chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 min after the injection I developed arm pain and a headache. Over the next 36 hours I developed a migraine, extreme body aches and severe arm pain. This was distinctly different arm and body pain compared to the first dose. I now understand the intractable headache after the first dose was a migraine. It was a horrible experience!!!!!!!. I laid down with ice on my body and finally took Tylenol after 24 hours. I was not able to get out of bed without pain; my life ceased for the duration. It was as it an alarm was set because ~ 6:00 a.m. Monday the 15th I woke up afraid to move only to learn that my body has reset and the pain was gone. I had returned to myself with only residual right arm pain.
has no immunity after his Pfizer COVID vaccine; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has no immunity after his pfizer covid vaccine on an unspecified date. The outcome of event was unknown.  Information on Lot/Batch number has been requested.
Swollen painful red rashy area at injection site approximately 2 hrs after injection. Cold compresses and cortisone cream.
Within 10 hours patient was extremely nauseated; had an upset stomach; 8 days after the first dose she had COVID arm; The 2nd dose made patient extremely ill /was sick after the 1st and 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (8 days after the first dose she had COVID arm), ILLNESS (The 2nd dose made patient extremely ill /was sick after the 1st and 2nd dose), NAUSEA (Within 10 hours patient was extremely nauseated) and ABDOMINAL DISCOMFORT (had an upset stomach) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (highly allergic to sulfa drug.).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE REACTION (8 days after the first dose she had COVID arm). In April 2021, the patient experienced NAUSEA (Within 10 hours patient was extremely nauseated) and ABDOMINAL DISCOMFORT (had an upset stomach). In 2021, the patient experienced ILLNESS (The 2nd dose made patient extremely ill /was sick after the 1st and 2nd dose). At the time of the report, VACCINATION SITE REACTION (8 days after the first dose she had COVID arm), ILLNESS (The 2nd dose made patient extremely ill /was sick after the 1st and 2nd dose), NAUSEA (Within 10 hours patient was extremely nauseated) and ABDOMINAL DISCOMFORT (had an upset stomach) outcome was unknown.            Concomitant medication not reported.   8 days after the first dose she had COVID arm. The 2nd dose made her extremely ill. Within 10 hours she was extremely nauseated, very ill and she had an upset stomach. Since she was sick after the 1st and 2nd dose. She did not get the 1st booster or the 2nd booster.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-736311 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736311:Bivalent Case
When I got the first shot om February 27th, I felt ok.  But, in the third week my calves began to feel a little off. When I got the 2nd  shot on March 27th, I seemed to have more energy for two days. Almost three days after Shot #2, my legs and feet started tingling and twitching.  I had no appetite, couldn't sleep, and had a panic attack.   My symptoms are persisting three weeks later.  I spoke to Dr. by phone on April 7th.  He said it was probably an extreme inflammatory response.
Injection site reaction - very sore, "cant move my arm. "  Developed sx about 24* after vaccination:  fatigue, body aches, headache, LUNG PRESSURE.  Progressively worsening today.
Swelling, redness and blistering of left upper arm which started on 5/1/02. Area of erythema 7cm X 10cm.
waking in the middle of the night because his hands feel like they have fallen asleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (waking in the middle of the night because his hands feel like they have fallen asleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HYPOAESTHESIA (waking in the middle of the night because his hands feel like they have fallen asleep). At the time of the report, HYPOAESTHESIA (waking in the middle of the night because his hands feel like they have fallen asleep) outcome was unknown. Not Provided          Reporter did not allow further contact
infection that spread to my groin and was big in area; a rash on my butt; pimples; Psoriasis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 29Oct2021 at 13:00 as dose 3 (booster), single (Lot number: ph8028) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Lisinopril, reaction(s): "known allergies: Lisinopril". Vaccination history included: BNT162b2 (DOSE 2, SINGLE, lot number: EN6208,, Administration time: 01:00 PM,, Anatomical location: Right arm), administration date: 15Mar2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: En6201, Administration time: 01:00 PM, Anatomical location: Left arm), administration date: 22Feb2021, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 04Nov2021, outcome "not recovered"; RASH (non-serious) with onset 04Nov2021, outcome "not recovered", described as "a rash on my butt"; SKIN INFECTION (non-serious) with onset 04Nov2021, outcome "not recovered", described as "infection that spread to my groin and was big in area"; ACNE (non-serious) with onset 04Nov2021, outcome "not recovered", described as "pimples". The events "infection that spread to my groin and was big in area", "a rash on my butt", "pimples" and "psoriasis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin infection, rash, acne, psoriasis.  Additional information: Patient reported ''Days after the booster had a rash on my butt, turned into an infection that spread to my groin and was big in area. (photos available). At the same time had some strange growths, pimples, one large area that Dr (Name withheld) took a biopsy, Psoriasis. Took moths of appointments, trying different remedies. 24Jun started Tremfya $8000 out of pocket for a years treatment. For 69 years, no skin problems or infections and no Family history, talked to 5 of my siblings''. AE treatment included Creams, Ointments, Something for infections and now. No other medical history. No covid prior vaccination. Covid was not tested post vaccination.   Follow-up attempts are completed. No further information is expected.
