chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIZZINESS; This spontaneous report received from a patient concerned a male 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 not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness. This report was non-serious.
Patient came in 2 wks after vaccine's were given complaining of pain in her arm that radiates down her arm.  Pain still persists & wakes pt up at night.  She has been treating it with ADVIL.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 19-OCT-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (lot # 0468AE, exp date 04-APR-2013) (dose and route of administration were not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
high pitch scream, area around rt thigh red & hard, fussy;took temp as soon as got home was 102 oral stayed @ 102 for 5hr;
injection site arm hurts; injection site arm is red; injection site arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site arm hurts), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE SWELLING (injection site arm swollen) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (injection site arm hurts), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE SWELLING (injection site arm swollen). At the time of the report, VACCINATION SITE PAIN (injection site arm hurts), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE SWELLING (injection site arm swollen) outcome was unknown. Not Provided      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.
Temp elevated 104.5 after vaccinations per mom. Afebrile now. "Red spots" on (R) leg. No treatment given - cool compress prn.
On 08/29/2021, I started having congestion and a little bit of cough. On Wed. 09/01/2021, I had my medicine check and that's when I knew I had COVID-19. I was given a COVID-19 --Positive. On 09/03/2021, I had a IV-Synthetic antibodies.
dose was given too soon from first dose.  (14 days apart) .  error in administration was noticed after injection given.  no immediate problems with patient occurred.
Patient came into pharmacy 9/21 to report that 9/19-20 she was feeling exhausted, lethargic, dizzy, her arm below injection site was red and hot (approx 3 inches in diameter, not surrounding shot, but approx 1/2 inch below), and a sore at edge of Band-Aid of unknown cause.
headache; tired with first dose; foggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Feb2021 10:30 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 16Feb2021, outcome "recovered" (18Feb2021), described as "headache"; FATIGUE (non-serious) with onset 16Feb2021, outcome "recovered" (18Feb2021), described as "tired with first dose"; FEELING ABNORMAL (non-serious) with onset 16Feb2021, outcome "recovered" (18Feb2021), described as "foggy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hand trembling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "hand trembling". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Let thigh with swelling and redness on lateral upper thigh measuring 6 cm by 8cm. Induration in center of redness measuring 3cm by 5 cm.
patient started experiencing generalized body aches (moderate - severe, worse in bilateral hips), fatigue (moderate), tachycardia, and low grade fever the day after getting 2nd covid19 vaccination with Pfizer.
Sore arm the day after; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 25Mar2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown that the patient diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 26Mar2021, the patient experienced sore arm the day after vaccination. The clinical outcome of the event sore arm was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
diarrhea; upset stomach; redness at injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site). On 08-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL DISCOMFORT (upset stomach). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
NONE H1N1 intranasal vaccine given to patient before the age of 2 years dose misadministration
Headache; This is a spontaneous report received from a Pfizer sponsored Program from a contactable consumer or other non hcp. A female patient of an unspecified age received her 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 an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. The event was assessed as non-serious. The outcome of the event was reported as unknown.  Follow-up attempts completed. No further information expected
Patient is fully vaccinated.  Hospitalized on 12/8/2021 for 5 days and tested + for COVID 12/8.  90-year-old female patient presented to the ED yesterday for urinary frequency. Acute Hypoxic Respiratory Failure, COVID 19 Viral Pneumonia. The patient states that she does not have any shortness of breath, cough, chest pain, nausea, vomiting, or diarrhea, though she is on 3 L of nasal cannula when assessed.  The patient states that she does not really know why she is here, though she does have a history of recurrent UTIs as well as overactive bladder with no other past medical history on file. CXR Bibasilar infiltrate or atelectasis. Treatment:  oxygen, steroids, antimicrobial, remdesivir. Discharged.
