chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible headache; had a combination of both Pfizer and Moderna; had a combination of both Pfizer and Moderna; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Terrible headache), COVID-19 IMMUNISATION (had a combination of both Pfizer and Moderna) and INTERCHANGE OF VACCINE PRODUCTS (had a combination of both Pfizer and Moderna) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Occipital neuralgia.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Terrible headache), COVID-19 IMMUNISATION (had a combination of both Pfizer and Moderna) and INTERCHANGE OF VACCINE PRODUCTS (had a combination of both Pfizer and Moderna). At the time of the report, HEADACHE (Terrible headache) had resolved and COVID-19 IMMUNISATION (had a combination of both Pfizer and Moderna) and INTERCHANGE OF VACCINE PRODUCTS (had a combination of both Pfizer and Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Patient had a mixture of both Pfizer and Moderna. Patient reported that the occipital neuralgia was a worsening and noting it started days after the vaccine. This last time it started 5 days but before that with each vaccine patient had occipital neuralgia patient did not got it from the vaccine.  Patient reported that after getting each dose patient got a terrible headache, the first one lasted for few days and after the second one had a terrible headache for 2 weeks.  No treatment information was provided.
12 hours after the injection on 4/14/2020, I developed chills and muscle ache which resolved on 4/15/2020. On Friday evening 4/16/2020, I developed an itchy red rash all over my body. Rash and itching persists as of time of completing this form. I developed the same but milder rash 2-3 days after the first Pfizer shot as well.
It seems like my arthritis pain has seemed to have gotten worse, especially in my feet, I thought I had broken my toe, it was swelling, I could not wear shoes, I had to but wide shoes to even be able to wear shoes comfortably. I made an appointment with the doctor who performed an exam, she said it wasn't broken, but it did feel like arthritis was in the toe. She gave me steroid shot, advised me take ibuprofen when I had a flare. I issue is not as bad but my feet do still hurt me, it's not as intense but the pain is there.
This spontaneous report as received from a consumer refers to her cousin of unkonwn age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, strength, frequency, route and lot number were not reported). Secondary and concomitant therapies were not reported. The patient's cousin stated "that her cousin was diagnosed with autism, after receiving M-M-R II (dose, strength, frequency, route and lot number were not reported). Secondary and concomitant therapies were not reported. The patient's cousin stated "that her cousin was diagnosed with autism, after receiving M-M-R II. The outcome autism was not reported. Additional information is not expected because no reporter details were provided.
had sitffening of whole body, rolling of eye, frothing at mough & making gurgling sounds noticed by mom when was driving-taken to ER-but in ER was fine;
3-20-12 Mom states child had bad bright red rash to (R) thigh. The red spots are on his legs, arms, face, trunk area. The spots mom states are raised but not oozy. No fever. States he is itching. 3-22-12 Went to dr and got blood test drawn. Dr prescribed a cream but hasn't got it cause it not covered by medical card.
just felt very tired, headache and had a fever of 38 the following day.  OK by the next day and fever gone.  Arm  still a little sore
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 03/10/2023. I didn't contact my doctor and decided to wait it out. After about five days, I felt worse, and I went to the hospital for a couple of days. I had a high fever, low oxygen level and just felt bad. I never had congestion or a runny nose. As of today, I am feeling better with no lingering symptoms.
myocarditis; myocarditis; rapid heart beating; shortness of breathing; tingling all over body; unable to sleep when lay down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "abnormal hormones" (unspecified if ongoing); "myocarditis symptoms", start date: 2020 (unspecified if ongoing), notes: myocarditis symptoms back in 2020. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), DISEASE RECURRENCE (medically significant), all with latency 3 weeks after the suspect product(s) administration, outcome "recovered" and all described as "myocarditis"; HEART RATE INCREASED (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "rapid heart beating"; DYSPNOEA (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovering", described as "shortness of breathing"; PARAESTHESIA (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "tingling all over body"; INSOMNIA (non-serious), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "unable to sleep when lay down".   Clinical course: Her myocarditis symptoms back in 2020. Patient was a female with PCOS and abnormal hormones. She had experienced symptoms of myocarditis 3 weeks after her first dose of Pfizer. She had rapid heart beating, shortness of breathing, tingling all over her body and unable to sleep when she lay down. After her symptoms which lasted about a month they stopped and she has random shortness of breaths and no other symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Throat hurting; Crying; Lymph nodes are swollen; fever of 99; This is a spontaneous report from a contactable consumer or other non-health care professional. This reported reported for her granddaughter. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not re-ported. On an unspecified date in Aug2021, the patient experienced throat hurting, crying , lymph nodes are swollen, fever of 99. It was further stated that reporter stated, Well I am calling about my granddaughter. She got her first COVID shot on 04Aug (Confirmed as 04Aug2021) but she is having side effects or something after 3 days. She, her throat hurting she is crying. I need to know what to do about that. I do not have the lot no right now, should she go and see somebody? Obviously right? because it is her lymph nodes are swollen and she has a fever of 99, yesterday she did not have any fe-ver. When asked to provide the medical information department, reporter stated, No that was okay. I will just take her in else somewhere. The patient underwent lab tests and procedures which included pyrexia: normal yesterday she did not have any fever, pyrexia: 99 on an unspecified date. The clinical outcome for all the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 17-DEC-2015 the patient was vaccinated with the first dose of GARDASIL (dose, lot# and route unknown). On 01-MAR-2016 the patient was vaccinated with the second dose of GARDASIL (lot # L006549, dose and route unknown). No adverse effects were reported. Additional information has been requested.
