporter considered the chest heaviness, headache and stomach cramps to be related to BOOSTRIX and MENVEO. The reporter considered the chest heaviness, headache and stomach cramps to be related to CERVARIX. Additional details provided were as follows: The patient received all the 3 vaccines during the same day office visit. The patient complained of chest heaviness, stomach cramping and headaches, which began the evening following the administration of the vaccines. The healthcare professional reported that, the patient came back into the office on the day of reporting and further test were ran in which all vital signs (physical examination), blood work and EKG (electrocardiogram) readings were found to be normal. The reporter believed CERVARIX might have caused the series of reactions for the patient. No further information was reported regarding the event.
I received the vaccine on the 18th of April. I started to have stiffness throughout my body around April 23, 2022. It got to the point where I was unable to walk. My neck, knees, back and shoulder hurt. I am just getting to where I can step down on my right foot, but it is still really swollen. I received my vaccine in the left arm. The doctor gave me a shot of steroids and a prednisone pack. I am slowly getting better. I called my doctor yesterday because my foot was so sore. I am going in today to have blood work completed. I am currently using a walker to get around. I tried to make it to my vehicle one day and when I got in, I felt like I was going to pass out. I was lightheaded and in a lot of pain.
rash came again but worse, covering more of the tops of her hands; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN5318, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 at 15:45 (at the age of 47 years old) as dose 2, single for COVID-19 immunisation. No medical history was reported. The patient has no known allergies and prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included zinc; elderberry [sambucus nigra], vitamin c [ascorbic acid] and turmeric - all taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EL9263), via an unspecified route of administration, administered in left arm on 04Feb2021 at 04:45PM  (at the age of 47 years old) as dose 1, single for COVID-19 immunisation and experienced rash on top of both hands, extending to a couple fingers and itchy rash. On 26Feb2021, the patient reported that the rash came again but worse, covering more of the tops of her hands. It was same as before, but it didn't show up until about 2 days after the second shot. At 9 days after the shot, it was still here and was not any better. The patient was using hydricortizone cream as treatment. The patient haven't seen a doctor about it, but have taken pictures. Since vaccination, the patient has not been tested for COVID-19. The patient did not recover from the event.  No follow-up attempts are possible. No further information is expected.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 37-month-old female patient who experienced high fever and possible pneumonia. At 37 months of age, the patient received the first dose on 20-Apr-2010 along with a second dose of VAQTA (Merck Sharp & Dome). On 21-Apr-2010, the patient experienced high fever, visited the emergency room and was subsequently hospitalized on 22-Apr-2010. A possible pneumonia was suspected. Treatment was not reported. On an unspecified date in Apr-2010, the fever resolved and the patient was discharged from the hospital. The outcome of the possible pneumonia was unknown. No additional information was available at the time of this report.
Metal taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: er8727] via an unspecified route of administration in the right arm on 22Mar2021 at 08:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Mar2021 at 09:00, the patient had experienced metal taste in mouth. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event metal taste in mouth was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Initial information received on 9/29/06 from another company regarding a subject who was enrolled in a clinical trial sponsored by the other company. A two month old female subject was enrolled in the prophylactic open study 10531. On 7/11/06, the subject received initial doses of the following vaccine, ActHib, Pediarix, and Prevnar. The vaccine were administered intra muscularly in the thigh. The subject also received a dose of Rotavirus vaccine, administered per OS on the same date. The lot numbers were not reported for any of the vaccines. The subject had a history of gastrointestinal reflux disease, which started on 6/29/06 and continued at the time of reporting. On 7/20/06, nine days after the first dosed of Rotavirus vaccine, ActHib, Pediarix and Prevnar, and 20 days after the last dose of lansoprazole, the subject developed a fever of unk origin (temp of 38.9 deg C) and was hospitalized. Relevant tests on 7/20/06 included a lumbar puncture, as well as blood and urine cultures. The lumbar puncture was negative and all cultures were neg. No details of relevant assessments were available. The subject was treated with paracetamol, ampicillin trihydrate, ceftriaxone sodium and cefotaxime. The subject was discharged from the hospital on 7/22/06. The investigator considered that there was a reasonable possibility that the fever may have been caused by rotavirus vaccine, Pediarix, ActHib and Prevnar, and that the event was possibly due to the concomitant medication with lansoprazole and the subjects medical condition of gastroesophageal reflux disease, the investigator also replied that although it is possible the childs fever was due to the rotavirus vaccine, he believes that the possibility is quite small and more likely attributable to a viral syndrome.
