chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Vaccine 12/23/20 (Weds) at 12:30pm, in left upper arm. Severe (Vice-Like) headache in back of head 5 minutes after, lasted til next morning. Lots of Sneezing over weekend on days 2-4; Monday 12/28- woke at 4a and was extremely dizzy and almost lost balance-went back to bed. Again at 5a and 10am but added vomiting along with any movement, could only lie flat on back, any movement of head caused reaction. No taste when vomiting, minimal smell; came back later in day. Advised to go to ER for Covid Test, since I had worked closely with someone else positive the previous week. Husband had to call an ambulance when I couldn?t make it out of the bedroom due to weakness, true vertigo-room was completely spinning and couldn?t keep my balance, and severe vomiting with any upright movement. Covid test negative. ER diagnosed as BPPvertigo because no other outright viral symptoms; only sneezing before; but they noted fluid in my left ear- said wasn?t infected. Told them of headache in back left rear of head, behind ear, and pressure behind left eye. Positive Dix-Hallpike;nystagmus. Vertigo continued, even with medication through Thursday 12/31/20 and turned to dizziness that subsided by Saturday 1/2/21. Weds 12/30/20- severe left ear pressure, feeling of fullness; focal pain/headache in bone behind left ear began, and pressure behind left eye increased. Low grade fever 1/2/21-1/4/21 (99.9). Seen by ENT on 1/4/21 due to continuing symptoms; and was misdiagnosed originally by ER- diagnosed by ENT as Acute Viral Labyrinthitis and Vestibular Neuritis. As of 1/6/2021- symptoms continue.   *suspected recovered from Covid March 2020
Patient complained of left arm pain to pharmacist a couple of days later.  Rph told her that muscle soreness was normal, to apply ice, and take Tylenol, and will call pt back in a couple of days to see how she was doing. 2 days later, rph called her back and pt said she still had pain. Rph suggested she see her doctor.
Rash started 3/7/03 on Rt. side of abdomen and chest & then spread to trunk. Rash was described as erythematus and macular with questionable central raised papule, minimal itching. MD states diagnosis = Erythema Multiforme-hypersenitivity rash. Infectious disease doc states "diagnosis = "Disseminated Vaccinia".
Information has been received from a registered nurse concerning a 15 year old female, that had emigrated from Mexico and was getting immunizations on an accelerated schedule, who on 11/26/2002 and on 01/29/2003 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # not reported).  Concomitant medications included hepatitis B vaccine recombinant (yeast)(manufacturer unknown)(Lot # not reported), poliovirus vaccine and tetanus toxoid.  On 11/30/2002 the patient compained of an itchy rash on her lower legs that resolved shortly thereafter.  On 01/29/2003, on hour after receiving the same four vaccines, the patient developed a worse rash on both arms and legs.  She presented to the nurse in the health department where she received the vaccines and it was noted that her rash appeared to have lessened with only itch marks present.  The patient was treated with diphenhydramine hydrochloride (Benadryl).  She had no shortness of breath on either occasion.  Additional information has been requested.
Swollen arm; Red spots on injected site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red spots on injected site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red spots on injected site). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red spots on injected site) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Redness swelling and burning sensation of the left arm from the injection site distally to just above the elbow.
Pruritis, erythema, calor and swelling of left arm from injection site down to hand. started evening after vaccination and has continue to today. Pt presented to pharmacy for diphenhydramine and advice.
Fever, breathing difficulties and shaking. Chest xray, bloodwork, IV fluids and urine test.
Administered only the liquid component; Administered only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA748A, expiry date 13th September 2024) for prophylaxis.   On 25th November 2022, the patient received Menveo. On 25th November 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 09-JAN-2023 Reporter's comment: A pharmacy manager asked for information about the administration of only the liquid component MenCYW-135 Liquid Conjugate of Menveo The pharmacy manager asked for safety information and if patients had to be revaccinated. The reporter consented to follow-up. This is 1 of 2 linked cases reported by same reporter. Additional supportive information: The patient only received the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023002246:Same reporter
Gardasil and menactra given in the right arm, and tolerated well.  Tdap given in the left arm and promptly after vaccine delivered, patient leans forward and his body tenses.  I am able to prevent him from falling and help him up onto the examination table, where he arouses with some mild confusion.  The incident lasted about 5-10 seconds.  He states he was really nervous about getting the vaccines today.  I examine him and find everything WNL.  Provide him with some water and graham crackers (from the school nurse), and he starts to feel better.  Mother states that has never happened before.  After some more rest, he feels well and mother opts to take him home.
