chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They shot me with a shot and that made my period come; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "They shot me with a shot and that made my period come".  Additional information- The patient was walking and talking fine not had fever and did everything on own.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received on 20 November 2009, sanofi pasteur employee became aware of this event at a conference. The attendee who provided this information learned about the adverse event from a consumer. it was reported that two children received PANDEMIC INFLUENZA H1N1 VACCINE and then got the "flu". The trade name, manufacturer, lot number, route and site of administration were not reported. Additional information was requested from the consumer, but the only information he had at the time was that the children had returned to school. The consumer stated he would forward any additional information to the company representative if obtained. Documents held by sender: None.
Information has been received form a 60 year old registered nurse with no pertinent medical history and no drug reactions or allergies, who on 17-FEB-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) intramuscularly instead of subcutaneously. There was no concomitant medication. The nurse reported that within 2 hours the patient experienced muscle soreness at the injection site. The soreness worsened during the night but was subsiding on 18-FEB-2011. There were no lab diagnosis/studies performed. The patient did not seek medical attention. Follow up information has been received from the nurse indicating that on 17-FEB-2011 at 15:00 she was vaccinated with ZOSTAVAX in the right deltoid. On 17-FEB-2011 at 19:00 the patient experienced muscle soreness. At the time of the report, the patient had recovered. No further information is available.
Lymphadenopathy throughout body (arm, breast, groin, knee), severe joint pain in knees with swelling, nerve pain in neck and torso, severe tinnitus, calf heaviness/leg giving out, neuropathies - persist since 1st dose.
Seizures; Changed his personality; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received DTPa (DTPa vaccine) for prophylaxis.   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 seizure (serious criteria GSK medically significant and life threatening) and personality change (serious criteria life threatening). On an unknown date, the outcome of the seizure and personality change were unknown.   It was unknown if the reporter considered the seizure and personality change to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the patient almost died from DPT vaccine, mainly seizures. The vaccine had changed patient's personality also. It was reported that vaccines are harmful and useless.
BLEEDING IN BRAIN; COULD NOT SEE WITH HIS EYES; COULD NOT WALK; PAIN IN LEGS; SHARP PAINS THROUGH HEAD; BLEEDING FROM HIS EYES; BLEEDING FROM HIS EARS; SICK; This spontaneous report received from a consumer (patient's sister) concerned a 67-year-old, White, not Hispanic or Latino male patient. The patient's height, and weight were not reported. The patient's past medical history included covid-19. His concurrent conditions included inability to see after he got something sprayed into one of his eyes in jail and wheelchair user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Since the day of the shot, the patient had been sick. On 02-JUN-2021 (about 2-3 days after the vaccination), the patient experienced side effects. He had bleeding in his brain due to which he could see with his eye, could not walk, had so much pain in legs, and sharp pains through his head. The patient was getting worse. On an unspecified date in JUN-2021, the patient had bleeding from his eyes and ears. The patient could not walk at the time of reporting. He had one good eye (not the eye with which he could not see due to bleeding in brain) but could not see from it too as he got something sprayed into it previously. Hence, he lost both eyes and could not see at all at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding in brain, could not walk, could not see with his eyes, pain in legs, and sharp pains through head, and the outcome of bleeding from his ears, bleeding from his eyes and sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210632304 - Covid-19 vaccine ad26.cov2.s - BLEEDING IN BRAIN , COULD NOT SEE WITH HIS EYES , BLEEDING FROM HIS EYES . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Right arm is red below the injection site about the size of 2 quarters; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Right arm is red below the injection site about the size of 2 quarters) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Right arm is red below the injection site about the size of 2 quarters). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site erythema, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Right arm is red below the injection site about the size of 2 quarters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Patient received Zostavax on 30 May.  By the next morning, she reports soreness on her upper lip and "canker like sores" in her mouth.  Two days later (June 2) she woke up to blisters on her face, in the shape of a "C" from her cheekbone down to her chin.  She made a visit to clinic where she was diagnosed with Shingles and was prescribed Valtrex.  On Monday, June 4, she saw her regular physician who confirmed a diagnosis of Shingles.
Painful red swelling at injection site 3? in diameter, flu like symptoms next day with achy joints, swollen glands, tiredness during the with low-grade fever of 99.5 F by 5:00 pm
24 hours post vax, the child developed emesis, loose stools and increased temperature. Ibuprofen given, status epilepticus developed (initially controlled with Phenobarbital and Dilantin then versed drip). Pt developed encephalopathy with associated liver failure, acidosis and other metabolic abnormalities, intubation and ICP monitoring. Developmental and physical delay, seizures and hypotonia.
hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.      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.   No concomitant medications were reported. No treatment medications were reported.
