chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was vomiting and felt nauseous; she was vomiting and felt nauseous; This is a spontaneous report from a contactable consumer (patient).   This female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 13Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on 23Dec2020 for covid-19 immunisation and had a sore arm and her head felt heavy. On 13Jan2021 about an hour after the second dose, the patient was vomiting and felt nauseous with outcome of recovered on 14Jan2021.  Information about lot/batch number has been requested.
Severe right shoulder pain starting within a couple hours after injection.   Pain is sometimes entire arm, and sometimes only in shoulder.  Experiencing sharp pain.  Arm experiencing  numbness, tingling and pain.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284750 (same reporter). This case involves an eight year old patient (gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number U1997A and Exp. Date 30 Jun 2019) via intramuscular route in the left deltoid on 03-Oct-2018, which was outside of the recommended temp range (below 32F). The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Dizziness immediately after getting/lightheaded; Headache immediately after getting; Rash up arm and across chest; having difficulty breathing; nausea; vomited a little bit, just clear liquid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Lot number: FC 3181, Expiration Date: 31Oct2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness immediately after getting/lightheaded"; HEADACHE (non-serious), outcome "unknown", described as "Headache immediately after getting"; RASH (non-serious), outcome "unknown", described as "Rash up arm and across chest"; DYSPNOEA (non-serious), outcome "unknown", described as "having difficulty breathing"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; VOMITING (non-serious), outcome "unknown", described as "vomited a little bit, just clear liquid".  Additional information: A pharmacist noticed a few side effects from 4 patients in one week that were all the same and were coming from the same Lot FC3181. Four people have had same or similar side effects with a same batch headache immediately, dizziness immediately, rash going up the arm and across the chest, all within this last week. A female within 5 minutes had dizziness and lightheaded, she started having difficulty breathing, all vitals were good, also had nausea and vomited a little bit, just clear liquid. No further details provided.  Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070497 Same reporter/drug, different patient/similar AE;US-PFIZER INC-202101070496 same reporter/drug, different patient/similar AE;US-PFIZER INC-202101070495 Same reporter/drug, different patient/similar AE
100 degree fever for 24 hours, general body aches and lethargy.  36 hours later the fever is gone but lingering, less severe aches
Inflammation around sinus area, ears, eyes, and lower back of head. Dizziness and balance problems. Brain fog (impaired thinking). All symptoms continued to get worse for 2 weeks after initial dose. Took 1600 mg of ibuprofen daily to reduce symptoms with limited success. Stopped ibuprofen after 1 week due to upset stomach. Used natural anti-inflammatories (alpha lipoic acid 600 mg).Dizziness and balance problems improved and were mostly resolved by the end of week 4. Brain fog slowly improved and  mostly resolved by the end of week 5. Inflammation in head still present around right ear even after week 7. Inflammation is the worst sleeping flat on back. Must sleep in reclined position.
medical assistant administered a 3-day expired MENACTRA to a patient with no adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old female patient who experienced medical assistant administered a 3-day expired menactra to a patient with no adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Apr-2022, the patient received suspect Meningococcal a-c-y-w135 (d conj) vaccine Solution for injection at a dose of 0.5 ml once (strength, expiry date :unknown) lot number not reported via unknown route in unknown administration site for vaccination.  On 18-APR-2022 the patient developed a non-serious medical assistant administered a 3-day expired menactra to a patient with no adverse event (expired product administered) (latency :same day) following the administration of Meningococcal a-c-y-w135 (d conj) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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.
Fatigue, ,increased cough, egg sized swelling and pain in right arm, loss of appetite, general feeling of something not right beginning  mid day after the injection and continuing now, two days after injection.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. The reporter considered the vaccination failure and pertussis to be related to DTPa vaccine. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the reporter had 3 sons who all were highly allergic to the pertussis in the DPT vaccine so they ended up having the DT shots without the P but her daughters were fine and did not have an issue. None of her sons ever got whooping cough but one of their sons (the patient) did have whooping cough and he did have the vaccine. This was something the reporter always wondered about. This case was considered as suspected vaccination failure, since the laboratory confirmation and time to event onset was not provided. The reporter was not willing to contact for GlaxoSmithKline safety team to discuss further.
