chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown demographics. No information about the patient's pertinent medical history, drug reactions or allergies was provided. On an unspecified date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported), which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (also reported as "sterile water diluent"). The vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit for 45 days. Digital data logger was not involved in recording the temperature excursion. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Seizure, not responding and tongue popping and high fever. Called 911 and rushed to Emergency.
Patient presents with a bruised arm (upper deltoid area).  Patient states that she moaned in pain during the injection. She states that it immediately felt like electricity traveling down her arm and that it ached even more the following day.  She states that her pain has consistently improved over the past few days.
I have been having ongoing headaches for years. Just recently when I received the last shot on 9/13/2017 I started to experience more headaches, eye pain, jaw pain, muscle pain and chest pains. Last month I was diagnosed with fibromyalgia.
3 DIFFICULT DAYS; This spontaneous report received from a patient via social media from a company representative concerned a patient of unspecified age and sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received first and second dose of Sinovac (covid-19 vaccine inact (vero) cz02) (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported administered for prophylactic vaccination.  It was reported that the patient was perfect and had no consequences, and mentioned work and sport at 100 percent following vaccination with first and second dose of Sinovac (covid-19 vaccine inact (vero) cz02) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (third dose) (dose number in series 2) (suspension for injection, route of admin, batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered  for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced unspecified adverse event and it was stated that the patient still remember 3 difficult days (coded as adverse event nos) after the covid-19 vaccine ad26.cov2.s (third dose) (dose number in series 2) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received fourth dose of Novavax (form of admin, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported administered for prophylactic vaccination and mention the patient was perfect. It was stated that, " 24 hours after the (4th ag. COVID19) vaccination with Novavax : how is my Mother, how am I, We are perfect: absolutely no consequences, Work and sport at 100 percent it is like after the 1st and 2nd with Sinovac". The outcome of 3 difficult days (coded as adverse event nos) was not reported. This report was non-serious.
Soreness under upper arm, swelling about the diameter of an orange and redness and raised about 1/4 inch and very tender to touch and very warm. Itched a little which caused me to discover the reaction. Severe headache and very sweaty and just felt bad. Didn't sleep well the first night before I even knew I was reacting and 2nd night didn't sleep well either due to sweating and pain. Had a rapid heartbeat and could feel my heart beat when still and had sores on tongue. Pain and bruising moved down the underside of upper arm.
Dizziness, nausea, and shakes for about an hour until they stopped.  Patient thought about going to the ER until it stopped.
Patient complains of pain starting within hours of injection, consulted doctor 3 days later and was diagnosed with tendinitis of left shoulder. Patient was prescribed a sling and hydrocodone/APAP for pain (unable to take ibuprofen due to XARELTO) and was also given a cortisone shot by the doctor. Patient will be starting physical therapy 3 times a week going forward.
rheumatoid arthritis she had a flare; run over by a truck; became stiff and hurt all over; jaw hurt; headache; hurt all over/ achy feeling; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) (seriousness criterion medically significant), FEELING ABNORMAL (run over by a truck), MUSCULOSKELETAL STIFFNESS (became stiff and hurt all over), PAIN IN JAW (jaw hurt), HEADACHE (headache) and MYALGIA (hurt all over/ achy feeling). The patient was treated with Physical therapy for Rheumatoid arthritis; Physical therapy for Feeling abnormal; Physical therapy for Musculoskeletal stiffness; Physical therapy for Pain in jaw; Physical therapy for Headache and Physical therapy for Myalgia. On 17-Mar-2021, PAIN IN JAW (jaw hurt) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) had not resolved and FEELING ABNORMAL (run over by a truck), MUSCULOSKELETAL STIFFNESS (became stiff and hurt all over), HEADACHE (headache) and MYALGIA (hurt all over/ achy feeling) outcome was unknown.            No relevant concomitant medications were reported.  The patient stated how long this flare up would last and should she continue to go to physical therapy.  Company Comment: 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-048039 (Patient Link).; Sender'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.
On Thursday June 24th at approximately 6:00am I woke up drenched in sweat, took my temp, it was 100.7, muscle aches, severe fatigue, headache, sore arm where injection took place. I took a bath and started feeling better around 10pm Thursday evening, no fever, only a little fatigue, muscle ache, headache, chills. On Friday June 25th around 4am I started feeling feverish again, took temp, it was 100.4. I feel very fatigued again, muscle aches got better, headache got worse now sensitive to light.
On 12/23 evening, began with hive like rash over injection sight, sight hot to touch, swelling to site, itching, restricted movement due to pain. Took Benadryl and Tylenol, symptoms began improving 12/26, mostly resolved.
swelling on her upper lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swelling on her upper lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swelling on her upper lips). At the time of the report, LIP SWELLING (swelling on her upper lips) outcome was unknown.             No relevant concomitant medications were reported.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.