Vaccine injected too high, into the shoulder joint. Immediate pain and tingling down my arm. Continued pain down to the elbow for the rest of the day. Seemed to resolve by the following morning
The spot turned red and swelling of arms and swelling of upper chest under breast, and stomach. A lot of pain in arm. It is now going on 4 weeks and still swollen and hurt.
Recipient complained of pain and swelling the day after receiving the vaccine. Now the second day after receiving the vaccine there is noted swelling/redness and itching. Recipient advised to use warm compress.
Had an exaggeration of Left lateral epicondylitis that was present at the time; With in 2 days wrist pain became pronounced bilaterally/Pronounced joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 09Feb2021 at 09:45 (at the age of 56-years-old) as a dose 1, single for COVID-19 immunisation. Medical history included lyme disease, my body that had older injuries (Joint pain has become far worse in areas of my body that had older injuries and were not in pain at the time of the 1st injection). The patient had known allergies to shellfish allergy (allergy to clams). The patient did not receive any concomitant medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Feb2021 at 04:00, after first dose of vaccine the patient had an exaggeration of left lateral epicondylitis that was present at the time and within 2 days wrist pain became pronounced bilaterally and on the same day at unspecified time the patient experienced pronounced joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with voltaren gel for ankle and PT for Knee. The clinical outcome of all the events was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
The nurse administered the vaccine into patients arm.  He then walked over to the waiting area with his parents.  This took a few minutes.  Within about 8-10 minutes of receiving the vaccine, he said he was feeling "light-headed" and then he passed out.  He seized for about 30 seconds before regaining consciousness.  The paramedics were called and they tried to get his blood pressure up.  They were not able to get it to come up and so they transported him to the hospital.
10 hours after shot developed fever 102.  Shaking and holding chest.  Was able to calm her down.  Fever started to break in the afternoon on 04/01.  Continued to vomit all day probably because of the fever.  Gave liquids only. By 9:00 pm fever fluctuating 99 to normal.  Hopefully by 4/2 all symptoms will have passed.  I did not take her to the doctor for this although when the symptoms started I was very concerned because she does not speak and I didn?t know if she was having chest pains.
This spontaneous case reported by a consumer, describes the occurrence of neck pain and musculoskeletal stiffness (neck felt like a brick) in a 74-year-old patient, of an unknown gender,  who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced neck pain and musculoskeletal stiffness (neck felt like a brick). At the time of the report, neck pain and musculoskeletal stiffness (neck felt like a brick) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Child was given HAV vaccine on Friday, September 13, 2002.  Developed pruritic, papular rash, starting on ears, spreading over entire body.  Rash began day after vaccine was administered.  Also had some swelling of ears and cheeks. Per 60 day follow up: Unknown if pt recovered.
This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4120129-00 (AbbVie). A 57-year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Route: Intramuscular), for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Sep2021, outcome "recovered" (2021), described as "Rheumatoid arthritis flare up"; ILLNESS (non-serious), outcome "recovered", described as "Sickness"; PAIN (non-serious), outcome "unknown", described as "Pain"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Hand swelling"; JOINT SWELLING (non-serious), outcome "unknown", described as "Joint swelling". The action taken for adalimumab was unknown. Causality: Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) Causality as per reporter for the event's rheumatoid arthritis flare up, Sickness, pain, hand swelling, and joint swelling were Reasonable possibility. Causality for suspect: Pfizer BioNTech covid-19 vaccine (tozinameran) Causality as per reporter for the event's rheumatoid arthritis flare up, Sickness, pain, hand swelling, and joint swelling were possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2 cannot be ruled out. 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.
Patient called HD informing nurse she had received flu shot at apt on Wednesday and noticed raised knot type area near injection site.
approx 13 days p/ vax pt devel a rash w/pustules followed by malaise.
2 month patient was given ProQuad instead of Prevnar. The wrong vaccine was ordered. On 8-03-2022 the physician called the mother of the patient and explained that the baby had received the wrong vaccine. Explained that side effects include fever, soreness at the injection site and rash.
pt recv vax 1AUG95 & APR96 pt exp full-blown chicken pox;
pain in left arm at injection site from time left pharmacy to present (three weeks), warm to touch, swollen, low-grade fever
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild
Fever (39° C), several pain at the injection site, fatigue, headache, axiliary swelling. Take rest at bed and Tylenol.
