chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient via other manufacturer concerned a 50-year-old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry date: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received non-company suspect drugs included adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: unknown and expiry date: unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced infection and had surgery in MAR-2022 and had been in and out of hospital due to infections. Number of days of hospitalization was not reported. It was unknown if patient was discharged. On an unspecified date, the patient felt like she went downhill post receiving Covid vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable and action taken with adalimumab was not reported. The outcome of the infection, felt like went downhill and surgery was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0:20220612987-COVID-19 VACCINE AD26.COV2.S- surgery, infection - The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Second dose in series was given one week prior to when it was due. Patient informed of incident and advised to call the Health Department with any adverse reactions.
On March  15  my injection sight was really sore  so I looked at it and I had  a large rash  When I massage it feels warm to the touch.
Large heat rash on the arm of injection. This rash appeared a week after the first dose. The rash was about 3 inches below the injection and formed a red band across my arm. I am black [dark skined] and red redness was very noticeable. I slept with ice packs on my arm and took acetaminophen. The heat rash is starting to go down. Are is just warm at the moment and still tender.
I started with neck pain and upper back pain that developed overnight. Every morning, I felt like I had done manual labor the day before. Beginning at the end of August or beginning of September, I started noticing pain in both of my hips and glutes. By the end of September, the pain, stiffness, and weakness spread to the upper half of my thighs. It made it more difficult to rise from a seated position.  By early November, the muscle issues had spread to my shoulders and upper half of upper arms. It made it difficult to raise my arms. By December, I began having Tendonitis issues in my left elbow and my left thumb. In January, I began having Tendonitis issues in my right elbow. The Tendonitis issues prevent me from putting my hands behind my back. Beginning in February, I began having pain in my hands in the morning that eases up throughout the day. It feels more joint related that muscle related. Beginning in March, I began having an unusual sensation in my left knee and lower half of my quad. It felt like a swollen knee and tugging sensation in my quad when my knee was bent, but I did not experience pain. On March 11, I began feeling pain in that knee. All the muscle symptoms seem to get worse overnight and are at their worst first thing in the morning and after periods of inactivity. It has been treated with Celebrex with minimal improvement. I?ve taken Ibuprofen with minimal improvement. I?ve also taken Prednisone with a great amount of improvement while on a short high dose regiment and moderate to minimal improvement on extended lower doses.
under 18 years old and received Moderna COVID19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old and received Moderna COVID19 Vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old and received Moderna COVID19 Vaccine). On 08-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old and received Moderna COVID19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.
Information has been received from a nurse concerning a female patient who was vaccinated with the first and second 0.5ml dose in the series of GARDASIL (Lot # unknown). The nurse reported that the patient had a rash after receiving the first and second dose. It was unknown if the patient sought medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
a dose of PROQUAD was inadvertently administered instead of VARIVAX/ this was human error and not product confusion; No adverse effects reported; This spontaneous report was received from a registered nurse, referring to a 1 year and 12 days old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.     On an unknown date, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis instead of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, route, dosage schedule, lot number and expiration date were not reported). Confirmed that this was human error and not product confusion.   No adverse effects were reported.
Pt. given VARIVAX instead of ZOSTAVAX given IM instead of SQ
I felt extreme upper shoulder and neck pain, not relieved by massage, pain relievers or muscle creams. It is chronic and feels like a tightening and numbness of my whole neck area. I have full range of motion of my neck, but it is uncomfortable to turn it.  I saw an orthopedist who ordered an MRI which showed some cervical spondylosis, but not enough to cause my symptoms. Had 8 weeks of physical therapy with no change or improvement in symptoms. Acupuncture (2 sessions) and massage did nothing as well. I continue to have the neck pain/stiffness and numbness daily now, almost a year later.
No adverse event; Temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving VARIVAX states that there have been administered doses; This spontaneous report was received from a registered Nurse referring to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   Since 28-JUL-2020, varicella virus vaccine live (oka/merck)(VARIVAX) had intermittent temperature excursion to temperature of - 14 Celsius degrees (°C) to 10°C (maximus -9.5°C) for 38 hours and 30 minutes. On 24-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002843, expiration date 23-JAN-2022 0.5 ml (route of administration not provided) for prophylaxis (it was also reported that the lot # S032357 expiration date 14-OCT-2020 was involved, but not information of administration was provided) (Product storage error).  The call was made due to a digital data logger. No previous temperature excursion was reported.
