chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 25 year old female with no medical history and no known allergies who on 12-AUG-2008 was vaccinated with a dose of GARDASIL. There was no concomitant medication. On 13-AUG-2008 the patient experienced a bruise on the same are where she received GARDASIL. Also, a white bump developed at the injection site. No lab/diagnostic tests were performed. At the time of reporting the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint. No further information is available.
pt reports having what felt like a lump in her throat, my tongue was tingling, and lips were numb. Heart rate was 126." I went to the clinic at Hytrol and was given a Benadryl ."
I was in remission with Polymyalgia rheumatica and off prednisone for 3 months. Getting both vaccines at the same time cause my immune system revved up and cause a relapse of the condition. Really regret getting both shots at the same time. The information on the news was getting both at the same time is fine and it isn?t. They really should be spaced out.
Started getting a few mild aches about 11:00pm. To bed @ midnight. Woke up suddenly with chills,severe aches,body hot.  Teeth chattering so hard I had to clamp them tight and body shaking so hard and uncontrollably.  I could barely walk to the bathroom I was shaking so hard.  Lasted at least an hour maybe more before starting so subside.  Had a 100 degree fever all day. Still had bad aches all day gradually subsiding by about 5:00pm.  Not sure I'll get another vaccine!
Information has been received from a consumer concerning her approximately 22 year old daughter with no medical history or allergies who in 2002 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). There was no concomitant medication. It was reported that the pr experienced dry eyes and a lack of tears which has resulted in scarring of her corneas. The mother noted that she "never had problems like this prior to receiving Recombivax HB vaccine" and that her daughter still suffers from these problems "at the present time". She was considered not recovered. Medical attention was sought. No product quality complaint was involved. Upon internal review, scarring of the cornea was considered an other important medical event (OMIC). Additional information is not expected. Per follow up report received on 06/14/2005:  Patient still had not recovered.
Child developed a fever as high as 104.3 degrees farenheit, along with localized redness and swelling of right thigh about 24 hours after vaccine administration. Mother called in to report this to the nurse on 6/27/19 and the child was scheduled to be seen the same day in office. Provider concluded that symptoms are due to vaccine reaction. Patient treated symptomatically with acetaminophen and ibuprofen for fever and pain relief.
she then would develop this immune reaction after every covid-19 vaccine and it would get less severe with each one; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4625954 (Agency).  A 31-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Flare up" (unspecified if ongoing); "Swollen lymph node" (unspecified if ongoing); "Marijuana usage" (unspecified if ongoing); "Relapsing remitting multiple sclerosis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Complex ptsd" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Disk bulging" (unspecified if ongoing); "Disk degeneration" (unspecified if ongoing); "Dysphagia" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL; PAXLOVID; VITAMIN B COMPLEX; VITAMIN D3; CALCIUM MAGNESIUM WITH VITAMIN D3; TYLENOL; IBUPROFEN; CBD OIL. Vaccination history included: BNT162b2 (Dose: 1), administration date: 21Apr2021, when the patient was 30-year-old, for Covid-19 Immunization, reaction(s): "swollen lymph node/Recurring swollen lymph node", "swollen lymph node/Recurring swollen lymph node", "big lump under armpit"; BNT162b2 (Dose: 2), administration date: 14May2021, when the patient was 30-year-old, for Covid-19 Immunization, reaction(s): "where she would receive the vaccine she would develop a swollen lymph node". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "she then would develop this immune reaction after every covid-19 vaccine and it would get less severe with each one". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a licensed practical nurse concerning a male patient with sulfa eye drop hypersensitivity and a history of migraine, allergies, and sleep disorder who was vaccinated SQ with a 0.5 mL dose of MMR II in 1998 and in 1991. Concomitant therapy included nortriptyline and IMITREX. Subsequently a laboratory test showed that the patient had a low titer for mumps. The patient sought medical attention at the physician's office. The patient's low titer for mumps persisted. No product quality complaint was involved. Follow-up information was received from a licensed practical nurse on 15-JUL-2008, indicating that, on 19-JUN-2008, the patient received a third dose of MMR II (Lot number 660207/0453X). The patient had two doses of MMR II given at a pediatrician's office. Also, the date of the first dose was changed from 1991 (month unknown) to 01-AUG-1991 (day unknown). It was also noted that the patient received "DPT" vaccine and also "OPV" vaccine on 27-OCT-1988 and in August 1991. Diagnostics on 02-JUN-2008: Mumps Virus IgG AB - 0.97 (values between 0.91 and 1.09 are considered "equivocal" low). Also, an Anti-HB's Titer was done (date in question, reported as "3/13/10") but results not reported. Additional information has been requested.