On 25 November I started to feel itchy and had originally attributed it to cold weather and dry skin. The itchiness was at its worst on 26 November and I had noticed after a shower that I had broke out into hives on my back/shoulder area. I went to the local urgent care and was given a one time dose prednisone and Benadryl. The next day I picked up a prescription for prednisone 50mg and had also bought Zyrtec 10mg. The hives subsided, but every so often I still feel itchy and I have dermographia. I take Zyrtec 10mg daily to stop the itchiness.
Pt admitted to inpatient facility tested positive for covid. Family reports pt has had covid vaccines. No info on place, date, company, lot, etc.
Syncopal episode after receiving immunization (within a few minutes); fell from exam table where he was sitting injured two upper central incisors; sustained a comminuted nasal fracture.
Patient noticed slight swelling in arm before going to bed woke up in morning and swollen down to elbow.
Pt received vaccine at 1611 to the left arm then waited 15 for minutes in the observation area. She then stared to drive herself home and developed numbness to the right lateral face and right neck. She came back the vaccine site and had numbness to her left lateral face. She was was without edema, impaired vision, talking, swallowing and her neuro exam was normal.
Pt is a 19 mon old little boy who was in the office for wcc and vaccination on 8-29-2008; One day after vaccination (8-30-08), pt began to have vomiting nbnb, ~7times; On the second day (8-31-08) pt had red warm area on Left thigh > right thigh and it felt firm and pt felt like he had a subjective fever; pt went to urgent care for eval that night after fever increased to 102.7. Parents were told that pt had possible cellulitis at site of the injections on the left and was told to take po clindamycin and sent home. Pt continued to vomit and was unable to consistently take po antibiotic; also temp increased to 103. So pt returned to ER on 9-1-08 and was given 1 dose of IV clindamycin for possible cellulitis coverage in Left thigh and had blood testing (cbc/bld cx)  and urine testing and a KUB - all of which parents were told was nl; pt was sent home again. Pt was seen in the PCP office for f/u on 9-2-08.  Pt had a red area on Left thigh-mildly pink area medial area ~3x3 cm and small 8mm nodule in center. no fluctuance; not hot to touch; not consistent with cellulitis.  Pt was not taking po and seemed ill appearing. Pt was still having fevers as well at home (day 4-5 of fevers) so pt was sent for inpatient admission at hospital to try to determine fever origin as leg lesion did not seem to represent cellulitis.  Per parents, inpatient doctors did further testing and gave IV fluids and they diagnosed probable viral syndrome, fat necrosis in thigh, and sent him home as fever had resolved (await inpatient hosp records and final outpt cultures.) 9/9/08-records received for DOS 9/2-9/3/08-DC DX: Fever and abdominal pain now resolved. Fat necrosis with possible cellulitis, status post vaccine now resolved. Most likely viral syndrome gastroenteritis with some dysphagia and feeding difficulty now resolved. The afternoon of August 29, 2008 developed emesis and following day fever up to 102.7, rhinitis. On August 30, 2008 developed erythema around vaccine site on left leg. Unable to keep oral antibiotic down. Developed intermittent abdominal pain, decreased oral intake, did not want to swallow seemed to choke with attempts to eat solids. Urine output decreased. Listless, mild dehydration.
Information has been received from a certified medical assistant referring to a patients of unknown age and gender. There was no medical history or concurrent condition reported. On 03-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L012036, expiry date: 07-APR-2017) (dose, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 5APR96 & w/in 5 mins of vax pt turned beet red over 50% of body;the was treated w/epi & was recovered as of the date of this report;
Information has been received from a registered nurse concerning an 8-year-old female with no pre-existing allergies, birth defects or medical conditions who on 22-JUL-1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 29-JUN-2007, the patient developed various lesions on her back and legs that had a 4 day duration. There were approximately 15 lesions in various stages. The patient was afebrile. There were no other symptoms. It was reported on WAES# 0707USA01595 that all other "sibs" have had chickenpox. It is unspecified if medical attention was sought. No laboratory or diagnostic tests were performed. The patient recovered on 09-JUL-2007. The patient had no adverse events following prior vaccinations. The R.N. also reported four of the patient's siblings developed chickenpox following varicella virus vaccine live (Oka/Merck) WAES numbers: 0706USA04088, 0707USA01591, 0707USA0194, 0707USA1595). This report is one of several reports from the same source. Additional information has been requested.
SORENESS OF INJECTION SITE, FATIGUE, BODY ACHES, FEVER ON NIGHT 2 (LAST NIGHT)
Felt warm and cold and had runny nose and headache, took Tylenol 11/11/02 client fine. Case closed.
