chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient has undergone COVID 19 treatment with Paxlovid from 27Jul2022 to 01Aug2022. She had rebound symptoms after 5-day of Paxlovid treatment on 07Aug2022 and the patient was recovering from rebound symptoms. She has not received other medications within 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Was told by patient on 11/30/2012 that she was admitted to hospital (I think that she said on 10/31) and was diagnosed with Guillain-Barre due to vaccination.
Headache; Fever of 103 degrees; Muscle Aches; This case was reported by a nurse via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache, fever and muscle pain. On an unknown date, the outcome of the headache, fever and muscle pain were recovered/resolved.   It was unknown if the reporter considered the headache, fever and muscle pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported, but it could be 61 or 62 years. The patient received Shingrix couple months before the date of reporting. The patient experienced short lived side effects such as fever, muscle aches and headache that resolved quickly.  The reporter did not ask if 1st dose of Shingrix was also administered at the same pharmacy as the 2nd dose. The reporter consented to follow up. For tolerance of 2nd dose of Shingrix refer case US2019195392.
Pt. presents to ED C/O redness, pain and swelling at injection site gradually getting worse. Diagnosed with injection site reaction to Rt. upper arm with early cellulitis. Pt given AUGMENTIN 825 mg PO BID, MOTRIN and advised warm compresses as prophylaxis.
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 31-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
March 24th-31st: No other reactions or side effects after injection except a bruise at injection site. April 1st: Raised bump at injection site. April 2nd: Raised bump is now noticeably red, warm to the touch, and slightly itchy. Patient takes Aleve(NSAID) to manage back pain, will take an antihistamine if the itching increases.
Stomach issue\pain in the right quadrant which she describes as intermittent pain; musculoskeletal pain; Joint issue; pain in the lymph node of the arm; nauseated; headache\intermittent pain in back of her head; feels like hit by a truck; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ABDOMINAL DISCOMFORT (Stomach issue\pain in the right quadrant which she describes as intermittent pain), MUSCULOSKELETAL PAIN (musculoskeletal pain), ARTHRALGIA (Joint issue) and LYMPH NODE PAIN (pain in the lymph node of the arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Primary biliary cholangitis (Autoimmune disorder).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). On 21-Apr-2021, the patient experienced LYMPH NODE PAIN (pain in the lymph node of the arm), NAUSEA (nauseated), HEADACHE (headache\intermittent pain in back of her head) and MYALGIA (feels like hit by a truck). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach issue\pain in the right quadrant which she describes as intermittent pain), MUSCULOSKELETAL PAIN (musculoskeletal pain) and ARTHRALGIA (Joint issue). At the time of the report, DYSPNOEA (shortness of breath), LYMPH NODE PAIN (pain in the lymph node of the arm) and MYALGIA (feels like hit by a truck) outcome was unknown, ABDOMINAL DISCOMFORT (Stomach issue\pain in the right quadrant which she describes as intermittent pain), MUSCULOSKELETAL PAIN (musculoskeletal pain), ARTHRALGIA (Joint issue) and HEADACHE (headache\intermittent pain in back of her head) had not resolved and NAUSEA (nauseated) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant FU. Medical history added. New events added and outcomes updated for previous events.
Rash that started at injection site within  24 hours that has spread over to neck within 48 hours-upper torso and left upper arm around armpit. Raised and warm to touch.
convulsion; aches; This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (convulsion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (convulsion) (seriousness criterion medically significant). an unknown date, the patient experienced MYALGIA (aches). The patient was treated with Surgery (Heart Surgery) for Seizure. At the time of the report, SEIZURE (convulsion) and MYALGIA (aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment for the events included was heart surgery, received 3 stents and physical therapy. The patient was taken to the hospital. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-237450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-JUN-2021 contains non-significant information. Batch number /Lot number added; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded
Information has been received from a physician concerning an adult pt who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt had previously been vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced injection site pain. The pt sought unspecified medical attention. Additional information is expected.
Information has been received from a physician concerning a female patient who in July 2009 (day unspecified), was vaccinated with the first dose of GARDASIL.  Within the first 48 hours after the injection, the patient had heart palpitations, dizziness and light headedness, which resolved after the 48 hours.  It was unknown if the patient sought medical attention.  Additional information has been requested.
ADVERSE REACTIONS; This spontaneous report received from a patient via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Patient experienced extreme arm pain, dizziness, nausea, and sedation from the vaccine. Roughly 4-6 hours after the shot, she passed out at home, hitting her head and went to the ER that  evening for a full checkup.
Day 38 post first dose/trying to get 2nd dose scheduled but; A Spontaneous report was received from a consumer concerning female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and second dose scheduled but has not been successful.  / Inappropriate schedule of product administration.  The patient's medical history was not reported. Concomitant Medications were not listed.  On 30 Jan 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: unknown) for prophylaxis of covid 19 infection.  On 09 Mar 2021, the patient reported that trying to get second dose scheduled but has not been successful. (Inappropriate schedule of product administration).   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event Inappropriate schedule of product administration was resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown with no associated AEs.
