chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date.).    Concomitant product use was not provided by the reporter. Patients administered Moderna vaccine monovalent beyond the 30 day beyond use date. Batch number 939902 (BUD - 02Sep2021). No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant Follow up Appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Nerve twitching began on left forehead  @ 10/9/19 and got worse, moved towards rear of left side of scalp over next few days.. Major outbreak began on evening of 10/11/19. Severe red rash, swelling, and discomfort. Went to walk-in clinic on 10/12/19 and got Shingles diagnosis. Dr prescribed Valacyclovir 1 gm (started taking Rx 10/12/19 late afternoon). Symptoms worsened 10/13/19 with more swelling and redness extending around entire left side of scalp. Blisters developing and seeping. Left eye swollen and closing. Went to Primary Care Dr on 10/14 ? confirmed Shingles. Went to Opthamologist; confirmed that Herpes was NOT in eyeball. Photos available if necessary.
This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, after vaccination, the patient developed a prolonged headache. At the time of the report, the outcome of the event was unknown. The causality between the event and the GARDASIL 9 was not reported. Additional information has been requested.
One wk after immunization pt was irritable, starring off, not eating. Going to bed at 12 midnight. nml bedtime 8-8:30. Poor coordination. Holding head when asked what's wrong, by mother seemed to have difficulty expressing self.
11 days after getting booster, my palms started itching. Itching got worse and red patches appeared every place I touched or scratched. Saw dermatologist on Nov. 11; prescribed 8 day course of prednisone; the prednisone did nothing to stop the itching or redness. Started taking Zyrtec 5mg 2x daily; itching stopped 1 hour after taking first tablet. Zyrtec seems to relieve itching but redness continues... blotches and streaks, randomly on abdomen, feet, hands. Second appointment with dermatologist about symptoms and she agrees probably allergic reaction to Moderna booster. I was diagnosed with dermatograhism. Advised to continue Zyrtec for 3 months and follow up at that time, unless symptoms get worse.
I went in for fatigue. The labs came back low in Potassium and Vitamin D. I was put on Drexel Vitamin D.
low-grade temperature: 99 degrees; Chills; General malaise; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient (not pregnant) received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (right arm) on 20Dec2020 15:15 at single for COVID-19 immunization. There was no medical history. No known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low-grade temperature: 99 degrees, chills, and general malaise on 21Dec2020 (13:00). There was no treatment received for the adverse events. The patient has been tested for COVID-19 post vaccination. COVID test post vaccination: Nasal Swab on 15Dec2020, Result: Negative. The outcome of events was recovered on an unspecified date in Dec2020. This case is non-serious.
One week post vax, pt experienced lower back pain radiating to his knees which comes and goes. Symptoms resolved in 1-2 weeks.
Intense itching and arm very red Prior to this from time of shot for 48 hours arm was very painful
Cellulitis left arm, treated with Bactrim DS 1 BID for 7 days.
rash started 2 days later (all over, red, itching);required visit to Er;injected w/Kenalog & given DPH;2nd ER visit made d/t itching
Pt was injected 6/17/12 noticed redness in area on 6/18/12 hurt when touched only does not bother her otherwise approximately 5 in long.
20 minutes after vaccinations patient fainted, hit his head, after lying down for 20 minutes, while sitting fainted again - when recover complaint of headache where he hit the floor (right occipital). Physical exam normal - Neurological exam normal. Decided to send him to E.R in ambulance for CT scan and further eval.
72 hours after receiving the vaccine experienced severe itching, burning and swelling in vagina ( possible lichen planus doctors are following) required Benadryl and Triamcinolone Acetone Ointment USP, .10%. All tests negative for UTI, vaginal infection. Symptoms lasted 12 days. Patient has never had these symptoms prior to vaccine.
