chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and FATIGUE (Tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylactic vaccination.    The patient's past medical history included Feeling abnormal (The patient reported that she had not been feeling good.). Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included WARFARIN SODIUM for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient received dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (Achy) and FATIGUE (Tired). At the time of the report, PAIN (Achy) and FATIGUE (Tired) outcome was unknown.            No treatment medication reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
LACK OF EFFECT/VACCINE DID NOT WORK; LOW ANTIBODIES WHEN TESTED; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 15-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: cancer, and the patient is not being treated for cancer and the patient is not using immunosuppressive therapy at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had performed antibody test and the results came back as low (low antibody count). The patient reports that the Janssen Covid-19 vaccine did not work (lack of effect) and the patient also states that he cannot travel due to antibody testing requirements in other countries due to his low antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lack of effect/vaccine did not work and low antibodies when tested was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product quality complaint number: 90000197727.; Sender's Comments: V0; 20211032610-COVID-19 VACCINE AD26.COV2.S-Lack of effect. This event is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Patient passed out a couple minutes after administration of vaccine. This was caused by his severe phobia of needles described to me before administrating vaccine. Patient stated this has happened before in the past. Patient fell to floor and regained consciousness shortly after. Stood into chair and given water. Became nervous and vomited a few times. Patient normalized after 30 minutes. Wife picked up patient and went home. Followed up with condition of patient and was feeling great and have no symptoms.
This spontaneous report was received from a 71 year old female patient reporting on herself with sciatica. The patient's concomitant therapies included vitamins. The patient's has no drug Reactions or allergies. No information was provided regarding the patient's medical history. On 26-OCT-2017, the patient was vaccinated with ZOSTAVAX in the left arm for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 28-OCT-2017, the patient developed pain starting near her left shoulder radiating down her left side to her left hip an intermittent headache. The consumer states she was evaluated at a local urgent care facility, by an unspecified physician assistant, and was prescribed tramadol hydrochloride (TRAMADOL), methocarbamol (ROBAXIN), and ice compresses. The reporter also stated that the symptoms improved after taking the medication, but eventually returned. The pain was improved with movement. The outcome of the events pain starting near her left shoulder radiating down her left side to her left hip an intermittent headache was reported as resolving. Additionally, the reporter did not provide causality assessment between he events and vaccination with ZOSTAVAX.
71y.o. female who lives with husband. She had exposure to COVID. She had been vaccinated.  She developed chest pain on R side.  She came to EC and found to be COVID positive and she had PE. She is asymptomatic.  Discussed role of isolation going forward. PE, seen on CT, will arrange AC on dc. Minimum 3-6 months. Discussed risk of bleeding. Discharged to home.
A non-serious report of "we gave a partial (1/2) of H1N1 to 5" was received from a physician concerning an 18-year-old male. The patient's medical history was not provided. On 20-Oct-2009, the patient was inadvertently administered half of H1N1 dose. There was no adverse event associated with this administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
About 15 minutes after the injection, excruciating neck pain and accompanying stiff and immobile neck. Pain in knees also.
Shortly after injection my arm felt was sore as if I just had a flu vaccine. Approx 1930 my arm then felt as if I just had a tetanus booster then followed by chills, body aches,  had 100.5-101 fever (on Friday).  Chills on Friday resolved while taking Tylenol as well as body aches. continued with Tylenol 1000mg every 6 hrs. Saturday woke up with no fever, chills body aches resolved.
From telephone contact received at manufact. on 19Jun2002, it was reported that a 2 year old female was administered a dose of Tripedia vaccine in deltoid. Date of vaccination unknown. one to two days after vaccination, pt developed a very red area at the injection site apprx. 6cm. Area hot to touch. No other reported symptoms.