Right shoulder pain at immunization site, limited ROM. Came to clinic on 10/8 still with discomfort.
Sore arm; a little nausea; sick to stomach; morning sickness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cholesterol" (ongoing), notes: Diagnosed with before 2007.; "Hypertension", start date: 2007 (ongoing); "Coronary artery disease", start date: 2007 (ongoing); "Interstitial lung disease" (ongoing); "10 coronary artery stems" (unspecified if ongoing); "Water pill" (ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE taken for hypertension (ongoing); ENALAPRIL taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE taken for fluid retention; REPATHA taken for blood cholesterol abnormal (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Feb2021, outcome "unknown", described as "Sore arm"; NAUSEA (non-serious) with onset 05Feb2021, outcome "recovered" (Feb2021), described as "a little nausea"; ABDOMINAL DISCOMFORT (non-serious) with onset 05Feb2021, outcome "recovered" (Feb2021), described as "sick to stomach"; MORNING SICKNESS (non-serious) with onset 05Feb2021, outcome "recovered" (Feb2021), described as "morning sickness". Therapeutic measures were taken as a result of pain in extremity.  Additional information: First dose: felt kind of a little nausea, sick to stomach like had morning sickness: With the first dose Pfizer Covid Vaccine the caller felt kind of a little nausea, sick to stomach like had morning sickness. This began happening within a couple hours of receiving the first dose Pfizer Covid Vaccine and lasted maybe 30 hours or so. The caller occasionally has a sore arm: The caller clarifies the sore arm occurred after receiving the first dose Pfizer Covid Vaccine. First dose: Sore arm: After the first dose Pfizer Covid Vaccine the sore arm began maybe 5 or 6 hours after receiving and the caller iced arm and took Tylenol. With the first dose Pfizer Covid Vaccine the caller felt kind of a little nausea, sick to stomach like had morning sickness. This began happening within a couple hours of receiving the first dose Pfizer Covid Vaccine and lasted maybe 30 hours or so. The caller clarifies the sore arm occurred after receiving the first dose Pfizer Covid Vaccine. After the first dose Pfizer Covid Vaccine the sore arm began maybe 5 or 6 hours after receiving and the caller iced arm and took Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine nodule at injection site, developed approx 48 hours after injection, pain at injection site began at injection and remains, no increase in pain noted with nodule appearance. Nodule size is approx dime sized/subQ/firm
Swollen lymph nodes, swelling into chest, severe chest pain and extreme discomfort. Swelling is much worse than 2nd dose. More pain and swelling in much larger area. Symptoms began about 24 hours after dose.
This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 16-year-old female patient who received the BEXSERO. Concomitant products included MENACTRA. On 16th April 2018, the patient received BEXSERO (intramuscular) .5 ml. In April 2018, 12 hrs after receiving BEXSERO, the patient experienced injection site induration and injection site swelling. On an unknown date, the outcome of the injection site induration and injection site swelling were not recovered/not resolved. The reporter considered the injection site induration and injection site swelling to be almost certainly related to BEXSERO. Additional information was reported as follows: The patient received a dose of BEXSERO on the left deltoid. On 16th April 2018, the patient received MENACTRA on right deltoid. The patient had a 6 by 10 sized raised induration at the injection site. The patient concomitant medication also included unspecified birth control pills. The manufacturer for MENACTRA was reported as non-GlaxoSmithKline.
