chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intense fatigue/malaise, nausea, vomiting, child could not keep food or any fluid (including water) down for almost 48 hours, zofran prescribed by pediatrician to reduce nausea. child did not leave bed for almost 24 hours.   onset of symptoms occured 4 hours after injection.  Child appeared healthy prior and immediately following injection.
Initially local reaction - redness, then tiredness, headache, sore arm, wheezing, denies fever.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were not reported. On 10-JUL-2018, the patient was vaccinated with improperly stored Oka/Merck VARIVAX (lot # N034552, expiration date 05-DEC-2019) subcutaneously for prophylaxis (Product storage error), which was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1807USA010240.
1 dy s/p vaccination, site developed erythema 2 dy s/p vacc, pain/fever/warmth developed. O.V. 3/24: low grade fever, tachycardia; local eryth. warmth & tenderness at site with induration.
I have Shingles.; My left arm has a lot of blisters.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 09Apr2021 at 14:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to crustacean.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 07:00, the patient experienced Shingles and left arm had a lot of blisters. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with valacyclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events shingles and blisters were not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Headache, Fainting, Dizziness, Tiredness child was given ibuprofen. Pain continues.
Presented with muscle pain in left shoulder and left side that got progressively worse over a few days.   Went to Orthopedic Walk-In clinic on 4-27-21.   Clinic did x-rays  with no findings and treated with prescriptions for muscular related problem.  Went to pharmacy to pick up scripts after Clinic appt.  While waiting for my scripts to be filled I started having shortness of breath and pain in my chest.  Went to Memorial ER and they did chest x-ray and CT Scan and determined I had Blood Clots in both lungs.  Treated with blood thinner and admitted overnight.  Discharged 4-28-21 with prescription for Blood Thinner.
Severe left arm pain that spread under arm and involved underarm lymph nodes and around tissues, swollen , tender  and warm to touch area lasting for 6 days post-vaccination. General extreme fatigue and malaise.
"At the time that I received the Flu vaccine, I felt more pain and stinging than I have in past years, not only at the injection site but numbness radiating down by arm to my fingertips. It has been around 3 weeks since getting the shot. I still have extreme pain in my Left arm. There is no redness or swelling. At times I think the pain in more soft tissue pain or muscular pain. Other times it seem to be in the Shoulder joint. I have extreme difficulty getting my shirt off. I seem to have ok range of motion if I move my arm very slow. The pain is much worse at night and first thing in the morning. I think Ibuprofen helps sometimes and not at other times. The pain has not gotten worse overtime, but it has not gotten better either."
died 2 weeks after getting the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's aunt) that a female patient of unspecified age received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Caller mentioned that there patients who passed away after taking the vaccine but no proof if caused by the vaccine. Caller said she knows someone in her 30s and her aunt who died 2 weeks after getting the vaccine. The patient died on an unspecified date. Outcome of the event was fatal. It was unknown if an autopsy was done.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101352464 Same reporter/ drug/ event for different patients; Reported Cause(s) of Death: died 2 weeks after getting the vaccine
Arm on the side of injection going numb occasionally after injection. 12 hours after injection hand on the injection side was still going numb more frequently and starting to have stabbing pain.  24 hours after injection pain spread to the feet. 2nd morning after injection numbness and pain spread to both hands and both feet. Called the doctor at this point and was told to monitor for any increased "climbing" pains. The pains are not constant they come and go, if that changes I was told to come in.   3rd-morning pain and numbness are still in the injection side hand and occasional pains in the right foot, but has decreased.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMh significant for htn, af, aflutter, primary malignant neoplasm of penis. Pt was 96 years of age. No cause of death noted, or recent hospitalizations noted.
shortness of breath; throat felt really tight; joint pain; body aches; nausea; fever/higher fever up until 100.2 Degree F; injection site hurting, swelling; injection site hurting, swelling; coughing; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, via an unspecified route of administration on 19Jan2021 at a single dose for an COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Jan2021, the patient had the "normal" adverse effects: joint pain, body aches, nausea, fever. On the 21Jan2021, she developed shortness of breath since her throat felt really tight and was prescribed with steroids, but she still feels tightness in her throat. On the 25Jan2021 she got higher fever up until 100.2 Degree F. On 26Jan2021, she went to urgent care and they did a COVID test on her and prescribed an inhaler for her. Today the test result came back negative but she still got nausea, injection site hurting, swelling and coughing in Jan2021. The event nausea, throat felt really tight, injection site hurting, swelling and coughing was not recovered while for other events was unknown.  Information about batch/lot number has been requested.
pt called questioning the worsening of his arthritis shoulder is a side effect of the shingrix vaccine. He received his vaccine on his right arm but his left shoulder arthritis has been getting worse and he wanted to know if shingrix vaccine could cause it
Itchiness; Redness; Swelling; Pain at injection site; Body Aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE PAIN (Pain at injection site) and MYALGIA (Body Aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 PRURITUS (Itchiness), ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Body Aches) and CHILLS (chills). At the time of the report, PRURITUS (Itchiness), ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Body Aches) and CHILLS (chills) outcome was unknown.            Benadryl used for treatment.
