chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 3MAR97 & 4MAR97 soon p/vax pt devel warmth in lt leg;the leg was warm to the touch;pt also devel ataxia;pt held lt leg & would not bear weight on it; Follow up received 8/01. Concommitant therapy included PPD skin test. It was reported that the patient experienced fever and fussiness for 48 hours following the vaccination. On Mary 4, 1997, "soon after shot", the patient developed warmth in left leg, and refused to stand, walk, or bear weight on the left leg. There was "no apparent reaction at the vaccine site". The patient was seen by a physician on Mary 6, 1997. The patient was not sleeping well at night, and would not walk since the time of the vaccination. The patient began to crawl again on March 6, 1997. There was no redness, swelling or induration at the injection site. The patient had no range of motion in hips or knee, but moved lower extremities equally in supine. Patient would flex leg at the hip and knee but there was no way to get patient to put foot down on the floor. The physician questioned whether this could be a neuropathy, and thought it could be a reaction to the varicella vaccine. The patient also developed eczema consisting of red raised bumps in the diaper area on March 9, 1997. Also, she was dragging her left foot when walking. The patient was seen again by a physician on March 10, 1997, at which time the patient was crawling. The patient began to bear weight and walk when using a push toy for balance. However, the patient did not lift right foot off the ground, but dragged it. Patient dragged the dorsum of fore foot on the ground and then moved into a plantar stance again. The patient did not pick left foot up off the ground very much, and was slightly pronating ankle. The patient seemed "a little weak", but did not seem to be any pain or distress. Her condition seemed improved since the time of the previous office visit, but she was "a long way" from her condition prior to vaccination. It was noted that the patient did not need the push toy for balance prior to the varicella vaccine; patient had been walking independently with good balance. The patient was seen on March 20, 1997, at which time her balance was still poor. Patient received physical therapy. Left leg was slightly weaker. As of March 21, 1997, the eczema persisted. Patient was being treated with hydrocortisone at that time. It was noted "slow but definite improvement to date." Follow-up information reported that the patient was seen on June 2, 1997 for 15-month well child check up. The physician noted that the patient had completely recovered. This is an amended report. The adverse event terms were changed from eczema, sleeping disorder, and warm sensation to atopic dermatitis, insomnia, and skin warm to touch. The recovery status was updated to yes. The onset date now reads 03/03/97 instead of 03/03/97.
My left arm was very sore when I went to bed and I couldn't lift it without help. Around 1am, I woke up feeling sweaty, hot and cold. It felt like a fever with chills. My arm was hurting worse than before and I had a terrible headache. I couldn't sleep for the rest of the night. Around 7am, I got up and took 2 tablets of acetaminophen. It relieved my headache and some of the pain in my arm. I'm very tired and moving slowly.
CDC revised administration of Covid vaccine by eliminating the monovalent and advising to administer with first dose bivalent. Days later it was advised to increase the initial dose of 6 months- 5 years bivalent Moderna to the 6 years and up. This vaccine was administered prior to the increase being communicated to us. It was only recognized when we attended a Moderna information session. This was not communicated until April 28th through the Department of Health
Pt recvd MMR vax on 27SEP91; w/in 6 hrs vax pt devel muscle pain in neck; pt was seen in ER: no further details were provided;
Seen on 1-22-07 with an overnight Hx sore throat and ear pain while swallowing. Parent were all sick, was afebrile at visit non-toxic, not ill-affecting, no exudates/lesions on tonsils. Pt was due for Varicella #2. Throat cultures done and Varivax #2 given. Pt returned on 1-25-07 with the Hx skin rash from 1/24/07. 1-25-07 petechial rash seen. plts-21c. Bleeding gum (+) Pt taking medications. Platelets remained low 2/5/07 and then unproved. No urine retention.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received FLULAVAL quadrivalent. On an unknown date, the patient received FLULAVAL quadrivalent at an unknown dose. On an unknown date, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to FLULAVAL quadrivalent. Additional information received: Sales rep, phoned in to report that Dr. has been noticing pain, redness and swelling with FLULAVAL QIV. This is all the information that the sales rep had about these AE's.
