chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX. Concomitant products included PRILOSEC, ezetimibe and LEXAPRO. On 2nd April 2018, the patient received SHINGRIX (intramuscular). On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, upset stomach, chills, headache and fever. On an unknown date, the outcome of the pain in arm, upset stomach, chills, headache and fever were recovering/resolving. The reporter considered the pain in arm, upset stomach, chills, headache and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm and later that day, she reported soreness in the arm. Later that night, the patient reported fever, chills, headache and upset stomach. The patient noted that she had every side effect listed in the Package Insert, but she could only verbalize the events listed on this report. At the time of report, the patient noted that the events had only slightly improved.
Patient received his Shingrix vaccine on 7/14/22 & as of now his arm is still sore & he claims has a month on it from the vaccine but it is not near Deltoid region of Admin.
Headache, Myalgia, FACIAL NUMBNESS, TINGLING SENSATION AT THE EXTREMITIES Narrative:  Employee got the covid vaccine second dose , 02/04/21, 230pm Employee relates to facial numbness, tingling sensation at the extremities, body ache, chills This continues till the following day 2/5/2021 Employee missed work 2/5/2021, 02/08/2021  Other Relevant History:
Information has been received from a company representative she reported that she read about a teen in High School article. The article talks about a 14 year old female who experienced seizures after receiving the first dose of GARDASIL (Lot # was not available). Upon internal review, seizure was determined to be other important medical event. This is one of several reports from the same source. Additional information has been requested. Attempts are being made to verify the existence of an identifiable patient and reporter.
sore arm at shot site; headache; chills; aching; tired; third shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 10:15 (Lot number: FJ8757) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 25May2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0167), administration date: 04May2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "Sore arm".  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "third shot"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome "recovering", described as "sore arm at shot site"; HEADACHE (non-serious) with onset 30Nov2021, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 30Nov2021, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 30Nov2021, outcome "recovering", described as "aching"; FATIGUE (non-serious) with onset 30Nov2021, outcome "recovering", described as "tired". Therapeutic measures were not taken as a result of vaccination site pain, headache, chills, pain, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Red blotchy rashes all over her back, terrible headache. Also had difficult swallowing but that went away
patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 7 patients. This report is for 5th of 7 patient.   A patient of unspecified age and gender received the first dose of BNT162B2 (BNT162B2 also reported as Pfizer Covid vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that 7 coworkers was tested positive for COVID after receiving first dose of the Pfizer Covid vaccine on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same drug/AE, different patient
A spontaneous report was received from both a physchian and helathcare worker (on the same phone call) concerning a patient (age and gender unknown). On 01-DEC-2014, the patient was inadvertently administered ZOSTAVAX instead of their first dose of (Oka/Merck). No adverse effect was reported. The outcome was unknown. Additional infromation has been requested.
she felt unwell (fever, chills, muscle aches) after the vaccine, which was not cocerning. She also developed some unexplained bruising on her upper thighs, inner arms, which have resolved. They were not painful. They completely resolved in one week. I saw her routinely today - she showed me pictures of the bruising.
Left arm  (shoulder, half way to elbow) swollen,  red,  hot to touch
Lump; Covid arm reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump) and VACCINATION SITE RASH (Covid arm reaction) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     The patient's past medical history included unidentified flu (it was all symptoms (no taste, fever) of covid but at the time it was unidentified) in January 2020. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI-SPRINTEC) for Birth control, THYROID (ARMOUR THYROID) for Thyroid disorder, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), FUROSEMIDE (LASIX [FUROSEMIDE]), POTASSIUM CHLORIDE and DOXAZOSIN MESILATE (CARDURA) for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Lump) and VACCINATION SITE RASH (Covid arm reaction). At the time of the report, VACCINATION SITE MASS (Lump) and VACCINATION SITE RASH (Covid arm reaction) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatments medications was reported.   This case was linked to MOD-2021-331634.
Three quarters to one inch diameter lump at injection site. Raised and hot to touch with erythma. Benedryl 25mg po given. Ice applied to affected area for 15 minutes.
Dizziness, Tachycardia, Nausea.  Progressed within one hour of administration.  Patient returned to health center at 12:15 pm.  50 mg Benadryl administered.
Left underarm and left breast pain; Left underarm and left breast pain; This is a spontaneous report from a contactable other hcp (patient). A 59-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: Fa6780), via an unspecified route of administration, administered in Arm Left on 12Jul2021 16:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension and Penicillin allergy. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received within 2 weeks of vaccination: Blood pressure meds. The patient experienced left underarm and left breast pain on 13Jul2021. The outcome of the events was not recovered.
High fever/chills, followed by coughing up large amounts of dark red blood for 5 days.   No other symptoms besides this.  Abruptly stopped on 5th day
Slight sinus headache with congestion, tiredness.  Following morning woke up with a mild sinus headache with congestion and pressure.  Headache and congestion got gradually better in the evening.  Second morning after vaccination, woke up around 3am EST with slight dizziness and congestion.  Could not go back to sleep.