9 days p/vax pt devel fever 102 PO, enlarged neck glands w/pain, flu-like sx that lasted till 25APR93 (3 days); 27APR93 rash red fine on trunk of body;
I occasionally get the feeling of an "armband" around my arm (left arm, around the injection site).  When I raise my left arm (where the injection was), my muscles feel weak. There is a dull pain (about a 1). I attributed the hurt in the earlier months to the injection. 7 months later, I really feel it is due to the injection. Now, my shoulder seems to emit some pain when I raise my arm.  This does not happen on my right side. I did not feel these symptoms before the shots.
4-5 hours after immunization patient developed hives----> resolved after 1 dose BENADRYL; patient also complain of leg pain at injection site.  24 hours after immunization noted local reaction (erythema, warmth, induration) around injection site.  When measured at clinic 82.4 Fahrenheit immunization local reaction 10 x 7 cm.
Stroke symptoms (numbness on left hand, then developed into loss of control of left hand and left leg, and also drooping of left side of face) showed up about three weeks after 1st dose of Pfizer COVID19 vaccine, and stroke occurred on 04/12/21 which is two days after the 2nd dose of Pfizer COVID19 vaccine.
Information has been received from a physician concerning a 21 year old female patient with no pertinent medical history and no drug reactions/allergies, who in approximately October 2008, a few months ago (exact date unspecified) was vaccinated with an initial dose of GARDASIL vaccine. There was no concomitant medication. Since receiving the GARDASIL vaccine, coincidently the patient had not had her period the past 2 months. The patient was not pregnant and not in a relationship. The patient had no underlying medical conditions that would explain this as she exercised regularly but not to excess, she was thin but not underweight, and she did not have a medical issue such as PCOS (polycystic ovary syndrome). She had an upcoming appointment with her gynecologist. No other symptoms were present. As of 22-DEC-2008, the patient's outcome was unknown.  Additional information has been requested.
Fever on days 2 and 3 with painful joints and back pain. Fell on day 2 after vomiting and almost blacked out
On 10.06.21 at 00:30 hours woke with headache, temperature of 101.4F, dry cough, legs aching, shortness of breath, O2 level 89 - 90,. Went to local clinic for Covid-19 test at 08:00 hours. PCP called around 13:00 hours who recommended go to hospital. After waiting 90 minutes only to find out that there were 40 patients ahead of us, went to urgent care. Put on O2, EKG taken. Was there about one hour.Sent to Medical Center by ambulance. Blood and urine samples taken. X-ray of lungs taken. Nothing was noted to be of concern. At hospital about 3 hours. Left at 19:00 hours.
C/O nausea, vomited x 1, c/o ache joints flu like symptoms, no local symptoms.
Just got Covid on Sept 1st. I was really sick. I was coughing and had a fever felt like a flu.
I had my vaccination on 10/26/2022. On 12/31/2022 I started to experience a sinus headache, sinus congestion and a scratchy throat. I tested COVID-19 positive on 01/07/2023. I contacted my physicians office on 01/09/2023 and was prescribed PAXLOVID. I presently feel good on 01/26/2023.
On 01/22/2001 the patient experienced varicella rash and upper respiratory infection with a slight fever. Medical attention was sought. Prescription drug treatment was not required. On 02/01/2001 the patient recovered from varicella rash, upper respiratory infection and slight fever. No further information is available.
This was my first time getting a Moderna Booster . My 3 previous covid vaccines were Pfizer .  See previous info as well . I got Moderna booster and then 3.5 hours  my face got itchy and felt swollen. My eyes and nose and throat were very itchy . My tongue felt a little swollen. I took a Benadryl 25mg and symptoms resolved in 1 hour .
General muscular stiffness commencing roughly 30 hours after vaccination, lasting several hours. Midway through that stiffness, lumbar back pain developed  limiting normal activity. No history of back surgery and no other incident of similar back pain in many years. Lumbar issue has not resolved as of three days after vaccination.
Redness and swelling of arm below the deltoid muscle. Patient report is is tender and painful.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, DIPHENHYDRAMINE CITRATE, PARACETAMOL (EXCEDRIN PM HEADACHE) for Headache, at an unspecified dose and frequency. On 04-Feb-2021, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.   This case was linked to MOD-2021-034974 (Patient Link).
swelling pain, reddness @ Td inject site; 3AUG93 TC to mom arm appears to be improving w/application of heat;
DIARRHEA, PAIN IN THE LUNGS, FEELING LIKE I WAS GOING TO PASS OUT AND CHILL FROM MY RIGHT ARM TO MY LEFT. IS THIS NORMAL AFTER A H1N1 FLU SHOT.
