chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the shot and I got them/ suspected vaccination failure; had the shot and I got them; 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 reporter was patient. The age at vaccination was not reported. The patient had the shingles shot and experienced shingles so bad and they still reoccur so year. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Tiredness, weak, fever, coughing for about two months(bronchial cough), shake on the inside of body
Presented to ED with SOB/ lethargy; + covid test at home; Initially on 4 LPM O2; Also found to have UTI; CXR: No PNA Labs: D-Dimer 1.64; CRP 8.22 Ferritin 278.1; TX: Maxipime, Decadron, Vit C, zithromax, Rocephin, Vit D3, Lovenox, Solu-medrol, singulair, zinc; O2 back to room air at d/c; responded very well to steroids and antibiotics; weaned off of oxygen to room air; did not require remdesivir. Urine culture is positive for ESBL E coli UTI. Patient is cleared to be discharged home on azithromycin, Bactrim and Medrol Dosepak.
Father reports several hours after receiving vaccines, child began having uncontrolled twitching to extremities intermittently over several hours in addition to comprehensible but speech unrelated to topic of discussion, altered attention, lack of eye contact and hallucination of white hallway. Symptoms reportedly continued through morning and mid-day after vaccines. No loss of consciousness noted. Symptoms resolved by afternoon of following day.
HEADACHES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) 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 patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headaches was not reported. This report was non-serious.
Patient received Vaccine Booster (Dose 3) which had hindsight was expired past 10 weeks in refrigerator temperatures.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Flu vaccine for prophylaxis. The patient's past medical history included lung cancer (surgery to remove lung cancer, left lower lobe was removed). Concurrent medical conditions included emphysema and stent placement. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness in her arms which lasted for approximately one week. Additional information was not reported. The patient consented to follow up with her physician and herself. This case has been linked with the case US2018218491, reported by the same reporter for the same patient.
Received 0.5ml MMR vaccine diluted with vial (~0.7ml) sterile diluent. Approx. 5 minutes post receiving vac. pt c/o "tingling sensation shoulders to head." Given 25mg Benadryl po. After approx 15 minutes, c/o "tingling sensation" spreading from neck down body and c/o tightness at throat. Taken to ER at this time.
Information has been received from a 68 year old male consumer with high cholesterol and no drug reactions/allergies, who on 07-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck). (Lot numbers not reported). Concomitant therapy included simvastatin (manufacturer unknown) and CRESTOR. The patient reported that he experienced moderate to severe left shoulder pain after given the ZOSTAVAX (Merck) vaccine. No lab diagnostics studies were performed. At the time of the report, patient had not recovered. The patient did not seek medical attention. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose on 21st February 2018, experienced chills and lethargy, for tolerance see case US2018GSK111503). On 30th May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills, lethargy and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, lethargy and fever were unknown. It was unknown if the reporter considered the chills, lethargy and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine after lunch. The patient experienced low fever. The patient's symptoms were less severe as compared to the same events which occurred after the first dose of SHINGRIX. The suspect vaccine lot number and expiry date was not available. This case is one of the 5 cases, reported by the same reporter.
pt recvd vax approx 5 mins later, site was red & lt shoulder red; no rash; no SOB or dyspnea; pt watched; DPH given;
Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) had resolved. Not Provided      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.   Concomitant product used was not provided by the reporter.  Treatment information was not reported.   Reporter did not allow further contact
This spontaneous report was received from a physician referring to a 17 year old male patient. Patient's current conditions, medical history, concomitant medications, drug allergies or reactions were not reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 first dose (strength, dose, administration route, anatomical site of injection, lot number and expiration date was not reported) for prophylaxis. On an unspecified date, the patient experienced inflammation of a ligament in his knee (unspecified), it was reported that the patient continued to play sports and tore the ligament in his unspecified knee (ligament rupture), date not provided. Additionally it was reported that on an unspecified date the patient received his second dose of GARDASIL 9 and experienced severe costochondritis of his rib cage and chest wall. The patient saw a health care professional (HCP) although it was unknown if the patient received treatment for the events, if lab diagnostics or studies were performed . At the reporting time, the patient was healthy (recovered). And the reported did not assess the causal relationship between the events ant therapy GARDASIL 9.
After the 3rd dose of the vaccine my Triglycerides increased from 58 on 12/07/2020 to 473 on 11/22/2021 and further increased to 2,089 on 12/02/2022.  I am currently on a no sugar no carbohydrate diet.  Blood work will be repeated
2-3 cm induration/swelling left deltoid area. No erythema/cellulitis.  Complaining of pain with abduction.