3 week history of fevers, chest pain - pleuritic and a pericardial effusion - all following a flu shot. Cardiology consultation noted. (Etiology very possible immunization reaction).
then slow but surely cramping came back/then went off and started coming back again/Since a week ago&even in the middle of the night last night/he almost got the full muscle from his leg cramping/specially the left leg/started having problems again; gave patient a little bit of diarrhea; has been having some rather adverse side effects; started having severe leg crampings, went off and started coming back again; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (has been having some rather adverse side effects), MUSCLE SPASMS (started having severe leg crampings, went off and started coming back again), MUSCLE SPASMS (then slow but surely cramping came back/then went off and started coming back again/Since a week ago&even in the middle of the night last night/he almost got the full muscle from his leg cramping/specially the left leg/started having problems again) and DIARRHOEA (gave patient a little bit of diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy peripheral (neuropathy on his feet). Concomitant products included GABAPENTIN for Neuropathy peripheral, LEVOTHYROXINE, FOLIC ACID and OMEPRAZOLE for an unknown indication.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (has been having some rather adverse side effects), MUSCLE SPASMS (started having severe leg crampings, went off and started coming back again) and DIARRHOEA (gave patient a little bit of diarrhea). On an unknown date, the patient experienced MUSCLE SPASMS (then slow but surely cramping came back/then went off and started coming back again/Since a week ago&even in the middle of the night last night/he almost got the full muscle from his leg cramping/specially the left leg/started having problems again). The patient was treated with MAGNESIUM for Leg cramps, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (has been having some rather adverse side effects), MUSCLE SPASMS (started having severe leg crampings, went off and started coming back again) and MUSCLE SPASMS (then slow but surely cramping came back/then went off and started coming back again/Since a week ago&even in the middle of the night last night/he almost got the full muscle from his leg cramping/specially the left leg/started having problems again) had not resolved and DIARRHOEA (gave patient a little bit of diarrhea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16April2021 patient first messaged his doctor, who told him to drink more water and take magnesium. That treatment did help the patient, it kind of got off it, gave patient a little bit of diarrhea.
Patient has swelling, redness, and hot to the touch below where the actual injections were. I spoke with her on 11/3/17 @ 2:12pm and the swelling is going down.
Information has been received from an investigator concerning an 8 week old male with concurrent conditions of ankyloglossia congenital and gastrooesophageal reflux disease who entered a study. Previous therapy history on 06-OCT-2011 included RECOMBIVAX HB, IM 0.5 ml IM injection one dose. On 06-DEC-2011 the subject was randomized to receive DTaP-HepB-Hib-IPV, PREVNAR 13 and ROTATEQ at 2, 4, and 6 months of age. On 06-DEC-2011, the subject was vaccinated with the first dose in series of 0.5 ml IM dose (injection site not provided) of DTaP-HepB-Hib-IPV. Other study vaccines received on 06-DEC-2011 included the first dose of 0.5 ml IM (injection site not provided) PREVNAR 13 and the first 2.0 ml oral dose of ROTATEQ as part of the study to complete the childhood immunization series. Concomitant therapy included TRI-VI-SOL. On 06-DEC-2011, the patient experienced fever (moderate intensity) and was hospitalized on the same day. On 06-DEC-2011, the subject was admitted to the local hospital after being seen in the ER for fever of 100.9 (unit of measure not reported) for work up of possible sepsis. The subject received first doses of study therapy on 06-DEC-2011 and was admitted that evening. The subject was treated with ROCEPHIN IV suspension, IV (06-DEC-2011 to 07-DEC-2011) (dose and frequency reported as unknown). On 06-DEC-2011, the subject had the following lab tests and results: blood culture was negative and urine culture was negative, CSF showed normal glucose and protein, ESR normal at 14, CRP was 1.0, CBC normal (not further specified), urinalysis was normal (not further specified), BMP normal (not further specified) and a chest x-ray was normal. On 06-DEC-2011, the subject was recovered from the fever. On 08-DEC-2011, the subject was discharged from the hospital in stable condition; discharge diagnosis was fever with sepsis ruled out. The action taken with study therapy was none. The reporting investigator considered that the fever was possibly related to all study vaccines. The investigator's impression was reported as fever reaction to vaccine, mild. Follow-up information was received on 14-DEC-2011 from the investigator, the following fields were updated: labs/diagnostics and the narrative. Follow-up information was obtained on 10-JAN-2012 from the investigator. The following fields were updated: labs/diagnostics and narrative. Follow-up information was received on 13-JAN-2012 from the investigator. The following fields were updated: labs/diagnostics and narrative. Additional information is not expected. This is an amended report, it was requested to reconcile the Relationship to Pneumococcal and ROTATEQ as related.
