chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the evening of 4-18-2021, I noticed the palms of my hands and feet were extremely itchy. Lotion did not relieve the itch I eventually put ice on them so I was able to sleep.   I woke up 4-19-2021 and felt itchy all over but no noticeable rash. I took my last antibiotic pill around 9 am. By 2:00pm I started getting small ?hives? on my arms. By 4pm my arms were covered and my chest and neck had began to break out.   By the time I reach the urgent care (4:45pm) my back and stomach, and upper legs had become affected also. I received a steroid shot in the muscle of my buttocks.   I got home around 6pm and put cool towels on my legs and eventually the rash was almost completely gone.    I woke up 4/20 around 6am with the chills and goosebumps all over feeling cold, but sweating like crazy. The rash/hives had came back and even worse/covering more of my body than before.  I am now taking  Prednisone 2x per day for the next 7days  starting 4/20 11am
Suspected Guillain Barre Syndrome.  With bowel incontinence, urinary retention, motor and sensory weakness. Seems to all be involving S1-S5 nerves only.  Had some mild foot drop on 3/25/2021 but then developed severe symptoms starting 4/15/2021 with rapid progression leading to hospitalization on 4/17
Continuous sinus drainage, fever, upper respiratory since receiving the vaccinations.  Typically only sick 2 or 3 times a year.  I've already been on 2 rounds of antibiotics and steroids since receiving second vaccination.  Currently running fever and battling sinus again and hoping to fight it off without having to receive medical treatment.  Unusual for me to be sick this much and close together.
Patient developed 5x6 cm erythematous flat induration with indistinct border on left lateral deltoid with 2 puncture marks noted inside induration
Both feet swollen particularly toe area.; Bad rash on left foot, slightly less on right. On left leg a minor rash.; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) via an unspecified route of administration in the right arm on 15Mar2021 at 14:00 (at the age of 70-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN8728) via an unspecified route of administration in the left arm on 08Apr2021 at 14:45 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis, knee pain and surgery. The patient previously received some sulfa drugs (MANUFACTURER UNKNOWN) for unknown indication and on unknown dates and experienced sulfonamide allergy. Concomitant medications included apixaban (ELIQUIS), duloxetine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and aripiprazole (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:00, the patient experienced both feet swollen particularly toe area, which was badly swollen one night ago, bad rash on left foot, slightly less on right and on left leg a minor rash. It was unknown whether therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events both feet swollen particularly toe area, bad rash on left foot, slightly less on right and on left leg a minor rash was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient became ill with pneumonia on 1/29/21 and then recurrent pneumonia on 2/10/21. Pt's plan of care was subsequently changed to comfort-focused on 2/11/21 and patient was deceased that same day.
Two lumps above clavicle suspected to be swollen lymph nodes on the left side (same side of vaccine injection). One lump is soft and moveable, and one is pea sized and it is firm and also moveable. Both lumps are painless. Discomfort and tension on the side of the neck where the swollen lymph nodes are. I noticed the lumps about two weeks after the first vaccine dose. The day after the second dose, the lumps swelled a bit more and neck tension increased.
Extreme thirst Very sleepy  Fast heart rate Chills Rash and itchy at injection site
Patient received a Moderna vaccine for first dose and Pfizer for second. Denies any adverse reaction. Medication administration error.
