chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 8 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 05-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
Pt complained of arm hurting and then moved to waiting area to continue sitting. Pt's eyes rolled back and pt passed out briefly. When pt came to, she vomited and remained pale with dark circles under her eyes. Pt was shaking. Pt was assessed for any SOB or chest tightening, itching, all of which she reported as 'no'. Mother said pt once responded in a similar manner after a tick was removed from her daughter. RPh offered to call 911 for emergency help to have pt assessed. Parents declined emergency treatment. RPh advised that pt be seen by ED for assessment. Parents said that they would call their insurance plan's RN. RPh said she would f/u with parents this evening.
so sick; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program. A 56-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization; desvenlafaxine succinate monohydrate (PRISTIQ), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unknown date, the patient was so sick right now from this being messed up, had to go cold turkey off the med, patient was so sick from going cold turkey, and got sick from the Pfizer vaccine and patient health was just crashing. The outcome of the event was unknown.  Follow-up attempts completed. No further information is expected.
No adverse symptoms reported; inadvertently administered an expired dose of GARDASIL 9; GARDASIL 9 used in a 4 week old patient; This spontaneous report was received from a licensed practical nurse and refers to a 4 week old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 03-FEB-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, vaccination site and dose number were not reported), lot # N010497, expiration date 15-JAN-2020, for prophylaxis.
Red, itchy, bumpy rash covering my body (sever eczema) with lymph node enlargement significantly in neck, arms, and knees. Several treatments received including steroids, topical creams. Lymph node enlargement is still significant. Rash is limited to shingle rash area.
pt came to clinic 25FEB94 to pick up birth control pills; needed a booster Td & MMR; pt was given both @ separate sites; called the clinic on 1MAR94 to report pain, redness, fever @ site (lt arm); pt was told to come in; seen by MD;
Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Medium, Systemic: Shakiness-Mild, Additional Details: Patient received the first pfizer covid vaccine. Her 15 minute waiting period was almost up when she experience a seizure and fell from her chair. Staff ran over to assist her and lied her down. Seizure last less than 1 minute. Patient was alert and remained on floor for another 15 minutes. A staff member offered to call paramedics twice and each time patient and grandmother refused. Patient left with grandmother after a total of 30-40 minutes with no issues and walked out on her own.
Significant swelling at injection site, still a welt after almost two months.  Left arm is weak and don't have full use or mobility due to pain in the shoulder and tricep when trying to use arm behind the back (for example to zip up a dress, etc.).
administered Kinrix on 10 weeks old; due for DTaP vaccine, and nurse inadvertently pulled and administered Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-week-old female 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 18th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong 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: 29-JUL-2022 Reporter's Comments: The clinic supervisor reported that, the 9 weeks old infant was due for DTaP vaccine, and nurse inadvertently pulled and administered Kinrix. The patient not had any prior DTaP vaccines. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient was 9 week old at the time of vaccination, which led to inappropriate age at vaccine administration and inadvertently received Kinrix instead of DTaP vaccine, which led to wrong vaccine administered.
Redness, Swelling, Pain, Difficulty Lifting Arm (5 days later)
Complains of weakness, headache, low fever, difficulty breathing at times. Numbness around site & legs.
