chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report was received from a nurse concerning a 39 year-old, female patient participating in the mRNA-1273 Emergency Use Program and experienced a very swollen arm, pink circle around the site (of injection) the size of a half dollar, pain, low grade fever, and feeling tired.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient reported her arm being very swollen and painful with a pink circle around the site, the size of a half dollar. She also reported a low-grade fever (99.4F) and just feeling kind of tired.  Treatment for the event included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The events of injection site erythema, injection site pain, pyrexia and fatigue are listed in CCDS.
A nurse reported an 18 month old female received Acel-Imune on 8/25/99 and subsequently developed an injection site reaction characterized by a 7 cm x 8 cm area of redness, swelling and warmth. The child was treated with Keflex. This is 1 of 2 pt's from this facility who developed an injection site reaction following receipt of Acel-Imune.
headache; injected arm became swollen and hot to touch about the size of an egg; injected arm became swollen about the size of an egg; injected arm became hot to touch; a 55 years old patient received a dose of Flublok Quadrivalent via subcutaneous route; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 55 years old female patient who experienced headache, injected arm became swollen and hot to touch about the size of an egg (vaccination site inflammation), injected arm became swollen about the size of an egg (vaccination site swelling) and injected arm became hot to touch (vaccination site warmth), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1925 via subcutaneous route in the left arm.  On an unknown date, the patient experienced a non-serious headache, injected arm became swollen and hot to touch about the size of an egg (vaccination site inflammation), injected arm became swollen about the size of an egg (vaccination site swelling) and injected arm became hot to touch (vaccination site warmth)   (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was an actual medication error due to inappropriate route of vaccination. A 55 years old patient received a dose of flublok quadrivalent via subcutaneous route.  Employee Health visit 03Oct2019.   (Other relevant tests included no lab data.)  Final diagnosis was injected arm became swollen and hot to touch about the size of an egg and headache.   Treatment: Steroid cream and ice to injection site.  The patient outcome was not reported for headache and  injected arm became swollen and hot to touch about the size of an egg. The patient was not recovered from injected arm became hot to touch. The patient was recovering from injected arm became swollen about the size of an egg.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Patient experienced dizziness about 10 minute after injection. Laid down on floor with feet up. Given some juice since had not eaten yet for the day. Patient feeling better in about 5 minutes.
Narrative: HPI: 48y/o M, last seen 1 month ago for eczematous dermatitis thought 2/2 to COVID vaccination. Since that time, patient has been using triamcinolone ointment 1-2x daily as well as hydrocerin to good effect. He states that the rash is clearing significantly and he is no longer pruritic.
Migrane, Fatigue, Low grade temp, pain at injection site, Nausea
Day 1: Extreme fatigue and drowsiness  Day 2 - 4:  Headache.  extreme fatigue, excruciating arm pain, and drowsiness Day 4:  Runny nose, sneezing, headache.  fatigue, and drowsiness.
Pt face color turned pale, nonresponsive, upper body stiffened, rt hand twitched. RN applied smelling salts to nasal area & pt. responsive post-3 seconds. Face became flushed. Post-10 seconds pt's face became pale, pt. again nonresponsive, entire body stiffened and upper & lower body in seizure posturing position. Applied smelling salts & pt responsive post 7 seconds. Face flushed once again. Pt stated "I don't know what happened but I think I just wet my pants". Pt. lost urinary control during seizure and urinated on self. Observed pt for 30 minutes. RN offered to contact family member, pt declined. Once pt stable escorted pt out of immunization room & pt insistent on ambulating out of building by self. Pt again declined RN repeated offer to contact emergency contact.
