chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of sickness in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 28th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving SHINGRIX, the patient experienced sickness, pain, decreased appetite, sleepiness and feels awful. On an unknown date, the outcome of the sickness was unknown and the outcome of the pain, decreased appetite, sleepiness and feels awful were recovered/resolved. It was unknown if the reporter considered the sickness, pain, decreased appetite, sleepiness and feels awful to be related to SHINGRIX. Additional details were provided as follows: The case was previously reported to the doctor. The caller called to report that the patient was sick after receiving the SHINGRIX. The patient stated that for 4 days after she feeling horrible. She also mentioned that, the symptoms that she had, were worse than the flu. The patient suffered from aches, pains, loss of appetite and she also slept a lot and she did make her doctor aware of her symptoms. The patient stated that she did not want to take the 2nd dose of the vaccine. The patient's husband also experienced symptoms after receiving the vaccine for tolerance see case US2018164425. The caller gave permission to contact the pharmacy where she received the vaccine. The patient gave permission to be contacted to her physician.
Orange sized lump appeared at injection site. Ice applied and pressure. No discoloration noted at site. Site evaluated by Dr.
Fever around 102 degrees, malaise, lethargy, "flu-like symptoms", swollen/red arm, sore arm, skin on arm peeling 8 days post injection
Vaccine on 5/6, on 5/7 with mid-retrosternal chest pain with radiation to left lower rib cage and left neck - still with pains on 5/13.  5/30/08 ER record from 5/07/2008 received with DX: Chest pain, possibly musculoskeletal in origin. Pt reported sudden onset of stabbing constant chest pain, unrelieved. 7/10 intensity. Also c/o L sided neck pain.  PE WNL. Cause of chest pain unclear.  D/C to f/u with cardiologist. 6/20/2008 Received cardio F/U report dated 5/29/08 with DX: Chesp pain noncardiac in origin. PE (+) for tenderness on palpation of the L axilla area to LUQ. Feet puplish and cold with reduced perfusion and face flushed. Suspected muskuloskeletal pain/costochondritis tx with NSAIDs.  Pulmonary consult for chest nodule negative with resolution of the nodule.
Patient says since this morning she has had redness, swelling and pain down to her elbow from the injection.
J96.00 ACUTE RESPIRATORY FAILURE 10/11/2022 ABNL HEAD MRI J96.00 ACUTE RESPIRATORY FAILURE 10/11/2022 ADENOCARCINOMA LUNG, UNSPECIFIED SITE
Site itched much longer than normal. On or around January 23 I woke up with severe pain in my back/shoulder area and I had lost grip strength in my left hand. I still have pain and loss of grip strength.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 29-MAY-2012, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 671861/1907AA with expiry date of 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
A day or 2 after injection, site was red, swollen, hot. Sore to touch, not sore with movement. Had headache. Took no OTC meds, went away w/o treatment.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 4:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 4:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 77.74.  Concomitant products were not provided.  On 03-NOV-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-OCT-2021, vial was moved to clinic on 03-NOV-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-NOV-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (just felt a little tired and achy) and FATIGUE (just felt a little tired and achy) 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 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (just felt a little tired and achy) and FATIGUE (just felt a little tired and achy). At the time of the report, PAIN (just felt a little tired and achy) and FATIGUE (just felt a little tired and achy) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. Patient had no fever. This case was linked to MOD-2022-454620, MOD-2022-451926 (Patient Link).
48 hours after my first vaccine I started having a vaginal discharge that appeared the color of milky tea. No obvious bleeding, no cramps, no itching, no odor, no rash or other symptom. It required me to change a panti-liner 6-7 times qd for seven days. Sometimes it was absorbed by the pad, sometimes it appeared to be like jelly.   At the same time I started to feel symptoms of a cold; chest pressure, increased fatigue, mild headache, joint discomfort. Oral temp was 100.2 F. usual is 96.4-97.6F.  Later I woke with a night sweat, my body and the sheets were soaked but I was too tired to change them. The next morning I felt fine. Only the vaginal discharge continued unchanged for one week.  Hx complete hysterectomy.