01/24/22 presents to ED for "SOB and hypoxia". PMHx of "COPD, hypertension, liver cirrhosis with ascites"
Pt was exposed to her 2 year old daughter who was vaccinated with varicella virus vaccine live on 04/19/1999. On approximately 05/01/1999 the pt experienced itchy bumps that look like bug bites under her right breast and on the right side of her neck. She also experienced bumps around the right side of her waist. The pt also developed scattered lesions under the left breast, on the left side of the neck and on the left side of her waist. The bumps were pink and raised, and some were composed of dry skin that was peeling. Pt was treated with Aveeno. Pt was diagnosed with a dermatitis rash.
SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT MUCH. UPON WAKING DAY TWO, I HAD A VERY PRONOUNCED ACHE IN THE BACK OF LEFT SHOULDER AND THE ACTUAL SHOULDER BLADE WAS SORE AND PAINFUL TO THE TOUCH. I DID NOTHING THE FIRST DAY OF THE DISCOMFORT (THINKING IT WOULD GO AWAY). I NOW APPLY CBD/THC BALM ON THE AREA 3 TIMES A DAY AND I'VE BEEN TAKING EXTRA STRENGTH TYLENOL , TWO TABLETS,  THREE TIMES A DAY. I AM SLEEPING IN A ZERO-GRAVITY MODE ON MY SLEEP NUMBER BED...OTHERWISE I CAN'T SLEEP AT ALL.  I HAD A HOLE IN MY ROTATOR CUFF SURGUCIALLY REPAIRED ABOUT 18 MONTHS AGO AND THE PAIN I HAVE NOW ACTUALLY FEELS LIKE MY SHOULDER FELT BEFORE AND FOR AWHILE AFTER THE SURGERY! I AM BEGINNING TO WONDER IF THERE IS A RELATIONSHIP TO THE TWO EVENTS.
Rash on both arms - onset L upper arm 1 hr after TWINRIX #2 dose. Spread down L arm to hand then to R arm.
This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 57-year-old female patient who received FLUARIX. The patient's past medical history included rheumatoid arthritis. Concurrent medical conditions included ankylosing spondylitis, allergic reaction to antibiotics and allergy. On an unknown date, the patient received the 1st dose of FLUARIX (intramuscular) .5 ml. On an unknown date, unknown after receiving FLUARIX, the patient experienced allergic reaction, condition aggravated, extensive swelling of vaccinated limb, injection site swelling and injection site induration. On an unknown date, the outcome of the allergic reaction and condition aggravated were recovered/resolved and the outcome of the extensive swelling of vaccinated limb, injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the allergic reaction, condition aggravated, extensive swelling of vaccinated limb, injection site swelling and injection site induration to be related to FLUARIX. Additional information received: The reporter called to ask RN in office (the patient) can receive BOOSTRIX and if it has anything in common with FLUARIX TIV. to the best of their knowledge, FLUARIX TIV caused the patient to have an allergic reaction of local swelling and induration to 2-3 inches at site of injection on first dose 2-3 years ago when she was 56-57 year-old. A repeat dose of FLUARIX TIV the next year resulted in her whole arm swelling, which required doctor's office attention (see case US2015GSK043064).
Information has been received from a medical assistant regarding a 4 month old female who received her 2nd dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 02/04/03, and developed some redness at the injection site.  This pt experienced redness at the injection site after receiving her 1st dose of Prevnar on 12/03/02.  She also experienced a "cellulitis-type event", 2 days after receiving her 3rd and 4th doses of Prevnar on 06/25/03 and 10/07/03 respectively.  Indication for Prevnar was immunization.  Product was administered on 02/04/03.  Dose regimen was 1 dose (IM).  Concomitant medications were not reported.  On 02/06/03, two days post-immunization, the child developed redness at the injection site.  The redness resolved without treatment.  No additional information was available at the time of this report.