This case was reported by a physician via call center representative and described the occurrence of fasciitis in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced fasciitis, muscle spasm and pain in arm. On an unknown date, the patient experienced numbness in fingers and injected limb mobility decreased. The patient was treated with ibuprofen, TORADOL, FLEXERIL, MEDROL DOSE PAK, DILAUDID and NORCO. On an unknown date, the outcome of the fasciitis and muscle spasm were unknown and the outcome of the pain in arm, numbness in fingers and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the fasciitis, muscle spasm, pain in arm, numbness in fingers and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient's husband reported this case. The patient received SHINGRIX in the left deltoid. The patient experienced severe pain at injection site, which was lasting more than week (8 to 9 days) and was getting worse. Pain was initially in the deltoid area where injection was given. In the evening of 26th July 2018 to the morning of 27th July 2018, pain got to the shoulder blade area, upper arm and forearm. There was a very severe pain and the healthcare professional called their physician on Saturday, 28th July 2018 and the physician advised to give muscle relaxer as the patient might had spasms. The physician gave her FLEXERIL 10 mg every 8 hours and Ibuprofen, pain was not improving so took patient to emergency room (ER) on Sunday, 29th July 2018. The physician in the ER indicated the patient might have mild fasciitis because injection might not have been given the belly of the muscle and might have entered that fascia. The ER physician continued FLEXERIL and added NORCO, in the ER patient received intravenous DILAUDID and TORADOL. Pain improved somewhat on scale of 10 was 4 to 5 and after discharge, there was no improvement in pain. On Monday, 30th July 2018, the physician put the patient on MEDROL DOSE PAK might be due to inflammation. Pain was not getting better and was getting worse in left capillary area. Less than a month after vaccination, the patient experienced could not lift shoulder up and numbness in fingers. The patient could not lift shoulder up, only a little bit. At the time of reporting the patient was saying, she was having numbness in fingers every so often not persistently. The physician stated he reported this to the pharmacist that administered the vaccine and the pharmacist might have reported this event to GlaxoSmithKline.
pt recv vax & felt very sick, & by the following day had a fever 104;devel arthralgias & was subsequently dx w/lupus erythematosis;
A lot of pain in the arm; Could not sleep; Woke up with bone pain; Woke up with shivers; Going to stand and gets tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A lot of pain in the arm), INSOMNIA (Could not sleep), BONE PAIN (Woke up with bone pain), CHILLS (Woke up with shivers) and FATIGUE (Going to stand and gets tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (A lot of pain in the arm), INSOMNIA (Could not sleep), BONE PAIN (Woke up with bone pain), CHILLS (Woke up with shivers) and FATIGUE (Going to stand and gets tired). At the time of the report, PAIN IN EXTREMITY (A lot of pain in the arm), INSOMNIA (Could not sleep), BONE PAIN (Woke up with bone pain), CHILLS (Woke up with shivers) and FATIGUE (Going to stand and gets tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Patient was administered bivalent vaccine which was beyond the 30 use by date; no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The beyond use date was reported as 08-Jan-2023 and all of the patients were 12 years and above but HCP did not have the information if some of them were below17 years old. No treatment details were reported. This case contains information for the 8th of 15th adult patients (4th of 4th patient, administered on 11-Jan-2023) described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:MASTER  CASE
the patient was given Moderna covid instead of Fluzone HD, pt already has taken 3 doses of Pfizer covid
Uncontrollable facial twitching around lips and eyes for approximately 45 minutes.  Inability to smile or move mouth easily.
slight numbness around jaw and down sides of neck, heart beat racing  ( it lasted about 10 minutes)
Patient was given wrong dosage of Covid vaccine. She was given 0.2 ml instead of the required dose for age which is 0.3ml. Patient was notified of incident. Patient will return to receive the correct dosage at later date.
Information has been received from a physician concerning a 4-year-old male with no pre-existing allergies, birth defects or medical conditions who on 02-JUN-2004 and 12-JUN-2007 was vaccinated with his first and second dose of varicella virus vaccine live (Oka/Merck). There were no illnesses at the time of vaccination. On 17-SEP-2007 the patient was diagnosed and treated for "less than or equal to 20 lesions appearing to be varicella". On 21-SEP-2007, 4 days later, the patient was seen in the office for an ear infection and was given antibiotics. At the time of the report the patient's status was unknown. Additional information has been requested.
No additional adverse event; ROTATEQ underwent a temperature excursion and was administered to patients; This spontaneous report was received from an administraror, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 19-AUG-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) orally, lot# T033634 and expiration date 16-MAR-2022, for prophylaxis (strength, dose, frequency were not reported).  The temperature excursion was of 32.4 Fahrenheit degrees (°F) for 1 hours 24 minutes. A previous temperature excursion was not reported. No adverse effects were reported.  This is one of two reports received from the same reporter. Sender's Comments: US-009507513-2108USA007723.
Narrative:  Patient reported throat stretching and feeling of flushing after receiving first dose of COVID-19 vaccine. Symptoms lasted approximately 5 minutes and resolved after observation in an exam room. Of note, pt did not eat prior to receiving the vaccine. Left for home after observation period.
One week after shot - headache, aches and chills, low grade fever. very tired, no energy, stuffy and runny nose, - this lasted three days Low grade headache and sinus like symptoms continued for over a week - I  called my on-line insurance and spoke with a nurse and a doctor.  I was told to just treat the symptoms  so I took  mucinex and tylenol and lots of water  Two weeks after the shot - the injection site became red, rashy and feverish - I used ice and took a benedryl - currently treating
On the day of of the vaccine, I experienced Nausea and a head ache.   The following 2 days I experienced body aches and fatigue.  On the third day after the vaccine I experienced chills, low grade fever (99.5), diarrhea, fatigue, body aches, sore throat,  and a cough.  On day 4, I still feel very tired, exhaust easily, minor body aches, sore throat, and a mild cough.
