chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next day I had a swollen lump under my arm. It was the same side as the vaccine. There was a lot of pressure there and it got big like an eyeball. I generally felt unwell the next day so I didn't go to work. I have never had a lump like that before and it hurt every time I moved my arm. It never went away but the swelling and the pain went away but with the subsequent vaccinations, it grew larger and never went away. I thought it was a swollen lymph node but it turned out be. It exacerbated after the 2nd vaccine. It got smaller and less painful and never went away. After the 3rd vaccination, it did the same thing as the 2nd one. It was swollen and felt more sore. It remained pretty large after that one. It seemed like it continued to grow. The swelling went down but the shape changed. The doctor confirmed it was not a lymph node. It started to grow into the tissue. It was now in an oblong shape and felt like it was connected to tissue. I had a mammogram last fall and they did extensive imaging of that lump and also saw a breast lump. They Biopsied the breast lump and the additional lump and diagnosed it as a Lipoma. Lipoma generally stays under the skin but this one was growing into the tissue under my arm. I think I needed to have it re-evaluated as it has started to feel funny again. The surgery was performed to extract and there was also a lumpectomy performed at the same time.
Patient started feeling warm in the evening of the immunization was given, the area around turned red and swollen. Next morning the area from elbow up was swollen, beet red, burning, painful to touch. The redness, burning, swelling lasted several days (approximately one week). On 1/25/18 patient got rash on the same upper arm, that was later diagnosed by he physician as shingles. Patient was prescribed and is currently taking Zovirax 800 #14 1bid
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 64-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. It was reported that vials had not undergone any temperature excursion.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU received with non significant information.
A report has been received from a Study Investigator concerning a 21 year old, female subject, Height: 162.0 Centimeters; Weight: 44.4 Kilograms, enrolled in study therapy started on 03-Jun-2013 for Influenza vaccine. The patient experienced pregnancy which started on 05-Sep-2013. Study product therapy was discontinued on 03-Jun-2013. The patient recovered from the event of pregnancy on 29-Oct-2013. The event(s) occurred during the Follow-up period of this study. The outcome of the pregnancy was reported to be an Elective abortion on 29-Oct-2013. The report was considered to be non-serious. The Study was unblinded on 07-Mar-2014.
Information has been received from a consumer concerning a male child who was vaccinated with a dose of MMR II on an unspecified date. Subsequently the patient lost his hearing on an unspecified date. The outcome was not reported. Upon internal review, lost hearing was determined to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Patient had red cheeks similar looking to "slapped cheek, (Hands, foot, mouth disease)?" Rash on all limbs. Small petechiae bumps.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt. fainted a few minutes after he received the vaccine ~12:30pm. The pharmacist and family members attended to him until 911 emergency responders arrived. When he woke up, he told them he had not eaten, or had anything to drink all day. He also stated he had fainted in the past when receiving previous vaccinations.  He declined to be brought to the hospital, and went home w/ his family. Pharmacist checked up on him at the end of the day and he stated he was feeling fine.
Severe headache developed 7 hours after vaccination - resolved next day. Fever developed 7 hours after vaccination - resolved next day. Prior low/mild tinnitus worsened between 12-24 hours after injection - has not resolved/returned to baseline level.
COULD NOT LIFT ARM ABOVE SHOULDER WITHOUT PAIN SHOOTING THROUGH SPOT; LOCALIZED MODERATE TO SEVERE ARM PAIN ON DAY 17 AFTER RECEIVING THE SHOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced could not lift arm above shoulder without pain shooting through spot, and localized moderate to severe arm pain on day 17 after receiving the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from localized moderate to severe arm pain on day 17 after receiving the shot, and could not lift arm above shoulder without pain shooting through spot. This report was non-serious.
