chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Night sweats; Tiredness; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), FATIGUE (Tiredness) and MYALGIA (Sore left arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (ESTARYLLA) for Birth control, ZOLPIDEM TARTRATE (AMBIEN), CLONAZEPAM, vitamin D and Multivitamin.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced NIGHT SWEATS (Night sweats) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and MYALGIA (Sore left arm) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL A) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 05-Mar-2021, NIGHT SWEATS (Night sweats), FATIGUE (Tiredness) and MYALGIA (Sore left arm) had resolved.            On an unknown date, chest x-ray and blood work was completed, no results reported.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-138830 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2016) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Soreness, very slight swelling  in left arm.  Not terribly painful but noticeable when moving that arm.  Now, 4 days later there is still a bit of tenderness. I am expecting there to be less or none tomorrow.   I don't think this is a serious result but still it is a reaction but possibly others have encountered.
immune thing; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune thing".  Additional information: Caller's concern Caller (name withheld) asks if her wife is due to get her booster shot not until Mar asking if there is a reason why she can't get it early. He also said that her wife has some immune thing asking if she can safely take the booster dose after four weeks.   No follow-up attempts are possible;information about lot/batch number cannot be obtained.No further information is expected.
Resident received 2 doses of Pfizer COVID vaccine 1/12/21 and 2/2/21 and then 2 doses of Moderna vaccine 4/1/21 and 4/29/21.No adverse events noted.
p/ pt recv vax approx 13 days later pt exp temp, chills & general flu-like sx, rpt MD noted pt broke out in a scattered vesicular rash.
Acute autoimmune hemolytic anemia 1/31/06 Review of dc summary confirms diagnosis of autoimmune hemolytic anemia of unknown etiology. Treated with IV steroids. Child was described as pale and slightly jaundiced. Fever of 100.2 at home treated with Tylenol.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 70-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unknown date at 0.5 ml single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced severe edema and erythema after the vaccine was delivered. It was reported that the doctor administered diphenhydramine hydrochloride (BENADRYL). The outcome of severe edema and erythema was unknown.
Systemic: Pt was injected with vaccine after RPh stuck herself with needle. -mild
1wk p/vax pt exp pain in arm muscle @ site of inj; there is no redness or swelling;MD thinks has bursitis in shoulder;also has an unsteady gait which favors rt side
I was having numbness, tingling and pain in both hands and arms. Doctor gave me steroid injections in both wrists as treatment for carpal tunnel.
For a couple of days after the injection, there was pain (similar to a tetanus shot) in the arm. That went away, but now the arm is swollen and red (no pain at this time)
Fever, headache, chills, nausea, insomnia.  Treatment was time, rest, hydration, and eating enough carbs.
This spontaneous report was received from a health professional refers to a 13 month old patient. Current condition and medical history were not reported. On 23-MAR-2015 the patient received (Oka/Merck) VARIVAX 0.5 ml, subcutaneous (lot # K005426, expiry date: 15-APR-2016) or VAQTA 0.5 ml, intramuscular (lot # K009506, expiry date: 22-SEP-2016), that were improperly stored. Concomitant medications were not reported. No adverse effects were reported. Outcome of the event, incorrect product storage was unknown. Reporting health professional considered the event to be not related to (Oka/Merck) VARIVAX or VAQTA. This is one of two reports received from the same source. Additional information has been requested.
Information has been received from an unspecified reporter referring to a 49 year old patient of unknown gender. Information regarding concurrent conditions and medical history was not provided. On 08-MAY-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose #, lot #, route and application site were not reported). This is one of two reports received from the same source. Additional information has been requested.
