chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt seen 9 days from covid vaccine (given elsewhere) with report of bilateral foot burning and numbness, slowly improving, had eye symptoms of tearing now resolved
This spontaneous case was reported by a nurse and describes the occurrence of CHEST PAIN (Severe chest pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CHEST PAIN (Severe chest pain). On 15-Mar-2021, CHEST PAIN (Severe chest pain) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional information document received.  Updated both the reporters (HCP and Consumer) address and mail ID, patient DOB from 7-Jan-1959 to 25-Jul-1966. Added route of administration of vaccine.  Updated as per additional SD, Batch number of vaccine dose 1 from 02M20A to 029A21A; Vaccine start date from 11-Mar-2021 to 12-Mar-2021.
When got shot my heart rate went up right away.  Felt faint.  Doctor took blood pressure and was very high.  Had me lay down and took blood pressure several more  times until it went back down to normal.  Took about 20 minutes.
-INJECTION SITE PAIN- -HEADACHE, SEVER -TIRED -MUSCLE PAIN-ESP. LEFT ARM -CHILLS, SWEATING, SHIVERING -NAUSEA BEFORE : FELLING GREAT! 04/02/2021 4PM - SHOT                   11PM - BED - SORE INJECTION SITE AND LEFT ARM NOT FEELING GREAT TAKE 1 IBUPROPHEN FOR                               ARM PAIN 04/03/2021 7AM - AWAKEN N INCREDIBLE HEADACHE CHILLS, SHIVERING, SWEATING NAUSEA                            STAYED IN BED ENTIRE DAY, SLEEP                            WHEN GET UP - CHILLS, SHIVERING INTENSIFY                            NO FOOD, JUST SIPS OF WATER 04/04/2021 AM & PM 36+ HOURS LATER= DILL HEAD, WEAK                                 EAT SOME BLAND FOOD, STOMACH AREA                                STILL SENSITIVE, STIFF LOWER LEGS 04/05  72 HRS: BACK TO "NORMAL"!
Patient complained that the same night after she got the vaccine she ran a fever (did not take but stated she was very hot), had a headache, felt flushed, and actually stayed home from school the next day. One week later, the injection redness was gone, but patient still has soreness to her arm with movement or lifting.
Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. The reporter reported that she had been administering ZOSTAVAX via dry subcutaneously to these patients on unknown dates to the under arm area instead of the deltoid region (lot# and dose unknown). In additional the pharmacist stated that she gave ZOSTAVAX at more of a "90 degree angle than a 45 degree angle with a 5/8 inch needle". There was no information about concomitant therapy. No adverse effects were reported. Additional information has been requested.
Emesis, fever of 103. Swelling, rash, painful to touch and limited range of motion of arm.
Pt reports fever started the evening of 5/13/2021. Pt reports he took Tylenol 1x last night.
weak after first dose; Was tired; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak after first dose) and FATIGUE (Was tired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak after first dose) and FATIGUE (Was tired). At the time of the report, ASTHENIA (weak after first dose) and FATIGUE (Was tired) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2023-719728 (Patient Link).
Infant to clinic w/father.  He stated infant experienced reddness on both thighs later that afternoon(3/17)after receiving vaccines.  The reddness spread to his torso and arms.  Father denies any rash, itching, or complaint by child.  Nurse who serviced infant on visit to clinic. 3/26/03- Father instructed to see pediatrician, infant was seen in the clinic for respiratory infection and and nasal congestion.  MD did not address rash.
Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L008353, expiration date 11-SEP-2016; lot # L03058, expiration date 10-FEB-2017; lot # L032761, expiration date 24-FEB-2017; lot # was reported as "L040415", expiration date 13-APR-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment.; COVID 19 Treatment.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's hypothyroidism" (unspecified if ongoing); "Known allergies: sulfa drug" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of Covid-19. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251666 same patient, different drug/AE.;
About one day after vaccination, the patient presented to the pharmacy with swelling of the upper left arm. The shoulder and bicep/tricep region were swollen, red, warm and painful to the touch. Patient reports that it had been spreading down her arm since 12 hours since injection.
pt recv vax & w/in 12hr post vax pt exp chills, nausea, vomiting, h/a & fatigue;a visit to employee hlth office was required;sx resolved w/in 24hr w/o tx;
Period the day after. Came off period on Friday so 4 days of pill and random period
At about 2 pm, 2-19-2021, I became very light-headed rather suddenly, and could barely stand up or walk.  (A trip from my bed to the bathroom was difficult.)  This proceeded to severe nausea (I retched into the. toilet bowl a couple of times and came close to vomiting).  I dosed in bed and the severity of the symptoms eased, but I really haven't felt completely over it until today (2-22-2021).
Father reports via telephone call, approx 5-10 min after vaccinations, pt complained of "shortness of breath, passed out, then had seizure for 40 seconds." Pt taken to ER where "vital signs were normal." Dad reports no prior history of seizures.