Person administering vaccine inadvertently gave Janssen instead of Pfizer Booster. Situation was immediately recognized and explained to the patient. Patient was informed of CDC recommendation to NOT give booster of Pfizer following cross-administration of vaccines. Patient as given printed copy of the VAERS form and told to contact VAERS and local health department with any noted adverse reactions.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium
Left Upper arm patch of erythema with elevated skin temp. non tender from good muscle strength, Benadryl 1tsp every 6 hrs.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a physician for long-term prevention of shingles and zoster-related conditions/preventing shingles on a long-term or permanent basis (prophylaxis). Subsequent, after vaccination with zoster vaccine live (ZOSTAVAX) the patient was treated for shingles. As a direct and proximate result of use of the vaccine live (ZOSTAVAX), the patient will continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries, including but not limited to medical losses and cost that included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages, and will continue to suffers such losses, and damages in the future. The outcome of the event shingles was not recovered.
Very soon after administration patient experienced itching around injection site and a sensation down arm and into fingers. I observed at pharmacy and patient went home. Patient took BENADRYL at home. Next day injection site was warm, swollen, red itchy, and hard. Large red circle around injection site.
Lump on left deltoid area - hives- swelling - redness - itching - burning and tired. Client has very slight edema in left arm and redness, lump noted at this time.
Information has been received from a physician concerning an 8 year old male who on 22-AUG-2000 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) 0.5ml (Lot number not reported). In Sep 2006 the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) 0.5ml (Lot number not reported). On the last week of May 2008(approximately 26-MAY-2008) the patient developed over 100 varicella like lesions and fever. The patient was seen in the office and treated with ZOVIRAX. As of the time of the report the patient is recovering. Additional information has been requested.
I experienced nausea, redness in face and neck, with itchiness and flushed feeling within 20-30 minutes of receiving vaccine (started around 3:55pm). Felt cold with pale hands. Seen by ambulance crew at clinic site and given IV fluid, steroids and benadryl. Had dry mouth and itchiness in throat. Taken to hospital and developed red blotches on hands and arms.  I was given epinephrine around 5:30 when nausea,  dry mouth, and itchy throat did not subside. Discharged at 9:30.
High fevers 104.3, vomiting. Pt also got a severe case of pimply looking almost like chicken pox or measles from her trunk down. Rash started continued to spread for two days. Fever 10 days later.
The second dose resulted in ten scratches developing; Hurt; The second dose resulted in ten scratches developing; Lost my sense of taste and smell; Lost my sense of taste and smell; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date were unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 on an unspecified date which resulted in two scratches and they hurt. On an unspecified date, the patient resulted in ten scratches developing, hurt, lost my sense of taste and smell. After each dose patient had developed scratches on arm which look like a cat scratched and they hurt. Patient had picture of the arm. The outcome of all the events was unknown.  Information on the lot/batch number has been requested
I started having a significant amount of neck pain near the base of my skull and down my neck and upper back, which is unusual for me. I have not experienced pain like that in the past.
vomited, yellow eyes, would not eat, not producing white cells, no clotting, jaundice, assumed hep;bile ducts damaged; tiredness;needs liver transplant-liver failure;
Received immunization 10/12/06 DTaP, HIB, IPV, Pneumococcal.  Seen in office 10/13/06 with extreme fussiness, cough, nasal congestion, decreased oral intake, temp 102.8 rectally.  Mild head lag.  Admitted to hospital.  Nasopharyngeal swab negative.  Inf A/B and RSV, lumbar puncture done.  Blood and urine cultures neg.  Patient also had URI signs/symptoms.  Follow up with immunology for allergy to acellular pertussis.  Hospital MR received for a direct admit for this 4 month old for c/o extreme fussiness, cough, fever, and nasal congestion on the day following vax. PE: Mild head lag noted. Nasal congestion and turbinate hypertrophy with green nasal discharge..  Slightly coarse breath sounds bilaterally.  Otherwise normal. Txd with IV fluids and antibiotics.  Discharge home after 2 days. Discharge Instructions and Disposition: Upper Respiratory Tract symptoms, resolved irritablility, and head lag that was likely due to an immunization reaction. 02/22/2007 MR received from immunology consult in F/u to the head lagging, floppiness, and moaning the infant experienced with fever after his 4 month vax. PE: WNL. Parents report child has fully recovered. Impression:  Floppy baby syndrome which has been seen with the pertussis componant of the immunization.  It is not believed that this is a true allergy to the vaccine.