This case was reported by a other health professional via call center representative and described the occurrence of raised liver function tests in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 2nd January 2019, the patient received SHINGRIX. On 20th February 2019, 49 days after receiving SHINGRIX, the patient experienced raised liver function tests and sickness. On an unknown date, the outcome of the raised liver function tests and sickness were unknown. It was unknown if the reporter considered the raised liver function tests and sickness to be related to SHINGRIX. Additional details were provided as follows: No lot or expiration date available or other details regarding administration since it was at a pharmacy (consumer value store). After receiving SHINGRIX, the patient's liver function tests were elevated and she got really sick. On 20th February 2019, when she was seen, she was not feeling well. Her Alanine aminotransferase (ALT) was 321 and Aspartate aminotransferase (AST) was 232. On 26th February 2019, her ALT was 296 and AST was 161. On 7th March 2019, her AST was 175 and ALT was 335. On 18th March 2019, her ALT was 431 and AST was 193. On 1st April 2019, the patient's AST was 47 and ALT was 49. The patient consented to follow up.
Pt had a vasovagal episode right after the vaccine was administered.  Pt c/o Flushing/sweating and dizziness.  Initial BP 88/31 -- > 124/66, 76, 16 -- > 135/68, 67, 18.  Pt recovered and was stable.  Released from the vaccination site.
This spontaneous report as received from a medical assistant refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (exact dose, route of administration and anatomical location were not provided). There were no adverse events reported. This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
Pt. felt nauseated and dizzy. On 2 occasions she vomited.
19MAR93 @ noon started feeling like had temp; 330PM started burning up, arm was really sore, @ site of inject headed up like a pimple-a red line rectangular line below shot;
Nausea, diarrhea, fever, chills x 5d. Pt had enlarged lymph nodes x 7d. Pt dehydrated x3d. Pt tx with 2L LR. Advised to hydrated, eat clear diet advance to BRAT diet as tolerated
Ringing in ears started some time in july with low volume and by end of august the ringing increased drastically which affected my sleep.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-DEC-2012, the patient was vaccinated subcutaneously with lot # (671610/1164AA) ZOSTAVAX on 18-DEC-2012. The anatomical location was not reported. No other co-suspects or concomitant medications were reported. On an unknown date it was discovered that the patient was administered expired ZOSTAVAX. The patient experienced no adverse event. No treatment information was reported. This case was linked to case 1212USA008170 which was received from the same reporter. Additional information has been requested.
pt recv vax 6JUL96 & that same day pt exp pallor followed by cyanosis of the lips & chin;past hx reported that the pt exp similar sx but of lesser severity following 1st dose of vax;
The patient had pain in the left arm on the first day. The next day, the are became red and swollen, with increased pain. It was also itchy. By the 2nd day, the redness and swelling was from the top of his shoulder to his elbow. No fever, chills, induration or fluctuation.
Severely fluctuating blood pressure, chills, heart rhythm irregularities, muscle weakness, numbness face, hand, arm than legs-pins-needle sensation-then stiffness-paralized flu shot at 8a, appt-symptoms hit within 10 mins. Drs. felt I was having a heart attack or stroke-BP hitting 198/100 and more-had CAT scan, MRI-ruled out, heart tests, blood tests, symptoms stayed-told to rest take it easy.
Customer complained of a headache starting 08/11/2021 at 2:00 am - she doesn't usually get headaches and was wondering if it could be from the vaccine she received 07/30/2021 at 1:00 pm
Pt. started acting as if intoxicated for 30 min post vaccination. EMS contacted and allowed patient to return home
A little headache; Achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization, reaction(s): "A little headache", "Achy"; Bnt162b2 (Dose: 02), for COVID-19 Immunization, reaction(s): "A little headache", "Achy"; Bnt162b2 (Dose: 03), for COVID-19 Immunization, reaction(s): "A little headache", "Achy". The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "A little headache"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "Achy".  Additional information: He was calling on behalf of his wife who had the 5 COVID-19 vaccines. The first 4 times she had minor reactions and the last time she had the Bivalent booster, he had a very negative reaction and woke up the next morning with some memory loss and he was wondering if that's anything. He was calling on behalf of his wife who had the 5 COVID-19 vaccines. The first 4 times she had minor reactions and the last time she had the Bivalent booster, he had a very negative reaction and woke up the next morning with some memory loss and he is wondering if that's anything that we've had reported on in previous cases. That we've been had reported on in previous cases. Reporter stated his wife had the 4th Pfizer shot mid July and received the bivalent booster on 03Nov2022. Reporter stated she only was a achy and had a little headache after the previous vaccines. Reporter stated after the 5th vaccine she was a little groggy and experienced some of the same things from the previous vaccines. Reporter stated in the middle of the night, around 2:30 AM to 3 AM, she was shivering and shaking and almost convulsing. Reporter stated she woke up at 8 AM and was warm because she had put clothes on and went back to sleep and slept until noon, which is 4 hours longer than her normal schedule. Reporter stated she had no recollection of getting the booster, experienced memory loss describing it as early onset Alzheimer's. Reporter stated she knew who her husband was but did not remember that her daughter is getting married or that her mother had passed away. Reporter stated his wife went to the ER and had an MRI, CT scan, blood work and urine and nothing was wrong. Reporter stated by 12 AM she was starting to come back and at 2 AM she had her memory back and now has minor lapses but is pretty much back to herself. Reporter stated she was diagnosed with global transient anemia due to the violent reaction that she had to the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Become tired after returning home from getting the vaccine. I fell asleep and woke up to large hives on my face. Not much longer and the hives/itching spread down my back and chest. Face became swollen. Benadryl cream was initially attempted, but only briefly subsided the itching and reaction continued spreading. I took oral quick release Benadryl and was able to prevent the reaction from continuing. I had to take a secondary Benadryl dose a few hours later and extreme joint pain accompanied the allergic reaction.