No additional AEs; patient received GARDASIL 9 at 61 years of age; This spontaneous report was received from a pharmacist and refers to a 61 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  In October 2021, the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose number, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events was reported.
tiredness; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness and upset stomach. On an unknown date, the outcome of the tiredness and upset stomach were recovered/resolved.   It was unknown if the reporter considered the tiredness and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After consultation with the representative the patient understood that the tiredness and upset stomach were normal. At the time of this report, the patient did not need any information and stated if the patient would experience any further problem, then the patient will contact with his/her Primary Care Physician (PCP). The patient inquired, what should be the average length of time for the side effects to last. The reporter did not consent to follow up.
Nausea and chills first eve., followed by extreme muscle and nerve pulsating pain - L. arm lost mobility and limited range of motion for 2 wks., with radiating discomfort into L. shoulder and neck. Inability to sleep or find comfort for this period. Improved to dull achiness - worse at night. Treatment: Prescrip. methylprednisolone and scheduled P.T.
She got her vaccine, she had none immediately.  Friday she had the shot and on Sunday (yesterday), about 5:00 PM she got violently dizzy.  She was seeing some people and they held her up and got her back home.  She has had dizzy spells in the past, but nothing like this, which those are normally related to not eating.  She contributes the vaccine to this reaction.  She went home, resting, and lasted a few hours and she was fine when she got up this morning.    She called her PCP and they said she should contact the clinic which there is nobody there unless there is an appointment scheduled.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was received as follows: This case was reported by the physician for himself. The patient received SHINGRIX on the left deltoid. He experienced soreness at the injection with the first dose of SHINGRIX vaccine which lasted for about 2 days. No further details were provided. This case has been linked to the case US2018149833, reported by the same reporter for the same patient.
I had a pressure in my chest when I saw my doctor and he notice a increase in liver enzymes and he changed my asthma meds. Then he sent my to my cardiology and he took me off the Mesalamine and Spironolactone thinking that sometime theses maybe the ones that's is making you feel bad. He ran two test and he also check my liver enzymes again and they had come down but still wasn't normal. Cardiology sent me to see Gastroenterologist. He did a ultra sound on my liver.  I can not take the Booster Dose 3 until my health issue with my liver got under control. I had the biopsy 12/07/2021 and that when the Autoimmune Hepatitis was confirmed. I tested positive for COVID 19 02/16/2022. My symptoms is a fever, headache, body aches, nausea, congestion, cough and extreme fatigue.
An exam of 9/11/00 had a dry patch on abdomen. On 9/12/00, he developed a rash which scabbed 10 days later. On 10/6/00, he was seen by MD, due to itching and rash. MD dx'd eczema and infected rash. Pt was started on Cephalexin for 10 days, antihistamines and steroid cream.
Patient administered vaccine after the manufacture's date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. The vial did not undergo any temperature excursions. Date vial was initially stored in the refrigerator was unknown. Total of 168 doses were given from LOT 048C21A with expiration date 09-Nov-2021. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non-significant information.
Patient stated since she received the second booster 04/13/2022, she has experienced the following: * Sleeping almost the entire next day after the vaccine  * Having a mild fever for at least 2-3 days post vaccination.  * Fever blisters that appeared all of a sudden a few days post vaccination around her mouth.  The Fever blisters have increased over the past week, insude her mouth, down her tongue and throat as noted by her pcp.  Patient saw her pcp 04/25/2022 and was prescribed a mouth wash to help with blisters.   Here pcp instructed her to notify the health department where she received her booster.   Patient reported she "passed out " with her first booster in Nov 2021  and resulted with a broken ankle.  Patient received first booster at a pharmacy, not the health department.