Rash/red dots; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and had rash which broke out on chest.  At the time of reporting, the patient came for 2nd dose and still having red dots on her chest.
I received the vaccine on Feb. 1, 2021.  I had a sore arm for two days after which I had no pain.  On Feb. 9 my arm in the shot area started to swell and was sore.  In the morning the area was bright red, still sore.  At about 12:00 there was a dark line below the bright red area.
Swelling at shot site - area red bruised. Seen in off hours clinic - "infection" Rx for Augmentin. Improving
Dizziness, Tachypnea & NauseaVomiting Narrative:
Patient reported a headache after 1 hour of receiving vaccine. Left arm sore/painful with increased swelling of lymph nodes in axillary area/neck. No fever present. Pt. to f/u with PCP.
syringe fallen apart; she was not sure how much did she administer; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (syringe fallen apart) and UNDERDOSE (she was not sure how much did she administer) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced DEVICE CONNECTION ISSUE (syringe fallen apart) and UNDERDOSE (she was not sure how much did she administer). On 19-May-2021, DEVICE CONNECTION ISSUE (syringe fallen apart) and UNDERDOSE (she was not sure how much did she administer) had resolved.        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.   No relevant concomitant medications were reported.   Treatment information was not provided.
This spontaneous report was received from a Licensed Practical Nurse concerning to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 14-NOV-2017, the patient received an improperly stored dose of PNEUMOVAX 23 (lot # N023651, expiration date 20-MAY-2019) (dosage schedule, dose number and route not reported) for prophylaxis. No adverse effects reported. The time frame of the temperature excursion ranged between 47F to 77F (70F) for 72 hours, which was recorded by a data logger. No previous temperature excursion was reported.
Patient reported excessive vomiting for 13 hours after the vaccine , body chills and aches, headache, and diarrhea. Patient continues to have these symptoms.
HPV Vaccine was administered at 10:41am in her left Deltoid. Immediately after receiving vaccine, the patient lifted her arm and said it was very painful. The nurse recommended warm compresses and elevation of the arm. Patient left office and called back at 11:20 with increased concern about pain and tingling in left arm that radiated to her left side and left leg. She arrived back to the clinic and was seen by the provider at 11:45. Vital signs were within normal limits and assessment was benign with the exception of her arm being red and skin mottled on her left arm and hand. She reported her skin hurt all over and she said she was unable to move her arm. She received TYLENOL and BENADRYL and within 30 minutes she was feeling much better and just had mild pain at the injection site.
Information has been received from a 66 year old female patient with drug allergy to trimethoprim concerning herself. Patient's pertinent medical history included high blood pressure. On 09-JAN-2010 the patient was vaccinated with ZOSTAVAX (dose, strength, route were not reported). Concomitant medications included unspecified medications. On 20-JAN-2015, the consumer developed shingles and had symptoms resulting in chills, severe headaches, pain the left arm and shoulder and neck. 4 days after those symptoms, the patient broke out in "blisters" over her arms. VALTREX was given as treatment for the shingles. There was no lab diagnostics studies performed. The patient had called the doctor for medical attention. Outcome of the shingles was not reported. Causality between the shingles and ZOSTAVAX was unknown. Additional information has been requested.
WITH HER 1ST VACCINE SHE SAID HER LYMPH NODES WERE SWOLLEN. TODAY SHE SAID SHE WAS HAVING AN ALLERGIC REACTION AND ON SITE EMS RESPONDED. VITALS BELOW. NO SIGNS OF ALLERGIC REACTION, BUT HER LYMPH NODES WERE SWOLLEN. DIPHENHYDRAMINE WAS GIVEN TO BE ON THE SAFE SIDE. SHE WAS RELEASED TO HOME.
Vaccine administered In Patients  LVL, Vaccine inadvertently  administered at age three and not between required age range of 4-6years of age, Pt legal guardians have not reported any ASE to health center regarding the Vaccine, LPN attempted to call Legal guardians to inform them of inadvertent administration and to ask about any possible ASE's related to Vaccine administration. Pt's legal guardians unavailable LPN left brief Voice mail requesting a return call. LPN informed Company medical director of inadvertent administration.
