chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The injection itself was high on my arm and was very painful as it was administered (much more so than a typical vaccination in the arm).  The pain has been persistent, and has gotten worse over time.  No fever, no inflammation at the injection site other than a red dot that resolved over about one week.  On advice of my physician (nurse practitioner) I've been icing the shoulder three times a day and taking ibuprofen 800 mg q 6h - this has not led to any improvement - to the contrary the pain is getting worse and the shoulder is losing substantial mobility.    Something seems to have been done wrong - and am wondering if the injection itself was given in the shoulder or tendon rather than intramuscularly.
Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton the expiration date when the QR code was scanned. No adverse events were reported. Vial did not underwent any temperature excursion. Vial was placed in refrigerator on 29-Oct-2021.  No treatment medications were reported.
16SEP91 pt recvd OPV/DTP/HIB given 11AM & 230PM c/o irritability, t103 & listless; given APAP; 9PM taken to Hosp w/t104.7 & vomited started on Pediolyte & mist tent & APAP;
blurred vision, elevated troponin (3.7), elevated BP, migraine, chest pain
immediately after getting the shot my arm was sore. About 3 hours after getting the shot My neck, back and leg muscles all started getting sore an I was fatigued. By 7 hours after the vaccine I was coughing and had a runny nose along with all muscles in my body being sore, fatigue, and a mild fever. 0600 10/08/2021 all muscles are so sore that it hurts to move, chest hurts and the fatigue continues.
Moderna covid-19 vaccine eua  Swollen knot in arm, not at injection site, maybe the lymph node listed in possible side effects. Soreness.
mom brought pt in for shots 6AUG92; p/shots completed pt fainted, semi stiff, pale, & was incontinent of urine; duration of episode was approx 1 minute;
Gradually progressive peripheral neuropathy in toes then fingers.; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231) solution for injection, via an unspecified route of administration in left arm on 10Jan2021 14:30 at a single dose for Covid-19 immunization. Medical history included Paroxysmal Atrial Fibrillation, (HTN) hypertension, obesity, intermittent asthma, and benign prostatic hyperplasia (BPH). Patient had no known allergies. Concomitant medication included apixaban (ELIQUIS), atorvastatin (ATORVASTATIN), losartan (LOSARTAN), dutasteride, and tamsulosin hydrochloride (JALYN). The patient experienced gradually progressive peripheral neuropathy in toes then fingers on 18Jan2021. No treatment received. The event resulted in doctor or other healthcare professional office/clinic visit. The second dose was administered on 31Jan2021 at 9am (lot number: EL9262) in right arm. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 after vaccination. Outcome of the event was not recovered.  No follow-up activities are needed. No further information is expected.; Sender's Comments: Considering the plausible temporal association, the reasonable possibility that the reported progressive peripheral neuropathy in toes then fingers (Neuropathy peripheral), occurred 8 days after the first dose,  is related to BNT162B2 vaccine cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
One week later, on November 9th, 2021, I woke up with extreme pain in my lower back.  I was rush to the hospital that evening, I could not go from a sitting position to a standing position.  I was diagnosed with a staph infection in my spinal canal that extended from L2, L1, T12, T11 and T10.  I was rushed in to EMERGENCY SURGERY on November 12, 2021, to remove the pus and staph from my spinal canal.  The blood cultures came back positive for Staph - NO MRSA.  I was sent home from the hospital on Tuesday Nov 16th, 2021, after insertion of a PICC line, and am currently on IV Cefazolin infusion at home, every 8 hours for the next 8 weeks.
On 6/19 the pt experienced red bumps, generalized on body and itchy. On 6/20 the bumps became fluid filled lesions and a temp of 99.4.  The pt has 23 lesions. The pt was exposed ot a child who received varivax.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore Arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ATORVASTATIN, METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D3, MULTIVITAMIN [VITAMINS NOS] and FLUOROURACIL for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore Arm). At the time of the report, INJECTION SITE PAIN (Sore Arm) outcome was unknown.            No treatment medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-033059 (Patient Link).
