chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pneumonia; A spontaneous report was received from a male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed pneumonia.  The patient's medical history included a sinus infection. The concomitant medications were not reported.  On 03-MAR-2021, 7 days prior to the onset of the event, the patient received his first of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 09-MAR-2021, the patient was tested positive for pneumonia which the patient believed was from a previous sinus infection. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, pneumonia, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
9 day post vax pt had episode of szs, felt warm,eyes rolled back, lips blue,limp body,mucous coming out of mouth.
re raised warm area of induration 7.5 cm by 6cm well below site of injection on left arm
A couple days following the injection, began experiencing chest pain and shortness of breath while trying to sleep. Symptoms remained for three continuous days following onset.  Symptoms were prevalent enough to lead to an impromptu doctor visit, and an ER visit the following day.
Department of Health received a call from her sister, in response to a call/letter/text sent out to all recipients of the Janssen vaccine. She stated that her sister received the J and J vaccine on 3/12/21 (confirmed in State vaccine system) at the hospital where she receives her oncology care.  She reported the following:  "She had a massive stroke on MARCH 27TH, 2021 leaving her paralyzed on the right side with the inability to speak, swallow, or see. She was initially diagnosed with Ovarian cancer approximately three and one half years ago. She was chosen for a study with Pharmaceuticals and her diagnosis was changed to a vary rare form of cancer called clear cell carcinoma which originates in the gynecological area. She did have a previous stroke approximately three years ago, (just after original diagnosis) but she was on a different course of treatment at that time...Oncologists have explained that this most recent stroke event would not be considered a side effect of her current treatment routine. She wanted to bring it to the attention of the health department in case it needs to be looked at more closely by the J&J research/scientific team. She passed away on 4/5/21. Her current treatment consisted of palliative chemo only. "  Decedent was a resident but was vaccinated in another state. After the CVA she was brought to the hospital and subsequently transferred to the Medical Center where she died on 4/5/2021. Sister is willing to speak with any investigators if deemed necessary.
Seen on 8/26/15 at office for c/o fever, body aches and local reaction Lt arm at injection site. 8/27/15 seen this AM c/o H/A, neck pain and swollen and red at injection site. WBC at 15,000. Doxycycline prescribed.
Patient called the pharmacy to report hives. Post vaccination she felt that her arm was a little itchy. The next day she broke out in hives and does not report any difficulty breathing. She will follow up with doctor.
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via other manufacturer concerned 6 decade old adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, and moderate to severe chronic plaque psoriasis. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient experienced psoriasis flare up/break out on left buttock and sore arm when treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) The patient was previously treated with Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown and expiry: unknown) dose not reported (1 in once), administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with Pfizer Biontech Covid-19 Vaccine (tozinameran) (dose number in series 2) The patient received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 09-NOV-2021 for prophylactic vaccination which was off label dosing frequency. Age at time of vaccination 53 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient had Non-company suspect drug included: Humira (adalimumab) (solution for infusion in pre-filled syringe, subcutaneous, batch number: unknown and expiry: unknown) dose and frequency were not reported from 20-OCT-2017 for psoriatic arthritis and moderate to severe chronic plaque psoriasis. On 09-NOV-2021, the patient had off label dosing frequency (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220607090.
Vaccine given on 1/14/21.  In the early AM of 1/21/21, I noticed in my left upper arm a lump and redness.  It was itchy as well.  During the day, the redness and size of the lump increased.  On 1/22/21 on waking up, the lump size had about doubled in size.  It continues to be red but itchiness has decreased.
Heart rate 160-180 upon exertion - first event 180 for 20 minutes during routine 10 k run then squeezing chest pain  at end  that subsided with rest. Reproduced for weeks afterwards.  Full cardiac work up and monitor showed sinus tachycardia with minimal exertion in otherwise Normal athletic patient most consistent with myocarditis following Covid vaccine.
Pain in the base of the cervical spine; Pain in the hands; Pain in the neck; Loss of appetite; Pain in the shoulders, arm joints; Nausea; Pain in the injection site; This spontaneous case was reported by a physician and describes the occurrence of SPINAL PAIN (Pain in the base of the cervical spine), PAIN IN EXTREMITY (Pain in the hands), NECK PAIN (Pain in the neck), DECREASED APPETITE (Loss of appetite) and ARTHRALGIA (Pain in the shoulders, arm joints) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included AMIODARONE for Blood pressure.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE PAIN (Pain in the injection site). On 05-Jan-2021, the patient experienced SPINAL PAIN (Pain in the base of the cervical spine), PAIN IN EXTREMITY (Pain in the hands), NECK PAIN (Pain in the neck), DECREASED APPETITE (Loss of appetite), ARTHRALGIA (Pain in the shoulders, arm joints) and NAUSEA (Nausea). On 02-Jan-2021, INJECTION SITE PAIN (Pain in the injection site) had resolved. At the time of the report, SPINAL PAIN (Pain in the base of the cervical spine), PAIN IN EXTREMITY (Pain in the hands), NECK PAIN (Pain in the neck), DECREASED APPETITE (Loss of appetite), ARTHRALGIA (Pain in the shoulders, arm joints) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient began to experience pain at the injection site the first two days after receiving the vaccine and then it resolved. The patient went to urgent care and was prescribed Natroxe and Vitamin B complex.  Treatment information was not provided.  Company Comment - 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.; Reporter'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.
