chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. This case is one of the 10 cases reported by the same reporter for the same vaccine. Additional information received: MD updating previous AE report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
She had upper chest discomfort. She stated she had tense pressure in her chest just lingering there. Her heart felt fluttery which went away.  Body aches and became tired. The body aches did subside.
Breakthrough COVID infection after completing primary series in May2021; Breakthrough COVID infection after completing primary series in May 2021; his is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2021, outcome "unknown", described as "Breakthrough COVID infection after completing primary series in May2021"; COVID-19 (medically significant) with onset May2021, outcome "unknown", described as "Breakthrough COVID infection after completing primary series in May 2021".  Clinical course: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a fever - it came and went. The highest was 103. I had congestion, runny nose, body aches and it was two days of fever on/off. The rest of the symptoms lingered for a few days. The cough came on the 3rd day and that lingered for a week longer than the other symptoms. I took a rapid test and a normal test at the same time and they both came back negative - those tests were 3 or 4 days after I noticed symptoms. They gave me something for a cough - it numbed my throat. I was only able to take one of them. It was a capsule - gelled with pearls in them. It totally numbed my throat.
On 1/12/2021 about 6 pm I got a temp on 101.4, the next day 1/13/2021 my temp was 100.5 and my joint and muscles hurt and I was very tired sleeping about 20 hours. On 1/14/2021 I has a temp of 100.2 and still sore. I got a rapid covid test that day which was neg and a PSR was sent as well that came back neg as well. My temp went back to normal round 4pm on 1/14/2021 and I wasn't as tried or sore by 1/15/2021. Felt back to normal that afternoon 1/15/2021.
Pt developed multiple large, raised, red areas all around arm and going up shoulder. Painful to touch. R arm.
Pain on arm; Very itchy rash on both armpits, around her neck and below her breasts; Very itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Very itchy rash on both armpits, around her neck and below her breasts), PAIN IN EXTREMITY (Pain on arm) and PRURITUS (Very itchy rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced RASH (Very itchy rash on both armpits, around her neck and below her breasts) and PRURITUS (Very itchy rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain on arm). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form. At the time of the report, RASH (Very itchy rash on both armpits, around her neck and below her breasts) had not resolved, PAIN IN EXTREMITY (Pain on arm) outcome was unknown and PRURITUS (Very itchy rash) was resolving.        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.   No concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: No specific follow-up information recorded.
Pt woke up at approx 1:00 am on 09/13/2021 with uncontrollable shaking, severe body aches, severe headache.  Administered Tylenol and put her back to bed.  She woke up at approx 8:00 am on Sunday, 09/12/2021 with hallucinations and headache.  Administered Tylenol and gave her cold water.  It took approx 10 mins for her to become lucid again.  For the rest of the day, headache and fatigue were main symptoms and were manageable.  At approx 10:00 pm on 09/12/2021, she complained of nausea.  On Monday, 09/13/2021, patient seems to have returned to baseline. Tylenol was administered, prophylactically.
Pt developed a "fixed " rash on anterior, abdomen described as erythematous macular-papular. Extremely pruritic- no drainage or bleeding.
1. Suspected COVID-19 virus infection  2. Fever, unspecified fever cause  3. Cough  4. Acute nonintractable headache, unspecified headache type
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 14-NOV-2017, the patient was inadvertently vaccinated with a properly stored but expired dose of VARIVAX lot number L043624 and expiration date of 03-NOV-2017 for prophylaxis, reconstituted with water sterile diluent. No adverse effects were reported.
Redness, pain, and swelling throughout entire upper left arm around injection site. Icing area 3 times per day for 10 minutes. Physician notified. Redness remains today, 1/25/21.
RASH, ECZEMA, HIVES, CRYING, ALLERGIES, COULD NOT BE CONSOLED.
Follow up received on 08/22/2003: "I am responding to your VAERS request regarding the patient, who died on 07/29/2003.  An autopsy was performed at our facility; however, the cause and manner of death are ruled as pending at this time.  A copy of the autopsy will be forwarded to you upon its completion."
