chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, was tired, no energy.  No rash or fever, perhaps a reddened area around the vaccine site but it went away.  About a week later she found a lump by accident under her arm in the armpit but down a little further towards her breast.  The lump is painful when she puts pressure on it when she's trying to sleep.  She knows it's there.  She went to her PCP yesterday, 5/24/21 and he told her that they will watch it and it should dissipate.  He did not give her any treatment for it.  She did also have a stiff neck on the side of her vaccine and a headache, which have disappeared.  She just wishes it would go away as it's a nuisance.  Her doctor said that it was swelling of the lymph node.   If she wears something tight it hurts her, but otherwise it doesn't, especially if she wears a bra.  She just does not have the energy that she had before.    She did get a Prolia shot on 2/4/21 but had no reactions from that, and was told that it would not interfere with the vaccine.
p/ pt recv vax approx 24 days later pt devel moderate Bell's palsy. MD attention was sought. treated w/acyclovir 24 hrs p/ onset
Severe hives and itching to forearms, groin, chest, back, neck. Lasted until 50mg of Benadryl took effect at approx 9pm on 9/15. Hives were resolved, but then returned at 5pm on 9/16. 25mg of Benadryl taken again....resolution pending.
Whole body itching; severe lip swelling; chills/rigors; body aches; This is a spontaneous report from a contactable Physician (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at left arm on 11Jan2021 13:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced whole body itching, severe lip swelling, chills, body aches, rigors 14Jan2021 16:00. Treatment received for the events included Allegra and Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was Recovered with lasting effects.
4 X 5 area of erythema warm to touch around site of DTaP right thigh
Woke up feeling short of breath.  Sore throat shortly thereafter. Shortness of breath resolved.
Broke out in a itchy rash, under arms, side of torso, inner thigh, outside thigh, and mid back.
During week of 4/24/00, the pt started having severe joint pain and stiffness in all joints. Visited doctor on 5/5 and given medication for arthritis. Pt was having no problems before receiving vax.  Follow up 08/26/2002: "Medical records indicated that his medical history inclued versicolor, hypercholestorolemia, hypertriglyceridemia, hemorrhoids, Dupytren's contesture of the hands, hand stiffness, osteoarthritis of the lower back, and flat feet.  The vaccinee sustained a skull fracture during a motor vehicle accident in the 1950's.  surgical history included Dupuytren's contracture surgery "years ago", hemmorrhoidectomy (1955). On 02/11/2002, in a statement of injuries, the vaccinee's attorney alleged that the vaccinee "suffers from joint pain and fatigue.  he also suffers from fibromyalgia.  The vaccine provider made a telephone call to the vaccinee on 04/02/2001, regarding a recent chest-x-ray.  In the office notes, the physician wrote, "Patient has increased interstitial markings on chest x-ray and will need follow-up pulmonology consult...also patient tells me he'll be in a research trial of MTX and Hemicade with...rheumatologist for his RA.  Currently just taken off Plaquenil.  On 02/12/2002, as of 04/02/2001, the rheumatoid arthritis was ongoing.  The outcome of the fibromyalgia was not specified."
Narrative:  74yo male with widespread diffuse large B-Cell lymphoma and is followed by heme/onc died at home with home hospice care. Pt had received pfizer covid vaccines on 2/2/21 &2/24/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Ringing ears within 10 minutes after vaccine given and lasting an hour. Started feeling out of breath at 11:30 am 9/15/21 and like my heart is racing.
Hurt; Put straight up the skin; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Hurt) and intramuscular formulation administered by other route (Verbatim: Put straight up the skin). The outcome of the injection site pain was not reported and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that, did your shot go straight up your arm, or was it just a regular shot.  The patient was put straight up the skin in her/his arm. hurt like pushed the chair back. The patient was put straight up the skin in her/his arm, which led to Intramuscular formulation administered by other. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information. Note: as per narrative it seems that vaccine was not administered intramuscularly hence conservatively event Intramuscular formulation administered by other was capture.
Patient complained of burning and skin color change on bilateral arms following vaccination. Patient evaluation completed and complained of throat tightness.
Pt was scheduled to receive the flu vaccine. The pt received the COVID Spike Vax accidently in addition to the flu vaccine. The pt had received the Spike vax vaccine the night before.