On the 8th day after my vaccination, I felt a little itch around the area, with red lumps, a bit swollen, and felt heavy. I constantly feel tired and fatigue. On the 11th day after the vaccination, I felt little soreness on my left breast. The redness and itchiness come and goes throughout the day. I have researched on CDC website and I read that I have typical symptoms of COVID Arm. I am scheduled to take my 2nd shot on April 29th.
Pt vaccinated with DTP/OPV/HIB phone call from ER 9JAN91 at 1210PM requesting info re: child's status on visit 8JAN91. Informed ER child well-given 2nd DTP, OPV & 1st HBCV - ER stated child "SIDS" found by mother - brought to ER via rescue.
Onset of symptoms about 12 hr after injection 6 Am on 2/15/06 when pt awoke with burning, throbbing, stinging pain in middle of left armpit and radiated about 2 inches down left side and lasted about 2 days until 2/17/06. Pain then lessened and was gone by 2/20/06. Today 2/21/06 pain is still gone. Only mild soreness in left deltoid during entire event. No temp.
lower back pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm) and BACK PAIN (lower back pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Feb-2021, the patient experienced AXILLARY PAIN (sore arm).   On 08-Feb-2021, the patient experienced BACK PAIN (lower back pain). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency and PARACETAMOL (PAIN RELIEVER) for Low back pain, at an unspecified dose and frequency.   On 03-Feb-2021, AXILLARY PAIN (sore arm) had resolved. At the time of the report, BACK PAIN (lower back pain) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Patient with biopsy proven severe cutaneous lichen planus that began day of first vaccine and progressively worsened every week. After initial vaccine had itching for which she took benadryl and epi pen. Second vaccine with more itching. Rapid response called. Was admitted to hospital after second vaccine. Treated with high dose steroids. Seen by allergy who gave her dupilumab without improvement. When I saw her started her on acitretin and did another biopsy which showed lichen planus. Continued on acitretin and methotrexate added as well. Is now slowly improving. Rash covers 80% of BSA and is very slowly flattening.
Initial unsolicited report received from a physician via other company (Pfizer) (under manufacturer reference number- 2014065832) on 25 February 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced allergy to vaccine (tetanus shot). Laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Anaphylactic. SOB, Tight throat, Itchiy Throat, Hives.
This spontaneous report as received from a registered nurse refers to a 64 years old patient of unknown gender. On 08-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K003600, expiration date verified as 10-MAR-2015 (also reported as 19-MAR-2015) 0.65 ml dose once, subcutaneous (dose number was not reported) for shingles, that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Turn pale white, red under eye; blue above lips, thristy; clammy skin;
after patient returned home, she was on the porch talking to a neighbor, but then developed a headache 9/10 , and came inside the house and laid down on the tile floor, Mom took her temp via forehead 101.5. While laying on the floor felt nauseated and vomited several times until her stomach was empty. Did eat breakfast this morning prior to visit. At the same time she felt the headache, nausea and vomiting, also was aware of a sharp pain starting in the left arm, going up to her shoulder and radiating to her scapula.  After 5 mins after vomiting, felt better , headache 3/10 on the pain scale.Mom gave her BC powder ( contains aspirin) for the continues scapular pain . I spoke to mom at 220 pm, and she was feeling better and at the lab getting COVID 19 tested for college
Besides the usual soreness on the arm where I received the injection on the day of the vaccination, on the day following after work I began to feel overly fatigued and before I before I went to bed I was having a fever. The fever seems to have worked itself out over the night, although I do have some lingering fatigue (as well as a minor headache).