Initial unsolicited case received on 18 November 2014 from a consumer who is the patient's daughter. An 85 year old female patient with a history of allergies to penicillin and latex and a medical history of stroke, glaucoma, acid reflux and a diagnosis of Alzheimer's was vaccinated on 09 October 2014 with FLUZONE HIGH DOSE, lot number route and site of administration were not reported. Forty-eight hours later, the past was "lucid", knew people, places, events around her and was speaking in full sentences for 2 1/2 weeks after vaccination until 27 October 2014. The patient had been diagnosed with Alzheimer's and has been in a skilled care of residential living facility. The patient has not spoken in full sentences and did not communicate or always know people and surroundings. The reporter thinks her mom may have something other than Alzheimer's and that testing procedure for diagnosis for Alzheimer's "did not accurately reflect her status". The caller declined to provide a healthcare provider contact and wants no one other than herself to be contacted. The patient outcome is unknown. Documents held by sender: None.
This is in follow up to reports previously submitted on 4/4/03. Information has been received from a lawyer regarding a case in litigation concerning a male minor child who in 1994 and 1996 was vaccinated with hep B vaccine recombinant. Concomitant therapy included HIB conjugate vaccine (HIBTITER) in 1994; TRIPEDIA and HIB conjugate vaccine Haemophilus B conjugate vaccine (ACTHIB) in 1994 and 1995; and ACEL-IMUNE in 1999. It has been alleged that through these vaccinations administered to the pt during the first several years of his life, he received very high doses of mercury contained in thimerosal, a highly toxic preservative. It has been further alleged that as a result of the mercury in the thimerosal containing vaccinations received during these developmental years, the pt suffered and in the future will continue to suffer from the toxic neurological effects of mercury poisoning, including but not limited to autism. Upon internal review, toxic neurological effects, mercury poisoning, and autism were considered other important medical events (OMIC). Follow up on 12/03/03: "Additional information was received on 11/24/03 through a telephone call from Merck.  The reporter stated that the pt's age was nine-years old.  The time frame of the vaccinations was 1994 through 1999.  It was reported that the pt received ACTHIB in 1994 and 1996, TRIPEDIA in 1994 and 1995, HibTITER in 1999, and RECOMBIVAX HB in 1994.  The reporter also stated that the information received regarding this case came from the legal department and company policy only allows very little information to be released.  He stated that he had no further information at this time and did not expect an update.  No further information is anticipated, this case is considered closed.  Upon internal medical review, this case was assessed as "not medically confirmed".  Follow up on 04/07/04 states: "Additional information was received on 11/24/03 through a telephone call from manufacturer.  The reporter stated that the pt's age was 9 years old. The time frame of the vaccinations was 1994 through 1999. It was reported that the pt received ActHib in 1994 and 1996, Tripedia in 1994 and 1995. HibTiter in 1999, and Recombivax HB in 1994.  The reporter also stated that the information received regarding this case came from the legal dept and company policy only allows very little information to be released. He stated that he had no further information at this time and did not expect an update. No further information is anticipated, this case is considered closed. Upon internal medical review, this case was assessed as "not medically confirmed."
Body aches, fever, urinary urgency and incontinence, right arm tender, erythematous, and edematous, weak, drowsy, decreased appetite, headache.
Chills to the point my body was in spasms that would  not stop, high fever, body aches as if hit by a truck, headache, bowels in distress, inability to urinate.  This is my 5th Covid vaccine and although I have a reaction each time, never to this level. Thought I would have to go to ER
pt recvd vax 7NOV or on 8NOV; pt does not know who administered vaccine; pt devel pain, swelling, redness around inj site;saw MD 17NOV95, tx for cellulitis w/oral & IM ATB
could not raise his arm and it stung then that feeling moved from his upper arm down to his elbow; looked puffy; had a pain sensation; he got a bad rash on it; Initial information regarding an unsolicited valid non-serious case was received from a consumer/ non-healthcare professional via Agency (Reference number- 00515270) and transmitted to Sanofi on 11-Mar-2021.  This case involves a male patient who could not raise his arm and it stung then that feeling moved from his upper arm down to his elbow (hypokinesia), looked puffy (skin swelling), had a pain sensation (pain), and he got a bad rash on it (rash), after he received vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included OSELTAMIVIR PHOSPHATE (FLUCLE).  On an unknown date, the patient received INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On an unknown date, patient who could not raise his arm and it stung then that feeling moved from his upper arm down to his elbow (hypokinesia), looked puffy (skin swelling), had a pain sensation (pain), and he got a bad rash on it (rash), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown, at the time of reporting.  There will be no information available regarding batch number in this case.
