chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A vail had been left out from the previouse work day on 8/26/2022 and then administerd on 8/29/2022 patient was contacted and they said they were fine. I will follow up in the week. and advised them to call if anything came up
This case was reported by a consumer and described the occurrence of Guillain-Barre in a 76-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other healthcare professional has not verified this report. Concurrent medical conditions included gas and high cholesterol. Concurrent medications included PREVACID and LIPITOR. On 12 November 2008, the subject received unspecified dose of FLULAVAL (intramuscular, unknown). On 26 November 2008, 14 days after vaccination with FLULAVAL, the subject experienced feeling weak, could not walk. On 01 December 2008, the subject was diagnosed with Guillain-Barre. At an unknown time after vaccination with FLULAVAL the subject had numbness (hands and legs) and was nonresponsive. The subject was hospitalised. The subject was treated with normal immunoglobulin (IVIG). The daughter of a female subject reported that her mother received an immunization of FLULAVAL on 12 November 2008. On 28 November 2008, the subject reported feeling weak, and had difficulty walking. During the period of 26 November 2008 to 01 December 2008, the subject's symptoms had become worse. On 01 December 2008, the subject was hospitalized. A diagnosis of Guillain Barre syndrome was made. The subject received IVIG and is still unresponsive. At the time of the report, the subject remained hospitalized. At the time of reporting the events were unresolved.  2/2/09 Received hospital medical records of 12/1-1/20/2009. FINAL DX: Guillain Barre syndrome s/p IVIG & plasmapheresis; left shoulder rotator cuff tear. Records reveal patient experienced ascending LE weakness & paralysis & RUQ abdominal pain x 4-5 days.  Had similar symptoms 14 yrs prior that responded to outpatient steroids.  Neuro consult done.  Tx steroids initially then, w/IVIG w/minimal improvement then plasmapheresis x 2.5 weeks.  Initially HTN tx w/meds & diuresis.  Became hypotensive w/plasmapheresis, antiHTN meds d/c. Developed thrombocytopenis due to DVT prophylaxis & meds changed.   Developed low grade fever & ID consult done.  Tx w/IV antibiotics for possible early cellulitis.  Tx w/PT/OT & transferred to inpatient rehab & continued to be followed by neuro.   Improved & d/c to home w/continued PMR & Neuro f/u.
Arm very sore; shoulder very sore; Felt lousy for 1 and 1/2 days after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: Felt lousy for 1 and 1/2 days after), pain in arm (Verbatim: Arm very sore) and shoulder soreness (Verbatim: shoulder very sore). The outcome of the feeling bad was resolved (duration 2 days) and the outcome of the pain in arm and shoulder soreness were not reported.   It was unknown if the reporter considered the feeling bad, pain in arm and shoulder soreness to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad, pain in arm and shoulder soreness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023. This case was reported by a patient via interactive digital media. The patient just had the second shot of vaccine.  The patient felt lousy for 1 and 1/2 days after.  The patient arm and shoulder very sore. There are other people that took the vaccine shot, did not.  Patient felt lousy for 2 days after the second shot, sore arm and shoulder.  The patient stated that it was so far, so good.  The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR067347:Same reporter / same product, Invalid case
This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 25-JUL-2016, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 lot#K010220 with expiry date: 22-JUN-2016 (dosing detail were not reported). No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Booster dose; spiral cirrhosis; muscle pain in her thighs and legs; Arthritis in her left hip; cramps in the right leg/ cramps in thighs, right hip; has a hard time walking/ can't barely walk; 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 81 year-old female patient received bnt162b2 (BNT162B2) (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), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose: 2), administration date: Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster dose"; HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "spiral cirrhosis"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain in her thighs and legs"; MUSCLE SPASMS (non-serious) with onset Oct2021, outcome "unknown", described as "cramps in the right leg/ cramps in thighs, right hip"; GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "has a hard time walking/ can't barely walk"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis in her left hip". The events "spiral cirrhosis", "muscle pain in her thighs and legs", "cramps in the right leg/ cramps in thighs, right hip", "has a hard time walking/ can't barely walk" and "arthritis in her left hip" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hepatic cirrhosis, myalgia, muscle spasms, gait disturbance, arthritis, prescribed with Aspirin, Tylenol and Tramadol which works sometimes. Putting heat compress seems to help but it wasn't like this before she got her shot also stated that it just seems more persistent.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt received 3 injection and was asked to stay for 10 to 15 mins afterwards per protocol . Within 3 mins of injections pt become faint and slide over on the table . She regained consciousness after approx. 1 minute. Vitals were checked and where WNL. Dr was notified. Pt was able to ambulate on her own within 15 mins. and was fully alert. She was discharged at that time
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-JAN-2015 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5 ml (HSA, lot # J006136, expiration date 22-OCT-2016, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 456 hours with the highest recorded temperature of 6 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Left arm surrounding both injection sites w/ warm protrudes , 3X6 cms Erythema, redness   diminished in 1st 24 hours w/ press         next 78 hours78 hours
RN administered vaccine.  Upon charting, RN noticed an extra dose in Hepatitis B present in Vaxelis vaccine.  This was the first time RN had administered Vaxelis vaccine.
