chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard to lift her arm; itching on her shoulder; shoulder swelled up; shoulder hard; shoulder red; shoulder blotchy; arm hurt at vaccination site; hives on left forearm, then right forearm; tightness in her throat; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on left forearm, then right forearm), THROAT TIGHTNESS (tightness in her throat), LIMB DISCOMFORT (hard to lift her arm), PRURITUS (itching on her shoulder) and SWELLING (shoulder swelled up) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced URTICARIA (hives on left forearm, then right forearm), THROAT TIGHTNESS (tightness in her throat) and VACCINATION SITE PAIN (arm hurt at vaccination site). On 07-Mar-2021, the patient experienced LIMB DISCOMFORT (hard to lift her arm), PRURITUS (itching on her shoulder), SWELLING (shoulder swelled up), MUSCULOSKELETAL DISCOMFORT (shoulder hard), ERYTHEMA (shoulder red) and RASH MACULAR (shoulder blotchy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 28-Feb-2021, URTICARIA (hives on left forearm, then right forearm) and THROAT TIGHTNESS (tightness in her throat) had resolved. On 02-Mar-2021, LIMB DISCOMFORT (hard to lift her arm) and VACCINATION SITE PAIN (arm hurt at vaccination site) had resolved. At the time of the report, PRURITUS (itching on her shoulder), SWELLING (shoulder swelled up), MUSCULOSKELETAL DISCOMFORT (shoulder hard), ERYTHEMA (shoulder red) and RASH MACULAR (shoulder blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant provided   This case was linked to MOD21-047293 (E2B Linked Report).; Sender's Comments:  MOD21-047293:Crosslink
Patient was in 30 min observation are for 20 min when felt like her throat was closing, taken to ADR site for monitoring and intervention, of Benadril was given, symptoms didn't resolve, Epi IM was given and 911 called, patient transferred to ED
The Patient received her flu vaccine on the evening of Wednesday 9/21/22. She called into the Pharmacy on Friday evening  (9/23/22). She complained of a "knot" on her right lower neck/decolletage region. She asked if she could come into the Pharmacy to have a Pharmacist examine it. The Pharmacist-On-Duty at the time examined the patient's right arm in which the flu vaccine was administered. Although no obvious bruising was noted, the patient's right upper arm/deltoid felt very warm to touch. The Pharmacist had the patient raise her arm above her shoulder so she could demonstrate that she still had full range of motion in her right arm. The Pharmacist also felt the "knot" that the patient had mentioned in the phone call. The "knot" was a soft, movable nodule which was about the size of a quarter.
Soon after injection was received, left arm became inflamed, swollen and warm to the touch from injection site LUE to left elbow. Persisted for approximately five days. ROM then became painful and limited.  As I was out of state with limited insurance coverage until returning home, I deferred medical intervention until May 12, 2021, when I saw my PCP. She diagnosed frozen shoulder, and prescribed physical therapy. I was seen by a therapist on six occasions - 5/28, 6/3, 6/10, 6/16, 6/24, and 7/1/2021. Discharged to self care. ROM is improved, though not WNL, and occasionally uncomfortable.
Runny nose; tachycardia; Weakness; flu like symptoms; Sore/dry throat; Sore/dry throat; nausea; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on the left arm, first dose on 18Dec2020 (lot number: EH9899) and second dose on 08Jan2021 08:15 (lot number: EL3246), both at a single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medications were not reported. Patient did not receive other vaccines in four weeks prior to vaccination. The vaccine was given at a hospital. The patient reported sore/dry throat and nausea started Sunday (03Jan2021), weakness and flu-like symptoms on Monday (04Jan2021), then runny nose and tachycardia on Tuesday (05Jan2021). No treatment was received for the events. Patient has not been tested for COVID post-vaccination. Outcome of the events was not recovered.
On 7/7/99, the pt experienced severe pain in her shoulder and pain down her back on the same side of the vaccine with tingling in her hand. The pt sought medical treatment. The pt was treated with ibuprofen for the pain, however, the pain did not abate. The reporter noted numbness is going all the way down the arm and progressing down the leg as well.