A 44 year old male re-vaccinee was vaccinated on 2/20 and had subsequent symptoms of a low grade fever, malaise, nausea and vomiting. On 2/28, he noticed a small red patch on his upper left forehead with two small "pimples", which he rubbed open. Instead of healing, the lesion expanded during the subsequent days. On 3/4, he noticed 1-2 "bumps" on his left eyebrow and on his upper left eyelid, with some additional lesions over the next few days. He had no ocular symptoms. He visited his physician on 3/7 and was also seen by a dermatologist and an ophthalmologist. The forehead lesion was described as a 1.5 x 2.5 cm deep red plaque. It was significant for two confluent black eschars approximately .6 x 1.0 cm in total diameter. There were no vesicles. His left brow and upper eyelid contained approximately 5 faint pink macules and patches with superimposed vesicles that were less than 1 mm in diameter, appeared superficial and were in the same stage of development. Many were grouped though not in the typically florette pattern of herpetic vesicles. None were eroded or crusted. Very small vesicles were also present on his upper left eyelid but did not involve the lash margin. His ophthalmological exam was negative for keratitis, blepharitis, or conjunctival involvement. His vaccination site revealed a major reaction. The scab on his forehead and the eyelid vesicles were unroofed, and swabs for viral culture, DFA, and PCR were obtained from these sites and from his vaccination site. He was placed on valcyclovir and trifluoridine eye drops with close outpatient follow-up.
reported to onsite medical clinic at 11:30am after taking 2 puffs of albuterol, c/o HA/lightheaded/dizzy, VSS, developed mild SOB/clammy/groggy, sent to Emergency Room for evaluation and treatment where it was documented that she had an anaphylaxis reaction to the vaccine administered at 0800 on the same day at a community vaccination event
I had it, I got both shots/suspected vaccination failure; I had it on my back and chest,; pain was terrible, like someone threw a pot of grits on me, I cried; terrible scars; Rash; cried like a baby for a month it looked like someone; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, scar, crying and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, crying and rash were recovered/resolved and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, scar, crying and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles on back and chest.  The pain was terrible and he/she cried like a baby for a month they looked like someone threw a pot of grits on the patient. Shingles recovered within a month.  The patient experienced shingles again, refer case US2021AMR261359 second outbreak. The patient's doctor said the patient was a carrier of the virus and event after getting both shots, the patient would get the rash as if the patient had got shingles always. It left the patient with terrible scars. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR261359:2nd outbreak
Intern pharmacist vaccinated patient with Moderna vaccine stored outside of refrigerator for greater than 24 hours.
Fever of 100.8, body aches, and headache...this was after the first dose
c/o leg pain, swelling lin difference in legs. Limping - warm to touch. 3 days later - still puffy. Bruises noted, none at inject site. c/o leg pain.
I was diagnosed with interstitial pneumonitis, I had a lot of coughing and a fever when I went to the doctor. A follow-up showed that Hashimoto's disease caused the flare up.
First reaction was Moderna Arm ... & then Tinnitis (constant ringing in left ear).  Difficulty sleeping w/ ringing 24/7.  Ringing is worse when laying down.  Continuous ringing in both ears after the 2nd dose.
Large (size of grape tomato), mobile, nontender left supraclavicular lymph node noticed 12 days after vaccination.  Did not connect the lump with the vaccine, and Googled "lump above collarbone." BIG MISTAKE.
Approximately seven minutes after my injection, I tasted   a metallic taste in my mouth and I began experiencing  extreme rapid heartbeat , extreme shakiness and extreme panic and anxiety.. I quickly alerted a nurse who had me lay down and took my vitals and gave me something to eat and drink. They observed me for an additional half hour and then released me as I was feeling mostly better but still shaking a little.
her stomach was very full and cannot eat much before full.; stomach larger than normal; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (her stomach was very full and cannot eat much before full.) and ABDOMINAL DISCOMFORT (stomach larger than normal) in a 54-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (her stomach was very full and cannot eat much before full.) and ABDOMINAL DISCOMFORT (stomach larger than normal). At the time of the report, ABDOMINAL DISTENSION (her stomach was very full and cannot eat much before full.) and ABDOMINAL DISCOMFORT (stomach larger than normal) outcome was unknown.            No concomitant medications were reported.   Treatment medications were unknown.   The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-231216 (Patient Link).