Took a shot Wednesday and my arm is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th April 2022, the patient received Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine on wednesday and his/her arm was still sore. Additional supportive information: The follow-up would not possible, as no contact details were available.
Headache, Myalgia, Arthralgia, NauseaVomiting, flushed Narrative:
Information has been received from a registered nurse concerning a 6 year old female with no known allergies or pertinent medical history who on 19-JAN-2007 was vaccinated SC with a "standard" second dose of Varivax. There was no concomitant medication. About a week after vaccination, on approximately 26-JAN-2007 the patient had a local reaction at the site of injection. The patient's symptoms included a golf ball sized welt which was warm and tender to the touch. Medical attention was not sought, lab studies were not performed. On an unspecified date the patient's symptoms subsided and she recovered. There was no product quality complaint involved. No additional information was provided. Additional information has been requested.
On April 5th I received my first dose and a few days later on the 04/07/2021 I experienced chest racing, dizziness, and out of breath. On April 8th or 9th I saw my doctor who did an EKG and it came back abnormal. I think it was enlarged heart and I was referred to Cardiology and it took a while to get an appointment which was made June. They repeated an EKG that came up normal and my symptoms had subsided by that time. I didn't feel well up until about mid-May. I saw him again in July for a stress test and those results were normal.
pt recv vax & devel localized severe muscular pain/rigidity for several hr;the entire rt arm was immobilized;
pt came into minute clinic more than 2 weeks after her second covid 19 vaccine. she continues to have low back pain/muscle pain. OTC pain medication helps but continues to have symptoms once these wear off.
Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased blood pressure; skin redness with blotches on face and neck; uncontrollable shaking; chills.  These diminished to tolerable level within 30 minutes after onset.  Evening of injection:  nausea, vomiting, fatigue, muscle cramping.  Next day:  nausea, light headedness
FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO HAVE HOT FLASHES WITH FEELING THE CHILLS..  IN THE EVENING MY LEFT HAND WAS LIKE ICE BUT MY RIGHT SIDE WAS NORMAL AND WARM.  CHILLS / NO FEVER .   COLD HAND WAS GONE IN THE MORNING.. ABOUT 5 AM HORRIBLE HEADACHE WITH BLURRED VISION... TOOK TYLONAL AT 9AM.. FELT BETTER BY 11AM.  CHILLS/AND SLEPT MOST THE DAY.  I DO NOT BELIEVE I EVER HAD A FEVER.  SUNDAY LEFT ARMPIT LYMPH NODES SWOLLEN AND SORE.  MONDAY FEELING BETTER BUT LYMPH NODES STILL ACHE LIKE A BRUISE.  I DO NOT BELIEVE I EVER HAD A FEVER.. JUST CHILLS.   OH>>>. RIGHT SIDE OF MY NECK WAS STIFF FOR A BIT THE FIRST DAY.
pike on ear infections; dizziness; always spinning; affected equilibrium; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (pike on ear infections), DIZZINESS (dizziness), VERTIGO (always spinning) and BALANCE DISORDER (affected equilibrium) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018b21a and 037c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR INFECTION (pike on ear infections), DIZZINESS (dizziness), VERTIGO (always spinning) and BALANCE DISORDER (affected equilibrium). The patient was treated with OFLOXACIN at an unspecified dose and frequency and MECLIZINE [MECLOZINE] for Dizziness, at an unspecified dose and frequency. At the time of the report, EAR INFECTION (pike on ear infections), DIZZINESS (dizziness), VERTIGO (always spinning) and BALANCE DISORDER (affected equilibrium) had not resolved.            Concomitant medicine reported as a lot of medication   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received on 20-Sep-2021 contains no new information.; Reporter's Comments: Med Info  CASE CROSSLINKED MOD-2021-145591 HCP of the patient stated he had seen a pike on ear infections
Pt recvd vax & began crying which cont for the next 4 hrs; felt warm to touch & devel local react of redness & swelling of the DTP site of inject; pt recovered; No further details were provided;
RECEIVED FLU SHOT SEPT. 28 IN LEFT ARM. ANTERIOR NEEDLE PLACEMENT NOTED AFTER INJECTION. NO PAIN AT TIME OF INJECTION. NORMAL POST VACCINE TENDERNESS FOR A  COUPLE DAYS. OCT 1 (DAY 4)- FIRST FEELINGS OF A  DEEP FULLNESS/ ACHE NOTED. THIS SENSATION OCCURS EVERY COUPLE OF DAYS FOR A WEEK OR TWO. PROGESSED TO EVERYDAY. NOV 2- FIRST SENSATION OF NUMBNESS AND TINGLING IN RING AND PINKY FINGERS WHILE ARM WAS NOTED TO BE BENT FOR A PERIOD OF TIME, LASTING A FEW MINUTES. NOV 3- SENSATION (DEEP BURNING)/ ACHE IN UPPER ARM SPREADING DOWN FROM INJECTION SITE TOWARDS ANTECUBITAL REGION. MORE SEVERE NUMBESS AND TINGLING NOTED IN FINGERS, LASTING A COUPLE HOURS. REPORTED TO EMPLOYEE HEALTH AT THIS TIME.