Headache; arm was aching a lot; have been experiencing cloudy vision in the left eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 52 year-old male patient received bnt162b2 (BNT162B2), administration date 08May2021 (Lot number: ERZ613) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot No: ER8732, Unknown NDC and expiration.), administration date: 17Apr2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 08May2021, outcome "not recovered", described as "have been experiencing cloudy vision in the left eye"; HEADACHE (non-serious) with onset 09May2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 09May2021, outcome "recovering", described as "arm was aching a lot". Therapeutic measures were taken as a result of headache.  Additional Information: The caller (mother) was calling for her son (Withheld) . The patient got the second dose of the Pfizer covid vaccine on Saturday 08May2021. A few hours later, the patient's left eye started to get cloudy and it's still cloudy. The caller felt that this was from the vaccine and wants to know if it has happened to other people?  Was there anything the caller has to do? How long is this going to last? The patient is up to minus nine in his vision. The patient also had a bad headache and was in the bed and couldn't go to work on 09May2021, and his arm was aching a lot. The patient's left eye being cloudy started at about 6:00 or 7:00 pm that night he received the vaccine. The patient woke up at 5:00 am on Sunday with the headache and took some Tylenol and it went away. number of Pfizer covid vaccine: Unknown. Expiry Date of Pfizer covid vaccine: Unknown Other Products: No. Patient History: No. Investigation Assessment: No.  No follow-up attempts are possible. No further information is expected.
When vaccine was administered about 0.1mL was given and the remainder of the dose spilled on the outside of the patient's arm. Additional dose given on opposite arm.
Daughter called and said her mother was experiencing pain and redness at the injection site. She says it is sensitive and painful to the touch. No fever or other symptoms.
A few hours after vaccination, pt developed erythema, pain to injection site. Area was erythematous a few hours after receiving injection. Pain described as tenderness with radiation down the arm.
1110:  Alerted that we had a medical patient. 1111: At patient side to find the patient wa slouched over and having snoring respiration?s. The patient appeared pale and diaphoretic.  1112: Contacted Safety Supervisor and also contacting 911. 1113: The patient was seated upright to open airway and asked if he could wake up. Patient was breathing on his own, eyes open, but not tracking. The patient was not responding to painful stimuli. 2 person lift assist to get the patient off the chair and laying on the floor. The patient then had seizure like activity, arms clenched at his side. 10 second passed by, the patient having minimal postictal phase, and the patient immediately sat upright, asking what happened. The patient informed mobile crew that he started to feel hot and dizzy before he started to dream.  Vitals taken: BP: 110/54, HR: 40, R: 18,  SPO2: 99%, CBG: 108.  1116: Patient care transferred to paramedic unit to transport to closest hospital.
vial was initially stored in the refrigerator: 25Apr2022/ Date(s) of administration of vaccine: 25Apr2022; Moderna booster administered after expiry 01Apr2022/Date(s) of administration of vaccine: 25Apr2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna booster administered after expiry 01Apr2022/Date(s) of administration of vaccine: 25Apr2022) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator: 25Apr2022/ Date(s) of administration of vaccine: 25Apr2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 031A21A and 039A21A) for COVID-19 vaccination.     Patient was not allergic to medications, food and other products. It was unknown whether the patient ever had COVID + test or diagnosis. Acute and Chronic illnesses at the time of vaccination was reported as not applicable.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna booster administered after expiry 01Apr2022/Date(s) of administration of vaccine: 25Apr2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator: 25Apr2022/ Date(s) of administration of vaccine: 25Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna booster administered after expiry 01Apr2022/Date(s) of administration of vaccine: 25Apr2022) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator: 25Apr2022/ Date(s) of administration of vaccine: 25Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was initially stored in the refrigerator on 25 Apr 2022. The vial did not  undergo any temperature excursions.   This case was linked to MOD-2022-551003 (Patient Link).; Sender's Comments:  :MOD-2022-551003 Patient 2
Anal Nerve Numbness to comes and goes about 5 secs every 10 minutes or so. It started during the middle of the night about 12 hours after receiving the Pfizer vaccine booster shot. 1st dose on 4/1/21, 2nd dose on 4/22/21, booster on 11/04/21. I visited my primary care physician on 11/8/21 and she encouraged me to report it and said it sounded similar to facial nerve palsy that she has seen reported as covid vaccine side effects. It is still occurring no matter what position I am in, I have also been to my chiropractor for treatment with no relief.