This is a spontaneous report from a contactable consumer (patient). The reporter reported similar events for 3 patients, this is the first report of three. A 52-years-old male patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in his left arm on 28Oct2021 (Batch/Lot number was not reported) (at age of 52-year-old) as dose 3 (booster), single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient previously got his Shingrix vaccine two years ago in 2019 for immunization. The patient previously received the first dose of BNT162B2 on 08Mar2021 (at age of 52-year-old) for COVID-19 immunization, received the second dose of BNT162B2 on Mar2021 (at age of 52-year-old) for COVID-19 immunization. The patient is suspecting he is experiencing an adverse reaction with the Pfizer COVID 19 booster. He has experienced ophthalmic herpes zoster. He received the COVID booster last Thursday 28Oct2021. He started having symptoms last night 04Nov2021. It has improved because he started Valtrex. He consulted his optometrist and internal medicine doctor. It is really strange, he got his Shingrix vaccine two years ago in 2019. He has spoken with two other people who have experienced the same thing as him. He knows they haven't reported. He truly believes it was from the vaccine. Event outcome of ophthalmic herpes zoster was recovering.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101529294 same reporter/drug/event, different patient;US-PFIZER INC-202101529295 same reporter/drug/event, different patient
mom reports on 8DEC94 that p/ vax pt cried pretty much continuously for 48 hrs; fussy all noc & info the AM of the 2nd morning p/vax;
Upset stomach - 18 hrs post vaccine. Fever 12 hrs later increased 3 degrees- resolved in 2-3 days. emesis-few episodes.
2nd dose administered from vial that had been in refrigerator for 32 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (2nd dose administered from vial that had been in refrigerator for 32 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (2nd dose administered from vial that had been in refrigerator for 32 days). On 16-Jun-2021, PRODUCT STORAGE ERROR (2nd dose administered from vial that had been in refrigerator for 32 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Fever; Chills; Feeling very run down; Pain at injection site; Swelling at the injection site; This case was reported by a physician via sales rep and described the occurrence of fever in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pyrexia (1st dose received on an unknown date, refer linked case US2019AMR167943).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever, chills, fatigue, injection site pain and injection site swelling. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the fever, chills, fatigue, injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the fever, chills, fatigue, injection site pain and injection site swelling to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and had fever, chills feeling very run down for a couple days.  The pain and swelling at the injection site.  More severe of these reactions than normal. The reporter agreed to follow up.
Patient was vaccinated with 2 doses of Pfizer vaccine. 2/27/21 and 3/20/2010. No adverse reaction.  The patient developed symptoms 7/15/2021 and tested positive for covid 19 infection. he was hospitalized with severe covid 19 pneumonia and required high flow oxygen. at this time he remains hospitalized.
Information has been received from a physician concerning a 12 month old male who on 07/15/2004 was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant therapy included HIB conj-hepatitis B vaccine.  On 07/22/2004 the patient developed a fever and was brought to the physician's office on 07/23/2004 with fever but no other symptoms.  On 07/24/2004 the patient refused to eat or drink, temperature was 99 degrees, and had loose stools but was not dehydrated.  On 07/25/2004 the physician spoke to the mother on the telephone and the patient had a spotted red rash on face and trunk.  The patient was drinking fluids and the temperature was 101 degrees.  The patient was instructed to increase fluids and take acetaminophen and use nystatin cream on rash.  On 07/26/2004 at 2:00AM the patient had a fever and was cranky.  The patient also had a loose stool and was sent to the emergency room and was diagnosed with probable roseola.  It was reported to be unknown if the patient was hospitalized.  No product complaint involved.  Additional information has been requested.
On 12/2/2022, I started to experience a cough, aches, chills and a low-grade fever. The next day the fever increased to 102 degrees. I tested for Covid-19 on 12/04/2022 at the clinic. I was also tested for influenza A and B, and they were negative. I was not given any medication at the clinic. I contacted my PCP and he suggested PAXLOVID, but there was a conflict with a medication that I take. My doctor suggested that I take MUCINEX for the congestion I was still experiencing. I had a chest X-Ray performed and it was clear. I tested negative on 12/17/2022 and 12/19/2022.
(R) arm swelling and redness round firm induration hot to touch pain w/arm movement x 4 days slowly getting better.
mom reported that pt's diapers were tainted w/blood; first diaper more last nite, & 1 diaper less red, this AM pt is otherwise OK;
arm is swollen/ Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; arm is itchy/ Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; My arm is so sore/ Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; arm is red / Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; This is a spontaneous report from a contactable nurse (patient). A 73-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 20Aug2021 10:00 (Lot Number: EW0170) (at the age of 73-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included 9/11 lung disease, penicillin allergy and contrast dye allergy. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient stated that she just wanted to report a side effect from the COVID-19 vaccination as she had the reaction. The patient experienced severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter on 21Aug2021 02:00 AM. The patient woke up on the morning of day of reporting and her arm was swollen, red and itchy. The adverse event led to doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the adverse event. The outcome of the events was not recovered.
