chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had syncope episode & loss consciousness hitting back of head on concrete floor.  BP 80/54.  Was taken to observation area to be monitored & ice to hematoma on back of head.  He laid flat until dizziness subsided & could resume walking.  BP 116/76  Mother came to pick him up.  Instructed to watch for signs of brain injury.
pain in  eye; headaches; injection site pain; Watering eyes; mouth felt funny; nauseous; pain inside of ear; palpitation; light headed; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), EAR PAIN (pain inside of ear), PALPITATIONS (palpitation), DIZZINESS (light headed) and EYE PAIN (pain in  eye) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced NAUSEA (nauseous), EAR PAIN (pain inside of ear), PALPITATIONS (palpitation), DIZZINESS (light headed), INJECTION SITE PAIN (injection site pain), LACRIMATION INCREASED (Watering eyes) and FEELING ABNORMAL (mouth felt funny). On 15-Apr-2021, the patient experienced EYE PAIN (pain in  eye) and HEADACHE (headaches). On 14-Apr-2021, NAUSEA (nauseous), EAR PAIN (pain inside of ear), PALPITATIONS (palpitation), DIZZINESS (light headed), INJECTION SITE PAIN (injection site pain), LACRIMATION INCREASED (Watering eyes) and FEELING ABNORMAL (mouth felt funny) had resolved. On 16-Apr-2021, EYE PAIN (pain in  eye) and HEADACHE (headaches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
8 hrs later, I was back on the long Covid Rollercoaster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long COVID", start date: Feb2022 (unspecified if ongoing), notes: I have been suffering with long COVID since the 1st week of Feb. The patient's concomitant medications were not reported. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious) with onset 2022, outcome "unknown", described as "8 hrs later, I was back on the long Covid Rollercoaster".  Additional information: It was reported that patient have been suffering with long COVID since the 1st week of Feb. Had 1st vacation yesterday. After about 2hrs, felt like was finally on the road to recovery. 8 hrs later, was back on the long COVID Rollercoaster. Due to get 2nd Pfizer vaccine 28Apr.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Significant pain at injection site that lasted about 36 hours and prevented any touching of the site. Also had mild headache and some generalized myalgias. These also resolved after 36 hours.
Patient fainted roughly 5 minutes after receiving vaccine. Prior to fainting patient was able to move himself to the ground to avoid a fall related injury.
pt recv vax MAY95 & 24JUN96 pt was exposed to chickenpox;10JUL96 pt exp a lack of response & devel chickenpox;no further details were provided;
aching muscles; The case was initially processed as Invalid (as there is no indication that the patient experienced an adverse event under the suspect product BNT162B2) but upon follow up event was reported so the case is upgraded as Valid Case.   This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program . A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL9264 and expiration date were not reported) intramuscularly in left arm on 02Mar2021 at 10:30 at single dose for covid-19 immunisation. Patient had a first dose (Historical vaccine) of BNT162B2 on 09Jan2021 at 16:00 intramuscularly in left arm (Batch/Lot number: EL3302). On 02Mar2021 (after 2nd shot on the same day) at 18:00 patient aching muscle. Patient took Tylenol for event and was fine. The case was non-serious as per reporter. The outcome of the events was recovered.   Follow-up (30Mar2020): This is a follow-up spontaneous report received from a contactable consumer. This consumer responded in response to the Non-HCP letter sent to the patient which included that: event, treatment, outcome added related to Second dose of vaccine, first dose captured as historical vaccine.   No follow up attempts are needed. No further information is expected.
Burning, itching, at injection site and satellite area on lower -mid left side of abdomen. No dyspnea, no wheezing.
Pt recvd 3 doses of Engerix-B vax & 21SEP91 it was determined that pt did not respond to the vax series;
Prior to these 2 vaccinations, he had had mild to moderate reactions to previous vaccines, he dealt with eczema all over his body and extremely constipated. The last 2 vaccinations he ever had and ever will have were the two listed above. After these 2 were given he became lethargic and stopped making eye contact. For months I dealt with outburst of cries for no reason, stopped laughing and smiling and stopped making eye contact. Completely changed demeanor.
Sudden full body red, prickly rash along with chills.  lt lasted several hours.  I took a Claritin that melts in your mouth.  As of the time of this writing at 4:50pm, I have not symptoms.
lay down for a few hours; lost appetite  (he said he didn't eat much for supper); arm hurt; This case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (did not experience any side effects with the first injection). Concomitant products included fluticasone propionate + salmeterol xinafoate (Advair).   On 23rd June 2020, the patient received the 2nd dose of Shingrix. On 23rd June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 25th June 2020, the patient experienced sleepiness and appetite lost. On an unknown date, the outcome of the sleepiness, appetite lost and pain in arm were recovered/resolved.   It was unknown if the reporter considered the sleepiness, appetite lost and pain in arm to be related to Shingrix.  Additional details were provided as follows: It was reported that after the second injection his arm hurt. On the third day after the injection he experienced lost appetite (he said he didn't eat much for supper) and had to lay down for a few hours. The symptoms were gone the following day. The reporter did not consent to follow-up. This case was linked with the case US2020115708, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020115708:same reporter
Nausea, general malaise, at 1000, headache and dizzy that lasted 3 weeks.