Narrative: Patient stated she felt little improvement after oral Benadryl given, was monitored for 35 minutes by clinician. Did not want Epi pen given, did not want to go to local Emergency room for treatment, but chose to go home, knowing what to do when she got home in case of further complications and or reaction. Has an EpiPen at home. Had a driver to take her home and husband in attendance at home.
Initial unsolicited report received from a consumer (parent) on 02 August 2015. A male patient had received a dose of meningococcal vaccine (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. Medical history and concomitant medication were not reported. On an unknown date, after vaccination, the patient had reacted so bad to the shot. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Mother reported baby received 4 month shots on 7/9/02. Pt seen in Peds; arrived via ambulance for cardiopulmonary arrest. Unknown reason.
Extremely swollen gland under arms; Pain in glands; Pain in shot site/Shot arm left arm worse; slight fever; tiredness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jul2022 at 17:30 as dose 1, single (Lot number: FN2908) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Coconut" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; PREMARIN. Past drug history included: Macrotatin, reaction(s): "Allergy"; Benydryl, reaction(s): "Allergy". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 12Jul2022 at 07:00, outcome "not recovered", described as "Extremely swollen gland under arms"; LYMPH NODE PAIN (non-serious) with onset 12Jul2022 at 07:00, outcome "not recovered", described as "Pain in glands"; VACCINATION SITE PAIN (non-serious) with onset 12Jul2022 at 07:00, outcome "not recovered", described as "Pain in shot site/Shot arm left arm worse"; PYREXIA (non-serious) with onset 12Jul2022 at 07:00, outcome "not recovered", described as "slight fever"; FATIGUE (non-serious) with onset 12Jul2022 at 07:00, outcome "not recovered", described as "tiredness". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, vaccination site pain, pyrexia, fatigue.  Additional information: There were no other vaccine in four weeks.
Reporter could not wake patient up; Oxygen dropped; Not doing too good; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 Vaccine. Medical history included lung cancer (they just told him he has lung cancer), ongoing smokes (She reported that he still smokes). The patient's concomitant medications were not reported. Consumer reported her husband was administered the first dose of Pfizer COVID-19 Vaccine. He refused to take the second dose of Pfizer COVID-19 Vaccine because he is not doing too good; and because of the events he experienced after being administered the first dose of Pfizer COVID-19 Vaccine. She clarified that the events he experienced after being administered the first dose of Pfizer COVID-19 Vaccine included: Right after the first dose of the vaccine was administered she does not know what happened but his oxygen dropped; that happens too because he won't wear his oxygen like he should; but reporter could not wake him up so he had to go to the hospital. The patient underwent lab tests and procedures which included oxygen saturation: dropped on unknown date. Therapeutic measures were taken as a result of oxygen dropped. The outcome of the events was unknown.    Information about lot/batch number has been requested.
1st shot was 2/5/21 with only soreness at injection site and arm for 7 days.  2nd shot on 3/10/2021 thru 4/30/2021 uncontrollable muscle spasms in the left bicep below the injection side lasting till 4/30/2021.  I tried to recreate these spasms on my own and could not.  On 7/30/2021  I developed Bell's Palsy on the Left side of the face that lasted for 30 days.  On 7/31/2021 the muscle spasms came back in the same left bicep for 7 days.  Up to this point I have only missed school and work a total of maybe 5 days for a sickness in my lifetime.
I experienced pain in left shoulder radiating down to waist and up to neck and nausea.  The upper arm was hot  and swollen but not red. It was difficult to sleep and I could not rest on my left side or roll over.  I could not raise my left arm for about 36 hours.  About 48 hours from onset I was able to work but had limited range of motion in the left shoulder and upper arm.   Fourteen days later I have a full range of motion but am still taking Tylenol for continuing pain in the upper arm and shoulder.
Regular soreness for 2 days post injection. 3rd day started to be concerned of pain and aching in shoulder. Has been over 2.5 weeks and still sharp deep joint pain, limited range of motion and soreness.