received three doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 4B53D, expiry date 10th October 2022) for prophylaxis.   Previously administered products included Shingrix (2 doses received on an unknown date).   On 8th June 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 8th June 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided are as follows: The patient received three doses of Shingrix which led to extra dose administered. No further information were provided. The reporter consented to follow up.
Patient developed burning and tingling along left abdomen extending to low back, describes symptoms were similar to that of his shingles rash in 2014. No rash developed until 7/30 - erythematous, with few papules on LEFT low back. Patient was started on anti-viral-Valacyclovir 1000mg PO TID X 7days.
ADVERSE EVENT; This spontaneous report received from a patient 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event was not reported. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hive developed after 2nd dose of Covid 19 vaccine) 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. On an unknown date, the patient experienced URTICARIA (Hive developed after 2nd dose of Covid 19 vaccine). At the time of the report, URTICARIA (Hive developed after 2nd dose of Covid 19 vaccine) outcome was unknown. No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter. Reporter did not allow further contact.
Patient was vaccinated on 12/28/20. On 12/29/20 she developed some reddish area around 2cm in diameter at the injection site with slight itching and discomfort. Besides this there were no other complains
About two hours after injection, it felt like I was having a heart attack. Severe chest pains, headache, nausea, fever, sweating. After several hours I took 325mg of Aspirin, and after about an hour symptoms started to subside.
Pt woke up the morning following the vaccine and was unable to bear weight on either leg and had incomplete range of motion in left arm. Movement gradually returned to legs that day + ROM returned to arm in 2 days.
This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (A LOT INFLAMMATION) and PAIN (SOME SORENESS AND ACHING) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis, Plaque psoriasis and Ulcerative colitis. No Medical History information was reported. On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced INFLAMMATION (A LOT INFLAMMATION) and PAIN (SOME SORENESS AND ACHING). At the time of the report, INFLAMMATION (A LOT INFLAMMATION) and PAIN (SOME SORENESS AND ACHING) outcome was unknown.    Concomitant products were not provided. Treatment medications were not reported.
contracted COVID-19 omicron; contracted COVID-19 omicron; FACILITATED COLLECT  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): 22K-163-4262637-00 (Agency).  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at citrate free and second regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for crohn's disease, rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown.), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome "recovered" (07Jan2022) and all described as "contracted COVID-19 omicron". The action taken for adalimumab was temporarily withdrawn. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of contracted COVID-19 omicron with HUMIRA(ADALIMUMAB) was a reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN): The reporter's causality for the event(s) of contracted COVID-19 omicron with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Extreme pain in hours following shot in left arm. 2 weeks later, pain subsides but now excess salivation. Can't take meds or eat - salivation makes her nauseous.
Information has been received from a medical assistant concerning a 68 year old white female who on 25-OCT-2005 was vaccinated in the left deltoid with a second dose pneumococcal 23v polysaccharide vaccine, intramuscular (lot#"06072").  In the evening of 25-OCT-2005, the same day as the vaccination, the patient's arm was warm to the touch and red.  The patient was instructed to apply ice and take Ibuprofen (ADVIL).  The on 27-OCT-2005, it became worse and the patient went to the emergency room where she was treated with epinephrine 0.5 cc and methylprednisone (MEDROL DOSEPAK).  On 31-OCT-2005, the patient returned to the office and was recovered.  Additional information has been requested.
Patient had some wheezing and difficulty breathing about 3 hours after the influenza vaccine was administered. She used an albuterol inhaler that she had, and it helped her breathe better. Later that evening, around midnight, she had a low grade fever, chill, and body aches. She started feeling better about 24 hours after the shot was administered.