22 yo male with h/o leg numbness with onset of symptoms during the 1st week in July, awoke in the AM with patchy numbness in the legs bilaterally to the mid-thigh, stable since onset without worsening or improvement. He reports that his walking and leg movements become more difficult as the day progresses; they are better in the AM, but not normal. In the morning, he has persistent numbness, with decreased speed of walking, reports inability to jog or run (may catch himself or have the feeling that his legs are 'going out.)' He reports that later in the day he may have increase in his 'lack of feeling' and increased difficulty walking. His strength and sensation in the arms are normal, possibly slightly decreased due to lack of exercise. He reports that he had problems with achieving erections initially, although reports that this has normalized for the past two weeks. Bowel and bladder function are normal; last bowel movement last PM, with normal frequency of bowel movements over the past month. He reports urination is normal as well, has not noted increased urinary frequency, urinary urgency, or incontinence, and has had no bowel incontinence. Seen by doctor on the 17th of July who recommended prompt referral to Neurology. He went out of town for a weekend, reports that he saw a doctor, with MRI's done at hospital. Denies any prior similar episodes or family history of similar problems. He denies any recent illness or fevers. He was last deployed early this year (returned 1/09/08).  SEE ATTACHED NEUROLOGY SUMMARY. INITIALLY PT QUESTIONED THAT HIS SYMPTOMS WERE RELATED TO HIS 2ND ANTHRAX VACCINE, BUT DID NOT PROVIDE DOCUMENTATION OF A MORE RECENT ANTHRAX VACCINE. 9/26/08 Case closed w/medical records that accompanied report.   FINAL DX: Guillain Barre syndrome Records reveal patient experienced numbness of legs, difficulty walking; sexual dysfunction early July, 2008.  Seen by ortho clinic & referred to neuro clinic 8/4/08.  Decreased bilateral LE reflexes.  Tx w/IVIG.  Improved approx 16 days s/p IVIG w/resolution of numbness knees to ankles.  However, feet/ankles numbness & weakness persisted; & legs tire quickly.
I had a fever and body aches about 10 hours after injection but around 13 hours after vaccination, I started having a severe burning sensation down my left arm and left leg.  It subsided after about 30 minutes but I was left with paresthesia in my left arm and left leg.  I occasionally have sharp nerve pains in my left calf and foot.  My hand was slightly numb for the first two weeks after this occurrence but has since recovered.  The paresthesia symptoms have not subsided.  I am currently scheduled to see a neurologist.
Moderately severe aches of large muscle groups, bilaterally, of the trunk and limbs and left neck (unilaterally). Chills, no detectable fever when checked with thermometer. Vaccine administration site swelling, peak approximately 2x3cm diameter at 24-30hrs post-administration, induration with mild redness. Symptoms persisted approximately 48 hrs; residual administration site soreness persists as of 1355CST on 5Sep19. Self-care:  bed-rest 8hrs, limited activities for 2days, and 1600mg motrin divided into 4 doses on 3-4Sep19. Have received most vaccines, from Anthrax to Japanese Encephalitis, and Rabies to Yellow Fever as an adult; the 2nd dose of Shingrix was associated with the most marked adverse event I've ever experienced, and the first one I've ever reported on myself-- although VAERS reporting was part of my job for years.
hair has been falling; eyebrows thinned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN.), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair has been falling"; MADAROSIS (non-serious), outcome "unknown", described as "eyebrows thinned".  Additional information: Caller states that her hair has been falling ever since she got the second shot of the Pfizer Vaccine. Caller would like to know what to do and when it will be out of her system. Caller reports that her hair has been falling out all day long since the covid vaccine. She reports her eyebrows thinned out first. States she didn't' think it was the shot, her eyebrows almost disappeared. Proceeds to state after the second shot is when it started.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
not feel well after the first dose; Tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported for a male patient (son-in -law) received first dose of bnt162b2 (Covid 19 vaccine; solution for injection) via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunisation. The patient medical history and Concomitant medications were not reported. The patient tested positive for Covid-19 on 25Mar2021 after getting the first dose of Pfizer vaccine. The patient did not feel well after the first dose. The patient underwent lab tests and procedures which included Covid 19 positive on 25Mar2021. The outcome of the events was unknown.   Information about Lot/batch number requested.
PREPARATION AND ADMINISTRATION ERROR. PATIENT RECEIVED 180 MCG OF PFIZER COVID 19 VACCINE IM.
Client reports waking up at 6:45am the day after receiving the Pfizer booster @ approx 3:15pm. States that she went to brush her teeth and when she looked in the mirror, she noticed that both of her lips and jaw/cheeks were swollen. Other symptoms included numbness of both lips and some difficulty swallowing. Client call at approx 9:30am on 11/15/22 to report symptoms, at which time, she was advised to notify and be seen by her PCP. At the time she called, she said that the swelling had improved but she continued to have numbness in both lips with some tingling sensations described as the numbness wearing off after a dental appointment. Denies any difficulty breathing, tongue or throat swelling. Spoke with client on 11/17/22. Per client she was advised to take Tylenol by her PCP. Reported that she continued to have numbness in in lower lip. Client presented to clinic 11/21/22 for and stated that she continues to have numbness in her mid-lower lip.