Severe abdominal pain/Severe abdominal cramping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Severe abdominal pain/Severe abdominal cramping) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN (Severe abdominal pain/Severe abdominal cramping). On 16-Mar-2021, ABDOMINAL PAIN (Severe abdominal pain/Severe abdominal cramping) outcome was unknown.            No Concomitant medications was reported Treatment information was not provided
Patient called to report facial twitching.  Reports it was on both sides, but more prominent on the right side. She had contacted her PCP and they were going to have her come in for labs.
Patient was given 1st dose of Gardasil, along with Menactra, in the left deltoid.  Gardasil was given first, and then Menactra.  Patient was seated at time of administration of vaccines.  Within 5 seconds of the vaccines being given, the patient felt faint and closed her eyes.  She lay down and said she felt dizzy.  She was lethargic but responsive.  I came into the room within 1 minute of this episode.  The patient was laying down but felt better.  She denied any visual changes had occurred -- just that she felt faint and dizzy.  Blood pressure was 102/70.  She was given some juice.  She felt much better after about 5 minutes and was sent home.  Her mother will watch her and call me if any further problems.  No further Gardisil vaccines will be given to her.
Patient was very nervous about receiving  the shot. According to her mother, this is a common occurrence. 5 minutes after receiving the vaccination, the patient stated she was feeling nauseous. She was provided a trashcan and threw up twice. After hydrating with some water, she had no further adverse effects
2wk p/vax pt had rash, fever to 105 & joint pain;currently has working dx of JRA, pt taking pred, ASA, Naprosyn;Annual follow-up states the pt has not recovered and that she has rheumatoid arthritis, is anemic and has an elevated SED rate.
FIRST ONE I HAD MOST OF MY COVID SYMPTOMS RETURN:  HIGH FEVER, CHILLS, BODY ACHES, NIGHT SWEATS, HEAD ACHE.  LASTED ABOUT 1 DAY.  SECOND SHOT BODY ACHES, CHILLS. LASTED ABOUT 1.5 DAYS.
Skin Redness and Swelling...Dr prescribed Cetirizine, Ranitidine and Benadryl Cream.
a week after the second shot I developed Shingles. My father in law had the same thing happen to him; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (father-in-law).  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient developed Shingles. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021365144 same reporter/drug/event, different patient
SINCE 3/6/2021, WHOLE BODY TURNS RED AND IT ITCHES AND BURNS FOR ABOUT 15-30 MINUTES, AND THEN GOES AWAY.
Mild/moderate swelling of my tongue, phrenulum and lower face (lips, chin, cheeks).  No difficulty breathing or discomfort.  No treatment was taken.  The swelling lasted about 10 hours and tne disappeared.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for  this case. No concomitant medications were reported. On 2021, the subject experienced slept for 12 hours afterwards felt wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slept for 12 hours afterwards felt wiped out was not reported. This report was non-serious.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4377338-00. A 34-year-old female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years and on 03Dec2021 as dose 2 , single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "pain as well as swollen knees associated with ankylosing spondylitis"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "flare up". The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of "pain as well as swollen knees associated with ankylosing spondylitis" and "flare up" with the suspect product(s) BNT162b2 was provided possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporters causality for the event(s) of Flare up with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporters causality for the events(s) of pain as well as swollen knees associated with ankylosing spondylitis was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information provided in the narrative, a possible contributory role of the suspect vaccine to reported event of ankylosing spondylitis and condition aggravated cannot be excluded.
rash appeared along a scar line and her belly button; This is an initial spontaneous report from a contactable consumer. A 79-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: unknown) in right arm via an unspecified route of administration on 27Jan2021 09:15 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus Verbatim: Diabetic, High blood pressure, hernia repair, big huge scar, had MRSA, tummy tuck. He had a hernia repair and a big huge scar because it went and had MRSA. He had Hernia repair and tummy tuck in England 17 years ago. Concomitant medication included insulin (INSULIN). On 28Jan2021 rash appeared along a scar line and her belly button. Scar was 10 inches long. Rash won't go away, but it was not itching. Rash was not lumpy, but different spots all over. It did not itch. Thought it might be fading, but not sure. Outcome of the event was not recovered.
