chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EK5730), on 07Jan2021 as dose 2, single (Lot number: EL1284) and on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "post surgical hypothyroidism" (unspecified if ongoing); "secondary to papillary carcinoma of the thyroid" (unspecified if ongoing); "seronegative inflammatory arthritis" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; OLMESARTAN; HYDROXYCHLOROQUINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Negative; (27Jul2022) Positive; (11Jul2022) Positive, notes: I tested positive on PCR on 11Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient developed rebound COVID on 27Jul2022 after taking Paxlovid. Patient tested positive on PCR on 11Jul2022 I started Paxlovid on 12Jul2022 and finished on 16Jul2022. Patient tested negative on the home antigen test 18Jul2022 patient developed symptoms again on 26Jul2022 Patient tested positive on the home antigen test 27Jul2022.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
diagnosed him with cellulitis; Pain in arm; cannot move his arm; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (diagnosed him with cellulitis), PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move his arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8878) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move his arm). On 17-Mar-2021, the patient experienced CELLULITIS (diagnosed him with cellulitis). At the time of the report, CELLULITIS (diagnosed him with cellulitis), PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move his arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, X-ray: no results provided (Inconclusive) X-Ray of  arm.         No concomitant information was given. On 08-Apr-2021, received second dose of vaccine. Treatment information was given as the patient was advised to take two anti inflammatory and two antibiotics.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter contact details updated.Laboratory details updated.New event added.Second dose information updated.Treatment information added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
After patient received ZOSTAVAX, there was severe swelling at the site of injection within couple of hours. Got subsided within 2 days of taking MOTRIN. Pt developed skin rash at the site after 24 hrs. Localized reaction noticed. Pt advised to continue pain med & start on BENADRYL. Follow-up will be done.
Within 10 minutes of receiving vaccines, the patient started itching and had hives appear behind his ear, right arm, stomach, and face. Mother unsure if patient's throat was itching. Mother reported that he had no trouble talking and denies any shortness of breath. Mother then gave a dose of CLARITIN followed by 5 ml of children's BENADRYL. After administering the medications to the patient, the mother and patient returned to the clinic where symptoms improved and hives were absent 10 minutes following medication administration. Patient and mother stayed at clinic for assessment for approximately 20 minutes after medication administration. Patient's mother encouraged to notify primary care physician as well as if symptoms reoccurred or patient had difficulty speaking or was short of breath, to call 911. Mother voiced understanding. At 12:45, mother of patient was contacted via telephone for status of patient. Mother reported that patient had no other signs or symptoms and was acting and playing appropriately.
The patient developed 2 lumps (one on either side of her neck at the base of her neck). She states she did not experience any pain or itchiness.  The lump on the right side started to disappear when she reported her adverse reaction.
swelling on the injection site (left side); pain from head to toe on the side; dizziness; weakness; not feeling well; tongue became heavy and then dry; tongue became heavy and then dry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "swelling on the injection site (left side)"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "pain from head to toe on the side"; DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "dizziness"; ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "weakness"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "not feeling well"; TONGUE DISORDER (non-serious), TONGUE DRY (non-serious) all with onset Apr2021, outcome "unknown" and all described as "tongue became heavy and then dry".  Additional information: Patient took Pfizer 1st shot on 09Apr. Noticed swelling on the injection site (left side) and have pain from head to toe on the side. Also had dizziness, weakness and not feeling well. Also mentioned her tongue became heavy and then dry before experiencing the other symptoms. Asked what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I began feeling off at dinner that, went pale, feverish, began shaking uncontrollably, weakness, crushing headache with neck and shoulder pain. I passed out in the car on the way home from dinner. These symptoms continued for 48 hours and was so intense I was clenching my jaw, which led to TMJ. I couldn't drink anything hot or cold, and am unable to chew on that side for 2 weeks. The TMJ is still lingering and I am now in corrective braces to try to correct it.
Raised red spot developed/warm to the touch & sore - no treatment reqd. Sympt. resolved in 3-4 days.
Mild neuropathy in last two fingers of injection arm. Neuropathy presents as "the tinglies" and is mild and transient. The neuropathy began approximately 2 weeks after the first dose. It was also experienced approximately 30 minutes after the second dose of the vaccine.
Once given flu shot, patient immediately explained a soreness in neck & swelling in throat, "swollen glands". Asked pt to take slow deep breaths, she did so without difficulty. Patient was given 2 teaspoonfuls of BENADRYL per her request. Patient's doctor was called & told us to send her to ER, 911 was called & patient was taken to ER.