Chills 48 hours Severe pain in all joints  48 hours Mild pain in all joints  48 hours after severe pain
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medicine were reported. No treatment medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live significant follow up: Updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:
Vaccine expired on 04-Apr-2022 and administered on 25-May-2022.; doses were administered after the expiration date/Administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date/Administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and administered on 25-May-2022.) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date/Administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and administered on 25-May-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date/Administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and administered on 25-May-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that vaccine their office administered were expired at the time of administration.  The vials were thawed on same day of administration and the vial did not undergo any temperature excursions.  The patient had no known reactions at office. The patient's weight was reported as 230 with unknown units.  No treatment information was provided.
Patient received vaccine after published expiration date. Moderna analyzed lot 007B21A and indicated vaccine maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event. This was administration error with no adverse event.
Initial unsolicited report received from a non health care professional on 17 September 2015. This case is linked to case 2015SA143288 (same reporter) This case involves a (age unknown) female patient who was vaccinated with a [dose not reported] intramuscular [dose series not reported] dose of FLUZONE QIV (batch number UI440AE, expiry date 30-JUN-2016) in "right and left deltoid" on 15 September 2015.  Illness at time of vaccination was not applicable and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy (NKA). Concomitant medications were not reported. On 16 September 2015, one day following the vaccination patient had had cellulitis and injection site redness, swelling, pain and warm to touch. Patient required emergency room (ER)/doctor visit. Patient laboratory investigation was not reported. It was reported that, patient treated for cellulitis with ABX (antibiotics). The outcome of event was not recovered. List of documents held by sender: none. Follow up information received non-healthcare professional on 16 November 2015. A 35-year-old female patient received vaccine in left deltoid. Patient did not have any Illness at time of vaccination and pre-existing physician-diagnosed allergies, birth defects and medical conditions was reported as no.
Redness, blotchiness around injection site (R) deltoid) and (R) axilla. Temp 98.2.
Mother of child called me 4/7/2015 to inform me that child developed rash on arms and trunk approximately 90 minutes after receiving Tdap vaccine. Rash continued to worsen. Mother took child to urgent care, where child received epinephrine.
Patient  presented for the second dose on 9.3.2021 and showed me the sore that resulted from the first vaccine. He reported it started a few days post injection but didn't think too much about it until his spouse said something when she saw it a few days ago.  Patient also reported on 9.3.2021 that he had sores in his mouth and sore teeth a few days after the injection. Those had resolved by 9.3.2021.
This spontaneous report was received f rom a 55 year old female consumer regarding herself. The patient's pertinent medical history included breast cancer. The patient did not have any drug reaction/allergies. On 22-JAN-2016, the patient was vaccinated with ZOSTAVAX (lot # unspecified), 0.65 ml/one injection, subcutaneously . Concomitant therapies included raloxifene, amlodipine, Lisinopril (manufacturer unknown), fish oil, Vitamin D3 and baby aspirin. On 22-JAN-2016, the patient experienced injection site pain, swelling and feverish feeling around the injection site. The patient did not seek medical attention. No Product Quality Complaint (PQC) was reported. No lab diagnostics studies were performed. The outcome of the events were reported as recovering. Causality assessment was not provided. Additional information has been requested.
Pt experienced red, hot and painful bump at site of injection, the evening of vaccination. The following day, her arm swelled up to her elbow and around her arm, (did not pass the elbow). After the 4th day, the pt noticed a pus filled pimple-like bump on her arm at the injection site, which popped later on the 4th day. Pt also experienced itching at the site and nausea, the first few days after receiving the vaccination. Pt was seen in the ER on 1/11/03 and received naproxen, acetaminophen and prednisone.
After first dose I was running fever, overall feeling of unwell, and migraine headache starting on the following day of receiving vaccine and lasting 3 days.  After second dose I woke up with overall feeling of unwell, kidney pain, and migraine headache off and on. Today is 7 days after receiving vaccine and I still have of and on migraine headache which is uncommon for me.