Patient presented with a rash on the left bicep near vaccination site and papular rash upper chest.
felt feverish; fatigued; sore body; headache; nausea; feeling really ill; This is a spontaneous report from a contactable consumer (patient). A 38 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via an unspecified route, administered in Right arm on 16Mar2021 at 11:45 (38-year-old at vaccination) as Dose 2, Single for Covid-19 immunization. She was non-pregnant at time of vaccination. The patient's medical history included spondyloarthritis. No known allergies. The patient's concomitant medication(s) included duloxetine hydrochloride (CYMBALTA), lorazepam, celecoxib (CELEXA), etanercept (ENBREL), Vitamins within 2 weeks of vaccination. The patient was not diagnosed with Covid prior to vaccination. The patient had not received any other vaccine within four weeks prior vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route, administered on Left arm on 23Feb2021 at 12:00 (38-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. On 16Mar2021 at 15:30, the patient had experienced a headache and nausea within several hours of vaccine which lasted two days. On 17Mar2021 (Day after vaccination), the patient also felt feverish, fatigued and had sore body. On 17Mar2021 and 18Mar2021, she felt the most symptoms and was feeling really ill. The patient was not tested for Covid post vaccination. No treatment received for resulted events. The outcome of the events headache, nausea was recovered on an unknown date in 2021, feeling really ill was unknown and the outcome of other events was recovering.  No follow-up attempts are possible. No further information was expected.
This spontaneous retrospective pregnancy report was received from an unknown age female patient concerning herself. The patient's pertinent medical history, concurrent conditions and allergies were not provided. On an unknown date, prior to her pregnancy, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) as prevention from the varicella virus (dose, Lot # and frequency were not reported). Secondary suspect and concomitant medications were not reported. The last menstrual period and estimated delivery date were unknown at the time of the report. On an unknown date, the patient delivered a baby (unspecified demographics and outcome). It was reported that the patient was not pregnant at the reporting time. The patient reported that her physician recommended a "booster" of an unspecified varicella vaccine because her "titers were low when she was pregnant". The outcome of varicella virus test negative was unknown as well as the causal relationship between this event and varicella virus vaccine live (oka/merck) (manufacturer unknown). There was no PQC involved.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a two-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Nov-2011, the nurse did not realize that the FLUMIST had expired before administering it to the patient and the patient received expired FLUMIST. The product expired on 02-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
On 7-2-2022 started with sinus then went to coughing and congestive. Feeling weak an unable to walk very far without stopping and leaning on something for support. Went to Dr. on 7-2-2022 diagnosed with upper respiratory or possible covid. Did covid test came back positive 7-7-2022. Doctor started me on Azithromycin 250mg for upper respiratory on 7-6-2022 and Paxlovid for Covid 7-7-2022.
Case number PHEH2012US007219 is an initial spontaneous report received from a nurse on 30 Mar 2012 with the follow-up received on 30 Mar 2012: This case refers to 11-years-old male child. He was vaccinated with MENVEO (batch number: unknown) intramuscularly and TDAP (other manufacturer) on an unspecified date. He felt "sick to his stomach" within five minutes after vaccination. He put his head down at his knees for a little bit and stomach ache and nausea gone away. Within ten minutes after vaccination, he fainted and hit the back of his head on the floor. He was treated with ice and received oxygen. He went home and slept for hours. He was dizzy at night, but recovered completely by the next day. Reporter suspected the events were related to MENVEO and TDAP. Follow-up received from a nurse on 30 Mar 2012: Updated adverse events and event outcome.
Mom states approx 8 hrs p/pt had vax pt had limpness, high pitched cry, blue lips, "jerky" like movements of hands; Seen @ hosp by ER MD;
Patient reported having suicidal thoughts, hearing voices.  Patient started self harming after 1st does of vaccine.  After 2nd dose of vaccine the self harm got worse and she became very depressed.
Lower back pain/ Pain in my back and killing me; messed me up because my back is aching; It started attacking my body now; It is attacking my body, my bladder, liver; Having chills at night; And this 'coughing' (Not clarified) pain; It started attacking my body now; It is attacking my body, my bladder, liver; I am in pain; I am hurting and this has affected my body/ It started attacking my body now; It is attacking my body, my bladder, liver; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 (Lot Number: EN6208) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 (Lot Number: not reported) as dose 1, single for COVID-19 immunization. The patient reported that she was having a reaction from the vaccine. She was having lower back pain and coughing (not clarified) pain, it started attacking her body now (as reported). She also stated that it was attacking her bladder and liver. The patient felt she was alright but reported that it was attacking her. The patient was also having chills at night. The patient stated she would go to emergency room. The patient reported that she had pain in back and that it was killing her and it messed her up. She stated that she was in pain; and hurting and that it has affected her body. It was unknown if patient received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
On April 4, I took him to the hospital, they confirmed he had pneumonia with a high temperature. He begin to have seizure and had to be put on oxygen. He stayed in hospital for 4 weeks. The hospital started him on  rehab  treatment. The hospital confirmed he may have had a stroke. My dad was full of fluid in lung, he started forgetting a lot of things. He also diagnose  with AFIB.