On the midnight of April 29, 2021, I got fever at 100.4 degree. On the morning of May 1, the fever was gone; in the afternoon, I suddenly felt back pain. The pain lasted for about a month. During the time, I didn't see doctor and didn't take any medicine. On May 30, 2021, I suddenly got right leg pain which made me couldn't walk for even 20 steps. The whole right leg from the heel to the butt feeling painful. Those pain I felt like muscle pain, tendon pain, ligament pain and nerve pain. It's already the 7th week. Even though now the pain is lighter than before, but it's still painful. I took some medicines to ease the pain, but I didn't go to doctor.
had pain the night of injection, called the pharmacy the next morning. patient stated he was in a lot of pain and cannot even lift the coffee cup with his left arm. told patient to take ibuprofen and ice and massage it. have been following up with the patient throughout the week. he stated he can not bear the pain unless he takes a pain medication. he has been taking ibuprofen 600 mg alternating with Advil 200mg. took a hydrocodone left over from dental procedure but that did not help. today the patient stated he is 80% better/back to normal function. he doesn't have any tingling, swollen arm or redness
Pediarix administered to a 8 y/o; wrong vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25th March 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th October 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: Reporter stated that 8 year old patient administered Pediarix. Following information was shared with 2nd line specialist. Reporter stated that patient was not intended to receive any vaccine during his visit but inadvertently received Pediarix. While the patient was waiting in the clinic, a nurse confused the patients and by error they administered Pedirix to this patient. Moreover, the reporter mentioned that the patient was up to date with his vaccinations. Reporter consented to follow. Additional supportive information: As patient inadvertently received Pediarix at 8 years of age which led to inappropriate age at vaccination and wrong vaccine administered.
INITIAL ARM SORNESS PROGRESSIVE OVER A 2 WEEK PERIOD WITHOUT RESOLUTION, PATIENT REPORTS TIGHTNESS IN UPPER ARM RADIATING TO NECK AREA. NO SWELLING OR REDNESS AT INJECTION SITE UPON EVALUATUION ON 1/5/15.
Patient states that this morning her arm felt dull and achy from her shoulder down to her fingertips of her left arm.
Crohns disease flare up; Coughing; patient did not felt good after getting second dose of covid vaccine; This is a solicited report based on the information received by Pfizer from Company (Mfr. Control No. : 21K-163-3993563-00).  from the marketing program facilitated collect received from a contactable consumer (the patient) .     A 68-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 0.4 mL, Citrate free for Crohn's disease  .  Medical history included hernia repair on 2016 , ongoing Crohn's disease.     There were no concomitant medications. On an unknown date the patient received the first dose of BNT162B2 vaccine without any complication. The patient experienced Crohns disease flare up  (medically significant) on 12Jul2021 with outcome of not recovered , coughing  (non-serious) on 2021 with outcome of unknown , patient did not felt good after getting second dose of covid vaccine  (non-serious) on 2021 with outcome of unknown.  The action taken in response to the events , for adalimumab was unknown.  The reporter assessed the causality between the event not feeling well and the vaccine as probable, the causality  between cough and the vaccine was not reported; the causality between Crohn's disease flare up and the vaccine as reasonable possible.  The reporter' s assessment of the causal relationship of the event cough with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available.   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 RAs, Ethics Committees, and investigators, as appropriate.
little more than light soreness in the arm where he received the Moderna COVID-19 injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little more than light soreness in the arm where he received the Moderna COVID-19 injection) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (little more than light soreness in the arm where he received the Moderna COVID-19 injection). At the time of the report, PAIN IN EXTREMITY (little more than light soreness in the arm where he received the Moderna COVID-19 injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were provided.   This case was linked to MOD21-072534, MOD21-072518 (Patient Link).
My arm all the way to my neck on the left side was painful for a week after vaccination. What bothers me is the pain in the left side of my breast (cheek close to my left arm) it was painful like someone punched me in that area for about 2 weeks.
Right sided facial paralysis, diagnosed as bells palsy, also right facial pain later diagnosed as trigeminal neuralgia, patient was seen in hospital for symptoms
Increased Temperature, severe generalized muscle pain. 2 days later developed sore throat and bilateral lymph adenopathy (neck).
Pt was held for 30 min. and developed headache, bradycardia and lightheadedness. Pt evaluated held for 45 min. and sent to ER for evaluation as symptoms persisted
Numbness & tingling in feet, ascending to chest level; now diagnosed w/GBS;
The vaccine was given past the beyond use date. Moderna was notified and per Moderna that vaccine maintained the necessary activity to protect against COVID-19. No additional intervention required. Patients first COVID vaccine was J&J.
