chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About a week and a half after receiving my second dose, I noticed a tightness in my chest. I have been feeling very fatigue and heaviness in my legs when I walk.
Caller was difficult to hear during call.; Bruise on injection arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 29Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced bruise on injection arm on 30Dec2020, caller was difficult to hear during call on an unspecified date. The outcome of events was unknown.  Information on the Batch/Lot number has been requested.
This dose was given at 5 months and 5 days, too early.  Should have been given at 6 month spacing.
Was seen in office again on 10/4/18. Initial reaction was local at site and extended down to elbow by the next days, then began having sore throat, headache eye swollen. BENADRYL being given, lab done. 10/5 called rash under arms, around neck, down back worse. Prednisone given 10/7/18. Taken to hospital and admitted. Is currently still in hosp.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Concomitant medication was not provided. 196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up information received: Added age group and updated narrative.
patient reports her upper lip began to get numb, feeling like novacaine from the dentist.  no swelling or difficulty breathing.  then her eyes began to feel dry and her ears feel "swollen inside" but no pain.
Aches, throwing up, head ache, breathing heavy, shortness breathe, weak,  shacks, chills, fever
Office manager calling on behalf of a Provider to report that a patient received a dose of VARIVAX was administered on Aug 11, 2022 and PROQUAD was given on 8/18/2022.  No other issues reported.  AE follow-up can be sent.   NO PQC; This spontaneous report was received from an office manager concerning a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 11-AUG-2022, the patient received a dose of with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, lot #, expiry date, and route of administration were not provided); and on 18-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (strength, lot #, expiry date, and route of administration were not provided), both administered for prophylaxis (inappropriate schedule of product administration). No other issues were reported.
Nasty headache/back of neck/head. Major dizziness, nauseated, CLAMMY, SWEATY, hoarse, my eyes ached & watery, low energy + body aches, especially legs.  The headache actually began only hours after the shot. I still have symptoms but they are gradually decreasing, except have YET been unable to kick the nasty headache caused by this stupid flu shot. Might as well have signed up for a kissing booth with an infected individual.
Tinnitus on both ears. None stop very high pitch.  Never had it beforehand.
Migraine triggered 5 minutes after injection of vaccine and have been daily since then. My migraines had been under control for almost one year.  3? area of swollen redness with severe itching at injection site. SEVERE itching. This lasted app 7 days.
Information has been received from a pharmacist concerning her 79 year old father with a history of chemotherapy, surgery and splenic marginal zone lymphoma and splenectomy who in May 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). In June 2007, (one month after vaccination) the patient developed a bilateral leg rash from the thigh to the ankle. The patient was seen by dermatologist who prescribed an unspecified steroid cream for the rash. The physician also performed a biopsy (type unspecified) that was reported to be negative. The rash was concentrated in the right lower leg. At the time of the report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been received from the pharmacist who stated that the patient had splenic marginal zone lymphoma treated in the past with chemotx and a subsequent splenectomy. The pharmacist reported that prior to the splenectomy the patient's WBC count ran consistently above 200,000 and he was anemic and thrombocytopenic. Post splenectomy the patient is no longer anemic or thrombocytopenic and his WBC count ran generally in 20-30,000 range. The pharmacist reported that her father was immunocompromised. It was also reported that the patient developed a rash on both legs within 1 month post-vaccination. The rash on both legs from the thighs to ankles, and front to back of each leg. It was reported that at present the rash persisted on a small area of the right leg only. The patient continued to experience significant itching both in places where the rash as well as other areas of the body in which there was no rash. The patient never had any past skin issues.
sore arm / soreness; large, hard, red area at the injection site; large, hard, red area at the injection site; This case was reported by a other health professional and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, injection site induration and injection site erythema. On an unknown date, the outcome of the pain in arm, injection site induration and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site induration and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. The patient developed sore arm, a large hard and red area at the injection site. The symptoms were improving but still remained at the time of reporting.  The reporter consented to follow.
Red, hot lump appeared at site of injection immediately after receiving injection subsided after 3 hours. Reappeared with intense burning and itching 3 days later. Lasted 4 days so far.
This spontaneous report has been received from a registered nurse referring to an unspecified number of unspecified patients. No concurrent or medical history was reported. On unspecified dates were administered unspecified numbers of improperly stored doses of GARDASIL (lot number J010668 - expiration date 29-APR-2016), dose, route, frequency and anatomical location were unknown. No adverse event was reported. No further information was provided. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers 1507USA010881, 1507USA010882, 1507USA010883, 1507USA010884). Additional information has been requested.