Former 32 week preemie, received PENTACEL, ROTATEQ and PREVNAR 3/31/15. Red, hot swollen leg noted 4 hrs later, through evening pt had 3 episodes of very exaggerated startle reflex, one episode myoclonus. No fever at that time but developed fever to 102 next AM. Had several spells of choking, turning blue, apneic x 20 min with AM feed. The patient is a 12 week old female who presents for a follow up. This is a follow up visit for other (she was here yesterday for her 2 mo immunizations). Received PENTACEL in right leg, PREVNAR in left leg, and ROTATEQ by mouth. Right leg with some swelling, redness and warmth yesterday. Then last night mom noticed 3 episodes, about 15 secs apart, where patient had "stiffening of her legs and arms", and eyes rolled back in her head. Mom states that it was almost like an exaggerated startle reflex. Episodes lasted about 3 secs each. About 4 AM today, her left leg straightened, and then Dad saw some bouncing of her leg. This AM she woke up with a fever of 102. Her breathing has also been faster, louder, and more irregular than usual. Also, this AM she has had about 6 episodes of breath holding, and turning blue while taking her MBM bottle. Mom has blown in her face, and then she breathes again. She's been spitting up more forcefully and frequently than she did before yesterday. Child seemed perfectly well before getting vaccines yesterday AM, no fever, feeding well and gaining well. Parents are medical professionals (dad general surgery, mom RN) with no vaccine prejudices; older brother is fully vaccinated without any problems. As per yesterday's notes, after getting PENTACEL, PREVNAR and ROTATEQ developed marked fussiness, right thigh (site of PENTACEL) was red, hot and swollen. She did have an unusually loud cry and was very difficult to console. I saw her back in the office about 5 hours later and did confirm all the above findings. Afebrile on both visits. She continued to be very fussy through the night and did get BENADRYL and TYLENOL at about 6 PM. Increased salivation noted. At 9 PM mom started to change her diaper and patient had an unusual movement "like an exaggerated startle reflex" in which she stiffened, arms flew out in front of her with fingers spread, legs stiffened and toes pointed down, and her eyes grew very wide, then rolled back in her head. This only lasted about a second but was repeated 3 times over a minute. Then at midnight dad observed "myoclonic jerking" of left leg for a few seconds. She did vomit once last PM and has continued to spit up more than usual this AM. Temp of 102 at 8 AM today; mom was monitoring temperatures yesterday and those were normal. No fever noted at the time of the unusual motor movements. At 8:30 feed this AM child was fussy, crying and choking with feeds to the point of turning blue, apnea lasted for about 20 seconds. Several times mom had to withdraw bottle, blow in child's face and stimulate her to resume breathing. Last TYLENOL at 8 AM this AM, no fever here. Fed ok at 12:30 today.
neuropathy in arms, legs & face; Booster dose; Chest pain; fluctuation in BP; hyperglycemia; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 19 year old male patient received BNT162B2 (Batch/Lot number: unknown) at the age of 19 years as dose 3 (booster), single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for Covid-19 Immunization; Bnt162b2 (Dose Number: 2), for Covid-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "neuropathy in arms, legs & face"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; CHEST PAIN (non-serious), outcome "not recovered", described as "Chest pain"; BLOOD PRESSURE FLUCTUATION (non-serious), outcome "not recovered", described as "fluctuation in BP"; HYPERGLYCAEMIA (non-serious), outcome "not recovered", described as "hyperglycemia". The events "neuropathy in arms, legs & face", "chest pain", "fluctuation in bp" and "hyperglycemia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: fluctuation. It was unknown if therapeutic measures were taken as a result of neuropathy peripheral, chest pain, blood pressure fluctuation, hyperglycaemia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
started seizing approximately 1 hour after 2nd dose of pfizer covid vaccine; taken to the Emergency room, and eventually transferred to ICU.  Has seized over 100 times since event started. Is in Hospital (form would not let me fill out hospital info).
Had been 10 years and needed TD booster. Received it while at work. That evening, developed 2 1/2 cm size welt. Site was itchy, warm to touch and arm painful to move. Outer redness spread to a 6 1/2 cm diameter size over course of 4 days. By 3/6/2000, the redness was gone but continued to have tenderness at site with 2 1/2 cm diameter firm to touch area at site. No treatment used except Benadryl.
She came by today, 10/13/18, and showed me left arm, said it was very sore. She had somewhat off a red ring around her arm in the area where the shots were given. It went up under her arm too (armpit). She said her lower arm had started hurting too. Been hurting for 2 days. Started the night she had gotten the shots. She said it was sore feeling when she lifted her arm.
