chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itches in her legs; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches in her legs) and VACCINATION SITE PRURITUS (Itchy at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PRURITUS (itches in her legs) and VACCINATION SITE PRURITUS (Itchy at injection site). At the time of the report, PRURITUS (itches in her legs) and VACCINATION SITE PRURITUS (Itchy at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  No treatment information was provided.   Reporter did not allow further contact; 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
Headache, nausea, fatigue and chills. About 8 hours she took medicine and fell asleep. She said she was just overall uncomfortable and doesn?t want to get her 2nd dose.
I receive the vaccine in the afternoon and in the evening I started my menstrual cycle and it is extremely heavy and it has been going on for nearly a month. This has been nonstop and this is completely abnormal for me. I typically have my period for maybe 4 to 5 days.
Information has been received from a health professional concerning a patient (19 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Moderna covid-19 vaccine EUA  Flu symptoms - Fever, chills, aches, nausea, headaches - mild fever started first day, more and other symptoms started second day 2/20 - Rash on neck, pinkness and swelling on left arm below injection site
Chronic chest pain which continues as of 11/20/2021 which was the last contact I had with this patient. She was seen by a cardiologist who ruled out myocarditis.
2nd shot, I got inflammation, extremely sore redness in a 2.5in. diameter, swelling, hot to the touch, for 3 days so far. Motrin did not help the pain.
Patient received a vaccine that was 17 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received a vaccine that was 17 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received a vaccine that was 17 years old). On 06-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received a vaccine that was 17 years old) had resolved.        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.   No relevant concomitant medications were reported.  No treatment information was reported.
This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 72-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 5th January 2007).  On 20th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and influenza-like symptoms. On an unknown date, the outcome of the chills and influenza-like symptoms were unknown. The reporter considered the chills and influenza-like symptoms to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 71 or 72 years. The patient was a hospital employee. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. Additionally this case was linked with case US2018GSK117734, reported by the same reporter the same patient (for 2nd dose). The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Previously diagnosed with COVID 19 11/7/2020  and had a mild residual cough that was improving and almost completely resolved. Post vaccine this cough recurred. The presentation and frequency increased and was similar to that of when I was actively infected. This cough has worsened over the days following the vaccine.
This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced soreness in arm since the day she received the vaccine, date unspecified, until the time of the report. The reporter stated that they understand that soreness is not the common side effect of the vaccine but still wanted to know if this was okay or if there was a need to report further to the buyer. The outcome of the event was unknown. Information on the batch and lot numbers has been requested.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 7/7/2021 ASCENDING THORACIC AORTIC ANEURYSM ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/16/2021 ASCENDING THORACIC AORTIC ANEURYSM HYPOXIA 8/17/2021 ASCENDING THORACIC AORTIC ANEURYSM ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 7/7/2021 BIPOLAR 1 DISORDER, MANIC EPISODE, SEVERE W PSYCHOTIC FEATURES ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/16/2021 BIPOLAR 1 DISORDER, MANIC EPISODE, SEVERE W PSYCHOTIC FEATURES HYPOXIA 8/17/2021 BIPOLAR 1 DISORDER, MANIC EPISODE, SEVERE W PSYCHOTIC FEATURES ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 7/7/2021 RIGHT BIMALLEOLAR FX DISPL INIT ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/16/2021 RIGHT BIMALLEOLAR FX DISPL INIT HYPOXIA 8/17/2021 RIGHT BIMALLEOLAR FX DISPL INIT ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 7/7/2021 HX OF EMERGENCE DELIRIUM ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/16/2021 HX OF EMERGENCE DELIRIUM HYPOXIA 8/17/2021 HX OF EMERGENCE DELIRIUM ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 7/7/2021 ALTERED MENTAL STATUS, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/16/2021 ALTERED MENTAL STATUS, UNSPECIFIED HYPOXIA 8/17/2021 ALTERED MENTAL STATUS, UNSPECIFIED ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 7/7/2021 ASCENDING THORACIC AORTIC ANEURYSM ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/16/2021 ASCENDING THORACIC AORTIC ANEURYSM HYPOXIA 8/17/2021 ASCENDING THORACIC AORTIC ANEURYSM
Postherpetic neuralgia on stomach; Flared up of chronic dermatitis; This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included post herpetic neuralgia (had postherpetic neuralgia off and on). Previously administered products included zostavax with an associated reaction of herpes zoster (received Zostavax in 2015). Concurrent medical conditions included dermatitis (chronic dermatitis).   In October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several weeks after receiving Shingrix, the patient experienced post herpetic neuralgia and dermatitis flare-up. On an unknown date, the outcome of the post herpetic neuralgia was not recovered/not resolved and the outcome of the dermatitis flare-up was recovering/resolving.   It was unknown if the reporter considered the post herpetic neuralgia and dermatitis flare-up to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received a dose of Shingrix vaccine into the left arm and a few weeks later she experienced post-herpetic neuralgia on the right side of her stomach that was still present. The patient also had chronic dermatitis that flared up less than 6 months after having her first Shingrix vaccine (currently in remission). The patient was calling to ask if it was okay to go ahead with her second vaccine. The patient was referred to health care professional. The reporter did not consent to follow-up.
