chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. here 11/10/16 for flu clinic 0.5 QUAF flu dose. S/s developed later that eve and pt was seen for same in office on 11/11/16. S/s = (Lt) upper arm with 71/2 x 6 cm erythema, induration, warmth and tenderness. Afebrile tx with ibuprofen and warm compresses prn.
Sore throat, some post nasal drip, congestion and fatigue. I didn't have a fever or ache. I was able to work from home. I took a covid test friday may 20th morning I was positive. the symptoms still stayed the same throughout. I would characterize it as a mild cold, I've had head colds that made me feel much worse than this did.
Narrative:  HPI: 92-year-old male here today with fatigue, decreased appetite, cough and shortness of breath over the last week. He states he has been vaccinated for Covid. He denies any fever but has felt chilled. Denies any chest pain. No shortness of breath at rest but states when he exerts himself he feels short of breath. He states anytime he eats anything he has vomiting, he denies any abdominal pain. Denies any loss of taste or smell. No swelling in his legs or new rashes. He has not tried taking anything for his complaints. Nothing specifically seems to make him feel better or worse. He states he has only been able to drink a few sips of water and soda here and there. He denies other complaints at this time. He is here by himself. Medical Decision Making 92-year-old male here with failure to thrive, inability to eat or drink over the last week, nausea, vomiting, cough and shortness of breath feeling generally unwell. Lab work obtained. Thrombocytopenia noted, he does have a history of this however appears worse than baseline. He does not have any active sites of bleeding at this time, will hold on transfusion. Hemoglobin appears to be at patient's baseline. Creatinine elevated above baseline, potassium mildly elevated, I do not appreciate evidence of pneumonia on chest x-ray. No leukocytosis. Will hold on antibiotics at this time. Lipase is elevated, IV fluids were given. Covid testing is positive. In the setting of his age, comorbidities, inability to eat or drink, I do anticipate admission at this time. He was given steroids in department. He is not hypoxic and has been maintaining oxygen saturation on room air. He is agreeable to admission at this time. Hospitalist consulted. Patient to be admitted. Discharged to home with home health
- [ ] Day 1: severe migraine (2-2.5 hours after the shot) - [ ] Day 2: muscle aches, nausea, fatigue - [ ] Day 3: muscle aches, migraine, serious heartburn, nausea, dizziness, cold sweats, fatigue, loss of breath, abdominal/chest pain (questioned if it was a heart attack) - [ ] Day 4: nausea, cold sweats, fatigue, abdominal pain, mild muscle aches, dry mouth - [ ] Day 5: woke up at 1100. Already very fatigued and cold sweats. Dizzy. Napped from 1415-1545. Dry mouth. - [ ] Day 6: fatigue, nausea, dry mouth, injection arm numb/tingly.  - [ ] Day 7: fatigue, nausea, dry mouth, mild migraine, lower abdominal pain  - [ ] Day 8: nausea, abdominal pain
weak; Uneasiness; Tired like the energy was sucked of me; Arm sore; Weight/pressure on my head; body aches all night; could not sleep; A spontaneous report was received from a 50 year old female patient who is also a nurse. The patient is a participating in the mRNA-1273 Emergency Use Program and who experienced uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak with the use of mRNA-1273.    There were no relevant medical history or concomitant medications provided.  On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient, experienced the non-serious events of uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak. The patient noted she took the vaccine the day prior at work, at approximately 10:00am, and experienced the reported events when she got home. The patient confirmed she felt a little better the morning after, but still weak. Treatment included 500mg paracetamol before bed.   There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the reported events of uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak were unknown at the time of this report.  Causality was not provided for the events of uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak.; Reporter's Comments: This case concerns a 50 year old, female patient, who experienced non-serious unexpected event of feeling abnormal, pain in extremity, head discomfort, insomnia, and asthenia, and non-serious expected event of myalgia and fatigue. The event of feeling abnormal, fatigue, pain in extremity, head discomfort, myalgia and insomnia occurred 1 day (same day) after mRNA-1273 (lot# Unknown). The event of asthenia occurred 2 days after mRNA-1273 (lot# Unknown). Treatment included paracetamol. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
4-5 episodes of upper arm shaking and legs stiffening 2 days after vaccines of PENTACEL, PREVNAR, ROTATEQ.
swelling of lt deltoid 8cm w/erythema Td was used to avoid pertussis because mom had a rxn
Received shot in left arm 10/6 about 10:30AM. By that evening 100 degree temperature, left arm throbbing. Arm continued to throb the entire next day. Temperature 99-100. By Monday 10/8 spoke to family doctors office. Monday evening, noticed rash on left upper chest. On 10/11 diagnosed with herpes zoster.
