chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He was paralyzed,couldn't use his legs, hand, got collapsed; Lack of strength; Injection site was annoying, rubbing, scratchy; down deep in his muscle a slight feel pain at injection site; extreme dizziness lasted for a day and a half.; shortness of breath; A spontaneous report was received from a consumer concerning himself, 70 years old, male patient who experienced he was paralyzed, couldn't use his legs, hand, got collapsed/paralysis, injection site was annoying, rubbing, scratchy/injection site pruritus, down deep in his muscle a slight feel pain at injection site/injection site pain, shortness of breath/dyspnoea, lack of strength/weakness, extreme dizziness lasted for a day and a half/dizziness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) on 24 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection.    The patient was paralyzed, he couldn't use his legs, hand, got collapsed. Injection site was annoying, rubbing, scratchy, down deep in his muscle a slight feel pain. He also had shortness of breath, lack of strength and extreme dizziness lasted for a day and a half. Treatment of the events was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event he was paralyzed, couldn't use his legs, hand, got collapsed, injection site was annoying, rubbing, scratchy and down deep in his muscle a slight feel pain at injection site was unknown and of events shortness of breath, lack of strength, extreme dizziness lasted for a day and a half was recovered.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Injection site pain and injection site pruritus are consistent with the known safety profile of the vaccine
This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of GARDASIL (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified.  Follow up information was received from the medical assistant on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time.   Follow up information has been received from M.A.  It was reported that a patient with 16 years old received a dose of GARDASIL with lot# J013324, exp date 12-FEB-2016, on 23-JUL-2014.  This is one of several reports received from the same reporter. Additional information is not expected, since all follow ups requested to complete the case were received.
15MAY97 2PM mom told clinic pt had rxn from last set of shot w/in 5hr of vax lasting almost 24hr;mom reports t103-104, red, edema & warm to site;could not recall which thigh & screaming lasting long periods of time while awake;
back pain; pain at injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), INJECTION SITE PAIN (pain at injection site) and HEADACHE (slight headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to diclofenac reported.).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced BACK PAIN (back pain), INJECTION SITE PAIN (pain at injection site) and HEADACHE (slight headache). At the time of the report, BACK PAIN (back pain), INJECTION SITE PAIN (pain at injection site) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatments were reported.   This case was linked to MOD-2021-068634 (Patient Link).
61 y.o. female who presents with chest pain and syncope.  Patient reports she began feeling ill around 6:00 p.m. last night.  Patient reports she was having nausea, vomiting, and diarrhea.  She denies any hematemesis or hematochezia.  Patient states she awoke around 11:00 p.m. and felt like she was needing to vomit so she went to the bathroom.  Patient reports that upon getting up she noticed pain across her chest.  She described her pain as a midsternal pain with radiation across the chest.  She described as a dull pressure.  She currently reports no chest pain upon arrival to ER.  Patient reports associated shortness of breath, lightheadedness, nausea, vomiting, and diaphoresis with the pain.  Patient's cardiac risk factors include hypertension, smoking, age, obesity, and family history.   Once patient was in to bathroom, she states she began having nausea, vomiting, and diarrhea.  Patient subsequently passed out and hit her head on the bathtub.  Patient had slight nose bleed.  Patient's family found her lying in the floor and call 911.  Patient was unsure of how long she was out during her syncopal episode.  admitted to hospital Observation dx chst pain, vasovagal syncope
ON 4/30/21--- RED, HEAT, SWELLING TO GOLF BALL SIZE TO 2" ABOVE ELBOW FOR 3 DAYS.  TOOK IBUPROFEN, BENEDRYL EVERY 6 HOUS 5/4/21--  LITTLE BETTER BUT STILL RED .  GETTING SMALLER.  FRONT OF ARM AND UP AROUND SHOULDER STILL INFLAMMED AND RED
After received DTAP vaccine, got hives on the site. Size 15 cm wide x 10 cm long. Hot to touch. Ice pack to the site. BENADRYL given per MD's order.
Starting 5 hours after the injection I developed severe pain in the lymph nodes under the armpit of the arm where I received the injection radiating into my breast and down my inner arm to my elbow.  It did not start to lessen for 2 days, and I still have pain in my armpit 3 days later.  Starting about 12 hours after the injection, I began experiencing extreme fatigue, low grade fever, muscle aches, dizziness, and nausea, all of which passed completed after about 36 hours.