Pt given Varivax at 9AM. About 18:00 developed temperature. Third night temperature max 103.  Then started with vomiting x3 in early AM 0200.
foreign body reactions; dermatological filler Reactions / Reactions; Swelling came back on her eyes and lips; Eye swelling; Facial swelling right where she had fillers; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (Facial swelling right where she had fillers), LIP SWELLING (Swelling came back on her eyes and lips), EYE SWELLING (Eye swelling), FOREIGN BODY REACTION (foreign body reactions) and SKIN REACTION (dermatological filler Reactions / Reactions) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced SWELLING FACE (Facial swelling right where she had fillers). In July 2021, the patient experienced LIP SWELLING (Swelling came back on her eyes and lips) and EYE SWELLING (Eye swelling). On an unknown date, the patient experienced FOREIGN BODY REACTION (foreign body reactions) and SKIN REACTION (dermatological filler Reactions / Reactions). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK dosage form; CEFALEXIN (CEPHALEXINE) for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, SWELLING FACE (Facial swelling right where she had fillers), LIP SWELLING (Swelling came back on her eyes and lips) and EYE SWELLING (Eye swelling) had not resolved and FOREIGN BODY REACTION (foreign body reactions) and SKIN REACTION (dermatological filler Reactions / Reactions) outcome was unknown.            No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: follow up received on 16-jul-21 with events added and outcome.
Inject site swollen & warm to touch, persistent severe h/a p/1st 2 doses of Rabies vax;
General weakness, h/a, fever, body aches, rash to inject site started 8JUN91;
heart is "pounding"; resting heart rate was anywhere from the high 70's BPM to 100 BPM Just lying in bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "no symptom"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "no symptom".  The following information was reported: HEART RATE INCREASED (non-serious) with onset 23Nov2021, outcome "unknown", described as "resting heart rate was anywhere from the high 70's BPM to 100 BPM Just lying in bed"; PALPITATIONS (non-serious), outcome "unknown", described as "heart is "pounding"". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got 3rd vaccine on 23Nov2021, starting that night and for a few days after that, resting heart rate was anywhere from the high 70's BPM to 100 BPM, just lying in bed, it was 100 BPM. (patient had virtually no symptoms with the first 2 shots). Now, even with slight activity, BPM goes over 90 and patient's resting heart rate is anywhere from 60 to 80+. This was not the case before 3rd shot. It feels like heart is "pounding" even when resting.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender who on 10-APR-2105 was inadvertently vaccinated with an expired dose (expired product administered) of ZOSTAVAX 19400 PFU (expiration date 18-FEB-2015) (dose, lot # and route were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
I took the vaccine on 13th Jan. Since yesterday (1/20/21) I had swelling and redness at the vaccine site. Today it became more hardened and swollen and there is inflammation above the left clavicle region. Also I feel itching in the arm where injection was done.
15cm x 11cm, severe local reaction at Anthrax shot site. This was shot #2 out of 6.
My upper left shoulder where I had my H1N1 vaccine has become progressively more sore. I can't even lift my arm much above shoulder level without experiencing severe pain. It continues to worsen every day and I am almost 4 weeks from the shot.
high ocular pressure was caused by the Herpes virus /  dormant in his system / This exacerbated it; My...... is......Guillain-Barre disease; high ocular pressure (over 40) / ended up with shunts in both eyes; This case was reported by a consumer via other manufacturer and described the occurrence of ophthalmic herpes zoster in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant) and increased intraocular pressure. On an unknown date, the outcome of the ophthalmic herpes zoster, guillain barre syndrome and increased intraocular pressure were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, guillain barre syndrome and increased intraocular pressure to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced Guillain-Barre disease.  The patient had a few side effects from it. The patient was not allowed to have the influenza vaccine and this had been highly publicized over the years on TV and also written instructions when one receive it.  So the patient had not taken the Flu vaccine now for many years. The patient took a while though for this information to be publicized not to get it.  Two years before, the patient received the Shingles vaccine. Shortly after he develop extremely high ocular pressure (over 40) and saw several eye specialists.  Finally one infection Ophthalmologist researched and found the cause of high ocular pressure was caused by the herpes virus which they think was dormant in his system until he received the Shingles vaccine. This exacerbated it. He ended up with shunts in both eyes as a result and had been on several eye drops daily. The concern was with new vaccine. The patient was afraid of what could happen if the fact he had Guillain-Barre disease and took this vaccine could cause any further problems.  That was they were asking if someone at Pfizer to reassure one way or other whether he should take this Covid 19 vaccine.