101 degree fever, achy, shivering, headache, extreme dizziness, slight nausea. Still have these symptoms 20 hours later.
Below is the documentation of the call made by the patient to the nurse: Patient called saying she had a tetanus shot Monday and has had a H/A since.  Denies head trauma, allergies, or sinus problems.  No fever and injection site slightly uncomfortable WNL (R deltoid).  H/A started about 4 PM Monday (5th) and persistent though today it is not as intense.  She has taken Aleve, ibuprofen, and Tylenol, all just taking the edge off.  Other than H/A, no other issues. I informed her H/A is a possible side effect and most normal side effects can last up to 3 days.  Today is the 3rd day and intensity is decreasing so to monitor today but if continues tomorrow or gets worse needs to seek med attention.  We have no appts today or tomorrow so will need to go to Urgent Care or ER.  She stated understanding. I tried reaching the patient several times to see if headache resolved and when but unsuccessful.
2" reddened area at site, pain radiating down arm. Pain in underarm & down side (L); headache. Noticed AM of 10/19/11. Application of cold compress.
On 04/26/21 @ 2 am.. felt a sharp pain on left side of chest.. felt weird . Got out of bed to see if Id feel better... began to get clammy/sweaty- especially behind my neck... felt faint and dizzy- woke my husband up and told him my symptoms in case I d pass out.. he helped me to car and took me to hospital...
Site of injection red, slightly swollen, hardness at site c/o slight burning sensation at injection site.
Immediately after receiving the IM vaccine patient states she experienced shortness of breath but felt very warm all throughout her body. The symptoms lasted for a couple minutes and quickly resolved.
24hr p/vax pt began having inc temp, w/highest reading 101-A wk later the MMR devel swelling bilat from behind ears, running along jawline to chin-diff swallowing-went to local ER;ER MD told pt had the mumps;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 10:30 as dose 5 (booster), single (Lot number: 6h9703) at the age of 60 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Specific lot number unknown. Assume that the Nurses who administered the vaccine used FLUZONE. 4x8 cm rash at injection site multiple small erythematous papules. Pallor of underlying skin. Not painful, slightly pruritic. We have seen an unusual number of local reactions this year.
Arm hurt the day of injection, a little more than I thought to be normal, and then it got worse over the next 3 weeks, at which point I had contacted my doctor, and my doctor sent me to physical therapy and an Orthopedic Dr, to seek both pain relief and to try to regain range of motion and strength in affected arm.
pruritic rash started on the ipsilateral elbow flexor, spread to wrist, web spaces, then all flexor folds in all 4 limbs. These lasted for about 5-7 days and disappeared on their own. I did not take any medication or apply any creams or ointments.
Kinrix and Daptacel received the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a child female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (DAPTACEL) for prophylaxis.   Previously administered products included Daptacel (On 16th August 2022, received 1st dose of Daptacel).   On an unknown date, the patient received the 2nd dose of Kinrix, Kinrix Pre-Filled Syringe Device and the 2nd dose of DAPTACEL. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comment: The reporter called to report that a patient had received a dose of Kinrix the same day that the 2nd dose of Daptacel vaccine was received. The reporter did not specify the date of vaccination when Kinrix and Daptacel were given at the same time. The reporter consented to Follow-up. Additional Supportive Information: Patient received Kinrix and Daptacel the same day, which led to overdose of DTP component.
Nothing happened after the vaccine.  On April 28th my wife & I contracted COVID-19, Two days later after a trip, I had a COVID-19 home test and I tested Positive, I had little fever for 1 day. Mild symptoms, but after week symptoms were gone. I monitored my blood pressure all the time and it was normal but between the end of May and end of September I was examining my blood pressure again and I discovered my blood pressure has gone up dramatically, the numbers double from 65/minute to 125/minute constantly, several times a day. I was preparing to go to see my doctor, but at the end of September I got my 5th vaccine. I got the adverse condition after the 4th dose. I had two home tests, one after 8 days and it was positive and the one after 12 days and it was negative.