1-st day hand numb and dizzy at the end of the day.  I had to take aspirin which only decreased the symptoms The next three-five days so dizzy that I was nausaed and threw up.  First two days I had trouble holding down food because I was dizzy and nauseated.  By Friday at time my heart felt like it was racing but when I checked my heart rate was normal.  I also felt hot and upper chest muscles to the left hurt.  By Saturday evening I felt really sick.  My heart felt like it was racing but when I checked it was normal.  I then checked my blood pressure it was 120 and it is never high.  I then two hours later and it was 108 and checked an hour later it was 102.  I didn't that if it fell under 100 I would go to the hospital but it didn't.  On Monday, I was still vomiting and trying to get through my Zoom class.  I refused to go to the hospital  because I am afraid to catch COVID there.  By the end of the week, I was feeling better but still slightly dizzy and nauseous.  When I took the second vaccine, my symptoms were not as severe as after the first shot.  I was still dizzy and nauseous but not so sick to vomit or to stay in bed all day.  I still felt my heart racing but this time I didn't check my blood pressure. Also after the second vaccine. the symptoms didn't last as long (not more than seven days).
Weakness, dizziness, shortness of breath,  and brief moments of loss of consciousness.
Individual described lip and face redness and tongue tingling.  She stated it felt as though her throat was swelling.
Systemic: Dizziness / Lightheadness-Medium, Systemic: patient said her ears felt like she was under water-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: within 5 minutes of vaccination, pt said she felt like she was going to pass out, her vision was blurry/weird & her ears felt like she was under water. She was sweating & felt clammy and I asked if she ate/drank today and she said she had about 2 hours prior. I helped her to floor % put her in recovery position. after 2 minutes pt stated she was starting to feel better. After 10 minutes patient was able to get off the floor and back into a chair. Had her drink gatorade, her bp was normal.
Itching and redness in different locations, like her shoulder, lower back, side, elbow, arm and rib cage; Itching and redness in different locations, like her shoulder, lower back, side, elbow, arm and rib cage; random patches of itching and redness in different locations; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ZW0187), dose 1 via an unspecified route of administration, administered in right arm on 01Jul2021 (at the age of 48-years-old) at a single dose for covid-19 immunization.  Medical history included brain operation from 2017 for cysts on her brain, the last was in 2017.  There were no concomitant medications.  The patient experienced patches and  itching 1-2 days after her first dose. Patient reported it was random patches of itching and redness in different locations, like shoulder, lower back, side, elbow, and arm. She stated it was random, and little patches were also around her rib cage . Patient said it lasted for a couple weeks after she had her first vaccine on 01Jul2021. Events were treated with calamine lotion. The outcome of the events was reported as recovered in Jul2021.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 91-year-old female patient who received SHINGRIX for prophylaxis.  On 30th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2019, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis (serious criteria GSK medically significant), extensive swelling of limb, injection site warmth and injection site pain. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the injection site cellulitis, extensive swelling of vaccinated limb, injection site warmth and injection site pain were unknown. It was unknown if the reporter considered the injection site cellulitis, extensive swelling of vaccinated limb, injection site warmth and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left deltoid. Last night of the reporting day, the patient woke up with a swollen arm around the injection site area. The patient drove herself to the emergency room and she was diagnosed with possible cellulitis and sent home with prescription for antibiotics. The batient's blood count (CBC) was normal and patient did not have a fever. The repojrter described area of swelling as being 3 x 5 inches in size, raised and warm to the touch and painful.
Redness, swelling, itching, headache, and bruising at the injection site.
DID NOT TOOK DOSES ON TIME; A spontaneous case report was received from a nurse on 17-Oct-2019 for four consumers.  Based on the information obtained from the nurse four individual case safety report PVX201910-000804 (PVX2019-2599; first consumer), PVX201910-000805 (PVX2019-2600; second consumer), PVX201910-000806 (PVX2019-2601; third consumer), and PVX201910-000807 (PVX2019-2602; fourth consumer) were created and cross-linked in the database.  This case (PVX2019-2601) described a consumer who "did not take doses on time" (PT: Product dose omission), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif, and then did not take the remaining doses for several days.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take doses on time" was considered as not applicable.  ; Sender's Comments: Company's Comment: The causality of the event "did not take doses on time" was considered as not applicable. US-PaxVax Berna GmbH-PVX201910-000804:
nows the vaccine expired in January 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (expiry date JAN-2023) for prophylaxis.   On 12-JUL-2023, the patient received Havrix. On 12-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: nows the vaccine expired in January 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 Pharmacist did not have vaccine lot number at the time of reporting, but knows the vaccine expired in January 2023. Reporter did not have any patient details available at time of reporting. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received expired Havrix, which led to expired vaccine used. This case had been linked with US2023101230, reported by same reporter.