Immediately after receiving Gardasil, Patient's eyes rolled back, her whole body started twitching and she passed out.  Lasted 15 seconds.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 02-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
MIGRAINE; DIFFICULTY SPEAKING (STUTTER WITH A SLIGHT SLUR); This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use the patient did not have any no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced difficulty speaking (stutter with a slight slur). On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) Clear, EKG (NR: not provided) Negative, and Toxicologic test (NR: not provided) Negative. On an unspecified date, the subject experienced migraine. Treatment medications (dates unspecified) included: escitalopram oxalate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty speaking (stutter with a slight slur), and the outcome of migraine was not reported. This report was non-serious.
I developed this arm soreness that never went away. The soreness continued to worsen. By July 2021, my arm was hurting quite badly. The bone hurt deep inside. It was difficult to pick things up and it was pretty painful. The pain started high up and progressed down to my thumb. I went to the doctor. I was recommended to see an orthopedist. I was given a steroid shot, which helped considerably. However, the underlying pain is still there.
Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis.   On 20th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and paracetamol (Tylenol). On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The patient experienced pain for 10 days following the injection. It has resolved. She called complained of pain about 3-4 days after and the pharmacist told her to use ice and Tylenol and then she called again asking he report it to the manufacturer.  The reporter consented to follow up.
Sharp shooting knife-like severe pains and twitching in multiple muscle areas beginning in left lateral chest rib cage area progressing to arms, fingers, legs bilaterally, head and torso, and aggravated by deep breathing(a catch in the breath) following Janssen COVID 19 Booster dose. I was awakened by these pains in the early morning following the injection and the symptoms are continuing. I had a similar but more severe reaction to the initial first dose which lasted over three days in May, but I was unsure if these adverse reactions were related to the vaccine but now after taking the Booster dose I decided to  officially report these findings, as they are clearly related. Called doctor's office to report symptoms
Cold feeling in the chest; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold feeling in the chest) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, 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 experienced FEELING COLD (Cold feeling in the chest). At the time of the report, FEELING COLD (Cold feeling in the chest) outcome was unknown.            The patient was taking other medication. No treatment medications were reported.   This case was linked to MOD-2021-406741 (Patient Link).
I had a sore throat, ear pain, congestion, and a cough. This lasted for about two and a half weeks total. I went to the doctor and had a negative COVID-19, RSV, and Flu test. They prescribed Amoxicillin. I am feeling much better now.
No adverse effects; patient received one dose of improperly stored MMR II; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 12-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), albumin status: rHA, lot # R031681, expiration date 01-NOV-2020 (dose and route of administration were not reported) for prophylaxis, reconstituted with properly stored sterile diluent, lot # reported as N029636, expiration date reported as 29-MAR-2020. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of above 47 degrees Fahrenheit (48 degrees Fahrenheit) for 7 hours. There were no previous excursions reported. The data logger was involved.
Large area of swelling and tenderness at injection site. Approx 12 cm diameter on right thigh. + erythema. Took approx 1 week to resolve. No treatment.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 19-SEP-2014, the patient was vaccinated with an improperly stored ZOSTAVAX Lot Number J014811, Expiration date: 21-FEB-2015 (also reported as 21-FEB-2014) (dose and route were not reported). No adverse effects were noted. This is one of several reports from the same source. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine 3 minutes after vaccine, patient complained of chest pressure, flushing and felt clammy.  A medical response was called and pt was placed in a recliner. He is alert and oriented and feels shaky. His wife is with him and states this is a normal reaction to similar situations in the past. Just not always something that happens. 1538 BP 158/78, HR 65, resp 20 1542 BP is 163/78, HR 60, resp. 20. Skin is warm and dry, he states his lower lip is numb and has a bit of trouble drinking from a bottle of water. Medical response felt he was improving and plan was to keep him in recliner for another 20 minutes. Was given a few sips of apple juice. No oximeter was available to check O2 sat. @1558 he again complains of mid-sternal chest pain, skin warm and dry, speech clear and moving all extremities without difficulty. Complains of tongue and cheek tingling. Brief episode of nausea. ER staff was called and patient was transferred to ER via Wheel chair. He at times complained of dizziness and trouble with keeping his eyes open. Denies pain in his arms. BP 190/84, HR 62, R 18.   At ER:  EKG with sinus bradycardia, no acute ischemic changes. Troponins x 2 are negative.  Symptoms resolved.  Discharged from ER after evaluation.
inj site itchy day p/vax given in rt deltoid & is hard;no redness or swelling; t98.7 21JUN96;