Incorrect age group--17 y.o. received Moderna.  Patient received second dose of Moderna on 4/9/21.  No AE.
Sore arm (muscle not injection) for 2 days and a headache for a week - and still having.
Patient was 17 years 7 months at the time of vaccination (vaccine approved for 18 years +). Patient has not experienced any adverse reactions.
This was patient's first COVID-19 vaccine. It looks like she should have been given 0.25 mL, however, was given 0.5 mL.
developed a rash on her legs and hands; This is a spontaneous report from a contactable consumer. This consumer reported for a 19-year-old female patient (daughter) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 26Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history included Down syndrome and autism, and she was not verbal. The patient's concomitant medications were not reported. On an unknown date patient developed a rash on her legs and hands. Patient would see a doctor but wanted to check if it was a reported side effect. The event outcome was unknown.  No follow up attempts were possible. Information about lot/batch number could not been obtained.
Right arm pain/ numbness down to hand. New rash "like heat rash" below inject. site, swelling at site. 4/23 (3:45PM) Some tenderness shoulder joint. Not able to raise arm. Slight redness below site.
Vaccine was injected too high on the arm, just below the acromion and possibly into the bursa or tendon. Shoulder pain and weakness have persisted for over 4 weeks and required now two orthopedic surgeon visits where impingement of rotator cuff tendon was diagnosed. Has also required physical therapy. MRI has now been scheduled to assess ongoing pain and weakness.
pounding irregular heart beats lasting long periods of time and stronger.  muscle and joint pain at intervals.  lasting  several weeks, not every day
Exposed to a low temperature of 31.5 degrees; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   In JUN-2023, the patient received Bexsero. On 15-JUN-2023, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Exposed to a low temperature of 31.5 degrees). The outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 03-AUG-2023 The reporter reported that on 15th June 2023 the Bexsero vaccines from the lot number 5AR2D was exposed to a low temperature of 31.5 Fahrenheit. The reporter stated that the vaccine was administered between 15th June 2023 to 21st June 2023. The reporter did not had specific date of vaccination for the patient. The reporter stated that at the time of reporting the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The Boostrix vaccine temperature was exposed to 31.5 degrees Fahrenheit, which led to incorrect storage of drug. The reporter did consent to follow up. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023105930:same reporter US-GSK-US2023105935:same reporter US-GSK-US2023105934:same reporter
Many patients were coming in for their 12, and 16-year-old shots all day, but especially the afternoon.  The patient that the error occurred with came in for a second dose of pediatric Pfizer.  I had not given this vaccine in quite a while and just pulled up the shot like I had been doing with the 12 and 16-year-old shots and forgot to dilute the medicine and drew up 0.2 ml of the undiluted vaccine.  The patient?s mother was there when I gave the vaccine.  After giving the vaccine I told the mother to wait for 15 minutes in the lobby with the child.  A few minutes later my supervisor came in to the vaccine room and noticed that the Pfizer vial was not as full as it should be.  I then realized that I did not dilute the vaccine.  We checked on the patient.  She had no symptoms or irritation at the site, and she stated that she felt fine.  Then we consulted the vaccine coordinator on what to do next.  She discussed with the supervisor what to explain to the Mother.  The supervisor explained to the mother to keep an eye on the patient and that the area of the shot might be red and irritated and to call us with any questions, and to seek emergency help should anything severe occur.
This case was reported by a healthcare professional and described the occurrence of red induration in a 46-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  On 24 October 2007 at 14:15 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm.  On 24 October 2007, immediately after vaccination with Flulaval, the subject experienced red induration and injection site hot to the touch.  The subject was treated with Tylenol.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.
Localized arm swelling/redness/warmth about 2 inches in diameter, worsened in past 2-3 days Tongue burning/numbness/tingling constant since vaccination x 10 days now
ACUTE ONSET ATRIAL FLUTTER/FIBRILLATION, ASYMPTOMATIC, ON 6/19/21, LASTED 2 DAYS UNTIL SUCCESSFULLY AND PERMANENTLY REVERSED WITH ELECTROCARDIOVERSION.
At home the night of the shot before bed he felt a pain in his left heel and his "ankle didn't want to work" (pt words). The next AM (03/13/19) he woke up and his whole left leg "didn't want to work". He went to get back into bed and figures he must have passed out while he sat as he ended up sitting on the floor. His wife could not get him to answer/respond so she called 911. He came to but ambulance took him to ER. He reported he had a hard time walking (left side didn't want to work). They put him through testing, diagnosed no heart attack/stroke. They said he was slightly dehydrated. They gave him some anti-inflammatory shot (he didn't know what) but it helped. He has since been back on his ibuprofen (OTC) and/or Meloxicam which seems to help.
Pt reported feeling light-headed/dizziness, vision changes (tunnel vision) and shaky, also reported palpitations (she attributed all symptoms to insufficient caloric intake), felt feverish but no fever, temp was 97.3F. Hands were stable, no rash or difficulty breathing.
A large area of erythema over area of injection site and a large welt to lower back extending into mid-buttocks. I saw her initially, started anti-histamine treatment and abx, and advised follow up with PCP.