Patient presented to the ED and was subsequently hospitalized for acute kidney injury and cellulitis of right leg within 6 weeks of receiving COVID vaccination.
CHIEF COMPLAINT:   C/O of L sided chest pain at 18:00 - has resolved - bilateral ankle edema  increased confusion - admited x1week new dx of Afib - transfusion low vitamin levels  - nauseated decreased oral intake   HISTORY OF PRESENT ILLNESS:     78-year-old woman with past medical history of alcohol abuse, dementia, vitamin deficiency, B12 deficiency, folate deficiency, atrial fibrillation presents with family member for concern for chest pain as well as edema lower extremities. States symptoms are acute. Patient reports chest pain yesterday. Cannot describe quality of chest pain. Cannot describe severity of chest pain. On arrival to ED placed on cardiac monitor and found to be in atrial fibrillation with rapid ventricular rate in the 120s to 130s. No shortness of breath reported. Patient's family member also states that very difficult to move around the house and she is getting more immobile.
Lower and middle back pain that is progressively worse; Trouble getting up; Lower and middle back pain; This spontaneous case, initially received on 05-Sep-2018 reported by a Pharmacist in and concerns a 36-year-old, adult male patient.  The patient did not receive any concomitant medications.   On 31-Aug-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: reported as full dose, batch number: YF36705, expiry date: 15-May-2019, route of administration, anatomical location: not reported) for active immunization against influenza. The Seqirus confirmed that, the reported batch number was Afluria PFS 0.5ml x 10 (QIV).   On an unspecified date, after vaccination, the patient experienced lower and middle back pain which progressively worsened and had trouble in getting up. It was reported that, the patient did not receive any treatment.   At the time of this report, the outcome of the events was not reported.  The reporter assessed the case as non-serious.; Reporter's Comments: A 36-year-old, male patient experienced lower and middle back pain, condition worsened and movement disorder on an unspecified date after vaccination with Afluria Quadrivalent. The causality of the events was unassessable due to the lack of onset latency.
2nd moderna vaccine given at 21 days instead of 24 days--no adverse reaction at this time
Pt recvd Engerix-B on 26APR90, 23MAY90, & 23OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Pt vaccinated with DTP mother noticed light rash face, back, legs & top of feet. Child "very hot", given fever medicine.  Rash gone 07DEC90.
Patient was very anxious while receiving immunizations. Approximately 5 minutes after immunizations, patient developed intense itching of feet/lower legs and began wheezing. Patient became very sweaty and sleepy 2-3 minutes later. Albuterol 2.5mg started and EPIPEN Jr given. Itching improved. After albuterol complete, still wheezing/tight chest, so second treatment started. Sats 88-90% during this time, Heart Rate in 120's. EMSA called during this process to transport to ER. Patient did not develop hives.
Dose 1: swollen lymph nodes. Dose 2: had fever, sore arm and body aches.
12/29/20 chills, achy, temp 106, rash upper and lower back. 12/31 symptoms resolved able to return to work.
This spontaneous case reported by a consumer, describes the occurrence of diplopia (woke up with double vision) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine, batch/lot# 004F21A, 039K202A and 026A21A) for COVID-19 immunization. No medical history reported. Concomitant products included Paracetamol (acetaminophen) for an unknown indication. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 29, 2021, patient experienced diplopia (woke up with double vision). At the time of the report, diplopia (woke up with double vision): not resolved. No treatment medications reported. This case linked to MOD-2021-386478, MOD-2021-386431 (patient link).