Initial report received on 23 October 2008 from a health professional. A 60 year old male patient, with no known allergies and a history of high cholesterol, received on 21 October 2008 a right deltoid intramuscular injection of FLUZONE (lot number U2749AA). Concomitant medications included Prostatin, Trazocine, and an unspecified cholesterol medication. The patient had no illness at the time of vaccination. On 22 October 2008, approximately 24 hours after vaccination, the patient noted an area around the injection site resembling ring worm with blisters. Additionally, a similar area was noted toward the back of the arm and the patient complained of pain (site not specified). At the time of the report, the patient had not recovered and was to be evaluated by a physician. Follow up information was received on 18 December 2008 from a health care professional. The patient required a doctor's visit, but did not have any laboratory tests or diagnostics completed. The patient did not received any vaccinations at the same time or within four weeks of FLUZONE. No other information was provided.
about 4 hours after the shot, his injected leg had swelled to nearly twice the original size.  His father took him to the pediatricians office where they gave him some motrin and we were told that this was normal.  This was only the beginning.  In the following months his speech and behavior began to regress and continued doing so.  9/26/08 Reviewed PCP medical records of 5/16/07-7/15/2008. FINAL DX: ASD, speech & global developmental delay Records reveal patient experienced otalgia 5/07.  On 3/31/08 parent expressed concern re speech, repetitive behaviors, parallel play, not following commands, tantrums.  Hearing test WNL.  Referred to early intervention program & began ST 6/08.  RTC 4/1 w/left leg injection site swelling, dx w/local reaction.  RTC 7/15/08.  Scheduled for developmental pediatrician eval 9/30/08.  Now screaming & stimming. 1/27/2010 He is still developmentaly delayed but slowly catching up ti his peers. He still has intestinal issues and we are just currently finding that his immune system is over active and is attacking some body areas.
The rashes from it were scabby, oval shaped, and itchy; Had eczema all over the place/eczema presented grossly/eczema at that point was around her breast and scalp; Got bloody discharge twice from left nipple,blood from the scabs; If she itched too much, clear liquid would come out; Duct in breast is enlarged; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Had eczema all over the place/eczema presented grossly/eczema at that point was around her breast and scalp), NIPPLE EXUDATE BLOODY (Got bloody discharge twice from left nipple,blood from the scabs), BREAST DISCHARGE (If she itched too much, clear liquid would come out), BREAST DISORDER (Duct in breast is enlarged) and RASH PRURITIC (The rashes from it were scabby, oval shaped, and itchy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Asthma. Concomitant products included MOMETASONE FUROATE (NASONEX) for Allergy, LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) for Asthma.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ECZEMA (Had eczema all over the place/eczema presented grossly/eczema at that point was around her breast and scalp), NIPPLE EXUDATE BLOODY (Got bloody discharge twice from left nipple,blood from the scabs), BREAST DISCHARGE (If she itched too much, clear liquid would come out) and BREAST DISORDER (Duct in breast is enlarged). On 19-Feb-2021, the patient experienced RASH PRURITIC (The rashes from it were scabby, oval shaped, and itchy). At the time of the report, ECZEMA (Had eczema all over the place/eczema presented grossly/eczema at that point was around her breast and scalp), NIPPLE EXUDATE BLOODY (Got bloody discharge twice from left nipple,blood from the scabs), BREAST DISCHARGE (If she itched too much, clear liquid would come out), BREAST DISORDER (Duct in breast is enlarged) and RASH PRURITIC (The rashes from it were scabby, oval shaped, and itchy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided  The patient stated that 3 weeks after she received the 1st dose, she had to be seen by a dermatologist as well as a breast care specialist. She states that she had to get mammograms and ultrasound of the breast done because her duct was enlarged and also stated that the eczema at that point was around her breast and scalp.   This case was linked to MOD-2021-414693 (Patient Link).
1ml dose was given to a 19-year-old patient by mistake instead of a 0.5ml.; Inappropriate ageat vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 19-year-old male patient who received HBV (Engerix B) (batch number SX27B) for prophylaxis.   On 19-AUG-2023, the patient received Engerix B. On 19-AUG-2023, an unknown time after receiving Engerix B, the patient experienced accidental overdose (Verbatim: 1ml dose was given to a 19-year-old patient by mistake instead of a 0.5ml.) and inappropriate age at vaccine administration (Verbatim: Inappropriate ageat vaccine administration).  The outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 20-SEP-2023 The pharmacy technician called to report a 1ml dose was given to a 19 year old patient by mistake instead of a 0.5ml, which lead to accidental overdose and inappropriate age at vaccine administration. The reporter consented to follow up only by phone, no email provided.
