chrisvoncsefalvay/vaers-outcomes huggingface dataset:
coughing; 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 COUGH (coughing) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing). At the time of the report, COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided   Reporter did not allow further contact
Itchy generalized rash / abdomen / arms mottled skin on arms. Tongue swelling with difficulty swallowing. Pt. took herself to hospital and was treated with steroids and BENADRYL. D/C home same day.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4168730-00 (RA).  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1141915) at CF for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UMBILICAL HERNIA (medically significant), outcome "recovered" (18Nov2021), described as "Umbilical hernia"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Low grade fever". The patient underwent the following laboratory tests and procedures: pyrexia: (2021) low. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of umbilical hernia. It was unknown if patient was enrolled in a COVID-19 vaccine trial. In Aug2021, he underwent an umbilical hernia surgery and it was successful. As of 18Nov2021, he recovered from the surgery.  The reporter's assessment of the causal relationship of the events with suspect product (Bnt162b2) was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events umbilical hernia, Fatigue, Pyrexia and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
EXTREME LETHERGY, NAUSEA, REFUSING TO EAT OR DRINK, ELEVATED HEARTRATE, FATIGUE, ELEVATED TEMP
Headache; Fever; Stomachache; General malaise; Oxygen saturation decreased/ oxygen level was 96 then went down to 95, then 94, and then 93; feels real weak; This is a spontaneous report from a contactable consumers. A 65-year-old male patient received second dose of bnt162b2 (PFIZER COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route of administration in left arm (at the age of 65-year-old) on 16Mar2021 as single dose for COVID-19 immunisation. Medical history included open heart surgery from Apr2020 to an unknown date, hypertension from Apr2020 to an unknown date, Autonomic dysfunction from 1989 to an unknown date and COVID-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported. The patient did not had any other recent vaccinations or not started any new medications. The patient previously received first dose of bnt162b2, (PFIZER COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via unspecified route of administration (at the age of 65-year-old) on 23Feb2021 as single dose for COVID-19 immunisation. The patient experienced headache, fever, stomachache, general malaise, oxygen saturation decreased and feels real weak on Mar2021. The second dose was given yesterday and this morning he is having adverse reactions, and she would like to know what they can do to help him. She says he had a high fever, a stomachache, and a headache. She says his oxygen level was 96 then went down to 95, then 94, and then 93 on Mar2021. Patient says that his headache, fever, and stomachache are getting a bit better, but he had general malaise and feels real weak. He says he feels very bad like when he had COVID-19 this past Jan2021. He says that it was diagnosed with a deep swab, not the shallow one, in both nostrils and was a 24 hour test that was positive, it was not a rapid test. He says he had recovered from COVID-19. The patient underwent lab tests and procedures which included oxygen saturation: 95, oxygen saturation: 94, oxygen saturation: 96, oxygen saturation: 93 on Mar2021 and sars-cov-2 test: positive on Jan2021. The outcome of the events headache, fever, and stomachache was recovering and other events was unknown.   No follow-up attempts are possible. No further information is expected.
Pt reports he developed red,hot,swollen patch 6x8cm in size, tender to touch, soreness. Pt felt feverish.
2/27/21 back of the neck started swelling, intestines gurgling, and a headache. 2/28/21 swelling to entire upper body and severe headache. Right front side a rib pushed out. Slept sitting straight up, could not put pressure on my spine at all. Spouse drove me to the chiropractor on 3/1/21 to have the rib adjusted. Six hours later my heart was literally pounding out of my chest for about a minute. Next day the swelling started to subside and can breathe again. Could lean back on my spine without any issues. Chiropractor on 3/3/21 and will go back next week. Intestines are still gurgling and 3/12/21 experienced diarrhea.
Recipient reported feeling light-headed after receiving COVID Vaccine.  He reported similar symptoms after receiving a flu vaccine.  He was observed for 15 minutes and no additional symptoms.  He had some fruit juice and accompanied to his car where he chose to rest.    He called after 15-20 minutes and lightheadedness had not resolved. returned and individual continue to rest in his car.   3:17 - BP - 152/92, HR - 83 and pulse oximeter - 98% 3:23 - BP 145/88, HR - 83 3:40pm Individual called PCP and spoke with nurse who reported that she would relay information to MD. 3:55 - Individual reclining in car and reports feeling better.  Rates lightheadedness a 3 on a 10 point scale.  Denies dizziness and nausea. 4:15pm Discussed options of going to hospital or having family member pick up.  Individual able to return to workplace and then home after reporting that he felt better.
This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (parent).  An infant male patient received, on an unspecified date, in 2014, at the age of 2 months, pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP); polio vaccine inact (IPV); hib vaccine (HIB); rotavirus vaccine and hepatitis b vaccine; all for immunization. Relevant medical history and concomitant medications were unknown. Her son received the vaccines and he had a breathing issue. He went to the hospital where they kept him overnight; they had to put him on an apnea monitor. At the age of 4 months, he received another vaccine (unspecified) and he stopped breathing, his heart rate went down, and he had to have a sleep apnea machine at home after the incident. Clinical outcome of the adverse event was unknown at time of this report. Pfizer is Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities. No follow-up attempts are possible, information about lot numbers cannot be obtained.