Soft tissue infection; Still having problems using his arm; Elbow was huge and swollen, moved up towards the injection site; Rendered elbow immobile; A spontaneous report was received from a consumer (patient), concerning himself, a 76 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced soft tissue infection, knot under the skin below the elbow which has increased in size (soft tissue swelling), elbow was huge and swollen, moved up towards the injection site (joint swelling), still having problems using his arm (vaccination site movement impairment), area under his elbow was huge and swollen/moved towards injection site (joint swelling), and rendered elbow immobile (joint disorder).  The patient's medical history was not reported. Concomitant medications reported were unspecified blood thinners, unknown medications for heart and high blood pressure.  On 27 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscular in upper right arm for prophylaxis of COVID-19 infection.  The consumer stated that the events started from 30 Jan 2021. He noticed a knot under the skin below his elbow. The patient stated that he rubbed alcohol on the injection site in the spot on his elbow to see if it would help. The next morning, on 31 Jan 2021, the area under his elbow has increased in size, was huge and swollen, rendered elbow muscle. It had moved up towards the injection site and was about five inches long by two-three inches long. The consumer stated that he had met with urgent care via video and they think that it could be in the lymph nodes. The consumer stated that the doctor wrote him a prescription for an antibiotic to treat a soft tissue infection, but he has not picked it up yet. The consumer stated he was still having problems using his arm. Treatment medications included was ibuprofen, acetaminophen, alcohol, ice packs and hot packs.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of events, soft tissue infection, knot under the skin below the elbow which has increased in size, elbow was huge and swollen, moved up towards the injection site, still having problems using his arm, area under his elbow was huge and swollen/moved towards injection site, and rendered elbow immobile were considered as not resolved.; 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.
Soreness at injection site but also having general weakness in both arms and both legs. A simple task of brushing teeth or hair makes it seem like I am lifting weights for about an hour. Energy level decreasing but cannot sleep due to restlessness and muscle soreness. Started on date I gave and have continued since with no sign of stopping
Patient hasn't received 2nd dose yet and it's been past 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient hasn't received 2nd dose yet and it's been past 42 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient hasn't received 2nd dose yet and it's been past 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient hasn't received 2nd dose yet and it's been past 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported. No treatment medication was not reported  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient stated  that she did not experienced an adverse events from the vaccine.
Tingling at injection site immediately after recieving vaccination.   Numbness in arm at injection site at ~1hr after vaccination.  Numbness spread to upper arm (shoulder area) at ~3hrs after injection.   Numbness spread to entire upper arm (shoulder to elbow) within ~14hrs after injection.    Numbness resolved after 24hrs.
first booster at the end of October last year Caller was due for second booster but ended up getting the pneumonia vaccine and had a pretty bad reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (first booster at the end of October last year Caller was due for second booster but ended up getting the pneumonia vaccine and had a pretty bad reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE for an unknown indication.    No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and dose of PNEUMOCOCCAL VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (first booster at the end of October last year Caller was due for second booster but ended up getting the pneumonia vaccine and had a pretty bad reaction). At the time of the report, IMMUNISATION REACTION (first booster at the end of October last year Caller was due for second booster but ended up getting the pneumonia vaccine and had a pretty bad reaction) outcome was unknown.            No concomitant drug reported. No treatment information was provided by the reporter.
headache after 1st dose; chills after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after 1st dose) and CHILLS (chills after 1st dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache after 1st dose) and CHILLS (chills after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache after 1st dose) and CHILLS (chills after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   This case was linked to MOD-2021-028922 (Patient Link).