15-20 days after the 2nd vaccine is when he started to feel the neck pain, tingling in shoulder down to finger tips, tingling/pain behind left thigh, along with chills/cold feeling throughout the body. He also stated that the injection site just feels hard (he stated the pharmacist got injected in the wrong tendon).  Patient stated he stretched and exercised but the pain hasn't subsided. He stated that he took tylenol but not for long and it helped with the pain but not the tingling.   As of 4/12/21 @1:15pm patients symptoms have subsided only thing he still feeling is the neck pain and a little tingling. Patient took tylenol and applied icey hot and didn't help.  Advised patient to take the tylenol and possibly get a muscle relaxer cream otc to apply to neck along with applying an ice pack. Patient stated he will schedule an appt with his PCP for friday 4/16/21. Will follow up on 4/14/21.   Rcvd follow up call on 4/17/2021 at 9:45am: Pt reports that his PCP prescribed him Prednisone 10 mg to be taken twice a day for 3 days first, if pt is still have pain or discomfort PCP advised to take Prednisone for additional 2 more days. PCP had also recommended pt to discontinue use of heat, and to apply ice gel pack around the neck and shoulder area. Pt reports he has been applying the ice gel pack for 10-15 minutes on and off, seems to help with the pain and inflammation but the tingling sensation is still there. Pt reports he can sleep on his side and back now after following PCP recommendations. Pt have a follow up appt with PCP on Wednesday 4/21/2021 for re-evaulation, if symptoms has not gotten better or subsided than PCP will prescribe nerve testing to be done and refer to a neruologist. Pt reports that on the pain scale of 1-10, when the symptoms started his pain level was a 9 but now it is at a 4. As of today (4/17/2021), pt reports the can completely rotate his head to the right with no problem but still have limited range of motion to the left side of his neck (causing discomfort and pain). Pt describes the tingling sensations as "feels like little ants in me, like there is thousand of them" and "cold rushing liquid feeling"; this tingling sensation is happening throughout the day. The tingling sensations are triggered by simply laying his left arm on the desk or doing simple task like typing on a keyboard occurring anywhere from 3-5 seconds duration. The pain in his left arm gets trigger depending on his left arm movement. Pt also reports there is still pain down the back of his left thigh (sore, tight, and throbbing pain feeling). Pt reported that the Publix Pharmacist may have struck a tendon in his left shoulder area, per pt stated the pharmacist administered the injection from behind him injecting the syringe at a diagonal angle.
Pt complains of arm pain when moves arm feels started at time of injection cannot sleep on arm or move without feeling pain.  There was and is no bruising or lump on 11-3-14 when pt reported.
Puncture site began itching with redness and swelling, continued for 8 days.
Chest pains that lasted on and off; Sweating; Tired; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains that lasted on and off), HYPERHIDROSIS (Sweating), HEADACHE (Headache), FATIGUE (Tired) and PYREXIA (Fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced HEADACHE (Headache). On 08-May-2021, the patient experienced CHEST PAIN (Chest pains that lasted on and off), HYPERHIDROSIS (Sweating), FATIGUE (Tired) and PYREXIA (Fever). On 08-May-2021, CHEST PAIN (Chest pains that lasted on and off), HYPERHIDROSIS (Sweating) and PYREXIA (Fever) had resolved. On 09-May-2021, HEADACHE (Headache) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Grandmother reported 24 hours after receiving flu shot pt had large "lemon" size knot at injection site with some elevated temperature. Given TYLENOL, warm compresses to site.
