chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles, had the two Shingrix doses/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 4th September 2022, unknown after receiving Shingrix and Shingrix, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). The patient was treated with valaciclovir (Valacyclovir) and gabapentin. 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the on Sunday 04 September 2022 patient was diagnosed with shingles. The patient was prescribed Valacyclovir and gabapentin as treatment. The patient went to pharmacy to get the medications the pharmacist recommended that patient should get the Shingrix vaccine after recovered, patient told him that he already received two doses. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Difficulty breathing; Growling sensation in chest; Heart palpitations; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Growling sensation in chest) and PALPITATIONS (Heart palpitations) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Chemical injury (Toxic Injury from her previous employment) in 1999. Concurrent medical conditions included Sleep apnea (previous medical history). Concomitant products included VITAMIN E NOS and CALCIUM for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FATIGUE (Fatigue), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Growling sensation in chest) and PALPITATIONS (Heart palpitations). The patient was treated with VITAMIN D [VITAMIN D NOS] ongoing since an unknown date at a dose of UNK dosage form and CLONIDINE in February 2021 for Adverse event, at a dose of UNK dosage form. On 06-Feb-2021, FATIGUE (Fatigue), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Growling sensation in chest) and PALPITATIONS (Heart palpitations) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was using CPAPA machine. The patient reported that those symptoms caused her to go to the Emergency Room on 05-FEB-2021.
On 02/23/2021 around 8:00 AM, I started having shivers. Around 9 AM that same day, the shivers had increased. I also had a headache and felt warm, and had a fever of 101-102. Those symptoms lasted until that evening because I had went to sleep around 8:00 PM. By the third day 02/26/2021 I woke up feeling fine with no symptoms. Tylenol was taken for these symptoms and no medical treatment was received.
p/vax pt exp lt side pain to neck; shoulder area; burning sensation; remained steady & worsening by 8/23; improving w/use of advil & heat
Pt developed a RT Leg DVT  Deep Vein Thrombosis and Pulmonary emobolus.   Started haveing symptoms of dyspnea. ,  low oxygen saturations in the 80s and RT pleuritic chest pains  one week after getting the shot.  He had never had  a DVT or PE before.   Was seen in Emergency on 03-23-2021  .  He was admited on 02-23-2021. Started on anticoagulation and went to the  cath lab to have intraarterial administration of  TPA in pulmonary arteries.
Immediate reaction at time of injection, felt a sense of nerve reaction thru entire body, similar to contrast injection b/4 CT scans. Within a minute, sleepy, fatigued, muscles in neck, shoulders, back became achy. Felt feverish. Ended up with a temp of 100.3 for 24 hours. During the night, awoke hot and sweaty, later awoke freezing cold and shaking from head to toe. Felt ill for 24 hours. NSAID and TYLENOL didn't help.
day blisters on mouth; night sweats; vomiting; shakes; headache; muscle aches; nausea; chills; 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 BLISTER (day blisters on mouth), NIGHT SWEATS (night sweats), VOMITING (vomiting), TREMOR (shakes) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced VOMITING (vomiting), TREMOR (shakes), HEADACHE (headache), MYALGIA (muscle aches), NAUSEA (nausea) and CHILLS (chills). On 22-May-2021, the patient experienced BLISTER (day blisters on mouth) and NIGHT SWEATS (night sweats). At the time of the report, BLISTER (day blisters on mouth), NIGHT SWEATS (night sweats), VOMITING (vomiting), TREMOR (shakes), HEADACHE (headache), MYALGIA (muscle aches), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported.    Reporter did not allow further contact
FINGERS NUMB; SHAKING LIKE A RABBIT; This spontaneous report received from a consumer concerned a female of unspecified age. 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, 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 27-JUN-2021, the subject experienced fingers numb. On 27-JUN-2021, the subject experienced shaking like a rabbit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fingers numb, and shaking like a rabbit. This report was non-serious. This case, from the same reporter is linked to 20210660727.
