chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt and mother came back saying that pt felt itchy. (Mother said same thing happened to her and asked pharmacist if remembered. Pharmacist did) RPh inspected injection site and looked red with scratch marks. Pt mom also showed a couple of spots that daughter thought might have been mosquito bites but mom said could be hives because there were multiple spots on thigh above knee above ripped jeans on right side. Mom also said pt had a spot on her back. Rph offered patient liquid diphenhydramine orally (50mg) (20mL of 12.5 mg/5mL diphenhydramine). Pt took orally and was asked to wait an additional 15 minutes. Afterwards pt said she felt ok. Mom said she would give her more benadryl at home if she needed it and would watch closely and if anything happened would take her to ER.
Redness and swelling of site and the arm from shoulder to elbow.  Cold pack applied.
Patient's mother stated that after pt. received the covid shot, his psoriasis condition got worse and did not return to what it was like before the covid shot.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 25-FEB-2015 the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml (rHA (recombinant human albumin), lot #J014876, expiration date 21-NOV-2015, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
VACCINE ON 4/30 WAS GIVEN TOO EARLY, PATIENT IS NOT IMMUNOCOMPROMISED NOR MEETS AGE REQUIREMENTS FOR A SECOND BOOSTER YET
PAPULAR RASH AND ITCHING TO BILAT ARMS, TORSO.
Patient felt lightheaded, went down but did not lose consciousness. Vital signs were checked and within normal limits, glucose was low at 64 even though patient had eaten. Patient complained of left sided (same side as injection) achiness for two days after shot.
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via other company manufacturer (Pfizer) concerned a 26 year old female. The patient's height and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered to left arm on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 25 years old.  Concomitant medications included amoxicillin trihydrate/clavulanate potassium. The patient additionally received non-company suspect vaccine of elasomeran (Spikevax) (dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered to left arm on 23-OCT-2021 for prophylactic vaccination. Age at time of vaccination 26 years old.  On an unspecified date, the patient experienced covid-19 infection (confirmed covid-19 infection) (dose number in series 2). The patient received an unspecified medication for treatment of Covid-19 from 25-MAY-2022 to 29-MAY-2022.  On 06-JUN-2022, the patient tested positive for Covid-19 again with symptoms recurring (confirmed clinical vaccination failure) (dose number in series 1). Symptoms included headache, fever, chills, congestion and body aches.   The action taken with covid-19 vaccine ad26.cov2.s and elasomeran (Spikevax) was not applicable. The patient was recovering from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000236414.; Sender's Comments: V0: 20220634597-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
2nd dose approximately 20 days early; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 32-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event.   On 4th November 2022, the patient received the 2nd dose of Havrix. On 4th November 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 14-NOV-2022. Reporter's Comments:  The nurse had reported the patient received dose two of Havrix approximately 20 days early. The reporter had consented to follow-up Additional supportive information: The patient had received her 2nd dose of Havrix prior to the recommended interval, which had led to shortening of vaccination schedule.
Significant flu-like symptoms including fever (100.4), full body aches, chills, nausea, and vomiting
Patient came in 1/22/08 indicated she had had some twinges in arm when she moves it a certain way since she has had her flu shot.  Said it is there for just a little bit and then goes away.
Database showed that this person was due for meningoccal conjugate as of 03/13/2019. I asked the patient if she had ever had a meningitis vaccine and she said "No". I did not realize that the vaccines showed up just as Meningococcal. Once putting it into the chart I seen that she had already had vaccines. I reviewed the database again and seen that they were in the Meningococcal spot not the meningococcal conjugate. Health department was contacted and verified that there was no harm to the patient. The patient was contacted as well and was made aware that she received an extra dose of the vaccine. PCP notified as well. Incident report started at my place of employment. Database helpdesk was contacted by clinical directed due to error in database report form.
body aches all over; feeling of fogginess; salivating; Arm soreness; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (body aches all over), FEELING ABNORMAL (feeling of fogginess), SALIVARY HYPERSECRETION (salivating) and PAIN IN EXTREMITY (Arm soreness) in a 24-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 medical history provided). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety and Depression, DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ 24+4) for Birth control.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced PAIN (body aches all over), FEELING ABNORMAL (feeling of fogginess), SALIVARY HYPERSECRETION (salivating) and PAIN IN EXTREMITY (Arm soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 08-Jan-2021, PAIN (body aches all over), FEELING ABNORMAL (feeling of fogginess) and SALIVARY HYPERSECRETION (salivating) had resolved. On 14-Jan-2021, PAIN IN EXTREMITY (Arm soreness) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-054220 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054220:2nd Dose
"COVID arm".  Localized, raised rash around the injection site. Circular. About an inch and a half in diameter. Slight sore feeling, not itchy but occasionally painful. Pain extends through the muscle in the top of the left arm, radiating to the arm-pit area. Not bad, but annoying.
