chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke; When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 31Oct2023 as dose number unknown, single (Lot number: HF1068, Expiration Date: Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 31Oct2023, NEEDLE ISSUE (non-serious) and all described as "When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke". Additional information: they had experienced an issue with the Prevnar 20 and reporter was not sure if it is here the LOT number or what the end of the prefilled syringe when they were activating the safety needle feature like after they administered the vaccine it was breaking off. This was the three that they had. Reportability Determination: This complaint for Reported that after the vaccine was administered when they pull the needle out of the patient and when they went to activate the safety feature of the needle, the tip just breaks off. There was not an issue to the patient, for Prevnar 20, is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury.   Causality for "when they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353292 Same reporter/drug/event for different patients.;US-PFIZER INC-202300353439 Same reporter/drug/event for different patients.;
Initial Complaint: Dizzy  2:43   BP 114/76  HR 64  Resp 18.  Patient stated feeling dizzy.  Laying on the floor with pillow.  HA 2:50   Patient stated she feels a little better.  Is sitting up on the floor 2:55   BP 106/64  HR 64  Resp 16   Patient sitting in chair.  Stated not dizzy  5/3/21...Follow up call placed/message left.  No return call or text received
Approximately 5 days after receiving vaccine patient presented to office complaining of worsening resting hand tremors and had a temperature of 101 F. No other source of infection found including negative chest x ray and urine studies. CBC was within normal limits. Patient with seizure history however never had symptoms similar to this. Neurological exam normal in office. Fever resolved the next day.
elevated temp 10-12hr;shoulder soreness;swelling, rash @ inj site 12hr, malaise, dizzy, light-headed, overall achiness (shoulder, neck lt side of back)
Patient developed a varicellaform rash 26 days after administration of Varivax.
48 hours post ZOSTAVAX immunization pt came to Rph w/fist sized, red, warm, swollen area at site of injection. we recommended that she see her MD who prescribed her KEFLEX 500 mg (BID) as precaution. 24 hour later the rash area was markedly improved per pt.
Onset of uterine cramps about 45 minutes after injection, with a pain level of 4/10. Have continued non stop since injection. Very tightly concentrated cramps at cervix. Pain level ranges from 2/10 to 7/10 every day. Received vaccine 14 days ago and cramps have not gone away. No other reproduction illnesses currently, and uterine cramps are not normally experienced during any other times, or if so range from a 1/10 to 3/10 during menstrual cycle.  Skyla IUD has been inside since 8/21/2019.  Dark purple bruising at injection site approximately 2inches by 3inch. Bruising is faintly present and still sore to touch as of 2/17/2021
After client received his vaccine client stated he is experiencing tingling around his mouth and watery eyes. Vital signs obtained by EMS.  BP 123/73, HR 62, O2 sat 99%, Temp 98.0; Client stated she feels better. Client discharged home by EMS.
Vasculitis-non-blanching rash on entire body except face x 3 days.
Donor states 'soon after' getting the vaccine she developed dizziness and felt her heart racing. Donor states these symptoms continued from the morning of 1/13/19 until the morning of 1/14/19. Donor states she spent the whole day in bed due to these symptoms. Donor denies fever, pain, rash, headache, nausea, vomiting, vision changes or weakness. Donor was made to wait 20min at the center post vaccine. At the 20min mark, donor stated she felt fine.
56 yo Male states he was in his usual state of health until he had a routine primary care appointment yesterday and received a pneumonia vaccine to his left deltoid. He states shortly after getting home he began having general body aches and nausea and vomiting.
Site: Pain at Injection Site-Mild, Systemic: vommiting-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient's initial pulse was 99. Five minutes later, her bp was 88/48 and her pusle was 53. Five minutes later, after her second assessment BP was 88/48 and pulse was 53. Family was notified. Five minues later, her bp was 138/86 and pulse was 63. Two more sets of vital were taken over the next 20 minutes until family arrived. Patient was attended by this nurse until she left the facility with her mother. Patient instructed to f/u with provider.
Rash; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and INJECTION SITE PAIN (Injection site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History provided).    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and INJECTION SITE PAIN (Injection site pain). At the time of the report, RASH (Rash) and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.