This case was reported by a consumer via other manufacturer and described the occurrence of injection site swelling in a 68-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included dupilumab (Dupixent). On 14th December 2018, the patient received the 2nd dose of SHINGRIX. On 14th December 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, intestinal cramps and injection site erythema. On 15th December 2018, the patient experienced nausea, abdominal tenderness, exhaustion and diarrhea. The patient was treated with ice pack (nos). On an unknown date, the outcome of the injection site swelling, injection site pain, nausea, intestinal cramps, abdominal tenderness, exhaustion, diarrhea and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling, injection site pain, nausea, intestinal cramps, abdominal tenderness, exhaustion, diarrhea and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: On 13th December 2018, the patient received Dupixent two injections subcutaneously (SQ) and was due to follow with one injection SQ every other week for allergy induced asthma. The patient received the SHINGRIX vaccine on left arm. On 14th December 2018, immediately described as 2 to 3 hours after the vaccination, the patient began to experience injection site reaction of the left arm characterized with swelling of the left arm, the left arm being sore and had the left arm turning red. On the night of 14th December 2018, less than a day after receiving SHINGRIX, the patient began to experience severe upper intestinal cramps. One day after receiving SHINGRIX, the patient experienced nausea, intestinal cramps, lower and upper abdominal tenderness, diarrhea and exhaustion. There was no treatment for  these events. However, treatment included usage of ice for the injection site reactions on the left arm. No additional information was provided.
patient received 2nd dose of covid 19 Pfizer vaccine on 9/20/2021 - 3 days later presented to ED with crushing chestpain radiating to left arm and jaw accompanied by shortness of breath; admitted to hospital with NSTEMI; of note - patient has brother who had MI at 46 years old
42 days after vaccination, patient was taken to the local ER with right side facial weakness, was dx with a stroke. Family friend called to report.
Headaches starting January 3rd. Nausea and flu-like symptoms starting around January 15th. Low back pain started early January. February 2, patient had one "violent seizure-like episode" with strong involuntary muscle contractions at school. Ambulance was called, patient went to ER. Diagnosed with low potassium. February 3, patient had several more episodes at school. Ambulance was called again, patient went to ER and had several more episodes in the ER, and admitted to hospital. Possible dystonia? Several more episodes in the hospital with total lab and diagnostic test work-up. Discharged February 8 with diagnosis of anxiety. Was given Kepra which took her from 30 seizures a day to 15 a day. Patient taking 500 mg bid. Back pain remains at an 8 which increases to 10 right before an episode. Patient is aware and alert during seizure-like episodes and states they are extremely painful muscular contractions. Has follow-up testing with pediatrician and ob-gyn, and has been referred to specialist.2/27/09-records received-for DOS 2/3-/2/8/09-presented with back spasms after 1 day history of multiple episodes of flexing back and flexing hands foreward and flexing legs backwards with severe pain.  10/8/09 Multiple hospital records, DC summaries, and ER record received.   Service dates: 2/3/09 to 2/8/09. Patient admitted for back spasms. Multiple episodes of flexing of back, flexing of hands forward, and flexing of legs backwards.  LABS and DIAGNOSTICS: EEG - Normal. MRI - WNL.  Service dates: 4/1/09 to 4/5/09. Admitted for worsening of muscle spasms and dystonia which appear to be affecting her breathing.  ER Service date 4/12/09 Patient c/o nightly episodes of spasm-like pain. Spasms of feet, arms, neck amd eyes. Extension of neck, eyes roll back. Head jerking and screaming. Nausea and abdominal discomfort. Depressed. Not attending school. Presented with feet plantar flexed with fully extended legs, slight tremor. Wrists in decorticate position and head turned to left. Speech difficult. Heat intolerance. Admitted to hospital.  Service dates: 4/12/09 to 4/14/09. Admitted for increasing dystonic reactions. Intractable muscle spasms.  ICD-9 Codes: 781.0 Abnormal involuntary movement, 786.09 Dyspnea & respiratory abnormallity, 780.2 Syncope and collapse, 724.8 Symptoms of back.
pt recvd MMR vax 24APR91 & 28APR91 devel generalized pruritic rash;
This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Polyps (polyps in duodenum) in October 2019 and Surgery (bile duct removal by surgery) in October 2019. Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Drug allergy (Aleve allergy), Allergic reaction to analgesics (Codeine allergy), Allergic reaction to analgesics (allergic to Opioids), Cholesterol, Anxiety, Restless leg syndrome, Acid reflux (esophageal), Insomnia, Osteoporosis, and Hypothyroidism. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40) for Acid reflux (esophageal), HYDROXYZINE HYDROCHLORIDE (ATARAX [HYDROXYZINE HYDROCHLORIDE]) for Allergy prophylaxis, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, COLESEVELAM for Cholesterol and Drug therapy, LEVOTHYROXINE for Hypothyroidism, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia, DENOSUMAB (PROLIA) for Osteoporosis, CLONIDINE for Restless leg syndrome. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and PAIN IN EXTREMITY (sore arm). At the time of the report, RASH (Rash) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Patient reported that there were no changes in medical history after vaccination. It was reported because of polyps in duodenum patient had a surgery in Oct-2019. Patient has completed the first booster dose. No treatment information was reported. This case was linked to MOD-2022-553214, MOD-2022-553295, MOD-2022-553296 (Patient Link).