Redness, swelling, hot to touch in the area of the injection. This is the second shot.  With the first one, the symptoms appeared a week and a day after the injection - itching and redness, followed by increasing spread of redness, hot to touch, and growing to nearly the entire upper arm.  Doctor's visit 2 weeks after the inoculation.  Week's worth of antibiotics - reaction was gone after 3 weeks. Second inoculation  was Monday of this week, at 11:40 AM.  By evening, a small red, hot swollen patch (not itchy) appeared.  Spread the next two days. Today is Thursday, and it's larger and hotter and more achy.  Was advised at Rite Aid to take Tylenol if symptoms occurred. It's not helping.
Upset stomach, fatigue, gas and diarrhea starting in the evening and continuing to next day. Most intense around 8:00 p.m. and gradually improving until following afternoon.
Tingling, numbness left hand, leg and arm, feeling of anxiety 3-23-15. Also c/o headache following 1st RABAVERT given 3-15-15.
The day after the vaccine, my left arm hurt.  Approximately two to three weeks later, I experienced extreme fatigue and muscle weakness.  I seen three doctors before going to the clinic.  My muscles wasted away in my shoulders and my left hip was in pain and I limped.  I could not dress myself, tie my shoes, wash my hair and could barely drive my vehicle.  I am unable to walk up stairs and walk a long distance.  I fall alot and am not strong enough to pick myself up.  My shoulder bones hurt and ache constantly.  I was put on Prednisone in June of 2007 and underwent pt and ot therapy, to no avail.  In December of 2007, I was also put on Lyrica and Boniva in February.  I went back to the Clinic and they now put me on Methotrexate along with the prednisone, Lyrica and Boniva.  I am still not functionable.  04/04/2008 MR received for several OVs between 4/19/2008 and 2/28/2008 with DX: necrotizing myopathy. Pt reports myalgias and upper extremity weakness beginning a few days after Flu shot  12/11/06 and worsening over the next months.  Requiring assistance with ADL and work related activities. Significant functional impairment noted.  PE(+) for Proximal upper limbs/shoulder girdle atrophy with significant weakness.  Unable to fully abduct shoulders. Proximal weakness of lower limbs. Some improvement with prednisone, however has had several recent falls. Sleep is disturbed. Appetite poor.  Depressed affect. Pt developed rash on chest 2/2008 as well as erythema over the knuckles. ? dematomyositis.
Reddened, slightly raised area at injection site; Patient complained of some itching at site and discomfort at touch.
Soreness; Fatigue; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6202) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took promethazine (PHENERGAN) and experienced drug allergy (sensitivity). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC), biotin (MANUFACTURER UNKNOWN), birth control pills and fibe, all for unknown indication from an unknown date and unknown if ongoing. On 09Mar2021 at 16:30, on the same day of vaccination, the patient experienced soreness, fatigue and dizziness. Dizziness occurs most when turning head or trying to move quickly. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness, fatigue and dizziness was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
On an unspecified date, the pt received 1st dose of Lymerix with no reported events. On 6/28/00, the pt received 2nd dose of Lymerix and 4 to 6 hours later, the vaccinee experienced a fever > 102F, rash and arthralgia. The pt was dx'd with acute Lyme disease. The pt was treated with doxycycline hyclate and "responded".
P/nap pt could not walk for 30min; whelp down leg & ankle, swollen, red, fever 101.8, blister on ankle rt leg; Pt jumped & jerked shot out-bathed area w/alcohol; Sat AM looked like a bite w/red streaks & red patches until Mon PM, t100.4;
3 days of mild left should pain following the vaccine which he said felt typical that pain resolved. On the 10th day following vaccination with the J&J he developed severe left shoulder pain and thought that maybe he had a rotator cuff injury. He was seen for that with an MRI which was negative but then developed muscle weakness, fasciculations, atrophy, decreased range of motion. The pain has gone down a bit but has been there ever since and his neurologist believes that it is Subacromial-subdeltoid bursitis related to the vaccine possibly Parsonage-Turner Syndrome (PTS).
contracted covid (was fully vaccinated); contracted covid (was fully vaccinated); This is a spontaneous report from a contactable other health professional and a contactable consumer (patient). A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient contracted covid (was fully vaccinated) last month in Sep2021, now resolved. The outcome of the events was recovered.    The Lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the events drug ineffective and COVID-19 cannot be completely excluded.The case will be reassessed if additional information becomes available.