Nose bleed evening 2/12/2021 Nose bleed morning 2/13/2021
The patient received the 1st Moderna covid vaccine lot # 028L20A on January 22  and had a mild reaction.  She received   The 2nd dose lot number 030M20A  on February 19th.  That night she had pain in her right arm.  Over the next 12 hours she developed pain extending from her right arm to her right axilla.  Over the next 2 days she developed bruising on the right lateral side of her right breast.  By 3 days after the shot she had developed a painful approximately 10 cm bruise extending from the right axilla to the right breast.  since that time the bruise has improved
Fisher variant of Guillian Barre with ataxia, L6th, L5th, accommodation, also R tract lesion with L periph visual loss L>R eye.  6/12/07 Received hospital records from provider which included consults, ER records, labs & x-ray reports as well as provider notes & vax record.  Returned to office on10/13 w/complaints of right ear pain & tx w/drops but worsened & was placed on antibiotics 10/16/06.  Seen 10/23 for med adjustments.  Returned on 12/13/06 for left eye visual field deficit for approx 4-5 mos & for last 6 weeks numbness on left cheek.  Returned to office 12/19/06 w/worsened vision loss left eye, vision loss comes/goes & occasionally was blinded in left eye. Trigeminal nerve weakness noted.  Referred to neuro opthamologist who dx w/fisher variant of GBS.  Vision improved.  On 4/11/07 returned to office stating had lost vision completely for 90 min approx 1 mo earlier & had been having a lot of double vision & seeing spots.  Opth thought ocular migraine (hx ocular migraine).  Neuro consult indicates that patient experienced flu-like symptoms for about 3 weeks s/p flu shot & prior to developing vision problems.  Continued w/ gait & balance disturbance, fatigue,  & resolving droopy left eyelid.  Neuro could not provide dx other than possibly early MS.  Patient seen in ER on 12/18/06 for severe HA, pressure behind left eye & tingling on left side of face. FINAL DX: Fisher variant of Guillian Barre syndrome.
Bad Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad Headache) in a 76-year-old female 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Bad Headache). At the time of the report, HEADACHE (Bad Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Patient Given 1st dose Moderna 03/26/2021.  Patient given 2nd dose Pfizer today 08/31/2021.   Disclosed to patient. No adverse effects in 30 minutes of monitoring.
pt recvd vax 22FEB94 & on 7MAR94 devel unilateral parotitis; No further details were provided;
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-395985 (Patient Link).
This spontaneous report was received from a registered nurse and refers to a 11 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L016124 with expiration date of 06-MAY-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 51 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Pt with syncopal episode after/during HPV #1 admin. Occurred after receiving MENACTRA, Hep A and V2V #2. Vitals nl. Came to after 2-3 sec. Monitored x20 min.
night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats). At the time of the report, NIGHT SWEATS (night sweats) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment information provided.
Approximately 10 hours after receiving the injection, I experienced extreme chills, nausea, elevated heart rate. The last time I experienced symptoms like this was on the first day I started chemotherapy and had an allergic reaction to one of the chemo drugs (bleomycin). I had a delayed reaction hours later and went to the ER. It was determined it was an allergy. So I took Claritin D 24 H and saw the symptoms I was experiencing last night dissipate.
On January 10th, I started getting heart palpitation, I had PVC premature ventricular contractions. Started January 10th, got very severe, I went to the hospital, I still have them, better now but not gone.  On 11/11 got the vaccine but on 12/25 I got exposed to COVID-19. I had a home test, and it was Negative. I felt under the water for less than 24 hours. A week after that's when my other symptoms started.
L arm-HAV/Tdap adm 07/17/08 - local rxn per pt report. (4cm in diameter area)  Warmth, red, tender x3 days.
Pt was given a Pfizer covid vaccine 3 ml that was improperly diluted with 0.8 ml sterile diluent vs 1.8 ml. Pt was monitored for 15 mins after receiving per protocol & left the clinic without adverse reaction
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. Since 21-JUN-2017 the patients were vaccinated with improperly stored GARDASIL 9 (dose, lot #, expiration date and route were unknown) for prophylaxis. No adverse effects were reported. The coldest temperature was 32 Fahrenheit, time frame was unknown. There were multiple temperature excursions previously. The call was because of a data logger. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004182: US-009507513-1708USA004183: US-009507513-1708USA004184:
Patient had received vaccine on 7/7/2019 approximately 11:45am. Everything was fine during administration and patient had waited in store for about 10 minutes after administration was complete and reported feeling normally. According to the patient, symptoms began around 5:30pm that same afternoon and it started with nausea and chills. Throughout the evening and night, she felt restless and had a severe headache. She continued to feel chills and also felt very hot as well during the night. Loss of appetite also occured in the morning, patient states that she usually has a hardy breakfast but was unable to eat this morning (7/8/19) so she decided to stop in and inform us.
PT REPORT HAVING SHINGLES LESIONS ON LEFT SIDE OF HER BODY AS WELL AS A SORE ARM. PT CALLED HER PROVIDER HOWEVER ELECTED TO NOT SEEK ANY TREATMENT AT THIS TIME. SHE IS GOING TO WAIT AND SEE IF THE LESIONS SELF-RESOLVE.
This spontaneous report was received from a registered nurse via a company representative and refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On unknown dates, an unspecified local university notified area clinics about an outbreak of mumps. The outcome of the event of mumps was unknown. The relatedness between the event of mumps and M-M-R II was not reported. Additional information has been requested.