Expired DTaP vaccine administered, box of immunization had expiration date highlighted, busy day-missed that vaccine needed to be removed from stock.
Patient received PREVNAR 13 in left deltoid. Experienced pain a few hours after. Patient went to MD and diagnosis was possible tendonitis after injection.
Shortly after the shot itching all over began, with no hives.  About 15 minutes after the dose, started with racing heart rate, shortness of breath, dizziness and near syncope, weakness, nausea.  Then started with 30 minutes of legs spasming/trembling.  Ears, throat, tongue itching and wheezing.  No treatment administered by the facility.  I used my own inhaler for the wheezing.  Was then largely fine for about 6 hours at which time arm soreness began, following by fever, sweats, chills, exhaustion, nausea, lymph node swelling, body aches.  High fevers and sweats for 36 hours (Did not take over night or through next morning but must have been well over 102 as I felt like I had pneumonia and  felt remarkably better and could eat the second evening at which time I could check and it was 102).  Already much improved by beginning of third day.  Towards the middle/end of week one, however, began with eye pain and increased asthma symptoms, some transient hives periodically, and physically tired.  Palpitations and chest pain began late last evening.  If it gets like after shot 1, I will seek medical evaluation this time.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2021 11:00 (Lot number: EN6200) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild stroke", start date: 18Jan2021, stop date: 18Jan2021, notes: Stroke-minor /No recurrence; "Carcinoid tumor on appendix", start date: 31Mar2006, stop date: 01Apr2006, notes: Removal of appendix on 31Mar2006. No recurrence; "Hypothyroidism", start date: 12Jul2012 (ongoing), notes: Take Levothyroxine daily; "she had Atrial Fibrillation" (unspecified if ongoing), notes: She had a heart monitor placed 21Feb2020. Her heart monitor never showed Atrial Fibrillation after one year of being monitored.; "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); SYNTHROID taken for hypothyroidism, start date: Jul2012 (ongoing); ATORVASTATIN taken for blood cholesterol abnormal, start date: Jan2020 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Vaccination facility type was Doctor's office/Urgent care. Vaccine was not administered at a Facility. No prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021373556 same patient/drug, different event/dose
16 days after receiving my first Covid vaccine shot (The 1st of the 2 shots required)  Around 7pm on May 5th I started having a hard time breathing & slight chest pains. I decided to lay down & that seemed to make it worse. I've never had any issues like this before so I figured it would eventually go away on its own & continued to try and lay down on my bed but as each hour passed it continued to get harder and harder to breath & each breath I took became increasingly strained & felt as though my lungs weren't letting me take in large breaths, only short gasps. By 2am May 6th, 2021, I knew something was obviously veryyy wrong! I drove myself to the closest ER (that being Hospital approx 5 minutes away) & was admitted. After running several tests, I was presented with the news that I had ACUTE RESPIRATORY FAILURE, PNEUMONIA, HYPOXIA, PLEURAL EFFUSION & ACUTE SYSTOLIC CONGESTIVE HEART FAILURE...
Patient was suppose to receive Meningococcal B (Trumenba), instead received Meningococcal A, C, Y and W-135 (Menactra). No adverse effect noted. Attempting to reach patient to give Trumenba in addition to the Menactra.