Anaphylaxis; This is a spontaneous report from a contactable pharmacist.  A 55-year-old female patient received the bnt162b2 (BNT162B2; also reported as: PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history included eosinophil process allergic reaction, fish, iodine and shellfish allergy; all from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient previously took rabies vaccine for immunization and experienced anaphylactic reaction on an unspecified date. On 17Dec2020, the patient experienced anaphylaxis; which required hospitalization, and was assessed as medically significant. The patient was hospitalized for anaphylaxis from 18Dec2020 to an unknown date. The clinical course was reported as follows: The pharmacist called about a patient who received the COVID-19 vaccine on 17Dec2020 and started having a reaction approximately 30 minutes later. The patient used epinephrine (EPIPEN) and 50 mg of diphenhydramine hydrochloride (BENADRYL) and returned to the hospital on 18Dec2020. The patient was currently in the intensive care unit (ICU) receiving an epinephrine drip. The patient had a previous history of an anaphylactic reaction to the rabies vaccine, eosinophil process allergic reaction, fish, iodine and shellfish allergy. The patient was stabilized but continued to have reactions (not specified). The pharmacist had not seen the patient and was reaching out to Pfizer on behalf of the physicians. The pharmacist believed this had been reported by the hospital. The pharmacist had no patient information. Therapeutic measures were taken as a result of anaphylaxis. The clinical outcome of the event, anaphylaxis, was unknown.   The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event anaphylaxis due to temporal association. However patient previous history of allergic reaction cannot be excluded to have played a contributory role
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-JAN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798, expiration date 12-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated subcutaneously with an expired lot # (671022/0745AA exp date 18-AUG-2012), 0.65 ml of ZOSTAVAX on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
HOT FLASHES; COLD ON OUTSIDE; HOT ON INSIDE; SWEATING; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (HOT FLASHES), COLD SWEAT (COLD ON OUTSIDE), FEELING HOT (HOT ON INSIDE) and HYPERHIDROSIS (SWEATING) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-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 HOT FLUSH (HOT FLASHES), COLD SWEAT (COLD ON OUTSIDE), FEELING HOT (HOT ON INSIDE) and HYPERHIDROSIS (SWEATING). At the time of the report, HOT FLUSH (HOT FLASHES), COLD SWEAT (COLD ON OUTSIDE), FEELING HOT (HOT ON INSIDE) and HYPERHIDROSIS (SWEATING) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Patient was leaving store after receiving her vaccination and began experiencing dizziness and confusion, causing her to move to the floor. Emergency services were contacted, and she was transported to the hospital. She had received HD flu vaccines in 2018 and 2019 with no known adverse events. The incident was witnessed by another customer.
Headache & Myalgia  Narrative: DOSE 2-DAY 1-2-SWELLING/PAIN/ DISCOMFORT AT INJ SITE DAY 1-HA; DAY 2 HA MUSCLE ACHE  Other Relevant History:
SHORTNESS OF BREATH; STOMACH CRAMPS; HEADACHE; LEFT ARM SORENESS; TIREDNESS; WORSENING OF FLUTTERING OF HEART; This spontaneous report received from a patient concerned a 74 year old  female. The patient's weight was 266 pounds, and height was 62 inches. The patient's past medical history included concussion in 2019, spinal injuries, anaphylaxis shock after medicine took for bone and swelling, and concurrent conditions included non alcohol user, non-smoker, and reaction to iv dye, fluttering of the heart, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient was previously treated with steroids for swelling.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered one total, on 08-APR-2021 in left arm for prophylactic vaccination. Concomitant medications included roprinolil, atorvastatin, lisinopril , propranolol , salbutamol sulfate(inhaler) as needed, oxybutynin, and paracetamol as needed, all drugs were used for unknown indications. On 09-APR-2021, the patient experienced worsening of fluttering of heart, tiredness. On 10-APR-2021, the patient experienced left arm soreness. On 13-APR-2021, the patient experienced headache. On 17-APR-2021, the patient experienced stomach cramps and recovered on 21-APR-2021. On 19-APR-2021, the patient experienced shortness of breath. It was reported that patient had experienced shortness of breath before shot but not as often. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from stomach cramps on 21-APR-2021, and was recovering from headache, worsening of fluttering of heart, left arm soreness, shortness of breath, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: v0:20210447945: covid-19 vaccine ad26.cov2.s -Worsening of fluttering of heart. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Right arm MENACTRA was given 4/30/2018. That day pt w/no difficulty breathing or shortness of breath. Able to play baseball in evening. Pt complained 5/1/2018 in the morning reporting redness, swelling and warmth. Pt also advised itchy sensation and feeling that the skin is tight. Pt w/no pain on pressing the reaction per mother. Also patient is right handed and has no difficulties with moving his hand and fingers. Eventually discussed with mother when she contacted offices 5/2/2018 -> if patient w/warmth, skin tightness needs to be evaluated at ED/office as concerns of infection/Genpath compartment syndrome. Mother understands. Informed mother to give BENADRYL 25mg, if symptoms worsen. Patient to return to clinic or seek medical attention.
the fluid was clear, rather than cloudy.; experienced some pain immediately upon injection that lasted all day.; This spontaneous report has been received from an approximately 35-year-old female patient concerning herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in January 2022 (reported as 2 months ago), the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot #, and expiry date were not provided), for prophylaxis. She noticed the pharmacist vigorously shaking the vial prior to administering.  The patient reported that she experienced some pain immediately upon injection, that lasted all day. She did not seek medical attention. On 28-MAR-2022, the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot #, and expiry date were not provided), for prophylaxis. It was administered at the pharmacy. The patient stated the pharmacist did not shake the vial and she noticed the fluid was clear, rather than cloudy (Liquid product physical issue). She also mentioned that the pharmacist claimed they had shaken it, but they did not witness this, nor did the appearance of the fluid seem this way. The patient was concerned if this would affect efficacy of the vaccine.  The patient did not experience any pain at all following the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9); however, at the time of reporting, the patient's pain experienced upon injection of the first dose was unknown.  The causal relationship between experienced pain and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Reaction left thigh approx. 4" area redness and pain around both injection sites.