08/08/2005 Patient in with parent c/o pain at injection site of td given 08/02/2005 per provider pts site is warm and tender with pain radiating to hand, treated with Keflex and referred to pediatric Neurology
he was admitted to the ER for neuropathy and pain radiating down his arms, legs and genitalia; he was admitted to the ER for neuropathy and pain radiating down his arms, legs and genitalia; his symptoms are getting worse; This is a spontaneous report from a contactable physician (parent) via medical information team. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration on 09Aug2021 as dose 2, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown; Expiration date: unknown) via an unspecified route of administration at single dose for Covid-19 immunization. On 09Aug2021, patient was admitted to the emergency room for neuropathy and pain radiating down his arms, legs and genitalia. As per agent, his symptoms were getting worse. Adverse events resulted into emergency room visit. The outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events Neuropathy and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced twice about six years before the reporting date). On 1st May 2018, the patient received the 1st dose of SHINGRIX. On 25th July 2018, 85 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the pharmacist who herself was the patient. The patient had an outbreak of Shingles. On 6th August 2018, the patient was seen in urgent care where the diagnosis was confirmed and the patient was prescribed VALTREX.
High fever for 6 days, Full body rash, itching, lethargy, lack of appetite, drowsiness. Treated with tylenol, cold compresses, rest, luke warm baths.
Approx. 12 hrs after injection, hives, urticaria across chest, arms, hands and wheezing improved with 10mg loratadine.
I had a sore throat, congestion and had a difficulty sleeping for 3 days, coughing, sneezing, body aches. I used MUCINEX D to help with the congestion at night. I used a home COVID-19 test that once it showed positive called my doctor. He advised me to quarantine.
Patient received  COVID dose  at 9:20am and by 9:45am patient started experiencing diaphoresis, dizziness, no difficulty breathing or swallowing, pulse ox was 98%, pulse was 47, and BP was 90/60.  MD on site assessed and indicated need for epinephrine 0.3mg dose which was administered at 9:51am and EMS was contacted.  Patient started feeling better and at 9:55am EMS arrived to transport patient to ED.
CLIENT BROUGHT THE FLU CONSENT FORM TO RN TO RECEIVE HER FLU VACCINE AT CLINIC. CLIENT STATES SHE WANTS THE FLU VACCINE HOWEVER, SHE IS ALLERGIC TO WHOLE EGGS. CLIENT STATES SHE IS ABLE TO CONSUME FOOD WITH EGG AND EGG PRODUCTS SUCH AS CAKE, CUPCAKES, AND CASSEROLES WITHOUT ANY PROBLEMS. NOTIFIED CLIENT THAT AN EGG ALLERGY IS NOT A CONTRAINDICATION FOR THE FLU VACCINE. THE LAST TIME SHE RECEIVED A FLU VACCINE WAS 29 YEARS AGO. CLIENT STATES THAT SHE HAD A LOCALIZED REACTION AND THE SITE OF THE INJECTION WAS SWOLLEN AND RED. ASKED THE CLIENT IF SHE WANTED TO GO AHEAD AND RECEIVE THE FLU VACCINE TODAY. CLIENT GAVE CONSENT TO RECEIVE HER FLU VACCINE.  NOTIFIED CLIENT THAT SHE WILL NEED TO HANG OUT FOR ABOUT 20 MINUTES AFTER HER FLU VACCINE FOR HER SAFETY AND TO WATCH FOR ANAPHYLACTIC REACTIONS. CLIENT VERBALIZED UNDERSTANDING. FLU VACCINE WAS ADMINISTERED BY RN AT 0835. CLIENT STATES SHE FEELS SOME SHORTNESS OF BREATH AT 0847. ASSESSED THE CLIENT. CLIENT IS TALKING, CONSCIOUS, AND APPEARS TO HAVE NO CHANGES IN COLOR. RN TOOK CLIENT'S BLOOD PRESSURE ON RIGHT ARM:156/98. RN TOOK PULSE: 60 AND RESPIRATIONS: 16. ANOTHER EMPLOYEE CALLED 911 AT 0850. I SPOKE TO DISPATCH AND NOTIFIED DISPATCH OF SITUATION AND ANSWERED THEIR QUESTIONS.  EMT/PARAMEDICS CAME TO THE SCENE AT 0854. GAVE REPORT ON THE CLIENT TO THE EMT.  PARAMEDICS TOOK CLIENT'S VITALS AND ASSESSED THE CLIENT. CLIENT STATES SHE IS FEELING BETTER AND HER SHORTNESS OF BREATH IS SUBSIDING. CLIENT STATES SHE DOES NOT WANT TO GO TO THE HOSPITAL. AFTER ABOUT 10 MINUTES OF PARAMEDICS ASSESSING AND TALKING TO THE CLIENT, THE PARAMEDIC NOTIFIES CLIENT THAT SHE CAN SIGN A REFUSAL FORM. CLIENT SIGNS THE REFUSAL FORM. PARAMEDIC LETS HER KNOW THAT IF SHE HAS ANY OTHER ALLERGIC REACTION SYMPTOMS SUCH AS CHEST PAIN, HIVES, ITCHINESS, SHE DOES NEED TO GO TO THE ER IMMEDIATELY. CLIENT AND CLIENT'S HUSBAND VERBALIZED UNDERSTANDING. EMT/PARAMEDICS LEAVE THE SCENE AROUND 0911. I TOOK CLIENT'S BLOOD PRESSURE AT 0913 AND IT WAS 160/86 LEFT ARM. CLIENT STATES SHE IS DOING BETTER AND SHE IS ABLE TO GO HOME WITH HER HUSBAND. LET CLIENT KNOW THAT I WILL BE CONTACTING HER TOMORROW TO SEE HOW SHE IS DOING. CLIENT VERBALIZED UNDERSTANDING.