Patient had presented for office visit with nurse for second Pfizer dose of the primary series. Patient was given Pfizer bivalent booster instead. Patient and her provider were both made aware of this. Incident report also filed. Patient did not experience any adverse reaction while in office
Erythema left anterior thigh with swelling approximately 4"x3" at site of immunization. DTaP given 9/26/05. Noted at office visit 9/28/05 at 10:30. Mom stated intermittent temp 103 9/27/05. None at office visit 9/28/05.
Pt reports fever, chills and soreness. He is currently being prescribed antibiotic for cellulitis.
3/23/21 On day of vaccine #1 had arm soreness lasted about 3 days. 3-30-21 1 week later developed a rash at injection site that grew to about 5 by 6 inches, swollen, a little itchy and sore.   4-3-21Subsided and swolleness went down and rash subsided to about a 3 x 3 inch spot and now today 4-6-21 the rash has returned to same arm just in about 3 inches away from injection site
Patient had a red, swollen left foot which started around 8pm on the day he received vaccines. No fever or other joint swelling. Slightly more fussy. No vomiting. Had a loose stool the next morning.  No complications after two month vaccines. Feeding normally. Normal energy. Otherwise well appearing. The next morning the foot was basically back to normal, maybe still mild swelling but nothing mother would've noticed if she hadn't seen the changes last night. There is not overt erythema or swelling at the injection sites.
S---Ambulance is stationed at a Covid19 vaccination clinic. A female employee of the site host was seen by EMS monitoring the clinic who appeared to be in distress. The monitor approached her, discovered she had been given a vaccination shot approximately one hour prior. The monitor called the ambulance crew over to evaluate the woman. She states she doesn't feel well. Her pulse is rapid (130 bpm). She is assisted inside where vitals are taken. BP is 140/113, HR 113, RR 30, O2 stat 98% on room air. Patient speech demonstrates 3-word dyspnea. Her hands are blue. Patient consents to a more thorough exam in ambulance; stretcher is brought to her side, she is placed Fowlers, strapped with 5-point restraints, and moved to ambulance for transport to hospital for further evaluation. O--Cardiac monitor is attached to patient. A normal sinus rhythm with no ectopy is shown. Lung sounds clear equal. No evidence of trauma. Patient states she is nauseous. Vitals are elsewhere in this report. Other than conditions described, exam is unremarkable. A--Possible reaction to C19 vaccine. Possible anxiety. P--Transport to hospital. IV attempted, no success. 4.0 mg. ondansetron ODT is given to good effect. Trip uneventful. Arrival at hospital, patient is taken to Room 3. Patient looks much better, states she doesn't want to be admitted to ER. and signs (attached) refusal of screening exam at the ER. Patient is given a courtesy return ride with ambulance.
Pt recvd vax on 24OCT91 approx between 930-1230PM; pt stated that sx started 2AM on 25OCT91; pt states that also exp high fever, dizziness, vomiting, sweating & swollen rt arm;
if a patient test positive for Covid-19 how long should they wait before getting the Moderna Vaccine, when can they get the second dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (if a patient test positive for Covid-19 how long should they wait before getting the Moderna Vaccine, when can they get the second dose of the vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (if a patient test positive for Covid-19 how long should they wait before getting the Moderna Vaccine, when can they get the second dose of the vaccine). At the time of the report, COVID-19 (if a patient test positive for Covid-19 how long should they wait before getting the Moderna Vaccine, when can they get the second dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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 concomitant information provided by the reporter No treatment information provided by the reporter  This is a spontaneous case concerning  a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of Covid -19. The event occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of Covid -19. The event occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
allergic reaction / continues to worsen; red; itchy; blotches on his skin; painful blotches on his skin; blisters on his legs and feet; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced allergic reaction, erythema, pruritus, itchy rash, skin pain and blistery rash. On an unknown date, the outcome of the allergic reaction, erythema and pruritus were not recovered/not resolved and the outcome of the itchy rash, skin pain and blistery rash were unknown.   It was unknown if the reporter considered the allergic reaction, erythema, pruritus, itchy rash, skin pain and blistery rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated he has what seems to be an allergic reaction and it continues to worsen.  He reported red itchy painful blotches on his skin. He also reported blisters on his legs and feet.  He has seen a dermatologist and is taking a steroid cream. He reported that he was allergic to a lot of things" so he was unsure if this is related to the Shingrix or not. He declined to provide any information beyond that.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR178479:same patient
1 hr follwoing vax-inconsolable intense screaming/crying, large hard spot surrounding & above inject site, followed by red blotchiness & swelling of entire lt leg, fever 101.5-102; unusally fussy 2 wks; tx APAP;
Pt presents today with c/o redness and warmth to touch at injection site (upper left arm). Redness measures 19 cm across by 10 cm down. Pt does report pain as well. Injection administered on 10/15/14. Pt reports flu vaccine administered by pharmacy on 10/15/14 - TX: Ice to area; Keflex if swelling continues. Call Monday to update call if fever develops.