Patient had a massive hemorrhagic stroke 4 days after the Moderna vaccine. She became disabled.  She was previously healthy.
while in mom arms pt began to gasp for air & became hypotonic & unresponsive; eye did not roll back, but became glassy; pt did not jerk arms or legs; upon vigorous stimulation pt vomited a large amt & became reponsive again; t101.6 R; pale
pt was getting his first covid vaccine with his mom. pt was vaccinated first then mom was vaccinated. After mom was vaccinated I had my bad to the patient and his mom throwing away supplies, Pt passed out and was not responsive to mom or to myself the pharmacist. I thought the patient needed an EpiPen and went to get the EpiPen out of the pharmacy and while my back was turned mom stated that the patient convulsed a few times. By the time I returned with the EpiPen pt was not convulsing and had passed out and started to recover and become responsive. Pt was pale but was aware of his name, birthday, date, and current president. A tech called EMS. Pt was talking when EMS arrived and color had started to return to normal. pt was able to walk out to the ambalance to be checked out. Mom stated she wanted to take pt to ER for more evaluation.
Nausea, diarrhea, vomiting, sweats, chills lasting about two hours.
The vaccine was supposed to be given intramuscularly but was given subcutaneously instead. A patient is having tenderness and rash on her injection site.
Muscle aches, fatigue hours after the injection. 12hours was hard to sleep accompanied by all over body aches. Body aches continued into the day after the injection, accompanied by headaches, fever, and fatigue.
It is likely pt received an undiluted pediatric dose.  Pt's guardian reported that pt had a sore arm and was given Tylenol to treat.  Pt had no further complaints at last contact.
BODY ACHES; FEELING HOT; IN BED WHOLE DAY; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 43 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced in bed whole day. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, feeling hot, in bed whole day, and headache on 10-APR-2021. This report was non-serious.
The pt was disoriented, experiences loss of short and long term memory, dizziness, aches, pain, increased depression, increased Fibromyalgia symptoms.
Within 24 hrs of vaccine administration, child developed swelling and redness in right thigh (site of Dtap), which progressed, requiring ED visit. She had low grade fever as well. Treated with oral antibiotics and Benadryl.
was supposed to get her period around the same day as her 2nd vaccine (17Jun2021) it is now 12Jul2021 and she has still not gotten it; This is a spontaneous report from a contactable consumer, the patient. A 14-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0185), via an unspecified route of administration in the arm left on 17Jun2021 17:00 as dose 2, single (at the age of 14-years old) for covid-19 immunization. Medical history included ongoing asthma and allergies to penicillin family. Concomitant medications included montelukast sodium (SINGULAIR), beclometasone dipropionate (QVAR), clarithromycin (CLARITIN), allergy nasal spray and vit. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0185), via an unspecified route of administration in the arm left on 27May2021 17:15 as dose 1, single (at the age of 14-years old) for covid-19 immunization. On 18Jun2021, the patient was supposed to get her period around the same day as her 2nd vaccine (17Jun2021) it was now 12Jul2021 and she had still not gotten it. The patient visited the doctor or other healthcare professional office/clinic for the events. The patient did not receive any treatment for the events. The patient did not receive any other vaccine in four weeks. The patient had not covid prior to the vaccination and the patient had not tested for covid post vaccination. The outcome of the event was not recovered.  Follow-up attempts were completed. No further information was expected.
Periodic twitching in left shoulder. Started 7 days after 2nd shot. Has been happening for 3 days now.
Triggered A-Fib Event 12 hours after vaccination -increased dose of Diltiazam required - returned to normal after 6 hours
Information has been received from a registered nurse (R.N) concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 17-NOV-2016, the patient was vaccinated with an unspecified dose of PROQUAD via intramuscular route instead of the recommended subcutaneous route, (lot number M001152 with an expiration date of 05-JUL-2017) (dose and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805505 was crossed linked to original cases 201804863 due to same reporter.
Pt developed hives all of his body. Injection site was swollen and pink. The symptoms are resolving.