After the second booster more episode and more violent episodes of genital herpes; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (After the second booster more episode and more violent episodes of genital herpes) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 018F21A, 011A21A and 030M20A) for COVID-19 vaccination.     It was reported that patient has never been diagnosed or tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: Influvac-Tetra2022 (Influvac-Tetra2022) on 21-Mar-2022 and Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot and Influvac-Tetra2022. Concurrent medical conditions included Genital herpes since 2017.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GENITAL HERPES (After the second booster more episode and more violent episodes of genital herpes). At the time of the report, GENITAL HERPES (After the last booster more episode and more violent episodes of genital herpes) had not resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-563448 (Patient Link).
Began vomiting yellow/green emesis.  Became disoriented x 4.  Shortness of Breath.  Oxygen saturation 75% room air, Temp-97.5, Pulse-36, BP-70/37.  Placed oxygen on at 3liters/minute via nasal canula; oxygen saturation up to 98%.  Blood Glucose-295; increased to 368.  Complained of pain 8/10 in lower abdomen with guarding.  Called emergency medical services to transport to hospital for evaluation.  EMS gave Atropine in route to ER.  He was admitted to local Health Hospital in for diagnosis of Bradycardia.
Patient was given 3 doses RABAVERT vaccine that had been stored improperly in the freezer.
Patient has a red, warm, hard spot in her arm where the second dose was administered; Patient has a red, warm, hard spot in her arm where the second dose was administered; Patient has a red, warm, hard spot in her arm where the second dose was administered; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included overweight. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient has a red, warm, hard spot in her arm where the second dose was administered on unspecified date. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Approximately 6 hours after receiving the vaccine I experienced the typical chills, followed by fever (around 9pm). Then, I experienced pulsating muscle pain that radiated out of my lower back; it was excruciatingly painful. Then, I experienced migraines that were on & off the entire night. In the morning around 4am, since I was unable to sleep more than 4 hours, I had difficulty walking. Not only did I feel weak, but my legs began feeling numb. Within 24 hours, those symptoms went away (praise God), but I almost became paralyzed. I could not stop crying with how much pain I was in. In addition, for 3 weeks after the vaccine, I would get a headache each morning upon waking. I do not have a history of any of these symptoms.
mild discomfort at injection site; mild tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2021 08:15 (Lot number: EL9265) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL (ongoing); GLUCOSAMINE (ongoing); LISINOPRIL (ongoing). Vaccination history included: Bnt162b2 (1st dose , Administration time: 08:30, Lot number: EL3248, Vaccine location: Arm left), administration date: 16Jan2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "Very light soreness at injection site", "discomfort at injection site". The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown", described as "mild discomfort at injection site"; FATIGUE (non-serious), outcome "unknown", described as "mild tiredness".  Additional information: The patient had not received any other vaccines within 4 weeks prior vaccination and had no additional vaccines administered on same day.  No follow-up attempts are possible. No further information is expected.
A pharmacist reported that an unidentified patient received Pnu-Imune 23 vaccine (pneumococcal vaccine polyvalent) in 2002. The patient developed an injection site reaction characterized by bruising and swelling. No additional information was available as of the date of this report. MANUFACTURER'SCOMMENT: The reporter indicated that 4 to 6 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
On the underside of arm, if she raises her arm, is very tight; Itchy; It was pink; Typical sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (On the underside of arm, if she raises her arm, is very tight), PAIN IN EXTREMITY (Typical sore arm), PRURITUS (Itchy) and ERYTHEMA (It was pink) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (Typical sore arm). On 10-Jan-2021, the patient experienced MUSCLE TIGHTNESS (On the underside of arm, if she raises her arm, is very tight), PRURITUS (Itchy) and ERYTHEMA (It was pink). On 04-Jan-2021, PAIN IN EXTREMITY (Typical sore arm) had resolved. On 13-Jan-2021, ERYTHEMA (It was pink) had resolved. At the time of the report, MUSCLE TIGHTNESS (On the underside of arm, if she raises her arm, is very tight) and PRURITUS (Itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a nurse concerning a "high school age" female who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported).  Subsequently the patient experienced numbness in her hands and arms and fainted in school.  The patient was brought to the ER but was not admitted.  Per the nurse, the healthcare provider in the ER did not think there was anything wrong with the patient.  The patient was then taken to her family practice physician and she had an MRI which came back normal.  The numbness lasted 2 - 3 weeks and the patient is now fine.  The nurse stated that the patient will not be continuing with the GARDASIL series.  Additional information has been requested.