Administered Dose of Heplisav-B to a 9 Month Old; Administered as Third Dose in the Series; Initial Report Received on 29-Aug-2022  An assistant nurse manager reported that a 9 month-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. No known allergies were reported.  No relevant concomitant medications were reported.    On 29-Aug-2022, the 9 month-old patient received a dose of HEPLISAV-B (Lot # 935843, expiration date 08-Oct-2022 and NDC # 43528-003-05) in the right vastis lateralis (route not reported) from a registered nurse. It was reported that HEPLISAV-B "was administered a third dose in the series". No adverse events were reported.   No additional information was reported.   Company comment. The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Information has been received from a physician concerning a 15 year old male who on 16-NOV-1995 was vaccinated with the first dose of MMR II (route, site, dose and lot number not reported). On 09-FEB-2009 received the second dose of MMR II (route, site, dose and lot number not reported). On 01-DEC-2009 the patient experienced mumps (thought the date diagnosed was reported as 16-NOV-2009). The patient was afebrile. The outcome for mumps was not reported. Follow up information has been received from the physician who reported that the that the 15 year old patient at onset date (also reported as 14 year old) experienced mumps on 12-NOV-2009 (previously reported as on 01-DEC-2009). The date of diagnosed was reported as 13-NOV-2009 (also reported as 16-NOV-2009). The patient was afebrile and experienced right parotitis. No further information is available.
8 days after receiving Moderna shot  # 1(received on 03/22/2021), a 1 1/2+/- inch round raised red bump itchy rash developed at the injection site. It remains the same as of 9:00PM EST this evening, although the itch has subsided. It remains warm to touch with little bumps in the raised area. No fever. The day before this reaction, I had my annual physical with no issues at the time. Prior to this reaction, 30 minutes after receiving the injection on 03/22/2021, I experienced a sudden red flush to my cheeks that lasted for only 15 minutes.  No swelling of face, neck, throat. No elevation in heart rate noted.  The evening following the day of injection, I had a 99.4 degree fever for about an hour, then fine. No fever since. No other reactions.
Pt Rc'd Tdap (BOOSTRIX), HPV in (R) arm when he became dizzy and fell face first to the floor. He was checked by our PA and left in stable condition.
Swelling, redness around inj site, hot to touch, hurt to walk. Prescribed diphenhydramine 12.5mg/5mL = 7.5mL PO TID, PRN x5 days.
Right arm red injeciton site. Red deltoid area right arm and swollen, no treatment done.
chills, fever 101.3, headache, myalgia, arthralgia, fatigue
Afluria Quadrivalent MDV 0.25ml was given to a child between the age of 6 month - 35 months.  On the vial, box the vaccines came in and the instruction sheet. It states okay to give this vaccine to these age groups.    6 month - 35 months 0.25ml   36 months and older 0.50ml The state does not approve this vaccine for the age group of 6 months-35 months. -Due to the amount of mercury and its not preservative free. -The vaccine is prepared from virus grown in embryonated chicken egg and inactivated with beta propiolactone. Each 0.25ml dose contains 12.25 mcg mercury/dose Parents mother states that patient had no reactions to the vaccine. She will contact Dr due to having more questions. She will follow up at the clinic PRN.
Infection in both arm and back of neck; Infection in both arm and back of neck; This is a spontaneous report from a contactable consumer (Patient). This consumer reported in response to Non-HCP letter sent to cross reference case another dose.   A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in left arm on 13Jan2021 at 11:30 as single dose for COVID-19 immunization. Medical history and Concomitant medications not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FV9231), on 23Feb2020 (as reported) at 8:50 for COVID-19 immunization. On an unspecified date, the patient experienced infection in both arm and back of neck. The events did not require a visit to Emergency Room/Physician Office. There were no predisposing factors and no culture performed. No antipyretic used. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Patient reported feeling clammy, lightheaded, short of breath, anxious, and nauseated after vaccination Patient seen by medical team and vitals improved after patient drank Gatorade  Patient reported not having anything to eat in the morning Patient has history of anxiety Patient refused medical transport and signed medical form, patient stated symptoms improved Patient will have a family member pick him and his daughter up to drive home
injection site is painful; Wrong route of administration; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was given Shingrix subcutaneously which led to incorrect route of product administration. The patient experienced injection site pain. The patient reported the event to her physician's office. The office administrator did not want to follow up with this report, but would have the physician handle everything instead. The reporter did not consent to follow up.
Patient felt lightheaded, heat going up from stomach and tightness in the throat. Called 911, vitals were checked. Patient felt better.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the pt was administered with the zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a healthcare provider at a clinic, for the long-term prevention of shingles and zoster-related conditions. On an unknown date, pt suffered from injury shingles, resulting from the zoster vaccine live (ZOSTAVAX). Pt was treated by a doctor at clinic. The outcome of the event was unknown. The event was considered to be related to the zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
PATIENT STATED THAT HE HAD A BASEBALL SIZED LUMP ON HIS ARM APPROXIMATELY 5 DAYS AFTER HIS VACCINATION.  IT LASTED ABOUT 3 DAYS.