Expressive swelling arround injection site; Pain, worse than Covid vaccines; This case was reported by a consumer via sales rep and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date May 2024) for prophylaxis.   Previously administered products included Moderna covid vaccine with an associated reaction of pain (on an unknown date received vaccine).   On 29th January 2023, the patient received Shingrix (intramuscular) .5 ml. In January 2023, 1 day after receiving Shingrix, the patient experienced swelling arm and pain. On an unknown date, the outcome of the swelling arm and pain were unknown.   It was unknown if the reporter considered the swelling arm and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The patient experienced expressive swelling around injection site and had pain 1 day post injection.  The pain was worse than Moderna Covid vaccines.
Symptoms: shoulder pain, loss of range of motion. Signs: thought it was residual pain from vaccine but realized it was an injury after a week of persisting and increasing pain; unable to sleep on left side (injection site); unable to do yoga or exercises involving arms; discomfort placing bag or purse on left shoulder.
PATIENT PRESENTS DIZZINESS AND FAINTED OXYGEN WAS PLACED AT 3 HOURS. THE SIGNS AND REACTION.
t103+ starting 3-4hr p/vax;unconsolable crying >3hr;irritable;no rx needed x/NASID/APAP use PRN;
had mild foggy head; upset tummy; diarrhea; just not feeling right; This is a spontaneous report received from a contactable consumer (Patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection and Lot Number: EN6201) via an unspecified route of administration in Arm Left on 08Feb2021 16:45 (age at vaccination: 67 years) as single dose for COVID-19 immunization. Medical history included Reiters syndrome and mild food allergy to turkey. Concomitant medications were reported as none. Patient did not received other vaccines in four weeks. Patient did not had other medications in two weeks. Patient did not had COVID prior vaccination. She was not tested for COVID post vaccination. On 09Feb2021 24 hours after receiving vaccine she had mild foggy head, upset tummy, diarrhea and just not feeling right. Lasted about 36 hours. All the events were considered as non-serious. No treatment was received for the events. The outcome of events was recovered on an unspecified date in 2021.  Follow-up (24May2021): Follow-up attempts completed. No further information expected.
lt arm swelling, erythema, warmth distal to inj site;actual inj site non tender, no masses palpable;
experiencing tingling in his left arm fingers,The tingling in his right arm comes and goes; After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.; After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (experiencing tingling in his left arm fingers,The tingling in his right arm comes and goes), TASTE DISORDER (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.) and PAROSMIA (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 022C21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced PARAESTHESIA (experiencing tingling in his left arm fingers,The tingling in his right arm comes and goes), TASTE DISORDER (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.) and PAROSMIA (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.). At the time of the report, PARAESTHESIA (experiencing tingling in his left arm fingers,The tingling in his right arm comes and goes), TASTE DISORDER (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.) and PAROSMIA (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-434288.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow-up source document contains no new information. On 29-Dec-2021: Follow-up source document contains no new information.
Pt. cranky and cried intermittently post immun. Appeared to be exp. pain in L thigh when extremity moved or touched. Ate norm. and slept through night. Seen by MD applied cold packs to site w/ good results.
12-14 hrs p/vax mom noted pt had a high pitched cry, followed by inc resp secretions, difficulty breathing & arching of the back; this lasted a few mins followed by signs of lethargy; on arrival to ER pt began acting nl self; had neg EEG;
Hive like rash that started on body as isolated spots and has become progressivly worse, to include large welts all over body but especially on inside of legs, armpits, private areas, back, groin
Headache, Myalgia, NauseaVomiting, Chills, fatigue, decreased appetite, decreased ability to taste on 12/26-present Narrative:
This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received on an unknown date, for tolerance refer case US2018GSK202808). On 4th November 2018, the patient received the 2nd dose of SHINGRIX. On 4th November 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm and insomnia. On 5th November 2018, the patient experienced unable to eat. In November 2018, the patient experienced chills, fever, joint pain and general body pain. On an unknown date, the outcome of the pain in arm, chills, fever, joint pain, general body pain, unable to eat and insomnia were unknown. It was unknown if the reporter considered the pain in arm, chills, fever, joint pain, general body pain, unable to eat and insomnia to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The day before the reporting date, the patient received a dose of SHINGRIX and immediately, the patient presented with arm soreness, but she brushed it off. Less than a day after receiving SHINGRIX, in night the patient woke up in the middle with chills, fever (she was amazed that how could someone have both at the same time) and her joints and body were very sore and she could not sleep, it was that bad. The patient crawled out of bed on the reporting date, and she took a shower, thinking it would feel better after that but she was wrong. The patient was not able to eat and her entire body was aching. The patient asked a question regarding how long would this events last and would it leave side effects. The patient guessed, she should not have rushed into SHINGRIX vaccination. When the patient told lady at the pharmacy about her first experience, she was amazed and stated that it might have something else and told the patient would not get sick like that from SHINGRIX. She suggested that people should be forewarned of this problem.