Patient had received her second moderna dose. Patient began to cough and her husband stated a few minutes later that she was having an adverse reaction. I called for the emts to assist. When I asked if she was feeling ok she  said no in a very raspy voice and said she was having issues catching her breath. The patient took her own inhaler and was able to breathe easier within a few minutes. vitals were obtained by EMS. A few minutes later the patient started to have the shortness of air again and was unable to talk. EMS called 911 at that time. By the time the ALS services arrived the patient was able to breathe again and could talk. Patient refused transport. Patient was educated on the importance of seeking treatment if symptoms continued.
had mild symptoms after shot, redness, sore, swelling, heat by Sunday all was better.  Redness never went away. 7 days later 1/24/21, itching occured followed by redness which spread length wise, swelling and heat which lasted until  yesterday 2/1/21.  There is a dark circle on my arm  left from the shot.  I will be receiving my second shot on 2/12, in which I will bring to MA's attention
Swelling and cellulitis left thigh, fever, received DTaP and influenza vaccines in left thigh, went to emergency room 10/9/11, was admitted and treated with IV clindamycin. No organism identified but elevated CRP and considered likely an infection. Pt. being discharged to home from the hospital 10/12/11 with a 10-day course of oral clindamycin.
A bit of body aches  and fatigue after the shot. Intense chest pain, shortness of breath, stomach burning, and neurological symptoms started end of January. To this day I am discovering new neurological symptoms (mostly numb and prickling sensations all over my body) as well as new daily headaches and chest pain that comes and goes.
A female adult reported that she received '98-'99 formula influenza virus and Pneumovax 23 vaccines in 1998 and subsequently, developed a rash on her lower extremities. She was treated with diphenhydramine. She recovered.
PATIENT CAME IN FOR 2ND COVID-19 VACCINE INJECTION ON MONDAY, (3/29/2021) AND STATED THAT SHE EXPERIENCED A DULL HEADACHE, NAUSEA AND VOMITING WHICH BEGAN ABOUT 4 HOURS AFTER INJECTION.  ON WEDNESDAY, 03/31/2021, SHE WENT TO THE EMERGENCY ROOM WHERE SHE RECEIVED IV FLUIDS, NAUSEA MEDICATION AND TORADOL INJECTION.  HEADACHE WENT AWAY FOR A FEW HOURS.  WENT HOME WITH MIGRAINE AND NAUSEA MEDS.  ALTERNATED TYLENOL AND NAPROXEN FOR HEADACHE, AND ALSO ICE PACKS.  COVID TEST ON ER VISIT WAS NEGATIVE.  HEADACHE CONTINUED.  STATED THAT 04/26/2021 WAS THE FIRST DAY SHE FELT OK SINCE SHOT.
Resp. distress, RAD exacerbation secondary to vaccines. Albuterol via neb with O2.  Ipratropium via neb with O2. ORAPRED 30 mg x 1. Admitted to hospital. 11/18/09:  Hospital records received for dates of service 11/2/09 to 11/4/09. Final Dx:  Viral pneumonia in the RML, Asthma exacerbation, respiratory distress with hypoxia, perineal and perianal puritus, constipation.   Assessment:  Presented with a 2-day hx. of rhinorrhea, sneezing, wheezing, increased work of breathing, difficulty speaking in full sentences, productive cough.  O2 sats. in peds. office in low 90's, tachypnea and decreased oral intake. Orapred initiated.  IV fluids given for dehydration.  On day of D/C was in good condition, D/C to home.
Nasal congestion, coryza, lethargy, T 101-max 104.7. Tx sx with Tylenol.