Adjuvant leaked in HCP's arm during preparation; Adjuvant leaked in HCP's arm during preparation; Adjuvant leaked in HCP's arm during preparation; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Herpes zoster (Shingrix) (batch number GS57B, expiry date 29th September 2023) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint. The action taken with Shingrix was unknown. On an unknown date, the outcome of the occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 12-Dec-2022 Reporter's comment: The pharmacist reported an experienced vaccinator. Neither she nor anyone else had previously reported this complaint to the company.  During Shingrix preparation for administration, some of the adjuvant leaked from the stopper and onto the pharmacist's arm.  The vial was held upside-down when the adjuvant was being withdrawn.  The following questions were also asked that the customer inject air from the syringe into the vial during preparation. Prior to tipping vial upside-down and withdrawing adjuvant was the air injected. About 0.5 ml air was injected. From needle puncture in the stopper was leaked. No vial rubber stopper/metallic skirt detach or become loose during handling or without any manipulation. Yes, only the plastic flip-off cap was removed before handling. There was no evidence of leakage in package or carton. The suspect product was not administered to the patient.  The reporter prepared another vaccine for administration to the patient so the patient would receive the completed dose. The suspect adjuvant vial had already been discarded and was not available for return to GlaxoSmithKline. The reporter was advised to discard the extra antigen vial.  Pictures were not taken.  GlaxoSmithKline will replace with a single-dose pack.  Related adverse event and product quality complaint reports filed under the same case. The reporter did not denied for the follow-up. Additional supportive information: During Shingrix preparation for administration, some of the adjuvant leaked from the stopper and onto the pharmacist's arm, which led to occupational exposure while preparing product for administration and exposure via skin contact.
I received  the COVID-19 Bivalent Booster on 09/19/2022.  My adverse event started on 11/14/2022 in the morning around 8:00AM. I felt like I had a cold. I had a stuffy nose, and cough. On 11/14/2022 and 11/15/2022 the same symptoms. On 11/16/2022 I had a sore throat, cough, headaches and pain on both ears. It continued until Friday.  On Saturday  I woke up and saw there were blood in my right ear drainage. On 11/19/2022 I went the Urgent care I waited 4 hours for my treatment. The doctor at the Urgent Care prescribed me with Benzonatate and Cortisporin ear drop 4 drop 3 times a day.  I went to see my ear doctor  on 11/30/2022 because I still had the ear pain but reduced and I lost my hearing.  I normally use hearing aid but after what happened with my ear. The hearing aide wasn't helping I completely lost my hearing. The ear doctor gave me Antibiotics and Prednisone. I  have an appointment with the ear doctor tomorrow  12/21/2022 to see  the condition of my hearing loss. He is going to check if my hearing is back to  normal .
usually feel kind of run down for a couple days; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via social media.  This case involves a patient of an unknown demographic who usually feel kind of run down for a couple days (Fatigue), after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) the patient usually feel kind of run down for a couple days, following the administration of INFLUENZA VACCINE.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
BlurredVision, Headache, CoughWheeze, Hypertension, Syncope, shortness of breath
Local erythema and inflammation approx. 4x8cm area surrounding injection sites on left thigh.
COVID-19; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and COVID-19 (COVID-19) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q16M20A) for COVID-19 vaccination.    Co-suspect product included non-company product (PAXLOVID) for COVID-19 treatment.    The patient did not have any allergy to drug.  Previously administered products included for COVID-19 vaccination: COVID-19 vaccine (The patient had previously received a COVID-19 Vaccine.). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine.   In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2022, the patient started. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, DIARRHOEA (Diarrhea) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medication information was provided.  The administration time of Moderna vaccine was 12:15 P.M.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The device date was reported as 03-May-2022.  No treatment information was provided.  company comment:  This case concerns an 89-year-old female patient, with no relevant medical history and concurrent conditions, who experienced, unexpected, non-serious, of COVID-19, unspecified days after receiving mRNA-1273 vaccine as a third dose.  The patient reported receiving an unknown dose of mRNA-1273 vaccine approximately 9 months before receiving the third dose of mRNA-1273 vaccine.  No information was provided regarding the second dose of mRNA-1273.  Approximately 6 months after vaccination, the patient was started with (Paxlovid) on an unknown dose and frequency.  The outcome of the event was unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This case concerns an 89-year-old female patient, with no relevant medical history and concurrent conditions, who experienced, unexpected, non-serious, of COVID-19, unspecified days after receiving mRNA-1273 vaccine as a third dose.  The patient reported receiving an unknown dose of mRNA-1273 vaccine approximately 9 months before receiving the third dose of mRNA-1273 vaccine.  No information was provided regarding the second dose of mRNA-1273.  Approximately 6 months after vaccination, the patient was started with (Paxlovid) on an unknown dose and frequency.  The outcome of the event was unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Approximately 1 month after receiving vaccination patient still has quarter-sized bruise. She is also still having pain at vaccination site.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, 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 (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- 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 any concomitant medications were reported. No any treatment medications were reported.   This case was linked to (Patient Link).