Sore Arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter. A laboratorian called regarding a leukemia patient who reportedly did not present antibodies for the COVID-19 virus upon undergoing an antibody test   Reporter did not allow further contact
He got his vaccine, the next morning when he woke up and his mouth was dry and his lips were real dry.  He has had it ever since.  His tongue hurt a little bit and his mouth hurt.  He didn't have any problems prior to this.  His wife had a similar problem with her mouth which only lasted a few days, and he is still having problems.  He has some sores in his mouth and a little one on  his tongue, and dryness of his lips especially.  He went to the doctor for a yearly check up and mentioned it to her and she recommended the shot a while back, told her that he got the shot and told her about the mouth issues, and she said she had not heard of that before and could not think of ay prescription or anything to help his condition.  He has not gone back to check with her.
Started diarrhea in the evening of 03//22 and continued diarrhea the next few days. On 03/24, diarrhea became sticky and the color turned dark;  I started to feel dizzy, On the night, I fell on the floor when getting up from the toilet; I did not remember how I got back to the bed. I was sent to the ER the next day and diagnosed with GI bleeding. Tests showed I had low PLT counting. I received a transfusion. I had an endoscopy on 03/27, which showed I had duodenal bulb ulcer which was nonbleeding with pigmented spots at the base. Upon my insistence, I was discharged on 03/28 after another blood transfusion.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 20-MAY-2016, the patient was vaccinated with improperly stored dose of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
hives appeared all over my body; itched like crazy, went to the ER; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were unknown.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had the vaccine and hives appeared all over his/her body.  It had been itched like crazy and had went to the Emergency Room (ER).  The reporter stated that he/she had remembered when his/her friends had shingles. The pain and suffering they went through, it sounded to be unbearable. He/She never wanted to experience that kind of pain, which had made him/her wanted to learn more about this painful, blistering rash.  He/She had educated himself/herself about the risk for developing shingles, especially for people 50 years or older, and what she could do for the prevention. Additional supportive information: Follow-up would not possible as no contact details were available.
Lymphatic swelling on same side as injection site 7 days after vaccine received,  rash around injection site 11 days after vaccine received
HEART FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned an 18 year old male of an unspecified race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart failure. It was reported as "my supervisor's daughter had her 18 year old best friend die of heart failure after his vaccine" On an unspecified date, the patient died from heart failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221137274.; Sender's Comments: V0: 20221137297- Heart failure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: HEART FAILURE
Redness (6cm x 3cm), warmth, pain, swelling at injection site.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
RASH ON FACR LOWER LEFT QUADRANT OF FACE---AND VALTREX WAS GIVEN.
Within the first 5-10 minutes, heart began racing for several minutes. I sat and drank lots of water and pharmacist took my blood pressure which was over 200 (systolic) and over 100 (diastolic).  Eventually heart slowed and began to pound like a drum beating. My BP would not subside and I was asked if I wanted an ambulance. My wife was there so I opted to have her take me straight to medical center.  In route, I started having uncontrollable muscle spasms throughout my body (arms, legs, chest, jaw, etc.)  I was checked in for observation and my BP was still high at 212/95.  I was monitored and after 1 1/2-2 hours the muscle spasms began to attenuate.  Although my blood pressure remained high at 199/93, the Dr.
son didn't receive second shot / Beyond 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (son didn't receive second shot / Beyond 35 days for 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (son didn't receive second shot / Beyond 35 days for 2nd dose). On 21-May-2021, PRODUCT DOSE OMISSION ISSUE (son didn't receive second shot / Beyond 35 days for 2nd dose) had resolved.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up received , Product lot number added.
Zostavax (Shingles) 19400UNT  INJ Redness, soreness, swelling and itching. Size of red area is currently 3 1/2" long and 2 1/2" wide on upper arm. Site is very hard from swelling and aches. There is itching as well. Today's date is 9/23/2014.
Fatigue, body aches, night sweats (like menopause), painful under armpits (even on second day), headaches
After patient received the vaccine the patient sat down for 5 minutes before noticing he blacked out for a few seconds.  The patient alerted the staff of the black out.  The patient stated he had an elevated heart rate and that he was sweating.  The pharmacy staff took the patient's blood pressure which was 97/77 mmHg.  911 was called and the paramedics arrived shortly.  The paramedics took the patient blood pressure and screened them and ask if the patient would like to seek medical attention.  The patient denied a visit to the emergency room and stated he was feeling much better.
