chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a registered nurse concerning a 65 year old female patient with hypertension, hypothyroidism, allergies to propoxyphene hydrochloride and tetracycline a history of pneumonia, who on 09/22/2004 was vaccinated intramuscularly in the left deltoid with a 1/2cc dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination.  Concomitant therapy included Altace, Synthroid, Econazole, Hydrocort, minerals and vitamins and calcium.  The patient had a previous immunization in 1999 with pneumococcal 23v polysaccharide vaccine.  On 09/22/2004 at 23:00, the patient phoned the physician and reported she had developed a red tender knot on the spot of injection.  She reported swelling and pain near the injection site which spread from her shoulder down to her elbow.  The patient was advised to take Benadryl and to use ice on 09/22/2004 before coming back into the office.  The patient was seen by the physician in the office on 09/23/2004.  From follow up information it was reported that the physician noted the left arm was erythematous with angioedema down from the shoulder to the elbow.  The physician outlined the area with a pen and it was noted that on 09/24/2004 the redness had traveled beyond the pen mark and fluid was building up near the elbow.  The patient went to the emergency room.  There were no laboratory tests performed.   There was no product quality complaint reported.  The patient recovered on 09/30/2004.   Additional information is not expected.
left arm was stiff this morning; injection site pain; she just realized the Arnicare Gel was expired, saying she was surprised the Arnicare Gel still worked; has a charley horse pain in her left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 02Feb2021 as 1st dose single for COVID-19 immunization. Medical history included microcytic anemia and thalassemia from an unknown date and unknown if ongoing. Restless legs syndrome from 2015 to an unknown date Verbatim. Concomitant medications included cyanocobalamin, biotin and folic acid taken for microcytic anemia from an unspecified start date and ongoing. Ethinylestradiol, norgestimate taken for hormone therapy from Oct2020 and ongoing. She said she started taking Estarylla 0.25mg/0.035mg oral birth control pill for hormone regulation in Oct2020, saying she has been taking the Estarylla for 4 months steady now. The patient previously took ropinirole for Parkinson's disease and experienced syncope from an unspecified date. Reported she tried the Parkinson medicine, Ropinirole, and that the Ropinirole knocked her out, and she didn't like that, so she stopped taking the Ropinirole 2 years ago. On 02Feb2021 patient experienced has a charley horse pain in her left arm, injection site pain and she just realized the Arnicare gel was expired, saying she was surprised the arnicare gel still worked. Left arm was stiff this morning on 03Feb2021. Stated she has a bad left shoulder, saying she thinks she has a pinched nerve, so she asked to get the vaccine in her left arm. She said her left arm pain has improved on 03Feb2021. Therapeutic measures were taken as a result of he has a charley horse pain in her left arm and left arm was stiff this morning. Treatment received with Arnica gel to help with the left arm muscle soreness. She said the Arnica gel helped. The outcome of the events was recovered, whereas injection site pain was recovering.   Follow-up attempts are completed. No further information is expected.
they administered ADACEL to a 71-year-old patient with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received via pharmacist.  This case involves, administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] to a 71-year-old patient with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine INACT SPLIT 3V (Fluzone High Dose) for Prophylactic vaccination.  On 23-Aug-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength: unknown) (lot: U7648AA, Expiry date: 15-Feb-2025) via intramuscular route in the right deltoid for Immunization and they administered adacel to a 71-year-old patient with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Adacel) was not applicable.  Outcome: Unknown.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
T/C from patient - seen 11/6/09 in ER at the hospital, for fever, swelling, reddness and pain (L) upper arm - Given IV antibiotics and fluids. Sent home with PO. KEFLEX - 11/9/09 - having reaction from medication and will see PCP today.
Patient received undiluted 0.3 mL of Pfizer COVID vaccine during hospital stay.  Patient did not experience any side effects at the time of this report.  Patient remains hospitalized for co-morbidities.
Patient fainted the day following vaccine after waking up. Symptoms resolved quickly and patient was resting in bed when caregiver called.