No adverse affects reported; improperly stored doses of GARDASIL 9 has been administered to the patient on 5/26/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 26-MAY-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1621931, expiration date 26-JAN-2022; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was 30.2 Fahrenheit degree for 1 hour. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I reported using v-Safe for several days after the shot that I had mild symptoms; redness at injection site, mild swelling, ache.  That got steadily better each day, as reported to v-Safe each day.  Then v-Safe stopped asking.  On Day 9, 1/25/2021, my left arm started to itch at the injection site.  It then turned red in a 3-4" area, and on Day 10, 1/26/2021, the itching was so strong that I used a calming cream (ineffective), later followed by Hydrocortisone 1%.  Today, Day 10, 1/27/2021, is moderated, 2" red area, but still itching.
flu like symptoms (headache, body aches); feels weak and woozy; feels weak and woozy; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that an 82-year-old female patient started to receive bnt162b2 (manufacturer not specified), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced flu like symptoms (headache, body aches) yesterday she was feeling better but now feels weak and woozy The final outcome of events was reported as unknown.    Information on the Lot/Batch number has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication. On or about 01-APR-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 28-SEP-2015, the patient was treated by the physician for the onset of a rash, which was diagnosed as herpes zoster, or shingles. On or about 20-OCT-2015, the patient sought subsequent treatment from another physician for the onset of a rash, which was diagnosed as herpes zoster ophthalmic. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, herpes zoster ophthalmic was determined to be medically significant. Additional information has been requested.
Patient previously received first dose of Pfizer (Lot# 30145BA) on 10/20/21. Clinic ran out of Pfizer and could not provide her a 2nd dose of the same series. Patient asked if she may receive Moderna instead. Patient was administered a full dose of Moderna (Lot# 012F21A) on 11/17/21 at 16:28 and did not have any allergic reaction or adverse event during 15 min monitoring period nor upon leaving.    Moderna Lot #11F21A, exp 1/19/2021
At 6:45am on March 16, I felt my right eye cross inward.  I experienced double vision for approximately 5-8 minutes.  I checked my blood pressure, which was 158/89.  After about 10 minutes, my vision returned to normal.  I immediately went to the emergency department and was admitted.  I was diagnosed with a TIA.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received  on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Patient started with headache the night of vaccine and took Tylenol.   By 3am patient woke up with shakes, chills, fever, and did not feel well.  Patient ate very little and drank many fluids that day. In the morning of 5/6 patient noticed rash all over the body: back of body from hairline to buttocks--full back, back of upper arms, under breast and under belly line to private area--nothing on legs or feet or hands. Patient went to walk in clinic and prescribed Hydroxyzine HCL 25 mg, every 6 hours. Today patient is doing much better. Almost 75% of rash is gone; it is just pale rash now.  Patient's appetite is also back to normal.   Doctor's fax: 703.239.0442
Information has been received from a nurse concerning a 53 year old female patient in her practice who on 04-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669406/1357Z, Exp 15-JAN-2012). The nurse reported that the patient experienced low grade fever, injection site redness and pain after receipt of ZOSTAVAX (Merck), the patient went to see doctor. At the time of the report, the status of the patient was not reported. This is one of several reports received from the same source. The nurse requested a lot check for the lot number. A lot check has been initiated. Additional information has been requested.
The patient had: running nose, itching, chest cold, cough, increase blood pressure, according to the patient's daughter. Symptoms start 2 hours after vaccination.
Per RN at the clinic --- Pt c/o nausea, dry mouth, legs shaky, vertigo.  BP 140/100.  Pt was taken home by fellow colleague to be with husband.  No improvement so he took her to ER.   after 4PM- Employee/Nurse went to see how she was & she had already gone home.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number N011867 and expiration date of 08-NOV-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 9°C to 25°C with a time frame of 1 hour. There was no information regarding previous temperature excursion nor data logger involved. There was not product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA002495: US-009507513-1712USA002496: US-009507513-1711USA007577:
Patient was a 12 year old male who was inadvertently given a Pfizer 5-11 2nd dose.  No adverse effects were noted on patient; patient's mother was notified about the incident on 4/30/22.
Patient complained of "light headedness", hot face, grabbed throat, breathing appeared difficult.  Suspected angioedema.  Admin Epi pen 0.6mg at 11:43 am and called EMS.  At 11:45 am patient talked and said was getting better.  ER arrived approximately 11:48 am.  Patient returned to pharmacy P/O ID/C meds 3:07 pm.  Prednisone 40mg QD, Benadryl 25mg Q 6 hours, Pepcid 20mg Q 12 hours for 5 days.
pt had a positive COVID test on 8/16/21; was prescribed a Medrol Dosepak and Azithromycin; 8/20/21 pt to ED with increasing cough, SOB, hypoxia - O2 saturation 77% on RA; given O2 supplementation; developed worsening infection and sepsis with respiratory failure and ARDS; Decadron; required intubation with mechanical ventilation; not a Remdesivir candidate due to renal dysfunction; during hemodialysis, pt developed bradycardia hypotension and arrested; CPR, ACLS protocol performed; pulse returned then pt arrested again; ROSC; pt's family changed status to DNR and he passed away in the hospital
Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time