Delirium; Syncope; Altered state of consciousness; Dehydration; Pyrexia; This case was received via VAERS (Reference number: 1358559) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DELIRIUM (Delirium), SYNCOPE (Syncope) and ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Hospitalized for 8-10 (No vent).) in February 2021.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) (seriousness criterion medically significant), DEHYDRATION (Dehydration) and PYREXIA (Pyrexia). At the time of the report, DELIRIUM (Delirium), SYNCOPE (Syncope), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness), DEHYDRATION (Dehydration) and PYREXIA (Pyrexia) had resolved.        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.   Patient was treated with  IV fluid and condition improved after that.  Physician did not recommend dose 2.  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.; 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.
patient received 27 mcg of Pfizer instead of 10 mcg due to incorrect vial reconstituted - patient experienced no adverse effects from this occurrence
Patient was given Hepatitis A #2 of 1 pm 1-14-13. At 2 AM on 1-15-13 wake up with sharp pain upper left deltoid at injection site & radiated from upper left neck; back of left shoulder & radiated from upper left fingertips. Pain worsened on 1-15-13 during day & relieved slightly with ibuprofen "can lift left arm only half way up & having trouble lifting anything with left hand."
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-10 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I went from COVID negative to COVID positive; Negative, notes: I went from COVID negative to COVID positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment start/stop date: 25Jan2023/03Feb2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received H1N1 shot on 1-7-10 and c/o pain at time of injection, right arm pain. There was some tenderness at injection site, a little bump and maybe a sl rash about a week after she started having shooting stabbing like pains in the arm. The pain gradually got worse. Went to doctor and was taking ibuprofen for the pain and started PT. It seems to be worse with PT. Went to doctor a few days ago & he started her on some pain pills. It's better if she moves slowly & ices the area. X-ray was done.
Low grade ringing in my ears (tinnitus).  It is not too loud but is somewhat persistent. I have not sought any treatment for it.
2/14/08 Dx with cellulitis of left arm. Redness and swelling on outer arm to elbow and extends to inner arm 2.5 inches below the elbow. Dr. prescribed Keflex 500mg QID x 10 days, ice, rest and elevation. By the next day pt said arm was much better and today is completely better per phone conversation. (2/22/2008)
She was observed for 30 minutes in the center of vaccination. At around 40 minutes, she started to smell a strange odor, later a strange laryngeal foreign body sensation, her voice changed tone to hoarse (dysphonia). Later she had difficulty breathing through her nose and in seconds general shortness of breath. Marked pallor of skin and lips. Strange sensation of the extremities. She does not remember what happened, she had for a few seconds cloudiness or a sensation of faintness. She spontaneously recovered from the shortness of breath around 5 minutes, time that we were able to get to the emergency room. We consulted the Clinic, emergency room. Where she was observed and monitored for two hours. She recovered well. The evening of 6/5/2021 she had fever up to 100.6, nausea, headache, mild myalgia.
felt tired after receiving his second dose; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt tired after receiving his second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness, tender, red, warm. TYLENOL, ice TID. Is on doxycycline for acne.
Following her booster vaccine of Pfizer at 1440, patient stated feeling like her heart was racing and she appeared flushed. She complained of dizziness and patient and mother stated that she 'always feels like she's going to pass out' following any shot or when she gets blood drawn.  1440 BP: 153/85, HR: 113 appeared flushed, patient seated with feet extended above heart and given water to drink; EMS called 1445 BP: 146/86, HR: 112, patient finished water and said she was 'starting to feel better' 1455 BP: 151/83 HR: 88 color improving, less flush and EMS arrived to take over 1515 Patient stated feeling better at this point and was released by EMS with no visit to ED; mother drove patient home and was informed to monitor patient and if she continues to feel unwell or gets worse to take her to the ED.
Mostly fatigue the first few days, but more severe symptoms staying Friday evening 3/26/21. Abdominal pain, diarrhea, hot flashes/intermittent low fever, heavy fatigue, chills, muscle and joint aches, headache.  Tried to rest, took acetaminophen, hydration, soup. Called the doctor today 3/29/21 to see if I should come in. Was told it was probably vaccine side effects and if it was another kind of virus, they would just tell me to get rest and lots of fluids.