6OCT Friday eve T101, aches & pains, swelling lt arm elbow & up into back-area warm to touch lasted through;Sunday no sxs on Monday 9OCT fine rash on stomach, arms & legs;
This spontaneous report was received from a physician refers to a female patient of unknown age who a year ago, in approximately September 2011, was vaccinated with a 0.65 ml dose ZOSTAVAX (route and lot number not reported) at unspecified pharmacy. No other co-suspects were reported. No concomitant medications were reported. The physician reported that a year ago, in approximately September 2011, the patient developed cellulitis. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient developed cellulitis was unknown for ZOSTAVAX. Additional information is not expected.
This retrospective pregnancy case was reported in a literature article and described the occurrence of stillbirth in a 20-year-old female subject who was vaccinated with DTPa (with small D + P) (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of DTPa (with small D + P) (unknown route and injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine at 37 weeks of gestation. Within several hours of vaccination with DTPa (with small D + P), the subject experienced placental abruption which ended by a stillbirth. No congenital anomaly was reported. The subject was hospitalised.
I had the pleasure of taking care of your pt during her hospital admission from 8/28 through 9/1/02. Pt is a 4 month old female who presented with an ALTE. Pt received her immunization in your office on 8/26. That night, she had tactile temperature and began Tylenol treatment. Her mother noted approximately 7 hrs after her immunization that she had glassy eyes and appeared pale. She took her to an outside hospital. On the way to the hospital, she had generalized tonic clonic seizure activity of her arms and legs with her eyes rolled back into her head. This episode lasted approximately 1 1/2 to 2 minutes. When she was seen at the outside hospital, her mother reports that she was told it could not have been a seizure because pt looked so well. On 8/17, she had a temperature up to 102.1 and seemed tired all day. That night she slept more than usual. On the day of admission, she woke up screaming, which was unusual for her. She had decreased oral intake. She went to bed at approximately 7:40am and at 8:20am her sister screamed for her mother saying that the baby "had a booboo and that I didn't do it." Her mother found pt in the crib to be limp with her eyes closed. She had perioral cyanosis, blue finger beds and blue under her eyes. Her mother gave her two rescue breaths as she did not seem to be breathing, and tried to arouse her with sternal rubs. They called 911. She was brought to the hospital by a police officer. She was lethargic, pale and had poor respiratory effort. Her temperature at that time was 99.1 and she required two liters of blow by oxygen. She had blood, urine and chemistries drawn and received IV Rocephin and was transferred to hospital. Her hospital work up included an LP, which was normal, and EKG that was normal and a CT of her head that was also normal. While in the hospital, pt did not have any further episodes. She had a video EEG that was normal. Her newborn screen results were followed up on and they were also normal. She had a milk scan to rule out of the possibility of gastroesophageal reflux as an etiology for her ALTE; this was also normal. Tox screens were negative as well as lactage, pyruvate and ammonia. She also, on admission, had a normal carbon monoxide level. It is felt that pt's first episode may have been related to her immunizations and fever. However, her second episode was more severe and not as clear in etiology. As pt had done well and workup so far is negative, I recommend that she be discharged home on an A&D monitor and the parents received CPR training. They will follow up in your office in a week and will follow up in my clinic in 2-3 weeks to re-evaluate her status.
Night of: Arm sore, Shakes, Fatigue, Muscle aches  Took Tylenol, went to bed early. Had trouble sleeping/bad sleep.  Day after: Arm sore, Armpit sore, Fatigue, Muscle aches, Fever, Hot flashes, Headache (back of head-weird to move around too much)  Took Tylenol, drank water, rested in bed.  Third day: Arm sore, Armpit sore, Headache (back of head-weird to move around too much)  Fourth day (Today): Armpit sore, Headache (back of head-weird to move around too much), Some sort of inconsistent sharp nerve pain on upper back, neck, behind/ in front of ear, temples  Did  some minor neck stretches and massaging of area. Helped a little.