Pt recvd MMR 25SEP90; On 04OCT90 pt exp afebrile sz & one day later exp a febrile sz; Reporter did not attribute the pt's exp to vax w/MMR;
Redness and heat at injection sited and noted 24 hours after injection.  Area approx 6cmx6cm, no other s&s.  To follow up with family doctor to rule out allergy and poss txn r/t latex allergy.
blisters appear on my buttocks/diagnosed as having shingles; blisters appear on my buttocks/diagnosed as having shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20May2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "hx of shingles" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE HCL. Past drug history included: Biaxin; Penicillin; Codeine intollerance. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 20Apr2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 21May2021, outcome "recovered", described as "blisters appear on my buttocks/diagnosed as having shingles". The event "blisters appear on my buttocks/diagnosed as having shingles" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes zoster.   Additional information: Patient reported that within 24 hours of completing her second vaccine patient had blisters appear on her buttocks. After contacting a doctor and having a doctor examine them,  was diagnosed as having shingles. Patient received treatment with Valtrez. Patient did not have covid prior to vaccination. Patient tested for covid after vaccination. Patient had also received booster dose on 12Jan2022 (14:00) as dose 3 (booster), single.  The lot number for bnt162b2 was not provided and will be requested during follow up.
*Chills: Mild (body shaking, teeth chattering) from 9:00 PM on Saturday May 1st, 2021 to 1:00 AM on Sunday May 2nd, 2021.  Extreme (violent shaking, teeth chattering, had to be held down) from 1:15 AM to 2:30 AM on Sunday May 2nd, 2021. *Nausea: Medium (feeling the need to vomit) from 1:30 AM to 3:30 AM on Sunday May 2nd, 2021.  Mild (only able to eat bland food) all day on Sunday May 2nd, 2021. *Overheating: 2:30 AM-3:30 AM on Sunday May 2nd, 2021. *Muscle Aches: Mild all day on Sunday May 2nd, 2021 and Monday May 3rd, 2021. *Pain at Injection Site: Medium in the evening of Saturday May 1st, 2021.  Mild all day on Sunday May 2nd, 2021.
Fiery red with fever-right leg 5 in x 3 inch, left leg 2 in x 2 in, 3 hours after shots, suggested ice on leg and Benadryl by mouth
Received Varivax on 08/24/01. Rash on trunk and extremities smaller than chicken pox developed 09/03/01, fever of 104 on 09/05/01.
Patient received vaccine and about 10 minutes after came up to the consult window for a glass of water. Patient stated that she felt light headed and immediately fainted back and hit her head against wall and on the floor. Patient did regain back consciousness immediately after falling, but laid on ground until medic arrived. Patient was shaking per post shock and was stating "feeling warm." Did provide water as well as a jacket to rest her head and a cool compress. Mother was there by the side of patient and calmed her down while paramedics arrived. At around 3:50 medic arrived and took blood pressure and examined patient further.  Patient seemed fine but required further evaluation by medic.
Fever x 2 days, rash x 3-4 days, vomiting x 1 days.
Itchy, watery , red, swollen eyes with rash, hives, headache , shortness of breath.