I got a fever and felt ill. My arm hurt. Shortly after I started having fatigue and then was diagnosed with EOE.  My heart hurts, it didn't before.
Patient complaint of nausea after vaccination.  No vomiting, diaphoresis, color change, or tunnel vision. Vital signs stable throughout evaluation on - BP, pulse rate, and O2 saturation were all normal. Initial BP - 136/92  Pulse - 90  O2 sat 98%.    Symptoms were all self-resolving with time - 30 minute observation. No othostasis at discharge. This was clinically a mild vaso-vagal reaction.
Cellulitis at vaccination site 7cm x 9cm, warm, tender indurated swollen area. Treated with Keflex 500, 2 PO BID x10 days.
Initial misuse report received on 05 December 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, route and site of vaccination was not reported) on an unspecified date. The nurse reported that they gave only ACTHIB portion diluted with sterile water. As of 05 December 2013, patient did not have any adverse events. List of documents held by sender: none.
Reaction began on the evening of the injection as a small (1 inch diameter), raised, hard, red patch at the injection site on the right arm near his shoulder. The patch has grown to be about 2 inches in diameter.  The patch is also very hot to the touch.
This spontaneous report as received from a pharmacist refers to a newborn (gender unknown) patient of unknown age. On 24-OCT-2012 21:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
36 HOURS OF THE WORST FLU EVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 36 hours of the worst flu ever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 36 hours of the worst flu ever was not reported. This report was non-serious.
shakes; hard to eat/couldn't eat that much; kept sleeping; chills; body was sore; woke up throwing up that persisted and lasted through the night; diarrhea that persisted and lasted through the night.; felt fatigued which lasted the two days,still fatigued; Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again; felt like growing pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again), PAIN (felt like growing pains), DIARRHOEA (diarrhea that persisted and lasted through the night.), TREMOR (shakes) and FEEDING DISORDER (hard to eat/couldn't eat that much) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again), PAIN (felt like growing pains) and FATIGUE (felt fatigued which lasted the two days,still fatigued). On 29-May-2021, the patient experienced DIARRHOEA (diarrhea that persisted and lasted through the night.) and VOMITING (woke up throwing up that persisted and lasted through the night). On 30-May-2021, the patient experienced TREMOR (shakes), FEEDING DISORDER (hard to eat/couldn't eat that much), HYPERSOMNIA (kept sleeping), CHILLS (chills) and MYALGIA (body was sore). On 21-May-2021, PAIN IN EXTREMITY (Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again), PAIN (felt like growing pains) and FATIGUE (felt fatigued which lasted the two days,still fatigued) had resolved. On 30-May-2021, DIARRHOEA (diarrhea that persisted and lasted through the night.) and VOMITING (woke up throwing up that persisted and lasted through the night) had resolved. On 02-Jun-2021, TREMOR (shakes), FEEDING DISORDER (hard to eat/couldn't eat that much), HYPERSOMNIA (kept sleeping), CHILLS (chills) and MYALGIA (body was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
12/18/20- Left arm pain at site of injection-treated with rest, pain continues from 12/20-4/21 was hopeful that pain was temporary and would go away.  04/08/21- saw MD for check up, had complaints of left arm aching, told to start capsaicin cream 3x daily, take NSAIDs and home exercises as discussed 07/01/21- saw Dr. for check up and continued left arm pain -has complaints of intermittent tingling of left upper extremity, instructed to stop Capsaicin cream due to it not helping. MD made referral for Physical Therapy for left upper extremity pain
He experienced pain in the arm, at the injection site; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP) from medical information team.  A 42-year-old male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "He experienced pain in the arm, at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
01/24 Called my doctor and they gave me a heart monitor for 48hrs. and discovered I had AFib. Was given referral to the cardiologist and at that appointment on 01/27 was given different heart medications and doses. Appt. for cardiac ultrasound for 2/11. This test turned out all normal. New appt on 2/25 and is ongoing. Recently my heart palpitations have reduced in severity and amount.
Headache on top of patient's head which worsens when she stands upright. Also experiencing muscle tenderness. Symptoms started 1-2 days after vaccine administration. Patient denies any fever, nausea, or vomiting. Currently patient is still experiencing symptoms 9 days after it had appeared. Patient states HA is not relieved by APAP/ibuprofen, but oxycodone helps.
fever 103 assoc w/ 1 episode of shaking/cyanosis (brief period); rx APAP/Advil for fever; gastroenteritis/pharyngitis 3-4 days p/vax;
Pain at time of injection. Left deltoid. Pain persisted in left shoulder for months accompanied by decreased range of motion. Individual did not seek healthcare until 3/12/19. 03/12/19: (L) shoulder FROJM with discomfort with max abduction and introtation with adduction. Physical therapy ordered.