I woke the next day with my eyes swollen, headache, vomiting, chills, and fever of 101. The fever, chills, and vomiting stopped on 12/24. The swelling on my eyes remained. On 12/27, my toes, fingers , lips, and tongue starting tingling and the headache remained. I called my doctor, and she suggested I to an urgent care facility. I tried two different locations, but there were no available appointments. So I drank a lot water and took two Benadryl. The symptoms subsided in the evening, but has returned today 12/28.
cold on left side of her face; tingling sensation on left side of her face; soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of arm), FEELING COLD (cold on left side of her face) and PARAESTHESIA (tingling sensation on left side of her face) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00A3217) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of arm). On 24-Mar-2021, the patient experienced FEELING COLD (cold on left side of her face) and PARAESTHESIA (tingling sensation on left side of her face). The patient was treated with IBUPROFEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness of arm), FEELING COLD (cold on left side of her face) and PARAESTHESIA (tingling sensation on left side of her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pfizer-BioNTech COVID-19 Vaccine EUA Beginning approximately 10 minutes after the injection I felt increased anxiety and possible light headedness. This could have been anxiety about the injection and its short development and some unknowns. I felt quite stimulated through the evening on the day of vaccination and kind of tingly all over like I had too much caffeine (which I had not). The only real scary part was waking up the night of the vaccination with high anxiety, tingling, and an elevated heart rate around 100-120 bpm if I had to guess. This lasted about 1-2 hours until I was able to fall back asleep.  I am now two days out from vaccination and still have increased anxiety over baseline and some diffuse tingling/hyperstimulation.
Covid Arm - red rash, itchiness. Shot was 12 days ago, rash developed on day 11 in the afternoon and became itchy later in the evening. Remains itchy and red today.
significant pain, burning, left shoulder joint within 24  hours of receiving the vaccine.  symptoms continued for 39 days with remitting. X-rays at day 39 showed slight widening beneath the acromion process. treated via cortisone steroid injection into the joint.  pain continues.
Large blood Clotting after each dose during menstral cycle.Bled for more than 2 weeks.; Large blood Clotting after each dose during menstral cycle.Bled for more than 2 weeks.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 19Mar2021 04:15 (at 51 years old, not pregnant), single dose for covid-19 immunisation. Medical history included stroke, high blood pressure, diabetes mellitus, all from an unknown date and unknown if ongoing. The patient's concomitant medications was unspecified (mentioned other medications in two weeks: yes but prescribed). The patient had her first dose of BNT162B2 vaccine on 26Feb2021 04:15 at 51 years old, for COVID-19 immunisation on left arm. The patient experienced large blood Clotting after each dose during menstral cycle. Bled for more than 2 weeks. All on 27Mar2021 12:00. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination. No known allergies. No treatment for the events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Diagnosed with Pityriasis Rosea approximately 1 month following the 2nd Pfizer shot. Symptoms started approximately 2 weeks after vaccination.   No history of allergies or reactions to any vaccines.