Mild headache; overall body soreness, worse in left arm; overall body soreness, worse in left arm; Lack of energy; This is a spontaneous report received from a contactable consumer. A 40-year-old male received received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot number EP6955 and expiry date was not reported) via an unspecified route of administration, in the left arm, on 14Apr2021 at 14:00 (at the age of 40-years-old) as a single dose for covid-19 immunisation. Patient's medical history was not reported. Concomitant medications included tadalafil, allium sativum bulb (GARLIC EXTRACT), fish oil, colecalciferol (VITAMIN D3) and multi vitamin. Patient had previously received first dose of vaccine on 24Mar2021 at 14:00. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination included tadalafil, allium sativum bulb (GARLIC EXTRACT), fish oil, colecalciferol (VITAMIN D3) and multi vitamin. Patient did not have covid prior vaccination. Patient did not test covid, post vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. On 15Apr2021 at 09:00, patient experienced mild headache, overall body soreness, worse in left arm and lack of energy. The events were considered non serious. No treatment was received. The outcome of events was recovering.  Follow up(21Apr2021): This is a follow up-spontaneous report from a contactable Consumer. This Consumer (patient) reported in response to a letter sent which included that: No new information received.   No follow-up attempts are needed. No further information is expected.
9/9/21 hx of hypertension, comes in with history of acute on chronic back pain, accompanied by bilateral lower extremity paresthesias
Patient stated he has only received one dose of COVID vaccination and we gave him a booster not a first/second dose
Information has been received from a registered nurse concerning a 12 month old healthy female with no allergies who on Sept 21 2005 was vaccinated IM in the left thigh with 0.5ml dose of hepatitis B virus vaccine (+) Hib conj vaccine (lot 652010/0452R). Concomitant vaccinations on that same day included a dose in the right leg of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) and a dose in the right leg of poliovirus vaccine inactivated (unspecified). The RN reported that on Sept 22 2005, the patient developed a swollen leg and redness at the injection site. The RN described the injection site reaction as blood red not pink. Unspecified medical attention was sought an the patient was treated with Acetaminophen (Tylenol) and warm compresses. As of Sept 23 2005, the patients swollen leg and injection site redness were almost gone. Subsequently the patient recovered from all of her events. Additional information is not expected.
12/31/09 Dad noticed reddened area on right thigh. 12/30/09 Dad stated fever started. Right thigh reddened area 100mm x 95mm warm to touch and swelling.
I was fine the day of the vaccine.  But the next day I woke up with the worst headache and body aches all over.  I was in much pain that whole day despite taking tylenol.  Had mild fever (100.3) and chills on and off throughout the day.  By afternoon I could not function at all and stayed in bed completely.  The following day all the symptoms were mostly resolved except the fatigue.  The fatigue lingered another 10 days, keeping me from being able to do anymore than 2-3 hours of work each day.  Had to go back to bed often.  Finally doing better, but still get tired easily.
03/20/2003 @ 21:00:  Child started crying with pain in left arm-arm swollen-Mother called PMD, advised to give child Tylenol and apply ice-child feeling a little better today-advised to now applay warm compresses.
pt recv vax 4JAN96 & 14MAR97 pt exp typical varicella looking lesions (red spots) & a sl t99.8-100;total of 20 vesicles on face, chest, back, legs & buttocks;pt has a sl itch;
Pain in left arm starting 3-5 days (patient unsure of exact time frame) after vaccine. Described as a dull ache that is constant. Has been self-treating with ibuprofen. Doctor visit on 4/9/13, prescribed meloxicam.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # N010497, expiration date 15-JAN-2020, for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1803USA006513; US-009507513-1803USA009620; US-009507513-1803USA009621; US-009507513-1803USA009622; US-009507513-1803USA009623; US-009507513-1803USA009624.
no evident signs of reaction post vax; pt died on 16MAR92 was reported a SIDS death;
Joint pain; Decrease in appetite; Weight loss; Feeling mentally foggy; Low on energy; Nauseous; Lightheadedness; Diarrhea; Stiffness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4407934.  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Idiopathic pulmonary fibrosis" (ongoing), notes: Patient's concurrent condition included: Idiopathic pulmonary fibrosis. Concomitant medication(s) included: ESBRIET taken for idiopathic pulmonary fibrosis. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Decrease in appetite"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Weight loss"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling mentally foggy"; ASTHENIA (non-serious), outcome "unknown", described as "Low on energy"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; DIZZINESS (non-serious), outcome "unknown", described as "Lightheadedness"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient's past medical history was not reported. And reported that, we have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with withheld policies and procedures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives and facial swelling.  Swelling within the ears.  Migrain.  Nausea.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 07-MAY-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (10PK-0.5mlSD-PFS LLokw Tip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1416 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Narrative:  An error occured while administering the Moderna Bivalent booster on 10/05/2022. Patient was given .25mL instead of the full dose of 0.5mL vaccine. Patient was to return to campus for addition.25mL dose on 10/06/2022.
MA  reported that AccuVax dispensed  Influenza dispensed instead of Engerix-B. She reported that she gave influenza vaccine in error. The patient was contacted. Pt was assessed by NP with no adverse reactions reported after assessment. Patient vitals was obtained and charted and within normal limits per NP and MA.  Patient reported he no adverse reactions. DON notified. Accuvax  report submitted with  no findings at this time.  Incident reported  and corrective actions in process for employee and training.