Worst pain ever right side of my face, starting from my right Jaw, coming up all the way to my front head with a duration of almost 2 hours (04/10/2021, about 11:00 pm until 1:00 am), fever every night with night sweats since 04/09/2021, followed by body chills, sharp headache similar to first episode of 04/10/2021, light headed, dizziness since vaccine was taken, always very tired, no energy at all,  since vaccine was taken, I lost all my energy, my body is always on fire inside, my life is not going to be the same after I took this Covid 19 vaccine on 04/09/2021
Patient presented to vaccine clinic for second covid vaccine. Following first dose, patient had mild side effects in the observation area after the first dose of the covid, where she was observed in our reaction room area more closely, for feeling foggy and "just not right", however patient was fine to be able to be sent home. Patient was encouraged to contact physician to verify they should receive second covid vaccine.  When patient was in observation area, after receiving her second covid vaccine shot, she told the observation nurse that she had a headache. The nurse immediately took her to our reaction room area and was closely observed. Patient was talking and acting fine. Within minutes, she started to have a seizure. Documentation in patient's chart regarding incident. Patient then transferred via ambulance to ED.  Per EMS patient had 5-6 seizures requiring 4mg Ativan IM.  Patient reports she has seizures, is seen by Neurology and takes Keppra and Depakote. On further documentation review, patient was seen by Neurology and was felt to not have seizures.  She was also seen by psychiatry who noted that patient most likely has psychogenic nonepileptic seizure-like activity. Patient observed in the ED without further symptoms or episodes. Discharged to home.
Pt received Zoster vaccine on 9/8/2016.  On 9/16, pt noticed pain/ache in Left shoulder. On 9/18, she noticed a "red bumpy rash" along bra line of Left chest.  On 9/21, called PCP office and described the red bumpy rash, along with the sensation of tingling, burning.  On 9/22, pt came into office with the rash spreading and the start of clear blisters. Vesicular rash noted over Left breast, L axilla and Left upper back at T-4 level.  PCP prescribed Valtrex 1 Gm TID x 7 days and NSAID/Acetaminophen for pain.
Rash (urgent care visit); Shingles diagnosis; Severe pain/pain in right side lower back; Discomfort right side lower back; This case was reported by a consumer and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2022, the patient received the 1st dose of Shingrix. On 13th December 2022, 12 days after receiving Shingrix, the patient experienced shingles (serious criteria clinically significant/intervention required), pain and discomfort. On 17th December 2022, the patient experienced rash. The patient was treated with prednisone and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and pain were not recovered/not resolved and the outcome of the discomfort and rash were unknown.   It was unknown if the reporter considered the shingles, pain, discomfort and rash to be related to Shingrix.     Additional Information: Receipt Date: 21-DEC-2022 Reporter's Comment: The patient was self-reported this case. The patient reported that on a routine visit to general practitioner he was advised to receive Shingrix shingles vaccine and he received Shingrixvaccine. The patient stated that on 13th December 2022, 12 days after received Shingrix vaccine he experienced pain and discomfort at right side lower back. The patient reported that by on 17th December 2022, 16 days after received Shingrix vaccine he started to developed rash, so he went to urgent care facility where he was diagnosed as had shingles. The patient was now suffering from disease with severe pain. The reporter did requested to consent the follow up.
patient revaccinated on 2/28/03; had original vaccination in childhood; reports within 24 hours of vaccination well-demarcated, raised lesion with erythema without fluctuance or serous fluid, appoximately 7cm distal to deltoid vaccination site of right arm; patient denies pain, fever or exudates and is without lymphadenopathy; suspect normal lymphangitis; patient sent for evaluation; will evaluate patient within 24 hours
Won't take it, had a bad reaction to prevenar 13. /had an allergic reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown. single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Won't take it, had a bad reaction to prevenar 13. /had an allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female who was vaccinated with the first and second dose of GARDASIL. After receiving the first and second vaccines, the patient had a swollen neck. the patient would not be finishing the series. The patient had made phone call for medical attention. At the time of reporting, the patient recovered from swollen neck. Additional information has been requested. This is one of several reports from the same source.
fatigue; joint pain; headaches; nausea; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), ARTHRALGIA (joint pain), HEADACHE (headaches), NAUSEA (nausea) and DIARRHOEA (diarrhea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-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) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (fatigue), ARTHRALGIA (joint pain), HEADACHE (headaches), NAUSEA (nausea) and DIARRHOEA (diarrhea). On 22-Mar-2021, FATIGUE (fatigue), ARTHRALGIA (joint pain), HEADACHE (headaches), NAUSEA (nausea) and DIARRHOEA (diarrhea) had resolved. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Myalgia, Arthralgia, Fever, NauseaVomiting, soreness at injection site Narrative:
Since vaccine I have encountered Meibomian (MGD) in both eyes, one oil duct in each eye.  Prior to vaccine I had not had any incidences of MGD.