FIRST DOSE ADMINISTERED 48 HOURS AGO WITHIN 15 HOURS OF INJECTION, I STARTED EXPERIENCING A HEADACHE, FATIGUE, CHILLS, SLIGHT FEVER 99.4 FEELING POORLY
Ischemic stroke; Ischemic stroke causing car accident; This is a spontaneous report received a contactable consumer, the patient. This patient/consumer reported different events for different doses of the same product; this case refers to dose 2.An 84-year-old elderly [non-pregnant] female received the second dose of intramuscular BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose in the left shoulder (deltoid) on 16Mar2021 at 12:00 (at 84-years-old) for COVID-19 immunization. Relevant medical history included ongoing atrial fibrillation, penicillin allergy, fractured tibia (09May2020; surgery to repair fractured tibia, plate and screws installed). The patient has a family history of strokes in maternal grandmother. Concomitant medications included oral rivaroxaban (XARELTO) 20mg once daily for atrial fibrillation ongoing from an unspecified date. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162b2 (Lot EN6200) in the left shoulder (deltoid) on 23Feb2021 at 12:10 (at 84-years-old) and experienced periods of dizziness like atrial fibrillation was acting up every few minutes all day, both days, left arm was sore for a day, and was fatigued and took two naps each day. The patient denied any COVID-19 prior to the vaccine and the patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 28Mar2021 the patient experienced an Ischemic stroke and car accident. The patient reported that the events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient explained that she was hospitalized for thirty-two days, including seven days in the Intensive Care Unit. The patient assessed the events serious (life-threatening, hospitalization / prolongation of hosp., persistent / significant disability / incapacity, Important medical event). The patient was tested for COVID-19 post-vaccination via nasal swab PCR on 28Mar2021 which was negative. The patient received multiple treatments for the events including occupational therapy (OT), Speech/Swallowing therapy (ST) , Physical therapy (PT), gabapentin, acetaminophen (TYLENOL) twice daily (BID) and tramadol BID. The outcome of the events Ischemic stroke and car accident was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021216108 PFIZER (Same reporter/patient/product, different dose/events)
Severe Headache starting 5 days after vaccine.  Lasted 8 days.
Mom called the Health Department and stated that the pt. had a nose bleed around 2:00 PM. No other complaints or signs and symptoms. Mom states the child had never had a nose bleed before. Mom states the child held pressure to her nose and it stopped bleeding.
Hot, raised swollen redness around site and proximal to the site on upper arm. Persistent more than 48 hours.
4 hours after fatigue and body aches 10 hours after fever, chills, arm pain, body aches, headache 1 week redness and rash at injection site
Severe pain and swelling of right arm from shoulder to hand started 1 day after vaccine.  Difficulty moving right arm persisting on 10/5/20 when patient returned to office.
pt recvd vax & was vomiting; dec responsiveness; low grade fever 101.2; spontaneous resolution 30 min; seen in er; nl exam;
Ears blocked, pressure in head, loss of hearing. Next day -pain in abdomine followed by diahrea - general not feeing well,
This case was received from a health professional in the United States on 26 July 2007. A 17-year-old female with a history of "twitching in arm" received a subcutaneous right arm injection of Menactra (lot number U2378BA). The product was originally reported as Menomune, however a lot search confirmed it to be Menactra. Approximately two hours after vaccination, the patient complained of lightheadedness and dizziness, and noted that her "stomach hurts when she presses on it". The events had not yet recovered at the time of the report.
exhausted; stomach ached all day; Had a slight headache; Couple of days later collapsed in bathroom; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2  at vaccination age of 35-year-old via an unspecified route of administration in the left arm on 05Apr2021 17:15 (Lot Number: ER8729) as dose 2, single for covid-19 immunization. Medical history included asthma, high blood pressure, and had known allergies to bees. The patient did not have covid prior vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient's concomitant medications were none. The patient previously took Lisinopril but had Lisinopril allergy. The patient did not receive other vaccine in four weeks. On 06Apr2021 06:00 AM, the patient reported that she was exhausted the next day and her stomach ached all day. She had a slight headache and couple of days later (Apr2021), she collapsed in the bathroom. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
I experienced 4 hours later, I developed chills. 04-09-2021, started to have muscle cramping, chills, cramps in the palms of my hands and feet.  I stayed in bed  and drank OJ, multi vitamins. On 04-10-2021, started to feel bit better, chills went away, still had muscle body aches, cramping in my hands and by Sunday I noticed an aching sensation from my left shoulder to my left elbow, itchiness and also started to experience an aching, itchiness sensation on my back down the back of my leg and calf. I then made an appt with my provider to get evaluated. I had lab work done to check my platelets and a follow up was given to me that all was normal. After a few days, my symptoms got better, I have no symptoms today only a headache and muscle cramping to my shoulder areas these last couple of days.
fever; body aches; fatigue; headache; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old non-Pregnant female patient received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 (at the age of 52-years-old) as dose 2, single for COVID-19 immunization. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No other vaccine was given in four weeks. No known allergies were reported. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in arm left on 15Feb2021 15:00 (at the age of 52-years-old) as single for COVID-19 immunization. Patient experienced sore arm after first dose. No Other medications was given in two weeks. On 07Mar2021 at 11:00 the patient experienced fever, body aches, fatigue and headache. The patient did not receive any treatment for the events. The outcome of the events was recovered on unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Patient presented a few minutes after Tdap in RT deltoid and flu vaccine in LT deltoid. C/O RT arm shaking. I had her lay on her LT side. Shaking stopped. I brought her a cup of water. She was able to drink it. RT arm began shaking again. I had her lay down and advised Dr.