Given vaccines by nurse, dressed children and checked out. Walked out to the car and noticed that he was covered in pink blotches over face, neck, under his hairline, and front and back torso. Took him back inside and saw some pink papules develop on his thighs as well (looked like viral exanthem). He was re-examined by doctor and no signs of anaphylaxis but given Benadryl.
This spontaneous report was received from a nurse and refers to a 52 year old patient. The patient was human papilloma virus (HPV) positive prior to receiving vaccination. No other information concerning the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2015, the patient received the first dose of GARDASIL 9 0.5 ml, subcutaneously (lot # and expiration date not reported). In February 2016, the patient was vaccinated with the second dose GARDASIL 9 0.5 ml, subcutaneously (lot # and expiration date not reported). At the time of the report, the nurse declined to give the third dose to the patient. Additional information has been requested.
Approximately 2 months after tested positive for COVID-19.  I had post nasal drip, cough, fatigued, congestion. I was prescribed a Paxlovid. Tested negative after course of Paxlovid but began not feeling well and tested positive again a few weeks later.
Patient received booster dose Pfizer. First COVID-19 vaccine was Janssen 3/10/2021.
This is a spontaneous report from a contactable consumer (parent of the patient). A 17-years-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on 31Jul2017 at 16:00 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On 31Jul2017 at 16:20 (20 minutes after vaccination) the patient began feeling pain in her which got worse as time passed, which progressed to fever/chills and muscle/joint/skin/eye pain and general weakness, with trouble standing and difficulty moving her fingers, but no difficulty breathing. The patient was worst at 18:30-19:00 she had nausea and a periodic headache, and was extremely pale in her extremities. At 19.00 temperature was 100.7 hence the parents took her to the emergency room. Upon arrival they took her vitals. During the 2-3hr after, her symptoms lessened to the point of her wanting to go home. They immediately gave her TYLENOL and after about 1hr released her. At reporting time the patient was feeling much better, but tired. Tiredness started on unspecified date in 2017 and the outcome was unknown. The final outcome of the other events was recovering.
WEAKNESS IN LEGS; HEADACHES; SEVERE CHILLS; FEVER; HANDS AND FEET WERE NUMB; DEHYDRATION; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent condition included multiple sclerosis. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced dehydration. On 10-APR-2021 16:00, the subject experienced hands and feet were numb. On 10-APR-2021 16:00, the subject experienced fever. On 10-APR-2021 16:00, the subject experienced severe chills. On 11-APR-2021, the subject experienced headaches. On 12-APR-2021, the subject experienced weakness in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hands and feet were numb on 11-APR-2021 15:00, and fever on 11-APR-2021, was recovering from dehydration, and had not recovered from weakness in legs, and headaches. This report was non-serious.
Administration of Kinrix After the Expiration Date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 22-MAY-2023, the patient received the 1st dose of Kinrix. On 22-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Administration of Kinrix After the Expiration Date). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 24-MAY-2023 The reporter was a medical assistant. The reporter reported that the patient received an expired Kinrix vaccine. The reporter did not consent to follow-up. The patient received an expired dose of Kinrix vaccine, which led to expired vaccine used.
Chills, dizzy, fever, vomiting, arm numb and tingling, sore arm and joints, sneezing.
5 hours after I got flu shot, I was changing my shirt and seen rash on front of torso. They got worse 10/29/02. I went to friend again that same evening; I got more on back of legs. I called to report on 10/30/02.
Pt recv vax on 10/16/97; on 10/19/97 pt exp neuralgia from back of hand up the forearm to shoulder. From follow-up information received on August 3, 1999, it was reported that the patient recovered from this experience, "Symptoms likely due to coincidental slipped disk, positive MRI."
Pt with outbreak of about 30 lesions on back only. Suspicious for chickenpox.
Left upper arm inferiously with 11.0 X 9.0 C erythema with mild increased warmth, only slight induration at superior aspect.
On 3/8/04, given total 19.2cc Imogem rabies immunoglobulin-4cc was infiltrated in right forearm (15.2cc with 4 injections of 3.8cc IM right and left upper outer quadrant of buttocks at right and left mid vast lateralis. 3/11/04 she returned for rabies vaccine only. 3/15/04 she came for  day 7 rabies  Imovax and she has a rash on chest, arms, legs and on her back. She had huge rash size of a cross on her right forearm where it was infiltrated. She had a rash on legs and buttocks but not actually where shots were given. It would appear to be a reaction from rabies immunoglobulin. There was no rash on the sight of diptheria tetanus or rabies vaccine. She took antihistamine OTC. She also had been put on Clindamycin 300 mgx3dx7 days, finished 3/12/2004. Avalox 400mg  a day bidX7days. We changed her rabies vaccine to RabAvert which was to be given  fourth 3/22/04. She will finish on 4/5/05.
ERYTHEMA, DIAMETER APPROX. 3INCHES, WARM TO TOUCH, NO PAIN, SOME ITCHING, NO FEVER. MAINTAINED SAME SIZE FOR 24 HOURS.