A non-serious spontaneous report of "7 patients were inadvertently administered expired H1N1" was received from a health professional concerning a five-year-old female out of seven patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 19-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
It's been 2 months since I got the first one; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It's been 2 months since I got the first one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It's been 2 months since I got the first one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It's been 2 months since I got the first one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
pt recvd vax & reported GI upst w/in mins fever of 101 w/in 2 hrs, & redness & swelling (7cm x 3 cm) w/in 3 days @ site that lasted 2 wks;
I had head fog, sore throat, congestive, cough, fatigue, and pressure in head. Most of the symptoms lasted for about 5 days but the cough lasted for about 8 days. On Jan 24th and Jan 25th, I tested positive for both COVID-19 test.
Fever, severe fatigue, pain and swelling at injection site, joint pain and stiffness , muscle pain, abdominal pain, swollen and painful lymph nodes
Felt fine day of vac. Awoke Tuesday 17 August very Short Of Breath (SOB) with Dyspnea on Exertion (DOE) walking to the bathroom (12') caused DOE. Became a little  worse day by day until about September 1st when things started to improve. Pitting Pedal Edema gradually improved. No fever . Still having slight SOB and SOB though Pedal Edema is mostly gone. Sometimes very little energy.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 55-year-old male patient who received SHINGRIX (batch number G933B, expiry date unknown) for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On 22nd August 2018, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site pain, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the posterior aspect of the left deltoid and therefore there is a great possibility that it was administered by subcutaneous route rather than intramuscular route, which led to inappropriate route of vaccine administration and vaccine administered at inappropriate site. The patient complained of injection site pain and redness.
8-25-06 Patient viewed Menactra injection at approximately 11:45 in left deltoid.  Nurse preparing to give Hep A injection in right deltoid and prior to injection patient started complaining of feeling ill so nurse waited on Hep A.  Patient stated she was feeling like she did when she had received anesthesia to have (???) fixed.  Patient got pale and lost consciousness for minute or so.  Ambulance called and by the time they arrived the patient was conscious again.  When patient lost consciousness, her coloring around lips was blue and farial coloring very pale.  SN kept talking to client and touching/shaking shoulders and she tensed up and then started to wake up.  Ambulance crew checked VS and applied O2 for few minutes.  Patient able to answer questions appropriately but slowly and very shakey.  Mother arrived shortly past ambulance arriving and took client home past incidence around 12:30 8-25-06 4:30 p.m. t/c to clients home to check on her status.  States she slept most of the afternoon and still feels groggy.  No redness or anything at injection site.  Spoke with mother also who states patient is doing fair.  Instructed that if has any further problems should go to ER.  SN informed mother that both offices had been notified that client has had reaction to menactra (SN notified both doctor's offices around 2:00 p.m. 8-28-064:00 p.m. t/c to clients home and spoke with mother to see how client is doing.  States she went to work Saturday and is at school now.  Doing ok.  Left arm sore, some (???), no redness or knot and has color back.  Feels that things are ok.
Severe chills, body aches, stomach ache, headache, clammy, fever
Pt had adverse reaction to Covid vaccine. 0855 am: Patient began c/o throat tightening. Pt was brought to room 4 and assessed by provider. Stratus interpreter was used for assessment. Pt reported tingling lips, tight throat, and dizziness. Denied itching mouth or throat or difficulty breathing. Lungs clear to auscultation. No additional work of breathing. Heart rate 85. O2 97%. No facial swelling, lip swelling, cyanosis or angioedema.  0900 am: 25 mg Benadryl PO  0920: Pt reports no change. Throat feels like it is closing and lips are tingling. No swelling of lips or face. No angioedema noted. 920am: 25 mg IM Benadryl 4 mg Dexamethasone to R Deltoid 0935 am: Pt resting on the exam table. Breathing noted to be easy and unlabored.  RR 16, HR 65, 98% on RA.  Patient reports throat and lips are feeling better - no tightness of throat, and no tingling of lips 940am:  Patient calls for ride to come pick her up. 0950 am :  Patient reports feeling tired and slightly lightheaded.  Patient sitting on exam table x5 min.  0955 am:  Patient feeling ok to ambulate.  Nurse escorts patient out of clinic and leaves in care of family member.  Education provided on rest, fluids, no driving until side effects wear off.  Instructed to call clinic with questions.
Patient received Tdap vaccine while she was ins the hopsital in August. She came to the pharmacy in October for a flu vaccine and reported that she had a newborn.  Pharmacist recommended that if she had a young child at home she should get a Tdap booster for pertussis prevention.  Patient did not recall having received a TDaP vaccine in the hospital.  She got the TDaP vaccine. States that she now has neuropathy due to receiving the vaccine a second time.
Migraine 2 days on day two took 1 Excedrin, nausea and vomiting 2 days,  loss of appetite 6 days, joint and muscle pain lower body, back and arms 5 days, involuntary muscle movement 5 days,
Headache body aches, joint pain, chills Narrative:  employee states she was out of work 2 days due to symptoms