mom telephoned clinic day p/vax reporting pt had been awake & fussy most of noc-crying much of noc; did not lookfor rash @ this time; In AM when dressing pt noted hives on extremities; confirmed on visit to clinic; 6APR95 t100.2 R; P144;R44
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient also received Flulaval Quadrivalent Flu Vaccine on same day. Few seconds after 2nd COVID shot, patient fainted and slumped forward. She regained consciousness after a few more seconds with low blood pressure and low heart rate. She felt lightheaded right before fainting. Nurse practioner monitored her for another 20 minutes and patient was back to normal.
pt recv vax 14APR98 & 3 days p/vax 18APR98 pt devel joint pains in hands, ankles, toes, & feet;seen by rheumatologist & neurologist;pt does not have carpal tunnel synd;pt sx sort of autoimmune response;
Patient developed 1 inch sized redness day after vaccination to right upper thigh and grew daily until contact office on 6/15/20 late afternoon. Office visit on 6/16/20 found to have red, swollen area to right upper thigh measuring 28 x 14 cm. Patient denies any pain, fever or other symptoms. Dx: Cellulitis  Tx: Keflex and Prednisone
Within 30 minutes of injection, she started having all over body itching and flushing of her cheeks.  Dexamethasone IM, Benadryl IM.  Prescribed a Medrol Dose Pack to start the following day and ranitidine to start this evening.
Shingles outbreak side, chest & breast with arm redness, heat, itch & sore
Soreness, Joint Pain, Stiff arm & neck, Fever (104 degrees F), Chills, Aches & Pains in body/ muscles, Nausea, Vomiting, Loose bowels, Sweats, Tiredness, Loss of appetite.
Patient was seen in the office today for her first visit. She reports she started having hives and itching on her upper and lower extremities 5/6/18- 5 days after MMR and Varicella vaccines were administered. She was taking BENADRYL OTC 25 mg twice a day with relief. She stopped BENADRYL 2 days ago. Her symptoms are improving. Continues with itching. NO shortness of breath, chest pain, palpitations, facial swelling, throat swelling. Denies rash on back, chest, abdomen. She will take Cetirizine 10 mg daily OTC and Hydrocortisone 1% topical OTC as needed. I will see her back for follow up in 1 week. She reports she was told by her mother she had a possible reaction to Varicella vaccine as child with hives several days after the vaccine was given. MMR and Varicella vaccines were given due to "low titers".
This spontaneous report was received from the patient's mother and refers to a currently 5-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II 05. ml (route of administration, lot # and expiration date were not provided) as prevention of measles, mumps and rubella. On an unknown date, the patient experienced a localized injection site reaction, where his leg swelled up, became red, itchy and hot to touch, then turned black and blue. The patient received unspecified treatment for the events. The patient sought medical attention via seeing pediatrician. The outcome of the events was reported as recovered. The relatedness between the events and M-M-R II was not reported.
was really sick; No appetite; Chills; really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104; Body Aches/Severe body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was really sick), DECREASED APPETITE (No appetite), PYREXIA (really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104), MYALGIA (Body Aches/Severe body aches) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 001C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 05-Jan-2013 to an unknown date for Anxiety, DROSPIRENONE, ETHINYLESTRADIOL (SYEDA) from 05-Jan-2012 to an unknown date for Birth control, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 05-Jan-2020 to an unknown date for Seasonal allergy.   On 24-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104) and MYALGIA (Body Aches/Severe body aches). On an unknown date, the patient experienced MALAISE (was really sick), DECREASED APPETITE (No appetite) and CHILLS (Chills). On 26-Mar-2021, PYREXIA (really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104) had resolved. On 28-Mar-2021, MYALGIA (Body Aches/Severe body aches) had resolved. At the time of the report, MALAISE (was really sick), DECREASED APPETITE (No appetite) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, SARS-CoV-2 test: other (Positive) tested positive for COVID-19. On an unknown date, Infectious mononucleosis: other (Negative) Negative. On an unknown date, Influenza: other (Negative) Negative.         Platelets and kidney numbers were low. No treatment medication reported by the reporter.   This case was linked to MOD-2021-255845 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received as new events myalgia, chills, appetite absent were added. Concomitant medications were added. Start date of suspect drug for first dose was added. Patient demographic information was added. Event outcome for feeling sick, fever was updated from unknwon to recovered. Laboratory data was added. Causality of fever and myalgia updated.
experienced some pain the site; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 8-decade male patient (Patient Age reported as late 70s) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date patient experienced some pain in the site, it was mild and it went away. He wanted to know if he can continue with his daily medication, aspirin 81 mg and muscle rub. Outcome of the event was recovered.  The information on the batch number has been requested.