p/ pt recv vax approx 15 days later devel pox on trunk, face & legs
Start Date/Time: [Pfizer-BioNTech] 26Apr2021 17:00. Start Date/Time: [Pfizer-BioNTech] 10May2021 17:00; Developed cold sore on my lower lip 48hrs after receiving second dose of vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0173), via an unspecified route of administration, administered in left arm on 10May2021 at 17:00 (at the age of 29 years old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had not received any other vaccinations within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not have any allergies. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EW 0161) via an unspecified route of administration, administered in left arm on 26Apr2021 at 05:00 for covid-19 immunization.  On an unspecified date the patient experienced Inappropriate schedule of vaccine administered while on 13May2021 the patient experienced cold sore on lower lip 48hrs after receiving second dose of vaccine. The patient did not receive any treatment for the events.  The clinical outcome for Cold sores lip was not recovered.  Follow-up attempts completed. No further information expected.
Itching began within 5-10 minutes after injection. No hives ever developed. The itching would appear in different spots on my body and would come and go. Started on my left arm a little below the shot, then moved to the inside of that elbow. Then my ring finger on the opposite arm. Then then inside of my ankle on the opposite side. Then my opposite ear, which also felt a little warm and tingly or "off". Then my cheeks got a tingly/tight sensation. The next spot was the top of my opposite foot. Then I felt the itchiness in my back and then my inside opposite forearm. This persisted for about 3 hours on and off until I called the pharmacist. She advised to take 2 benadryl. About an hour after I took the benadryl (4 hours total from the injection) my symptoms subsided and I fell asleep for four hours, presumably from the benadryl. When I woke, the itching did not return. Last night (Sunday, 4/4) around 9:30 pm I noticed tiny red dots on my chest, stomach, inside of right arm and outside of left thigh. They are the size of the tip of a ball point pen. There is only one each on the leg and arm, but around 5-7 each on the stomach and chest. They are still here today (4/5 at noon).
A report has been received from a Health Professional concerning, Female subject who had been receiving Nasal FLUMIST. The patient's medical history included VSA (Ventricular septal defect). FLUMIST started on 19-Nov-2012. The patient experienced tested positive for Influenza A which started on 13-Dec-2012. The patient recovered from the event of tested positive for Influenza A on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received 24-Jan-2013 from Health Professional: New reporter added as Health Professional. Event outcome was updated from unknown to recovered. Relevant history was added. Patient details added. Patient reporter deleted. Reporter's details updated. County of administration was added. Lab detail added. Corrected report 29-Jan-2013. Action taken corrected from Unknown to Not applicable. Associated case ID added. Medical rep reporter added.  Corrected report 01-March-2013: The coding of the event of "Tested positive for Influenza A" corrected from "Influenza A virus infection" to "Influenza A virus test positive".
CLIENT HAS IMMUNIZATIONS ON 1/23/2009.  ON 1/24/2009, PARENTS WOKE UP TO CHILD HAVING DIFFICULTY BREATHING, THEN PARENTS REPORTED STOPPED BREATHING AND THEY HAD TO "BREATHE FOR HER".  MADE GAGGING NOISE. REPORTED SHOOK ALL OVER AND FELT VERY HOT. TAKEN TO ER.  DX- FEVER, FEBRILE SEIZURE, RT OTITIS MEDIA. TX- ROCEPHIN IV, TYLENOL.
The night I got shot I ran temp 102.8, was hallucinating seizure body aches headache. Lasted 2 days.