Patient had never been ill in the past nor had received any previous vaccinations.  At 2 years old she received her very first vaccine (Pentacel) in her thigh.  Within six hours, patient was vomiting profusely and became lethargic.  She had a fever of 101F and vomited approx. five times that evening.  Patient's mother spoke to doctor's office the next day and they insisted this was not a vaccine reaction but that she "probably caught something in the waiting room," despite them having a separate waiting room for well-child visits for this very reason.  Patient continued to be lethargic and present with nausea and vomiting for seven days.
5 MINUTES AFTER VACCINE GIVEN PT C/O NECK PAIN NAUSEA, VOMITED X3 IN 5 MINUTES, PALE IN COLOR, THROAT FEELS SHAKEY.
Wed, 7/14/21 - headache, body aches, fatigue, low appetite Thurs, 7/15/21 - body aches, fatigue, cough, sore throat, low appetite Fri, 7/16/21 - body aches, headache, fatigue, cough, loss of smell/taste, tested positive for COVID-19 via nasal swab
Pt received both doses of the COVID 19 Pfizer vaccine (on 1/25/2021 and 2/15/2021).  Pt presented to the ED on 8/11/2021 and tested positive for COVID-19.  At first, he had only generalized non specific symptoms relating to COVID (weakness, fatigue), and treatment was focused on blocked nephrostomy tubes with infection.  Starting on 8/14/2021, provider was notified that patient was having O2 desaturation to 83% and transient increases in O2 requirement (up to 10 L and then weaned to 6L).  Diagnosed with acute hypoxic respiratory failure, experienced episodes of hemoptysis.  Chest xray on 8/17 showed right upper lobe pneumonia.  Pt started on dexamethasone remdesivir on 8/14/2021.  Appears that COVID extended hospitalization but unsure by how many days.  Discharged from hospital on 8/23/2021.
Flu like symptoms, muscle pain and injection site pain. 1 day so far. Aleve for pain.
No additional AE; temperature excursion / temperature 9C; This spontaneous report was received from a licensed vocational nurse and refers to a 12 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 09-MAR-2021, the dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T006849, expiration date 16-JUN-2022 was stored improperly in a temperature of 9 degree Celsius (C) for 30 minutes and on 19-MAR-2021, it was administered to the patient (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No previous temperature excursion was reported. Digital data logger was involved. No adverse event (AE) was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2105USA007015: US-009507513-2105USA006749: US-009507513-2105USA007032: US-009507513-2105USA006817:
The patient stated that she had a low grade fever of 99 (unit not provided) and everything hurts even while taking pain medication.; The patient stated that she had a low grade fever of 99 (unit not provided) and everything hurts even while taking pain medication.; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2020180084). This case was split from master case #2020444687 for a female patient taking COVID Vaccine. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included ongoing rheumatoid arthritis. Concomitant medication included etanercept (ENBREL) taken for rheumatoid arthritis, start and stop date were not reported. on an unspecified date the patient stated that she had a low-grade fever of 99 (unit not provided) and everything hurts even while taking pain medication. The patient underwent lab tests and procedures which included body temperature: 99   on   Low grade fever of 99 (unit not provided Therapeutic measures were taken as a result of the patient stated that she had a low grade fever of 99 (unit not provided) and everything hurts even while taking pain medication. (pain). Outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
INITIALLY HEADACHE, THEN NUMBNESS OF LEFT HAND (4TH & 5TH FINGERS), GOOD GRIP AND +2 PULSE. DENIES CHEST PAIN OR SOB. NO SKIN CHANGES. VSS, ALERT AND OREINTED X 4. NO WHEEZING. NP CALLED TO SITE, ASSESED PATIENT. PT AMBULATED AND NUMBNESS IN ARM DECREASED, BUT STILL NUMBNESS IN 2 FINGERS SLIGHTLY PRESENT. OBSERVED FOR 20 MIN AND VERBALIZED UNDERSTANDING TO CALL EMS IF SIGNS OF RESPIRATORY DISTRESS OR REPORT BACK TO CLINIC IF EXPERIENCES OF NUMBNESS INCREASE.