Received both vaccines in the right arm, one above the other.  The first was the COVID Booster.  Pharmacist placed a bandage over that injection site and proceeded with the Flu Vaccine.  Upon removing the needle, blood began to run from the injection site.  Within 5 seconds, the patient began to show signs of vasovagal syncope, her eyes rolled backward, and she slumped in the chair.  When pharmacist and patient's mother attempted to revive the patient, her arms began to shake.  Within 10-15 seconds, the patient had begun to awaken, and was fully conscious within 20 seconds.  She had complete recall of D.O.B., current date, where she was, and where she was planning on going next .  She had no recollection of feeling light-headed, hearing any ringing in her ears, or any other warning signs that she might be experiencing any issues.  She said it just felt like she was falling asleep for a moment.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). Concomitant products included simvastatin. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd May 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were recovering/resolving. The reporter considered the injection site pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The pharmacist reported on behalf of the patient. The patient received SHINGRIX in the left deltoid. The reporter stated that the patient came back into the pharmacy the day after receiving SHINGRIX, and stated that he experienced injection site pain and body aches. The patient reported to pharmacist that, the symptoms started 4 hours after receiving the vaccine and it was a little better on the day of reporting.
Pfizer booster; Fever; Arthralgias; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 12:30 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm right, administration date 16Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. I don't have the card with me, Location of injection: Arm Left), when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 12:30, outcome "unknown", described as "Pfizer booster"; PYREXIA (non-serious) with onset 16Dec2021 12:00, outcome "not recovered", described as "Fever"; ARTHRALGIA (non-serious) with onset 16Dec2021 12:00, outcome "not recovered", described as "Arthralgias"; DIARRHOEA (non-serious) with onset 16Dec2021 12:00, outcome "not recovered", described as "Diarrhea". Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient needed to take ibuprofen to reduce the fever. The fever reduced but today started again with fever and arthralgias. The treatment received for the adverse event was Ibuprofen. The patient did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been tested for COVID-19 as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, redness, warmth, itching and pain surrounding injection site. Lesion is about 2.5 inches in diameter.  18 weeks pregnant at time of vaccination. Pregnancy has been uncomplicated prior to vaccination. No known complications at this time post-vaccination.
pt recvd vax & exp erythematous rash sl itchy, raised red welts, t102, malaise, irregular swelling of face, hot painful skin, joint pains, lower back, allerg react;
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included MTHFR gene mutation (MThfr compound heterozygous (sometimes she methylates, or absorb medications very quickly, and there are other times where she absorbs medications very slowly)), Fibromyalgia, Hypothyroidism (Low thyroid), Anxiety and Arthritis. Concomitant products included DIAZEPAM (VALIUM) for Anxiety, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Fibromyalgia, VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS], CALCIUM and ZINC for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient also included thyroid medication.  The patient received vaccine in her left arm, which was non dominant arm.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-329866 (Patient Link).
This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date in July 2016, the patient was vaccinated with most recent dose of GARDASIL 9 (dose, route, frequency, lot number and expiration date not specified) for human papilloma virus (HPV) vaccination. It was unknown if the patient was compliant to the dosing schedule. On an unspecified date, the patient developed ulcerative colitis. It was unknown, if patient received treatment for the event. It was unknown, if lab diagnostics/studies were performed. The outcome of the event colitis ulcerative was unknown. It was unknown, if the patient sought medical attention. Causality assessment was not reported. Product quality complaint (PQC) was not involved. Upon internal review, the event colitis ulcerative was determined to be medically significant.
Information has been received from a physician and a RN concerning her 24 month old daughter with no pertinent medical history and no known drug allergies who on 04May04, at 12 months old was vaccinated with a 0.5mL first dose of varicella virus vaccine live (lot648047/1346N). There was no concomitant medication. On 16May05 the pt developed 4 red vesicles on her back with white fluid centers. One vesicle was reported to have started to scab over at the time of the report. She was seen by the physician on 17May05. The physician diagnosed her with a mild case of varicella. She had a few lesions on her back, as well as a mild cough and congestion. No treatment was required. No lab diagnostic studies were performed. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Came in complaining of rash on her arm. Macular-papular rash noted above left elbow and extending down left arm to wrist. Complained of slight itching. No other rash noted on body, no other symptoms.
Pain in the spine; Numbness on the left of the spine; Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pain in the spine), HYPOAESTHESIA (Numbness on the left of the spine) and ARTHRALGIA (Sore shoulder) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced SPINAL PAIN (Pain in the spine), HYPOAESTHESIA (Numbness on the left of the spine) and ARTHRALGIA (Sore shoulder). At the time of the report, SPINAL PAIN (Pain in the spine), HYPOAESTHESIA (Numbness on the left of the spine) and ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Patient arrives to the emergency department by EMS for evaluation.  She was diagnosed with COVID on June 5.  She has been taking prednisone since she was diagnosed.  She states that today she had had increased shortness of breath and was trying to take her prednisone.  She was weak and fell onto her buttocks.  She then tried to get up and in turn called to the bedroom to try and help her self up on the bed and fell onto her bottom a second time.  She complains of pain to her right hip/thigh and right hand.  She did not hit her head there is no loss of consciousness.  She is not on any blood thinners.  She has no underlying lung disease.  She rates her pain a 4-5 on a 0-to-10 scale. Associated Symptoms: fall, injury, shortness of breath, weakness
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced flu like symptoms. This case has been linked with case US2018GSK164083, reported by the same reporter (patient's daughter). The reporter did not agree to be contacted for follow up.