Had immunization at 3pm (L) leg -> PENTACEL. Call from mom at 715 pm. Crying, inconsolable, left thigh red & swollen, not hot. Advised TYLENOL & recheck in AM. Did not see next day, apparently better.
140mmx150mm of measured induration and erythema. Patient reports itching. Afebrile.
Presented to hospital after being unresponsive at home.  Patient began having upper respiratory symptoms on the Sunday prior to admission with frontal sinus pressure. Began having diarrhea the day prior to admission.  Day of admission patient was found to be nauseous, hot, profusely sweating and short of breath on the toilet. While on the toilet patient went unresponsive, slumped over, lips turned blue and EMS was called. Patient was intubated upon admission to the ER.
Monday night pain on arm at injection site, Tuesday pain still there, Entire body started to ache. Couldn't stand. Runny nose. Could barely walk that night. Hallucinations sleeping at night, chills, tired.  Took1 Tylenol.
No sx until 18APR91; pt became a little fussy, no fever; pt settled down by bedtime & mom thought pt was sleeping; Mom found pt dead AM of 19APR91;
accidentally received Kinrix instead of Pediarix; 4 months old patient accidentally received Kinrix; 4 months old patient accidentally received Kinrix instead of Pediarix.( 2 dose).; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th March 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 30th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's comments: Nurse reported that 4 months old patient accidentally received Kinrix instead of Pediarix as 2nd dose. The consent to follow up was given. Additional Supportive Information: Four month old patient received Kinrix instead of Pediarix as 2nd dose, which led to wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Guillain-Barre Syndrome after receiving Typhoid Vi and Yellow fever vaccines. 4 weeks. Seen in ER and admitted inpatient ward for observation.
Normal labor and delivery on 10/12/2021. This visit was within 6 weeks of receiving the COVID vaccine.
Lymph node swollen under arm of injection site to the size of a golf ball also associated pain at lymph node  site.
After receiving October 2, 2018 the first SHINGRIX vaccine injection at Pharmacy, I had an outbreak of shingles on forehead starting on October 12, 2018. I went to my pharmacy care physician on October 16, 2018 who prescribed valacyclovir HCL 1 gram tablet to treat side effects of the shingles outbreak.
Headache pain at the insertion site, called out SL on 2/3 d/t to symptoms Narrative:
Cough, Dry non productive, lasts throughout the day, has been constant since 2 days after vaccine
Breakthrough case admission after 2 vaccines Moderna 2/28/21 Lot# 025A21A;  Moderna 3/24/21 Lot# 045A21A
Right after I got the tdap vaccine, I turned super pale and almost fainted, 11 hours later I started to get diarrhea, and nauseous, then at 4 AM I threw up. My stomach hasn't stopped hurting since, and its been five days.
After vaccination, the same night patient developed chills and mild fever, and diarrhea.  The patient still has diarrhea after 6 days of vaccines. The patient is a physician and taking OTC medication for symptomatic relief. But, he is still complaints about low energy.
This case was reported by a consumer and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX. On 22nd May 2018 16:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 22nd May 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain, pain in arm, back pain, muscle soreness, headache, joint pain and nausea. On 23rd May 2018, the patient experienced fever and somnolence. On an unknown date, the outcome of the injection site pain, pain in arm, back pain, muscle soreness, fever, headache, somnolence, joint pain and nausea were not recovered/not resolved. The reporter considered the injection site pain, pain in arm, muscle soreness, fever, headache, somnolence, joint pain and nausea to be probably related to SHINGRIX. It was unknown if the reporter considered the back pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a fever of 102.5 degree F. The patient developed pain at the injection site as well as shooting pain in her back and arms.
Fever, chills, body aches, and headache.  Tylenol, and sleep.  Lasted approximately 24 hours.
Case number PHEH2015US020963, is a combined initial and follow up spontaneous report received from a nurse on 15 Oct 2015 and on 20 Oct 2015, respectively. This report refers to a 49 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1413101) intramuscularly on 13 Oct 2015. No adverse event was reported following this maladministration.
High pitched screaming for hours, inconsolable, lack of appetite, when she did fall asleep if we laid her down she would immediately scream, low grade fever (100-101).