20 month old baby was administered Kinrix on Aug 7th 2023. It was supposed to be  the 2nd dose of DTAP and  IPV series; Kinrix was supposed to be  the 2nd dose of DTAP and  IPV series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 20-month-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22-MAR-2024) for prophylaxis.   On 07-AUG-2023, the patient received Kinrix. On 07-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 20 month old baby was administered Kinrix on Aug 7th 2023. It was supposed to be  the 2nd dose of DTAP and  IPV series) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was supposed to be  the 2nd dose of DTAP and  IPV series).  The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 12-Sept-2023 Nurse reported that this was supposed to be the 2nd dose of DTAP and IPV series. The reporter consented to follow-up. The patient received a dose of Kinrix as 2nd dose of DTAP and IPV series at an inappropriate age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyway. The patient stated that, Shingles vaccine was not absolutely preventable and stated, hope you did not get it. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Within 60 seconds of immunization, patient complained of feeling hot all over, then became profoundly weak and complained of severe low back pain. On exam, she was tachycardic, then developed redness and swelling of both ocular and oral mucosa as well as diffuse red rash. She was administered diphenhydramine 50mg orally, acetaminophen 1000mg orally, and epinephrine 1mg IM with complete resolution of her symptoms over the next 5-10 minutes.
W/in 18 hrs p/immun, mom reported that her son experienced vomiting & fever; then 1 hr later developed hives; w/in 3 days child asymptomatic;
Information has been received from a consumer concerning her 75 year old husband with no known allergies or pertinent medical history who on 12-JUN-2007 was vaccinated SC with a 0.65 ml one time dose of Zostavax (Oka/Merck).  Concomitant therapy included ezetimibe (MSD) and FLOMAX.  About a week after the vaccination on approximately 19-JUN-2007 the patient developed gout in his feet and it " keeps getting worse".  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Intussusception - reduced by air contrast enema (did not require surgery). Had vomiting/blood in stool - sent to hospital for treatment.  11/7/08 Reviewed hospital medical records of 9/2-9/3/2008. FINAL DX: Intussusception Records reveal patient experienced vomiting & bloody stools x 1 day.  Seen by PCP & was to be sleepy & lethargic. Admitted for observation s/p reduction of IS.  Progressed well & d/c to home.
tiredness; headache; muscle aches; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283), via an unspecified route of administration on 11Jan2021 at 11:00 AM at a single dose on the left arm for COVID-19 immunization.  Medical history included Barret's esophagus and glaucoma both from an unknown date and unknown if ongoing. Concomitant medication included dorzolamide;timolol maleate (manufacturer unknown) and pantoprazole (manufacturer unknown).  The patient did not have COVID-19 prior to vaccination. The patient did not have other vaccines in four weeks. The patient previously took codeine and experienced allergies. The patient experienced tiredness, headache, muscle aches, nausea and dizziness all on 12Jan2021 at 03:30 PM. The patient did not receive any treatment for the events. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
seasonal allergies; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEASONAL ALLERGY (non-serious), outcome "unknown", described as "seasonal allergies".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
- Within a few hours of vaccination, a headache was noted, a fever was developing, and the upper right arm/shoulder was painful to touch and abduction.  Gentle massage and movement of the arm/shoulder every 15-20 minutes was done to accelerate healing.  200mg of Aleve was taken at bedtime.  The headache, fever, and pain resolved after 72 hours. - 19 hours post vaccination, a fever of 100.0 F was observed.  200mg of Motrin was taken.  The fever resolved after 72 hours. - 24 hours post vaccination, pain, redness, and swelling was noted in the lymph nodes of the right armpit and underneath the right arm.  The pain and swelling resolved after 48 hours. - General fatigue was observed and resolved along with the other symptoms.