chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in my shoulder; unable to lift my right arm over my head; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2022 10:20, the patient received Shingrix. On 18th July 2022, less than a day after receiving Shingrix, the patient experienced shoulder pain and mobility decreased. The patient was treated with paracetamol (Acetaminophen) and meloxicam. On an unknown date, the outcome of the shoulder pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date:  18-JUL-2022 Reporter's Comments: The patient reported case for himself.  The patient took the Shingrix shot and about an hour to an hour and a half later the patient had pain in his shoulder that had persisted.  The patient took acetaminophen twice and meloxicam. The patient was unable to lift his right arm over his head without using left arm to assist.
Patient was mistakenly given Johnson and Johnson vaccine at 14 years of age. Johnson and Johnson contacted. Parent contacted, and informed .
Inflammation/pain in lower back/spine area. Prescribed orphenadrine citrate for treatment. Severe pain gone after treatment. Slight pain still remains. Inflammation/pain in left knee cap. Prescribed cortisone injection/physical therapy/tramadol. Severe pain was gone after treatment. Slight pain remains.
I woke up with the chills and body aches; pretty bad headache; fever got to 99.8 and took  Tylenol medicine for it. The next day after I was pretty much those same symptoms - I slept the whole day since I was not feeling good at all. The next day later I was fine.  I did have COVID in July, 2020.
An error occurred. Pt was given Pfizer gray top 12+ Bivalent as first dose. Pt informed of error. will come back to complete series.
can't walk; lost 80 pounds body weight; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (can't walk) and WEIGHT DECREASED (lost 80 pounds body weight) in a 69-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (can't walk) and WEIGHT DECREASED (lost 80 pounds body weight). At the time of the report, GAIT DISTURBANCE (can't walk) and WEIGHT DECREASED (lost 80 pounds body weight) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, weight: lost 80 pounds.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not reported.
It was reported that a female in her twenties, received Fluzone WV '99-'00 on 10/4/99. Within 4 hours, post vax, the pt experienced "weakness, headache, fever and general malaise". This is 1 of 3 similar cases by the same reporter:U199900891 through U199900893. No further information is available at this time. When additional information was provided, it was reported that this pt also experienced nausea and diarrhea. The pt also reports swelling 6cm X 6cm X 1cm at the site of the injection. The pt took Tylenol at the onset of the reaction. This "pt is 1 of identical twins with nearly identical reactions."
Rash on body, lasted several days. Treated with Benadryl. Erythema multiforme minor? Pt seen by dermatology.
He complained Fever and after that shortness of breath, and when I tried to see a Doctor he suddenly collapse and died
My daughter tested positive for Covid-19 on 01/16/2022 and that day is when my symptoms started like cough. On the 17th called and my doctor, scheduled my test for 18th for test. 19th. Results came back positive. My doctor prescribed Albuterol inhaler and I took OTC cold medication.
They administered patients and staff from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  The vial was initially stored in the refrigerator on 04 Nov 2021. Date(s) of administration of vaccine, some on 05 Nov 2021 and the other doses on 12 Nov 2021. The vial did not undergo any temperature excursions. HCP stated, no AE as a result of this misadministration.  No treatment information was reported.
1 week post vaccine had 1 day with a sore throat and runny nose. Developed right calf pain 04/19/2021.  Presented to ER on 04/25/2021 w/ a 2 day history of shortness of breath and some chest tightness worse with exertion, with worsening  symptoms at time of ER visit.   Admitted for observation  with "Pulmonary embolism without acute cor pulmonale and Acute respiratory failure with hypoxia"
Was vaccinated with H1N1 on 11/9/09. On 11/13/09 pt had experienced irregular HR, went to ER, had EKG, bloodwork, urine, and more. All normal, also CXR WNC then on 11/14, had "convulsions/seizure" witnessed by hockey team members. Went to ER had EKG, again normal. Pt believes reaction to shot. Has HX of: family members with multiple medical hX. Father MVP / bro MVP and hole in heart / closed on own, no surgery. PGM died age 50 (CAD) PGF sudden dead (MI). 11/25/09 Hospital records received for date 11/14/09. DX: dyspnea acute.Presented to ER w/ c/o HA, nausea, chest pain, SOB, increased HR, anxiety. 11/25/09 Medical records received for date 11/17/09. Holter monitor report: NSR. Stress echo report: negative. Cardiac echo: negative. 11/30/09 ER records received for date 11/13/09. DX: palpitations  Chief c/o palpitations, dizziness, SOB. Pt states worse w/ exertion.  Assessment: WNL.