Information has been received from a medical assistant concerning a 9 year old male who on 04/19/1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  The patient's mother reported that on the night of 04/07/2004 the patient developed 20 lesions.  There was no fever.  No further information is available.   Follow up information from the licensed practical nurse indicated that the patient was seen on 03/04/2003 and was diagnosed with varicella.  It was noted that he had numerous papules in different stages, widespread which started on 03/03/2003.  On 04/08/2004, the patient broke out again with approximately 20 lesions.  Subsequently the patient recovered.  It was also reported that the patient's brother was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed breakthrough chickenpox. No further information is expected.
left arm swollen; left arm painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swollen) and PAIN IN EXTREMITY (left arm painful) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Blood pressure high.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen) and PAIN IN EXTREMITY (left arm painful). On 16-May-2021, PERIPHERAL SWELLING (left arm swollen) and PAIN IN EXTREMITY (left arm painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   This case was linked to MOD-2021-229864 (Patient Link).
On the day of the vaccination later that evening, she noticed she was dizzy and she felt warm like she had a fever.  On June 12th, she woke up, went to brush her teeth and found 4-5 white sore spots/lesions on the inside of her lower lip.  She went to a doctor appointment right away that day.  Throughout the day and over the next few days the spots got worse and spread to the all over the inside of her mouth, tongue and on the outside of her lips.  She said this lasted for 1 week.  She went to the doctor that day on June 12th.  Doctor diagnosed her with stomatitis and thrush.  She said her tongue and throat were very sore and swollen.  She could barely talk and could not eat for 1 week.  She said that she lost 11lbs in that week.  Her doctor gave her Valtrex and that cleared up the sore spots/lesions.  She was also given a 'cocktail' to rinse her mouth.
The vial was mixed with bacteriostatic 0.9% Sodium Chloride. Patient didn't have any adverse events.
Shoulder injury - tendonitis or bursitis - decreased range of motion on left arm - anti-inflammatory tx ibu 800mg tid prn.
As the mother was bathing the child on 8/28/01, she noticed the left deltoid "swollen, red and hot to touch". The child was irritable and had a low-grade fever. She carried her to the ER where she was given treatment with Benadryl and ice packs. On 8/29/01, the arm site was "warm" with some redness but improved.
Pfizer-BioNTech COVID-19 Vaccine EUA Sore arm - started an hour later until 3/9 around 2pm Injection site soreness - started about an hour later and has continued Fatigue - started about 10pm on 3/7 until around 11pm on 3/8 Body aches - started about 10pm on 3/7 until 12pm on 3/9 Headache - started about 10pm on 3/7 until 12pm on 3/9 Swollen lymph nodes on left side, behind hear and throat - started about 10pm on 3/7 until 2pm on 3/9 Sore throat on left left - started about 10pm on 3/7 and has continued
Nurse notified employee health RN that the weekend following her flu shot she began experiencing drooping to her left eyelid that progressed to her mouth. She went to the ER and was diagnosed with Bell's Palsy. She is currently on steroids and beginning to see slow improvement. She is able to continue working.
Pt vaccinated with DTP/HIB experience crying 6-7 hrs after injection. Cried 2 hrs, fever 104+, no siezure, inject site slight swelling.
blinking uncontrollably; A spontaneous report was received from a consumer concerning a 42-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blinking uncontrollably.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event blinking uncontrollably.  Treatment details included antihistamines..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, blinking uncontrollably was unknown.
Seizure like incident. Eyes rolled back and up and baby was ?stuck? in this unconscious state for 1-2 minutes followed by postictal sleep. EEG came back normal in additional to blood work. She had no fever (99.1), was not anemic, and had no other sickness. Doctor attributed incident to a ?breath-holding? incident.
Severe weight loss - 02/25/2021 Patients weight was 136 lbs. 03/25/2021 Patients weight was 127 lbs. 04/01/2021 patients weight was 110 lbs. Death Occurred: 05/02/2021 Documentation (if needed) is available in the form of medical notes from ER & office visits & a death certificate.
extremely fatigued, inc temp-took APAP q 4hrs from time of vax
This spontaneous report was received from a physician via company representative regarding a 64 year old male patient. There was no information about concurrent condition and historical medication. On an unknown date the patient developed moderate case of shingles. Patient was seen by physician to seek medical attention. The outcome of moderate case of shingles was unknown. Causality was not reported. Additional information is not expected because physician does not want to get contacted.