No additional AE or PQC reported; Caller explained VARIVAX was administered after a temperature excursion; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # U025204 and expiration date 13-AUG-2023, administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 26.6 degree fahrenheit (F) for 1 hour, and 7.9 F for 30 minutes on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported.
Medical examiner reported pt was pronounced dead @ 136PM 9DEC97;autopsy to be performed;
Patient developed upper torso pruritus and 3 cm rash on right antecubital.  Is being treated with 50mg diphenhydramine PRN TID x 3 days.
On 3/14/00, the pt developed myalgia, arthralgia, headache, and chills. Tylenol was taken on occasion.
08/13/2021 PM general swelling, rash on the fore arm left arm then the right arm, by Sunday 08/15/2021 blister bowel pushing and hand formed mucus blister and blood blisters Fevers arches and pains until about 7 days and a round of 20mg Prednisone twice daily, two round of that and then after that given the antibodies Z-PAK. Not Azithromycin 250 Mg tablets.
An anonymised single pt print was received on 06/17/2002 concerning a 58 year old male pt, who experienced myocardial infarction 4 hrs after receiving FluVirin on 11/20/2001. At the time of reporting, the pt had recovered. There was insufficient info to determine the reporter's causality assessment.
Patient experienced a syncopal episode following administration of vaccine. She fell from a seated position, and hit her head on the floor. She regained consciousness within 15 seconds. She was offered medical attention but refused. An on-site EMT was available to evaluate patient.
Left side chest pain on the same side as the injection. The pain started after the first vaccine and has not gone away since. Treatment was sought at a local emergency room but there were no findings of any irregularities.
I gave a 5 year old child a Pfizer pediatric vaccination and she immediately became very lethargic and quiet.  She had been very animated when I gave her sister her vaccine 5 minutes before, but as soon as I walked in the booth to do hers she got very worked up and started to cry.  The administration of the vaccine went fine, but afterwards she threw up a little in her mother's hand.  We got her a bottle of water because the mother stated that the child didn't like the candy that she had chosen before the vaccine.  The mother and children sat in the booth for 20-30 minutes. The child was responsive just quiet and clinging to her mom.  I asked the mom if there were any other issues and she stated there were not.  The child was having no breathing issues, or a rash of any kind.  When they left, the mom placed the child in the back of the shopping cart to lay down.
after her second shot, 24 hours later she had a lot of pain, felt like someone started beating on her; first dose on 5Feb2021, second dose on 15March2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (after her second shot, 24 hours later she had a lot of pain, felt like someone started beating on her) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 5Feb2021, second dose on 15March2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 041L20A) for COVID-19 vaccination.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 5Feb2021, second dose on 15March2021). On 16-Mar-2021, the patient experienced PAIN (after her second shot, 24 hours later she had a lot of pain, felt like someone started beating on her). At the time of the report, PAIN (after her second shot, 24 hours later she had a lot of pain, felt like someone started beating on her) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 5Feb2021, second dose on 15March2021) outcome was unknown.            No Medical History information was reported. Treatment information was reported as unknown.   This case was linked to MOD-2022-538477 (Patient Link).   Reporter did not allow further contact
Legs are tender to touch; Pain seems more severe behind knees/Experienced pain down both legs to ankle; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Legs are tender to touch) and ARTHRALGIA (Pain seems more severe behind knees/Experienced pain down both legs to ankle) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Leg pain (three times) since 22-Aug-2021.   On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced LIMB DISCOMFORT (Legs are tender to touch) and ARTHRALGIA (Pain seems more severe behind knees/Experienced pain down both legs to ankle). At the time of the report, LIMB DISCOMFORT (Legs are tender to touch) and ARTHRALGIA (Pain seems more severe behind knees/Experienced pain down both legs to ankle) outcome was unknown.     No concomitant information was provided by the reporter.  No treatment information was provided.  The patient stated that the pain in the legs and knees started a day before the vaccination (22-AUG-2021). The patient stated that the pain in the legs lasts for 16 minutes for each episode and it goes away. The patient inquired if it was a blood clot. It was unknown if the patient was treated for the reported events.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up information received: Added medical history. Updated inarrative supplement
FEEL ICKY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported, in arm for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced feel icky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feel icky was not reported. This report was non-serious.