facial numbness/forehead; zoster encephalitis/focal  encephalitis; Central nervous system viral infection; inflamation brain stem; vasogenic edema/Vasogenic brain edema; face droop; Prominence of eyes/difficultly closing eye fully; Herpes encephalitis; Cerebellar  edema; Varicella-zoster; shingels; Eye irritated; blurry vision; tickling sensation in left ear/paresthesias; Eye swelling; facial weakness; trigeminal neuralgia; This case was reported by a lawyer and described the occurrence of encephalitis in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional information: The patient was diagnosed with zoster encephalitis.  The initial information was received on 21 July 2020, via medical records(the case was medically confirmed). The patient had family history of Parkinson's (father). The patient had allergy after second shot of Shingrix. As per pharmacy records the patient had injected shingrix 50 MCG injection on 30 December 2018. The patient had injected shingrix 50 mcg injection on 23 March 2019. The patient had injected Shingrix 50 MCG Suspension Reconstituted 1 Intramuscular x 1 now; second dose in 2-6 Months. The second dose of shinrix on April 2019. The patient got shingrix shot on 28 March 2019 with response to eye irritated and blurry vision. In May 2019, Shingrix shot caused inflammation response in brain stem, middle cerebellar peduncle/ Vasogenic (brain) edema. During 21 May 2019 to 22 May 2019 noted the patient had left face droop including forehead, face drooling, tickling sensation in her left ear.She was started on Decadron 4mg PO by her GP. Her symptoms improved over the next 10-14 days. As per progress, notes 28 May 2019 the patient had Eye swelling (left, Prominence of eyes and Cerebellar mass. The patient had hospitalization for facial numbness/possible reactive lesion (L) Pons from shingrix shot on September2019. As per Visit date, 17 July 2019 the patient had numbness on forehead and mid skull, facial weakness had improved, paresthesias, Herpes encephalitis, Varicella-zoster, focal encephalitis. The patient was admitted on 18 July 2019 and discharge on 19 July 2019 with diagnosis Zoster encephalitis/ encephalitis and Central nervous system viral infection (patient had procedures LUMBAR PUNCTURE). As per progress date 31 January 2020, the patient had shingels & trigeminal neuralgia left side difficultly closing eye fully(left), Cerebellar lesion(on May 2019 MRI)and Deficient blink reflex.
I received the booster vaccine around noon and that evening began to experience muscle aches and fatigue. The next morning I was impacted enough by the aches and the fatigue to cancel a preexisting audiology appointment that would involve a commute through heavy traffic and a rigorous hearing test. (The pharmacist had warned me that I might experience a stronger reaction to this vaccine than I had to my previous ones which were Moderna.)  I pretty much laid on the couch all day, and by evening the effects were wearing off. By the following morning I was pretty much back to normal. And the day after that, I was well enough to embark on a long plane flight. The reaction was not severe enough to cause me to be alarmed or seek medical care. While it was a stronger reaction than I'd experienced before, I felt it was completely manageable with rest and a Tylenol.
48 year old patient female comes to center for her first dose of PFIZER Lot FF2589, it is administered at 2:37pm by agent. Patient at 2:43pm refers feeling dizzy and at 2:45pm she lost consciousness, quickly the paramedic takes vital signs.
5 days after vaccines was administered on 5/21/2012, pt had generalized tonic seizure x 15 minutes. Went to hospital.
My child woke up with a huge bruise on her right forearm, the next day more bruising showed up all over arms, legs torso, then started heavy nose bleeds would last for an hour, blood would come from both sides. A slight touch bruising would appear. Heavy period. This continued on and off thru out the month of May 2016. Until my child was admitted to the hospital.
Patient received the immunization on 5/11/18 around 2 pm. He reports around evening of 5/16/18 he felt itching on the injected arm and on 5/17/18 he felt itchy, burning, sensation that is reminiscent of the time when he had active shingles before. He also notes rash that's appearing on the posterior side of his injected left arm from the wrist to the injected side (deltoid muscle).
Fell to floor immediately after receiving box. Over next few days developed joint aches, rash, N/V, HA and eye pain. Became difficulty to walk 7/5 and by mid July, dx w/Lupus. Lost 20#. Tx w/6 mos. 5/30/06 Received medical records from PCP which reveal Patient seen 7/7/03 for possible sun poisoning, working as lifeguard w/o sunscreen.  S/S included nausea, sore throat, swollen lymph nodes, headache & fever.  Had muscle aches x 2 weeks.  Exam revealed red throat (throat c/s neg) and blotchy rash on face & macular rash on txtremities.  Labs were ordered.  Records also included ER record of 7/8/03 which revealed patient had collagen-type disease & bone marrow depressions which was thought to be due to a viral illness. Additional labs were ordered. Patient returned to PCP following day & was referred to specialist./ss. 60 day Follow-up Information 10-OCT-2006: She continues to need medication for lupus and constant monitoring by doctors.
Shingles; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-10 VACCINE, solution for injection), via an unspecified route of administration on 28Feb2021 (batch/lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife reported that the patient received the first dose on 28Feb2021 and developed shingles on the same day. The patient was told by a doctor to wait 2 weeks before receiving the second dose. However, it was reported that it has been 8 weeks and the wife wanted to know if the patient can still get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.