Fever (still has fever 18 days later), rash, vomiting for 5 days straight, allergy like symptoms, bruised and warm to touch at injection site for 7days, behavior changes.
Fever of over 101 degrees Fahrenheit for 6 hours and persistent fatigue for 4 days.
This spontaneous report Was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided.     On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, for prophylaxis, that underwent a temperature excursion of 9 degrees Celsius during a time frame of 1 hour, (dose, route, dose number, lot number and expiration date were not provided). No adverse effects were reported, no product quality complaint (PQC) was involved. There was no previous temperature excursion and the call was not because a digital data logger. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA001148: US-009507513-1706USA005169:
The patient received the Pneumococcal Vaccine. The patient was informed of potential side effects such as flu-like symptoms or soreness at the injection site, and to report to any ER if adverse reactions occur (i.e SOB, rash). 0.5 ml of the vaccine was given Intramuscularly. Injection site: Left Deltoid. Patient Education Dialog: The patient needed instruction on this topic, preferred and received 1:1 verbal instruction (and written if pamphlet title included in note), had no barriers to learning and verbalized understanding. No F/U needs, further care/treatment/services or needs for information on additional resources were identified related to this education topic unless noted. January 6. 2011 5:50pm - veteran complained of pain to left upper arm in deltoid area noted 1/4cm bruising to area and beneath and 2 1/2 cm circular area of redness. Entry date Jan 08, 2011 at 16:40 Pt presented to (Nurses) station c/o arm itching, erythema had spread to cover the whole arm above the elbow. Pt received Pneumococcal vaccine on Thurs 1/6. Pt c/o pain at the site, 5 to 6 cm diameter redness at the injection site note on Thurs night. POD phone and instructed we continue to to watch the site. POD was phoned today and came to examine the site. Plans to prescribe diphenhydramine for itching and document allergic reaction to pneumococcal vaccine. 01/08/2011 17:14 - Patient seen and examined (by physician on call). He presents with redness on right arm at site of pneumococcal vaccine given 1/6/11. According to staff, redness has progressively worsened with spreading to elbow. Patient is afebrile with stable vs. Will order BENADRYL 25MG.
This spontaneous report was received from a health care worker (medical assistant) and refer to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 06-MAY-2016, the patient was vaccinated with improperly stored dose of VARIVAX (subcutaneous, in the left arm, lot # L043624, expiry date: 03-NOV-2017) (dose and frequency not reported). The vaccine was exposed to temperature of 26 Fahrenheit for 1 hour and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Additional information has been requested.
Pain in the bones and all the body. Headache all the time. Numbness in the arms.
One month after the second vaccine (April 23, 2021), I began expriencing vertigo type symptoms when I turn my head to the right almost passing out. I have sine been going to PT at an ENT doctor office with no relief.  DOSE 1: 03/26/2021 DOSE 2: 04/23/2021 DOSE 3 (BOOSTER): 10/29/2021
Ears ringing  upon waking up from nap 8 hours after the shot.  Ears ringing upon waking up in the morning. Hot and cold flashes. Headache so far for 2 days. Eyes hurting and sensitive to light. Left arm sore. Left armpit area feels tender. Body aches and fatigue. Strange knee pain I never felt before.
feel terrible; body hurts; strong headaches; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad, general body pain and headache. On an unknown date, the outcome of the feeling bad, general body pain and headache were unknown.   It was unknown if the reporter considered the feeling bad, general body pain and headache to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-June-2022 Reporter's comment: The patient self-reported the case via interactive digital media. The patient got the shot and felt terrible.  The patient's body hurt and had strong headaches. The patient asked if it was normal. Additional Supportive Information: Consent to follow up was not possible as no contact details were available.
Vaccine was reconstituted with less than the required amount of sterile dilutant. Patient was given the vaccine at a higher concentration than recommended.
No adverse event; Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.).    No relevant concomitant medications were reported.  No treatment information was provided.
Patient started getting a rash on face and ears that spread over entire body over a couple of days.  His neck, eyes, between eyes, lips all swelled up on day 2 & 3 of reaction then legs and feet swelled up and legs turned purple.