Area of redness/swelling about 4x3 inches (oval shape), warm to touch, itchy, tender that lasted from 2/6-2/19, resolving with ibuprofen, hydrocortisone cream, cool/ice compresses  Saw pt by televisit and looks like injection might have been given too low and was likely SC instead of IM
10 minutes after injection, patient with feeling of heart racing. No other symptoms at all including SOB, wheezing, vomiting, diarrhea, rash, abdominal pain. Vitals: HR 82, Sat 99%, BP 123/68. Patient given ice pack and observed for 30 minutes with no other symptoms. Released home without issue. Instructed to F/u with PCM.
felt suicidal; head pressure; head throbbing/ feels like head is being stabbed/ 3 months of chronic headache (daily head pressure and pain) since receiving the second dose; head burning; Lost two months of work; This spontaneous case was reported by an attorney (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (felt suicidal) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEAD DISCOMFORT (head pressure), HEADACHE (head throbbing/ feels like head is being stabbed/ 3 months of chronic headache (daily head pressure and pain) since receiving the second dose), BURNING SENSATION (head burning) and IMPAIRED WORK ABILITY (Lost two months of work). On an unknown date, the patient experienced SUICIDAL IDEATION (felt suicidal) (seriousness criterion medically significant). At the time of the report, SUICIDAL IDEATION (felt suicidal), HEAD DISCOMFORT (head pressure), HEADACHE (head throbbing/ feels like head is being stabbed/ 3 months of chronic headache (daily head pressure and pain) since receiving the second dose), BURNING SENSATION (head burning) and IMPAIRED WORK ABILITY (Lost two months of work) outcome was unknown.            The Patient emphasized that lot number 042L20A was discontinued in the beginning stages of the Moderna vaccination distribution. The patient had been to multiple specialists, had CT scans, MRIs, multiple prescriptions, and nothing has worked. Treatment medications included Tylenol, Aleve, prednisone, Topemax, sumatriptan and multiple others.  Very limited information regarding these events has been provided at this time. No follow up is possible.   This case was linked to MOD-2021-080204 (E2B Linked Report). This case was linked to MOD-2021-080106 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Updated medically confirmed to yes, patient medical history, suspect product details, treatment medications and added new events.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible. MOD-2021-080204:MOD21-033662
Patient received the vaccination high in the arm almost to the shoulder. Patient currently has limited mobility with pain. She was seen by her prescriber MD who has prescribed ibuprofen for pain relief and has told the patient to use hot compress at the site of injection.
Patient came to primary care clinic and received a second pneumoccoccal 23 (PPSV23) immunization approximately 15 weeks after having the PCV13 vaccination per provider order due to immunosuppression (s/p kidney transplant). The PPSV23 was given IM in the left deltoid. Administering nurse reported that the patient's deltoid muscle did seem somewhat odd shaped. Appropriate landmarks were found and immunization was administered in left deltoid. When injecting the needle into the patient's deltoid, the nurse reported feeling the needle hit bone, so needle was pulled back slightly and injected vaccine in muscle. Patient did not report to the nurse any sudden or severe pain at the time of the injection. Patient left clinic and returned home, where he performed a rigorous workout which included exercising his shoulders and arms (per later Emergency Department consult report). Approximately 2 hours after the workout, the patient reported developing severe, sudden pain in the left shoulder, preventing him from doing any movement of the left shoulder. Patient presented to the Emergency Department where CT was performed and interpretation by radiologist of the CT left shoulder showed "Small glenohumeral joint effusion with a few locules of gas could relate to inadvertent intra-articular injection given recent history of vaccine administration."  After orthopedic consult, patient was discharged, accompanied by wife from ED to home with oxycodone oral pain management. Per follow-up phone calls on 8/18/15 by Emergency Department MD and primary care nurse, patient's wife reported that patient was feeling much better and having adequate pain control of left shoulder pain. Reviewed with patient's wife the plan for patient to have follow-up with Orthopedic doctor on 8/20/15 and plan to review incident. Primary care provider was notified of event and plan for review.
Employee received flu injection to (L) deltoid. Became pale, diaphoretic and stated "I think I'm going to pass out". Immediately had stiffness of both arms and legs and thrust head back lasting 5 sec. and then leaned forward and non responsive for 10 sec. Employee then regained consciousness and began to talk. Given orange juice and peanut butter crackers and rested for 10 minutes. Stated she felt much better and left escorted by two friends.
Patient called on evening of 10/05/2021 complaining of muscle spasms across the chest, but had no chest pains or breathing problems.  The patient was asked if any reactions occured from the first dose and patient stated no reactions.  Patient was referred to provider but patient said had no provider at this time.  I tried calling patient to see if went to a provider and patient has not returned phone call.