Severe headache caused me to go to the emergency room where an MRI was administered to confirm a diagnosis of a dural venous sinus thrombosis 2 weeks after my last vaccine booster dose.  I was hospitalized for three days in blood thinners and have been prescribed / advised to take eliquis blood thinners long term as this is the second clotting issue I?ve had in my life (I?ve had a DVT in the past)
Information has been received from a physician concerning a 16 week old male with a history of forceps delivery bradycardia and a family history of asthma who on 04/25/2003 was vaccinated with a dose of hepatitis B virus rHBsAG (yeast) (manufacturer unknown).  On approximately 08/09/2003 the patient developed a dry cough, sneezing, rhinorrhea and wheezing at night.  On the morning of 08/16/2003 the patient's mother took his temperature which was 100 degrees F (rectally).  At 11:45 that morning the infant was seen by a physician.  The infant was active, feeding well, had no distress with breathing, and no skin rashes, nausea, vomiting, or diarrhea.  He was making 6 wet diapers/day.  He was not in contact with anyone who was sick.  His physical examination was within normal limits.  The physician noted that the patient had a probable viral URI.  Instructions were given for reassurance and to continue to monitor the infant.  It there was any worsening of his fever, lethargy, new rash or nausea/vomiting/diarrhea he was to return to the health center.  Additional information has been requested.  It was also reported that the patient's mother was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) during her pregnancy with him (WAES #0210USA01768).
The reporter stated that at an unspecified date and time, "the patient's right arm swelled up like a balloon." The reporter stated that the patient visited an urgent care and treated the patient for cellulitis in his right arm.; This spontaneous report was received from a physician via a company representative, referring to a 67-year-old male patient. The patient's current conditions, medical history, concomitant medications, drug reactions or allergies were unknown by the reporter.    On 09-OCT-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) for prophylaxis (reported as "because it was recommended at his age") lot #S017430, expiration date was not reported but upon internal validation was stablished as 18-MAY-2021 (dose, strength and frequency were not reported).   On an unspecified date in 2019, the patient's right arm swelled up like a balloon. The patient visited an urgent care center and was treated for cellulitis in his right arm with doxycycline for 10 days.   At the time of this report, the outcome of the cellulitis was unknown. The causality assessment between the cellulitis and the vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided.   Upon internal review, the event cellulitis was considered to be medically significant.
Three days after the shot was given there became a hard knot, about the size of a quarter and appeared bruised.  Then it appeared to become bigger and more bruised looking.  This has all happened and it's been 6 days since the vacine was given. Lanced site of vaccine administration for Prevnar.
devel hives, redness on face, neck & chest 1 day p/vax flu vax also h/a;tx DPH;
heart pounds, chest tightness, dizzyness, nausea.  I thought I was having panic attacks. experienced extreme fatigue and muscle weakness. Hospitalized 9/15/2009 because I was suicidal because I grew tired of living this way.  I was put on an anti-depressant (Lexapro), which has helped a little with anxiety (which I never had until after Garadasil adverse side effects). It is now 3/28/10, and I experience tingling sensation in my legs almost constantly and sometimes in my lower arms.  My chest is tight, and my muscles ache.  I still have symptoms that feel like panic attacks, but the worst would be the fatigue.  My eyes hurt, and pre-med major is difficult when so exhausted (let's not forget the difficulty of working full-time as well, as I am an independent student).  Since Gardasil, my life has become hell at a time when I should be in my prime.