Immediate rash and swelling in groin and upper extremities .  Swollen lymph nodes within two weeks.  Lymphoma diagnosis July
For at least 20 hours: Fatigue, woozy/clouded head, slow to process thoughts, fever ranging from 99.5 F - 101 F, lack of appetite Frequently during  the above 20 hours: "tingly" nerves across body, "swimming" sensation when turning head with delay in focusing, headache For hours 16-18 after vaccination: runny nose
Little bruising [from first dose]; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Little bruising [from first dose]) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Little bruising [from first dose]). At the time of the report, VACCINATION SITE BRUISING (Little bruising [from first dose]) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient took the second shot on 16-sep-2021 with lot number 037F21A, taken in left arm. patient states that her HCP is new, but she has an appointment coming up on 28Sep2021.  Treatment information was not provided. concomitant medication were not provided.   This case was linked to MOD-2021-324943.
Nurse administered 2nd dose of MMR earlier than recommended age.  AE reviewed after vaccine was administered and parent informed to monitor for symptoms. Currently no AEs reported by parent.
High fever 102 + , body aches, severe joint aches, swollen and peeling lips, headache, heart palpitations, chills and sweating. This lasted 3 days.  For these days I stayed home, kept hydrated and took tylenol and ibuprofen.  I thought the pfizer booster may have caused this severe reaction.  I am reporting this now, since I got my 4th booster recently, 11 months later and had the same reaction, but worse.  I changed from Pfizer to Moderna for my last booster.   I can not endure a severe reaction like this again.  There must be a new ingredient in the most recent boosters causing this severe allergic reaction.  I did not have a reaction to my first two Covid Pfizer vaccines that were not mRNA.  From reading online, I am guessing mRNA or RNA is the culprit.
Pt was fine after Immunization. Fainted in aisle. Was given orange juice, recovered pulse low, clammy skin, cold skin. Recovered and left here.
swelling of the lymph nodes; right armpit swelling, though, that was spreading out; her skin under her right armpit is "falling out" from under her right arm like a fat woman's; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0175, NDC number/Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 06May2021 17:00 at the of 53 years old as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included had Covid-19 from 2020 to 2020 (Had COVID-19 infection back in October-November). The patient asked if she needed to get the second COVID-19 Vaccine dose since she had the COVID-19 Virus in 2020. Family Medical History Relevant to AE(s) not provided. Concomitant medications were not reported. The patient did not receive any other vaccines on same Date of the Pfizer Suspect. The patient did not receive any other vaccine in 4 weeks prior to Vaccinations. On 07May2021 the patient experienced swelling of the lymph nodes, right armpit swelling, though, that was spreading out, and her skin under her right armpit was falling out from under her right arm like a fat woman. It was reported that, the patient stated she had swelling of her lymph nodes. The patient stated she had the COVID-19 virus in Oct2020 or Nov2020. The transferring agent stated the patient asked if she needed to get the second COVID-19 Vaccine dose since she had the COVID-19 Virus in 2020. The transferring agent stated she shared some information about the COVID-19 Vaccine with the caller. Reviewed and clarified the transferring agent's report details with the caller. Clarified she had swelling in her right armpit lymph nodes that she noticed on Friday morning (07May2021). For treatment reported she was taking Ibuprofen and icing her right armpit. She said she was taking 3-200mg Ibuprofen tablets since her right armpit lymph node swelling started. She said she didn't take any Ibuprofen today, though. She said she was at work, and did not have the Ibuprofen 200mg tablet NDC, Lot, and Expiration Date. Reported the swelling in her armpit right lymph nodes improved. She said she now had right armpit swelling, though, that was spreading out. She said her right armpit swelling did not look pleasant. She said her skin under her right armpit is falling out from under her right arm like a fat woman's. She said the difference in size between her right armpit and her left armpit was obvious. The adverse events did not result in Emergency Room nor Physician Office visit. She only called Pfizer to see if she should not take the second COVID-19 Vaccine. The patient did not undergo any relevant test. The patient received treatment for the adverse events. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
This initial spontaneous report was received from a physician referring to a 4 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015 at 10:10 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Patient had decreased range of motion, left arm felt numb, and developed heavy breathing with chest discomfort.
sinus infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunization. The following information was reported: SINUSITIS (non-serious) with onset 02Apr2021, outcome "unknown", described as "sinus infection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cranky, reduced appetite, fever (under 102 F), non-itchy rash over body & face.