Information has been received from a 79 year old female patient with diabetes referring to herself. The patient had no drug reaction/allergies. In June 2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, single injection, subcutaneous, lot# and expired date were unknown) for prevention of shingles. Concomitant therapies included TOPROL XL TABLETS and LOTEMAX. Approximately 6 weeks ago, on 03-JUL-2015, the patient developed shingles in her eye. The shingles made her eye first "feel like it had broken glass in her eye". About 5 weeks ago, on 10-JUN-2015, she developed shingles in her ear. The shingles in her ear made it "feel like she was underwater". The patient sought medical attention by office visit. No lab tests were performed. ZIRGAN was given for the events as treatment. At the time of reporting, the patient's eye just burned. The patient did not recover from the events. Additional information is not expected since the reporter refused to be contacted.
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Patient was unconcious and shaking violently after reciving both vaccines. Eyes rolled behind their head and started shaking. Patient unresponsive for 10 seconds but felt okay afterwards and was concious.
The pt experienced unconsolable crying lasting approximately 7 hours. Was seen in the MD's office and diagnoses as a possible reaction to the vaccine. The pt experienced a fever of 100.4, Tylenol was given and the pt eventually stopped crying and returned to "old self".
a bit of dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (a bit of dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (a bit of dizziness). At the time of the report, DIZZINESS (a bit of dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Fast pulse rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medications were not given.  The patient was easy and taking it all fine and had currently no side effects.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Significant follow up appended : updated reporter email and contact number, updated event outcome, deletion of event and added lab data
This case was reported by a consumer via sales rep and described the occurrence of headache in a 50-year-old male patient who received SHINGRIX for prophylaxis. In December 2017, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient did not know lot number or expiry date. The side effect reported headache on second day. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK017827.
Decreased responsiveness, pallor, shrill cry.  Noticed about 5 hours after shots administered.  Lasted total of less than 30 minutes.
1. arm soreness - started 5 am Apr 9; no treatment; resolved in about 3 days 2. chills - started 5 am Apr 9; no treatment; intermittent; resolved in 24 hrs 3. body aches - started 5 am Apr 9; no treatment; intermittent; resolved in 24 hrs 4. nausea - started 5 am Apr 9;  no treatment; intermittent; resolved in 24 hrs 5. vertigo - started Apr 12; Epley maneuver; resolved in about 7 days 6. cluster headaches (with light sensitivity) - started 5 am Apr 9; several treatments: Excedrin, oxygen, verapamil increased, sphenopalatine nerve blocks, occipital nerve block, Emgality injections; ongoing at Sep 27.
Patient began to complain of stomach pain. She became pale and limp. She was sleepy. All vital signs including heart rate, blood pressure, and blood sugar were within normal limits. She was give Gatorade to drink. It took about 30 minutes for her to regain normal consciousness.
Mom states pt cried "non-stop" for 5 hours after receiving 15 month shots. Child was not ill @ the time. Child woke from sound sleep and cried for 5 hrs. Fell back asleep - woke up fine. Mom also states this happened after 2 month shots 9/20/07 but never reported to physician.
Rash all over body, fever up to 102, muscle aches x 3 days
Swollen face and throat, difficulty breathing, light headed.  Took one Benadryl 25 mg  and slept poorly that night.  I went to work the next day because symptoms began to lessen.  Symptoms went away after 2 days.
Mom reports that after every flu vaccine, including H1N1 (which was that given on this date), the child had nose bleeds
Skin disorder; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Skin disorder) and FATIGUE (Tiredness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Concurrent medical conditions included Psoriasis (Moderate To Severe Chronic Plaque Psoriasis).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (Skin disorder) and FATIGUE (Tiredness). At the time of the report, SKIN DISORDER (Skin disorder) was resolving and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had spots on elbow or some spots and tired.  The reporter's causality for the events of Skin disorder and Tiredness was reported as No reasonable possibility for Humira.  No treatment medication were provided.  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.