Information has been received from a health professional concerning a patients who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 24-MAY-2007, the patient was diagnosed with chickenpox and currently waiting for blood work. The patient was seen in physician's office on 09-AUG-2007. The physician was in the process of determining if the reaction patient had was poison ivy or chickenpox. The physician was waiting for the blood work to confirm whether this was a chickenpox reaction. The physician did not want to provide any more information yet. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Additional information is expected.
covid vaccine was placed in refrigerator and was expired past 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter. No Treatment medications were provided by reporter.
Information has been received from a physician concerning a 20 month old white male who on 16APR2003 was vaccinated in the left thigh with a first dose of varicella virus vaccine live. There was no concomitant medication. ON 25APR2003 the patient had the onset of a varicella rash with the first lesions being seen. On 28APR2003 the patient was seen in the office and the patient was confirmed to have a classic diffuse vesicular rash . It was noted that the patient had no adverse events following prior vaccination. The reporter indicated that on 22MAY2003 the patient was seen and was well. No further information is expected.
Pt was given 0.25 mL of Bivalent booster, should have been given  0.5 mL. parents contacted and letter sent to home. Pt will come back in 2 months for full dosage.
PATIENT RECEIVED HER FLUZONE HD LOT # UJ285AA EXP 6/2/20.  AFTER 10 DAYS SHE GOT TINGLING IN FEET, DIZZY.  WENT TO URGENT CARE THOUGHT SHE HURT BACK.  GOT MUSCLE RELAXANT.  NEXT DAY FELT TERRIBLE WENT TO HOSPITAL AND WAS HOSPITALIZED FOR THREE WEEKS! Then she was sent to a rehab for 3 more weeks after that. Came back to town and came to see me and was told I needed to fill out a form. Don't know if hospital DID ANYTHING.
Nausea; fever; Pain and swelling in left arm; Pain and swelling in left arm; headache; muscle pain; Body pain; This is a spontaneous report from a contactable consumer (reported for herself). A 48-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP7534/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 at 14:45 (at the age of 48-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. Medical history included covid-19 from an unknown date and unknown if ongoing (If covid prior vaccination: Yes). Concomitant medication(s) included sumatriptan succinate (IMITREX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient experienced nausea on 22Mar2021 at 17:00, fever, pain and swelling in left arm, headache, muscle pain and body pain on an unspecified date in 2021. No treatment was given for the events. The clinical course was as follows: muscle pain a Injection site that spreads to shoulders and left jaw. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
very weak in knees and ankles as well as all over. no appetite. stayed in bed all day sleeping
pt felt lethargic @ 2PM; woke up 230AM 13OCT w/dyspnea & chills; some chest pain; t101; seen in ER: mid sternal chest pain, kept waking up, hot, t101, tachycardia, pyuria, pain, aches;
Information has been received from a medical assistant who reported that on 03-MAY-2007 another medical assistant at the office had part of the Pneumovax 23 splash in her eye while withdrawing the vaccine into a syringe. The medical assistant complained of burning. Her eyes were rinsed with an eye wash. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Within 18 hours his penis had swollen up  mostly on the left side (the shot was injected into  the left thigh).  It resolved in about 10 days.
5 hours after vaccine -> upset stomach aching all over felt chills cold took ADVIL. Next day very bloodshot eyes, still achy started to feel better after 24 hours. Completely better after 36 hours.
Received 1st dose a few years ago, recently given second; This case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received few years ago prior to the reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: Reporter's Comment: The vaccine field representative reported on behalf of a provider who was reported that the patient received a first dose of Shingrix vaccine a couple, or a few years ago and just recently received the second dose of Shingrix vaccine. The field representative initially stated that the provider said first dose of the series was received about 10 years ago, and then the field representative was attempted to clarify whether vaccine given was Zostavax or Shingrix, but the provider thought it was a shingrix dose given a few years ago. The provider was in rush and the representative was unable to clarify further. The provider was unaware of this was being reported to safety, and the representative did not ask the provider whether safety had permission to follow up. The reporter did consent to follow up Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Diffused itching & hives / rashes Mild pain in the arm where the shot was administered
Petechia type rash on arms, chest, back, neck and hives behind knees, down legs and on left ear
Large swelling in arm, size of baseball. Flu like symptoms. Two days of severe muscle pain (I have muscular dystrophy) then had outbreak of Herpes (I have genital herpes) severe. Severe headache for two days. Flu like symptoms decreased after 6 days.