Developed lymphadema and enlarged lymph nodes in left axilla. CT scan performed in May. Symptoms did not resolve until August
Initial information received for this unsolicited case on 12 February 2015 from a consumer who is the patient's daughter-in-law. An unidentified female patient was vaccinated on an unreported date with FLUZONE (Sanofi Pasteur), batch, route and site of administration not reported and at an unspecified time later she experienced encephalitis which required several hospitalizations. The patient's concomitant medications and medical history were not reported. Laboratory tests and hospitalization dates were not reported. The reporter refused to provide further information about the patient or event. The patient outcome is unknown. Documents held by sender: None.
Mild fever, headache, arms very sore, arms red/swollen from elbow to shoulder.
Patient received vaccine at outside institution so lot number is not available.  PCP is also at outside organization so limited information available.  Below is information from Emergency room visit.  12 y.o. male who presented to the emergency department for Rash that the patient noticed around noon today while at his friends house after a sleep over.  Patient received his first COVID vaccine yesterday at outside retail pharmacy at 1030am. Mother states it was Pfizer.  Patient states "noticed the rash last night when they went to and has no other symptoms such as fever, chills, runny nose, head congestion, difficulty breathing, swelling of the lips, tongue, mouth, throat. Denies nausea, vomiting, abdominal pain.  Patient states that is very itchy and they have been spreading and more been popping up since he noticed them.  He denies any history of eczema, sensitive skin, food allergies. Mother does state that 2 years ago, the patient had a severe to the influenza vaccine in which she describes it as 8 inch area of redness, hot to touch, swelling around the injection site.  No anaphylaxis reaction at that time either.  Discharged with oral decadron and benadryl.  Follow-up with PCP next day.
After about 10 mins i started to get headache, dizzy,. Got pale. Was put on cot. had heart palpitation felt cold and shaky. After about an hr and half i started to get back to normal. When i got up i started to walk funny. I was able to drive home. took  Tylenol when i got home.  ate a little soup. laid down and fell asleep. when i woke up a couple hrs later i still had a headache. took another tylenol.
p/receiving 2nd Engerix-B pt devel chest tightness which abated p/2 days; Reporter would not provide any addtl info;
2 inch diameter red mark area that was warm, hurt to touch, and lasted 5 days. Received vaccine on Friday, woke up Saturday morning with a fever of 102.3, chills, body aches, cough, fatigue and nausea. Ended up getting Covid tested on Monday, and tested positive because my cough and fatigue would not go away.
1/13 vaccination 9am 12 Hours later, I started getting patches of hives; spread to both arms, chest. I was quite miserable. I tried treat at home with Benadryl but it was not helping. I called the virtual health. NP recommended getting a steroid shot. I could not get as the clinic was closing. So I talked to a provider that I work with and she was able to prescribe a steroid and hydroxyzine. My hives waned but didn't go away. Allergist prescribed steroids for another 7-10 days before hives dissipated.  *was advised ok to have 2nd dose; no symptoms after.
Nauseated Mildly light headed D/C home 1550 - symptoms resolved
Bit red; Didn't swell up as much; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of erythema (received 1st dose on an unknow date and also experienced feeling of warmth and swelling, refer case US2022AMR139412).   In July 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced erythema and swelling. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the erythema and swelling were recovered/resolved.   It was unknown if the reporter considered the erythema and swelling to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR139412   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient got the second dose of Shingles vaccine this past July 2022. The patient stated the second dose of Shingles vaccine was not as bad as first dose, just a bit red and did not swelled up as much.  The reaction lasted less than the first Shingles vaccine dose.  Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR139412:Same reporter
Narrative: Employee tested positive for Covid-19 and was hospitalized despite full vaccination and boosters (Pfizer 1,2 and Boosters x2). Pt's last booster was on 03/31/2022. Patient died on 06/04/2022
Induration and swelling on the left thigh, appeared approximately 2 hours after vaccines administered. Diffuse urticaria appeared approximately 48 hours after vaccines given.
Pt received FLULAVAL on 10/28/2017. She developed fever and vomiting on 10/30/17 and presented to office on 10/31/17 with fever, tachycardia, hypotension, and rash. She was taken to ED and diagnosed with Toxic Shock Syndrome and admitted to the PICU for ABX, IVF, and dopamine. Over the next 24 hrs, she stabilized and was d/c on 11/4/17.
immed follwoing vax pt devel 1.5cm area of erythema & <0.5cm wheal; pt instructed to apply ice; 1 hr later mom stated pt had a 2 1/2cm reddened area, swollen; mom to give pt APAP; Mom called about 430PM & stated area had not gotten worse;
At 1 am, I woke up with chills. I was freezing, but my body was not cold to the touch according to my fiance. When I woke up around 7 am, I was exhausted for the rest of the day. I had a bad headache all day. I had a 100-degree fever that broke during the early afternoon. On the following two days, I had a mild headache that lasted through the afternoon. It felt like someone was pulling the muscle behind my right eyebrow.