Hot flashes 3-4 times a day. Never had them before. Got this booster and 2 days later I?m having terrible hot flashes. Need to take off clothing, cold compresses, ice water. They last for 20 minutes.
Patient fainted briefly (2-3 seconds.) Vital signs taken. Low blood pressure. Assessed by onsite medical staff.
DIARRHEA, STOMACH PAINS, SLEEPY FEELING, HEADACHE, FEELING TIRED AND WEAK, CHILLS AND NOT HUNGRY.
Tenderness around injection site, fatigue, headache, muscle & joint pain, chills & fever, slight nausea  Side effects started manifesting 24 hours after injection and lasted for full 24 hours, finally diminishing and going away 48 hours after injection.
Fever, nausea, injection site edema, red, itching, inflammation size 13 3/4 mm x 12 mm right thigh
Pfizer on 4/13 and 5/4. Positive on 10/21
Employee received MMR vaccine. About 22 hrs later noticed swollen neck glands on right, sore throat, fever, headache. Missed two days of work. Is recovering.
Information has been received from a pharmacist concerning a female adolescent patient who was vaccinated several weeks ago with a dose of hepatitis A virus vaccine inactivated (lot # not reported). Subsequently, the patient experienced a bilirubin value of 3 and transaminase value in the 700 range. As of 7/30/04 the patient's symptoms had not improved. No further information was provided. Upon internal review, the patient's experiences were considered to be other important medical events (OMIC). Additional information has been requested.
She was sitting in the 15 minute observation area when she reported pain in the arm of the vaccine and felt diaphoretic and fainted falling off chair & onto floor.  She lost consciousness and both arms and legs trembling  appeared like seizure like in nature; Medix ambulance called and assessment BP 94/58 P 74 O2 sat 98% blood sugar 89 L shoulder with approx 4cm red area bruising noted from fall onto floor ; when sitting up pt c/o dizziness and lite headed layed back down and was Alert and Oriented X 3; Medix to transfer to local hospital when transferring pt to gurney she has having tremors in her arms and legs eyes closed and able to answer questions appropriately
need to sleep much more than normal; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSOMNIA (non-serious), outcome "unknown", described as "need to sleep much more than normal".  Additional information: Reported need to sleep much more than normal. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fevers 104.3, lasted about 12 hours, extreme pain left arm, nausea, diarrhea, severe HA, fatigue
This is a spontaneous report from a contactable consumer (patient). A 44-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0180), at the age of 44, via an unspecified route of administration, left arm, on Jun 22, 2021, at 11:30, single dose, for COVID-19 immunisation. The patient has no known allergies. Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 44, via an unspecified route of administration, left arm, on Jun 1, 2021, at 11:30, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Jun 23, 2021, patient felt tightness under armpit and sore all around arm as patient lifted. On Jun 24, 2021, patient developed a swollen lymph. No therapeutic measures taken as a result of the events. The outcome of tightness under armpit, sore all around arm and swollen lymph: not resolved (at the time of this report).
Approximately 30 lesions - mostly on back with a few on arms, legs, face.
Redness and swelling right arm, firm shoulder area down to mid -upper arms. Redness covered area of both bandaids applied after giving DTaP and IPV. Also states had rash under arms and in groin area. All resolved by 6/6/04 . Mother doesn't know if he had temp.
No adverse event; Monovalent dose administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient).    No concomitant medications were reported.  It was reported that, the patient received monovalent dose after the beyond use-by date.  No treatment medications were reported.
Sleep I wasn't able to sleep to the point that I wasn't sleeping normally because I was sleeping very little and then it got to the point that I wasn't sleeping for a full day and now it's up to 48 hours of not sleeping. I had one visual hallucination after this vaccine it was in the evening. Dr. visit on the 24th virtual visit. I did a sleep study Saturday night August 28 to 29th.
After every COVID vaccination, including booster, about one week later I'd enter a severe depression and have severe anxiety. I have had these feelings before and know well how to handle them and cope. But this was consistent with every dose despite my life circumstances. The intensity was severe, needing me to reach out to my doctors and for help from my family every time. Every time I had to take time off work. After the booster, the depression and anxiety became so severe that I had to check myself into the emergency room to not take my own life. I had a hard time getting help because of the anxiety. And the thoughts in my head were darker then anything I have ever experienced. This occurred 5-7 days after every vaccine. And each time I got another one, the symptoms would persist for longer. If I hadn't had a psychology degree and known to get help for those thoughts, it is very likely that I could have died.