Dizziness; Weakness; Headache; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2023, the patient received the 1st dose of Shingrix. On 3rd January 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On 4th January 2023, the patient experienced dizziness, weakness and headache. On an unknown date, the outcome of the injection site pain, dizziness, weakness and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, dizziness, weakness and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-Jan-2023  Reporter's Comments: The case was reported by patient's husband. The reporter stated that the patient received first Shingrix vaccine day before the reporting. 24 hours later, the patient experienced dizziness, weakness, and headache.  The patient had soreness at the site of injection, immediately after getting the vaccine. The patient was still experiencing all of these symptoms.  The reporter did not have any further information regarding lot or expiration of the vaccine.  The reporter consented to follow up.
I started with significant pain in my left arm at the site of injection the day after injection. The day after I had significant swelling and pain in the lymph nodes in my axilla. This pain last for 3 days. After the pain in axilla resolved I started with significant post nasal drainage. So, 4 days after my shot I developed cold/flu like symptoms. These were very similar to the symptoms I had after actually contracting covid 19. These symptoms have now been present for 4 days. I have no chills or fever. I have had aches, severe sore throat, sinus pressure, nasal congestion.
Breakthrough case admission after three vaccines Pfizer 3/2/21 Lot# EN6202;  Pfizer 3/23/21 Lot# ER8727;  Pfizer 10/23/21 Lot# 30155BA
Customer was waiting in post vaccination area after receiving his second Pfizer CVD-19 Vaccine. Approximately 5 minutes post vaccination customer fainted and fell off of bench.  Customer was out for less than 5 seconds until waking up. Upon waking up customer was fully alert and oriented. Customer called parent's to come down and pick him up. Customer refused ambulance.  Customer was wearing a helmet (came in on scooter) at the time of fall. Upon departure I recommended that customer go to hospital or urgent care for follow up to ensure no underlying issues from his fall (head injury). Customer left when parent's came to pick him up.
No adverse symptoms were reported; 1 patient was administered a dose of improperly stored RECOMBIVAX (R006746, exp: 11/09/2020) on 11/20/2019.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, concomitant therapies and drug allergies was not provided.  On 20-NOV-2019, the patient administered a dose of improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot# R006746, expiration date 09-NOV-2020; dose, strength and route were not provided) for prophylaxis (product storage error). The temperature excursion was below 36 Fahrenheit degree (33.7 Fahrenheit degree) for 4 hours and 23 minutes. There was no previously temperature excursion. There was a data logger involved. No adverse symptoms were reported.
Redness, hot, inflammed skin at shot location and rectangular patch (1inch x 3inches) below shot location. Both are present 15 days after getting the vaccine.
pt recv vax & devel gen rash;pt was evaluated by an allergist;testing w/ a 1:1 dilution of DT was positive;pt recovered;
Severe pain in upper left back. Around the shoulder blade (not the shoulder). Needed to lay down to relieve pain, could not sit/stand for any length of time. Went to see a walk-in clinic doctor on 2/24/2023. Told them the pain was 8 out of 10. Was prescribed methocarbamol, lidocaine/prilocaine cream, naproxen and given a shot of tramadol.   Severe back pain continued. Went to see PCP on 2/27/2023, told her the pain was 7 out of 10 and was told to continue to use prescriptions and try to rest back as much as possible.  Some improvement after staying mostly in bed through 3/1/2023.  Needed to do some things on 3/2/2023 and pain level was between 5-7. The longer sitting or standing the higher the pain level goes.
This spontaneous report as received from a pharmacist regarding a 76 year old female patient with hypertension and no known drug reactions/allergies. On 08-JUN-2013, the patient received a dose of ZOSTAVAX, 0.65 ml, subcutaneously for vaccination purposes. (Lot # J000432, expiration date 04-OCT-2014). Co-suspect therapy was not provided. Concomitant therapies included SYNTHROID, DIOVAN, ALPRAZOLAM and FLECTOR patch. In June 2013, the patient experienced an injection site reaction of redness about 3 inches in length. There was no rash. At the time of the report, the patient had not recovered from injection site reaction of redness. The patient sought medical attention by visiting the pharmacy and was treated with unspecified ointment and BENADRYL. There were no laboratories performed. Relationship between the event ad therapy with ZOSTAVAX was unknown. Additional information has been requested.