This spontaneous report was received via a company representative from a female patient of unknown age, who is a nurse; referring to herself. The patient's medical history included herpes zoster 20 years ago, approximately in 1997; and gastric bypass.  The patient was not pregnant. The patient's concurrent conditions and drug reactions/allergies were not reported. Concomitant therapies included unspecified antibiotics. Approximately in 2012 (reported as 4 or 5 years ago), the patient was vaccinated with ZOSTAVAX 0.65 ml (route, frequency, lot # and expiration date were not reported) to prevent shingles. Near the end of 2016, the patient broke out with shingles (herpes zoster). None laboratory diagnostic studies were performed. The patient did not seek medical attention and it was unknown if she received any treatment. On an unknown date, the patient recovered from the shingles. The causality between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Rash covering left abdomen from belt line to chest; Minor nausea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 16Apr2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic fatigue, chronic pain, clinical depression, memory loss. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously took sumatriptan (IMITREX) from an unknown date for an unspecified indication and experienced drug allergy. On 17Apr2021, the patient experienced rash covering left abdomen from belt line to chest, minor nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events rash covering left abdomen from belt line to chest, minor nausea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
numbness & tingling, left arm, for 2 weeks following injection all-over itching (torso, arms, legs) with intermittent superficial rash (not hives) still happening 18 days after injection
This case was reported by a healthcare professional via sales representative and described the occurrence of decreased therapeutic response in a 53-year-old female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown) and experienced decreased therapeutic response. This healthcare professional reported two employees may have completed Hep B series years ago but are not sure. Titers were drawn within the last year and were found to be low. This is one of two employees. For the second employee case see A0892914A. Follow-up information received via the reporter on 10 December 2010 indicated that there was little to no information on this report. Remark was made that the subject was not even sure that she was immunized. No additional information is available.
extreme pain lower back, sciatic, right leg with 48 hours after injection, continues today extreme pain in base of toes on both feet, continues today stiffness and pain in neck, continues today I also experienced most of the same symptoms I had in November when I had Covid: severe aching throughout body, low grade fever, on fourth day after injection, extreme fatigue (couldn't keep my eyes open but couldn't sleep either.  These symptoms regressed in about a week.
Around 8:00 pm on Tuesday April 13, 2021 I started to get a really bad headache that was like sharp stabbing pains that would come and go. The next morning I woke up with sharp stabbing pains in the left side of my head and numbness/tingling in the left side of my face. As the day went on I started to feel worse  so I went to the emergency room. The doctor there checked me out and stated that I had Bell's Palsy and prescribed me three different medications.  I am currently on these medicines trying to get better.
Pt recvd MMR/HIB & approx 2 hrs later was very tired & just wanted to be held, later fever, sz, jerky movements, & eyes rolled back just 1 min or so;
Swelling, tenderness, redness. Some nausea is also attributed to the shot and occurs with the swelling.
Polyarthritis with joint effusions and no inflammatory changes, primarily ankles/knees, also wrists/elbows/fingers Treated with NSAIDs and Medrol Dosepak
I had a very rapid heartbeat. I couldn't get it to come down and ended up in the Emergency Room. I was diagnosed with AFIB and was prescribed Flecainide and Xarelto. I have a Cardiologist appointment tomorrow and this is still ongoing.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling around the injection site), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE PAIN (painful around the injection site) and VACCINATION SITE PRURITUS (itches around the injection 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 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling around the injection site), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE PAIN (painful around the injection site) and VACCINATION SITE PRURITUS (itches around the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling around the injection site), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE PAIN (painful around the injection site) and VACCINATION SITE PRURITUS (itches around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. NO treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. No medical history information was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. NO treatment information was provided.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced body ache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache. This report was non-serious.
fever, chills, fatigue, headaches, redness, swelling, and pain at the injection site
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after 30-day use by date or after manufacture date of expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. Concurrent medical conditions included Clot blood (Clotting). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Clot blood. On 06-Apr-2022 at 11:05 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022 at 11:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after 30-day use by date or after manufacture date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after 30-day use by date or after manufacture date of expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had no known drug allergy. It was reported that the patient did not have any acute illness at the time of vaccination and up to one month before. The patient had never been diagnosed with/ tested positive for COVID-19. The patient had no chronic or long-standing health conditions. It was reported that, 28 doses were administered after 30-day use by date or after manufacture date of expiry. The expiry date for the vaccine was given as 18-Mar-2022. The date of vial initially stored in refrigerator was unknown and vials were transferred from another store. The vial did not undergo any temperature excursion. The patient reported no adverse events from the vaccine. No issues or complaint. No information on treatment medications was reported.
Pt. dizzy, sweating, felt lightfoot, 130/80, lungs clear.