Developed 6cm diameter red rash around injection site - w/ mild pain and itching, no swelling, no discharge.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II (lot # L049314, expiration date 03-DEC-2017, dose and route were unknown) reconstituted with sterile diluent for prophylaxis. Diluent was not involved in the temperature excursion. The temperature excursion was at 47.2 Fahrenheit for 45 minutes. Previous temperature excursion was at 47.8 Fahrenheit for 1 hour and 16 minutes. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA003659: US-009507513-1708USA003660: US-009507513-1708USA003658.
Initial report was received from a health care professional on 24 October 2011. Two patient's (gender, date of birth and age were not reported) received an intramuscular injection of FLUZONE, lot number UH493AA (site of administration were not reported) on 02 October 2011. Ten hour post vaccination the patient's woke up from their sleep with chills and uncontrollable shakes. The symptoms lasted about forty five minutes. No further information was available at the time of the report. The patient outcome was reported as resolved/recovered. Follow-up information was received from a healthcare professional on 23 January 2012. The patient received FLUZONE in left arm. No further information was available at the time of the report. Documents held by sender: none.
patient presented to pharmacy with a Red, Swollen arm. The redness was a 3 inch circle around the injection site. The area was warm to the touch and sore. Patient was advised to keep an eye on area, to put a cool compress on, and take Tylenol of needed and if it seemed to get worse to contact her Doctor
Impressive swelling and redness of upper arm surrounding site of administration, mildly itchy, not painful per patient.
Dizziness, Headache,  Day 6 fatigued, Pressure headache Day 8 Headache Day 10 Pressure Headache, dizziness, noxious smells (feces-dirty cat liter) coming and going,  Narrative:
"I wake up at 4:30 AM with my Rt jaw swollen on the inside & my Rt. ear is killing me.  I have only a wisdom tooth on that side.  I don't think it's the tooth.  I think this is a reaction to that shot.  Can someone call me in an antibiotic."  Recommend visit to CMD.  Gave phone #'s of 2 local clinics which operate on 'sliding fee' basis & the # of the other HD.
woke up early the next morning after my second dose and was  really sick. I have a history of really high BP I was throwing up every 30 mins -45mins and I couldn't keep a sip of water down.   I went to Hospital ER around afternoon maybe around 05:00PM I'm not too sure. They gave me IV Fluids and something to settle my stomach . I was probably in there about 2 hrs but I felt better. By the time I went home I felt better.  I felt better by evening to take my BP medication which I did.
Approximately one hour post vax, the pt experienced general muscle aches, headaches and exhaustion. These symptoms resolved after 4 days. On 5/8/00, the pt received her second dose of Lymerix and approximately 45 minutes later felt severe pain in both knees, neck and "finger bones". Her hands became numb and she experienced lightheadedness, "wooziness", a little nausea and could barely drive her car home. That night she needed assistance to get into bed. She could not lift herself into bed. On 5/9/00 she felt tired and her knees, elbows, and neck still hurt but not like the previous day. On 5/16/00 she felt numbness from her waist up to her neck including her arms. He heart was racing and she "felt as if to pass out". She also felt feverish and sweaty. She saw her doctor and had blood work and an electrocardiogram. All tests were normal. Her physician felt she had a hypersensitivity reaction to Lymerix. No treatment was given. The information received on 5/17/00 reported she still had bilateral knee pain, lightheadedness, nausea and some diarrhea.
INCREASED HEART RATE; BREATHING INCREASE; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021; 08:40 am, into left arm, for covid-19 prevention. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced increased heart rate and breathing increase. Patient had covid screening a couple of days ago and it was negative. Patient reported that she got the shot at about 20 minutes to 9 am today and was fine till after dinner around 1:30 and her heart rate increased by 10 beats per minute (bpm) and she had increased breathing. Patient wanted to know if that was a bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and breathing increase on 05-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: Increased heart rate, and breathing increase. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Seen in Emergency Room for fever of 102-103 degrees, Myalgia, cough, slight photophobia, redness around innoculation site.
Weakness 11/7/09 -> 11/10/09. Headache 11/7/09 -> 11/11/09.
1/19/2021-right after injection light headiness , dizziness and balance off, some fatigue 1/20/2021- weakness, fast heart beat, fatigue 1/21/2021- Chest pain and some shortness of breath, heaviness in chest and fast heart beat, anxiety, tiredness and irritability, overwhelming feeling, anxious, fatigue (feeling really sick) 1/22/2021 some chest pains not as bad as Thursday, shortness of breath but also improving, irritability, anxious 1/23/2021 chest pain, shortness of breath improving, anxiety and nervousness, fatigue