Pt given H1N1 vaccination at school clinic at approximately mid-morning. At 4:30 PM, mother called office to report pt had rash on forearm to elbow. C/O headache, vomited once and had Temp of 99.5. Supervisor advised mother to take pt to Emergency room for evaluation. 11/13/09 Called mother-no answer-left message to call. 11/16-called mother-left message to call. Mother has not returned calls.
A physician reported via company representative that she "thinks" one of her patients inadvertantly received a fifth dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine. The patient developed hives sometimes after receiving the 5th dose of vaccine. No further information was available at the time of the report.
This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 61-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHIGNRIX at an unknown dose. On an unknown date, 122 days after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.  It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX 4 months ago from time of reporting. At the time of report, the patient had Bell's palsy. The patient wasnted to known the cause of the adverse reaction.
On Oct. 17, 2007 patient requested to be given flu shot with other staff of the dental clinic.  I accommodated all of them (5 staff and gave flu shots).  After about 4 days patient came to the clinic and showed me her arms with bluish discoloration.  Advice given to go to her PMD.  She informed me that she is on Coumadin for 1 yr. already.
Adverse reactions after 2nd dose; Arm's very swollen; Sick after; Didn't feel good 100%; Urinary Tract Infection; Lowered immunity; Tired; Arm's very painful/ achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reactions after 2nd dose), PERIPHERAL SWELLING (Arm's very swollen), ILLNESS (Sick after), FEELING ABNORMAL (Didn't feel good 100%) and URINARY TRACT INFECTION (Urinary Tract Infection) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reactions after 2nd dose), PERIPHERAL SWELLING (Arm's very swollen), ILLNESS (Sick after), FEELING ABNORMAL (Didn't feel good 100%), URINARY TRACT INFECTION (Urinary Tract Infection), IMMUNE SYSTEM DISORDER (Lowered immunity), FATIGUE (Tired) and MYALGIA (Arm's very painful/ achy). At the time of the report, VACCINATION COMPLICATION (Adverse reactions after 2nd dose), PERIPHERAL SWELLING (Arm's very swollen), ILLNESS (Sick after), FEELING ABNORMAL (Didn't feel good 100%), URINARY TRACT INFECTION (Urinary Tract Infection), IMMUNE SYSTEM DISORDER (Lowered immunity), FATIGUE (Tired) and MYALGIA (Arm's very painful/ achy) outcome was unknown.            Patient stated that she is taking other concomitant mediations but no further details provided. Patient stated that she is taking over-the-counter medications for the events and also stated that she is going to take antibiotics tomorrow (13-MAY-2021).
Redness and swelling of arm where vaccine was administered. Arm circumference reported to be 1/2 inch larger than unaffected arm.
patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 13-Aug-2021 from a Pharmacist via Global Medical Information (Reference number- 00723727) and transmitted to Sanofi on 13-Aug-2021.  This case involves a 17-year-old male patient reported that he was given an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 13-Aug-2021, the patient received 0.5 ml (total) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6594AA, expiry date 21-May-2021] via intramuscular route in deltoid (left or right) for prophylactic vaccination.  It was reported that, "Pharmacist states that expired MENACTRA was given to a patient. Pharmacist states that a medical assistant was trying to scan MENACTRA into their system, but it would not let him; becoming frustrated, the medical assistant administered the MENACTRA to patient without first scanning MENACTRA into their system. After administering MENACTRA, the medical assistant went back to try to scan MENACTRA into their system again; the pharmacist tried to help him and realized that the system would not let him scan the MENACTRA because the MENACTRA had expired".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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 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.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 8/7/2023 VASCULAR INSUFFICIENCY OF LIMB, UNSPECIFIED TYPE I95.9 HYPOTENSION 8/7/2023 VASCULAR INSUFFICIENCY OF LIMB, UNSPECIFIED TYPE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/7/2023 VASCULAR INSUFFICIENCY OF LIMB, UNSPECIFIED TYPE R09.02 HYPOXIA 8/7/2023 VASCULAR INSUFFICIENCY OF LIMB, UNSPECIFIED TYPE G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 8/7/2023 PLEURAL EFFUSION I95.9 HYPOTENSION 8/7/2023 PLEURAL EFFUSION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/7/2023 PLEURAL EFFUSION R09.02 HYPOXIA 8/7/2023 PLEURAL EFFUSION G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 8/7/2023 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE I95.9 HYPOTENSION 8/7/2023 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/7/2023 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE R09.02 HYPOXIA 8/7/2023 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 8/7/2023 HYPERLIPIDEMIA I95.9 HYPOTENSION 8/7/2023 HYPERLIPIDEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/7/2023 HYPERLIPIDEMIA R09.02 HYPOXIA 8/7/2023 HYPERLIPIDEMIA G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 8/7/2023 RIGHT BREAST LUMP I95.9 HYPOTENSION 8/7/2023 RIGHT BREAST LUMP J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/7/2023 RIGHT BREAST LUMP R09.02 HYPOXIA 8/7/2023 RIGHT BREAST LUMP
5 days following vaccination I woke up with severe itching and hives, redness and swelling all over my body. I took a Zyrtec pill and it helped. Went a day with no further reaction then the next day I woke early 2 -3 a.m. with severe redness, swelling, and itching which started in hands and arms the spread throughout the day to my entire body. Ended up with hives on lips and face with swelling as well. Went to NP was given Kenalog shot and took zyrtec as well as 25mg Benadryl. This calmed things down. However have had to continue taking zyrtec and Benadryl to control symptoms at this time.
Hardened edema and erythema in a 2 inch round area at injection site. Arm sore rated on 8/10scale. Painful to light  palpation, painful to lift from hanging down position. ROM reduced.
cried constantly for hrs; t103; seen by MD in ER who called pediatrician; thigh red x 1-2 days; no sz activity noted;
Shot administered at 10:50 am on Thursday April 8. Took 650 mg of tylenol and went to bed. Friday April 9 @ 2:33 am woke up to chattering teeth, a fever of 100 degrees F. At 9 am on April 9, started with extreme nausea. extreme bloating, swollen feet and hands and face. Intermittent vomiting throughout the day and night. Could not eat anything nor drink more than 2 oz. of water at a time without throwing up. My arm, at injection site developed a red rash (this happened in first dose but 6 days later) .By 8 pm on April 9 my face broke out in red, blood vessel blotches. Woke up on Saturday April 10, at 8 am. blotches away. They were not raised . Red, itchy blotches on the scalp, very itchy. Red, not bumpy.  Saturday April 9, 90% of the symptoms away, Vertigo and still nausea. Rash on scalp still persistent.
4 days after the vaccination patient mentioned that she thought something was wrong with her right eye. She said it was felt funny and was kind of blurry. It looked ok so we thought it might be her contact. She mentioned it again a few days later (or I asked, can't remember). It was still bothering her. She said it was blurry and felt wet when she woke up. It didn't look red or irritated and didn't hurt or itch. I told her to take a break from contacts for a few days but there was no improvement or apparent increase in any obvious symptoms. She was seen by her optometrist on 6/27 who sent her to an ophthalmologist who diagnosed her with anterior uveitis in both eyes, even though patient had only complained about the right eye. She had scarring and sticking of the pupil to the cornea. She was on atropine drops and steroid drops all summer. It was quiet at the end of August but she went for a followup appointment on 9/14/18 with Dr. where she is a student and it was come back in the right eye. She is on drops again. She never had this problem until a few days after receiving the TRUMENBA vaccine.
Post vax, client felt dizzy and was placed in chair by parent. Client is pale and complains of dizziness. BP 112/60, P-88. Fluids offered. At 17:00, BP 110/60, P-78, cold and pale but improved. At 17:10, much improved, up and walking. To call if any further problems.