The patient was administered the pediatric Pfizer vaccine without diluting it. At this time, the parent was unable to be reached. However, will try to call until we get a hold of the parent.
my arm start to pain after 7 days of second dose and its worse; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (my arm start to pain after 7 days of second dose and its worse) 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 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. On an unknown date, the patient experienced MYALGIA (my arm start to pain after 7 days of second dose and its worse). At the time of the report, MYALGIA (my arm start to pain after 7 days of second dose and its worse) outcome was unknown. Not Provided          No treatment medications were provided. No concomitant medications were reported.
pruritic rash began 31MAY98 in AM;began to not feel well that evening, felt dizzy & poss lost consciousness;apparently went to a dermatologist & was placed on oral steroids w/improvement;
Loss of appetite; Coughing; High fever (104); chills for over a day; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EW0175) via an unspecified route of administration in the left arm on 02May2021 at 11:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02May2021 at 16:00, the patient experienced high fever (104 degrees), chills, loss of appetite, fatigue and coughing. The patient underwent lab tests and procedures which included body temperature on 02May2021 and resulted as 104 degrees (units unspecified). The clinical outcome of the events fever, chills, loss of appetite, fatigue and coughing was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
During mass flu clinic for adults and children, a child under 18 years received 1 dose of "FLUARIX" meant for adults 18 years and above in error. No known adverse events. Follow-up - No adverse event occurred.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 25-JAN-2016 the patient was administered improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017) (dosage, strength and route unknown) (temperature 30 degree Fahrenheit, time frame 4 hours). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 26AUG97 & devel a rash on rt side of body;7 days later devel T101 & 5 welts around inj site gone in 1-2 days;
7 patients received a Moderna vaccine past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On January 26 2022 vial was initially stored in the refrigerator No concomitant medication information provided. No treatment medication information provided.
Aside from the fever, chills on Sunday May 16th my arm at the sight of the injections became itchy. As of today May 20 my arm is extremely itchy and red.
Case number PHEH2016US023413 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 31 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the right arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Lower back ache that will not go away. On the lower left side and runs into her thigh and leg; Lower back ache that will not go away. On the lower left side and runs into her thigh and leg; Sore arm for a day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Lower back ache that will not go away. On the lower left side and runs into her thigh and leg), PAIN IN EXTREMITY (Lower back ache that will not go away. On the lower left side and runs into her thigh and leg) and VACCINATION SITE PAIN (Sore arm for a day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BACK PAIN (Lower back ache that will not go away. On the lower left side and runs into her thigh and leg), PAIN IN EXTREMITY (Lower back ache that will not go away. On the lower left side and runs into her thigh and leg) and VACCINATION SITE PAIN (Sore arm for a day). On 04-Feb-2021, VACCINATION SITE PAIN (Sore arm for a day) had resolved. At the time of the report, BACK PAIN (Lower back ache that will not go away. On the lower left side and runs into her thigh and leg) and PAIN IN EXTREMITY (Lower back ache that will not go away. On the lower left side and runs into her thigh and leg) had not 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.   Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Within 4 hrs of vaccine, had 5 hrs incessant crying, inconsolability.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 12/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Heat, redness, swelling, pruritus at injection site; nausea, loss of appetite, malaise
Fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 039K20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PYREXIA (Fever of 103). At the time of the report, PYREXIA (Fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Body temperature: 103 (High) fever of 103.         No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Occipital Neuralgia (constant intense headache for 12 months, barely managed by pain medication, not impacted by migraine drugs, eventually ended only by Radio Frequency Ablation of the effected nerves in the spine done 12/7/22 and 12/21/22, one procedure for each side.  During 12 months of pain, hugely debilitating, mostly unable to work.
Patient received moderna as her second shot at Meijer pharmacy, however, after we gave the shot we realized she had already gotten one dose on Pfizer on 4-1-21 from a Walgreens pharmacy.
Tunnel Vision  - This happened at the same time as nausea, vomiting, muscle ache and pain, dizziness.  She woke up around 4:00 AM with the symptoms. Vision improved and was back to normal.  Other symptoms continued for 2.5 days.
Headache, Myalgia, Fever, CHILLS Narrative: STAYED HOME FROM WORK