Patient received FLUZONE on 10-24-11 and 2 days later developed tingling and weakness down her legs. Went to a neurologist and received steroids. Symptoms still occurred extending into arms hands and face. Patient has difficulty walking for prolonged periods of time. She went to several neurologists and was diagnosed with transverse myelitis secondary to flu vaccine.
Dose given from vial opened 26 hours prior to admin.  Expired vaccine given.
Patient reported having double vision for about 10 days after getting his booster vaccine. He did go to the eye doctor, and they could not find anything wrong with his eyes. He's concerned it could be related to the booster.
Patient was given 0.25mcg Moderna Bivalent Booster, patient was to receive 0.5mcg. Wrong dose given.
77 year old man with PMH of dementia.  He is acutely confused, history obtained from his wife who is a poor historian herself.  Has had worsening confusion over the past week. Has had decreased PO intake for about 3 days. No fevers, chills. Has chronic sinus issues. Has a little bit of a cough. No CP. He has been constipated. No vomiting.  He has been falling a lot lately. May have some coughing with eating. He has been vaccinated and boosted, moderna, booster on 12/10/21.  On arrival to the ED, he had a T of 97.2, heart rate of 120, blood pressure 126/74.  Labs show white count 15.9, hemoglobin 17, platelets 180.  Chemistry with sodium 160, potassium 4.8, chloride 118, bicarb 17, anion gap 25, BUN 69, creatinine 3.4 (baseline 0.8 in 2020) calcium 11.4, magnesium 3.4, AST 107, ALT 45, lactate 6.5, procalcitonin 7.16, troponin 96.  ABG on room air 7.47/27/68/95%.  He is COVID positive.  Chest x-ray with low lung volumes with possible left basilar infiltrate.  CT head with severe cerebral atrophy with frontotemporal predominance in no acute intracranial process.  PT IS INPATIENT AT THIS TIME.
I received the 1st Pfizer shot 09/10/21 and on 09/12/21 I woke up with severe arthritis in both hips. I waited for it to subside and it hasn't. My right hip feels unstable more so than the left and the pain radiates down from the outside of both hip joint down to the outside of both knee joints especially when I walk. I opted to get the J and J instead of the 2nd Pfizer and received that on 10/04/21, 24 days after the 1st Pfizer. I prompted my doctor to test me for autoimmune disorder (psoriatic, rheumatoid arthritis) which came back negative for all tests. I spoke with a pharmacist who said that people may have a reaction to the polyethelene (sic) glycol which the vaccine contains. I am very upset that it appears I may have to live with this for the rest of my life!!
Itchiness at site, rash from site to neck. Feverish (number not reported/not taken). Swelling at site to underarm.
Right deltoid about 2.5cm erythema, warmth; Left arm about 8x10cm warmth, erythema; No urticaria
Patient received Anthrax on 2 mar 04 Subsequently after .5cc (Bioport FAV 082) LA (Tricep area) Pt came into Immunization Dept 4 Mar 04 at 13:15. Complained of left upper very erythemic, edematous, tender to touch- unable to straighten out fully without greater pain. Stated he took 1 Motrin 800 on 3 Mar 04- but pain swelling greater as this was 1st time it happened with his Anthrax. Referred to PCM examined. Treatment Motrin 800 mg orally as needed every 8 hours for 72 hours. Ice pack to affected area. Avoid heavy lifting and use left arm for 72 hours- Return to clinic whenever necessary. Pt returned to duty.
Fever 102,  severe chills, severe body aches, headache, severe fatigue. Recovered completely after  48hrs. Stayed home from work for 1 day.
Tested Positive for Covid, after the first vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's daughter) reported for a 89-year-old female Patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: Blood pressure high. The patient experienced tested positive for covid, after the first vaccine on 28Jan2021. Reported as Yes, I have a question concerning my mother. She took the Pfizer vaccine, first shot on 27Jan. She got the Covid, tested positive and got the antibody serum on 09Feb. After she received the serum, they told her that she would have to wait for 9 days in order to start her vaccine program over again. So, she has to take two shots. Is that correct." The patient underwent lab tests and procedures which included covid-19: positive on 28Jan2021. Therapeutic measures were taken as a result of tested positive for covid, after the first vaccine. She took antibodies infusion serum for Covid. The outcome of the event was resolving.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.; Sender's Comments: Based on the close temporal relationship, the association between the event COVID-19 positive with BNT162b2 can not be fully 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.