Pt has been experiencing moderate muscle pain in the site of injection consistently since October. Says she believes it is due to the immunization. Recommended she see a physician as soon as possible.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (After 3rd dose was sick for about 2 weeks) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 003B21A) for COVID-19 vaccination. Concomitant products included: Lisinopril; Atenolol; Oxycodone; Tizanidine; Multivitamin for Women; Baby Aspirin; Fish Oil; Cranberry Concentrate [Vaccinium Macrocarpon]) for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (After 3rd dose was sick for about 2 weeks). At the time of the report, ILLNESS (After 3rd dose was sick for about 2 weeks) had resolved. No medical history was provided by the reporter. On 02 Dec 2021 patient received booster dose with the lot number 05 or 6 8H21A. No treatment information was provided. This case was linked to MOD-2022-470445 (Patient Link).
Case number PHEH2014US011746 is an initial spontaneous report received from a nurse on 09 Jun 2014. This report refers to a 11 year old female patient. Her past medical history and concomitant medications were not reported. The patient inadvertently received only Men CWY liquid conjugate component of MENVEO (batch number: M13014) without reconstitution with Men A lyophilized component intramuscularly on 29 May 2014. No adverse events were reported following this medication error.
Joint (mostly left knee) pain/Wrist pain (both); Back pain (upper & lower); Pain on left side of body; Sciatic nerve pain; Headaches; Weak hands; Nerve pain in second toe on right foot; Stomach pains; Pains on left side of abdomen; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female (non-pregnant) received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot number EW0182) via an unspecified route of administration on 09Jun2021 at 05:15 AM administered in Left arm as dose 1, single for covid-19 immunization. Medical history included EPI, IBS, Subclinical Hyperthyroidism. Concomitant medications included the patient received within 2 weeks of vaccination: Dietary supplements, herbal supplement and teas. Known allergies included Lactose intolerant, shellfish, vicodin, tetracycline, doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Jun2021, the patient experienced Joint (mostly left knee) pain, Back pain (upper & lower), Wrist pain (both), Pain on left side of body, Sciatic nerve pain, Headaches, Weak hands, Nerve pain in second toe on right foot, Stomach pains, Pains on left side of abdomen. The patient had a physician office visit due to the events. The patient did not take any treatment for the events. The outcome of the events was Recovered with lasting effects.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
after the first dose, he came home and that night he had a headache, the nest day he still had a headache and on this day he went to urgent care, after the second day he had a really bad headache was dizzy and had fever he could not get out of bed. he went to urgent care on the second day also. Urgent care suggested he visit his primary doctor.  On the third day he visited his PCP, the PCP took xray and MRI and prescribed painkillers. The primary doctor stated it was ok to take the second dose and after taking the second does of the vaccine that was taken at the same location and the lot number is EW0183 he got really sick. He had the same symptoms after the second dose but they became more severe. Also has severe pain in left side down abdomen.
103 degree fever for 15 hours before diminishing to 100 degrees for another 12 hours.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown dates the patient was vaccinated with GARDASIL (route, dose and lot number unknown) doses 1 and 2. The pharmacist reported that the patient received his first 2 doses of GARDASIL on unspecified dates and was due to receive his third dose on an unspecified date approximately one year ago. The patient would like to receive his third dose now. No adverse symptoms reported. Additional information has been requested.
First two weeks after the shot there were no  noteworthy issues. Approximately two weeks  later (March 11, 2021) I started to experience  deep upper body  aches.  It traveled down my left arm. This discomfort lasted throughout the 11th and 12th.  I took a pain reliever and the left arm stopped bothering me...my upper back and neck continued for the next three days.
PATIENT CAME BACK ON 5-6-19 AND STATED SHE HAD SEVER SWELLING AND ARTHRITIC PAIN DOWN HER ARM AND RIGHT HAND. SHE SAID IT STARTED ABOUT 3 DAYS AFTER VACCINE AND LASTED 4-5 DAYS. IT WAS HARD FOR HER TO MAKE A FIST. IT HAD RESOLVED ON ITS OWN BEFORE SHE STOPPED BY THE PHARMACY TO REPORT IT
Bell's palsy, R sided. R facial droop that started the morning of 4/12/21.
Pt told us he had adverse fear of needles and that he would be ok if we gave it to him. Pt started fading and turning white so he was told to lye down on the ground and became more responsive after that.