Information has been received from a registered nurse, concerning a female patient (age not specified), who on 15-OCT-2007 was vaccinated IM with a dose of PNEUMOVAX 23 (lot # not provided). Concomitant vaccine therapy included influenza virus vaccine (manufacturer unspecified). On 15-OCT-2007, following the vaccination the patient developed an injection site reaction of redness and swelling. The nurse added that the patient had also received a dose of PNEUMOVAX 23 last year. Additional information has been requested.
a consumer over the age of 65 years was in error not given the ordered dose of Fluzone Quadrivalent High Dose but was administered Fluzone Quadrivalent Standard dose with no adverse event; Initial information regarding this unsolicited valid non-serious case via The Agency (reference number: 00309763) was received from a pharmacist and transmitted to Sanofi 12-Oct-2020.  This case involved 89 years old female who was over the age of 65 years was in error not given the ordered dose of Fluzone quadrivalent high dose but was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringes standard dose of 0.5 mL (lot number and expiry date: not reported) (wrong product administered), on 09-Oct-2020, via unknown route in in unknown administration site for prophylactic vaccination. No other vaccines were administered.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  No adverse event was reported at the time of reporting.  It was a case of actual medical error due to wrong vaccine administered.  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.  There will be no information available on batch number for this case.
Headache for 4 days, pain at site of injection with severe redness and swelling, achy, low grade fever.   I used benadryl, lavender oil, tylenol, and hydrocortisone cream to treat my arm.
Developed gradually progressive facial asymmetry with facial numbness 24-36 hours after immunization. Seen in clinic the following week. MRI obtained and negative for CVA and started on prednisone for presumed Bell's Palsy. Slight improvement in facial asymmetry 1 week later
Pain in armpit; Swollen Lymph node; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 19Jun2022 at 19:00 as dose 3 (booster), single (Lot number: FP7135) at the age of 12 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FL0007, Location of injection: Arm Left), administration date: 29Nov2021, when the patient was 11-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left), administration date: 08Nov2021, when the patient was 11-year-old, for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 20Jun2022 at 01:00, outcome "not recovered", described as "Pain in armpit"; LYMPHADENOPATHY (non-serious) with onset 20Jun2022 at 01:00, outcome "not recovered", described as "Swollen Lymph node". Therapeutic measures were not taken as a result of axillary pain, lymphadenopathy.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. No COVID prior vaccination. COVID did not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
symptoms included: body aches, chills, possible fever, vomiting, and fatigue Treatment included: Tylenol (as directed) and rest Time course: Body aches, chills, fever, and vomiting only lasted about 2 hours. Fatigue persisted for about 15 hours.
Arm sore; injection site  became red, hot and swollen; injection site  became red, hot and swollen; injection site  became red, hot and swollen; there was little bit itching on there; injection site exactly is a darker shade.; still tender; it started growing, the redness spread.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site  became red, hot and swollen), INJECTION SITE WARMTH (injection site  became red, hot and swollen), INJECTION SITE SWELLING (injection site  became red, hot and swollen), INJECTION SITE PRURITUS (there was little bit itching on there) and PAIN IN EXTREMITY (Arm sore) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CONDITION AGGRAVATED (it started growing, the redness spread.) and INJECTION SITE PAIN (still tender). On 26-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (injection site exactly is a darker shade.). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (injection site  became red, hot and swollen), INJECTION SITE WARMTH (injection site  became red, hot and swollen), INJECTION SITE SWELLING (injection site  became red, hot and swollen), INJECTION SITE PRURITUS (there was little bit itching on there) and PAIN IN EXTREMITY (Arm sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (injection site  became red, hot and swollen), INJECTION SITE WARMTH (injection site  became red, hot and swollen), INJECTION SITE SWELLING (injection site  became red, hot and swollen), INJECTION SITE PRURITUS (there was little bit itching on there), PAIN IN EXTREMITY (Arm sore), CONDITION AGGRAVATED (it started growing, the redness spread.), INJECTION SITE DISCOLOURATION (injection site exactly is a darker shade.) and INJECTION SITE PAIN (still tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-017910 (Linked Report).; Sender's Comments:  MOD-2021-017910:Same reporter/ Different patient (Daughter)
pt recv vax 21OCT96 & 15NOV noted changes in sensations in hands & dec strength in upper extremities, dec sensation in tongue & lips & dec strength in facial muscles;transferred to another hosp in ICU w/weakness & sensory changes;dx G
To begin, I never, ever experience headaches and I never take Tylenol.  7 days after receiving the first vaccine, on the evening of the 03/31, I developed a severe headache.  It felt like a tightness around the perimeter of my forehead.  As the night went on, I took 1 table of extra strength Tylenol (Thank goodness my SO had a travel supply in his back pack) and went to bed.  The next morning I woke up with a mild headache and started working from home.  As the morning went on I developed chills, muscle aches, the headache got worse and I developed a dry cough.  Every time I coughed, it hurt my head.   After I drank 16 oz of electrolytes and took another tablet of extra strength Tylenol.  I started to feel better.  Went to bed, however, I was woken up at 1:45AM with the headache again and body chills.   When I woke up to start work, I still had the headache.   After eating breakfast, I took another tablet of extra strength Tylenol and drank more electrolytes.  By mid afternoon, I started to feel better.