Pt says she woke up Jan 21st (morning after Vaccine #1) and had diffuse body rash. She took Benadryl and the rash resolved after about a week. She had no other reaction. She consulted with her Dr. who recommended she still receive her 2nd dose.
Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; Slurred speech an difficulty swallowing; Slurred speech an difficulty swallowing; Feet felt super heavy and awkward; Significant urination; muscle aches; low-grade fever; very tired; Slight headache; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; blood sugar plummeted; This is a spontaneous report from a contactable consumer (patient).  A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:45 (Batch/Lot Number: CR8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Type 1 diabetes, Some allergy medications like zyrtec, topamax, Nortriptyline, allergic asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG); bisoprolol (BISOPROLOL); fexofenadine hydrochloride (ALLEGRA). Historical Vaccine included product=COVID 19, brand=Pfizer, lot number=EP7533, administration date: 04Apr2021, administration time =04:00 PM, dose number =1, vaccine location =Left arm for covid-19 Immunization. Reported Event: About 3 hrs after 2nd dose, lower back pain for 20 minutes followed by numbness in tongue, throat, lips, cheeks, hands, feet, slurred speech an difficulty swallowing. Extreme difficulty thinking. Feet felt super heavy and awkward, like they were bricks. She was a type 1 diabetic and her blood sugar plummeted. She had to stop her basal delivery for an hour, then she halved her basal rate for several hours. After laying down for a few hours, symptoms improved, but worsened when standing. Significant urination every 40 - 60 mins for several hours. In the morning, muscle aches throughout body, low-grade fever, very tired. Slight headache. Adverse event start date: 25Apr2021, Adverse event start time: 06: 30 PM, No treatment for AE. Lab data included blood sugar: plummeted on 25Apr2021. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
shoulder pain and believes the vaccine was given too high on the arm. went to the hospital to get checked and md believes it is a rotator arm injury
11/10/22 presents to ED for "body aches, headache, and weakness". PMHx of "CIDP"
Case number PHEH2015US002805, is an initial spontaneous report from a medical assistant received on 05 Feb 2015 and with follow-up received from a medical assistant on 16 Mar 2015. This report refers to a 17-year-old female patient. Concurrent condition included type 2 diabetes mellitus. Concomitant medication included metformin. Previous vaccinations were well tolerated. Her vaccination status was up to date. She was vaccinated with booster dose of MENVEO (batch number: M13064) at a dose of 0.5 ml intramuscularly into left arm on 04 Feb 2015 at 02:40 PM. No adverse event was reported following the maladministration. Follow-up received from a medical assistant on 16 Mar 2015: Patient's demographics (height and weight), vaccination details (dose, site, time), previous vaccination status, concurrent condition (type 2 diabetes mellitus), concomitant medication (metformin) and other clinically relevant information updated in the narrative.
p/vax pt devel problem to rt arm;alleges that suffered severe & serious personal injuries including extensive pain;alleged that as a result is permanently injured;
This spontaneous report was received from a nurse refers to a 29 year old patient. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a properly stored but expired dose of M-M-R II lot # M045400 and expiry date 14-NOV-2018,route via subcutaneously for prophylaxis(expired product administered and no adverse event). No adverse effects and no additional information was provided.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Stiff Neck-Severe, Additional Details: PT went to Emergency Dept 5 days post vaccination for severe Chest Pain and Stiff Neck, tests were ran, but nothing came up. ED dr said the J&J COVID vaccine was the likely culprit. Pt has since recovered, was not admitted to hospital.
5 hrs after shot, nauseated, then vomited, diarrhea, chills, no fever
No adverse effects; patient, who is pregnant, received a dose of GARDASIL 9; her flu vaccine, but instead gave Gardasil; This spontaneous prospective pregnancy report as received from a medical assistant and refers to a 38-year-old female pregnant patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The patient became pregnant with LMP of 27-JUN-2019 and EDD of 02-APR-2020. On 14-OCT-2019, the patient was accidently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the deltoid, # R011630, expiration date 12-DEC-2020 for prophylaxis instead of unspecified influenza virus vaccine (dose, site, route of administration, lot # and expiration date were not reported). No adverse effects reported.
Increased shortness of breath on 6/12/21, tested positive for SARS-CoV2 on 6/12/21. on 6/15 patient is on a medical unit on 5L O2 Nasal cannula