Pt. given PNEUMOVAX 23 vaccine 2/13/17 at 10:30 am. On 2/14/17 she had a warm feeling at injection site with erythema down to elbow. TX with Doxycycline for 10 days.
Migraine; High fever over 103, over 102 with meds; Joint pain; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old, non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14May2021 at 08:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included thrombocytopenia. The patient had no known allergies to medications, food or other products. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN) all for unknown indications from an unknown date. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 21:00, the patient experienced migraine, high fever over 103, over 102 with meds, joint pain and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 14May2021 patient underwent lab tests which include body temperature and the result was over 103( unspecified units) and over 102 (unspecified units). Therapeutic measures were taken as a result of the event high fever over 103, over 102 with meds which included treatment with unspecified medications. No therapeutic measures were taken as a result of events migraine, joint pain and vomiting. The clinical outcome of the events migraine, high fever over 103, over 102 with meds, joint pain and vomiting were not recovered at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
(R) arm swelling and redness after vaccine delayed reaction. Symptoms started 1 week after administration. Antihistamine oral and topical steroid cream.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-MAY-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 25-JUL-2014, the patient was treated by the hospital (by an unspecified healthcare professional) for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. On or about 29-SEP-2015, the patient sought subsequent treatment from the hospital (same hospital as the hospital on 25-JUL-2014) (by an unspecified healthcare professional) for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Day after injection on 1/13/21 Left arm became "looked like  bee sting" red, swollen, sore, hardened area at injection site, day 2 c/o itchiness.
Felt like he was hit by a truck; Really Intense Pain in his Arm (Second Shot); Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt like he was hit by a truck), PAIN IN EXTREMITY (Really Intense Pain in his Arm (Second Shot)), CHILLS (Chills) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced MALAISE (Felt like he was hit by a truck), PAIN IN EXTREMITY (Really Intense Pain in his Arm (Second Shot)), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, MALAISE (Felt like he was hit by a truck), PAIN IN EXTREMITY (Really Intense Pain in his Arm (Second Shot)), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.   This case was linked to MOD-2021-062852 (Patient Link).   Reporter did not allow further contact
Received vaccine after allowed expiry at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine after allowed expiry at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.  It was reported that four doses of the Moderna vaccine were given to three patients after being at room temperature for 12 hours. The vials were removed from the fridge at approximately 08:30 on 07-JUL-2021 and administered at 13:00 on 08-JUL-2021.  Treatment information, if any, was not provided.
pt recvd vax & 2 days later pt exp neuralgia-like pain in the lower extremities;No further details were provided;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 as dose 5 (booster), single (Lot number: GJ6739) for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3248), on 08Feb2021 as dose 2, single (Lot number: EM9810), on 02Nov2021 as dose 3 (booster), single (Lot number: FF2590) and on 11May2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydroxychloridine, reaction(s): "Known allergies: Hydroxychloridine"; Morphine, reaction(s): "Known allergies: Morphine"; Codeine, reaction(s): "Known allergies: Codeine"; Iodine, reaction(s): "Known allergies: Iodine"; Plaquenil, reaction(s): "Known allergies: Plaquenil"; Tramadol, reaction(s): "Known allergies: Tramadol"; Amitriptyline, reaction(s): "Known allergies: Amitriptyline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient started the first dose of Paxlovid since 31Jul2023.
patient's upper arm & shoulder sore starting upon getting vaccine. Numbing pain. Discomfort when moving arm. Full range of motion
Pericarditis/Myocarditis. Treatment still ongoing. Frequent ingestion of anti-inflammation medication
25 minutes after IM injection the patient began to have some itching, hives, scratchy throat and then a heavy chest feeling.   patient was treated with 25mg of oral diphenhydramine and assessed by one of our MD's that was in the vaccination area.   It was determined the patient should be taken to the ER for further assessment. The patient was alert upon transport to the ER.
Patient requested Janssen J&J vaccine.  On form, patient denied receiving any previous COVID-19 vaccine of any kind.  Shot was administered.  When insurance was billed for payment, claim was rejected, stating that one dose of Moderna was given.  When given this information, patient denied receiving any Moderna vaccine.  Insurance was contacted, and they gave us the date of first shot of Moderna (3/20/21) and the location of the shot.  Information was given to patient, patient still denied receiving any Moderna vaccine and said that "he would contact pharmacy to clarify the misbilling and rectify the situation".  After trying to contact patient multiple times on both 7/6 and 7/7, we called pharmacy to clarify if vaccine was really given.  Pharmacy responded that patient received both doses of Moderna vaccine (first on 3/20/21 and second dose on 4/17/21).  Incident report was started after receiving this information.  Patient has not return any of our phone calls in reguard to receiving both the full series of Moderna and the Janssen J&J vaccine.