She is having swollen lymph nodes showing up on her mammary glands; This is a spontaneous report from a Regulatory Authority. A contactable 67-year-old female consumer reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 20Apr2021 (at 67-year-old) in right arm as dose 2, single for COVID-19 immunization. The patient had no medical history. The concomitant medications of the patient included thyroid (Armour thyroid).The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date (at 67-year-old) as dose 1, single for COVID-19 immunization. On 06Jul2021 the patient had swollen lymph nodes showing up on her mammary glands. When paraphrased the above concern, consumer stated that she does not know but think that she had it on both but I does not know if on one or the other particular. The patient underwent colonoscopy and 3D Mammogram for which results were unknown. She had some blood work and they were all pretty normal everything was pretty good at that time, there was no alarming blood work. The patient was going to go to doctor and would know if she had something else or it could be a reaction from the shot.  No follow-up attempts were possible. Information about lot/batch number could not be obtained.
Pain, swelling, redness at injection site. Arm stiffness. Body aches, fatigue.
Narrative:  77 yo M with a PMH of HLD, OA, erectile dysfunction who presented to the ED on 8/11/2021 complaining of progressively worsening fatigue. Patient states he felt "drowsy" and fatigued for the past one and a half week which urged him to visit the ED today. Also states he had decreased appetite. Denied SOB, chest pain, cough, nausea or vomiting. Upon presentation to the ED, T 97.5, P 72, BP 159/85, sating 84% on RA, 96% on 2L NC. Labs significant for WBC 8.33, Na 139, K 4.2, sCr 0.85, Hb 13.1, COVID positive despite 2 Pfizer vaccinations on 1/27/2021 and 2/18/2021, D-Dimer 2.46, trop neg, BNP <100. VBG 7.44/37.7/17. CXR with patchy and "groundglass" bilateral mid and lower lung opacification, in the setting of underlying emphysema. Due to concerns for underlying COVID pneumonia, patient was admitted. Patient was started on dexamethasone, remdesivir and oxygen supplementation. Therapeutic dose of enoxaparin was also added. During the course of his hospitalization, his b/l crackles and clinical trajectory improved. Walk test on 8/15 showed resting sat on RA 91% and requirement of 5L NC to maintain sat>88% with amputation. Patient completed course of remdesivir. On 8/16 patient was able to be discharged to home with oxygen (5L), rest of dexamethasone course, and with quarantine instructions.
Feeling tired.   After about six weeks, rapid decline with COPD - trouble breathing and heart palpitations.
Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.
Pain, heaviness, and feeling like lower legs were going to buckle underneath me 3 days after receiving vaccine; heaviness,and feeling like lower legs were going to buckle underneath me 3 days after receiving vaccine.; Paresthesia in lower legs, arms, and hands 9 days after vaccination; Started period again 3 days after menstrual cycle ended.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EWO172), via an unspecified route of administration, administered in Arm Left on 03Sep2021 13:45 (age at vaccination 39 years) as Dose 1, Single for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing and food allergy from an unknown date and unknown if ongoing Known allergies: all nuts except for almonds. The patient concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced paresthesia in lower legs, arms, and hands 9 days after vaccination on an unspecified date in Sep2021.The patient experienced  pain, heaviness, and feeling like lower legs were going to buckle underneath me 3 days after receiving vaccine on 06Sep2021 and started period again 3 days after menstrual cycle ended on an unspecified date in 2021. The patient was not treated for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
2nd dose given 1 month after the 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given 1 month after the 1st). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2023 The reporter inquired about a patient that received the 2nd dose of Shingrix 1 month after the first dose of Shingrix. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Pt. had nausea and vomiting. He was fatigue and restless and had to call 911.