HYPOTENSION 2/24/2023 -- RECURRENCE OF SAME SYMPTOMS
Case number PHEH2015US003124, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 15 year old patient of unknown gender. Historical condition and concomitant medication were not reported. On 30 Jan 2015, the patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly at a dose of 0.5 ml. The reporter stated that, before vaccination the MENVEO had a temperature excursion. On 14 Jan 2015, it was stored at 0.4 degree Celsius for 16 hours and on 24 Jan 2015, it was stored at 0.8 degree C for 36 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
no adverse event reported but there was a administration error. Patient is less than 12 years of age and should have only received 2 doses. This patient received a total of 3 doses on 11/11/2021, 12/2/2021 and 5/2/2022
Non febrile sz 4 1/2 hrs p/vax; pt had pre existing sl rt cerebral ventriculomegaly @ birth); no prev sz activity hospitalized for spinal tap, CT;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and drug allergies/reactions were not reported. On an unknown date, the reporter stated that a patient missed a dose of GARDASIL but did not provide any additional information. It is unclear if the patient received the dose late. No adverse effects reported. At the time of the report, the outcome of patient missed a dose of GARDASIL was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 17-OCT-2012 16:10, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient had more localized redness; Patient was concerned that the second shot was given in the wrong spot on arm; Patient complained of body aches; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose in January 2022 and experienced Injection site Erythema, refer case US2022AMR085886).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, general body pain and vaccine administered at inappropriate site. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema and vaccine administered at inappropriate site were unknown and the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and general body pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR085886   Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: Patient received first dose of Shingrix back in January, 2022 and went in a month before reporting for second dose. Received both doses at local pharmacy, but when received the second dose, the shot was given lower in the deltoid region, more towards the inner arm. The patient had more localized redness than from the first dose and also complained of body aches for about a day or so after the second dose. Patient was concerned that the second shot was given in the wrong spot on arm due to the localized redness and body aches, especially since patient did not have these symptoms after the first dose. The reporter consented to follow up. Additional supportive information: The patient was concerned that the second shot was given in the wrong spot on arm, which led to vaccine administered at inappropriate site; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085886:Same reporter
Pt experiencing rapid heart rate at times of rest 120+ one week after injection.  Abdominal pain under ribs bilaterally.  Pain and tachycardia come and go and continue to come and go 4 weeks later.
Vomiting. Onset less than 1 hour from vaccination. No need for additional care or treatment.
pt recv vax 28SEP95 & that day devel fever, chills, swelling @ inj site, swelling & soreness of  inj arm & in the breast, along w/inflamed lymph glands;tx w/APAP;pt to ER on 30SEP95 w/malaise, neck pain & cont lymphadenopthy dx lymphadeniti
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, or concomitant medication. On an unknown date in 2013, 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, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2014, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt reports fever, chills, sore arm, nausea, fever 102F, fatigue.
Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensitivity.  I have migraine disease but since I began Aimovig injections nearly a year ago I have very few migraines,  Those I have had have been extremely mild, just headache usually relieved by otc meds. Additionally I have not had nausea and vomiting with any migraine episode for many years.  When I woke at yesterday morning, I was in extreme pain across the right side and back of my head and down to my neck and shoulders. 9 out 10. I took my prescription, Eletriptan .5 mg at 5:45 and went back to bed.  It gave little relief of symptoms. I was unable to sleep and at about 7 a.m. I was hit with waves of nausea and extreme violent vomiting. This last for several minutes. At approximately 9 a.m. I took a 2nd dose of Eletriptan and slept a little. Again at about 11: a.m. I was hit with another round of extreme nausea and vomiting which lasted about 5-6 minutes. I slept a bit and around 3 p.m. was finally able to drink a little water. Still very weak but pain had subsided significantly, down to about a 4 / 10.  By 6 pm. I was almost pain free ? symptom free though very weak still. Ate a little at about 7 p.m.  I know this was a migraine which I am diagnosed with but it was extreme even for me, and especially in recent years. It was very  unusual in timing and severity  and I felt it needed reporting.