This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had fatigue (tiredness) and pain (aches), onset 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
About 2 seconds after Moderna vaccine was given to patient, pt reported he was going to vomit. Pt was provided with a bucket to vomit if needed but did not end up doing so. Pt experienced physical sweating and was given some paper towels at his request. Pt denied ice pack at this time. About 3 minutes passed, symptoms subsided and patient was able to articulate what happened. Patient states he felt a major drop in temp. to freezing and then all of a sudden to boiling thus experiencing nausea. Pharmacist kept pt on observation for a 30 minute waiting time.
Information has been received from a certified medical assistant concerning a 19 year old female patient who on 31-MAR-2010 was vaccinated with the second dose of GARDASIL. On 01-APR-2010 the patient woke up with itching, swelling of the fingers and hives all over. At the time of the report, the patient had not recovered. Additional information has been requested.
Information has been received from a registered nurse concerning a 22 year old female who on unspecified dates was vaccinated with the first and the second dose of GARDASIL vaccine. Patient did not experience any problems. On 24-NOV-2008, the patient was vaccinated with the third dose of GARDASIL vaccine (lot number 661764/0650X)0.5 ml IM and experienced a lump in the injection site area shortly after on the same day. The lump was painful to touch. The patient sought medical attention, called office. The location of the lump was unspecified. The lump resolved on its own couple of weeks after received the third dose. Additional information has been requested.
Pt. states that after receiving the 3rd Booster of Moderna 10/25/2021, started experiencing symptoms that night of sore arm, chills, body shaking (lasting 2 + hrs). Symptoms have subsided, No noted Primary visit/communications.
Severe pain from neck down to left hand / fingers lasting about 72hrs. Cold/flu type symptoms (typical immune response for me to any vaccine, injection of any kind or any contact with surgical steel) starting within six hours and lasting about 10 days. Severe pain, weakness, tenderness specific to left elbow joint for approximately two months.
bruising in other areas other than the injection site; injection site bruising; This case was reported by a other health professional via interactive digital media and described the occurrence of contusion in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced contusion and injection site bruising. On an unknown date, the outcome of the contusion and injection site bruising were unknown.   It was unknown if the reporter considered the contusion and injection site bruising to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter asked, was the bruising common in other areas than the injection site.
Client phoned 2/2 - reports that (L) arm sore at injection site - & is painful when stretching arm - up to shoulder & down. Relates that after injection had 2" redness with bump - hot to touch & lasted a couple days. Phone call. 2/9 - client reports seeing Dr 2/4 - told "calcium deposit" after injection - due to local allergic reaction". States was instructed to use heating pad to arm when sleeping.
only the diluent portion of pentacel had been administered with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient and reporter reported only the diluent portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] had been administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Apr-2023, the patient received an unknow dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (with an unknown strength, expirty date, lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On 06-Apr-2023, the patient received only the diluent portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine had been administered with no reported adverse event (Product preparation error) (Latency: same day).  It was reported, Sales rep states that she spoke with a nurse that said she discovered that only the diluent portion of Pentacel had been administered to a 4-month-old male, administered on 06-Apr-2023.  Action taken: not applicable.  Outcome: Unknown   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 guidelines. 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.
When I got it Immediately started feeling sick and 2 days later my period started again even though I just had it. I bled heavy for 2 weeks and then it did not come back for 4 months and then it came back.
EXPIRED VACCINE USED; VACCINE VIAL PUNCTURED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced expired vaccine used, vaccine vial punctured, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine vial punctured, incorrect product storage and expired vaccine used was not reported. This report was non-serious.