Inflammatory response; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammatory response) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammatory response). At the time of the report, INFLAMMATION (Inflammatory response) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given by reporter. No treatment medication was given by reporter.  Company Comment : This case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced the unexpected non serious event of Inflammatory reaction after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after dose of mRNA- 1273 vaccine, dose number unknown. Very limited information was provided. The rechallenge is not applicable since only information about one dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received contains no new information.; Sender's Comments: This case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced the unexpected non serious event of Inflammatory reaction after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after dose of mRNA- 1273 vaccine, dose number unknown. Very limited information was provided. The rechallenge is not applicable since only information about one dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea after the 3rd shot), BACK PAIN ("Middle and Lower back killing me" after the 3rd shot), PYREXIA (Fever (Unknown Fahrenheit) after the 3rd shot) and ARTHRALGIA (Joints hurt after the 3rd shot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary embolism and Arthritis.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced DIARRHEA (Diarrhea after the 3rd shot), BACK PAIN ("Middle and Lower back killing me" after the 3rd shot), PYREXIA (Fever (Unknown Fahrenheit) after the 3rd shot) and ARTHRALGIA (Joints hurt after the 3rd shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 13-Oct-2021, DIARRHEA (Diarrhea after the 3rd shot), BACK PAIN ("Middle and Lower back killing me" after the 3rd shot), PYREXIA (Fever (Unknown Fahrenheit) after the 3rd shot) and ARTHRALGIA (Joints hurt after the 3rd shot) had resolved.            No concomitant medication is reported   This case was linked to MOD-2021-351022, MOD-2021-351016 (Patient Link).
Starting the next day after receiving the vaccine, when I woke up, I began to experience dizziness. When I rotated from a prone position to a sitting position, I would become very dizzy. Also, during different parts of the day I would experience dizziness. I would stay dizzy for about 5-10 seconds then it would resolve. I will be going in to see the doctor soon. After speaking over the phone, they believe its a change in blood pressure from going from sitting to standing or laying down to sitting or standing. My endocrinologist said its a known side effect of the booster that normally resolves in a day or two, but mine has not. My neurologist also believe its likely a result of the vaccine.
2 days after vaccination I had an extremely heavy menstrual cycle. I previously had very light periods because I am starting to enter menopause.  They typically lasted 3-4 days max. This cycle was so heavy with massive clots that looked like grape jelly. Flow was so heavy I had to stay home from work and had to change my tampon once per hour if not more. This lasted for 8 days with extreme cramping.  My next cycle came quicker than usual in only 24 days and lasted 9 days with the exact same symptoms.  By my third cycle my period returned to normal.
Very weak and Lightheaded numbness and cold in feet and hands and upper body, chills and fever and cramps 10:22am
COAGULOPATHY, UNSPECIFIED TYPE 3/9/2022 COLON POLYP  PERIPHERAL NEUROPATHY 2/24/2022 COLON POLYP  COAGULOPATHY, UNSPECIFIED TYPE 3/9/2022 ESRD (END STAGE RENAL DISEASE)  PERIPHERAL NEUROPATHY 2/24/2022 ESRD (END STAGE RENAL DISEASE)  COAGULOPATHY, UNSPECIFIED TYPE 3/9/2022 ESRD (END STAGE RENAL DISEASE)  PERIPHERAL NEUROPATHY 2/24/2022 ESRD (END STAGE RENAL DISEASE)
Pt reported that at  pneumococcal site she had pain, swelling, heat, redness which extended down to wrist. Contact ER - nurse advise to take Tylenol. She went to Dr on her traveling. On Monday at 6 pm given 10 days of cephalexin 500 mg to take qid. Direct back or used at 08:30 that decreased swelling. No redness, states she can now bend her elbow and it seem to be getting better. Client asked to call back when she returns from her visit out of town and give additional information of when symptoms subsided completely. She also stated that she did not have any difficultly breathing, no hives and no itching. The "Flu shot" site was without any reaction she said.
Moderate full body myalgias and low grade fever 100.2  approximately 20 hours later. Resolved spontaneously by 48 hours.
This case was reported by a physician and described the occurrence of peripheral neuropathy in a 58 yr old female pt who received hep A vaccine inactivated (Havrix). On an unspecified date in Dec 2003, the pt received the first dose of Havrix in her arm, immediately, following admin of Havrix vaccine, the pt experienced neuropathy in her arms, legs and feet, headache, nausea and high blood pressure. The reporting physician stated that the pt has seen a couple of physicians concerning this issue. The headache, nausea and high blood pressure improved, but the neuropathy of the arms, legs and feet was unresolved at the time of reporting (12Feb04). The reporting physician considered the events to probably be related to vaccination with Havrix.
Headaches started slowly along with dizziness feelings of floating or being on a drug  and then got more intense after second shot and continued after for weeks until I was told I may have Giant cell Aritise.  I had biopsy and was put on high does steroids.  That was negative.  I still get headaches and have headaches sensitive to the touch.
This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the unspecified number of patients were vaccinated with unspecified doses of ROTATEQ lot # K013868 and expiration date on 27-MAY-2016 (doses and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt seen on 5/26/99 stated lt swollen arm was red & very hot, & arm was slightly red. pt not seen by provider;pt stated arm was ok
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 14-year-old patient of unknown gender. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot number N023828 (expiration date 25-JUN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.