This spontaneous report as received from a registered nurse refers to a 25 patients of unknown age and sex. The registered nurse reported that VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 31 F degrees on 01-OCT-2012 and then, VAQTA (LOT #: 0628AE, exp 26-JAN-2015 and LOT # 0273AE exp 06-DEC-2014) was administered to 25 patients. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Patient's outcome was unknown. This is one report of several reports from the same source. Additional information has been requested.
This 52 year old was vaccinated on 19 July 2005 with Anthrax #1, Hepatitis B #2, and intramuscular Typhoid #1.  Approximately 21 July 2005 he noticed his legs felt "heavy as if loaded with weights" and he had difficulty running. He felt "short of breath as if winded" due to the effort of running. He had never felt this way running before. Within 2-5 minutes after completing the run his shortness of breathe resolved; however his legs still felt heavy. He denies any change in activities, shoes, diet, or weight carried/not carried. Approximately 23 July 2005 he reports swelling to his left elbow with gradual swelling to his right ankle, leg and then the left leg over the next few days. He also noted an 8-10 pound weight gain from 175-183 pounds during these 4-7 days. He denies any paresthesia, weakness or limitation in range of motion of any extremity. He stated he had a 4/10 pain that worsened with exercise due to the swollen joints. He complained that his shoes were tight and could barely tie the right shoe. There was minimal redness about ankle area which he attributed to his clothing. He denies insect bites or trauma known. His roommate advised him his right foot was swollen and said he had "legs of an 80 year old lady."  He reported two days prior to the AVA shot he was playing football and running without difficulty. Concurrently he noted onset of diffuse headaches 1-3/10 that remained a constant non-descript ache to his entire head from 20-24 July 2005.He reported experiencing night sweats from 22-25 July 2005. He stated he would wake up in the morning with his linen wet.  He denies any fever, illness or sleeping in a warm/hot environment.  He complained he just "felt like he was swelling up."  The sweating resolved spontaneously approximately 25 July 2005. He sought medical attention approximately 26 July. He was placed on Motrin and within 24 hours "felt the swelling begin to subside."  All extremity swelling resolved within 1-2 weeks without reoccurrence.
fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102.3 after 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 102.3 after 2nd dose). At the time of the report, PYREXIA (fever of 102.3 after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102.3 (High) 102.3.
arm pain / Right arm so sore; I could not raise arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm a day before reporting. Everybody had told the patient how painful the shot was, but patient not feeling any discomfort. The patient's right arm was so sore and could not raise it for two days. The patient did not want to be that big bad wolf. The follow up was not required.
10 hrs post Hep B vax #1 of series pt exp vertigo lasting approx 24 hrs;
PT C/O TINGLING TO THE HAND. PT DESCRIBES THE FEELING LIKE "PRICKING NEEDLES ON THE HAND".  VS@ 9:40 BP 115/70 HR 70 VS @ 9:46 BP 109/71 HR 71 PT WAS INSTRUCTED TO F/U WITH HER PCP. PT VERBALIZED UNDERSTANDING.
Generalized malaises, headache, body aches with heavy feeling in legs. "Foggy feeling". Localized reaction in deltoid area with swelling, redness, warmth, pain. All above signs/symptoms were reported by patient. Pt declined treatment.
Acute respiratory distress consistent with RSV. Went to Urgent Treatment Center as condition was worsening. Patient showed stridor.  No RSV test was given, and the doctor assumed RSV because he had received his COVID vaccine and had a history of croup. 16mL intramuscular dexamethasone injection was given, symptoms subsided within an hour and disappeared by the start of the next day.  He received the second Pfizer dose on the 23rd, and eight hours later showed the same coughing and stridor approximately eight hours later, with acute symptoms. We went to the same Urgent Treatment Center where he received albuterol sulfate via nebulizer, and oral dexamethasone of the same dosage. The Urgent Treatment Center referred us to the Emergency Room. We traveled to Hospital where he received two breathing treatments of racemic epinephrine. His symptoms did not subside, but because O2 and heart rate were stable for the duration of the time that we were there - even when he slept - they sent us home. He awoke with the stridor gone and with no further symptoms.