I woke up  about 4 am with no feeling on the right side of my face. After about 6 hours the feeling in my face began to return,  but it was as if my face was asleep, the feeling was of almost numbness, a tingling sensation. By about 6 p.m. my face was back to normal, however my lymph nodes in my neck and head had begun to swell about noon, and by the afternoon, were excruciatingly painful. This lasted for over 3 weeks. Taking 800mg of ibuprofen made the pain manageable.
Headache, swelling of shot, low fever, chills, muscle pain in entire arm and neck area, tiredness, nausea, stomach pain.
Found unresponsive but still breathing at  assisted living. Sent by ambulance to the hospital
I didn't have pain in the arm, after an hour I had a slight headache. The headache lasted about a day. After the 3-4 day I had serve diarrhea and stopped taking my supplements. It stopped for a couple days then came back for a day. I had no headache or pain, just 3 bad episodes of diarrhea. On March 24th I went into the Hospital with severe pain in my lower left back side. I thought I was passing a kidney side, with the pain I was having. When I got there they did a CT scan and blood work and it wasn't kidney stone but I had a blood clot on the lower left side of lung and the right side as well. They immediate put me on blood thinners. I was there for a day and a night. They released and put me on medication.  I've had minor pain but nothing like the pain I had before. I have since followed up with a Pomologist and PCP. Pulmonologist said I had blood clots but couldn't give me a cause. My PCP said she thought I had or have Covid. I asked to have my blood drawn and she said it was too late for that because I had taken the vaccine already.
Developed patch of red, blistered bumps on left gluteus cheek; tenderness and pain estimted at a 3; sought medical treatment; diagnosed by Drs as shingles; currently being treated with Valtrex.
Extremely tired . Woke up to hands itching and swollen . Lasted 4 days .
I got headaches after the first dose and with second dose were worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02May2021 11:00 (Lot number: EW0173) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19:Yes. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VITAMINS;AMINO ACIDS; ZINC; MULTIVITAMINS [VITAMINS NOS]. Past drug history included: Dipyrone, reaction(s): "allergy"; Tramadol, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 1, lot number: EW0153, administration time: 11:00 AM), administration date: 04Apr2021, when the patient was 47 years old, for Covid-19 immunization, reaction(s): "Pain in the teeth", "Malaise", "Throat pain", "Severe nasal congestion", "I could not get out of bed for 5 days/I have had to be in bed for several days/does not allow me to do my normal activities", "Severe daily headaches", "sensation of having my head inside a bubble", "General discomfort", "A lot of coughing". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "I got headaches after the first dose and with second dose were worse". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was No. Prior to vaccination, was the patient diagnosed with COVID-19 was Yes. Since the vaccination, has the patient been tested for COVID-19 was No patient reported that I have had to be in bed for several days, I had a strong general malaise, throat pain, severe nasal congestion and I could not get out of bed for 5 days. I still continue with severe daily headaches and a sensation of having my head inside a bubble, I continues with general discomfort, a lot of coughing, throat pain, pain in the teeth. The headache does not go away and it does not allow me to do my normal activities. I got headaches after the first dose and with second dose were worse.  Follow-up attempts completed. No further information expected.
Nurse from a clinic called as they administered an expired MENACTRA vaccine with no reported adverse event; Initial information received on 24-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown age and gender and it was reported nurse from a clinic called as they administered an expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On an unknown date, it was reported nurse from a clinic called as they administered an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] Solution for injection (batch/lot number, expiry date, strength: not reported) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: same day). Information on the batch number was requested  Action taken: Not applicable.  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.