NO ADVERSE EVENT at this time  Employee received full dose of 0.5ml instead of booster dose of 0.25ml
pt recv vax 26AUG97 & mom states child devel rash on forehead noc of vax fever 101-102;next day rash, under armpits to below diaper line;rash similar to heat rash per mom;instructed to take child to MD for eval;MD stated very mild rxn to v
6cm X 5.75cm area on anterior left with erythema and induration and tender to palpation.  Cellulitis of left thigh . Limping Prescribed Amoxicillin-Pot Clavulanate 875-125 MG
Severe Flushing (Head, Ears, Neck, Chest) for hours following injection; Slightly subsided after taking Allegra; Flushing came back less severe the following day
This spontaneous report as received from a consumer refers to a 51 years old husband with no drug allergies or reactions. The patient's medical history included shingles and restless leg syndrome. The patient was vaccinated subcutaneously with, .65 ZOSTAVAX (lot # not reported) on 16-JUN-2012. No other co-suspects were reported. Concomitant medications included acetaminophen, LORTAB, warfarin and AMBIEN. The patient's wife reported that on 14-JUL-2012, her husband developed a tear in his penis after having ZOSTAVAX vaccination. She explained that her husband's penis filled with blood as if he were having an erection after already having had intercourse immediately before this event, after this occurred the skin on the penis broke and began to "bleed out". Reporter explained that her husband has had to have surgeries beginning on 18-JUL-2012 to correct this issue and had received various forms of treatment associated with these surgeries (medically significant upon internal review). At the time of the report, the reporter's husband had also developed a shingles outbreak in large half dollar sized lesions all over his body. Unspecified tests had been conducted. The outcome of the events was reported as recovering/resolving. The patient sought medical attention. Additional information has been requested.
4 1/4 hrs p/vax pt was limp, very pale & brought to ER where extreme pallor & dec RR noted; resolved over 2 hrs;
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. In October 2014, the patient was vaccinated with the second dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). In September 2014 patient was vaccinated with the first dose of dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported. No adverse effect reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested.
Burn sensation inside of the mouth in the lower lip and in the roof of the mouth near at the throat.  No symptoms in the throat.
Stomach pains and neausea for at least 2 days, throwing up, diarrhea, migraines and joint aches following administered shots. Also to a mild degree in years 2008-14 continuous loss of teeth
Patient came in last night to the pharmacy and speak to the other pharmacist. She said the right arm where she got the PNEUMOVAX vaccine was red and swollen. She went to the urgent care and got KEFLEX and BACTRIM but said the doctor was not certain it is an infection. Alen recommended to take her antibiotics and we would check in the next day with the patient. I called the patient twice today at 9am and 10am but had to leave a message for patient to call back.
Pt was given the PEDIARIX that was to be given to her sister instead of a flu shot. No reaction noted at this time.
Small hives developed at injection site. Applied hydrocortisone bream. Developed into swollen bump that was red and hot. Lasted about 36 hours.
Patient has had upper respiratory symptoms for approximately 5 days.  Diagnosed with COVID-19 01/17/2022.  Is vaccinated fully.  Felt significantly weak today and had a fall without injury.  No loss of consciousness.  Found to be hypoxic on arrival of EMS.  Given supplemental oxygen and taken for further management.  Workup showed essentially normal LFTs, lytes, creatinine, hemogram.  Procalcitonin not elevated.  D-dimer normal at 469. Negative for flu and RSV.
LIMITED MOVEMENT TO ARM; PAIN IN ARM; This spontaneous report received from a patient concerned a 73 year old. 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: 1805022) dose was not reported, administered on 10-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced pain in arm. On 19-MAR-2021, the subject experienced limited movement to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm, and had not recovered from limited movement to arm. This report was non-serious.