Client's guardian stated "the baby was vomiting a lot this morning: he also is having fever of 100 degree F, the injection area feels warm and red; he is very fussy, I'm giving him TYLENOL to treat the fever". Guardian was advise to take child to his pediatrician to be evaluated; also to keep child hydrated and to watch for signs and symptoms of dehydration.
Case previously recorded as MA2009-3338. A consumer reported the following information via MedCom on 28 OCT 2009: A pregnant, female patient was vaccinated i.m. with S-OIV-FLUVIRIN (batch no. unknown) into the right deltoid on 28 OCT 2009. No adverse event was reported. MedCom Ref. no: NA09-007146.
Starting 12/31/2020 at approximately 0030, began experiencing nausea, vomiting, fever up to 101.4 F lasting one day. Also he had multiple episodes of incontinent diarrhea and fatigue on 1/1/2021 and 1/2/2021. He was treated for his symptoms with ondansetron and acetaminophen. All signs and symptoms resolved on 1/2/2020.
12:30 PM Pt walked away from nurse & fell to floor- fainted.  Nurse heard a thump.  Pt came too " I just got dizzy & hit my head. " No lump was noted on her head.  Pt ate lunch & remained alert.   1:30 PM Pt playing bingo- back to class. 7:30 PM Follow up call & LM asking how she was.  No reply from parents.
Patient received vaccine and went to sit down for her 15 minutes post injection time. After approximately 5 minutes, patient began feeling dizzy, very hot and light headed. Patient then laid down on the floor and elevated her feet. A cold compress was applied to her face and neck. Patient also drank a bottle of cold water and began feeling better after approximately 5 minutes. Patient stayed an additional 15 minutes and felt a lot better when she left.
No adverse events. Adult was vaccinated with pediatric dose of hepatitis B Engerix B.
Pt experienced tingling, numbness on same side of body as flu shot that lasted 3 weeks. Pt developed red, hot lump at injection site 5 days. Tingling and numbness progress to bilateral full body at 3 weeks became Bells Palsy, right sided. Pt still being treated with steroids, symptoms persisting.
While trying to immunize patient, syringe was defective and  most of dose squirted from syringe and none or very little was injected into patient.  Because of this an additional dose/new syringe of full dosage (0.2 ml pediatric formulation) was administered right after.  No other issues.
Discharge Physician: Medical Doctor Primary Care Clinician at Discharge: Medical Doctor Admission Date: 7/1/2022 Discharge Date: 7/5/2022  PRESENTING PROBLEM: COVID-19 Acute respiratory disease due to COVID-19 virus   HOSPITAL COURSE: Patient is a 85 y.o. female who presented on 07/01/2022 with increased work of breathing. She states that she has had an increased oxygen demand for about a week. At the assisted living, she was started on steroids and oxygen. She tested positive for Covid. She worsened and was sent to the ED for evaluation.  Upon arrival to the emergency department she had a CT thorax which was negative for PE.  Mild moderate chronic obstructive pulmonary disease/pulmonary emphysema was noted with evidence of old granulomatous disease.  She was started on methylprednisolone and COVID-19 testing was positive, and the started additionally on remdesivir.  Respiratory status improved.  It was felt that the majority of her respiratory symptoms were caused by chronic obstructive pulmonary disease and given the lack of significant airspace disease COVID was not thought to be her primary etiology of dyspnea.  She improved with glucocorticoids/bronchodilators.  She did receive a course of azithromycin.  Respiratory status returned to baseline on 07/05/2022 she was discharged home with a 6 day taper dose of prednisone
LETHARGY; FEVER; HEADACHE; This spontaneous report received from a consumer via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lethargy, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, fever, and headache. This report was non-serious.
After receiving the first dose of Pfizer pediatric vaccine, she fainted after sitting for approximately 2 minutes. Her parents said she has a history of passing out after having blood drawn. The patient came to almost immediately. She was given water and monitored for an additional 10 minutes. Offered to call emergency services, but declined. No other issues arose after initial fainting episode.
Rash bumps itch n scratches all over and is still continuing today Oct .5 - Benadryl n Claritin doesn't seem to help.