I had a UTI; My ears feel hot./she feels her neck and ears feel different; worst last night; she still feels full; my glands when I would swollen would be super sharp. I have swollen lymph nodes; soreness in arm/I had injection pain; soreness in arm/I had injection pain; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 08Feb2021 11:00(age at vaccination: 65 years) as 1st dose, single for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated that she had her first dose of vaccine at 11 AM yesterday. On 08 Feb2021, the patient experienced soreness in arm. The patient reported that throat doesn't feel sore and her ears feel hot. On 09Feb2021 at noon, the patient experienced her glands was swollen and when she swallows she had a sharp pain on one side, so right way, she ate chicken noodle soup and hot tea, and made it feel a lot better, she had swollen lymph nodes that have been a side effect as she saw it on the list, had a UTI (urinary tract infection) but was felt better and was taking a Macrobid 100mg capsule by mouth twice daily for UTI, so she thought maybe that would help, but her pharmacist said it would not help with swollen glands, but she did not know if it came from a UTI, her ears feel hot/she feels her neck and ears feel different, soreness in arm/I had injection pain, worst last night and she still feels full when she feels her neck and ears feel different. She was a massage therapist, she iced, and rubbed over it and can lift-up, last night it hurt to lift-up, she moved it around, now she can barely feel it, not like last night. It was reported that patient had no longer sharp pain. She had no thermometer, so unknown if she had a temperature, her face feels warm, but she was hot all the the time being 65. Patient was recovering from the events my glands when I would swollen would be super sharp. Patient had not recovered from the event still feels full. The outcome of the events UTI, my ears feel hot/she feels her neck and ears feel different and worst last night was reported as unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Right upper arm started swelling, became hot and itchy  and tender to touch. Informed MD 8-18-20 late evening  and instructed to apply cold compress, give Tylenol and Benadryl. Marked redness - symptoms spreading since started. Seen in  office 8-19-20 2:45 PM. Right upper detoid area red, swollen indurated 5x5 cm. left upper arm red 2cm  Given rx for Zyrtec and prednisone.
sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy ((mildly allergic)).    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore right arm). At the time of the report, VACCINATION SITE PAIN (sore right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-403231, MOD-2021-403232 (Patient Link).
Cardiac Arrest Spontaneous Subarachnoid Hemorrhage  Possible Cerebral Aneurysm Hypoxic-Ischemic Encephalopathy
LESIONS ON THE L CHECK W/REDNESS L FOREHEAD AND BEHIND L EAR. HAD 2ND VARICELLA SHOT WITH WELL CHILD VISIT 06/08
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates these patients were vaccinated with improperly stored doses of VARIVAX (lot#M024261, expiry date 31-JUL-2018, lot#M023384, expiry date 31-MAY-2018 and lot#M033213, expiry date 30-JUL-2018) for prophylaxis. No adverse effects were reported. The vaccines were exposed to the temperature of 33.9 degree Fahrenheit for 19 hours 32 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of the two reports reported from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013191.
This spontaneous prospective pregnancy report was received from a registered nurse refers to a 26 years old female patient. The patient's medical history included cervical dysplasia. No known allergies. The patient's history of previous pregnancies and live births was not known. Prior to vaccination (on 26-JUL-2012) a urine pregnancy test was performed which resulted negative. On 26-JUL-2012, the patient was vaccinated with first dose, 0.5 milliliter (ml) GARDASIL (lot number 0417AE, expiration date was 29-SEP-2014) intramuscularly (im) into the left arm (reported as left deltoid). No concomitant medications were taken by the patient. The patient was seen in the office on 16-AUG-2012 and a quantitative human chorionic gonadotropin (HCG) blood test was positive. Subsequently, the patient became pregnant with last menstrual period (LMP) of 23-JUN-2012 and the estimated date of delivery (EDD) was 30-MAR-13. The patient was exposed to GARDASIL during trimester 1. The patient was not experiencing any adverse effects. Pregnancy outcome was pending. Follow up information received. EDD was reported as April 2013 (previously estimated as 30-MAR-2013 according to the LMP). Additional information has been requested.
pt came in for first moderna booster and only handed moderna card and asked for booster. gave first booster 12/6/21. pt came in 4/21/22 looking for second booster. at this time noticed pt had two cards and when talking to pt found out he had a "moderna" card and a "pfizer" card. decline pt second booster as he already had 6 shots (3 of each)
This initial spontaneous case, was received from other-non health professional on 20-Oct-2017, concerns a 91-year-old, elderly female patient. The patient's current condition included hypertension, hypothyroidism, high cholesterol, and unspecified kidney disease since an unspecified date. Subject had a history of uterine cancer (dates not reported). On an unspecified date, the subject underwent hysterectomy and tripe bypass (dates not reported). Concomitant medication included NORVASC, LEXAPRO, levothyroxine, simvastatin and metformin for an unknown indication. On 07-Sep-2017, the patient was administered with first dose and on 18-Oct-2017, the patient was administered with second dose of FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no. 195237 and expiry date: May-2018). The patient was vaccinated with 2 doses in the same season (explicitly coded as inappropriate schedule of vaccine administered). It was reported that, no adverse event noted (explicitly coded as no adverse event). The reporter considered the case as non-serious.