6/11-6/14 : Extreme migraine, fever, extreme chills, fever,  extreme body aches, extreme fatigue, diarrhea 6/14-present: moderate migraines, moderate fatigue, moderate body aches, moderate fatigue, diarrhea
Developed swelling eyes; Itching; Rash; This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not reported.   This case was linked to MOD-2021-096932 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021
She reports that a week afterwards her arm was still sore and she took pictures to show her Dr, when she went and he gave her an antibiotic
Information has been received from a nurse referring to an unspecified number of unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. Since 21-JUL-2016, the patients had been administered doses of ROTATEQ (lot number and expiration reported as L027719, 28-APR-2017 and L035636, 21-MAY-2017). All of which were improperly stored. No adverse effects have been reported. There was no prior excursion. This report is for data logger. Additional information has been requested.
In with parents for generalized hives noticed by mother 1 hour after receiving PNEUMOVAX (cochlear implant). Very itchy. No facial swelling, respiratory distress, or GI symptoms. He received IM Benadryl and was transferred to ER and treated with steroid and Epipen. He improved after IV Benadryl. No fever or recent viral illness. No recent new detergent or topical used. Please see ER notes for details. Hives are significantly improved. Has a few lesions 1 hour before the next Benadryl dose. He is otherwise acting well as usual.
PT WAS GIVEN 5TH DOSE OF GARDASIL AFTER RECEIVING 4TH DOSE AT INITIAL APPOINTMENT WITH THE PROVIDER TO ESTABLISH CARE AT CLINIC. AFTER SPEAKING WITH PATIENT, IT WAS DETERMINED HIS PAST IMMUNIZATION HISTORY WAS NOT REVIEWED AT APPOINTMENT AND THAT HE HAD BEEN GIVEN 3 DOSES AT PRIOR PROVIDER.
Patient presented EKG consistent with anterior ST elevation MI with chest pains.  Due to the presentation I feel she should undergo urgent cardiac catheterization.
numb from the waist down; can't sleep; can't push up on her arm; Been sick as a dog; arm is killing her; freezing to death; Case reference number MOD-2021-010474 is a spontaneous case report sent by a Other on 20-JAN-2021 00:00:00 , which refers to a Female aged 71 Years .  The patients past medical history included: No adverse event   . .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  1 day later,  the patient developed numbness. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed chills,pain in arm,insomnia,weakness arm,Been sick as a dog. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Malaise . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Other did not declare any relatedness between numb from the waist down and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .  Update 1: 21-JAN-2021 00:00:00 .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for agency listing: Report Source- Other,  Age- 71 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Information has been received from a medical assistant concerning an 11 year old female who was vaccinated with the first dose of Gardasil. Concomitant therapy included DTaP (unspecified) (+) Menactra, both administered in the opposite arm. It was reported that 20 seconds after vaccination with Gardasil, the patient fainted. The patient recovered after five to ten seconds, although, bumped her head on the floor. X-rays of the patient's head were taken (results not reported). The outcome of the patient's head injury was unknown. Additional information has been requested. This is one of two reports received fro the same source. This is in follow-up to report(s) previously submitted on 6/14/2007.  Initial and follow-up information has been received from a medical assistant concerning an 11 year old female student with a history of headaches who on 30-MAY-2007 at 1:45 pm was vaccinated in the left arm with the first dose of GARDASIL (LOT# 654885/1424F).  Concomitant therapy included INFANRIX (Lot # U1986AA) and MENACTRA (Lot # U2142AA), both administered in the opposite arm at 1:45pm.  It was reported that the patient sat down for5-10 minutes after the vaccinations.  When she got up, "she gave about 10 steps and fainted.  She hit herself on the head."  The patient was observed and a head computed axial scan was performed.  The result was normal and showed no infarct, mass or bleed.  The outcome of the patient's head injury was unknown.  This in one of two reports received from the same source.  Additional information is not expected.