oxygen saturation drops down into the 60s and 70s/oxygen needs are now flucuating between 2 LPM and 4 LPM; Dehydration; Palpitations; kidney issues; feeling worse; Hemoglobin has been dropping from 13.4 down to 11.9; has continuous problem with candida; groin rash; This is a spontaneous report from a non-contactable consumer (patient). A 79-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose (at the age of 79-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date in 2021, patient had been feeling worse since getting his second covid shot in April. He stated he had to go to the emergency department due to dehydration, palpitations and kidney issues. His hemoglobin has been dropping from 13.4 down to 11.9. If he gets up and walks any distance his oxygen saturation drops down into the 60s and 70s. His oxygen needed were now fluctuating between 2 lpm and 4 lpm. He was put on a prednisone dose pack and was doing good until the day after it stopped, all the symptoms came right back. He also has continuous problems with candida and a groin rash. No further details provided. Therapeutic measures were taken as a result of oxygen saturation drops down into the 60s and 70s/oxygen needs were now flucuating between 2 lpm and 4 lpm, dehydration, palpitations, kidney issues, feeling worse, and hemoglobin has been dropping from 13.4 down to 11.9. The outcome of the events was unknown.  Information on lot/ batch number has been requested.
Patient received a JEV booster on 9 July 2019. Today (17July 2019) patient received a second booster due to the Hospital employee not verifying the most updated vaccination record. It was caught after the administration of the vaccine. The patient was informed and then monitored by myself for one hour to observe any adverse effects.
Fussiness, diarrhea, grunting, fever (Mood alteration)
I took the first dose of the vaccine on 03/09/2021 and the second dose on 07/02/2021. After the second shot I became lethargic ,dizzy, nauseous, no apatite,  and generally confused state of mind. I have had weird sleeping patterns.
headaches; reports a lot of pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old male patient received bnt162b2 (COMIRNATY), administration date 08Aug2021 (Batch/Lot number: unknown) as dose 1, single and administration date 29Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "headaches"; FEELING ABNORMAL (non-serious) with onset Aug2021, outcome "not recovered", described as "reports a lot of pressure". The events "headaches" and "reports a lot of pressure" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, feeling abnormal.  Additional information: PQC Present: No. AE Present: Yes. Question: Call comes in via (withheld).  Caller is a 67 year old consumer, DOB #  He received his first dose of the Pfizer BioNTech Covid-19 vaccine on 08Aug2021, and his second dose on 29Aug2021.  He has been having headaches since then.  States he has been to the doctor twice, and has not gotten any relief.  Reports that it is very annoying, and he cannot be around people when they're talking a lot, because it hurts.   He also reports a lot of pressure.  He has had shots and medications from the doctors.  He later states that he will get a CT.  The handwriting on his vaccine card from # is difficult for him to read, but he says for the first dose, it looks like FB0178 (he thought perhaps the 0 was a D); for the second dose, possibly FC3184.  He mentions that on the back of the card, it says 017Y1 for the first, and 1791 for the second.  He is asking if headaches are common after getting the vaccine.  E-transmitted back to Agency for possible additional AE information, as he declined filing a report before warm transferred. Response: Spoke from Experience.  LAB; Revised: 29Oct2021.  Referred back to HCP for further guidance and treatment. Reaction/event as reported by primary source: still having side effects    Is the patient also the reporter? Yes. Reporter type: Consumer or other non health professional. Is Pfizer covid 19 vaccine a Pfizer product? Yes. NDC number of Pfizer covid 19 vaccine: Not Provided. Expiry Date of Pfizer covid 19 vaccine: Not Provided. Other Products: Not Provided. Patient History: Not Provided. Investigation Assessment: Not Provided. The caller is calling about the Pfizer covid 19 vaccine and he is still having side effects. The caller wants to know how long its going to take before he can be himself again? The caller is 67 years old.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right upper Deltoid starting within 2 days injection site red hot swollen and tender, hard to touch, itchy. 3 1/2" circle. Subsided over 10 days developing fluid filled blister. 1/4" x 1/2 " itchy and sore to touch.
The day after I experienced brain fog and a minor headache.  24 hours after I had extreme joint pain in my shoulders, elbows, and even my jaw. 48 hours I developed a crippling migraine and throwing up constantly. I am now 53 hours post the 2nd injection and still have a migraine and nausea.