Rash around rib cage, looks like a burn; Very painful (rash); This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash and pain. On an unknown date, the outcome of the rash and pain were recovered/resolved.   It was unknown if the reporter considered the rash and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR134285   Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got his/her shots. The patient had a rash around his/her rib gage once and awhile very painful last about two weeks. No blisters and looks more like a burn. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR134285:Same reporter
her throat, her face, her nose and her scalp began burning from the inside/She felt like it was burning on the inside of her body; her lips were burning; caller stated that the pharmacist said she is allergic; she eats something hot it reactivates that burning feeling she had on the inside of her ear and the inside of her face.; The caller clarified that her scalp is burning as well, when she eats hot foods, and it is awful.; she was not really feeling well.; was very scared and hesitant to take the vaccine because of her allergies; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (BNT162B2, Pfizer BioNTech COVID-19 vaccine, Solution for injection), via an unspecified route of administration on 08May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at a local hospital. Medical history included hypersensitivity (She mentioned being a very allergic person and was very scared and hesitant to take the vaccine because of her allergies), food allergy (She added that a month ago, she could not drink coffee without milk, and now she can have coffee. But the symptom gets reactivated by certain food and is sporadic). Patient is also allergic to Macrobid (clarithromycin) and sulfa (Sulfa) and experienced skin burning sensation. The patient's concomitant medications were not reported. On 08May2021, following administration of the Pfizer BioNTech COVID-19 vaccine, she experienced the following symptoms: her throat, her face, her nose and her scalp began burning from the inside. she felt like burning on the inside of her body. She took benadryl and xanax and they did not help. Patient called the ambulance and went to the hospital. The patient stated that when she went to the hospital where they gave her a high dose of Tylenol but she said she kept feeling that way for the next 4 days and stated that now if she eats something hot it reactivates that burning feeling she had on the inside of her ear and the inside of her face. She clarified that her scalp is burning as well, when she eats hot foods, and it is awful and stated that she never knows what to eat and she has to eat her scrambled eggs cold. She reported that the symptoms affecting her scalp, her face, her nose, her sinuses, her hands, extremities and left foot. She described the symptom like little knives, felt like burning. She did not have the typical headache, her lips were burning. No swelling reported. She said that she was not really feeling well. She mentioned being a very allergic person and was very scared and hesitant to take the vaccine because of her allergies. She further added that they gave her a throat lozenge at the hospital. She has an appointment with her doctor on 21Jun2021. When she reported this experience to her doctor, he said to drink fluids and it will go away. She mentioned that she was to get the Johnson & Johnson COVID-19 vaccine, but it was removed from the market because of the blood clots reports. Outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Information has been received from a 27 year old female patient who on 08-OCT-2008 was vaccinated with a first dose of GARDASIL, when she was already 27 years old; the patient experienced headache and some fever. The caller cannot get the second and the third dose of GARDASIL because her insurance will not cover it because of her age. The patient did not seek medical attention. The patient recovered on an unspecified date. No further information is available.
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), CALCIUM, BIOTIN, LEVOTHYROXINE, ESCITALOPRAM, ATORVASTATIN, ALENDRONATE SODIUM, CARBINOXAMINE MALEATE (OMEGA 3), DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) and PROBIOTIC 10 for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE REACTION (delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of). At the time of the report, VACCINATION SITE REACTION (delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of) outcome was unknown. 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.  There is no information about treatment medications.
Flushed skin, face, and chest. Chest tightness. Possible hives.
Pt reported feeling dizzy, having a dry mouth, and "trouble swallowing". Pt assessed, no erythema or edema noted to throat or tongue. Vitals taken, 50mg Benadryl IM administered. Observation time extended to 30 minutes. Pt vitaled q5m. Pt reported relief by end of observation time and stated her symptoms had resolved.
Patient quickly developed a reaction to the ProQuad injection. 5 minutes after administration patient had a 1 in x 1 induration on his thigh, and a 1.5 in x 1.5 in red area. At the time of this report, area has still not resolved.
Arm pain; Sleepiness; Sweating and low pressure sensation; Sweating and low pressure sensation; Nausea; Shortness of breath; A never-felt pain in veins and arteries by several parts of the body: left arm, right ankle, anterior skull, left armpit, heart, several points in the lungs.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection; Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 23Mar2021 at 16:15 (at the age of 62-years-old) as dose 1, single for COVID-19 immunization. Medical history included mononucleosis from 2011 to an unknown date and hemorrhagic dengue from 2014 to an unknown date. Concomitant medications were not reported. Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccine within 4 weeks and other medications in two weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 26Mar2021, after first vaccination, the patient experienced arm pain, sleepiness, sweating and low pressure sensation, nausea, shortness of breath and a never-felt pain in veins and arteries by several parts of the body: left arm, right ankle, anterior skull, left armpit, heart, several points in the lungs. Patient did not receive any treatment for the events. Outcome of all events were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
pt recvd vax; next day pt reported light headedness, weak, nausea, dizzy, pulse & BP elevated; t also elevated;