3AM had sz @ home lasting 8-9mins, went limp, had fever seen @ ER 325AM; no known history of sz; t101.8 & rash on trunk; dx febrile convuls; undetermined origin probable viral illness pt put on Motrin
Information has been received from a consumer who stated that she had "seen TV shows and read newspaper stories with people saying that they had received MMR II themselves with no problem, but their children develop autism after getting MMR II, and it seemed like it was second gestation children like this who get autism from MMR II." Upon internal review, autism was determined to be an other important medical event. No further information is available.
Fever - 2-3 days post vaccine. Parents gave OTC Ibuprofen.
Initial literature case received on 29 Dec 2009: This patient was vaccinated with influenza virus vaccine (influenza virus vaccine monovalent), on an unspecified date. The patient experienced demyelinating disease on an unspecified date. The outcome of the event was not reported.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 07-JAN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K005429, expiration date: 15-APR-2016) (dose, route of administration and frequency were unspecified). Concomitant medications were not reported. It was stated that the temperature and time frame were 10 degrees F for 24 hours and that it had a previous temperature excursion of 9 degrees F for 5 days and 12 hours. No adverse events were reported and no product quality complaint was involved. Additional information has been requested.
The pharmacist accidentally gave the patient a Pfizer covid shot which is 2 days past expiration date .
Tennis ball sized edema & erythema (R) deltoid, appeared same day as injection - tx: ice, prednisone 5 mg/4 mg/3 mg/2 mg/1 mg.
Received Td vaccine in left deltoid on 04/11/2002. Reports arm swelled at injection site with itchy rash over knot. Knot still present today (04/23/2002) size of silver dollar. No rash visible today.
Day after sharp head pain, two days after patient broke out in hives and rash over body.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 ADENOCARCINOMA, LEFT LUNG UPPER LOBE
Initially, my arm was only sore but then my stomach began to 'bubble'.  I felt like I had gas and needed to burb and pass gas but I had not eaten anything for a while and I have never had the experience like that.  Over the evening I felt a bit nausea and had looser stools but the feeling like my belly was on fire was severe. I felt my belly was swollen and it was getting worse.    I put ice on my belly through the night, I couldn't sleep and got up to sit up more.  It was not resolving so I took an Ibuprofen  around 8 am.  It took a little while but it did finally resolved and I was able to sleep.  I do feel like my joints are more stiff and painful since this event.   I don't have stomach issues which is why I feel that this was different.  this was the booster.  I had not such experience from the first two vaccines.  Those I only had a sore arm and was very tired.  I rested and had no other issues.  I had the Pfizer for all three of my vaccines.  1.  EN6200; EN6205 and 330308D.  (Lot Numbers)
School Hep B #2 given 05/19/2003.  Lot # ENG5289C9.  2 days later patient had nausea and vomiting and diarrhea.  Also had rash on neck.  Did not take to PMD.
Started having bowel issues, diarrhea for weeks after, bloody diarrhea, weight loss (over 20 lbs), nausea, fatigue,  Abdominal pain.
(R) arm hot to touch. Swollen. Diarrhea x 5-6 QD x 2 days.
Lots of dizziness and nausea. Even after a long nights rest, the dizziness does not go away. The dizziness began the day of vaccine around 8pm and has not subsided.
Headache (Frontal) and top "8" on 1-10 pain scale, constant ache. Erythema, induration ( 5 x 7 cm area) noted on Lt. upper arm injection sites. Took Ibuprofen 200mg at 1:00pm headache gone now. Advised to ice site and use OTC BENADRYL or ibuprofen.
Swollen thigh where shot was administered.  Taken to ER by mother.  ER Doc gave Tylenol & Benadryl.
Pfizer vaccine was taken out of cold storage 04/06/23 and is good refrigerated for 70 days. The vaccine was given 74 days after taken out of cold storage thus was given after the beyond use date. Pfizer was notified. Discussed situation with Dr. Patients who received the vaccine after the beyond use date was recommended to be revaccinated.